[Senate Hearing 105-179]
[From the U.S. Government Publishing Office]
S. Hrg. 105-179
MAMMOGRAPHY
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARINGS
__________
FEBRUARY 5, 1997--WASHINGTON, DC
FEBRUARY 20, 1997--PHILADELPHIA, PA
FEBRUARY 24, 1997--PITTSBURGH, PA
MARCH 3, 1997--HERSHEY, PA
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
U.S. GOVERNMENT PRINTING OFFICE
44-044 cc WASHINGTON : 1998
_______________________________________________________________________
For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-056448-4
COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington DALE BUMPERS, Arkansas
MITCH McCONNELL, Kentucky FRANK R. LAUTENBERG, New Jersey
CONRAD BURNS, Montana TOM HARKIN, Iowa
RICHARD C. SHELBY, Alabama BARBARA A. MIKULSKI, Maryland
JUDD GREGG, New Hampshire HARRY REID, Nevada
ROBERT F. BENNETT, Utah HERB KOHL, Wisconsin
BEN NIGHTHORSE CAMPBELL, Colorado PATTY MURRAY, Washington
LARRY CRAIG, Idaho BYRON DORGAN, North Dakota
LAUCH FAIRCLOTH, North Carolina BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri DANIEL K. INOUYE, Hawaii
JUDD GREGG, New Hampshire DALE BUMPERS, Arkansas
LAUCH FAIRCLOTH, North Carolina HARRY REID, Nevada
LARRY CRAIG, Idaho HERB KOHL, Wisconsin
KAY BAILEY HUTCHISON, Texas PATTY MURRAY, Washington
TED STEVENS, Alaska ROBERT C. BYRD, West Virginia
(Ex officio) (Ex officio)
Majority Professional Staff
Craig A. Higgins and Bettilou Taylor
Minority Professional Staff
Marsha Simon
Administrative Support
Jim Sourwine
C O N T E N T S
----------
Wednesday, February 5, 1997
Page
Opening remarks of Senator Arlen Specter......................... 1
Opening remarks of Senator Kay Bailey Hutchison.................. 3
Statement of Richard D. Klausner, M.D., Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 5
Prepared statement........................................... 8
Statement of Susan J. Blumenthal, M.D., M.P.A., Deputy Assistant
Secretary for Health, Assistant Surgeon General, U.S. Public
Health Service, Department of Health and Human Services........ 10
Prepared statement........................................... 14
Opening remarks of Senator Tom Harkin............................ 19
Draft report of panel............................................ 20
Draft report..................................................... 21
Breast cancer diagnosis.......................................... 27
Different breast cancers......................................... 30
Outstanding work................................................. 33
Statement of Frances M. Visco, Esq., president, National Breast
Cancer Coalition, Philadelphia, PA............................. 35
Prepared statement........................................... 38
Statement of Susan Brawn, president and CEO, Susan G. Komen
Breast Cancer Foundation, Dallas, TX........................... 39
Prepared statement........................................... 41
Statement of Diana Rowden, chair, Susan G. Komen Breast Cancer
Foundation..................................................... 42
Prepared statement........................................... 43
Statement of Ann Marilyn Leitch, M.D., associate professor of
surgery, the University of Texas Southwestern Medical School,
Dallas, TX..................................................... 44
Prepared statement........................................... 46
Statement of Barbara Monsees, M.D., associate professor of
radiology, chief breast imaging section, Mallinckrodt Institute
of Radiology, Washington University School of Medicine, St.
Louis, MO...................................................... 48
Prepared statement........................................... 50
A breakpoint in incidence--age 40................................ 53
Statement of David G. Hoel, Ph.D., member, consensus development
panel, professor and chairman, department of biometry and
epidemiology, associate director, Hollings Cancer Center,
Medical University of South Carolina, Charleston, SC........... 66
Prepared statement........................................... 68
Risks or benefits................................................ 69
Prepared statement of Senator Larry E. Craig..................... 71
Prepared statement of Senator Olympia Snowe...................... 72
Letter from Jeanne Petrek, M.D., FACS............................ 73
Thursday, February 20, 1997
Opening remarks of Senator Specter............................... 75
Statement of Dina F. Caroline, M.D., Ph.D., chief, division of
gastrointestinal radiology and mammography, department of
diagnostic imaging, Temple University Hospital................. 77
Prepared statement........................................... 79
Statement of Bonita Falkner, M.D., acting director, Institute of
Women's Health, Allegheny University of the Health Sciences.... 81
Prepared statement........................................... 83
Statement of Stephen A. Feig, M.D., chief, division of
mammography and professor of radiology, division of breast
imaging, Thomas Jefferson University........................... 84
Prepared statement........................................... 86
Statement of Daniel C. Sullivan, M.D., associate professor of
radiology, University of Pennsylvania Medical Center........... 88
Prepared statement........................................... 90
Statement of Robert C. Young, M.D., president, Fox Chase Cancer
Center......................................................... 92
Prepared statement........................................... 94
Medical institutions............................................. 95
Opening remarks of Senator Specter............................... 104
Statement of Lu Ann Cahn, reporter, WCAU-TV, NBC-10.............. 105
Prepared statement........................................... 106
Medical determination by NIH..................................... 107
Statement of Barbara DeLuca, executive director, Linda Creed
Breast Cancer Foundation....................................... 109
Prepared statement........................................... 110
Statement of Barbara Mallory, M.S.N., R.N., nurse consultant,
Philadelphia Department of Public Health....................... 111
Prepared statement........................................... 113
Statement of Lawrence Robinson, M.D., M.P.H., Philadelphia
Department of Public Health.................................... 114
Prepared statement........................................... 115
Statement of Frances M. Visco, Esq., president, National Breast
Cancer Coalition............................................... 116
Prepared statement........................................... 117
Treatment component.............................................. 119
Monday, February 24, 1997
Opening statement of Senator Specter............................. 123
Statement of Thomas S. Chang, M.D., assistant professor of
radiology, University of Pittsburgh School of Medicine and
staff radiologist at Magee-Women's Hospital.................... 123
Prepared statement........................................... 127
Statement of Victor G. Vogel, M.D., M.H.S., professor of medicine
and epidemiology, director, Comprehensive Breast Cancer
Program, University of Pittsburgh Cancer Institute and Women's
Hospital....................................................... 129
Prepared statement........................................... 131
Statement of Howard A. Zaren, M.D., director, Mercy Breast
Center, Mercy Cancer Institute, the Mercy Hospital of
Pittsburgh..................................................... 132
Prepared statement........................................... 134
Statement of D. Lawrence Wickerham, M.D., associate chairman and
director of operations, National Surgical Adjuvant Breast and
Bowel Project and faculty member, department of human oncology
at the Allegheny University of the Health Sciences............. 135
Prepared statement........................................... 137
Opening remarks of Senator Specter............................... 148
Statement of Diane F. Clayton, breast cancer survivor............ 149
Prepared statement........................................... 150
NIH panel consensus.............................................. 151
Statement of Yvonne D. Durham, program coordinator, American
Cancer Society, Mammogram Voucher Program...................... 152
Prepared statement........................................... 153
Mammography...................................................... 154
Statement of Laurie S. Moser, executive director, the Susan G.
Komen Breast Cancer Foundation, Pittsburgh Race for the Cure... 155
Prepared statement........................................... 157
Statistics....................................................... 158
Statement of Judy Pottgen, volunteer, American Cancer Society.... 159
Prepared statement........................................... 161
Self-examination................................................. 161
Monday, March 3, 1997
Opening remarks of Senator Arlen Specter......................... 167
Statement of James F. Evans, M.D., director, surgical oncology
and assistant director, general surgery, Geisinger Clinic...... 168
Prepared statement........................................... 171
Statement of Mary A. Simmonds, M.D., chief, division of
hematology and medical oncology, Pinnacle Health Systems....... 173
Prepared statement........................................... 175
Statement of David M. Van Hook, M.D., assistant professor of
radiology, chief of mammography, the Milton S. Hershey Medical
Center, Pennsylvania State University.......................... 180
Prepared statement........................................... 181
Impact of mammography............................................ 182
Statement of Lois A. Anderson, cofacilitator and founder,
Surviving Breast Cancer Support Group and cocaptain,
Pennsylvania Breast Cancer Coalition, York, PA................. 187
Prepared statement........................................... 189
Statement of Lorene Knight, Pennsylvania Breast Cancer Coalition. 190
Prepared statement........................................... 192
Statement of Hon. Katie True, State representative, 37th
legislative district........................................... 193
Prepared statement........................................... 194
Motive of money.................................................. 195
MAMMOGRAPHY
----------
WEDNESDAY, FEBRUARY 5, 1997
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington DC.
The subcommittee met at 9:25 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Hutchison, and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
STATEMENT OF RICHARD D. KLAUSNER, M.D., DIRECTOR,
NATIONAL CANCER INSTITUTE
ACCOMPANIED BY WILLIAM R. HARLAN, ASSOCIATE DIRECTOR FOR DISEASE
PREVENTION
U.S. Public Health Service
STATEMENT OF SUSAN J. BLUMENTHAL, M.D., M.P.A., DEPUTY
ASSISTANT SECRETARY FOR HEALTH, ASSISTANT
SURGEON GENERAL
opening remarks of senator arlen specter
Senator Specter. Good morning. The hearing of the
Appropriations Subcommittee on Labor, Health and Human
Services, and Education will now proceed.
Our hearing today involves the issue of mammograms and on
January 23 a report was issued by the National Institutes of
Health Consensus Development Conference concerning breast
cancer and screening for women between the ages of 40 and 49,
with the essential conclusion being that there was insufficient
evidence to warrant mammograms for women between 40 and 49.
That report was greeted by considerable controversy, to put
it mildly. Dr. Daniel B. Kopans of the Harvard Medical School
said that the committee's report was fraudulent. Dr. Bernadine
Healey, former head of the National Institutes of Health said
that she was very disturbed or at least was quoted as saying
that she was very disturbed that a group of so-called experts
challenged the notion of early detection, saying, What they are
saying is that ignorance is bliss. Dr. Richard D. Klausner,
Director of the National Cancer Institute characterized his
response as being shocked at the finding.
It was greeted with some substantial concern in many
quarters, including the U.S. Senate, which heard a resolution
yesterday introduced by Senator Snowe, and many of us spoke on
the floor, including my distinguished colleague from Texas,
Senator Kay Bailey Hutchison. The resolution passed by a vote
of 98 to 0, expressing concern about those findings.
When I took a look at the conclusions as they were
reported, there was not enough evidence to conclude that women
in their forties would not benefit from mammograms as a part of
routine health screening, the converse question occurred to me,
which is this: is there sufficient evidence to conclude that
women in their forties would not benefit from mammograms as a
part of their routine health screening.
If you put the burden of proof on saying that the medical
evidence has to establish a benefit, as opposed to the evidence
being inconclusive or in equipoise, with a very substantial
body of evidence saying that the mammograms are very important,
then it seems to me that we are allowing the burden of proof
issue to dominate, with so much evidence, although perhaps
inconclusive or perhaps even in equipoise as to whether it is a
matter of benefit.
Ordinarily, we have these hearings to find the facts and to
decide what to do. I would say at the outset of this hearing
that I have a fixed opinion on this subject, that women in
their forties ought to be tested with mammograms. Just as a
personal aside, I had a situation where the doctors concluded
that I should not have an MRI and I insisted on an MRI and
finally got one. They found a life-threatening situation with a
meningioma. I have yet to understand why, in a context when
there is a noninvasive proceeding which can be accomplished,
that medical experts are reluctant to undertake that test.
I think that there is over-concern about the costs
affecting this ratio. The real issue is our health system
whether we have enough MRI's and mammogram machines and experts
to administer them to handle the people who could reasonably
benefit from them. I am convinced that we do.
You might have to give an MRI in the middle of the night
for $100 or for $75, instead of at 3 o'clock in the afternoon
when it is convenient to the patient at $800 or whatever the
cost may be. But with the experience that I have had, I am
convinced that we ought to err on the side of safety.
There is a real problem of the consequence, it seems to me,
of this study having been released, of discouraging many women
from having mammograms. People do not like to go and get tests
because they are afraid of what the tests may show. With this
tremendous splurge of publicity that women cannot benefit from
mammograms who don't need mammograms in the 40 to 50 age
category, I think it is going to discourage a lot of women from
going to get the mammograms.
Let me say just a word or two about the doctor-patient
relationship. This is about as fundamental a relationship as we
have in our society, and I think that sometimes we do not
really focus--or the doctors do not, and I think lawyers are
equally bad and judges are even worse--on the impact of their
statements on people.
When I had my test and somebody told me I had a few weeks
to live, it was a pretty important impact. When specialists say
women do not need mammograms it may be hard to get them back on
the mammogram trail.
I talked yesterday to Secretary of Health and Human
Services, Donna Shalala. I had hoped she would be at this
hearing today. She has just returned from overseas and she has
other commitments. It may be preferable, as she said to me last
night, to hear from the scientists before hearing from the
policy experts.
It is my recommendation, thought, and hope that Medicare
and Medicaid will cover mammograms for women in their forties.
If that is done, that will be the strongest national signal
about the conclusion of the public policy in the United States
on this subject.
We all know that if this test comes out and is accepted as
not being indicated for women in their forties, the insurance
companies will not pay for it and managed care will not pay for
it. Then people will not have them available.
So I think this is an area which needs to be corrected.
Let me welcome my distinguished colleague, Senator Kay
Bailey Hutchison. While not a member of this subcommittee, she
is always welcome.
Senator Hutchison, do you care to make an opening
statement?
opening remarks of senator kay bailey hutchison
Senator Hutchison. Thank you, Mr. Chairman. Since I am new
to the Appropriations Committee, this is my first hearing, and
I am a new member of the subcommittee.
Senator Specter. May I recant? You are, indeed, a member of
the committee. You just joined and you are also a member of
this subcommittee. And you are, therefore, doubly welcome.
Senator Hutchison. I thank you. It is not your fault
because we have not had a meeting yet and I am the most
freshman member of the Appropriations Committee.
I am very pleased to have this opportunity and I want to
thank you, Senator Specter, for having this hearing. When I saw
what the advisory committee for the National Cancer Institute
and other organizations did a couple of weeks ago, I was
appalled, and I know every woman member of the Senate is
equally appalled.
I guess 3 years ago, when we had testimony before a hearing
called by Senator Mikulski, we registered that we were
absolutely sick about the health care plan that was before us
not requiring mammograms and having mammograms covered before
the age of 50. So this is like a festering sore, frankly.
I think it is time that we speak frankly. I hope we can
speak with one voice with the facts.
I think, to just recapture a little of the history, up
until 1993, the National Cancer Institute did recommend
mammograms for women before 50, ages 40 to 49, every 2 years,
and then after 50 every year. Then a study came out in Canada
that said, I think, that it was not shown to be effective. They
then rescinded the guidelines.
Since then, I think other studies have come forward. In
1995, investigators found a 24-percent lower-death rate among
women who received mammograms in their forties. In 1996,
Swedish researchers in two studies found a 44-percent and a 36-
percent lower-death rate among women who received mammograms in
their forties.
Right now we have a mixed message. Breast cancer is the
leading killer of women in our country. Of the 43,900 women
estimated to die from breast cancer this year, 10,000 will have
breast cancer between the ages of 40 and 49--10,000 women in
this country.
Now I hope that whatever you do, you will help us send a
crystal-clear message with the facts. Maybe the facts are not
100 percent. But we know that more women will be saved if they
start having screening for breast cancer before the age of 50.
Most States require coverage by insurance companies for
mammograms starting at the age of 35. If there are risks
involved with this, say so. We do it in every medicine that I
take. We do it in every other procedure that I can think of. I
mean, a doctor will say: Senator Specter, we do not recommend
an MRI on this, but there may be a 15-percent chance that you
need one. So he knows the facts and he takes his chances.
Or a doctor will say to a women: you are 45, we don't think
it is necessary for you to have this procedure, but these are
the statistics. It shows an overwhelming improvement in your
chances if you do. There is a 1 percent chance--or whatever it
is--that you might have a better chance not to get breast
cancer from having the mammography. Why not just put the facts
out there with a clear message: here is what the statistics
show and here is what the risks are.
I think what happened with the advisory committee is the
worst of all worlds. What I worry about the most is that now
that we have this mixed message from the experts, insurance
companies are now going to start saying if we do not have clear
scientific evidence from the experts that this needs to be
done, then it is no longer in the required category and we
should move it to optional with the insurance companies.
These are questions that should not be raised with a mixed
message.
So I am going to ask those of you who are testifying today
to help us get a clear message. Tell us what the risks are.
Tell us what the advantages are. There is no question that the
advantages outweigh the risks.
I cannot understand why this is treated so much more
deferentially than any other disease or any other medical
treatment where they tell you what the risks are and what the
rewards are. And yet, now we have all of these doctors getting
together on a panel and saying well, we are just not going to
make a decision.
It is not acceptable. I hope that because Senator Specter
has held this hearing that you will clarify what you think we
ought to do, and I hope you will work with us in a positive way
to have a clear message to the women of this country that the
disease that is killing more of us than any other disease does
have a remedy. Maybe there are a few risks, but we know we can
save 9,500 lives this year if we will stick to the advice that
you have given us in the past. Give us the facts. We can take
the facts.
Thank you, Mr. Chairman. I look forward to hearing from the
experts.
Senator Specter. Thank you. Thank you very much, Senator
Hutchison.
The statistics on the funding provided by the Congress on
breast cancer I think are worth a moment or two.
The starting figure from fiscal year 1981 was $33.9
million, and that has escalated to $419.6 million this year.
I have been a member of this subcommittee since I came to
this Senate in 1981. Notwithstanding cuts in many other
branches, the funding on NIH and on breast cancer has gone up
exponentially.
When Senator Weichert was chairman here, he was a leader.
When Senator Chiles was here, he was a leader. Senator Harkin
as chairman was a leader, and we have carried that forward.
I know that Senator Harkin wanted to be here and I think
will be here. There is a commitment to try to increase the NIH
funding very materially.
I said on the Senate floor last week 7.5 percent, trying to
raise it to $952 million more over the $12.4 billion which NIH
has at the present time.
Last year in our subcommittee we eliminated some 130
programs, not that they were not good programs, but on a
priority scale they were of lesser importance than research,
which we think is at the top of the list, especially when you
consider that last year, 184,000 women were diagnosed with
breast cancer and the estimate is that some 44,000 women will
die this year from breast cancer, or 1 in 9.
We will turn now to you, Dr. Klausner. Richard Klausner has
been associated with the National Institutes of Health since
1979, when he began his research career at the Cancer
Institute. In 1995, Dr. Klausner became the 11th Director of
the NCI. He has an impressive list of credentials with training
at Yale, Harvard, and Duke. I don't know why they put Yale at
the head of the list, but they did, Dr. Klausner. [Laughter.]
His research has been recognized with numerous awards and
honors.
Dr. Klausner, we welcome you here and look forward to your
testimony.
We are going to put on a green light which will signify 5
minutes. To the extent that you can stay within that, we would
appreciate it, leaving the maximum amount of time, therefore,
for questions and dialog. We do have a very extensive list of
witnesses to follow our two very distinguished physicians here,
Dr. Klausner and Dr. Blumenthal.
Dr. Klausner, the floor is yours.
summary statement of dr. richard d. klausner
Dr. Klausner. Thank you very much, Senator Specter, Senator
Hutchison. I want to thank you for your interest in this
important issue.
Some 2 weeks ago, a conference was held at the NIH that
brought together experts from around the world in all aspects
of mammography, as well as an independent consensus panel in
order to address the confusing and often contentious issue, the
debate that surrounds the question of the age at which a woman
should begin regular screening mammography.
On behalf of the National Cancer Institute, I had asked for
this conference in response to reports of new data, primarily
from Sweden, that addressed the great gap in our knowledge
concerning the potential benefit of population screening of
women aged 40 to 49. And, as hoped, the conference successfully
stimulated the bringing together of new information and the
presentation of new and updated analysis.
From a scientific point of view, the value of any screening
test used in a healthy population depends upon the incidence of
the disease, the mortality associated with that incidence, as
well as the performance characteristics, the shortcomings and
risks, as you said, of the screening procedure.
A woman's risk of breast cancer does not suddenly change at
any particular age, but gradually and steadily rises. It is not
surprising, therefore, that the value of widespread screening
follows a similar pattern of increasing value at increasing
age.
There is and has been general agreement that there are
benefits from regular screening mammography between the ages of
50 and 69. While breast cancer does occur in young women in
their twenties and thirties, because of its low incidence in
this age group, screening for all women in their twenties and
thirties has not been considered warranted. So we are left with
the issue of the transition of women between the ages of 40 and
49.
As a woman enters her forties, she is moving from a time
where regular population screening has not been recommended to
one where it is proven to be beneficial.
One of the complexities of the question is when is the line
crossed. Is it at 40, 42, 44, or 50? Rather than concluding
that there is only one right answer to that question, the
consensus panel concluded that each woman should make an
informed decision in the decade of her forties that is the
right answer for her.
Despite some press accounts, I stated at the end of the
conference that I agreed with the sentiment of a woman needing
the information to make her own decision. But I also stated
that I had concern with the balance and tone of the discussion
in the panel's draft report. It is my opinion that the draft
report of the panel overly minimizes the benefits of
mammography and overly emphasizes the risks for that
population.
I believe that a balanced and careful statement of both the
pros and the cons of screening is essential for a woman to make
an informed decision whether to initiate regular mammography
and at what point.
Do we now have evidence that would support a woman's
decision if she decides to begin screening mammography in her
forties? The best data we have is from eight randomized
clinical trials involving over 180,000 women, including the
five most updated Swedish studies.
Few trials have enough instances of death from breast
cancer to achieve statistical significance in answering that
question. But analyzed all together by a procedure called meta-
analysis, there is now a 15-percent statistically significant
reduction in mortality for screening beginning in the forties.
The meta-analysis included the eight randomized clinical trials
that were conducted over 30 years in the United States, Sweden,
Canada, and Great Britain.
I would be happy to discuss further the interpretation in
the questioning period.
What does this mean to an individual woman? In general, a
woman in her forties has a 1 in 66 chance of being diagnosed
with breast cancer and a 1 in 190 chance of dying from breast
cancer that develops in that decade. A 15-percent reduction
would lower these odds of dying to about 1 in 220.
This year, as we heard, over 30,000 women in their forties
will be diagnosed with breast cancer and a 15-percent reduction
in mortality would mean over 1,600 lives saved.
Why would a woman choose not to have a mammogram? What are
the limitations and downsides of mammography?
The first relates to false positives and medical procedures
involved in the followup of these false positives. If women
were to receive yearly mammograms for 10 years, it is currently
estimated that as many as 30 percent will have an apparent
abnormality detected. And up to one-fourth of these will result
in a biopsy or an invasive procedure. Only one-forth of those
for women in their forties would prove to be cancer.
In other words, most abnormal mammograms do not signify
cancer. Beyond false positives, mammography may miss up to 25
percent of breast cancer in young women.
What about the risk of radiation? This is a theoretical
concern, but it is based largely on exposure to very high doses
of radiation and in much younger women. While the risks of
radiation should not be completely dismissed, there is no
direct evidence that exposure of women in their forties to the
levels of radiation used in mammography causes breast cancer or
poses any other health risk.
I would be happy to say where we should go from here, but I
see the red light is on. Would you like me to just sum up?
Senator Specter. Take a few more minutes, if you wish, Dr.
Klausner, to sum up.
Dr. Klausner. Thank you.
So, where do we go from here? The presidentially appointed
National Cancer Advisory Board, which is the oversight and
advisory board legally constituted to advise the National
Cancer Institute will and had planned to discuss the issues of
screening mammography and the results of the conference, the
results that included not just the consensus report but, very
importantly, the stimulation and presentation of lots of new
data on which we can all make decisions.
Based upon those discussions, the NCI will move forward in
terms of information and education positions and the research
we need to do to address this question for women at all ages.
We must provide information to every woman and her
physician or care giver to ensure that such information is
accurate, is current, is balanced, and is user friendly.
NCI long has had and will continue to have a vigorous
program in mammography research, including new approaches, such
as digital mammography and image analysis, and in nonionizing
approaches to cancer imaging, such as ultrasound, MRI, optical
scanning, microwaves, and others. Dr. Blumenthal will discuss
this.
The NCI will continue its long-standing commitment to
support research in new modalities of imaging as well as the
important area of molecular detection. We must strive to
enhance the value and reduce the limitations of current
mammography. The NCI, the CDC, and the Department of Defense
are supporting the breast cancer surveillance consortium, a
national mammographic screening and outcome data base which, by
the year 2000, will include over 1.8 million screened women,
3.4 million mammograms, and 34,000 cancers, which will provide
valuable data to improve the practice, the interpretation, the
delivery, and the followup for mammography, as well as an
invaluable research data base.
Mammography is not a cure for breast cancer. Better
screening methods will not ever replace the need to find real
preventions and curative therapies. Mammography has an
important place in our current approach to breast cancer, but
we do tend to overestimate its benefits. We must remember that
70 percent of breast cancer deaths in women over 50 will still
occur, even with regular mammography.
We must not lose sight of the fact that we have to be
relentless in our search for a cure.
Women deserve to be active and educated participants in
their own health care decisions, and we cannot produce
certainty where it does not yet exist. Physicians and
scientists must be active partners with consumers to use both
the best evidence as well as the best judgment to help each
woman to reach a decision that is right for her.
prepared statement
Based on current evidence, we must inform women that there
are pros to screening mammography as well as limitations for
initiating screening mammography in their forties. We must be
wholeheartedly committed to helping each woman weigh these pros
and cons, as you said, as a critical part of her health care.
Thank you, and I am happy to answer any questions.
Senator Specter. Thank you very much, Dr. Klausner.
[The statement follows:]
Prepared Statement of Dr. Richard Klausner
Good morning, Senator. I am Richard Klausner, Director of
the National Cancer Institute. I am here to talk about
mammography screening for women ages 40-49. I want to thank you
for your interest in this important issue. Two weeks ago, a
conference was held at the NIH that brought together experts in
all aspects of mammography and an independent consensus panel
to address the often confusing and sometimes contentious debate
that surrounds the question of the age at which a woman should
begin regular mammography. On behalf of the NCI, I had asked
for the conference in response to reports of new data,
primarily from Sweden, that addresses the great gap in our
knowledge concerning the potential benefit of population
screening of women age 40-49 and, as hoped, the conference
successfully stimulated the presentation and discussion of new
and updated data.
From a scientific point of view, the value of any screening
test used in a healthy population depends on the incidence of
the disease, the mortality associated with that incidence as
well as on the performance characteristics, shortcomings, and
risks of the screening procedure. A woman's risk of breast
cancer does not suddenly change at a particular age but
gradually and steadily rises. It is not surprising, therefore,
that the value of widespread screening follows a similar
pattern. There is general agreement that the population of
women between the ages of 50-69 benefits from regular
mammography While breast cancer does occur in very young women,
there is general agreement that, because of its low incidence
in this population, screening, for all women in their 20's or
30's is not warranted. So we are left with the issue of women
age 40 to 49. As a woman enters her forties, she is beginning
to move from a time when regular population screening is not
warranted to one where it is proven to be beneficial. The
question is where that line is crossed. Is it age 40? Age 42?
Age 46? Or Age 50?
Rather than concluding that there is only one right angrier
to the question, the Panel concluded that each women should
make an informed decision in the transition decade of her
forties that is the right answer for her. Despite some press
accounts, I stated at the end of the conference that I agreed
with this conclusion of the Panel. My concern was with the
balance and tone of the discussion in the Panel's draft report.
It is my opinion that the draft report of the Panel overly
minimizes the benefits and overly emphasizes the risks for this
population. A balanced statement of the pros and cons of
screening is essential for a woman to make an informed decision
whether to initiate regular mammography in her forties.
Do we now have evidence that would support a woman's
decision if she decides to begin screening mammography in her
forties? The best data we have is from 8 randomized clinical
trials involving, about 180,000 women, including the 5 Swedish
studies. Few trials have enough instances of death from breast
cancer to achieve statistical significance, but analyzed all
together, by a procedure called meta-analysis, there is about a
15-percent reduction in mortality. The meta-analysis included
eight randomized clinical trials that were conducted over the
past 30 years from the United States, Sweden, Canada and Great
Britain. I would be happy to discuss the interpretation of
these studies in the question period. What does this mean to an
individual woman? In general, a woman in her forties has a 1 in
66 chance of being diagnosed with breast cancer and about 1
chance in 190 of dying of breast cancer that develops in that
decade. A 15 percent reduction would lower these odds of dying
to about 1 in 220.
What does this mean? This year, over 30,000 women in their
forties will be diagnosed with breast cancer and a 15 percent
reduction in mortality would mean over 1,600 lives saved. This
year, about 27,000 women in their fifties will be diagnosed
with breast cancer and over 3,300 lives would be predicted to
be saved via mammographic screening in that age group.
Why would a woman choose not to have a mammogram? What are
the limitations and downsides of mammography? The first relates
to false positives and the medical procedures involved in
follow-up of the false positives. If women were to receive
yearly mammograms for 10 years, it is estimated that as many as
30 percent of all women will have an apparent abnormality
detected. An estimated one-fourth of these will result in
biopsies and, for women in their 40's, only about one-fourth of
these biopsies will prove to be cancer. In other words, most
abnormal mammograms do not signify cancer. Beyond false
positives, mammography may miss up to 25 percent of breast
cancer in young women, a percentage that falls to 10-15 percent
in older women (i.e., women over age 50).
What about the risks of radiation? This is a theoretical
concern, but it is based largely on exposure to very high doses
of radiation and in much younger women. While the risks of
radiation should not be completely dismissed, there is no
direct evidence that exposure of women in their 40's to the
levels of radiation used in mammography causes breast cancer or
poses any other health risk.
Where then do we go from here?
The National Cancer Advisory Board will discuss the issue
of screening mammography of women in their forties in order to
provide guidance to the NCI concerning how we move forward with
information, education and research. We must provide
information to every woman and her physician or caregiver and
to ensure that such information is accurate, current, and user-
friendly.
The NCI has long funded vigorous programs in digital
mammography, in image analysis, and in non-ionizing approaches
to cancer imaging such as ultrasound, MRI, optic scanning,
microwaves, and other technologies. Dr. Blumenthal will
describe some of these efforts in her opening statement.
The NCI will continue its long-standing commitment to
support research in new modalities of imaging and molecular
detection, and we must strive to enhance the value and reduce
the limitations and problems of current mammography. The NCI,
CDC and DOD are supporting the Breast Cancer Surveillance
Consortium, a national mammographic screening and outcome data
base which, by the year 2000, will include over 1.8 million
screened women and provide valuable data to improve the
practice, interpretation, delivery and follow-up of mammography
in this country.
Mammography is not a cure for breast cancer. Better
screening methods will not ever replace the need to find real
preventions and curative therapies. Mammography has an
important place in our current approach to breast cancer, but
we tend to overestimate its benefits. We must remember that 70
percent of breast cancer deaths in women over 50 will still
occur even with regular mammography. We must be relentless in
our search for a cure.
Women deserve to be active and educated participants in
their own health care decisions, and we cannot produce
certainty where it doesn't yet exist. Physicians and scientists
must be active partners with consumers to use both the best
evidence and the best judgment to help each woman reach a
decision that is right for her. Based on current evidence, we
must inform women about the pros and cons for initiating
screening in their forties. We must be wholeheartedly committed
to helping each woman weigh these pros and cons as a critical
part of her health care.
Thank you. I would be pleased to answer any questions.
summary statement of susan j. blumenthal, m.d.
Senator Specter. We are now going to hear from Dr. Susan
Blumenthal before turning to the first round of questions.
We welcome Dr. Blumenthal here. The President appointed her
as the country's first Deputy Assistant Secretary for Women's
Health, and she also serves in the position as Assistant
Surgeon General.
Dr. Blumenthal has received the highest honors of the
Public Health Service for her scientific and educational
contributions for the advancement of women's health. She
coordinates the implementation of the national action plan on
breast cancer and serves as its cochair.
Dr. Blumenthal has been a leader on imaging and took the
initiative with the Central Intelligence Agency to get a
special million dollar grant from CIA which was then
supplemented by an additional million dollars on the
proposition that if CIA could do imaging from outer space
through the clouds and find out what was going on on tiny
particles of ground thousands of miles away, that that imaging
process could be of special benefit for the detection of breast
cancer.
Almost 1 year ago, last March Dr. Blumenthal presided at a
session of the Hospital of the University of Pennsylvania on
the advantages of those new imaging techniques. At that time,
we found that there was a need for clinical trials.
The Congress has not passed the budget, which had been due
on September 30, 1995, in our continuing efficiency. So we were
able, when we passed the budget in April, the next month, to
get a special grant of $2 million for clinical trials. That
started last September. I think we set a record for getting
something done in the Federal Government bureaucracy.
Dr. Blumenthal has been in this field for a very long time.
We welcome you here this morning, Dr. Blumenthal and look
forward to your testimony.
Dr. Blumenthal. Thank you very much, Mr. Chairman and to
you, Senator Hutchison. I want to express our gratitude to you
both for your leadership in the battle against breast cancer.
I direct the United States Public Health Service's Office
on Women's Health. It is the focal point for the coordination
of research, service delivery, and education programs across
the agencies of the Department of Health and Human Services. We
work with other governmental agencies, with women's groups,
consumer groups, and health care professional organizations to
advance women's health in the United States and
internationally.
My remarks this morning are going to address current
departmental programs to improve breast cancer detection and
diagnosis to ensure that today's mammography is of the highest
quality and that women have access to this life-saving
technology. I then want to describe other initiatives underway,
some in partnership with other Federal organizations, to bring
the field of breast imaging into the 21st century, so that we
will have more accurate methods to detect and diagnose this
disease in all women.
I also want to provide you with a brief progress report on
departmental efforts in the fight against breast cancer.
Since currently there is no cure for breast cancer or
method to prevent it from occurring, the key to saving women's
lives is the early detection of the disease, when treatment is
the most effective and survival rates are best. That is where
today's x-ray mammography has proven crucial.
Mammography is a life-saving technology that can detect
breast cancer more than 1 to 2 years before a lump can be felt.
When it is detected at its earliest possible stage, 5 year
survival rates are 93 percent and 10 year survival is 76
percent. Early detection also means that breast sparing
surgery, lumpectomy, can be performed.
But did you know that until just 2 years ago, a woman could
go to a mammogram facility and not know if that machine was 20
years old, or if the person who positioned her or interpreted
the mammogram had adequate experience to do so?
The Food and Drug Administration's implementation of the
Mammography Quality Standards Act now ensures that women are
guided to the safest and most reliable mammography in their
communities. Today, it is illegal for a mammogram facility to
operate without that FDA seal of approval.
Recognizing the importance of the quality of screening
mammograms, the Agency for Health Care Policy and Research
developed clinical practice guidelines to define the roles and
responsibilities of mammography facilities, the health care
provider, and women themselves to ensure quality mammograms.
Additionally, the Centers for Disease Control and
Prevention Breast and Cervical Cancer Early Detection Program
is providing mammograms to women nationwide at low or no cost
to those who cannot afford them. To date, over 1 million low
income, minority, and underserved women have been screened for
breast or cervical cancer under this very important nationwide
program.
Since breast cancer is primarily a disease of older women
with 60 percent of cases occurring in women over the age of 65,
it is important that we educate this group of women about the
importance of mammography.
Recently, a screening benefit was added to Medicare, but
less than two-thirds of women were using this life-saving
benefit.
So 2 years ago, in direct response, the administration
launched an educational campaign to encourage the use of
mammography by Medicare eligible older women.
There are many barriers that keep women from using
mammography, such as cost, fear, concern about pain and
radiation exposure, and inadequate information about the value
of early detection. In an effort to break down these barriers,
the U.S. Department of Health and Human Services has undertaken
educational initiatives, often in partnership with public and
private sector organizations, to increase women's use of
screening mammography and to reach underserved and priority
populations. The NIH and CDC are supporting many important
programs in this area.
Further, the Department has made the latest information
about breast cancer available to the public and to health care
providers through Federal resources, such as the NCI's
information line--1-800-4-CANCER, the cancer fax, and on the
Internet. In October 1996, the U.S. Public Health Service's
Office on Women's Health launched an Internet web site for the
national action plan on breast cancer that is providing a
gateway to information resources on breast cancer for the
public and health care providers.
But despite these improvements in the quality and
utilization of mammography, it is still a 40-year-old
technology. It misses 15 to 20 percent of cancers; 80 percent
of the lesions that it finds are benign, which results in
unnecessary medical procedures, including surgical biopsies
that can leave scars and can be somewhat disfiguring to the
breast. That is why the Department has made it an urgent
priority to bring a new generation of breast cancer detection
technologies to the battle against this disease.
Today, studies are being supported that have the potential
for revolutionizing breast cancer detection and diagnosis. Let
me take a few minutes, if I might, to describe some of these
technologies to you.
Senator Specter. The red light is on, but take a little
extra time, Dr. Blumenthal.
Dr. Blumenthal. Thank you.
First is breast ultrasound. Unlike other innovative imaging
techniques that I will discuss, it already has an established
role in the diagnosis and management of breast disease. High
resolution ultrasound can determine whether many lesions are
benign cysts or solid lesions, and the features of solid masses
can be further analyzed with this technology to help
differentiate those that are most likely to be benign from
those with malignant characteristics.
Digital mammography is the most promising new technology
for improved detection of breast cancer for large-scale
screening programs. In sharp contrast to conventional
mammography, digital mammography actually generates images
directly on the computer where the image can be digitally
enhanced, improving image quality and allowing radiologists to
detect smaller lesions using lower radiation doses.
In addition, digital mammography opens new avenues for
improved detection, including computer assisted diagnosis,
where the computer actually serves as a second opinion,
enhancing radiologic interpretation and improving the ability
to distinguish benign from cancerous lesions. Also, digital
mammography will provide opportunities for telemammography,
where using telemedicine approaches breast images actually can
be transmitted by computers and satellites from community
clinics in remote areas to academic centers or other sites for
expert radiologic consultation.
Senator Specter. Dr. Blumenthal, I note that you are on
page 5 of an 11 page statement.
Dr. Blumenthal. Let me just highlight a few remaining
points.
Senator Specter. Your full statement will be made a part of
the record. I do not want to hurry you unduly, but it is a long
statement.
Dr. Blumenthal. Today, we are supporting an
interdisciplinary, multidisciplinary collaboration of academic
centers to facilitate the implementation of digital mammography
on a larger scale.
I also want to inform you that breast MRI has emerged as
one of the most promising novel technologies for the detection
and staging of breast cancer in women, particularly with radio
dense breast tissue.
Unlike either conventional or digital mammography, MRI does
not involve ionizing radiation.
Position emission tomography, the PET scan, is also an
important new strategy. It produces an image of the biochemical
and physiologic process in the body. This molecular imaging
technology, we believe, will help us to find tumors when there
are only a few cells present. PET scan can help detect primary
tumors, as well as the spread of breast cancer to the lymph
nodes and other regions of the body.
Finally, deeply concerned about the limitations of
conventional mammography, 2\1/2\ years ago the U.S. Public
Health Service's Office on Women's Health developed the new
frontiers in breast cancer imaging: from missiles to mammogram
project to help adapt advanced imaging technology from the
defense, intelligence, and space communities to help improve
the early detection of breast cancer.
After all, if we can see missiles 20,000 miles away in
distant skies and with the Hubble telescope see the surface of
Mars, then surely we should be able to detect small lesions in
women's breasts right here on Earth.
So we reached out to the CIA and DOD and have been working
with them over the past 2 years to transfer their imaging
technologies used for missile and target recognition to improve
the early detection of breast cancer.
We are now supporting a multisite clinical trial
coordinated by the University of Pennsylvania working with
other major academic centers, to explore the effectiveness of
these imaging technologies to enhance the accuracy of
mammography and MRI's.
Preliminary studies are showing that these technologies
significantly improve in the accuracy of mammography and MRI's.
Finally, breast biopsies are being improved with new
imaging technologies using the optics from the Hubble space
telescope. We are able to improve image-guided stereotactic
needle breast biopsy, which is a relatively noninvasive
procedure with only minimal scarring. We are also searching for
new technologies that will enable us to find biological markers
for breast cancer in the blood, the urine, or nipple aspirates.
To facilitate the transfer of these technologies, we have
established a Federal multiagency imaging consortium on women's
health with representatives from all relevant agencies of the
Federal Government to identify potential technology transfer
opportunities from these agencies to improve the detection of
breast cancer and other diseases in women.
These are just a few of the important initiatives underway
to improve the accuracy of the detection of breast cancer for
women of all ages. I do not have time to give you a report card
on other departmental initiatives, but I want you to know that
the administration has made the fight against breast cancer a
top national health priority. The Department has increased
funding and has a number of programs and activities underway.
prepared statement
In summary, Mr. Chairman, the initiatives and programs of
the Department of Health and Human Services are making
significant difference toward progress in the fight against
breast cancer. The Department's efforts to eradicate breast
cancer are being deployed on many fronts, increasing basic and
clinical research, improving early detection and diagnosis,
enhancing the range and effectiveness of treatments and
preventive interventions, and improving access to breast cancer
services.
We are grateful for your support, Mr. Chairman, and for
that of the committee. We pledge to continue to work together
until the war against breast cancer is won.
[The statement follows:]
Prepared Statement of Susan J. Blumenthal, M.D., M.P.A.
Mr. Chairman, members of the Subcommittee, thank you for the
opportunity to speak before you today and for your leadership in the
battle against breast cancer. I am Dr. Susan Blumenthal, Deputy
Assistant Secretary for Women's Health and Assistant Surgeon General in
the U.S. Department of Health and Human Services. I direct the U.S.
Public Health Service's Office on Women's Health, the focal point for
women's health issues in the Department that coordinates women's health
research, health care services, policy and public and health care
professional education across the Department, collaborating with other
government organizations, and consumer and health care professional
groups to advance women's health in the United States and
internationally.
My remarks will address current Departmental programs to improve
breast cancer detection and diagnosis to ensure that today's
mammography is of the highest quality and that women have increased
access to this lifesaving technology. I then will describe other
initiatives underway, some in partnership with other Federal agencies,
to bring the field of breast imaging into the 21st century--to develop
more accurate methods to detect and diagnose this disease in all women.
I also will provide you with a progress report on Departmental efforts
in the fight against breast cancer.
As you know, breast cancer is one of the most complex and
devastating public health problems in our country today. It is perhaps
the most dreaded and feared disease in women. It has become an epidemic
in our country: the number of women affected by this disease has
increased from 1 in 20 over a lifetime in the 1950s to 1 in 8 today.
And, while there has been good news in that the overall mortality rate
from breast cancer has dropped for the first time in recent history 5
percent among women nationwide the death rate continues to increase for
women of color, though at a far slower rate than ever before. It is
thought that this overall positive trend is related to the increased
use of screening mammography by women in this decade, coupled with
improvements in treatment.
Improving conventional mammography
Since currently there is no cure for breast cancer or method to
prevent it from occurring, the key to saving women's lives is the early
detection of the disease, when treatment is the most effective and
survival rates are best. That is where today's x-ray mammography has
proven crucial. Mammography is a life-saving technology that can detect
breast cancer more than 1 to 2 years before a lump can be felt. Experts
agree that it can decrease mortality rates by 30 percent in women over
the age of 50. And, when it is detected at its earliest stages, 5 year
survival rates are 93 percent and 10 year survival is 76 percent. Early
detection also means that breast sparing surgery lumpectomy can be
performed.
FDA implementation of the mammography quality standards act
Until just two years ago, a woman could go to a mammography
facility and not know if the machine was 20 years old or whether the
person who positioned her for the test or interpreted the x-ray had
adequate training. The Food and Drug Administration's implementation of
the Mammography Quality Standards Act now ensures that women are guided
to the safest and most reliable mammography in their communities.
Today, it is illegal for mammography facilities to operate without
certification by the FDA.
Mammography guidelines
Recognizing the importance of the quality of screening mammograms
in the early detection of breast cancer, the Agency for Health Care
Policy and Research (AHCPR) developed Clinical Practice Guidelines--
Quality Determinants of Mammography--with separate versions for
mammography providers, health care professionals, and consumers. The
guidelines define the areas of responsibility for each member of the
health care team delivering mammograms, including women themselves.
CDC breast and cervical cancer early detection program
Additionally, the Centers for Disease Control and Prevention's
Breast and Cervical Cancer Early Detection Program is providing
mammograms nationwide at low or no cost to women who cannot afford
them. To date, over 1 million low-income, minority and underserved
women have been screened for breast or cervical cancer under this
important nationwide initiative that includes all 50 states, 3
territories, the District of Columbia and 13 American Indian tribes.
Medicare initiative
Breast cancer is primarily a disease of older women, with 60
percent of cases occurring in women over the age of 65. However, nearly
two-thirds of older women don't use Medicare's mammography screening
benefit. In direct response, two years ago, the Administration launched
an educational campaign to encourage the use of mammography by
Medicare-eligible older women.
Public education
There are many barriers that keep women from using mammography,
such as cost, fear, concern about pain and radiation exposure, and
inadequate information about the value of early detection.
In an effort to help break down these barriers, the U.S. Department
of Health and Human Services has undertaken educational initiatives,
often in partnership with public and private sector organizations, to
increase women's use of screening mammography.
The National Cancer Institute (NCI), for example, supports three
important leadership initiatives the National Black Leadership
Initiative on Cancer, the National Hispanic Leadership Initiative on
Cancer, and the Appalachian Leadership Initiative on Cancer. The first
two initiatives address a broad range of cancer control issues. The
last program focuses specifically on improving breast and cervical
cancer outreach activities.
Moreover, the Centers for Disease Control and Prevention (CDC) has
developed educational collaborations at the national level with a broad
range of private sector, public sector, and consumer groups, supporting
programs of national organizations from the AARP to the YWCA of the
USA, and from the American Indian Healthcare Association to the
National Migrant Resource Program to educate their constituencies about
breast and cervical cancer, to increase access to screening programs,
and to develop methods to reach underserved and other priority
populations.
Further, the Department has made the latest information about
breast cancer available to the public and to health care providers free
through Federal resources, such as the NCI's information line, 1-800-4-
CANCER, by the cancer-fax, and on the Internet. And in November 1996,
the Office on Women's Health launched an Internet web-site for the
National Action Plan on Breast Cancer (NAPBC) that provides answers to
frequently asked questions about breast cancer and serves as a gateway
to information on research, organizations, advocacy groups, educational
conferences and meetings, publications and other resources about breast
cancer. The web-site is found at: http://www.napbc.org.
new frontiers in breast imaging
Despite these improvements and initiatives to improve the quality
and utilization of mammography, it is nonetheless a 40-year-old
technology. It misses 15 percent to 20 percent of cancers, and 80
percent of lesions found by the technology are benign, resulting in
unnecessary medical procedures, including surgical biopsies. This is
why the Department has made it a priority to bring a new generation of
breast cancer detection technologies to the battle against this
disease. A range of studies are now being supported from basic
instrumentation and technology development to preclinical and clinical
evaluation that have the potential for revolutionizing breast cancer
detection and diagnosis. Let me describe some of these new technologies
to you.
Ultrasound
Breast ultrasound, unlike other innovative imaging techniques that
I will discuss, already has an established role in the diagnosis and
management of breast disease. High-resolution breast ultrasound can
determine whether lesions found on clinical examination are benign
cysts or solid lesions. The features of solid masses can be further
analyzed with high-resolution ultrasound to help differentiate those
that are most likely to be benign from those with malignant
characteristics. The same technology can be used to guide procedures
such as aspiration of cysts and needle biopsies of suspicious solid
masses.
Digital mammography
Digital mammography is among the most promising new technologies
for improved detection of breast cancer for large scale screening
programs. In sharp contrast to conventional mammography, digital
mammography generates images directly on a computer where the image can
be digitally enhanced, improving image quality and allowing
radiologists to detect smaller lesions using lower radiation doses. In
addition, digital mammography opens up new avenues for improved
detection, including computer assisted diagnosis, where the computer
serves as a ``second opinion,'' enhancing radiologic interpretation and
improving the ability to distinguish benign from cancerous lesions and
telemammography where, using telemedicine, breast images can be
transmitted by computer and satellite from community clinics and remote
areas to academic centers or other sites for expert radiologic
consultation. As we enter the 21st century, telemammography will bring
state-of-the-art academic radiologic expertise to underserved
populations in our nation and internationally.
Today, an international multi-disciplinary collaboration of
academic centers, and industry, supported by the NCI, is facilitating
the development, validation and implementation of digital mammography.
Breast MRI
Magnetic resonance imaging (MRI) involves the creation of images
from signals generated by the excitation of nuclear particles in a
magnetic field. Breast MRI has emerged as one of the most promising
novel technologies for the detection and staging of breast cancer in
women, particularly for those with radiodense breast tissue for whom
traditional or digital x-ray mammography may not be as effective.
Unlike either conventional or digital mammography, MRI does not involve
ionizing radiation.
Research suggests that MRI is able to pinpoint suspicious lesions
camouflaged behind dense breast tissue that traditional x-ray based
mammograms have been unable to penetrate sufficiently to accurately
detect. Additionally, MRI appears to be unique in its ability to define
the size, shape and potential spread in the breast of the tumor,
critical for disease staging and treatment planning. Preliminary data
suggest that this technology can detect lesions as small as 1-3 mm and
that high resolution MRI can improve the differentiation of benign
lumps from cancerous ones.
Positron emission tomography (PET)
The ultimate goal of new breast imaging technologies is to detect
breast cancer at its earliest stages ideally when only a few cells are
present, and long before conventional mammography can detect a tumor.
That's where the field of molecular imaging comes in. Positron Emission
Tomography the PET scan is a nuclear medicine imaging technology that
produces an image of the biochemical and physiological processes in the
body. PET makes it possible to detect primary tumors as well as the
spread of breast cancer to the lymph nodes and other regions of the
body. It is also able to image estrogen receptors and chemotherapeutic
agents.
importance of federal agency collaborations
The missiles to mammograms project
Deeply concerned about the limitations in conventional mammography,
the U.S. Public Health Service's Office on Women's Health 2\1/2\ years
ago developed the ``New Frontiers in Breast Imaging: From Missiles to
Mammograms'' initiative to adapt advanced defense, space, and
intelligence imaging technologies from the DOD, CIA and NASA--
capabilities estimated to be about 10 years ahead of medical imaging--
to the early and more accurate detection of breast cancer.
Medical and intelligence imaging share some common challenges. Both
must scan and compare two or more large areas to detect and precisely
locate small subtle changes in topography the tank that has been
deployed onto a landscape and is camouflaged behind trees; the small
cancerous tumor growing deep in a woman's breast, camouflaged by dense
breast tissue. And, in both intelligence and medical applications, an
incorrect analysis a missed cancer or a missed military target can have
tragic consequences.
Using CIA-developed computer algorithms called neural networks
(modeled after human brain cells), a computer ``learns'' the features
of the terrain from surveillance photographs and can detect subtle
changes in visually matched photographs taken over time, identifying
the construction of new buildings or troop movements, for example, and
distinguishing them from the context or ``normal'' landscape. Applying
this CIA technology to the detection of breast cancer, a computer can
be ``trained'' to recognize the features of an individual woman's
breast including the regions of cancer deposits, such as
microcalcifications, that might not be found on digital mammography. In
this way, the computer acts as a ``second reader.'' Preliminary results
have found that the CIA's neural network technology improves the
accuracy of mammography. This new technology is now being tested in a
major multi-site clinical trial conducted by the University of
Pennsylvania in collaboration with several other academic and
industrial partners, supported by the U.S. Public Health Service's
Office on Women's Health.
Another component of this multi-site clinical trial is the
application of CIA technology used to simulate 3-dimensional missile
launches to improve MRI's diagnostic capabilities, creating 3-
dimensional pictures of the breast where the volume, shape and size of
a tumor can be visualized. This technology is providing a new method to
determine the extent and spread of cancerous growth, to improve the
accuracy of biopsies, and to monitor tumor response to treatment.
Breast biopsies
Imaging technology is also being used in performing biopsies.
Eighty percent of women in the United States who undergo surgical
breast biopsies do not have cancer. As an alternative to surgical
tissue removal, image-guided needle breast biopsy that uses the optics
from the Hubble telescope developed by NASA is being studied for women
with non-palpable lesions. Image-guided needle biopsy offers the
potential advantages of minimized tissue damage, reduced waiting time
until diagnosis, and cost savings. A multi-institutional research
program is now testing the efficacy and cost-effectiveness of large-
core and fine-needle biopsies compared with more extensive surgical
biopsies.
Other research is developing methods to detect products of breast
cancer (antigens) in blood, urine, or nipple aspirates, and to detect
genetic alterations in women who are at increased risk for breast
cancer. Once cancer is diagnosed, studies of these types contribute to
characterization of breast tumors and can be useful in treatment
planning.
Facilitating new technology transfer opportunities
To bring these and other promising new cutting-edge technologies to
reality in the diagnosis and treatment of breast cancer, the U.S.
Public Health Service's Office on Women's Health established the
Federal Multi-Agency Consortium on Imaging Technologies to Improve
Women's Health, with diverse membership across Federal agencies,
(including the Department of Health and Human Services, FDA, Department
of Defense, Central Intelligence Agency, Department of Energy and the
Department of Commerce) to foster the identification, evaluation, and
transfer of intelligence, space, energy, defense, and other relevant
technologies to advance the current state-of-the-art in the early
detection and diagnosis of diseases in women, including breast cancer.
dhhs breast cancer initiatives
These new initiatives to improve breast cancer detection and
diagnosis are a critical component of the Department of Health and
Human Service's all-out assault against breast cancer. Today, real
financial muscle has been put behind the Administration's commitment to
eradicating this major killer of American women.
HHS spending on breast cancer
HHS funding for breast cancer research, prevention and treatment
has increased from approximately $276 million in fiscal year 1993 to an
estimated $541 million in fiscal year 1997. The Centers for Disease
Control and Prevention (CDC) are working to increase access for all
women to mammography screening and follow-up services, with resources
devoted to breast cancer services having increased from $42 million in
fiscal year 1993, to $81 million in fiscal year 1997. Cancer research
is vital to our understanding of how to prevent, detect and treat
breast cancer. The Clinton Administration has intensified research
efforts on breast cancer at the National Institutes of Health by
increasing funding from $229 million in fiscal year 1993, to $430
million in fiscal year 1997. FDA will spend about $26 million in fiscal
year 1997 to implement the Mammography Quality Standards Act. HHS also
helps provide treatment for breast cancer patients through the Medicare
and Medicaid programs and through the Indian Health Service.
Federal Breast Cancer Coordinating Committee
Additionally, for the first time, all agencies of government have
been mobilized to join in the battle against this disease through the
establishment and work of a Federal Interagency Coordinating Committee
on Breast Cancer that is fostering new collaborations in the fight
against this illness. A Federal inventory of breast cancer-related
initiatives has been prepared that will soon be available on the world-
wide web homesite of the National Action Plan on Breast Cancer.
National action plan on breast cancer
In October 1993, the National Breast Cancer Coalition presented
President Clinton a petition with 2.6 million signatures urging that
there be a new national strategy to fight this disease. DHHS Secretary
Donna Shalala convened a conference two months later, in December 1993,
followed by the establishment of the National Action Plan on Breast
Cancer, an innovative public-private partnership that is catalyzing new
action in research, health care service delivery, and education about
the disease. The implementation of the Plan is coordinated by the
Office on Women's Health.
The Plan involves public/private working groups on a number of high
priority action areas, including: (1) increasing research on the causes
of breast cancer, particularly the role played by environmental
factors; (2) increasing participation of women in clinical trials; (3)
developing national biological resource banks; (4) establishing a
comprehensive plan for counseling and educating women about the newly-
identified breast cancer genes; (5) using new information technologies
to improve breast cancer education for consumers and health care
providers; and (6) involving consumers in policy and research
decisions. Many new cross-cutting initiatives have been implemented in
each of these areas.
Breast cancer among the elderly
The Agency for Health Care Policy and Research (AHCPR) is currently
funding a five-year Patient Outcomes Research Team study on the care,
costs, and outcomes of early stage breast cancer. The study will
examine three alternative treatments for early stage breast cancer in
the elderly: modified radical mastectomy, breast-conserving surgery
with radiotherapy, and breast-conserving surgery without radiotherapy.
The project will look at quality and cost-effectiveness in these
projects and will develop clear recommendations for treating early
stage breast cancer in the elderly.
Office of Cancer Survivorship
Progress is being made in the battle against cancer. Today, we have
an entire generation of Americans who can call themselves cancer
survivors. On October 27, 1996, President Clinton unveiled the new
Office of Cancer Survivorship at the National Cancer Institute. Recent
success of cancer prevention, early detection, and treatment efforts
has created a new need: research into the physical, psychological, and
economic well-being of the growing number of cancer survivors. The
Office of Cancer Survivorship will support studies covering the range
of issues facing survivors of cancer, including: long term medical and
psychological effects; factors that predispose survivors to second
malignancies; reproductive problems following cancer treatment; and
their unique insurance and employment issues.
Closing
These initiatives and programs reflect the progress that is being
made in the fight against breast cancer. Both the Administration and
the Congress have made it a top national health priority. The
Department's efforts to eradicate this disease are deployed on many
fronts: increasing basic and clinical research, improving early
detection and diagnosis, and enhancing the range and effectiveness of
treatments and preventive interventions and improving access to breast
cancer services. We are grateful for the Committee's support and pledge
to continue our work together until this war is won. I would be pleased
to answer any questions you may have.
opening remarks of senator tom harkin
Senator Specter. Thank you very much, Dr. Blumenthal.
I would now like to turn to our distinguished ranking
member, Senator Harkin, who had been chairman. I have already
acknowledged his outstanding work when talking about him behind
his back, before he arrived.
Senator Harkin. And I appreciate that. You can talk behind
my back anytime you want if you say those things.
Senator Specter. The beard looks good.
Senator Harkin and I took the lead many years ago on the
separate unit at the NIH for women, and he has been a fighter
on these issues for many, many years.
You don't have an opening statement, do you?
Senator Harkin. I will just put it in the record.
Senator Specter. No; go ahead and make an opening
statement.
Senator Harkin. OK. I apologize for being late. We always
have too many things to do around here in the morning. I really
apologize because this is an area of very deep concern to me,
one that, as you know, Mr. Chairman, I have worked on for years
with you, in concert with you.
I want to thank the witnesses who are here, Dr. Blumenthal,
for your work in this area, and Dr. Klausner at NCI for all of
the fine work that you do out there. I have to leave here
shortly to make a presentation on a budget matter before the
Rules Committee.
I want to thank Fran Visco, too. I may miss your testimony.
I am going to try to get back here if I can to thank you for
your leadership. I have read your testimony and I hope and know
that we will all take it to heart.
I think what we have here is an area where reasonable
people may have different views on how we approach this. The
findings of the NCI panel in some ways are disturbing to me.
But in other ways I understand that women have to make their
own decisions on these things. Regarding their health,
regarding their background, and with the new areas of genetic
testing now where we are able to find genetic markers for
breast cancer, women will have to decide this for themselves.
I think our role is to make sure that if this is the path a
woman decides to go, regardless of her age, the health care
support ought to be there for them to have the proper screening
and the proper support mechanisms--if that is the path she
decides to go down.
I think that is really what we ought to be about doing,
providing throughout this country the information that women
need on which to make this decision.
I feel very passionately about this. My only two sisters
died of breast cancer at a very early age. Fran and I have
talked about that a lot. I often think, had they had the
information and the support mechanisms, how different things
would have been. They did not come from money. These were
relatively poor families. But if they had had the information
and the support mechanism there by which they could have gotten
the information, and then gotten the mammogram screening, and
then taken action, I think they would have survived. I feel
very confident of that.
So that is the way I approach this issue. I just hope that
this NCI panel finding, Dr. Klausner, is not sending some
erroneous signal out there that if you are below the age of 50,
you do not have to worry. I'll tell you that if you are below
50 and you have genetic markers, you have a family history of
the disease, you have to worry. You have to be concerned.
That is what worries me about this panel's finding. It's
not what it says but is the echo of what it says that goes out
and ripples through society.
I thank you for your leadership in this area. Again, I hope
that I can get back here after a bit. I hope that we can,
again, begin really focusing on getting out the information
women need to make an informed decision, putting the support
mechanisms in place, to make sure that no matter how poor any
person is they have the knowledge and they know that if they
want that mammogram screening, they are going to get it and it
is not going to bust them financially to get it; and if they
have problems and need followup, that that insurance coverage
is going to be there, too, whether it is for Medicare,
Medicaid, or private insurance. It has to be there.
Thank you very much.
draft report of panel
Senator Specter. We will now proceed with 5-minute rounds
of questioning from members of the subcommittee panel.
Dr. Klausner, in your statement you say, ``It is my opinion
that the draft report of the panel overly minimizes the
benefits and overly emphasizes the risks for this population.''
Aren't you flatly saying they are wrong?
Dr. Klausner. I'm saying that the balance of the data and
the evidence that they presented, the tone of the report, in my
opinion was not reflective of the balance of evidence we now
have, largely because I thought it minimized the evidence that
there is benefit and it over-emphasized certain risks, such as
radiation risk, which, as I said, I think is quite a
theoretical one.
Senator Specter. Isn't that an elongated way of saying,
again, that they are wrong?
Dr. Klausner. No; I do think that there is a difference
between sort of evidence in the verdict you reach and the way
you present it. We look at multiple pieces of evidence and we
weigh them in order then to reach a conclusion. I felt that the
conclusion was very defensible, that women need to be informed
to make a decision. But in order to be informed to make an
informed and educated decision, we have to be very clear and
not about whether there are pros--and I believe there are--but
what are the limitations. And there are limitations. Or else we
cannot expect women with the support of their physicians, with
the support of NCI, to be able to make that sort of informed
decision.
Senator Specter. Dr. Klausner, either I hear you saying for
a third time that they are wrong or I hear you saying something
candidly which is unintelligible.
The women in America in the age category of 40 to 49 need
to know in unequivocal terms whether a mammogram would be
helpful to them in detecting breast cancer. Yes or no?
Dr. Klausner. And as I said, I hope--I have been trying to
be very clear--that the evidence is, as far as I can read, that
there is a statistically significant benefit in terms of
reduction of mortality over long periods of time from
initiating screening at some time in your forties. I think I
have been very clear with that.
As I said, I disagree with that aspect of the report of the
panel.
Senator Specter. I take that as a yes.
Dr. Klausner, as a threshold question, how close are we to
a cure for breast cancer? The financing has been very
extensive. We are prepared to do what it takes. Congressman
Porter, who chairs the subcommittee on the House side, Senator
Harkin and I, and our predecessors, have been willing to put in
whatever money it takes if there is some realistic promise of
curing breast cancer.
You are the scientist. What is your evaluation of that?
Dr. Klausner. My evaluation is that I cannot say how close
we are to a cure for breast cancer or, indeed, whether there
ever will be one, single cure.
Breast cancer is probably multiple different diseases. That
has been one of the problems, not being able to distinguish one
from the other and treating them all the same.
Breast cancers, individual breast cancers, can be cured and
have been cured, and I think we will continue through the types
of discovery we are doing to learn what we need to find truly
effective treatments for breast cancer.
Senator Specter. Is the current funding for breast cancer
adequate?
Dr. Klausner. I think there are many opportunities, really
good opportunities, that we cannot fund with the current level
of funding.
Senator Specter. What level of funding would be adequate?
Dr. Klausner. I don't know the exact number to give you for
that.
Senator Specter. Well, we would be interested in your
number.
Dr. Klausner. Sure.
[The information follows:]
NCI Bypass Budget
The NCI Bypass Budget identifies several extraordinary
investment opportunities that will advance our knowledge of
cancer in general, and will greatly enhance our ability to
prevent, diagnose, and treat breast cancer in particular. These
investment opportunities include research in cancer genetics,
the development of better detection and imaging technologies,
new preclinical research models, and increased funding for
investigator-initiated research. The increase needed to fund
these investments is $269.5 million.
draft report
Senator Specter. Dr. Klausner, the report issued by the
consensus panel was denominated: draft-draft-draft.
Dr. Klausner. Yes.
Senator Specter. A question in my mind--and I know that you
are going to convene the National Cancer Advisory Board on
February 25 and 26--is why issue a draft report which has so
many open questions.
I think it may be worth just 1 minute because a lot of
people will focus on this dialog as to the import of what
doctors say as they reach their patients' ears, or they reach
the ears of people who are concerned about the particular
problem.
I referred in a very personal way to my own experience of
somebody looking at my MRI with a snap of the finger saying
``weeks to live''--an erroneous reading of my MRI, thankfully.
As Senator Harkin points out, the message has gone out to a lot
of women don't do it.
Dr. Blumenthal testifies about a variety of factors, fear,
concern of radiation, et cetera. If there is any reason not to
go to the doctor, let's not go, let's not get the test. The
concern is for what the test may show.
This has received enormous publicity. I do not know that
you can ever put the genie back in the bottle.
My question to you is, ``Why release a draft report which
is not final and is not the ultimate word.''
Dr. Klausner. That is a very good question.
Let me correct something. This is not an NCI report, nor an
NCI panel, nor an NCI advisory body.
Senator Specter. Well, didn't you appoint them?
Dr. Klausner. No. No.
Senator Specter. Then how did they come into existence?
Dr. Klausner. Let me explain. For about 20 years there has
been an independent jury type mechanism for consensus
conferences at the NIH. In order not to in any way be viewed as
prejudicing the outcome of a discussion about mammography, I
discussed this with Dr. Varmus and we went to an office at the
NIH that is separate from the NCI to ask them to convene this
independent panel. It is the panel's report, and that panel
report will be useful to us as we, then, proceed.
Senator Specter. So this is not NCI, not the National
Cancer Institute? It is the National Institutes of Health?
Dr. Klausner. No; the report actually is the report of this
independent panel. It is convened by the Office of Medical
Applications of Research within the office of the Director of
NIH, and I was not involved with choosing the panel. I met the
panel for the first time at the beginning of the meeting.
Senator Specter. Well, the document says, in addition to
draft-draft-draft, National Institutes of Health consensus
development statement.
Should I be asking Dr. Varmus this very good question?
Dr. Klausner. Let me just say that we have been discussing
the very good question about whether the process by which a
draft report is released so quickly after a very complex
conference.
Senator Specter. Well, who is responsible for releasing the
draft report, which has all the indications of being a
premature release?
Dr. Klausner. This particular process is the current
process of the NIH consensus process in the Office of Medical
Applications of Research. And, based upon this experience, we
are, in fact, discussing, and I have been discussing it with
the head of that office, with the person responsible for that,
as well as Dr. Varmus.
Senator Specter. Who is responsible for releasing the draft
report?
Dr. Klausner. The process is set up by this Office of
Medical Applications of Research and it is the report of the
consortium.
Senator Specter. Is there a person there?
Dr. Klausner. Yes.
Dr. Harlan is the Associate Director who oversees this.
Senator Specter. And is he responsible for releasing the
draft report?
Dr. Harlan. Yes.
Senator Specter. Would you identify yourself, please?
Please step up to the microphone, Dr. Harlan.
This is an important point as to why a draft report is
released.
You are Dr. William R. Harlan, Associate Director for
Disease Prevention of the National Institutes of Health.
The question is why release a draft report which causes
such concern before it is in its final form?
Dr. Harlan. The draft report was released for public
comment and for comment by the scientists who attended the
conference. The panel intended to take that comment and will be
taking that comment into consideration as it comes to a final
report.
We have been doing this, as Dr. Klausner mentioned, for
about 20 years, and it has always worked reasonably well
because we will make changes in it from that draft report.
But it has given the public and other public outside of the
panel a chance to comment on the report.
Senator Specter. Thank you.
Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman. I must admit to
you that I have mixed feelings about this report. On the one
hand, it does say to women that you should make your own
decisions. It says that you should be empowered to look at your
own health background and that you should be empowered to make
these decisions yourself. I like that. People ought to be
empowered to make those decisions.
On the other hand, I am concerned if the report, as echoes
of this report gets out, that somehow insurance companies and
other coverers will begin to rescind, deny, or to cut back on
coverage for women who do make that decision, who are in their
forties and maybe even earlier, but who, because of a family
history or their own particular situation, want to have the
mammogram. I am concerned that the coverage will not be there
for them.
I guess if I had a bottom line, as we always say around
here, my bottom line is sort of what I alluded to in my opening
statement. It is that we have to ensure that women have the
power to make these decisions themselves, and the insurance
coverage ought to be there for them, regardless at what age
they want to have this screening.
That is sort of how I am weighing this report. It is good
on the one hand and perhaps bad on the other hand if it sends
out the wrong signal.
I would ask you that it was not in any way your intention
or at all to send out any signal, or that you would deny that
there should be anything read into that to insurance companies
that they could in any way cut back on coverage for women in
their thirties, their twenties--I don't care--if they, in fact,
want this screening for themselves.
Dr. Klausner. Right. From my reading of the clear intention
of the panel, they did not intend that message at all.
Senator Harkin. I think that is an important message to
send out, very important.
Dr. Blumenthal. I think, too, actually in the consensus
panel report it recommended that women who choose to have
mammograms during this age period would receive reimbursement
for it. That was the panel's recommendation.
Senator Harkin. Go ahead, Doctor.
Dr. Klausner. Let me say one other thing. There is also a
difference between population screening, addressing all women,
and the issues that you raised of women with, for example, a
particular family history or a medical condition, or a
particular reason that would lead her to decide that at the age
of 30 or 35 it was medically appropriate, specifically, not as
a population screening but of her own decision.
Senator Harkin. Individually.
Dr. Klausner. As an individual test, and that is a very
different issue.
Senator Harkin. I guess the other thing that I am concerned
about is this. When it gets to that age, I agree that it ought
to be the individual making her decision, but the coverage
ought to be there fully.
I am also concerned about where there is no dispute about
the benefit of mammography for women over the age of 60, 62, or
65--and I forget just what that age is.
Dr. Klausner. It's 50.
Senator Harkin. Age 50? I thought there was no dispute over
age 60, but some dispute at age 50, and then it gets less and
less because of age factors.
But what I am concerned about then, if it is 50, is what
can we do if less than 50 percent--I understand--less than 50
percent of the women in that age group are, in fact, getting
mammograms, and there is no dispute about the benefit of that.
What can we do to raise up that 50 percent level?
Dr. Blumenthal.
Dr. Blumenthal. As I mentioned in my testimony, there are a
number of educational programs underway. The NIH and the CDC
have programs where they are working in partnership with other
public and private sector organizations, from the YWCA to the
Association of Retired Persons, to reach priority and
underserved populations, to educate and, using community
education methods, to motivate them to use this life-saving
technology, mammography.
Additionally, the Centers for Disease Control and
Prevention has a program, in all 50 States, that provides low
cost or free mammography to women who cannot afford them. This
has increased the utilization of this important procedure.
Senator Harkin. I'm sorry, but I have to go. You have been
very kind with the time, Mr. Chairman. But I just cannot leave,
however, without saying that this is all well and good and we
have to focus on this. But the chairman and I are working
together, again, to try to get increased funding for research.
This is what we have to focus on. A few years ago, I was
able to do a torpedo shot. We doubled the funding because I got
some money from star wars for it, for breast cancer research,
out of the Department of Defense. We have had modest increases
at NIH of 4 percent. That is fine, but that is not where it is.
Senator Specter and I are going to be proposing, again, an
approach where we can really get the funding up, not only for
this research but for all research at NIH. That is where we
have to focus our attention, on that research.
Dr. Blumenthal. Senator Harkin, it is really unacceptable
that in 1997 we do not have a more accurate technology to
detect breast cancer for all women. We pledge to work to
intensify our efforts, as we have been already, to discover
more accurate, earlier detection methods for all women.
Senator Harkin. That is where we need more research money.
Thank you very much.
Thank you, Mr. Chairman.
Senator Specter. Thank you, Senator Harkin.
Senator Hutchison.
Senator Hutchison. Thank you, Mr. Chairman.
I want to say that I will work with the chairman and the
ranking member for more funding, but I am not going to take it
from our missile defense systems. I think it should come from
other programs that are lesser in priority.
I have this question for you, Dr. Klausner.
I believe that you agree with us that there has been a bad,
erroneous signal sent through the baffling draft report of this
advisory committee. But this advisory committee is not your
council. It is not the one that will decide if you are going to
issue guidelines or if you are going to issue statements of
scientific fact.
My question to you is what are you going to recommend to
the panel that will come out of the National Cancer Institute,
which is the lead Government organization, as a recommendation?
Are you going to suggest that we go back to clear guidelines
that state what the potential risks might be? Or are you going
to let this report, with which I think you have said you
disagree, continue to muddy the water?
Dr. Klausner. We do not want to muddy the water. I think we
are going to work very hard to be as clear as absolutely
possible.
I have promised the National Cancer Advisory Board that I
will work, that the whole institute will work very closely with
them in formulating exactly our position. I feel it would
actually be unfair to them to prefigure what I think they
should conclude. That is going to be an important process, an
important discussion which we will have, which we will have
openly, and together we will come to a position as to
guidelines or not guidelines as to information, as to
educational products, as to the whole range of things that the
NCI needs to do to be very clear about information concerning
mammography.
Senator Hutchison. What would be the timetable of the
action of the panel so that NCI would have a position, which
you do not now have--or which you have, but have changed and
now we are hoping you are going to be a little more clear?
Dr. Klausner. The meeting of the National Cancer Advisory
Board is on February 25 and 26. I think it is going to very
much depend upon what is agreed to there, what work needs to be
done to craft our positions.
We will move as quickly as we can. That is what we promise.
A number of organizations are now in the process with new
information, with evolving information. I think the American
Cancer Society is planning a March meeting to reexamine their
guidelines.
So this is a time in which, with new information coming
out, new analyses, we need to take the time. We need to do it
as quickly as possible, but we need to make sure that what we
do, we do right, we do clearly, and we do well.
Senator Hutchison. Let me ask this question.
You testified that we have about a 25-percent miss as a
percentage in mammogram technology and accuracy. Dr. Blumenthal
named several new types of technology that seemed to be better.
Are we going to be able to get a better rate of accuracy
fairly quickly? And with the research dollars, are you going to
see that we target the technology to get better accuracy for
detection?
Obviously, I guess you have to make the decision are we
going to go for detection or cure and how do you spend the
dollars most wisely.
What is your suggestion?
Dr. Klausner. Well, the reality is we need to do both. I
mean, we can't put all of our eggs in one basket. We are
working on cure. We're working on early detection. We are
putting a lot of money into many different projects that are
ongoing now to answer exactly those questions.
We think new image analysis can bring us a long way to
better use of mammography, whether it is film based or digital
mammography.
Dr. Blumenthal talked about magnetic resonance imaging.
That is a very interesting approach. It seems to see more
abnormalities, but it has much more trouble right now than
mammography telling whether it is a cancer or a normal tissue.
That is being worked on very intensively.
All of these techniques take development. The investments
are being made.
We have a new task force at the NCI headed by Dr. David
Bragg, a very well known and eminent radiologist. It is a new
task force that is an ongoing think tank to provide
perspectives on where we need to go in detection technologies.
That is beginning now.
Senator Hutchison. Can we do better than 75 percent
accuracy pretty fast?
Dr. Klausner. I think we can. I don't know exactly how much
we can get that down.
Mammography is clearly changing. One of the limitations of
the studies we are talking about is some of them are 30 years
old using outdated mammographic technology. Mammography, while
it is an old technology, has gotten better. Reading has gotten
better. Film has gotten better.
There is no question. It is continuing to get better. I
would imagine that those numbers will go down.
But I suspect the way that they are going to go down much
more dramatically is by the development of some new aspects of
imaging technology.
Senator Hutchison. Thank you, Mr. Chairman. My time is up.
I do have a second round for this panel when my time comes
back.
Senator Specter. We are going to have a second round.
Senator Hutchison. Thank you.
Senator Specter. On the issue of the MRI's and the multi-
institutional testing which is being undertaken, coordinated at
the Hospital of the University of Pennsylvania, it has been my
understanding that there has not been quite the emphasis on
funding there that there might be.
Dr. Blumenthal, I would appreciate it if you would address
the expectation as to what the MRI could do by way of improving
the detection rate that Senator Hutchison talks about and the
issue of the adequacy of funding on that multi-institutional
MRI testing.
Dr. Blumenthal. That study I believe has been approved but
not funded yet by the NCI.
Senator Specter. Why hasn't it been funded?
Dr. Blumenthal. I cannot address that. I think Dr. Klausner
would need to do that.
Senator Specter. Dr. Klausner, why hasn't it been funded?
Dr. Klausner. I must say that I do not know. I am not aware
that that study has not been funded.
Dr. Blumenthal. We will request that NCI look into the
status of the funding for the multi-institutional MRI study.
[The information follows:]
MRI in Breast Cancer
In April 1996, NCI issued a Request for Applications [RFA]
entitled ``Multi-Institutional Cooperative Agreements for
Clinical Evaluation of Magnetic Resonance Imaging in Breast
Cancer.'' The applications submitted in response to this RFA
have been peer reviewed and are awaiting second level review by
the National Cancer Advisory Board. Once reviewed, NCI staff
will develop a recommendation for funding.
breast cancer diagnosis
Dr. Blumenthal. But several studies have been conducted on
the effectiveness of MRI in breast cancer diagnosis. Again,
preliminary evidence suggests that it is able to significantly
increase the accuracy of differentiating between benign and
cancerous tumors.
Senator Specter. How good can it get? What are the
prospects for eliminating the area of error?
Dr. Blumenthal. Right now MRI is seen as a diagnostic
technology rather than a screening technology. We need to study
MRI in many academic sites with many patients to evaluate its
effectiveness so that we can get definitive evidence.
Additionally, you mentioned about improving the accuracy of
conventional mammography through our missiles to mammograms
project using very inexpensive computer algorithms from the
intelligence community to improve breast cancer detection. Some
of our scientists who have been working for 10 years to better
improve detection on mammography of microcalcifications--which
are the deposits that many cancers produce--report that
accuracy has increased two-fold.
Senator Specter. Dr. Blumenthal, I want to shift gears
here. These subjects all would warrant a great deal of
examination but there is limited time. I want to focus for a
moment or two on the issue of gene detection.
Now the results on gene detection have been absolutely
phenomenal. We compliment the research which has been done by
the scientists across America in so many fields. There is
nothing more important than health, and that is why the
Congress has tried to put the funding into NIH.
There are some 27,000 research applications which were
granted and there are many more which are needed. Frankly, I am
disturbed to hear that NIH has not funded the multi-
institutional MRI studies because I know what an MRI can do.
Then we have the accomplishments and advances on gene
detection. If there is a determination through the genes about
a proclivity for breast cancer, that can be determined at a
very early stage.
Now there is not a protection for privacy on that kind of a
determination. The law of the insurance companies is that if
you do not make a full disclosure as to your situation, the
lawyers will call it fraud in the inducement, and the insurance
does not cover it. So if somebody knows they have a gene which
gives them a predisposition--Fran Visco is nodding; she is both
a lawyer and a breast cancer expert--it does not cover it.
We can legislate in the field, and I think we have been
derelict in not moving ahead. But the question for you, Dr.
Blumenthal, which I would like you to address is what can the
gene therapy show us in terms of a predisposition to breast
cancer? How can that be helpful to the treatment for breast
cancer, whatever can follow up from it, and what needs to be
done?
We can legislate on this federally to protect privacy and
to change the insurance laws so that if a woman can benefit
from having that determination made, she should not be
disallowed insurance coverage because if she had not done it,
she would be allowed insurance coverage.
Ignorance is not bliss, as Dr. Healy said.
So how can we address the gene issue and what are the
potential benefits for women's health if we make that
determination on an individual basis?
Dr. Blumenthal. The national action plan on breast cancer
has had a working group on hereditary susceptibility genes and
the legal and ethical issues surrounding their discovery.
These genes offer the promise of developing new treatment
strategies and one day the hope, perhaps, of repairing the gene
so the disease does not develop in the first place.
However, it has also opened up a Pandora's box of very
daunting legal and ethical issues, such as you mentioned.
Senator Specter. If we found a gene in a woman and knew the
predisposition, how would that help you, Dr. Blumenthal, in
caring for the woman?
Dr. Blumenthal. Right now, two genes, BRCA-1 and -2, that
have been identified that are associated with high risk for
breast cancer. There is a blood test available today to test
for these genes.
However, currently we recommend that this be used only in a
research setting because we are extremely concerned about work,
life and health insurance discrimination based on genetic
information, and because we do not have a way of preventing the
disease, and there are unclear recommendations about what a
woman can do in terms of intervention strategies.
So we are working on this right now. I think it is a very
important area. It is a promising area, but it is also
associated with a number of problematic issues.
One of the things that some of these new diagnostic
technologies may offer, such as MRI, is no exposure ionizing
radiation. This may be a better method to monitor women at high
risk of breast cancer who carry the gene, because there is some
theoretical concern that radiation exposure may be damaging to
women who carry this gene.
Again, I want to underscore that it is a theoretical
concern. But some of these new technologies may offer a
promising way of following women and detecting the disease in
women who are at high risk for breast cancer, especially those
who have a genetic predisposition.
Senator Specter. Before yielding to Senator Hutchison, I
would just like to ask you, Dr. Blumenthal and your department,
and you, Dr. Klausner, to supplement--because we cannot go into
the details now--as to what is doable on the gene line, how it
can be helpful in the treatment of women, and what kind of
Federal legislation you need to protect privacy so that we can
move ahead medically.
[The information follows:]
Understanding the Origin of a Disease
Once a gene has been identified, scientists have an
essential key to understanding the origin of a disease. While
treatments for such diseases take time to be developed,
isolating a gene can quickly lead to the development of a
diagnostic test. Such test can readily be used to determine
whether or not an individual carries an alteration in that
gene. Thus, within a short time after a gene is isolated,
individuals can be told whether or not they have an alteration
in their copy of this gene. Often, however, they cannot be told
at first what that information means to them in terms of their
future health or what strategies might be available to reduce
their risk of developing a particular disease.
Recently two genes that cause breast cancer (BRCA-1 and
BRCA-2) were isolated. Much debate has occurred as a result of
this discovery and the advisability of offering a test for
alterations in these genes to women. While those who test
positive have an increased risk of breast and ovarian cancer,
the actual risk to develop these diseases outside high-risk
families remains unknown. Even in high-risk families the risk
is not 100 percent. Those who test negative may still get
breast or ovarian cancer due to environmental factors or other,
as yet unknown, genes. While increased cancer surveillance and
prevention options can be offered to those found to have
alterations in their genes, the effectiveness of these
interventions remains uncertain. Furthermore, those who test
positive are at increased risk of discrimination in insurance
or employment. While the discovery of a gene and the
development of a genetic test may be viewed as a great
scientific advance, it may not result in an immediate benefit
to the persons who undergo testing. This interim phase, when
testing is possible but interventions are of uncertain benefit,
raises questions about the appropriate use of genetic
technologies and information.
The NCI is also establishing a Cancer Genetics Network,
which will serve as a dynamic informatics and research
infrastructure linking institutions that test individuals for
hereditary cancer suseptibility as well as provide counseling
and interventions to prevent cancer in these individuals.
The NHGRI has identified four areas which have high
priority for the Ethical, Legal and Social Issues (ELSI)
program. These priority areas, listed below, form the basis of
a recently released, revised Program Announcement, which will
serve to further focus future program activities.
Privacy and fairness in the use and interpretation of
genetic information.--This area includes studies of the meaning
of genetic information and how to minimize or prevent its
misinterpretation or misuse. Of particular concern is genetic
discrimination in health insurance and employment.
Clinical integration or new genetic technologies.--This
includes an examination of the impact of genetic testing and
counseling on individuals, families, and society and the
development of policy options related to the clinical use of
genetic technologies.
Issues surrounding genetics research.--Informed consent,
privacy, and other ethics issues related to the design,
conduct, and reporting of genetics research are included here.
Public and professional education.--Activities in this area
included the development and evaluation of alternative means of
providing education about genetics and related ELSI issues to
health professionals, policy makers, and the public.
The ELSI Working Group has formed a Task Force on Genetic
Testing which is examining the current state of genetic testing
in the U.S. to make recommendations that will ensure the
development and delivery of safe and effective genetic tests.
Specific issues being addressed are the scientific validation
of new genetic tests; laboratory quality assurance; and
education, counseling, and delivery of genetic tests. Several
federal agencies including the Food and Drug Administration,
Health Care Financing Administration, national Centers for
Disease Control and Prevention, and Agency for Health Care
Policy Research, professional societies, as well as the
biotechnology industry, insurers and consumers are
participating in the Task Force. In March 1996, the Task Force
released a set of draft Interim Principles for public comment.
The final Principles and Recommendations of the Task Force are
expected to be released in the Spring of 1997.
On October 4, 1996, the National Action Plan on Breast
Cancer and the ELSI Working Group held a workshop on genetic
information and employment discrimination. It is anticipated
that the recommendations from the workshop will provide
meaningful information to policy makers as they discuss the
need for additional legislative protections. The
recommendations from the workshop will be published and widely
disseminated to policy makers, consumer advocates, and other
stake-holders.
different breast cancers
Senator Specter. Senator Hutchison.
Senator Hutchison. Thank you, Mr. Chairman.
Let me ask one question to either of you. Is it true that
breast cancer, once it is there, whether detected or not, grows
faster in younger women, before the age of 50?
Dr. Klausner. There is mixed evidence about that. Probably,
overall, cancer in younger women is somewhat more aggressive.
But, as I said, I think the problem is lumping together lots of
different diseases.
There are many different breast cancers, some of which grow
slowly, some of which spread when they are still so small that
that is probably why mammography could not work, even if it saw
it when it was small, if it had already spread.
Those differences mean that breast cancer is different
diseases, and those different diseases will be spread probably
differentially across different ages. That is really important,
that we shift our focus to making sure that we are treating and
approaching the right disease with the right treatment. We
cannot lump all breast cancers together. Some grow slowly, some
grow rapidly, some spread very poorly, and some spread very
rapidly and very early. They are different diseases.
Senator Hutchison. I understand that and I know that if it
is a different type of strain it might be a slow grower or a
fast grower.
Dr. Klausner. There is some evidence that breast cancer on
the whole is somewhat more aggressive in younger women than in
older women. But this difference is not very dramatic.
Senator Hutchison. I understand that, but I do think that
it also emphasizes the need to err on the side of doing the
most that we can for a group that, with some reservations,
nevertheless, is mostly going to be affected.
Let me move to another subject.
Dr. Blumenthal, the breast cancer action plan got $14.75
million from this committee for the 1997 budget. The NAPB
steering committee, as I understand it, voted to use $5 million
on the plan and to send the rest to NCI for more scientific
research.
Do you agree with that allocation? Is the money better
spent for the research at NCI? What is the $5 million in the
breast cancer action plan being used for? Is that the right
allocation of the funds?
Dr. Blumenthal. The action plan right now has six high
priority working groups. I mentioned the one on genetic
susceptibility and on the legal and ethical issues surrounding
these genetic discoveries. Another working group is focusing on
stimulating more research on the etiology of breast cancer,
particularly on environmental factors--what is it in our diets,
in our workplaces, in our homes, radiation exposure in the
environment, atmospheric pollutants, pesticides that may be
contributing to the increased risk of breast cancer in our
lifetimes. This working group is also looking at why breast
cancer may have a higher incidence in certain geographic areas
of the country.
Another working group is examining how to decrease barriers
to women participating in clinical trials. Other priority areas
for the plan include involving consumers in research and policy
decisions and improving information dissemination to women and
their health care providers using new information technologies.
The plan has included a number of important activities that
are underway. We would be happy to provide you with a progress
report on them.
As you said, the committee did make a recommendation to
provide funding for more research at NIH.
This is a recommendation that will go forward to the
Secretary, and she will make decisions about the funding
allocations.
Senator Hutchison. Do you think that it is better used in
the actual scientific research? Is that the right allocation,
in your opinion?
Dr. Blumenthal. Senator, it is not my decision. We are
fighting a war against breast cancer on many fronts. For the
first time, we have mobilized all agencies of government,
working with the private sector, to fight this disease.
As Dr. Klausner said, we have a lot to do in terms of
finding the cure and a way to prevent breast cancer. But we
also have to improve early detection of the disease, improve
access and education. So we need to put our investment in many
different avenues when we are talking about all moneys
available in the fight against breast cancer.
Senator Hutchison. Do you work with the Susan Komen
Foundation for education and outreach to try to help women know
that they can do something about early detection and the
seminars that they have put together?
Dr. Blumenthal. We have had the privilege of working with
the Komen Foundation, with Nancy Brinker and Susan Braun, the
new executive director. We commend their efforts in terms of
raising awareness about breast cancer through the Race for the
Cure and also for their support of research.
We feel that they have been a very powerful force in our
country in the fight against this disease, as has the National
Breast Cancer Coalition and many other groups. We work with
them very closely to advance knowledge, to improve detection
and access to breast cancer services. It is a pleasure to work
with them.
Senator Hutchison. I would just say that both Susan Komen
and Nancy Brinker were tragically diagnosed with breast cancer
before the age of 40. So I think we just have to focus on this
issue and be more clear.
Thank you, and thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Hutchison.
We are going to have to move on to the next panel. But I do
want to make a brief comment about the question which you have
just raised.
The administration came back and asked for the figure of
somewhat in excess of $14 million on the action plan. There are
a number of items which are included there. The subcommittee
recommended that and it was approved by the full Congress and
signed by the President.
There are quite a number of items there which the
subcommittee and I personally think are very important--these
clinical trials which are being undertaken now, coordinated by
the Hospital of the University of Pennsylvania, this genetic
issue which is very important, the environmental issue, the
diet and the workplace issue. If you take $5 million out of $14
million and put $9 million back and more into research, the
question is what is the impact there when you have a research
budget of $419.6 million?
That is why I ask you the question as to what you really
need on research. When you are talking about the action plan
and those important items, I would not like to sacrifice them
unless we know that those marginal dollars really mean
something significant. Then there is the question about whether
we ought to have more funding.
We have $1.6 trillion in our Federal budget, and we have
not done an adequate job on assessing priorities. There is not
a higher priority than breast cancer. Since this action plan
has these important items, I don't want to see them eliminated.
If it is more money for research, let us know. Let us see what
we can do.
Fran Visco and I have corresponded on that. That is a
matter of great concern and it could take a whole separate
hearing. Perhaps we will have a hearing on it.
But I would like your evaluation, too, Dr. Klausner on the
benefits of these other lines.
Dr. Klausner. Absolutely. Thank you.
[The information follows:]
Scientific Investigations Into Breast Cancer
NCI holds scientific investigations into breast cancer as
one of its highest priorities. In 1997, 184,200 new cases of
breast cancer will be diagnosed and 44,190 women are expected
to die of the disease. The NCI breast cancer research portfolio
currently includes the full breadth of research on breast
cancer including risk factors, screening, diagnostics,
therapeutics, novel clinical approaches, prevention, and
quality-of-life issues.
One aspect of the NCI's efforts in this area is the
tracking of incidence and mortality data related to breast
cancer. For the first time since such records have been
compiled, the breast cancer death rate fell between 1991 and
1995. The decline in cancer mortality rates was 6.3 percent
with a larger decline (9.3 percent) in women under the age of
65. The NCI is convinced that these gains reflect the success
of both early detection via mammography screening and more
effective therapeutic interventions such as adjuvant
chemotherapy and hormone therapy. The newest statistics also
reveal very significant and positive trends in the breast
cancer mortality rates in African American women. In black
women, the breast cancer death rate dropped 1.6 percent between
1991 and 1995 compared to an increase of 20.3 percent in the
period from 1971 to 1990.
To optimize our efforts in breast cancer, NCI has
established a Progress Review Group, to assess research
opportunities in breast cancer and the activities of the NCI in
the context of these opportunities. It along with the Prostate
Cancer Progress Review Group represent the first use of this
mechanism. The Breast Cancer Progress Review Group will work
with NCI staff in conducting an in-depth evaluation of the
current state-of-knowledge regarding this area, survey the
literature and related fields of science, and recommend to the
NCI, through the National Cancer Advisory Board and the Board
of Scientific Advisors, how the Institute can optimally respond
to and stimulate research opportunities related to breast
cancer. This exercise will help set the NCI's research agenda
in breast cancer by identifying and prioritizing those
scientific opportunities that are most likely to expand our
knowledge base and that will ultimately reduce the burden of
this cancer. An important feature of the Progress Review Group
is its linking of planning at NCI with a comprehensive program
analysis and with all of the institute's program implementation
mechanisms.
The NCI has begun the Cancer Genome Anatomy Project (CGAP).
The first two goals of CGAP are designed to build an
infrastructure of resources, information, and technologies that
will provide a platform for the establishment of an index of
all genes that are expressed in tumors and support development
of new technologies that will allow high throughput analysis of
gene and protein expression as well as mutation detection. An
early component of CGAP is the preparation of tumor samples for
generation of cDNA libraries. During the first year of CGAP
libraries will be produced from tissue derived from breast
tumors (as well as from prostate, colon, lung, and ovarian
tumors) and from corresponding non-tumor tissue samples. This
project is aimed at accelerating our ability to develop new
markers for breast cancer and to provide accurate and
predictive diagnostic tests. Breast cancer is not one disease,
and the CGAP is intended to identify the molecular
characteristics that distinguish one breast cancer from another
in ways that will guide future approaches to the design and
choice of effective interventions.
The NAPBC's desire to identify research gaps and needs in
breast cancer etiology serves as the impetus for the
compilation of an inventory of research projects on breast
cancer etiology that is being conducted by the NCI on behalf of
NAPBC. A ``Breast Cancer Core Questionnaire Project'' is also
being conducted under NCI scientific leadership and
coordination for the NAPBC. This project is intended to improve
the availability, quality, and comparability of data on risk
factors for breast cancer.
Screening and early detection are important components of
reducing the burden of breast cancer. The National Cancer
Institute funds numerous research projects to improve
conventional mammography and develop alternative imaging
technologies to detect and characterize breast tumors. Efforts
to improve conventional mammography center on refinements of
the technology and quality assurance in the administration and
interpretation of the x-ray films. To advance the technology,
NCI is funding research to reduce the already low radiation
dosage; enhance image quality; develop digital mammography as
an improvement over the conventional, film-based technique;
develop statistical techniques for computer-assisted
interpretation of digitized images; and enable long-distance
image transmission technology for clinical consultations.
outstanding work
Senator Specter. OK. Thank you very much, Dr. Klausner and
Dr. Blumenthal. We appreciate your outstanding work in the
field.
Dr. Blumenthal. Thank you very much.
Senator Specter. Dr. Klausner, your board is meeting on
February 25 and 26?
Dr. Klausner. Yes; it is.
Senator Specter. We are going to schedule Secretary Shalala
in soon thereafter. Do you think you will have a conclusion
after that weekend so that we can start talking about policy
and Medicaid and Medicare, and where the Federal money is going
to go?
Dr. Klausner. I certainly would be happy to report to you
on what happens at that board, but I cannot speak for the board
as to when they will complete what they decide to do.
Senator Specter. All right. I'm going to take that as a
``yes'' answer, too.
Thank you, Dr. Klausner.
We are going to defer panel 2 and move right now to panel
3.
The schedules are incredibly complicated around here.
Senator Harkin had to go to another session. We all have
commitments. I know that the entire subcommittee would like to
be here.
I am due before the Rules Committee and am scheduled for
10:45, which is why we moved the hearing up to 9:15 from 9:30.
Then I have another commitment. We are announcing the special
counsel on the veteran's gulf syndrome issue at 11:45. So there
may have to be some interruptions in our hearing.
NONDEPARTMENTAL WITNESSES
STATEMENTS OF:
FRANCES M. VISCO, ESQ., PRESIDENT, NATIONAL BREAST CANCER
COALITION, PHILADELPHIA, PA
SUSAN BRAWN, PRESIDENT AND CEO, SUSAN G. KOMEN BREAST CANCER
FOUNDATION, DALLAS, TX
DIANA ROWDEN, CHAIR, SUSAN G. KOMEN BREAST CANCER FOUNDATION
ANN MARILYN LEITCH, M.D., ASSOCIATE PROFESSOR OF SURGERY, THE
UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL SCHOOL, DALLAS, TX
BARBARA MONSEES, M.D., ASSOCIATE PROFESSOR OF RADIOLOGY, CHIEF
BREAST IMAGING SECTION, MALLINCKRODT INSTITUTE OF
RADIOLOGY, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, ST.
LOUIS, MO
DAVID G. HOEL, Ph.D., MEMBER, CONSENSUS DEVELOPMENT PANEL,
PROFESSOR AND CHAIRMAN, DEPARTMENT OF BIOMETRY AND
EPIDEMIOLOGY, ASSOCIATE DIRECTOR, HOLLINGS CANCER CENTER,
MEDICAL UNIVERSITY OF SOUTH CAROLINA, CHARLESTON, SC
summary statement of frances visco
Senator Specter. I would like to call now the next panel:
Ms. Frances M. Visco, Ms. Susan Braun, Ms. Diana Rowden, Dr.
Ann Marilyn Leitch, and Dr. Barbara Monsees.
Let us begin with a fellow Philadelphian, Ms. Frances M.
Visco, first president of the National Breast Cancer Coalition
and a member of its board of directors. She serves on the board
of directors of the Linda Krieg Breast Cancer Foundation and
was appointed by the President as one of three members of the
President's cancer panel.
She also sits on the Department of Defense Breast Cancer
Program integration panel, which reviews Department of the Army
research programs, and she cochairs the national action plan on
breast cancer.
Your statement, as well as all the statements will be made
a part of the record. To the extent we can summarize, it will
be appreciated. We are going to have to observe the time limits
a little more circumspectly here.
We welcome you all here. Ms. Visco, the floor is yours. Our
prepared comments do not include the fact that you are a
lawyer, but you are a lawyer as well.
Ms. Visco. Thank you, Senator Specter.
I would like to start by answering a question that you
asked Dr. Klausner, and that is how much money we need this
year for breast cancer research. The National Breast Cancer
Coalition will be asking for $595 million in the National
Cancer Institute budget and $150 million for the Department of
Defense Peer Reviewed Breast Cancer Research Program. We will
be talking to you about that in great detail.
Senator Specter. Is that enough?
Ms. Visco. Probably not. If we can agree on more, I would
be happy to do that.
Senator Specter. Ms. Visco, I ask that question very
seriously to try to get an estimate. What is enough? How many
applications are there out there? If you can, quantify what is
enough. As I say, we have $1.6 trillion. It is up to us in the
Congress and in this Appropriations Committee and subcommittee
to make the determination.
Ms. Visco. Yes; we will continue to work with you to come
up with that number.
I want to take Senator Hutchison's invitation to speak
frankly and with the facts, and also with some emotion.
Senator Specter. Ms. Visco, I have just been informed that
I am due at the Rules Committee. I have to be a witness myself.
So I am going to have to recess this hearing. But I will be
back as soon as I can. We may have another recess, but we are
going to get it all done.
[A brief recess was taken.]
Senator Specter. We will reconvene the subcommittee
hearing.
We were in the midst of Ms. Visco's testimony when I had to
recess for a few minutes. To explain why I was gone, it was to
the Rules Committee where I was presenting a budget for the
Veterans' Affairs Committee. We are going to proceed now for 30
minutes and then I will have to excuse myself for a few minutes
more. But we will proceed and finish our business today.
I regret the interruptions, but that is just a necessity as
our schedules work out here.
Fran, you were on and we are going to start the clock
again. So you will get your full time.
Ms. Visco. Thank you.
I want to thank you, Senator Specter, and the members of
your committee for holding these public hearings to further the
public's education about the facts behind mammography
screening.
My name is Fran Visco. I am a breast cancer survivor, an
attorney. I am president of the National Breast Cancer
Coalition.
I was diagnosed with breast cancer in September 1987, when
I was 39 years old. My breast cancer was diagnosed through a
mammogram. I had a lumpectomy, radiation, and chemotherapy. But
I am here personally to speak in support of the findings of the
consensus panel.
I look around the room and I am impressed with the turnout.
I have been following the coverage of the consensus panel in
the papers and on television since shortly before the panel
convened. I am amazed at the attention we are all giving to the
question, and, frankly, I am somewhat appalled at the resources
many continue to devote to this question and at the outrage
that met the panel's conclusions.
Over the past 2 weeks, I have lost two very close friends
and great activists to breast cancer. They were both younger
than 50 when they died. A mammogram did not save their lives.
We need outrage over that fact. We cannot act as though
this issue, whether to recommend population screening of women
age 40 to 49, is the most important question in breast cancer.
We have to save our outrage for the fact that we do not know
how to prevent the disease, how to cure it, how to detect it
truly early, or what to do for an individual woman once we do
find it.
There is the fact that we know so little about minority
women and breast cancer. Let's save our outrage, resources,
energy, and time for the 44,000 women who die each year, for
the tens of thousands of women who have no access to health
care.
I am thrilled to hear, Senator Specter, that you are
outraged about the underfunding of breast cancer research and
are committed to making sure that is increased.
What happened here? Specifically, the consensus panel
looked at the data. They looked at the scientific data, from
trials not designed to answer the question we are asking and
trials that do not ask any questions about minority women, and
saw that a meta-analysis of the eight trials shows, I thought,
a 17 percent, but Dr. Klausner says a 15-percent decrease
mortality for women under 50. But the decrease does not begin
to show up for 10 years, raising the question, among others, of
whether the women who are now in their fifties are actually
benefiting from mammography at that age.
We don't know. The data are unclear.
This is nothing new. But we keep asking the question. I
don't think that some members of the scientific and medical
community are really looking for the answer anymore. I think
they are chasing after statistical significance, and we are
going to get it no matter what--if we have to play with
confidence intervals, wait a long enough time, throw out the
trials that do not fit our preconceived notions, get lost in
the details.
But the big picture does not change. We all admit the
numbers are not overwhelming. Whatever benefit may exist is
small.
The issue here is population screening. It is not
treatment. It is not the issue that the panel came up with as
to whether individual women should get these facts and then
make a determination. It is whether we should recommend to the
population of women 40 to 49 to get a mammogram every year.
Some seem to argue that the small benefit or those issues
should not matter, that public policy should be driven by the
fear that we will confuse women. Well, I have more faith in
women's ability to understand the truth, as do you, Senator
Specter, and you, Senator Hutchison, because what you talked
about earlier was the need for women to get the facts, to weigh
the risks and benefits, to get the pros and cons. That is what
we are asking for.
What is our goal here? A simple message is less confusing.
But in this situation, the simple message is wrong. We all want
it to be simple. We want mammography to work in all women. It
doesn't. We want to reduce breast cancer to a sound byte. It
cannot be. We cannot continue to sell women false hope simply
because we do not want them to be confused.
We should be devoting our resources to designing mechanisms
to get the message out to women; to get them to understand the
risks, the benefits, the pros, the cons, so they can make a
decision; to get the message out to women over 50 that women
over 50 should get a mammogram every year.
We know that those messages will make a difference. Let us
focus our resources and energy on making certain these women
have access to quality mammography, to follow-up treatment if
needed.
You have the power to enact legislation that will require
insurance companies and third party payers to pay for the
mammograms when the women in their forties get all of the facts
and decide that that is what they want to do.
Again, I am glad that you want to fund the research that we
ask for. We need to focus our outrage, our energy, our
commitment on guaranteeing access to quality health care for
all women and their families. There is no dispute that that
public policy will save many lives.
Senator, you have been a leader in Congress on issues of
breast cancer. I know I and the coalition have come to you many
times and asked you to support policy that is not popular but
is right. I know you look carefully at all of the information,
at the data. I hope you will do so now.
prepared statement
We cannot continue to give women false hope. If we tell
women in their forties to get a mammogram every year, we are
saying ignorance is bliss. What we need to tell them is that
there are pros and cons, there are risks and benefits. That is
the information they need to get. Then let them decide the
course of their own care.
Thank you.
Senator Specter. Thank you very much, Ms. Visco.
[The statement follows:]
Prepared Statement of Frances M. Visco
Thank you, Mr. Chairman and members of the Committee. I am
Fran Visco, President of the National Breast Cancer Coalition
and a breast cancer survivor. A mammogram detected my breast
cancer in September 1987, when I was 39 years old. Yet, the
Coalition and I support the findings of the NIH Consensus
Conference on Mammography. I am pleased to be here today to
explain why.
As you know, the National Breast Cancer Coalition (NBCC)
seeks to increase the influence of breast cancer survivors and
other activists over research, clinical trials, and public
policy and to ensure access to quality health care for all
women. NBCC is dedicated to the eradication of breast cancer
through action and advocacy.
The early detection of breast cancer is among NBCC's goals.
There is currently no screening method that detects this
disease truly early. Mammography is the only tool we have and
it is far from perfect. Let's be clear, screening mammograms
for women under 50 are not the answer to the eradication of
breast cancer. No matter how frequently used, or highly
advanced, mammograms will never prevent breast cancer, or
provide a cure. Making a difference in the fight against breast
cancer means making a commitment to research efforts focused on
unraveling the fundamental mysteries of this disease.
Of course we all wish there was a screening device that
worked for all women and provided ``early'' detection. But we
must not let our desire for an answer propel us to form policy
that is contrary to the facts. Even in women over 50,
mammography reduces mortality by 30 percent, not 100 percent.
For women under 50, the data are just not clear and simply do
not support a policy of population-wide mammography screening.
Therefore, the National Breast Cancer Coalition continues to
support randomized national clinical trials that will compare a
variety of screening methods, and their appropriate timing--to
truly determine what is in the best interest of women's health.
The Consensus Panel brought together a well regarded and
diverse group of experts, scientists, doctors and consumers to
consider the data in a thorough and open forum. They reached
their conclusions without bias or interference--and I see no
reason to dismiss their thoughtful findings. I am very
disturbed by the process I have witnessed. The Consensus Panel
was brought together to consider the science because we trusted
their expertise and judgment. We should not refuse to honor
their finding because we would prefer a different outcome based
on different science.
Rather than arguing about the Panel and its conclusions,
let us turn our collective energies to the questions that
remain as identified by the panel. Let's harness our resources
into research for prevention, truly early detection and a cure.
Let's focus on making sure that all women over 50 have access
to quality mammograms, and that all women have the health care
they need. Then, we can provide true leadership on behalf of
all women who have breast cancer, and all women who live in
fear of this disease.
summary statement of susan braun
Senator Specter. We now turn to Ms. Susan Braun, who serves
as chief executive officer of the Susan G. Komen Breast Cancer
Foundation, recently named president of that organization.
Prior to joining the foundation, Ms. Braun served in various
positions within the Oncology and Immunology Division of
Bristol-Myers Squibb.
Welcome and we look forward to your testimony, Ms. Braun.
Ms. Braun. Thank you, Senator. Before I get started, I
would like to thank you for your leadership role certainly in
this issue and other women's issues, and what you have done
through the years for breast cancer, and to Senator Hutchison,
as well, for being in the trenches back when, I think when
people did not even talk about breast cancer in public. We are
delighted to see your support for this issue as well. Thank
you.
As Senator Specter said, I am Susan Braun, and I am the
president and CEO of the Susan G. Komen Breast Cancer
Foundation. I am here representing our staff but also the 78
affiliates that we have in 38 States, who we polled prior to
coming here about their opinion on this issue as well, so that
we could be speaking with their voices as well as just a single
voice or two.
Our mission, the mission of the Komen Foundation, is to
eradicate breast cancer as a life threatening disease through
the advancement of research, education, screening, and
treatment.
We do fund millions of dollars of grants each year into
basic and clinical research, as well as into community
educational programs and screening programs because we do
believe and would reflect what Dr. Klausner said earlier, that
a cure or cures--and there probably are many forms of breast
cancer--are possible and they are increasingly possible with
the new research advancements that have been made. But we also
recognize and serve the needs of women today as a part of what
we do as an organization.
We believe that one of these needs is screening for breast
cancer.
I am sure that most people here are very aware that when
breast cancer is detected in its earliest stages before it has
become invasive, there is about a 95 percent chance of survival
for 5 years; whereas after the disease has metastasized to
distant parts of the body, that chance is reduced to about 20
percent.
So we do know, and I know there are a lot of data on both
sides, as to which kinds of cancer we are talking about. But
there are very firm data that early detection is absolutely
associated with longevity in breast cancer.
We are also very aware that mammography is anything but a
perfect tool. It is old. Its accuracy can vary for a number of
different reasons.
The consensus panel reviewed those reasons. Among them are
issues such as breast tissue density, even the techniques and
skills of the screening technician as well as the screening
radiologist or the one who reads the report. There are
absolutely false positives and there are false negative
readings, and those can be associated with both psychosocial
and economic consequences. It is far from perfect.
But it does extend life, and that is, really, where our
position derives its basis.
As you know, the consensus panel was charged with examining
the data that presently exist on breast cancer screening for
women in their forties. Fran is correct that those data, in
many cases, were not designed to address the issue of screening
for women in their forties. As Rick Klausner said, there are
many old studies within that body of evidence, and, clearly,
the panel had a very difficult task before them.
We do believe, though, in having reviewed these studies and
having reviewed the public literature that they did weigh
benefit far more lightly than they weighed risk in their
assessment; that the studies that they looked at in determining
the benefit which was primarily the end-point of mortality--and
there would be other surrogate end-points to look at--but that
they weighed those data more lightly relatively than they did
weigh the information and/or data which are light about risks.
For this reason, we feel that they failed to make a definitive
statement about mammography screening for women in their
forties.
We think, too, that clear guidelines of all of the
available data, properly weighed, would send a very strong
public health message and that is that mammograms should be
considered an essential part of the health and medical
screening of women in this country.
We are concerned and have heard voices of that concern,
particularly in the past couple of weeks, that a statement that
inappropriately sends a message that mammography is of
equivocal value truly can undermine the public health policy
and particularly for those individuals and health care
providers who are disincentivized to recommend screening or to
have screening.
Again, as Senator Harkin pointed out earlier, a minority of
women are screened through mammography now, and we would hate
to see what would happen if that number were to diminish even
further.
So we believe that women deserve this clarity, that all
members of society deserve this clarity, and we absolutely
believe that women should be able to make their own choices in
this matter, but that, clearly, the message that we send will
have an impact on the coverage of mammography, as well as on
the likelihood for those who may otherwise think they need not
be screened to have a better excuse not to.
But we also believe that those most knowledgeable about the
implications of this issue can best iterate the current
national position on mammography. So the Komen Foundation has
requested that our chair, Diana Rowden, who is sitting to my
left, also be asked to speak at this hearing.
prepared statement
Diana is a 44-year-old survivor, and I believe she speaks
very eloquently for not only the members of our affiliates,
again 78 affiliates in 38 States, and throughout the country,
but also for perhaps those 34,000 women in their forties who
will be diagnosed this year with breast cancer.
Thank you again for the opportunity for us to present our
operations.
[The statement follows:]
Prepared Statement of Susan Braun
My name is Susan Braun, and I am President and CEO of the
Susan G. Komen Breast Cancer Foundation. I am here representing
the staff members and the thousands of volunteers of the Komen
Foundation, which has affiliates in 38 states across the
country. Our mission is to eradicate breast cancer as a life-
threatening disease through the advancement of research,
education, screening, and treatment.
Although the Komen Foundation funds millions of dollars in
grants each year for research dedicated solely to breast
cancer, with a belief that a cure or cures will be found, we
also recognize and serve the needs of women today. One of these
needs is to have access to screening for breast cancer.
When breast cancer is found in its earliest stages, the
likelihood of five-year survival is over 95 percent. When found
after the cancer has metastasized (or spread to other parts of
the body), the likelihood of five-year survival drops to 20
percent. Clearly, early detection is a key to longevity for
those afflicted with breast cancer.
Mammography is far from a perfect tool for early detection.
It is old. Its accuracy can vary because of such diverse
factors as breast tissue density and the experience of the
technician and reading radiologist. There are false positive
readings. There are false negative readings. Each of these can
lead to psychosocial and economic consequences. Mammography is
far from perfect. Nevertheless, it does extend life.
The consensus panel charged with examining data on breast
cancer screening for women aged 40 to 49 had a difficult task.
We believe they acted in good faith, with a strong desire to
avoid harm to the public health. We also believe that this
concern for avoiding harm caused them to weigh risks more
heavily than benefits. For this reason, they failed to make a
definitive statement about mammography screening for women in
their 40s.
Komen representatives have reviewed the key benefit and
risk data published in the literature and as presented to the
panel in the two days that preceded the issuance of their
consensus statement. Our assessment is that the data
demonstrating risk are very weak when compared to the data
demonstrating benefit. One could further argue that the risks
associated with mammography (such as anxiety associated with a
false positive reading or even an essentially non-existent
radiation risk) pale in comparison to the benefits (such as
early detection of breast cancer and a significantly higher
longevity).
The current Komen Foundation guidelines for mammography
screening are that a woman should have a baseline mammogram by
age 40, be screened every one to two years between ages 40 and
49, and be screened annually thereafter. We are now considering
revisions for those guidelines, because the data indicate not
only that there are benefits which outweigh the risks of
screening for women in their 40s, but that once each year is
the appropriate screening interval.
Clear guidelines reflective of all available data, properly
weighted, send a strong public health message: that mammograms
should be considered an essential element in the annual health
and medical routines of women. Unclear guidelines, or a
statement that inappropriately sends the message that
mammography is of equivocal value, can undermine public health
policy by creating confusion, undue concern, and avoidance
excuses for disinclined individuals, healthcare professionals,
and--perhaps most critically--healthcare insurers. We believe
that women, and all of society, deserve this clarity.
We also believe that those most knowledgeable of the
implications of this issue can best iterate the current
national position on mammography. Therefore, the Komen
Foundation has also requested that our Board Chair, Diana
Rowden, speak at this hearing. Diana is a 44-year old survivor.
She speaks for thousands of Komen constituents, and perhaps,
too, for the 34,000 women in their 40s who will be diagnosed
with breast cancer this year.
summary statement of diana rowden
Senator Specter. Thank you very much, Ms. Braun. You have
taken over my function as chairman. You have introduced Ms.
Diane Rowden. [Laughter.]
Ms. Braun. Oh, I'm terribly sorry.
Senator Specter. That's OK. I will do it, anyway.
She is the chairman of the board of the Susan G. Komen
Breast Cancer Foundation. She has actively been involved in the
fight against breast cancer since she was diagnosed with the
disease in 1991.
In addition to her position at the Komen Foundation, Ms.
Rowden serves on the steering committee of the National
Surgical Breast and Bowel Project Cancer Prevention Trial.
Welcome, Ms. Rowden. The floor is yours.
Ms. Rowden. Thank you, Senator Specter, and thank you,
Senator Hutchison.
I had my first screening mammogram when I was 35 years old.
At that time, the screening guidelines recommended that a woman
have her first screening mammogram between the ages of 35 and
40; 3\1/2\ years later, I was diagnosed with breast cancer.
That screening mammogram did play a key role in my
diagnosis, and I do know in my heart that that screening
mammogram probably saved my life.
Because of this, I have committed myself in my volunteer
work with the Susan G. Komen Foundation to educate as many
women as I can about breast cancer. I know that mammography is
not a perfect tool. So I try to explain this to women. I try to
help them understand what they need to know about mammography
and other screening options, and I encourage women to do breast
self-exam and also to ask their doctors for a clinical breast
exam every year because mammography alone is not the answer.
My biggest concern about the latest commotion over
screening women in their forties is that we are sending a
message to these women that they need not be concerned about
breast cancer. Nothing could be further from the truth.
As Susan mentioned, some 34,000 women in their forties will
be diagnosed with this disease this year.
I also have a concern about women being told to make their
own decision. Yes; I think women should have a voice in their
health care. I think women of all ages, regardless of whether
they are 30, 40, 50, or 70, should be able to choose whether or
not to go through a screening.
However, the information that they are given has a lot of
impact on whether or not they choose to have screening. Many
women are under the impression that if they have no family
history of breast cancer, they do not need to be worried about
this disease. I had no family history of breast cancer, and the
truth is only 5 to 10 percent of women who are diagnosed with
this disease have hereditary breast cancer.
So there are many risk factors that we do not understand
that factor into a decision that even the doctors cannot always
guide a woman in her decision.
I am also concerned about studies that look only at
mortality as an end-point. There are many other issues of
concern: issues such as quality of life, issues about whether
or not a woman loses her breast to this disease, issues about
whether or not a woman has to have chemotherapy to save her
life. Because my cancer was found before it had spread to my
lymph nodes, I did not need to have chemotherapy. I did not
have that prolonged recovery, and it saved dollars, too. The
truth is it saved money.
prepared statement
I want more than anything to find a cure for this disease.
But until we find a cure, I think that all women over the age
of 40 should have access to the best possible screening
technology, and I think that all women of all ages deserve
better technology, better screening, better imaging, and
perhaps some technology that we have not yet thought of that
will find this disease before it takes a woman's life.
Thank you.
Senator Specter. Thank you very much, Ms. Rowden. Having
been involved yourself, your testimony and Ms. Visco's
testimony is especially powerful.
[The statement follows:]
Prepared Statement of Diana Rowden
My name is Diana Rowden, and I am Chairman of the Board of
the Komen Foundation. When I was 35, I had my first screening
mammogram. Although there was no breast cancer in my family, I
followed the screening guidelines, which at that time
recommended a woman have her first mammogram between the ages
of 35 and 40. Three and a half years later, I was diagnosed
with breast cancer. That screening mammogram played a key role
in the detection of my cancer.
My tumor did not show up on any mammograms nor could any of
my doctors feel a lump. But a radiologist who was very skilled
in reading mammograms did detect a change. This led to a biopsy
and the diagnosis of an invasive breast cancer. Fortunately,
the cancer had not spread to my lymph nodes, and I did not need
chemotherapy. Had the cancer already spread to my nodes, I
would have had chemotherapy, which would have meant prolonged
recovery and significantly higher cost for my treatment.
I started volunteering with the Susan G. Komen Breast
Cancer Foundation because I wanted to help educate women about
breast cancer. I know firsthand that screening mammography can
save lives. When telling my story to other women, I explain
that all women are at risk for breast cancer. I also tell them
that mammography is not a perfect tool, but that it can be of
benefit when combined with clinical breast exams and monthly
breast self-exam.
Compliance with screening guidelines among all age groups
is well below the level needed, and ambiguous screening
guidelines compound the problem. They make it that much easier
for women to doubt the need for any kind of breast cancer
screening.
I'm particularly frustrated by current government
guidelines. They send the message that women in their forties
need not worry about breast cancer. But nothing could be
further from the truth. It is estimated that in 1996, women in
their forties would account for 18.1 percent of newly diagnosed
invasive breast cancers. Women in their fifties were estimated
to make up 16.8 percent of the new cases.\1\
---------------------------------------------------------------------------
\1\ Source, American Cancer Society Surveillance Research, 1995.
---------------------------------------------------------------------------
Much has been said about the ``harms'' of screening women
in their forties: false negatives, false positives, over-
treatment, and anxiety. But these harms, or risks, are not the
exclusive domain of women in their forties. Women of all ages
experience anxiety when called back for a diagnostic work-up.
And mammography produces false negatives and false positives in
women of all ages.
Doctors and screening centers should explain the
limitations of mammography and the risks associated with any
screening. Women do not need to be discouraged from breast
cancer screening, but they do need informed consent.
The randomized clinical trials, which are being used as a
basis for determining whether to screen women in their forties,
use mortality as the end point: did the women die or not? I
urge you to consider other outcomes, which are also valid.
Women who have early diagnosis often have more surgical options
and less aggressive therapy. New research is leading to even
less invasive surgery, which will result in fewer complications
and shorter recoveries. This means savings in health care costs
as well as improved quality of life.
I am urging the government to change its guidelines to
include mammography screening for women in their forties. Until
we have a cure for this disease, ALL women over forty need
access to the best screening currently available. The
government needs to support better screening technology: ALL
women, including those under forty, deserve improved imaging or
some other method to detect breast cancer at its most treatable
stage.
summary statement of dr. ann marilyn leitch
Senator Specter. I would like to turn now to Dr. Ann
Marilyn Leitch, associate professor of surgery and the medical
director of breast disease programs at the University of Texas
Southwestern Medical School in Dallas. She was the president of
the American Cancer Society, Texas division, from 1995 through
1996, and presently serves on that division's board of
directors and as medical director at large.
Welcome, Dr. Leitch. The floor is yours.
Dr. Leitch. Thank you very much, Senator Specter and
Senator Hutchison, for allowing us to discuss an issue that is
very critical to the American Cancer Society.
You asked us in your invitation to discuss the findings of
the NIH Consensus Development Conference. We believe that the
conclusions reached by the panel were at variance with the data
that was presented and, therefore, did not offer women or their
physicians the best guidance.
Since the early 1980's, the American Cancer Society has
recommended mammographic screening for women in their forties.
In 1989, 11 other medical organizations, including the National
Cancer Institute, joined us in reviewing the data and issuing a
consensus statement that women in their forties should have
mammographic screening.
As you know, in 1993 the National Cancer Institute withdrew
their support of that recommendation citing a review of the
clinical data from trials and stating: ``Randomized clinical
trials have not shown a statistically significant reduction in
mortality for women under the age of 50.''
Today, this statement is no longer true. From data that was
presented at the consensus panel we have seen that two Swedish
trials have shown statistically significant reductions in
breast cancer mortality of 36 percent and 44 percent for women
invited to be screened with mammography.
In these trials, the benefit was observed after a longer
followup of 7 to 10 years. In addition, a meta-analysis, which
compiles the results from all eight clinical trials, has also
shown significant mortality reduction, and the numbers we have
had cited here are variable, but it is at least 16 percent.
When Dr. Klausner estimated that 1,600 lives would be saved
with mammography in this age group, if one takes the reduction
in mortality of 44 percent, which was reported in one of these
trials, we would see nearly 4,500 lives saved.
These studies provide a solid epidemiological evidence that
routine screening mammography is effective in reducing breast
cancer mortality.
The efficacy of mammography for women in their forties has
met the same scientific criteria that has existed for women
over the age of 50.
In 1993, when this data was reviewed, the observed benefits
of mammography were not considered to be statistically
significant. Now that more time has elapsed and further
analysis of these trials has been conducted, the benefits of
mammography have statistically been established according to
the criteria that are demanded.
I would like to touch a bit on the issue of risks that were
raised by the panel. The American Cancer Society believes that
in addition to downplaying the benefits of mammography, the
panel placed undue emphasis on the potential risk of
mammography, including the risk of a radiation-induced breast
cancer and the problems that arise from false positive or false
negative results.
We certainly believe these issues are important, and we
have devoted a lot of efforts to improving mammography quality
and interpretation. We have been in the forefront of that
fight.
But we fear that the unintended and unfortunate
consequences of this current debate will be to cause widespread
confusion among women and their physicians. This confusion will
not be confined to women that are 40 to 49. I am afraid it will
be conveyed to other women as well.
We are also concerned that the mixed messages that were
delivered by the panel may influence the health insurance
industry unduly to limit coverage for mammography for women in
this age group.
More importantly, what about the women who do not have any
third party carrier to provide for mammography and who depend
on public programs? What will our response be?
The American Cancer Society over the years has made
tremendous strides in educating women about the values of
mammography. We have broken down barriers of financial
problems, physical and psychological barriers. What we do not
want to happen now is that women will turn away from
mammography which, today, is the only tool that we have
available to detect a cancer early and reduce a woman's chance
of dying of breast cancer.
I take care of women every day. If a woman asks me what can
I do in my forties to prevent me from dying of breast cancer, I
tell her the first thing she can do is have a mammogram, be
examined by her physician, and practice breast self-exam on a
monthly basis.
The real or perceived risks of mammographic screening are
really very small. The risk of a radiation induced cancer is
really a theoretical risk and is far outweighed by the benefits
of mammography.
We know that a woman who has a tumor caught when it is less
than the size of a dime has a 90-percent chance of being alive
20 years after that diagnosis, and that is without
chemotherapy. That is with surgical treatment of breast cancer.
False positives and false negatives occur in any medical
test that is performed. We believe that emphasis should be
placed on improving mammography technology and interpretation,
rather than focusing on its shortcomings and throwing it out as
an appropriate modality for screening.
Breast cancer is one of the greatest health concerns of
women in the United States. And 1 in 64 women in their forties
will be diagnosed with this disease. It accounts for 18 percent
of the cancers that occur in women. Breast cancers that occur
in women occur in women in their forties.
It represents 12 to 15 percent of the cause of death for
women ages 30 to 59.
We do not believe it is good science or good public health
policy to limit screening for women ages 40 to 49 to those who
reportedly have a high risk. What we know is that most women
diagnosed with breast cancer in this age are not identified
ahead of time as having high risk. Thus, they would be deprived
of the benefit of early detection.
The American Cancer Society, despite the findings of the
panel, stands by its current guidelines for mammographic
screening. We believe that women in their forties should have
access to screening every 1 to 2 years and after age 50 on an
annual basis.
In early March, the American Cancer Society will convene an
expert panel to address these very issues. We are going to
review all of our current guidelines for mammographic screening
with all age groups.
prepared statement
We will review the data that was presented to the NIH
conference. Of particular importance to us is the issue of the
interval of screening. The data seem to suggest that for women
in their forties, the interval of 1 year may provide a greater
reduction in mortality than the current recommendation we have
of every 1 to 2 years.
We appreciate this opportunity to talk with you and the
attention that you have paid to this issue.
Senator Specter. Thank you very much, Dr. Leitch.
[The statement follows:]
Prepared Statement of Marilyn Leitch, M.D.
Mr. Chairman and members of the committee, I am grateful for the
privilege to be here today. The American Cancer Society commends you
for your concern about the impact of medical guidelines on health
practice and for calling upon our expertise on issues related to
reducing suffering and death from cancer.
The American Cancer Society (ACS) is the nationwide, community-
based voluntary health organization dedicated to eliminating cancer as
a major health problem by preventing cancer, saving lives from cancer,
and reducing suffering from cancer, through research, education,
advocacy, and service.
Mr. Chairman, in your invitation to the American Cancer Society,
you asked us to discuss the findings of the NIH Consensus Development
Conference on Breast Cancer Screening in Women ages 40-49. We believe
that the conclusions reached by the Panel were at variance with the
data presented, and therefore did not offer women and their physicians
the best guidance. Despite the review of a meta-analysis, two separate
reports of clinical trials, and numerous presentations of clinical
data, which have all demonstrated a decrease in breast-cancer mortality
and improved prognoses due to mammography in women ages 40 to 49, the
Panel concluded ``that the available data do not warrant a single
recommendation for mammography for all women in their forties.'' This
conclusion was surprising in light of the data presented by European
and U.S. investigators.
Since 1983, the American Cancer Society has recommended that women
ages 40 to 49 get regular mammograms. Due to inherent limitations in
the existing eight randomized controlled trials, the scientific basis
for this recommendation has not been as strong as that for women ages
50 and older. However, breast cancer is a serious health problem for
this age group, and this has led the ACS and other organizations to
carefully evaluate these and other data sources, and to periodically
review new data related to breast cancer detection in this age group.
When we first issued this guideline, we were confident that evidence of
benefit was sufficiently compelling to recommend regular mammograms to
women in their forties. It was the best advice. In 1989, 11
organizations, including the National Cancer Institute (NCI), reviewed
the data and joined together to issue a consensus recommendation that
women in their forties have regular mammograms. We reaffirmed that
position in a subsequent review of the evidence in 1992.
In 1993, following an international meeting to review recent data
on screening in women aged 40 to 49, the NCI withdrew its
recommendation for regular screening for women in their forties on the
basis that ``* * * randomized clinical trials have not shown a
statistically significant reduction in mortality for women under the
age of 50.'' Today this statement is no longer true. With the release
of two Swedish studies and a meta-analysis of all of the studies, we
now have solid epidemiological and clinical evidence that routine
mammography screening is effective in reducing breast cancer modality,
efficacy of mammography for women in their forties has met the same
scientific criteria as has existed for women over the age of 50.
Mr. Chairman the limitations of existing data have contributed to
the controversy over breast cancer screening for women in their
forties. Of the eight studies, only one was specifically designed to
evaluate the question of benefit for women ages 40 to 49, and the
conduct and results of that study have been controversial. The others,
the first of which began in the early 1960's, were designed to evaluate
the benefits of mammography in a wide age group of women, generally
women 40 to 70 years of age. In 1993, experts convened to discuss the
intermediate findings of the studies and acknowledged the data
limitations. Of particular concern was the small number of women in
their forties in each of the trials. The seemingly-observed benefits of
mammography were not statistically significant, that is, chance could
not be ruled out as an explanation for the observed benefit. Now that
more time has elapsed, and further analysis has been conducted, the
benefits of mammography have been statistically established according
to conventional criteria.
Since 1993, we have learned a great deal about breast cancer
detection in women in their forties. In fact, the genesis for the
recent NIH meeting held in Falun, Sweden in March 1996. Updated
analyses of individual and combined trial data, mathematical modeling,
and reports from community-based screening programs provide very strong
evidence of the benefit of screening. These findings led the NCI to
announce in late Spring that it would hold a consensus conference to
review the recent evidence. The Panel received an update on the
clinical trials on the efficacy of mammography. Two Swedish trials now
show statistically significant reductions in mortality of 36 percent
and 44 percent for groups invited to be screened. In these trials, the
benefits were observed after 7-to-10 years of follow-up. A meta-
analysis, or statistical compilation, of all seven population-based
clinical trials, or all eight clinical trials, has shown a significant
mortality reduction due to mammography. These studies provide clear
evidence that thousands of women's lives may be saved each year through
the availability of mammography for women ages 40 to 49. Indeed,
widespread participation in mammography by women in this age group has
already contributed to lives saved that otherwise would be lost,
according to a report in the Journal of the National Cancer Institute
in November 1996.
We acknowledge that we do not know the ultimate degree to which
mammography screening of women in their forties will reduce the risk of
breast cancer death, but it is probably higher than what has been
observed in the trials to date. Further, we have made significant
progress in the quality of mammography over the past several decades,
and in the United States all mammography facilities are required to
meet minimum standards and to be certified under the Mammography
Quality Standards Assurance Act.
In addition to the disappointing final recommendation of the
Consensus Development Conference, the American Cancer Society believes
the Panel placed undue emphasis on several issues related to the risks
of mammography. Though the issues of risk are important and should not
be ignored, we fear that an unintended and unfortunate side effect of
the current debate will be to cause widespread confusion and concern
among women and physicians, and that mixed messages might unduly
influence health insurance companies' coverage decisions. Over the
years. we have made superb strides in educating women about mammography
by breaking down financial, physical, and psychological barriers to
women seeking mammography screening based on our once-universal
guidelines. We fear that existing barriers and negative attitudes
towards mammography might be reinforced by this negative attention, and
women of all ages might turn away from mammography as today's most
important means of fighting breast cancer.
Risk of radiation-induced cancer
The risk of radiation-induced breast cancer from low-dose
mammographic exposures is a theoretical possibility, but no scientific
studies have ever observed carcinogenesis at such low doses. We believe
the known benefits of mammography outweigh any hypothetical risk for
future breast cancer due to radiation.
False positives and false negatives
False positives and false negatives are inherent to all medical
tests. We believe emphasis should be placed on improving mammography,
not identifying its shortcomings and abandoning the screening method
altogether. Strategies to manage or reduce anxiety, to the extent that
it exists, requires greater attention and further research.
Breast cancer is one of women's greatest health concerns, and for
good reason. One in sixty-four women in their forties will be diagnosed
with this disease. Breast cancer deaths represent 12-to-15 percent of
deaths for women ages 30 to 59. We believe it is not good science or
good public health to say that the needs of women ages 40 to 49 will be
met if guidelines are established to screen only those who fall into
certain risk categories. We know that such provisions will leave the
majority of women diagnosed with breast cancer in their forties
unprotected.
The economics of health care are another important and undeniable
aspect of this debate. Policy makers are struggling with the issue of
the cost-effectiveness of mammography. Because of the comparatively-
lower incidence rate of breast cancer in women under age 50 and the
higher ratio of benign to malignant biopsies in this age group, the
costs of detecting cancer for women in their forties is higher.
However, these costs must be weighed against the cost of more extensive
care due to treating an advanced case, and more importantly, the cost
of the loss of life.
The American Cancer Society believes that women should have access
to breast cancer screening every one-to-two years for women in their
forties and annually for women age 50 and over. We believe that women
should talk with their providers and be given all of the evidence in
order to reach an informed decision. The American Cancer Society will
continue to provide information designed to inform women of the
benefits and limitations of mammography screening. We are confident
that armed with information, women and their health care providers will
see mammography as the best current strategy to reduce death from this
disease.
In early March, the American Cancer Society will convene an expert
panel to review the Society's current guidelines for breast cancer
screening for women of all age groups and will include the new data
that were presented at the NIH Conference. Of particular importance is
the issue of screening intervals; existing data that were presented
suggest that the mortality benefit might be even greater if women ages
40 to 49 are screened annually, rather than at the Society's current
recommendation of every one-to-two years.
Thank you.
summary statement of dr. barbara monsees
Senator Specter. We now turn to Dr. Barbara Monsees, who
has served as associate professor of radiology at the
Mallinckrodt Institute of Radiology at Washington University
School of Medicine since 1990. She was appointed as chief of
the breast imaging section of the institute in 1993 and also
serves on the cancer information center medical advisory board.
Welcome, Dr. Monsees. The floor is yours.
Dr. Monsees. Thank you. Thank you for focusing attention on
this issue, which I think is so important. I would like to
reiterate some points that were just made.
I am going to focus my remarks primarily on the NIH
consensus conference process, as I was asked to do. Let me say
from the start that I believe that we do now have clear
scientific proof that mammography screening for women ages 40
to 49 can substantially reduce the death rate from breast
cancer.
At the conference, as just stated, updated information was
presented by investigators from the five major population based
screening programs in Sweden. Their most recent data shows a
statistically significant mortality reduction in two of the
clinical trials--as stated, 44 and 35 percent mortality
reductions.
These findings are very compelling because they show even
greater mortality reduction than the two earlier trials which
everybody uses and has demonstrated benefit for women over age
50--an age group which everybody acknowledges we should screen.
Also presented were meta-analyses, multiple different meta-
analyses. Whether or not the Canadian trials were included, all
of them were statistically significant. They ranged from 15- to
24-percent mortality benefit.
It is very important to note at this point in time that
randomized, controlled trials inherently underestimate the
actual benefit of screening, which is likely to be
substantially greater than measured in these trials.
In brief, I believe that if screened annually, using
today's improved mammographic equipment and techniques, breast
cancer deaths in women could be reduced in women of all ages by
40 percent or more.
In 1993, the NCI set statistically significant mortality
reduction as the requirement for accepting screening for women
in their forties. This requirement has now been met. These new
data should have been a key factor in the panel's
recommendation for supporting screening of women age 40 to 49.
Unfortunately, for as yet unexplained reasons, the consensus
panel chose to ignore the recent data presented and based their
statement on old data analyzed at the 1993 NCI meeting.
Senator Specter. Would you repeat what you think the
consensus panel ignored, please, Dr. Monsees?
Dr. Monsees. The consensus panel did not comment on the
Swedish trials that showed a 44-percent and a 36-percent
result. Each trial alone was statistically significant. They
gave an upper bounds of estimate of benefit of 30 percent.
Whatever the reason the panel chose to do this, I think it
is critical that we keep the scientific question of proof of
benefit as the basis for determining guidelines.
The issue of whether we should assign health care dollars
to screening should be kept separate from this process. That is
in your ball park.
If the purpose of this consensus conference was to analyze
the new data, the panel should have either accepted the new
data as proof enough to recommend routine screening for all
women over 40 or they should have refuted it. They did not.
In ignoring the new data, the panel's report reflects an
unbalanced presentation of the facts and has, unfortunately, a
surprising preoccupation with risks which are not unique to
women age 40 to 49.
Clearly, the 1993 NCI policy reversal created serious
controversy and substantial confusion among American women on
this issue. This situation was summarized in a report by the
U.S. House of Representatives Committee on Government
Operations entitled: ``Misused Science, the National Cancer
Institute's Elimination of Mammography Guidelines for Women in
Their Forties.''
The 1994 report concluded that the NCI failed to examine
objectively all the scientific evidence and excluded the
presentation of favorable information. This seems to have
happened again.
Given the controversial history and complexity of the
issue, I would like to pose a few questions for your
consideration that need to be carefully examined. Could this
issue have taxed the NIH consensus development model beyond its
intended purpose? Were the panelists given adequate time,
information, and instruction regarding the rules of evidence in
order to formulate the report?
As an observer in the audience, I can surely attest that
there was inadequate opportunity for comments from those with
opposing views. What were the roles of NCI staff in the
selection of exclusion of panelists, speakers, and topics?
One can only wonder how the influence of those involved in
the 1993 NCI policy reversal played out in the formulation of
the new panel and their report. Meanwhile, the panel's report
has only deepened the controversy and the public's confusion on
this important subject.
In conclusion, I hope the National Cancer Advisory Board
will reexamine all the evidence in an unbiased fashion and
conclude that mammography screening for women age 40 to 49 does
save lives.
I believe that the data are compelling and should be
accurately communicated to women who, ultimately, must decide
for themselves whether they want to be screened.
Separate from this issue, I believe that funding for
research must be a continued priority and one I hope, Mr.
Chairman, that the subcommittee will again vigorously support.
prepared statement
While it is certainly important that we continue to search
for new methods of prevention and for cure for breast cancer, I
do not think we should ignore this evidence that we now have
and the means already available to save women's lives today.
Thank you for the opportunity. I would be happy to answer
any questions.
[The statement follows:]
Prepared Statement of Barbara Monsees, M.D.
My name is Barbara Monsees. I am a physician practicing at Barnes-
Jewish Hospital and I am the Chief of the Breast Imaging Section at the
Mallinckrodt Institute of Radiology at the Washington University School
of Medicine in St. Louis, Missouri.
Thank you, Mr. Chairman, for inviting me to present the following
statement on the recent NIH Consensus Development Conference. I would
like to share my perspectives both as a medical professional and as a
woman who is a survivor of early breast cancer detected by a mammogram.
purpose of consensus conference
This consensus conference was convened to examine new breast cancer
data for screening women ages 40 to 49 that has become available with
longer follow-up periods since the 1993 decision by the National Cancer
Institute (NCI) to remove its support for screening women in this age
group. The purpose of the conference was to determine the answers to
these basic scientific questions. Does breast cancer screening for
women aged 40-49 save lives? If so, how large is the benefit? How do
these change with age? What are the other benefits? What are the risks?
I think it is critical that we keep these questions separate from the
issue often debated by health policy makers of whether or not we should
assign health care dollars for screening these women.
new evidence for women 40-49 years old
Let me say from the start, I believe there is now clear scientific
proof that mammography screening for women ages 40-49 can substantially
reduce the death rate from breast cancer. At the conference, updated
information was presented by investigators from the five major,
population-based, screening programs in Sweden. Their most recent data
shows a statistically significant mortality reduction in two of the
clinical trials of 44 percent and 35 percent, respectively. These
findings are compelling because they show even greater mortality
reduction than the two earlier trials demonstrating benefit for women
ages 50 and over an age group for which the benefits of mammography
screening are widely accepted. Also presented was an overview meta-
analysis of all five Swedish trials which revealed a 23 percent
mortality reduction. Adding the other clinical trials performed in
Edinburgh and the Health Insurance Plan (HIP) of Greater New York to
this meta-analysis maintain the 23 percent reduction. All of these
analyses are statistically significant. Two other meta-analyses of the
seven population-based randomized trials, have shown a 24 percent
mortality reduction for women aged 40-49. These meta-analyses have been
published in peer-reviewed medical literature in 1995 and 1996.
In addition, randomized controlled trials (RCTs) inherently
underestimate the actual benefit of screening which is likely to be
substantially greater than that measured in trials. In RCTs, breast
cancer deaths are compared between two groups. The study group is
invited to be screened, but not all women accept; their compliance with
screening has varied in the different trials. The other group, the
control group, is not invited to screening and they get their usual
health care. Some of these women have mammograms anyway and
``contaminate'' the control group. Both non-compliance by the study
group women and contamination by the control group women diminish the
measured benefit. Therefore, the actual benefit to women who partake in
screening is likely to be of a greater magnitude than indicated by
trial results. Furthermore, only one of the trials screened women in
their 40's on an annual basis, (screening intervals for these trials
varied from 18 to 28 months). Before the most recent data was known, it
had been estimated that if women in the two-county Swedish trial had
been screened annually, mortality reduction for women would have been
at least 35 percent.
Finally, mammographic equipment and technique has improved
remarkably since the 1980's when these clinical trials began. Standard
use of two mammographic views per breast improves the sensitivity and
specificity of mammography when compared to the one view per breast
exam used in some of the trials. In brief, if screened annually, using
today's improved mammographic equipment and techniques, breast cancer
deaths in women could be reduced by 40 percent or more.
related issues
The quality of mammography for American women continues to improve
through the accreditation programs of the American College of Radiology
(ACR) and their publications for physicians, physicists and
technologists, as well as national implementation of the Mammography
Quality Standards Act (MQSA) of 1992 through the Food and Drug
Administration (FDA).
Because of doubts about the validity of the results from the
National Breast Screening Study of Canada (NBSS) trials, there has been
much debate about whether their results should be considered in current
medical decision making although this trial was the basis for convening
the 1993 conference. Even if results from this trial are included in
the meta-analyses, there is an 18 percent reduction (still
statistically significant) in breast cancer deaths for women screened
in their 40's. Yet, substantial differences in its design as well as
its widely criticized deficiencies set the NBSS trials apart. All the
other RCTs were population based, while the NBSS was volunteer based.
In addition, significant bias was probably introduced into the trial
since women with obvious cancers were allowed to participate. The
randomization in the NBSS has been subject to much criticism and is the
most likely explanation for the excessive late-stage fatal cancers in
the study group. This methodological flaw likely resulted in a lack of
demonstrable mortality reduction in the NBSS. In addition, the quality
of the mammography in the NBSS was widely criticized. As noted by the
reference physicist, it was ``far below state of the art, even for that
time (early 1980's).''
origins of the controversy
In 1993, NCI set statistically significant mortality reduction as
the requirement for accepting screening for women in their 40s. This
requirement has now been confirmed by the new Swedish data referenced.
This new data presented at the consensus conference should have been a
key factor in the panel's recommendation for supporting screening of
women aged 40-49. Unfortunately, for as yet unexplained reasons, the
consensus panel chose to ignore the recent data and based their
statement on old data analyzed at the 1993 NCI meeting. This was the
same follow-up data used by the NCI to explain its withdrawal of
support for screening at that time.
If the purpose of the consensus conference was to analyze the new
data, the Panel should have either accepted the new data as proof
enough to recommend routine screening for all women over 40, or they
should have refuted it. In ignoring the new data, the Panel's report
reflects an unbalanced presentation of the facts and has a surprising
preoccupation with risks not unique to women aged 40-49.
Clearly, the 1993 NCI policy reversal created serious controversy
and substantial confusion among American women on this issue. This
situation was summarized in a report by the U.S. House of
Representatives Committee on Government Operations entitled ``Misused
Science: The National Cancer Institute's Elimination of Mammography
Guidelines for Women in Their Forties''. The 1994 report concluded that
the ``NCI failed to examine objectively all of the scientific evidence
on mammography'' and that the NCI ``excluded the presentation of
favorable information on mammography screening''. This seems to have
happened again. I think it is pertinent to point out that the current
NIH consensus process was overseen by a number of the same NCI staffers
who were criticized in this congressional report, some of whom are
known to oppose screening for women of this age group. Early in the
formulation of this conference, a number of my colleagues expressed
serious reservations about the selection of panelists, speakers and
agenda for the conference. All involved knew that this would be a hotly
debated issue and that the consensus conference would need to be fair
and credible.
I would like to note a few examples in the Panel's statement that
are factually inaccurate or misleading. Specifically, the Panel's
statement:
--Reports that the studies may show a benefit that is as great as 30
percent. However, the data provided from the Gothenburg RCT
shows a 44 percent decrease in deaths for these women.
--Suggests that the benefit in the new data could have been the
result of clinical breast examination (CBE) among the screened
women. This is completely unfounded in that CBE was not part of
the Swedish RCTs. This statement underscores the apparent
discordance between the scientific data presented during the
meeting and the conclusions drawn in the Panel's statement.
--Cites estimates only for women in their 40's without any frame of
reference with respect to women of other age groups. One of the
charges to the Panel was to provide information about how risks
and benefits of screening ``change with age''. So that the
public can put this information in the appropriate context,
comparable statistics should have been given for screening
women aged 50-59 and 60-69, where screening is widely accepted.
--Dwelt on screening harms, while dismissing data showing that the
recall rates and biopsy recommended rates are nearly the same
regardless of age. The statement that ``10 percent of all
screening mammograms are read as abnormal'' will likely mislead
women to believe that ``abnormal'' directly translates to
unnecessary biopsies. In most cases, this means a few extra
mammographic views or an ultrasound. Only 0.5 percent (one-half
percent) of women between 40-49 who are screened will need to
be biopsied based on the results from a routine mammogram.
Given the controversial history and complexity of this issue, I
would like to pose a few questions for your consideration. Could this
issue have taxed the NIH consensus development model beyond its
intended purpose? Were the panelists given adequate time, information
and instruction regarding the rules of evidence in order to formulate
their report? As an observer in the audience, I can attest that there
was inadequate opportunity for questions and comments from those with
opposing views. Perhaps the Panel was unwilling to look at the new data
because of these evidentiary rules. What were the roles of NCI staff in
the selection or exclusion of panelists, speakers and topics? One can
only wonder how the influence of those involved in the 1993 NCI policy
reversal played out in the formulation of the new panel and their
report. These are questions I cannot answer here today, but I believe
should be examined in the near future. Meanwhile, the Panel's report
has only deepened the controversy and the public's confusion on this
important subject. It has left women of all ages wondering about the
benefits and risks of mammography screening, creating doubt, aniexty
and resentment. We can only hope that it has not raised new barriers to
screening which will translate into lost lives.
where should we go from here?
In conclusion, I hope the National Cancer Advisory Board (NCAB)
will re-examine all the evidence in an unbiased fashion and conclude
that mammography screening for women aged 40 to 49 does save lives. I
believe that the new data is compelling and should be accurately
communicated to the women of this nation who ultimately must decide for
themselves whether to be screened.
Separate from this issue, I believe that funding for research must
be a continued priority and one I hope, Mr. Chairman, the Subcommittee
would again vigorously support. While it is certainly important that we
continue to search for new methods of prevention and cure for breast
cancer, we should not ignore this evidence and the means already
available to save women's lives today.
a breakpoint in incidence--age 40
Senator Specter. Thank you very much, Dr. Monsees. I am
going to have to excuse myself for a few minutes in a moment or
two. But I would like to raise one question about the magic of
age 40 with Dr. Leitch and Dr. Monsees.
Why 40? Why not 39, or 38? Why do you have a break point
there?
My own sense, from the experience I had, would be to do it
at an early stage, if there is any concern, and there is reason
for concern by just about everybody. You do not necessarily
have to act on what you have found with the biopsies, et
cetera. But what is the magic about age 40, Dr. Monsees?
Dr. Monsees. There is no magic about 40. That is a good
point.
What we do is we look at age-specific incidence. In other
words, if you took women all in their forties and compared them
to women in their fifties, and compared them to women in their
sixties, and you look at in each decade of life how many women
get breast cancer, it goes up with age.
Senator Specter. Would you select the age of 40 if you had
the job of selecting an age?
Dr. Monsees. That is a good question. I probably would,
right around that time, I would say.
Senator Specter. How about you, Dr. Leitch?
Dr. Leitch. Yes; I think it represents a breakpoint in the
incidence; 5 percent of the cases of breast cancer occur below
that age, and then you go from a little more than 4.5 percent
in the thirties to 18 percent in the forties.
So I think that that represents a reasonable breakpoint.
What I think has been confused a bit here is the issue of
someone who has identified high risk, for example, a strong
family history that suggests genetic predisposition, and the
breast cancer in their family members occurred in an early age.
That is a woman who really falls outside of what we consider
average risk for screening guidelines.
And so, that woman may well need to be screened in her
thirties.
Senator Specter. I am going to pick this up when I return.
We have a previously scheduled announcement of chief counsel
for our Veteran's Affairs Committee on Gulf Syndrome.
I am going to ask Senator Hutchison to proceed.
You may have a very long round, Senator Hutchison. I will
be back as soon as I can. If you run out of questions, put us
in recess and I will be back as soon as I can.
Senator Hutchison. Thank you, Mr. Chairman. I probably will
not be able to stay until you come back because I have another
appointment, as well. But I will do my round.
Senator Specter. OK. Then we can be in recess, and I will
return as soon as I can.
Senator Hutchison [presiding]. Thank you.
Let me ask the question of where we can best use the
Federal dollars. There was the issue, and I think Ms. Visco was
in on the decision, to target the money more toward the
scientific research than the breast cancer awareness action
project--the breast cancer action plan, I should say.
I would like to know from Ms. Visco on that issue and also
from the rest of you who would like to respond where you think
we can do the most good. That we are relying on two Swedish
studies as our best effort gives me some concern. With the
millions that we are putting into breast cancer research, it
seems that we ought to have at least some statistics of our own
and trials of our own that would have been well developed
enough to have shown statistics by this point.
But if we do not, what do we need to do to get the best use
of our Federal dollars toward the cure or toward the technology
for better detection? I would start with Ms. Visco and then go
to any of the others of you who have an opinion on the bigger
question, but first on the targeted question of the breast
cancer action plan money.
Ms. Visco. Well, the National Breast Cancer Coalition has
been a voice here on Capitol Hill since 1991, demanding more
money for breast cancer research. As you have heard of the
history of the increase in funding, with our partnerships in
Congress we have been very successful. We all recognize, as I
am happy to hear, and the Senate does also, that it is not
enough and we need to continue that. You have heard all of the
questions that we do not have an answer to. In fact, the
consensus plan identified a number of questions that we really
need to research, that we do not have answers to those
questions.
So we need to increase money, without question, into
research, both basic and applied research, clinical trials in
this area.
We also need to increase our efforts in outreach. Outreach
is done to a great extent in the private community. There are
many organizations like the Komen Foundation, Why Me? many
organizations, such as the Breast Cancer Resource Group, many
organizations that do outreach, get the word out, and try to
educate women.
In addition, the Federal Government places a great emphasis
on that and has a number of programs doing that.
Now all of those questions are pretty much aside from what
the steering committee of the national action plan on breast
cancer decided to do. The plan is a narrowly focused, well-
defined effort, and I will give you outside of the hearing as
much information as I can. I would be happy to sit down and
talk to you about it.
The steering committee, the plan identified six priorities.
The plan is a public-private partnership. It is an unusual
public/private partnership. We truly are equal partners in this
effort.
The Komen Foundation, the American Cancer Society, the
coalition--a number of outside organizations sit on that
steering committee in addition to various government
representatives.
We developed a plan within six priorities. We have working
groups within those six priorities that are across the country.
Membership from each of those working groups is from the
scientific/medical consumer, from all of the players that
should be at the table designing strategies.
Our intent is to design strategies where we see gaps, and
then to encourage those strategies to encourage the Government,
to encourage private, to encourage the scientific community,
everyone, to implement those strategies.
What we never wanted to do was institute a new bureaucracy,
a new funding mechanism.
Now this is the way the plan has worked. We came to the
determination that in order to do what the plan is supposed to
do, we needed about $4 million.
When the appropriation came for more than $4 million, we
said to the Congress--and we thought in a very responsible
way--that we really do not want to waste these resources, this
is the amount of money that this public/private partnership
determined unanimously that we need to spend. We believe that
the rest of the money should stay in the National Cancer
Institute budget, where it is now, to fund what we all agree is
underfunded resource into breast cancer.
Senator Hutchison. Thank you.
I would like now to open it to the panel on the bigger
question of where we can do the most good with our Federal
resources. Dr. Leitch.
Dr. Leitch. I think that I have a perspective on that which
may be a little bit different from some people here. Our
teaching hospital is a county hospital in Dallas. We see a
large number of minority women. In fact, they account for about
75 percent of the women that we see in our screening program.
So, in this population we have been able to see the costs
of taking care of women who are diagnosed late with breast
cancer. In our population in the 1980's, and really up until
the early 1990's, about 40 percent of our patients were
diagnosed with stage 3 or 4 disease, had never had screening
mammography, had never had any introduction to what was
involved, never entered the health care system prior to that
time.
When you have to take care of a woman with that stage of
disease, the cost to the system and whether that is Federal
dollars, State dollars, or county dollars, is tremendous. Not
only do those women have the cost of their care, many of them
are young women who have children. They have jobs that require
physical labor. They quit their jobs. They request disability.
There is public assistance that is required.
When they die, if their children are still minors, there is
the support of those children that remains.
Those types of costs are very hard to get into the record
in terms of estimate. In my view, when I am looking at the
dollars I would want to spend in our county hospital, I would
say I would rather spend the dollars to detect the cancer early
when I can treat it less aggressively, save money for the
system, than to let people wander in with tumors growing out of
their breast, which they do--I mean, we see this every week--
and then have to deal with that tragic consequence.
That is the way I would do it.
On the issue of research dollars going into mammography
versus going into understanding the nature of breast cancer and
how it develops, I do not think that we need to, say, do
another trial in the United States, for example, which may be
what you were referring to. I think it may be very hard to do
here because I think there is a lot of public sentiment that
women should be screened in this age group.
But what we do need to do is to take advantage of
information we already have about screening in the United
States. Dr. Klausner mentioned the NCI Breast Cancer
Surveillance Consortium, which puts together a data base of
mammographic data in the United States and would give us a
picture of that. That particular project needs more funding so
that we can really look at what goes on in quality programs of
mammography in the United States. What is the cost of it, what
is the false negative rate, what can we do to improve
techniques?
That would be very helpful, I think.
Senator Hutchison. Is that on the drawing boards for
Federal funding?
Dr. Leitch. I believe it is on for funding but is not
completely funded. It is for a continued funding request.
Senator Hutchison. I am very glad that you brought up the
perspective that you have from the county hospital, the
Parkland Hospital, and how early detection can become a
priority. Probably I think you have made a very good case for
it saving as many lives as research in the other direction. So
I am glad to have that perspective. It also calls for more
outreach. There is no question there.
Dr. Leitch. I would point out that when we implemented a
mammographic screening program in our hospital, the cases that
were diagnosed of breast cancer in those women were far weighed
to stage zero or 1, whereas the women who were not involved in
that screening program continued to come in with these very
advanced cancers.
Senator Hutchison. Dr. Monsees.
Dr. Monsees. I would like to share the same viewpoint, and
that is that I think we need to move now from validation of
screening mammography, which I think we have already done--we
know there is a mortality benefit--to implementation of
programs for the underserved. The population that was just
spoken of, that is the type of population that needs to be
reached--rural areas and the underserved in urban areas.
These women do not have access. They do not have the same
information or network to give them what they need to make
their own decision. This is what we are all talking about
today.
So I think we need to move from validation, which I think
has been done, to implementation.
The reason I am saying it in this way is that you raised
the question should we have our own study in the United States.
I think the answer, unfortunately, is going to have to be no to
that.
If we started a randomized controlled trial today, it would
take many years to come to fruition. It would take millions of
women, and it would likely be no more information than we have
now because in the United States there is widespread screening.
It would be very hard to tell people you cannot get screened
and you go get screened. This would not work.
Senator Hutchison. Well, it would be wonderful to have a
project for which no one volunteered. I think that says a lot
about perhaps the education efforts that we have made.
Dr. Monsees. Yes; so I think I would like to see focus on
these outreach programs so that we can reach women today who we
can help and at the same time have another strategy for basic
research. The technologies that were spoken about earlier--PET
scanning, magnetic resonance imaging, other types of things,
such as symptom mammography, which is a nuclear medicine test,
et cetera--these are technologies that we need to work on and
we need to put some dollars into so that we can see what role
they will have.
But if we start those projects today, I do not expect that
it is going to help this generation of women. That is for the
next generation of women. And if we put all of our dollars
there and abandon outreach with a product, mammography, that we
know we can use now and save lives, then we are going to
sacrifice those women alive today.
So my absolutely recommendation is that we have a two-
pronged approach here, that we start implementing and that we
look for ways to prevent breast cancer and cure it.
Mammography cannot do either of those. Mammography takes
advantage of what is called the window of opportunity. We can
find it, perhaps, when it is there and diagnosable, but that it
has not yet spread. And we can alter the national history of
the disease.
That is all it can do. It cannot prevent or cure in any
other way.
Senator Hutchison. Let me ask you, any of you, again, how
important do you think it is that the National Cancer Institute
come out with a clear guidelines that, yes, says what the
minimal risks are but goes back to the 1993 standard of
recommending mammograms between the ages of--well, I don't know
if they were at 35 or 40, but either 35 or 40 to 49 every other
year and then annually after that? Do you think it is important
that we have a clear signal from the National Cancer Institute
along these lines, perhaps with some changes, but something
clear? Or do you think we can continue with the progress that
we are making if the message remains muddled, as it has come
out from this panel?
Ms. Braun. Senator, I think we need a very, very clear
signal from the National Cancer Institute, and although the
points are very well taken and we agree with them that women
should be presented with all of the data, both the benefits and
the risks of mammography, as we know them to be today, that a
very clear signal is important for those who either do not have
the time or the interest in reviewing all of the data
themselves and, rather, would rely on others' recommendations,
and also because it will be critical, we know, in insuring
insurance coverage for women in the younger age bracket that
might otherwise not happen because the guidelines are not
definitive. Therefore, it would give any third-party payer a
rational excuse, if you would, to not cover mammography for
this group.
In addition, it simply sends confusion. One of the speakers
spoke earlier, and we have seen this again and again, as we
have spoken to our constituents, not only for the age group 40
to 49--because neither 50 nor 40 a magical cut-off point--that
it sends an unclear message about the value of mammography
overall. We are concerned that it might then also cut into the
utilization of mammography for women in the older age groups,
as well as those younger than age 50.
Ms. Visco. Senator, I believe that it is incumbent upon all
of us, including the National Cancer Institute, to tell women
clearly what the facts are. Sometimes the facts are that we
don't know, and sometimes the facts are just not very simple.
They are complex.
I think that is what the NCI must do. I do not think they
should issue guidelines based on two studies. That is not
scientifically sound. That is why we do meta-analysis and look
at several studies.
So I think it is incumbent upon the National Cancer
Institute to be clear about what it is we know and do not know
about mammography for women in this age group, and not to
simply say: ``do it.''
Senator Hutchison. Do you think it was a mistake pre-1993
to have guidelines that started this process of mammograms?
Ms. Visco. Yes; I do, because I think the guidelines at
that time were not based on scientific data. They were based on
a hope and a guess that if it worked in women over 50, it
should work on women in their forties. But we are talking about
screening a population. We are not talking about individual
women who feel that there is something wrong, or who are in a
high risk category, or women who simply want to have a
mammogram. We are talking about sending all women in their
forties a message: get a mammogram every year.
I believe that women are entitled to much more information
than that. They are entitled to know the pros, the cons, the
risks, the benefits, and that is what the consensus panel said.
Senator Hutchison. Do you think that you could write a
guideline that would state what the recommendation is and then
state the risks?
Ms. Visco. Yes; I do. I have a great deal of faith in
women. I work with them all the time across the country--breast
cancer activists and survivors. I think they are capable of
understanding complex messages.
I think it is incumbent upon us to get them the true facts,
and if it is complicated, then we have to find a way to help
them understand it. That is what we must do, rather than just
send a simple message that is not necessarily the right
message.
Senator Hutchison. Dr. Monsees?
Dr. Monsees. I fully support that women be informed and
that women can make their own health care decisions. I think
that that is absolutely crucial.
But one thing has been left out here, and that is that the
panel statement does not accurately reflect the facts. That is
a problem.
If we are going to give them the information, we had better
give them the correct information. We do not say that the best
mortality reduction you can expect is 30 percent when, in fact,
a trial has shown 44 percent.
I will remind Ms. Visco that the same type of evidence that
was once available to prove benefit for women over 50 was two
statistically significant trials. We now have the same level of
evidence, but even better, for women 40 to 50.
Why does it constitute proof for women over 50? But now the
rules have changed. Now it has to be better than that. We have
the same level of evidence for women 40 and up, and we should
begin screening, we should recommend screening, but we should
tell them the downside. We should say no test is perfect and
these are the limitations. When it comes down to the bottom
line and a woman asks, and she looks you straight in the face,
and she says tell me what I can do to minimize my death from
breast cancer if I am going to get it, at the top of the list
is going to be mammography.
Senator Hutchison. Dr. Leitch?
Dr. Leitch. I think the statement earlier that reflects the
importance of the NCI coming out with a specific statement is
the very one that Senator Specter made. The NIH panel has
identified with the NCI. When people see the results of that
consensus panel, they say this is the Government's position on
this issue. How does that then play out?
Well, if we are going to have Federal programs to fund
mammography, if the NCI position is that we are not certain it
is beneficial or specifically does not recommend it in that age
group, then how can you justify Federal funding for that
particular issue.
Like it or not, the NCI is identified with that panel to
some degree, even though--and here Dr. Klausner's statements
are perfectly true--the panel was designed to be independent,
divorced from the Government. Yet, the perception is that this
view reflects the NCI.
So the NCI needs to come out with a specific statement of
what their opinion is. If they do not think it is appropriate
for women to be screened, they need to say that's their opinion
and the reasons for it.
If the reasons in public health policy are related to
costs, that needs to be stated.
We do know that mammography and women in their forties can
detect small cancers. There is data to support that. It is not
a benefit that is confined to women in their fifties or in
their sixties. Mammography can be sensitive for women in this
age group and should be seen as such. Women should know that.
The estimate that up to a quarter of tests might result in
a false negative result quite over-estimates that, I think, if
you look at more modern studies. And, in fact, in a study of
the breast cancer detection demonstration project in the
1970's, only 10 percent of cancers that were detected in that
trial in women ages 40 to 49 were not picked up by mammography.
So I think to suggest that it cannot be effective in this
age group is false.
Senator Hutchison. Dr. Monsees?
Dr. Monsees. I would like to raise one other point, if I
might. When we are talking about truth of information and what
information should be provided, we need to make sure that it is
understandable and that it is spelled out completely. I will
give you an example.
In the consensus statement it was said that 10 percent of
mammograms are going to be false positive. We have to be very
careful when we throw that term around about what that means,
because the public is already afraid of breast cancer. Some
people will take that to mean--although it will be wrong--that
the 10 percent of women who have abnormal mammograms will
either have breast cancer or will go to biopsy. But, in fact,
the actual number is that biopsy will be recommended for less
than 1 percent of those women--of overall women, not of the 10
percent--and that most of the callbacks or the false positives
are, in fact, nothing more than an ultrasound or an additional
view mammogram, et cetera, for which there is not an invasive
procedure associated.
Biopsy these days is also easier than it ever was before.
We have now validated, I think, in the United States lesser
invasive ways to achieve tissue diagnosis for biopsy.
Senator Hutchison. Thank you. I think that is a very
important point on which to end. I think if you step back from
all of the information that we have received today, you have to
accept several truths. One is that breast cancer is the largest
killer of women in our country. It is something that can be
detected early, and it is clear that mammograms are the best
source of saving lives that we have at this point. Third, I
believe that there has to be a good, solid position from our
premier Government agency, the National Cancer Institute, with
all of the information they have, putting it in perspective,
making a recommendation to the women of our country and then
stating the risks. I think it is common sense and I think it
can be done.
I believe that you have pointed out today some of the
factual errors in the advisory panel's earlier draft. Perhaps
it got prematurely and that is not what they intended. But
there is still a remedy, and that is that there is still the
National Cancer Institute board itself. I think that we do need
to continue the efforts in research, both in the technology for
detection and also for cure. But also outreach appears to be
clearly one way to save lives. I think Dr. Leitch's testimony
was very targeted to that point.
So we have learned a lot. I think Senator Specter will be
back shortly.
I will recess the meeting until he returns to finish asking
his round of questions. I thank all of you for your testimony
and your input. I know we do all have the same goal, and that
is to save the over 40,000 women who will probably die from
breast cancer this year.
Thank you.
[A brief recess was taken.]
Senator Specter [presiding]. Our hearing will resume.
When I had to depart, I was asking Dr. Leitch about the
age, and Dr. Leitch was testifying about how some indicators
might warrant mammograms at an earlier stage than 40.
At what age at the earliest, Dr. Leitch, would you say that
collateral indicators might suggest a mammogram? What would be
the earliest age?
Dr. Leitch. For the average risk woman, I would say age 40.
For women who have a family history which would suggest early
onset breast cancer and a genetic component to their risk, for
those women it may be appropriate to start as early as age 30,
depending on the extent of the family history. This is actually
an area of research.
Senator Specter. What is the earliest that you know a
mammogram has been used on a woman, the earliest age?
Dr. Leitch. They are done on women even as teenagers. But
that is not something we recommend as a routine.
Where mammography is particularly inaccurate is in younger
women, under age 30.
Senator Specter. I ask that question to try to get some
line on this. People will be following what we are saying here.
You had this cut-off at 50 by a consensus report, not precisely
a cut-off but as a generalization.
What is the earliest aged woman you have ever known to have
been the subject of mammography--that is, the youngest?
Dr. Leitch. Well, I would say a woman in her teens. But I
would not personally do that unless I thought the woman had a
cancer, and in a teenager that is extremely unlikely.
Senator Specter. Ms. Braun, what is your sense of the age
of 40? I ask you especially because you had a breast with
cancer at 38.
Ms. Braun. Yes; I think, according to the incidence that we
are seeing right now, there is definitely a big jump between
women in their thirties and women in their forties. I think
that is why it is important that women do seek out clinical
breast exams and do breast self-exams every month, even though
I think age 40 is a good age to start mammography screening.
Senator Specter. Why do you choose 40 when you had the
incident at 38?
Ms. Braun. Based on incidence, the incidence that it is
shown.
Senator Specter. Other people?
Ms. Braun. Right.
Senator Specter. Dr. Monsees, you were testifying about
inadequate opportunity for comments when the consensus report
was made. Would you amplify that? Do you have first-hand
knowledge? Were you there? Did you see that they did not take
enough time to have comments from other people about their
findings?
Dr. Monsees. I was in attendance during the entire
conference, and when the statement was read and during the
comment period of time after that, I think it is fair to say
that throughout the entire conference there was never enough
time for people in the audience to make questions or comments.
They kept to the time limit.
Senator Specter. What was the time limit?
Dr. Monsees. Well, the first day was entirely
presentations. The second day were presentations up until about
noon. Then the panelists went to chambers to look at the
evidence. They came back the following morning at, I believe, 9
a.m., to read the statement. It was read publicly and then
there was about 90 minutes for comment. Then they had to go
back into chambers and talk again.
Senator Specter. When did they make the pronouncement that
women 40 to 49 would not benefit from mammograms?
Dr. Monsees. On the third day of the conference, in the
morning. I believe it was 9 a.m. The statement was read aloud
by Dr. Gordis, who was the panel chair, and then they asked for
questions and comments from the audience.
There were many people at the microphone when the comment
session was ended. But I can tell you that over the day and a
half preceding that, there were opportunities to ask questions
of people who presented to the panelists. People from the
audience had opposing views.
First up for questions were the panelists themselves. They
had an opportunity to ask the people who were presenting to
them. So that shortened the actual time for questions, and the
people who were in the audience almost never got to ask all the
questions they wanted to ask or to make all the comments they
wanted to make.
Senator Specter. I want to raise and do raise the issue of
the message which we have had a lot of talk about here today.
It escapes me as to why, when we say that women ought to make
an individual judgment, which I totally agree with--this is a
free world and people ought to make their own judgments--why
there would be any reticence within the arena of allowing
freedom of choice at any stage to say that you ought to have
the benefit of the thinking that it is helpful for those age 40
to 49--or whatever the scientific evidence may be.
One of the concerns that I have already expressed is the
way patients respond to doctors. Doctors are tremendous
authority figures.
You are nodding, Dr. Leitch. Do you agree that you are a
tremendous authority figure? [Laughter.]
Dr. Leitch. Well, it is true. You know, there are many
women who are incredibly bright and who ask a lot of questions
and are activists on this issue. But there are a lot of women
who are not, and they turn to their physicians, particularly
older women.
Senator Specter. This may be an imprecise analogy, but when
I came to the Senate, Senator Thurmond was chairman of the
Judiciary Committee. Senator Thurmond would ask the nominees
for Federal judgeships, ``Do you promise to be courteous?'' I
thought to myself what a nondirected question that is. What are
they going to say to ``do you promise to be courteous''? What
person about to become a Federal judge is not going to promise
to be courteous, especially when his confirmation is riding on
the line?
Then, when the person always said yes, Senator Thurmond
said, ``I ask you that question because the more power a person
has the more courteous he or she should be.''
I came to regard that differently, as to what an important
question that was, because judges tend to be very arrogant when
they are on the bench for a period of time. It is a very
difficult part of our society, the way a black robe changes
demeanor. It's something we work on in the Judiciary Committee,
to try to have judges who do not do that.
I make that comment because of the comments I had from the
doctor who scanned my MRI and said ``weeks to live.'' The sort
of impact that has is overwhelming.
Senator Harkin said we worry about the impact of the
message which has gone out here to women who are under 49.
Ms. Rowden, you were a patient. How do you feel about that?
Ms. Rowden. Well, I think doctors also need guidance. There
is a lot of information out there, especially for the general
practitioner to keep up with. I do think that women look to
their doctors for guidance, and with a lot of them, if the
doctor does not tell them to get a mammogram, they do not get
mammograms. And it has been shown that many women do not get
screening mammograms because their doctor never recommended
one. That is a significant problem. So we need to educate the
doctors as well as the women themselves and work together on
the problem.
When I go in for my checkups, I still look to my doctor for
guidance, whether it be my oncologist or gynecologist. But I
try to read up before hand or do reading afterward if they
raise an issue for me.
Senator Specter. Ms. Visco, let me begin with you on the
subject of the gene issue and the research that is being
conducted there. I know that you place a very, very heavy
emphasis upon research for the cure.
What is your view about the expenditures on research on
gene predisposition? That does not go to the issue of cure, but
it does go to the issue of detection or predisposition. What is
your thought about the advisability of expending substantial
sums of money to isolate the gene?
Ms. Visco. Well, I think it is important to spend a lot of
money on looking at the gene because the gene not only has the
ability to tell us who is at significant risk of breast cancer,
but it may have the ability to tell us about the etiology of
the disease. It may tell us something about how to prevent the
disease or really how best to treat it.
So we are looking at the gene once it has been isolated for
a lot of reasons other than whether women are predisposed.
We are concerned about the fact, as you mentioned quite
rightfully in the beginning, that we now have a test that women
can take to see if they may be predisposed to heritable breast
cancer. But we don't know what to do with these women once the
test proves positive, and we also don't have legislation in
place to protect them from discrimination in employment and the
provision of insurance. That is a public policy issue that I am
glad we can continue to work on together.
So I think we do need more money looking at the genetic
issues. We need more money looking at every issue in breast
cancer.
Senator Specter. On the subject of screening, it is a
question of the allocation of resources and the issue of the
environmental factors and the action plan which Senator
Hutchison raised. What assessment do you place on the value of
those kinds of activities?
I know this has come before your committee. I know you did
not place a value on them as high as research, but to what
extent do you think they are valuable in the overall picture?
Ms. Visco. Now, you see, I have to disagree. I think we do
place as high a value on outreach, on a lot of different
issues, on all issues to do with breast cancer in the goals and
mission of my organization. We are most known for our support
of research, but we are there on every issue in breast cancer.
The action plan is a particular situation where what we are
trying to do--as you know, it is my organization's petition
campaign that brought about the national action plan on breast
cancer, and I cochair that plan. The steering committee
consists of a public and private partnership, including the
American Cancer Society, the Komen Foundation, the National
Women's Health Network, and many private organizations and
government representatives.
What we wanted to do was to come together. We did not want
to create a new bureaucracy. We do not want a new funding
stream. Research is funded through NIH, through NCI, through
DOD, through other entities.
What we wanted to do was to do something different. We
wanted to bring together every player, every entity that has a
stake in breast cancer, bring them to the table, identify the
gaps: where do we need to jump start, where do we need to act
as a catalyst, and let's bring together, which we have done,
working groups from across the country, representatives from
all segments of society, to develop strategies and plans of
action on how to fill those gaps; and then to take those
strategies and not to be a new bureaucracy that implements
them, but to take them to the existing entities to implement
them. That is what we wanted to do.
The steering committee did exactly that, this public/
private diverse partnership, and we determined that the amount
of money we needed to make that happen was $4 million--looking
at all of the action plans from the working groups, looking at
the support that we need to go forward on the plan, that that
is what we needed. We did what we thought to be the very
responsible thing, to say to the government thank you, but we
don't need this much money for this effort. Leave it in the
National Cancer Institute budget for what we all agree is
underfunded breast cancer research.
Now the National Cancer Institute does outreach, also. We
have to remember that, too.
Senator Specter. The language on implementation of the
plan's activities says in ``other crosscutting Federal and
private sector initiatives.'' In the mentioning of cross
cutting initiatives, part of that picks up on items like
clinical trials where they have not been, at least as I
understand it, at the forefront of what the National Cancer
Institute has done, such as environmental issues, and diet sort
of things.
How do you assess the value of items like that in the
overall picture?
Ms. Visco. We place an extremely high value on all of those
items. That is why we are at the table at the National Cancer
Institute, the National Institutes of Health, and the DOD, to
make certain that the existing bureaucracy and the existing
funding streams are putting more emphasis in those areas. And,
in fact, we would be happy to, and intend to, sit at the table
with those representatives to talk about how they need to focus
the $14 million in those areas in the existing infrastructure.
Senator Specter. We have had Ms. Visco's figures as to what
we ought to appropriate.
Ms. Braun, would you care to give us your figure?
Ms. Visco. Before she does, I want to say, since you are so
open, that I would like to increase that figure. [Laughter.]
Senator Specter. OK, what would you like to have?
Ms. Visco. I would like to have $650 million in the
National Institutes of Health and go back to the $210 million
in the Department of Defense program that we started with in
1993.
Senator Specter. OK, now where did you get the figure?
Ms. Visco. The $210 million is based on the initial funding
of the program, which was not enough then, but it was enough to
fund what we thought to be a reasonable number of the proposals
that required and that merited funding.
In the National Cancer Institute, we are looking at issues
like generic research and new discoveries that have happened
over the past several years. What we want to do is make certain
that those areas move forward because we believe that we are
finally at a place where we know what questions to ask.
As a matter of fact, we have a signature campaign ongoing
through the coalition to ask for $2.6 billion for quality
breast cancer research between now and the year 2000. So we
have a plan on what to ask you for. Since you are open to
increasing the numbers significantly, we are going to move up
our plan and ask for more in year one than we had intended.
Senator Specter. What I would like you to do, Ms. Visco, is
to let me have as much detail as you can on how you get there
and what you expect to accomplish with that much money.
Ms. Visco. All right.
Senator Specter. These are very deep subjects, and I
started right off with Dr. Klausner not on any of these studies
that we are talking about. Is there a realistic likelihood of a
cure for cancer and how much money does he need.
Now he is under some constriction because he has to report
to a whole bunch of people, ending up with high level medical
technicians in the Office of Management and Budget. Sometimes
we do not exactly get the unvarnished opinions of some of the
experts. But we do get your unvarnished operation. Philadelphia
lawyers are famous for that.
Ms. Visco. Oh, yes. [Laughter.]
Senator Specter. I would like not only to have your figure
but how you got there and what you think can be accomplished.
Ms. Visco. Yes; I will get that information to you.
Senator Specter. Ms. Braun, do you want to give us a figure
in conclusion? You are going to have to go some to top $2.6
billion.
Ms. Braun. This is a nice place to sit. [Laughter.]
We absolutely concur that the figures are not high enough
where they are, and we agree with the coalition on the amount
of funding that ought to be allocated.
One area that we are particularly concerned with and
because of our own peer reviewed research program we look very
carefully at the areas into which we allocate our funds and
into which research endeavors we will be funding, just to
insure that we are looking toward areas--molecular biology and
genetics, for example--that can be lead to a cure or cures for
breast cancer.
But also we must look at potential causative factors on one
end of the spectrum. On the other end of the spectrum are the
issues of survivorship that people who have had breast cancer
or will have in the future, even if cured, will undoubtedly
face.
Senator Specter. Ms. Braun, do you have a figure?
Ms. Braun. A figure?
Senator Specter. That's what I'm asking you for.
Ms. Braun. $1 billion.
Senator Specter. Ms. Rowden, you are from the same
organization. Do you want to concur in that or do you want to
give us a different figure?
Ms. Rowden. I would concur with Susan.
Senator Specter. Dr. Leitch.
Dr. Leitch. The American Cancer Society is partnered in
this effort to petition the Congress, and we would agree with
that requested amount as well.
Senator Specter. Dr. Monsees.
Dr. Monsees. I will defer because I think that what has
been talked about here has probably been well thought out and I
am not an expert in that.
Senator Specter. All right. We thank you very, very much
for coming in. Your testimony is very helpful. You can be
assured that we are going to give this a lot of attention.
I have just been discussing the possibility of doing some
field hearings on this subject. It is a little different
atmosphere if you go back to the States and talk to people
about it, and I intend to do that in Pennsylvania.
Thank you. Thank you all very much for coming in.
summary statement of david g. hoel, ph.d.
We would now like to call Dr. David G. Hoel, our last
witness.
Our final witness is Dr. Hoel, member of the NIH Consensus
Development Conference on Breast Cancer Screening for Women. He
is chairman of the Department of Biometry and Epidemiology and
Associate Director of the Hollings Cancer Center of the Medical
University of South Carolina.
Prior to his at the university, Dr. Hoel served in several
positions at the National Institute of Environmental Health and
Sciences and was a visiting scientist and associate director of
the Radiation Effects Research Foundation, Hiroshima, Japan.
Welcome, Dr. Hoel. The floor is yours.
Dr. Hoel. Thank you. Thank you, Chairman Specter.
Senator Specter. Your full statement will be made a part of
the record. We would appreciate it if you could do your oral
testimony within the 5 minutes. Thank you.
Dr. Hoel. Fine. Thank you. I appreciate the opportunity to
testify before you this morning.
In my capacity as a member of the panel on breast cancer
screening for woman ages 40 to 49, I would like to describe the
process by which the panel is assessing available research and
deriving its conclusions.
Last fall, panel members were invited by the National
Institutes of Health's Office of Medical Applications of
Research to participate in the Consensus Development Conference
which was held January 21-23 at NIH.
The panel was charged with developing consensus statements
in response to five specific questions which were posed. The
questions were as follows:
One, is there a reduction in mortality from breast cancer
due to screening women ages 40-49 with mammography with or
without physical examinations? How large is the benefit? How
does this change with age?
Two, what are the risks of screening women ages 40 to 49
associated with mammography and with physical examination? How
large are the risks? How do they change with age?
Three, are there other benefits? If so, what are they? How
do they change with age?
Four, what is known about how the benefits and risks of
breast cancer screening differ based on known risk factors for
breast cancer?
Five, what are the directions for future research?
The panel was provided with copies of nearly 150 published
research papers and reports related to the questions. In
addition, the National Library of Medicine provided the panel
with copies of over 300 abstracted research papers.
Prior to the consensus conference, the panel received
abstracts and research papers from the invited conference
speakers. During the conference, panel members had the
opportunity to question the speakers and receive copies of
their slides. The major randomized clinical trials of
mammography and breast cancer mortality were represented and
the latest data and analyses were presented to the panel and
conference attendees.
The consensus panel was made up of individuals from a
variety of disciplines including radiology, oncology,
epidemiology and statistics, as well as representatives from
consumer groups.
The panel had a preliminary meeting on December 12-13,
1996, and at that time the five questions were discussed and
specific assignments were made with regard to the first four
questions. The purpose of this activity was to prepare a simple
outline of the key issues for each of the questions prior to
the conference in January.
The conference was held January 21-23, 1997. After the
completion of the conference presentations, the panel began its
deliberations and writing. The completed first draft of the
consensus document was finished on January 23 and was presented
that morning to the conference attendees. Comments and
questions were offered by conference attendees and the
committee subsequently returned to a working session at which
time the comments from the conference participants were
discussed and revisions were begun.
During this period, work was halted in order to accommodate
a press conference. At the conclusion of the press conference,
the panel adjourned and is now in the process of completing the
consensus statement.
There are four key points pertaining to the activities of
the panel:
One, the panel was restricted to providing answers to the
five specific questions in its charge.
Two, the panel is currently involved in the completion of
its work.
Three, the panel has had no contact or interactions with
any of the sponsoring bodies; namely, the National Cancer
Institute, the National Institute on Aging, the Office of
Research on Women's Health of the NIH, and the Center for
Disease Control and Prevention.
Four, the panel's conclusions are the consensus view of
members who have a broad variety of backgrounds and
disciplines.
prepared statement
Thank you. Please insert my prepared statement into the
record. I would be happy to answer any questions.
[The statement follows:]
Prepared Statement of David G. Hoel
Mr. Chairman and Members of the Committee, I am David G.
Hoel, Professor and Chairman of the Department of Biometry and
Epidemiology at the Medical University of South Carolina in
Charleston. I appreciate the opportunity to testify before you
this morning.
In my capacity as a member of the Panel on Breast Cancer
Screening for Women Ages 40-49, I would like to describe the
processing by which the panel is assessing available research
and deriving its conclusions. Last Fall Panel members (list
attached) were invited by the National Institute of Health's
(NIH) Office of Medical Applications of Research (OMAR) to
participate in the Consensus Development Conference which was
held January 21-23, 1997, at NIH. The panel was charged with
developing consensus statements in response to five specific
questions which were posed. The questions are as follows:
1. Is there a reduction in mortality from breast cancer due
to screening women ages 40 to 49 with mammography, with or
without physical examinations? How large is the benefit? How
does this change with age?
2. What are the risks of screening women ages 40 to 49
associated with mammography, and with physical examination? How
large are the risks? How do they change with age?
3. Are there other benefits? If so, what are they? How do
they change with age?
4. What is known about how the benefits and risk of breast
cancer screening differ based on known risk factors for breast
cancer?
5. What are the directions for future research?
The panel was provided with copies of nearly 150 published
research papers and reports related to the questions. In
addition, the National Library of Medicine provided the panel
with copies of over 300 abstracted research papers.
Prior to the consensus conference, the panel received
abstracts and research papers from the invited conference
speakers. During the conference, panel members had the
opportunity to question the speakers and received copies of
their slides. The major randomized clinical trials of
mammography and breast cancer mortality were represented, and
the latest data and analyses were presented to the panel and
conference attendees.
The consensus panel was made up of individuals from a
variety of disciplines including radiology, oncology,
epidemiology and statistics as well as representative from
consumers groups. The panel had a preliminary meeting in
December 12-13, 1996, and at that time the five questions were
discussed and specific assignments were made with regard to the
first four questions. The purpose of this activity was to
prepare a simple outline of the key issues for each of the
questions prior to the conference in January.
The conference was held January 21-23, 1997. After the
completion of the conference presentations, the panel began its
deliberations and writing. The completed first draft of the
consensus document was finished on January 23 and was presented
that morning to the conference attendees. Comments and
questions were offered by conference attendees and the
committee subsequently returned to a working session, at which
time the comments from the conference participants were
discussed and revisions were begun. During this period work was
halted in order to accommodate a press conference. At the
conclusion of the press conference, the panel adjourned and is
now in the process of completing the consensus statement.
There are four key points pertaining to the activities of
the panel.
(1) The panel was restricted to providing answers to the
five specific questions in its charge only.
(2) The panel is currently involved in the completion of
its work.
(3) The panel has had no contact or interactions with any
of the sponsoring bodies, namely, the National Cancer
Institute, the National Institute on Aging, the Office of
Research on Women's Health of the NIH and the Center for
Disease Control and Prevention.
(4) The panel's conclusions are the consensus view of
members who have a broad variety of backgrounds and
disciplines.
Thank you for this opportunity to address you and to answer
any questions you may have.
risks or benefits
Senator Specter. Thank you very much, Dr. Hoel. What is
your thinking on Dr. Klausner's comment that the panel
overemphasized the risks and underemphasized the benefits?
Dr. Hoel. This is the first I had heard that comment.
Senator Specter. Was Dr. Klausner consulted by the panel?
Dr. Hoel. Pardon?
Senator Specter. Was Dr. Klausner consulted by the panel?
Dr. Hoel. No.
Senator Specter. Before the panel reached its conclusions?
Dr. Hoel. No; as I said, we had no meetings with
individuals from the NCI. In fact, we didn't even have, say, a
welcoming visit that night. We wanted to stay perfectly
independent.
Senator Specter. Do you not think it would have been useful
to have had somebody from the NCI there to give you their
views? You don't have to take them, but would it not at least
be relevant to know what Dr. Klausner thinks about the subject?
Dr. Hoel. I don't think that was the--I can't speak for the
Office of Medical Applications and Research. But my
understanding is that it is to be a panel of nongovernment
individuals who will simply review the research literature and
materials.
Senator Specter. Well, who selected the individuals, if you
know?
Dr. Hoel. I assume it was the Office of Medical
Applications Research of NIH and, I also understand although I
didn't meet with, a steering committee.
Senator Specter. I just raise the question because you have
Dr. Klausner's very dramatic comment on being shocked. You have
the comment which Dr. Daniel Kopens of Harvard Medical School,
who said that the committee's report was fraudulent. You have
that kind of reaction.
I would just wonder why Dr. Klausner wouldn't at least be
consulted or talked to to get some input.
Dr. Hoel. Well, I cannot answer that. We were following the
procedures that were provided us by the Office of Medical
Applications Research.
I should say on his question about the balance, you see, we
were, as I mentioned in my summary statement, we were directed
to answer five specific questions. This was probably a basis of
how long the answers were, and the question about risks--they
are not that well known; I mean, the details about false
positives, false negatives, estimates of radiation risk and so
on. That is a longer answer because it has more subtopics.
Senator Specter. What do you think of Dr. Monsees' comment
that there was not enough time for input, comments from people
who were in attendance?
Dr. Hoel. We heard a lot of comments from the audience. But
I know in every case there were more individuals who wanted to
comment on the papers.
Senator Specter. Dr. Klausner has stated that the national
cancer advisory board will meet on February 25-26, and the
board and the National Cancer Institute will discuss the
consensus conference and make their own evaluation of the
benefits and risks of screening women 40 to 49.
Now we are going to have another group which is going to
meet on it.
Now I understand that in a free society people are able to
say anything they want at any time. But I just pose the
question about having a consensus report which has a banner of
the National Institutes of Health on it--it is a little hard to
find out exactly how it was constituted although obviously we
can do that--and the prospect of having a different conclusion.
Dr. Klausner has already expressed himself, that the benefits
were understated and the risks overstated, and his shock.
Looking to the future, is there not a better way to
organize our thinking and organize our conclusions, and if
there are going to be dissents to have them in the context of a
dissent, as opposed to having these different messages go out?
Dr. Hoel. Well, I think you have to understand that the
panel was not asked to recommend whether there should be
screening as a national policy.
Senator Specter. But didn't it pretty much come to a
conclusion, or has the media misinterpreted it, that screening
mammography is not really useful for women 40 to 49 ?
Dr. Hoel. What we said was that there was no measurable
mortality benefit until about 10 years post-entry into the
trials. Also, the trials themselves have various problems.
Now there are some new ones that are beginning that are
directed more at addressing this question.
Senator Specter. No measurable mortality benefits?
Dr. Hoel. Until about 10 years postentry into the trials.
Senator Specter. What was your thinking on the Swedish
study which contradicted that conclusion?
Dr. Hoel. Well, this is looking at all of the Swedish and
American studies. In fact, in the report, the draft report--and
you have to understand that it is still an ongoing process and
we are trying to rewrite it so there will not be confusion
about the 10-year point of where you start to see a benefit in
cancer mortality.
Senator Specter. Well, looking to the future on activities,
would it be preferable not to issue a draft report until the
final report is ready and all of these factors have been
digested and the final report is made?
Dr. Hoel. Well, that is a difficult question. I think that
one of the benefits we had was in reading the draft to the
conference participants, we were able to get feedback from them
and we'd be able to take that into consideration. So this was a
very valuable input to us.
Senator Specter. Well, you could get feedback from them in
a variety of ways without making a public disclosure of the
draft report.
Dr. Hoel. Yes; you could. But I'm saying this is basically
how the process is carried out in the consensus conferences.
Senator Specter. OK. We very much appreciate your work, Dr.
Hoel. I know it is not easy and I know there were people from
the panel quoted in the media expressing chagrin about their
scientific findings and having such a public outcry. It is not
an easy matter. But in the context of a message going out to so
many women in the United States and everywhere as to what the
import is, it is at least my thinking, and I believe some of
the others on this panel, that we ought to more closely
evaluate the kind of message that comes out, to see if we
cannot have a little more clarity before a draft report is
circulated.
This chapter is going to go on and on. As I say, I am going
to do field hearings in my own State, and there is going to be
another group meeting on February 25-26. As I said at the
outset, Secretary Shalala is going to come in to testify, but
wanted the scientists to testify earlier.
This is all very important as it impacts on the work of the
subcommittee and our appropriation process and, obviously, most
importantly on the impact of women who have to make these
important decisions.
material submitted subsequent to conclusion of the hearing
I would like to have inserted into the record statements by
Senator Craig and Senator Snowe, and also into the record a
very poignant letter from Dr. Jeanne Petrek dated February 3,
1997, resigning from the consensus panel because of her strong
disagreement with its conclusions.
[Clerk's note.--The following statements and letter was
received by the subcommittee subsequent to conclusion of the
hearing. The statements and letter will be inserted into the
record at this point.]
Prepared Statement of Senator Larry E. Craig
Mr. Chairman, I want to thank you for holding this hearing today to
address the serious issue of breast cancer screening for women ages 40-
49. I appreciate the opportunity to highlight this important issue. I
look forward to hearing the testimony of the witnesses here today as
well as assessing the recommendations of the NIH consensus development
conference.
As you know, breast cancer remains the most deadly and prevalent
cancer affecting American women today. The majority of women who are
diagnosed with breast cancer have no identifiable risk for this
disease. Breast cancer is the single leading cause of death for women
in their forties and fifties. This year alone, 33,000 women in their
forties will be diagnosed with breast cancer.
We need to promote behavior that encourages women to use the
available methods that assist in detecting this deadly disease.
Mammography plays a vital role in the detection of breast cancer.
Taking into account that mammography is not a perfect tool for early
detection of breast cancer, we now have compelling proof that
mammography screening for women ages 40-49 can substantially reduce the
death rate from breast cancer. Intervention through routine screening
for breast cancer through mammography, clinical breast exams and
monthly self-exams can help save the lives of women at a time when
medical science is unable to prevent this disease.
I am pleased to tell you that just yesterday, I was one of 98
members of the Senate to vote in favor of a resolution expressing the
sense of the Senate requiring stringent guidelines for mammography
testing for women between the ages of 40 and 49.
It is imperative that we direct appropriate resources into research
for prevention, early detection and a cure. We need to focus on making
sure that all women have access to high quality mammograms, regardless
of age. Until we have a cure for this disease, all women need access to
the best screening currently available.
______
Prepared Statement of Senator Olympia Snowe
Thank you, Mr. Chairman, for allowing me to testify before you
today on the decision of the National Cancer Institute's consensus
conference panel to refrain from recommending that women in their
forties seek routine mammograms. I appreciate your long-standing
leadership on issues related to women's health, and I commend you for
holding this critical hearing. In fact, this issue is so important that
yesterday, with the Chairman's assistance, the Senate voted unanimously
to pass my resolution on this very issue.
Breast cancer is one of the major public health crises facing
American women today, striking one in every eight women during their
lifetime. It will strike 180,000 American women this year, and kill
44,000 women--more than 10,000 of whom will be diagnosed with breast
cancer in their forties. For women in this age group, it is the leading
killer, and more women this year will be diagnosed with cancer in their
forties than in their fifties.
Mammograms are the most powerful weapon we have in the fight
against breast cancer. They enable us to detect and treat breast cancer
at its earliest stages when the tumors are too tiny to be detected by a
woman or her doctor, providing a better prognosis for treatment. An
estimated 23.5 million mammograms were performed in 1992 at a cost of
approximately $2.5 billion--a valuable down-payment in our fight
against an unmerciful killer.
The question about whether women in their forties should seek
regular mammograms has been an open-question for years. Yet persuasive
new studies by Swedish researchers and others [Malmo; Gossenberg;
Smart, Hendrick, Rutledge and Smith] indicating that mammograms benefit
women in this age group promised to put this question to rest once and
for all. In response to these studies, the National Institutes of
Health convened a consensus conference to revisit this critical issue.
On January 23, the consensus panel decided against recommending
that women in their forties seek routine mammograms. In making its
decision, the panel gave undue weight to hypothetical risks, such as
false-negative results that potentially provide women with a false
sense of security, false-positive results that produce unnecessary
anxiety, the potential for over treatment, and radiation exposure.
If we ever hope to improve survival rates for breast cancer, women
of all ages must receive accurate and consistent information regarding
the importance of mammograms. Women and their doctors look to the
nation's preeminent cancer research institution--the National Cancer
Institute--for clear guidance and advice on this issue. Yet, the
consensus panel refused to provide clear guidance, leaving a muddled
picture at a time when women are begging for answers.
Confusion on this issue is not new. In 1989, NCI, along with the
American Cancer Society and the American Medical Association, issued
breast cancer screening guidelines which advised women to begin having
mammograms at age 40. In 1993, NCI rescinded these guidelines, stating
that their review of clinical trials produced no evidence that
mammograms significantly reduced breast cancer deaths for women in
their forties. At the time, Congress and many experts--including groups
such as the American Cancer Society--questioned the appropriateness of
this conclusion, based on the available scientific evidence. This is
when I first introduced legislation urging NCI to reexamine this issue.
By rescinding its guidelines, NCI produced widespread confusion and
concern among women and physicians regarding the appropriate age at
which to seek mammograms. This confusion eroded public confidence in
mammography, and reinforced the ``information barrier'' which
discourages women from seeking care. It also lead many health insurers
to believe that coverage of mammograms for women in their forties is
unnecessary--a point we should not overlook. Four years later, we are
still mired in this controversy and these hurdles still exist.
Yet new studies strongly suggest that routine mammograms for women
in their forties can save lives. For example, one study conducted by
Smart, Hendrick, Rutledge and Smith found a 24-percent lower death rate
among women who received mammograms in their forties when the world's
population-based trials were combined; and Swedish researchers in 1996
in two studies found a 44- and 36-percent lower death rate among women
who received mammograms in their forties. And several studies have
concluded that breast tumors in women under 50 grow far more rapidly
than breast cancer in older women, suggesting that annual mammograms
are of value to women in their forties.
In studying the research and scrutinizing the statistics, the Panel
appears to have lost sight of the human dimension of this question, and
gave undue weight to the costs of screening, rather than the benefits.
The Panel emphasized that 2,500 women would be have to be screened to
save one life. But this one life represents someone's mother, wife,
sister, or daughter.
The panel also emphasized that up to one-fourth of all invasive
breast cancers are not detected by mammography in women in their
forties. Yet, the flip side of this statistic is that three-fourths of
all cancers in this age group are detected through mammography. While
it may not be perfect, that clearly amounts to saved lives.
Finally, the NCI panel also overemphasizes the risks of false-
positives, suggesting that many women would undergo unnecessary
surgical procedures. Yet, women with positive findings subsequently
undergo more refined diagnostic tests, including diagnostic mammograms,
ultrasounds, and needle biopsies to confirm the presence of cancer,
before any treatment decisions are made.
Appropriately, the Director of NCI, Dr. Richard Klausner, expressed
his surprise and disappointment over the decision of the consensus
panel, and has asked the NCI Advisory Board to convene next month to
revisit this issue. Former NIH Director, Dr. Bernadine Healy, affirmed
his views.
This is why I offered a sense of the Senate resolution yesterday
with my colleague from Maryland, Senator Mikulski, on this very issue.
This resolution expressed the sense of the Senate that studies needs to
further determine the true benefit of mammograms for women in their
forties. It also urges National Cancer Institute's Advisory Board,
which will meet later this month, to consider reissuing the mammography
guidelines it rescinded in 1993 recommending that women in their
forties seek routine mammograms. Alternatively, NCI should direct women
to other organizations which have issued clear guidelines on the issue,
such as the American Cancer Society. I am pleased that the Senate voted
in favor of this resolution so overwhelmingly.
American women and their physicians deserve to have clear guidance
on this issue. Yet the consensus panel ``passed the buck'' by refusing
to provide this clear guidance. I strongly believe that in light of the
new persuasive evidence, NCI should recommend routine mammograms for
women in their forties, until future research persuades us otherwise.
Not only will this clarify this issue in the minds of American women,
but it has significant implications for insurance coverage as well. And
most importantly, it will save lives. Thank you.
______
Letter From Jeanne Petrek, M.D., FACS
Memorial Sloan Kettering Cancer Center,
New York, NY, February 3, 1997.
Dr. John Ferguson,
Office of Medical Applications of Research, NIH,
Bethesda, MD.
Dear Dr. Ferguson: It is with considerable regret that I resign
from the NIH Consensus Development Panel. My reasons are as follows.
I agree that randomized clinical trials (RCT's) do not provide
evidence that mammographic screening should start in all American women
beginning at age 40. However, I yet believe that mammographic screening
is advisable for many women 40 to 50 years of age, depending upon
clinical factors and the woman's informed decision. This belief is
primarily based on the small, but significant, reduction in breast
cancer deaths found in the meta-analysis of the RCTs and the
improvements in mammography during the 15 years since even the most
recent trial.
There is no question but that a new RCT will yield scientific
evidence. However, it will require 2 years to design and fund, some 5
years to accrue and 5 to 10 years to evaluate survival. (It will
require 20 to 30 years to evaluate mammogaphic screening for radiation
carcinogenesis.) But the treating physician must deal with patients
now.
The draft would indicate that the majority of panelists believe
that screening in the 40's is without value. An example appears in a
New York Times (1/28/97). The panelist is talking to a patient in her
40's who was treated with mastectomy and chemotherapy. The patient
asks: ``What should I tell my 29 year old daughter?'' Dr. Laufman says:
``I told her that I would tell her daughter what I would tell my own
daughter: start having mammograms when you're 50. And stay very, very
tightly tuned to the research as it develops.''
The different perspectives on the value of screening in the 40's
apparently cannot be separated from what individual panelists bring to
the consensus document. This is apparent from the current one-sided
draft of the ``consensus'' document. The draft diminishes the survival
benefit. It overemphasizes the risks, while making no attempt at a
balanced presentation of risks versus benefits. The draft has not
appreciably changed or improved since its inception, despite changes
that I have recommended and despite my conversations with panel members
on these issues.
The document is unacceptable to note and I cannot have my name
associated with it.
Sincerely yours,
Jeanne Petrek, M.D.
subcommittee recess
Senator Specter. That concludes our hearing. Thank you very
much. The subcommittee will recess and reconvene at the call of
the Chair.
Dr. Hoel. Thank you.
[Whereupon, at 12:53 p.m., Wednesday, February 5, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
MAMMOGRAPHY
----------
THURSDAY, FEBRUARY 20, 1997
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Philadelphia, PA.
The subcommittee met at 9:30 a.m., in the ceremonial
courtroom, Federal courthouse, Philadelphia, PA, Hon. Arlen
Specter (chairman) presiding.
Present: Senator Specter.
NONDEPARTMENTAL WITNESSES
STATEMENTS OF:
DINA F. CAROLINE, M.D., Ph.D., CHIEF, DIVISION OF
GASTROINTESTINAL RADIOLOGY AND MAMMOGRAPHY, DEPARTMENT OF
DIAGNOSTIC IMAGING, TEMPLE UNIVERSITY HOSPITAL
BONITA FALKNER, M.D., ACTING DIRECTOR, INSTITUTE OF WOMEN'S
HEALTH, ALLEGHENY UNIVERSITY OF THE HEALTH SCIENCES
STEPHEN A. FEIG, M.D., CHIEF, DIVISION OF MAMMOGRAPHY AND
PROFESSOR OF RADIOLOGY, DIVISION OF BREAST IMAGING, THOMAS
JEFFERSON UNIVERSITY
DANIEL C. SULLIVAN, M.D., ASSOCIATE PROFESSOR OF RADIOLOGY,
UNIVERSITY OF PENNSYLVANIA MEDICAL CENTER
ROBERT C. YOUNG, M.D., PRESIDENT, FOX CHASE CANCER CENTER
opening remarks of senator specter
Senator Specter. Good morning, ladies and gentlemen. The
Appropriations Subcommittee on Labor, Health and Human
Services, and Education will begin this hearing.
The focus of our hearing today is on the issue of
mammograms for women in the age group 40 to 49, but we will be
inquiring into a broader range of issues as we pick up that
very important subject. The broader range of issues will
include the problems of cancer generally, problems after breast
cancer, funding by the U.S. Government on breast cancer
research, and the National Institute of Health. And we will
inquire into the possibility of assistance on the recent
discoveries on genes, what collateral issues there are on the
right to privacy, how gene research may be used in order to act
against the ravages of breast cancer, which is such a major
killer of women in America today. One out of every eight women
gets breast cancer, and we are searching for ways to combat it.
The funding for breast cancer has gone up tremendously
during the past several years, now in excess of $400 million.
And the question really is, what is adequate? That question was
asked directly of Dr. Klausner, the head of the National Cancer
Institute in the hearing in Washington recently.
We are committed to increasing the NIH budget. That budget
has gone up consistently during my tenure in the U.S. Senate,
notwithstanding cuts in other fields. Whether the chairman of
the subcommittee has been Senator Weicker or Senator Chiles--
now Governor of Florida--Senator Harkin, or my chairmanship, we
have found the funds to increase that important item.
We have a Federal budget of $1.7 trillion, which is a
staggering sum of money--really unquantifiable. I am personally
convinced that we can have a balanced budget in America and
still take care of our priority items like medical research.
Senator Harkin and I have eliminated some 134 programs from the
subcommittee, a saving of about $1\1/2\ billion, so we can
focus our money on education, Pell grants, guaranteed student
loans, and NIH research, including breast cancer. So it is a
matter of assessing priorities.
Then the panel came out with the conclusion that mammograms
were not useful for women. I think that is the categorization--
we will talk about it at some length today--for women 40 to 49.
It was immediately greeted with substantial cynicism and
criticism, and Dr. Klausner said he was shocked by it. My own
view, from what I know in the field, is that it is not a
correct finding, but we need to hear from the experts.
Dr. Klausner is convening a group of the National Cancer
Institute to go into the matter further and will be filing an
additional report. Secretary Shalala of Health and Human
Services will be appearing before our subcommittee in early
March. I am hopeful it will be March 5. The date has not yet
been finalized. This issue is far from over, and there is major
concern that, notwithstanding the advantages of mammograms, it
is really not the ultimate answer, more research is necessary
on better ways of detecting breast cancer.
For the past several years, we have used the techniques of
the CIA on imaging from outer space. The CIA has put up $2
million, a rather unusual allocation for the CIA, but they did
that--perhaps influenced at least in some small part that I was
chairman of the Intelligence Subcommittee at the same time I
was chairman of the appropriations Labor HHS Subcommittee.
There is nothing like being chairman, for those of you who do
not know the ways of the Senate. And we are having clinical
trials underway.
We have a very fast-track appropriation--$2 million, which
we got through. And those contracts were let last September,
setting a record for that, from our hearings last March, and
then getting the clinical trials underway by September, with
the contracts let.
We have a distinguished panel of witnesses today. And I
want to express my thanks and the thanks of the subcommittee
and the full committee, and really the entire Senate and the
Congress, that you have come today. While our hearing room is
not filled with people, there is substantial exposure by those
magic markers to my left, the television cameras. And I think
it is very important the American people understand the issues,
what is going on with breast cancer and what is going on with
mammography and what the needs are and the financing, and that
there is very intense work underway for the billions of women
who are really very concerned about their own problems with
breast cancer.
introduction
So, with that not-so-brief introduction, I would look to
call our distinguished panel of witnesses: Dr. Dina F.
Caroline, chief of the division of gastrointestinal radiology
and mammography at Temple University; Dr. Stephen Feig, chief
of the division of mammography and professor of radiology,
division of breast imaging, at Thomas Jefferson University; Dr.
Daniel C. Sullivan, associate professor of radiology at the
University of Pennsylvania Medical Center; Dr. Bonita Falkner,
acting director of the Institute of Women's Health, Allegheny
University of the Health Sciences; and Dr. Robert C. Young,
president of the Fox Chase Cancer Center.
Would you all step forward, please.
Our practice in the subcommittee and, for that matter, most
of the Congress, is to put the full statements in the record
and to ask the witnesses, to the extent possible, to limit
their opening statements to 5 minutes, and leave the maximum
amount of time for dialog and interchange among the panelists
at the conclusion of the testimony.
I am joined here by Bettilou Taylor, who is a staffer
second to none in the U.S. Senate. She has been working in this
field for many years. And if people want the real answers, they
call Bettilou or they call Craig Higgins, who really do such
outstanding work in this field.
We are going to proceed in alphabetical order. The list I
had is not alphabetical. We will move Dr. Falkner up ahead of
Dr. Feig, in alphabetical order. And when you have a group of
this preeminence, I do not want to make the decisions about
sequence. And we will start with Dr. Dina Caroline from Temple.
summary statement of dr. dina caroline
Dr. Caroline, thank you for joining us. You are an M.D.,
and a Ph.D. Is it necessary to call you doctor, Doctor?
Dr. Caroline. Absolutely not. You can call me Dr. Mom if
you like.
Senator Specter. Well, we welcome you here, and the floor
is yours.
Dr. Caroline. Good morning, Hon. Senator Specter. I am here
representing Temple University Hospital in Philadelphia. This
is a nationally known teaching institution, serving the health
care needs of the local community. The hospital also provides
the clinical environment to support the training and research
needs of the Temple Medical School, founded in 1892. Temple
University Hospital now has over 500 patient beds. In the
Department of Diagnostic Imaging at the Health Science Center,
we perform over 5,000 mammograms annually.
The recommendations regarding mammographic screening for
women ages 40 to 49 has been evolving since screening was
introduced in 1977, when the NCI and ACS recommended it for
women with first-degree relatives with breast cancer. Since
1983, the American Cancer Society has recommended screening for
women ages 40 to 49 every 1 to 2 years. Through 1989, these
guidelines were adopted by additional major medical
organizations. In the early nineties, individual radiologists
were beginning to advocate yearly screening for women aged 40
to 49, while other radiologists and other health care
professionals questioned the value of screening altogether.
This conflict of screening women ages 40 to 49 came to a
head in 1993, when NCI changed its recommendations, no longer
stating that, ``experts do not agree on the value of routine
screening mammography for women ages 40 to 49.'' Other
organizations, including the American Cancer Society and
American College of Radiology, disagreed with the changes. The
recent NIH conference convened January 20 of this year, with
the intention of achieving consensus regarding mammography
screening of asymptomatic women beginning at age 40. The
failure of the panel to achieve its goal has caused an uproar
in the academic and lay communities.
It is important to understand the context in which the
issue has received so much attention. Breast cancer is often
referred to as an epidemic in the United States because of its
prevalence, occurring in about one out of eight to one out of
every nine women over their lifetime. Literally every adult in
the United States is affected at some level by breast cancer.
For women, the fear of the disease strikes deeply on physical,
psychological and social levels.
The rise in interest and public awareness and research
funding for breast cancer has paralleled the rise in influence
and power of women in the United States in general. The issue
strikes every woman deeply and emotionally with disparate
forces, coupling intelligent, rational people with the gut-
wrenching fear of breast cancer. It becomes difficult to
separate analysis of the scientific data from personal bias,
fears and desires.
As new scientific data is acquired, recommendations for
screening may be expected to evolve. Analysis of data as it is
acquired takes time, and there is necessarily a lag between the
time that data is published and it undergoes scientific
scrutiny and is translated into policy by the major medical
societies and finally by Federal agencies. In medical research
and access--in particular, the issue at hand, breast cancer
screening for women ages 40 to 49--public demand for rapid
response to new information may have exceeded the ability of
the system to respond. The ramifications of setting policy are
enormous because of the implications regarding the financial
coverage for screening mammography. Recommendations made by
nationally recognized bodies are expected to be used as
guidelines for Medicare. And these same recommendations are
frequently used by insurance companies.
The controversy regarding breast cancer screening for women
ages 40 to 49 focuses on several issues. These have been
discussed at length at the consensus conference. Dr. Stephen
Feig, who is a participant at this hearing here, has written
extensive and convincing responses to many of the criticisms
opposing or questioning the value of screening women ages 40 to
49 for breast cancer. I will mention only a few.
The most important issue for acceptance of a screening
procedure is establishing the efficacy of that procedure; that
is, whether screened populations shows a decrease in mortality
from the disease compared to the unscreened population. The
potential benefit of screening mammography must be considered
in perspective of the possible adverse effects of screening
mammography. These include false positive results, subjecting
women to biopsies because of equivocal or worrisome findings on
the mammogram which prove to be benign at biopsy.
False positives are common because the goal of mammography
is not to miss any cancers. Thus, we are willing to accept a
certain number of false positives, which are acknowledged to
cause anxiety to the women involved and add to the cost of
mammography. False negative mammograms are also an acknowledged
real problem. The increasing availability and use of
percutaneous core biopsies is helping to decrease the number of
false positive surgical biopsies.
Senator Specter. Dr. Caroline, could you summarize the
balance, and your full statement will be in the record.
Dr. Caroline. Sure.
prepared statement
My final assessment for the available data favoring breast
cancer screening for women ages 40 to 49 is sufficiently strong
compared to the negative information to advocate for the
position. I would stress that I feel strongly that continued
research to improve early detection and prevention of breast
cancer must be supported and funded. This includes well
controlled screening studies for women in the age group and to
her modalities of funding, and possibilities for other non-
imaging modalities as well.
Thank you.
Senator Specter. Thank you very much, Dr. Caroline.
[The statement follows:]
Prepared Statement of Dina F. Caroline, M.D.
Temple University Hospital in Philadelphia is a nationally
known teaching institution serving the health care needs of the
local community. The Hospital also provides the clinical
environment to support the training and research needs of the
Temple Medical School. Founded in 1892, Temple University
Hospital now has over 500 patient beds. In the Department of
Diagnostic Imaging at the Health Science Center, over 5,000
mammograms are performed annually.
Recommendations regarding mammographic screening for women
ages 40 to 49 have been evolving since screening was introduced
in 1977 when NCI and ACS recommended it for women with first
degree relatives with breast cancer. Since 1983, the ACS has
recommended screening for women ages 40 to 49 every 1 to 2
years. Through 1989, these guidelines were adopted by
additional major medical organizations. In the early 1990's,
individual radiologists were beginning to advocate yearly
screening for women aged 40 to 49 while other radiologists and
other health care professionals questioned the value of
screening altogether.
This conflict of screening women ages 40 to 49 came to a
head in 1993 when NCI changed its recommendation no longer
stating that ``experts do not agree on the value of routine
screening mammography for women ages 40 to 49.'' Other
organizations including ACS and ACR disagreed with the change.
The recent NIH conference convened January 20th with the
intention of achieving consensus regarding mammography
screening of (asymptomatic) women beginning at age 40. The
failure of the panel to achieve its goal has caused an uproar
in the academic and lay communities.
It is important to understand the context in which this
issue has received so much attention. Breast cancer is often
referred to as an epidemic in the United States because of its
prevalence occurring in about one-eighth to one-ninth of women
over their lifetime. Literally every adult in the United States
is affected at some level by breast cancer. For women the fear
of the disease strikes deeply on physical, psychological, and
social levels. The rise in interest and public awareness and
research funding for breast cancer has paralleled the rise in
the influence and power of women in the United States in
general. The issue strikes every woman deeply and emotionally
with disparate forces coupling intelligent rational people with
the gut wretching fear of breast cancer. It becomes difficult
to separate analysis of the scientific data from personal bias,
fears and desires.
As new scientific data is acquired, recommendations for
screening may be expected to evolve. Analysis of data as it is
acquired takes time and there is necessarily a lag between the
time that data is published that it undergoes scientific
scrutiny, and is translated into policy by the major medical
societies and finally by the federal agencies. In medical
research and access, in the particular issue at hand, breast
cancer screening for ages 40 to 49, public demand for rapid
response to new information may have exceeded the ability of
the system to respond. The ramifications of setting policy are
enormous because of the implications regarding the financial
coverage for screening mammography. Recommendations made by
nationally recognized bodies are expected to be used as
guidelines for Medicare and these same recommendations are
frequently used by insurance companies.
The controversy regarding breast cancer screening for women
between the ages of 40 to 49 focuses on several issues. These
have been discussed at length at the consensus conference. Dr.
Stephen Feig, a participant at this hearing has written
extensive and convincing responses to many of the criticisms,
opposing or questioning the value of screening women ages 40 to
49 for breast cancer. I will mention only few.
The most important issue for acceptance of a screening
procedure is establishing the efficacy. That is, whether
screened populations show a decrease in mortality from the
disease compared to unscreened populations. The potential
benefit of screening mammography must be considered in
perspective of the possible adverse effects of screening
mammography. These include false positive results--subjecting
women to biopsies because of equivocal or worrisome findings on
the mammogram which prove to be benign at biopsy. False
positives are common because the goal of mammography is not to
miss any cancers. Thus, we are willing to accept a certain
number of false positives, which are acknowledged to cause
anxiety to the women involved and add to the cost of
mammography. False negative mammograms are also an acknowledged
real problem. The increasing availability and use of
percutaneous ``core'' biopsies is helping to decease the number
of false positive surgical biopsies.
Responses to the advocates of screening mammography (40 to
49) challenges raising the questions of potential risks or
adverse effects to screening mammography have been strong, if
not uniformly convincing. The potential risk of the cumulative
effects of the low doses of radiation to the breasts has
historically deterred many women from seeking, and physicians
from recommending, screening mammography. Dr. Feig has
addressed this issue and clearly has shown that even assuming a
``worst case scenario'', the benefit of mammography far
outweighs the risk of ``excess'' deaths from radiation-induced
cancers.
The issue of the diagnosis and management of ductal
carcinoma in situ (DCIS) is important, raising concerns of over
diagnosis and over treatment of a pathologic entity whose
natural history is often not aggressive. Pathologists are now
distinguishing between aggressive (comedo-type) and non-
aggressive forms of DCIS. There is a small (about 2 percent)
annual incidence of subsequent invasive cancer in patients with
DCIS. This rate is doubled in patients with positive family
history of breast cancer. Autopsy studies of women without
clinical breast cancer show a large number of cases with DCIS.
This holds true for women under and over the age of 50--but the
issue is no different for either age group. Granted that some
women diagnosed with DCIS may be overtreated, that option seems
preferable to not treating those that will become invasive.
Data supporting the efficacy of screening mammography in
women 40 to 49 years of age has accrued slowly. Convincing the
medical community of its validity has by no means been a
bandwagon jumped upon by all at first encounter. This is
because in the large screening studies there were not enough
women in the age group 40 to 49 to show a significant reduction
in mortality. Only by combining the data from all the studies
available and extending the time over which information was
analyzed have trends towards mortality reduction begun to
emerge in a convincing manner. The technique of analysis,
problems with design and methodology of the venous protocols
were presented at the consensus meeting. New data screening
projects in Sweden are showing impressive mortality reduction.
In my opinion, a reasonable working hypothesis would be that a
large yearly screening study performed by facilities conforming
to current standards (complying with the Mammography Quality
Standards Act, 1992) would show even more dramatic results.
In my assessment the available data favoring breast cancer
screening for women ages 40 to 49 is sufficiently strong
compared to the negative information to advocate for the
position. I would stress that I feel strongly that continued
research to improve the early detection and prevention of
breast cancer must be supported (and funded). This includes a
well controlled screening study in women aged 40 to 49 using
mammographic screening techniques conforming to the MQSA of
1992. Evaluation of new and emerging imaging modalities such as
MRI, digital mammography, nuclear medicine tumor imaging, and
high resolution ultrasound are but a few of the modalities
currently being evaluated as screening tools. Nonimaging
modalities such as serological test and genetic markers also
are under active investigation.
It is crucial that these modalities be given optimal
opportunities to mature and then that the accrediting agencies
be adaptable--constructed in such a way as to be able to react
with some efficiency to integrate new information and modify
existing recommendations in a timely manner and perhaps most
importantly that the insurers respond appropriately to the
recommendations.
Thank you for inviting me to participate in this hearing.
References for material contained in my testimony are available
upon request.
summary statement of dr. bonita falkner
Senator Specter. We now turn to Dr. Bonita Falkner, acting
director of the Institute for Women's Health and professor of
medicine and pediatrics at the Medical College of
Pennsylvania's Hollman School of Medicine at the Allegheny
University of Health Sciences. In her role as the director of
the Institute for Women's Health, she directs programs in
health research, health education and comprehensive health care
services for women.
Welcome, Dr. Falkner. The floor is yours.
Dr. Falkner. Thank you, Senator Specter. I appreciate the
opportunity to testify before you today. And it is gratifying
to see your attention on this important aspect of women's
health.
Breast cancer is the No. 1 cancer in women in the United
States, and is second only to lung cancer in the number of
women that it kills each year. A woman's lifetime risk of
developing breast cancer is now one in eight. So far, our best
defense against breast cancer is detecting it at its earliest
and most treatable stages. And that is where screening
mammography comes in. Allegheny has long made the detection and
treatment of breast cancer one of its top priorities. Our
breast centers offer specialized care to women who are at risk
of or had breast cancer, as well as comprehensive treatment and
support for women with breast cancer.
We work cooperatively with the Korman Foundation, the
American Cancer Society and other organizations to offer
screening mammograms to high-risk, underinsured and uninsured
women. We also offer mobile mammography programs in the
Delaware Valley and Pittsburgh areas, which provide no-cost or
low-cost mammograms in community settings, including
communities with high-risk populations. Last year, our mobile
mammography units provided more than 8,000 screenings,
including screenings for women in their forties. Physicians and
scientists all agree that mammography absolutely saves lives
when used as a regular screening for women ages 50 and above.
Study after study has shown that screening mammography
decreases mortality by 25 to 30 percent in these women.
Today's attention has turned to the controversy in
screening for breast cancer--namely, whether it should be
recommended for all women in their forties. There is no
question that breast cancer is a significant health concern for
women in this age group. Breast cancer is the leading cause of
death for women ages 40 to 49 in the United States. A 40-year-
old woman has a 2-percent chance of being diagnosed with
invasive breast cancer or a ductal carcinoma in situ in the
next 10 years. Her risk doubles by the time she reaches 49
years. Nevertheless, there is only a 0.3-percent chance of
dying from breast cancer during this decade.
The question, rather, is whether screening mammographies
should be recommended across the board for women in their
forties. The distinguished panel assembled by the National
Institutes for Health did a study of eight clinical trials
conducted worldwide over the past three decades. After careful
consideration of the pros and cons, it concluded that women in
this younger age group could not be given a single generic
recommendation. Rather, the decision should be made on a case-
by-case basis by a woman and her physician together. This moves
the recommendation of the committee from a public health
recommendation for a population of women to a medical
recommendation for individual women.
We agree with this conclusion when interpreted in the
context of optimizing the health of individual women. Within
this 10-year age range, from 40 to 50 years, women have greatly
varying medical situations that demand individualized
decisionmaking. Some fall into populations that put them at
higher risk and clearly call for increased vigilance--they have
a mother or sister with breast cancer, they are African-
Americans or Ashkenazi Jews; they have a history of breast
problems. Some women will have begun menopause or be
menopausal. Some will be on estrogen replacement therapy.
A physician consulting with a patient on mammography takes
all of these variables into consideration, and the physicians
temper their advice with their own experience. Many doctors
advise women selectively to have a screening mammogram based
upon their risk factors. Other physicians choose to err on the
side of caution and recommend annual mammography for all women
in their forties. There are no easy answers, and scientific
uncertainty exists.
The trials conducted to date have not enrolled
statistically large numbers of women ages 40 to 49, and many
trials began decades ago, when mammography technology was poor,
possibly skewing the results. There may be risk factors that
have not yet been identified or benefits of screening
mammography still to come to light. New trials are now underway
with today's technology, and it may show an increased value for
mammography. Additionally, future technology has the potential
to refine and improve our current methods for early detection
of breast cancer.
Very knowledgeable people have carefully examined the
trials that have been done so far. Depending on the
interpretation of the results, they have varying findings. One
conclusion reached is that the trials show no observable
benefit from screening in younger women. Others interpreting
the data differently find about a 15-percent decrease in
mortality when women receive screenings in their forties. And
this could translate to as many as 1,600 lives saved in a year.
Given all of these factors, we continue to conclude that
screening mammograms are appropriate for many women in their
forties, and we would like to offer four additional concerns.
Senator Specter. Dr. Falkner, could you summarize; your
full statement will be in the record.
Dr. Falkner. The scientific merits of mammography in
younger women should not confuse the facts for women 50 and
above. For this 50 to 69 age group, studies have shown that
mammography saves lives. Women in their forties should have
access to physicians' counseling on the issue, and access to
mammography. And we find it particularly troublesome to
consider that the panel's failure to endorse this procedure has
the potential to lead to failure on the part of insurers to
pay.
prepared statement
And finally, with the known excess mortality among minority
and disadvantaged women, particular effort must be made to
provide access to physician counseling and breast screening for
all of these women in these ages.
Thank you for the opportunity to testify.
Senator Specter. Thank you very much, Dr. Falkner.
[The statement follows:]
Prepared Statement of Bonita Falkner, M.D.
Mr. Chairman and members of the Committee, I am Bonita
Falkner, M.D., Acting Director of the Institute for Women's
Health and Professor of Medicine at Allegheny University of the
Health Sciences. I appreciate the opportunity to testify before
you today.
It is gratifying to see such attention paid to an important
aspect of women's health--screenings for breast cancer. Breast
cancer is the No. 1 cancer in women in the United States, and
is second only to lung cancer in the number of women it kills
each year. A woman's lifetime risk of developing breast cancer
is now one in eight. So far, our best defense against breast
cancer is detecting it at its earliest, most treatable stages.
And that's where mammography comes in.
Allegheny has long made the detection and treatment of
breast cancer one of its top priorities. Our Breast Centers
offer specialized care to women who are at risk of or have had
breast cancer, as well as comprehensive treatment and support
for women with breast cancer. We work cooperatively with the
Korman Foundation, the American Cancer Society and other
organizations to offer mammograms to high-risk, underinsured
and uninsured women. We also offer mobile mammography programs
in the Delaware Valley and Pittsburgh areas which provide no-
cost or low-cost mammograms in community settings, including
communities with high-risk populations. Last year, our mobile
mammography units provided more than 8,000 screenings--
including screenings for women in their 40's.
Our commitment to this area is also evident nationally. Our
physicians provide the leadership for the National Surgical
Adjuvant Breast and Bowel Project, one of the National Cancer
Institute's prestigious cancer treatment and prevention
research projects representing the nation's foremost work in
breast cancer.
Medical research, at Allegheny and at other institutions
throughout the country, has led to ever-improving treatments
for breast cancer. For example, trials led by the NSABBP showed
that lumpectomy and radiation therapy have results equivalent
to mastectomy, and were the first to show that chemotherapy
after surgery could improve survival.
Physicians and scientists all agree: Mammography absolutely
saves lives when used as a regular screening for women ages 50
and above. Study after study has shown that mammography
decreases mortality by 25 to 30 percent in these women.
Today's attention has turned to controversy in screening
for breast cancer--namely, whether it should be recommended for
all women in their 40's.
There is no question that breast cancer is a significant
health concern for women in this age group. Breast cancer is
the leading cause of death for women ages 40 to 49 in the
United States. A 40-year-old woman has a 2-percent chance of
being diagnosed with invasive breast cancer or ductal carcinoma
in situ in the next 10 years. Her risk doubles by the time she
reaches 49 years. Nevertheless, there is only a 0.3 percent
chance of dying from breast cancer during this decade.
The question, rather, is whether mammograms should be
recommended across the board for women in their 40's.
The distinguished panel assembled by the National
Institutes for Health did a study of eight clinical trials
conducted worldwide over the past three decades. After careful
consideration of the pros and cons, it concluded that women in
this younger age group could not be given a single generic
recommendation. Rather, the decision should be made on a case-
by-case basis by a woman and her physician together. This moves
the recommendation of the committee from a public health
recommendation for a population of women to a medical
recommendation for individual women.
We agree with this conclusion when interpreted in the
context of optimizing the health of individual women. Within
this 10-year age range from 40 to 50 years, women have greatly
varying medical situations that demand individualized
decisionmaking. Some fall into populations that put them at
higher risk and clearly call for increased vigilance--they have
a mother or sister with breast cancer; they are African-
Americans or Ashkenazi Jews, they have a history of breast
problems. Some women will have begun menopause or be
postmenopausal; some are on estrogen replacement therapy.
A physician consulting with a patient on mammography takes
all of these variables into consideration, and physicians
temper their advice with their own experience. While many
doctors advise women selectively to have mammograms based on
their risk factors, others choose to err on the side of caution
and recommend annual mammograms for all women in their 40's.
There are still no easy answers. Scientific uncertainty
exists. The trials conducted to date have not enrolled
statistically large numbers of women ages 40 to 49, and many
began decades ago when mammography technology was poorer,
possibly skewing results. There may be risk factors that have
not yet been identified, or benefits of mammography still to
come to light. New trials now underway with today's technology
may show an increased value for mammography. Additionally,
future technology has the potential to refine and improve our
current methods for early detection of breast cancer.
Very knowledgeable people have carefully examined the
trials that have been done so far. Depending on the
interpretation of the results, they have varying findings. One
conclusion reached is that the trials show no observable
benefit from screening in young women. Others, interpreting the
data differently, find about a 15-percent decrease in mortality
when women receive screenings in their forties--and this could
translate to as many as 1,600 lives saved in a year.
Given all of these factors, we continue to conclude that
mammograms are appropriate for many women in their forties. We
would also like to offer three additional concerns:
That the controversy over the scientific merits of
mammography in younger women not confuse the facts for women 50
and above. For women in the 50 to 69 age group, studies have
shown time and again that mammography saves lives.
Second, that women in their 40's have access to a
physician's counseling on this issue and access to mammography.
We find it particularly troublesome to consider that the
consensus panel's failure to endorse the procedure has the
potential to lead to a failure on the part of insurers to pay
for the procedure.
Third, with the known excess modality among minority and
disadvantaged women, particular effort must be made to provide
access to physician counseling and breast screening for these
women at all ages.
We agree wholeheartedly with the consensus panel's
statement that a woman should have access to the best possible
information in an understandable and usable form, and that her
health care provider must have sufficient information to
facilitate her decisionmaking process. I'd like to add that it
is important that the physician have adequate time to spend in
discussion with the patient as well.
Thank you for the opportunity to appear before you today.
This concludes my prepared statement. I would be happy to
answer any questions you may have
summary statement of dr. stephen a. feig
Senator Specter. We now turn to Dr. Stephen A. Feig, chief
of the division of mammography at Thomas Jefferson University
Hospital, professor of radiology there, chairman of the
Mammography Accreditation Committee, and the ad hoc Committee
on Mammography Screening Guidelines for the American College of
Radiology's Breast task force. Dr. Feig's analysis on radiation
risks of mammography was presented to the NIH Consensus
Development Conference.
We do welcome you here, Dr. Feig, and the floor is yours.
Dr. Feig. Thank you, Senator Specter.
This morning I am speaking on behalf of Thomas Jefferson
University Hospital, as well as the Philadelphia Chapter of the
American Cancer Society.
As a participant in the last month's NCI Consensus
Development Conference, I heard investigators from here and
abroad present data which provided indisputable proof of
substantial benefit of screening with women ages 40 to 49.
American women and their families should be heartened by these
results, even though they may be understandably disappointed,
confused and even outraged that these reports were ignored by
the panel.
When in 1993, the NCI dropped its former recommendation to
screen women in their forties, it specified the type of
scientific proof which would be needed to restore its
endorsement. Statistically significant proof of mortality
reduction in randomized clinical trials was not available at
that time. Such proof has now been obtained. It has been
published in respected medical journals such as Cancer and the
International Journal of Cancer, and was presented at the NCI
meeting. American women should know that a meta-analysis of the
most recent followup data from seven population-based
randomized trials shows a 25-percent reduction in breast cancer
deaths among women in their forties, and that two of the
Swedish trials did even better, showing statistically
significant reductions of 35 percent and 44 percent for women
who began screening in their forties.
Moreover, randomized trials will inherently underestimate
the benefit for women who are screened because, by design, the
trials compared breast cancer deaths among women who are
offered versus who are not offered screening. Yet not all of
the women who were offered screening agreed, while some not
offered screening obtained it on their own, outside the trials.
There are also other reasons why the benefit from current
mammography should be even greater than that found in the
trials. These would include improvements in mammography
technique and equipment since the 1980's, when the trials
began, the use of two mammographic views per breast rather than
one, and shorter screening intervals of every year rather than
every 2 years as in most of the trials. Annual screening is
much more effective than biannual screening, especially for
women in their forties. Several studies have shown that annual
screening of women between 40 and 49, with current mammography
techniques, should be able to reduce breast cancer deaths by at
least 40 percent. These studies were available to the panel,
yet they were ignored in their report.
Now that the required proof of benefit has been obtained,
the NCI should accept, advise and promote such screening rather
than look for new, unconvincing reasons not to do so.
Requirements for advising screening should not be made into a
game of ``catch me if you can.'' Breast cancer is far too
serious a disease for that type of chicanery.
The 1993 NCI process was severely criticized in a report of
the U.S. House of Representatives Committee on Government
Operations, entitled ``Misused Science: The NCI's Elimination
of Mammography Guidelines for Women in their Forties,'' which
concluded, and I quote, ``that the NCI failed to examine
objectively all of the available evidence of mammography
screening, and excluded the presentation of favorable
information on mammography screening.''
Inexplicably, the NCI staffers planning this conference did
not learn from the mistakes they made in 1993, and arranged a
conference which reads the same, old 1993 conclusion despite
the existence of overwhelming new evidence.
Why was screening down-played by the panel? Mortality
reduction from screening women in their forties did take longer
to appear due to a relatively smaller number of younger women
in the trials, as well as their faster breast cancer growth
rates. If younger women had been screened every year, their
benefit would have appeared about the same time and would have
had about the same magnitude as that for older women who had
been screened every other year.
The American Cancer Society, accordingly, is considering
revising its own guidelines to explicitly advise screening
women in their forties every year rather than every 1 to 2
years as it now does. Some of the benefits, it is true, for
women who enter the trials in their forties may have been due
to cancers detected after they reached age 50. A comparable
situation exists in every age group--women who began screening
at age 50, 60, or 70. But we do know that at least 75 percent
of the benefit for women who entered the trials in their
forties was due to cancers that were detected before age 50.
Senator Specter. Dr. Feig, would you summarize? Your full
statement will be made a part of the record. Please.
prepared statement
Dr. Feig. Yes; in America today, 20 percent of all breast
cancer deaths and 33 percent of all of the years of life
expectancy lost to breast cancer are due to breast cancers
found in women in their forties. Not to advise screening until
age 50 is unjustifiable and unconscionable.
Thank you, Senator.
Senator Specter. Thank you, Doctor.
[The statement follows:]
Prepared Statement of Stephen A. Feig, M.D.
My name is Stephen Feig and I am a physician practicing at
Thomas Jefferson University Hospital in Philadelphia where I am
Director of Breast Imaging and Professor of Radiology at
Jefferson Medical College. I chair the American College of
Radiology Committee on Mammography Screening Guidelines. Today,
I am speaking on behalf of Thomas Jefferson University as well
as the Philadelphia Chapter of the American Cancer Society.
As a participant in last month's NCI Consensus Development
Conference, I heard investigators from here and abroad present
data which provided indisputable proof of substantial benefit
of screening women ages 40 to 49. American women and their
families should be heartened by these results even though they
may be understandably disappointed, confused and even outraged
because these reports were ignored by the panel.
When in 1993, the NCI dropped its former recommendation to
screen women in their forties, it specified the type of
scientific proof which would be needed to restore its
endorsement. Statistically significant proof of mortality
reduction in randomized clinical trials was not available at
that time. Such proof has now been obtained, has been published
in respected medical journals such as Cancer and the
International Journal of Cancer, and was presented at the NCI
meeting. American women should know that a meta-analysis of the
most recent follow-up data from seven population-based
randomized clinical trials shows a 25-percent reduction in
breast cancer deaths and that two of the Swedish Trials did
even better showing reductions of 35 percent and 44 percent for
women who began screening at age 40 to 49.
Moreover, randomized trials will inherently underestimate
benefit for women who are screened because by design the trials
compared breast cancer deaths among women offered versus not
offered screening, yet, not all women offered screening agreed
while some not offered screening obtained it on their own
outside the trials.
There are other reasons why benefit from current
mammography should be even greater than that found in the
trials. These include improvement in mammography technique and
equipment since the 1980's when the trials began, use of two
mammographic views per breast rather than one, and shorter
screening intervals of every year rather than every other year
as in most of the trials.
Annual screening is much more effective than biennial
screening especially for women in their forties. Several
studies have shown that annual screening of women ages 40 to 49
with current mammographic techniques should be able to reduce
breast cancer deaths by at least 40 percent. These studies were
available to the panel, yet were ignored in their report.
Now that the required proof-of-benefit has been obtained,
the NCI should accept, advise, and promote such screening
rather than look for new unconvincing reasons not to do so.
Requirements for advising screening should not be made into a
game of ``catch me if you can''. Breast cancer is far too
serious a disease for that type of chicanery
The 1993 NCI process was severely criticized in a report of
the U.S. House of Representatives Committee on Government
Operations entitled ``Misused Science: The NCI's Elimination of
Mammography Guidelines for Women in Their Forties'' which
concluded that the NCI ``failed to examine objectively all of
the available evidence of mammography screening'' and
``excluded the presentation of favorable information on
mammography screenings'' inexplicably, the NCI staffers
planning this conference did not learn from the mistakes they
made in 1993 and arranged a conference which reached the same
old 1993 conclusion despite the existence of overwhelming new
evidence.
Why was screening benefit downplayed by the panel?
Mortality reduction from screening women in their forties did
take longer to appear due to a relatively smaller number of
younger women in the trials as well as their faster breast
cancer growth rates. If younger women had been screened every
year, their benefit would have appeared about the same time and
would have had the same aptitude as that for older women who
were screened every other year. The American Cancer Society is
considering revising its own guidelines to explicitly advise
screening women ages 40 to 49 every year rather than every 1 to
2 years as it now does
Some of the benefits for women who entered the trials in
their forties may have been due to cancers detected after they
reach fifty. A comparable situation exists for women who begin
screening at age fifty, sixty, or seventy. Yet at least 75
percent of the benefit for women who entered the trials in
their forties was due to cancers detected before age fifty.
In America today, 20 percent of all breast cancer deaths
and 33 percent of all years of life expectancy lost to breast
cancer are due to breast cancers found in women in their
forties. Not to advise screening until age 50 is unjustified
and unconscionable.
Not only did the NCI consensus panel ignore the proven
benefit, but also missrepresented possible adverse consequences
from screening. False negative mammograms do not just occur
below age fifty but are seen in all age groups. Mammography is
not a perfect test, but it is the best screening test we have
and no better test is available for the foreseeable future.
Only 3 percent of screening mammograms are positive,
requiring additional procedures for evaluation, but nearly all
of these procedures involve nothing more than additional
mammographic views or ultrasound. These may cause some mild
anxiety in some women but surely this is preferable to the
anxiety of dying from breast cancer.
Only 0.5 percent of women screened in their forties each
year need to be biopsied. Cancer is found in 25 percent of
these biopsies compared with 33 percent for women in their
fifties. Thus, false positive biopsy results are only slightly
lower than in older women.
Radiation dose from current mammography is extremely low.
Radiation risk is a theoretical possibility. If there is any
risk, it is slight compared with the proven benefit of this
life saving procedure.
Detection of ductal carcinoma in situ represents a
screening success. These are real cancers, but since they are
detected at any early stage, cure rates are over 99 percent. It
is possible that some of them may not progress to invasive
cancer, but there is no present way to predict which ones these
will be. To insinuate as the NCI did that ductal carcinoma in
situ in general should not be detected and should not be
treated is like playing a reckless game of Russian roulette
with women's lives.
Thank you for the opportunity to present this statement. I
will be glad to respond to any questions you may have.
summary statement of dr. daniel sullivan
Senator Specter. We now turn to Dr. Daniel Sullivan,
associate professor of radiology at the University of
Pennsylvania Medical Center and section chief for breast
imaging. He is a graduate of the University of Vermont College
of Medicine and has also been a professor of radiology at Duke
University Medical Center and Yale Medical School. Dr. Sullivan
served as a panel member of the NIH Consensus Conference on
Mammography, which took place in January.
Dr. Sullivan, welcome; the floor is yours.
Dr. Sullivan. Thank you, Senator Specter.
As you stated, I am chief of breast imaging at the Hospital
at the University of Pennsylvania. I also served as a member of
the NIH consensus panel looking at the issue of mammography for
women in their forties. And before I make a couple of other
points along the lines of previous panelists, I want to
emphasize that the draft statement released on January 23 from
the consensus conference was not and is not the final statement
of the consensus panel.
Over the last 3 weeks the panel has continued to revise the
draft, with the input of leading health policymakers, such as
yourself, cancer experts and advocacy groups and others. It is
my personal belief that the draft statement of January 23
understates the benefits of annual mammograms for women in
their forties and overstates the risks. And it is my hope that
the final consensus document will reflect a more balanced
viewpoint.
In my prepared statement, I have discussed some of the
specific issues, and I will not read that and go through that
again at this time, but I will be happy to answer questions.
I endorse many of the comments that Dr. Feig has made. He
has addressed some of these same issues, such as the
differences of opinion among panel members between evaluating
individual trials versus the meta-analysis and the issue of the
clinical significance of DCIS. Based on my clinical experience
and knowledge of the relevant data, I believe that for the
majority of women in their forties, especially in their mid-
and late-forties, the benefits of annual mammography outweigh
the potential harms.
Although it is true that the benefit on a population basis
is smaller than the benefit for elder groups of women, to me,
that does not mean that the benefit of screening is not
significant. Therefore, I advocate annual mammography for women
in their forties.
Dr. Feig referred to the importance of annual mammography
in women in their forties, and I have included a discussion of
that in my statement, and I endorse that. And we can discuss
that, again, further if you wish.
Moving on to some suggestions about where governmental
agencies or government policy could help. Clearly, continued
support for breast cancer research is needed. I know you have
been a strong leader in promoting increased funding for NIH
research in general, as well as funding for breast cancer
specifically. And one of those large efforts has to do with the
transfer of defense technologies to the evaluation of digital
mammograms, which I am involved in at the University of
Pennsylvania.
Senator Specter. You say defense technologies?
Dr. Sullivan. Defense technology. The program is sometimes
referred to as ``from missiles to mammograms.''
These investments in research have yielded a decrease in
the mortality rate for breast cancer in the last few years,
particularly for white women. This has not yet been achieved
for African-American women. This increase in survival
undoubtedly reflects things from screening mammography as well
as improvements in breast cancer treatment. Clearly, we need
more information about the basic biology of breast cancer. We
need breakthroughs in terms of real prevention of breast
cancer, and we need to understand why the improvements in
survival are not reaching all segments of our population.
Second, legislative protection for access to mammography
for all women is necessary. We know that third-party payers are
not consistent with respect to their willingness to reimburse
for mammogram screening. Over the past 10 years, many States,
including Pennsylvania, have passed laws mandating that third-
party payers cover mammography. However, provisions of these
laws vary from State to State, and some States do not have such
laws. Congress should consider legislation to make this
protection uniform across the country.
I have included in my statement a couple of more
suggestions, but I will not read that at this time. And I
conclude that I believe many people, both men and women, want
to have clear, understandable information about choices open to
them for health maintenance. Others rely on their trusted
health care providers to make recommendations for them. Both
are valid approaches and deserve our support.
I support the call for clear, understandable information
about the efficacy of mammography so that women can make
informed decisions. But it is equally important to provide
similar information to physicians and other health care
providers who will be advising their patients. Guidelines or
recommendations from professional organizations that have
studied the issue are entirely appropriate and necessary. Such
informed guidelines will assist health care providers who may
not have the background or time to evaluate all the available
evidence themselves.
prepared statement
In conclusion, for women who ask my advice, I reply that
annual mammography is likely to be a significant benefit for
women in their mid- to late-forties, and I hope and expect that
this opinion will be the recommendation of most if not all
organizations that study the issue. I am working to ensure that
this viewpoint is adequately reflected in the final statement
of the NIH consensus panel.
Thank you.
Senator Specter. Thank you very much, Dr. Sullivan.
[The statement follows:]
Prepared Statement of Daniel C. Sullivan, M.D.
Chairman Specter, staff members, guests. Thank you for this
opportunity to testify before the Senate Subcommittee on Labor,
HHS, and Education Appropriations regarding the recently
convened NIH consensus development conference on breast cancer
screening. In addition to my role as Chief of Breast Imaging at
the Hospital of the University of Pennsylvania, I also serve as
a member of the NIH consensus panel which is looking at the
issue of mammography for women in their forties
Prior to discussing the central points of my testimony, I
would like to make some preliminary remarks related to the work
of the consensus panel. Let me begin by emphasizing that the
draft statement released on January 23rd was not and is not the
final statement of the consensus panel. Over the last three
weeks, the panel has continued to revise the draft, and the
input of leading health policymakers, such as yourself, cancer
experts, and advocacy groups, among others, has been useful as
we work to craft a final statement on this issue. It is my
personal belief that the draft statement of January 23, 1997
understates the benefits of annual mammograms for women in
their forties and overstates the risks and it is my hope that
the final consensus document will reflect a more balanced
viewpoint.
By necessity, much of the panel and public discussion on
this issue has centered on matters of clinical and value
judgments guided by the available scientific data.
Unfortunately, these data do not provide a clear and
unambiguous answer on the question at hand. Because no single
randomized controlled trial includes large numbers of women in
their forties, many physicians, including myself, rely on the
results of meta-analyses, a statistical technique for combining
data from several small studies to increase the power of the
analysis. Results from the meta-analyses of the eight existing
randomized controlled trials show a 17 percent mortality
reduction for women who began screening in their forties.
However, others point out that the results of a meta-analysis
are strongest when one combines studies that are similar in
design and execution. While there are many points of similarity
among the eight randomized controlled trials, there are also
differences. Therefore, they look at the results of each trial
separately and point out that only three of the eight trials so
far show statistical significance for women in their forties.
Furthermore, there are differences of opinion about whether the
magnitude of a given benefit, either from a meta-analyses or
from an individual trial, should be considered ``small,''
``modest,'' or ``significant.''
The panel was asked to address specific questions, such as,
``What are the benefits of mammography for women age 40 to 49,
and What are the risks?'' The panel was not asked to make
policy recommendations or weigh the benefits versus the risk.
Again, however, it would be difficult, if not impossible, to
answer such questions without invoking one's value judgments or
clinical opinions. For example, our knowledge of the natural
course of ductal carcinoma in situ (DCIS) is, unfortunately,
incomplete. DCIS is an early form of breast cancer in which the
cancer cells are still located in the ducts where they formed
and have not spread into the surrounding breast tissue or other
parts of the body. Most clinicians, including myself, believe
that all cases of invasive breast cancer start as DCIS and,
therefore, a goal of mammography screening is to detect and
remove DCIS before it becomes invasive breast cancer. However,
some believe that many cases of DCIS will not become clinically
significant and, therefore, subjecting women to treatment for
all DCIS is not advisable. We do not have the necessary
scientific data to definitively settle this debate and
differing opinions about the natural course of DCIS lead to
conflicting positions regarding the risk/benefit analysis of
mammography for women in their forties
Despite the difficulties posed by the lack of clear-cut
scientific results, based on my clinical experience and
knowledge of the relevant data, believe that for the majority
of women in their forties, especially in their mid- to late
forties. the benefits of annual mammography outweigh the
potential harms. Although it is true that the benefit, on a
population basis, is smaller than the benefit for older groups
of women, to me that does not mean the benefit of screening is
not significant. Therefore, I advocate annual mammography for
women in their forties.
As you know, the frequency at which we should recommend
mammography for women in their forties has been a topic of much
debate. The current guidelines of the American Cancer Society
and the American College of Radiology, for example, suggest
that women in their forties have mammograms every one or two
years. This ambiguity in the guidelines has been a source of
confusion to women and many referring physicians. Much evidence
has accumulated over the past two decades that younger women
have a higher proportion of fast-growing breast cancers than
older women. The technical term for this biological attribute
of tumor growth is the sojourn time. To adequately detect
faster growing tumors at an early stage, we must screen more
frequently than would be necessary for early detection of slow
growing tumors. There are good data to suggest that results
from some of the randomized controlled trials underestimate the
benefit of mammography for women under age 50 because the
screening interval was every 2 years. The evidence suggests
that we should screen younger women every year to achieve
maximum benefits. This is not to say that there would be no
benefit from screening at 2 year intervals, but that the
benefit for populations with a short mean sojourn time, such as
women under 50, would be significantly better with annual
screening.
There are several areas of governmental policy where your
continued leadership, and the help of other government
agencies, could be extremely helpful. First, continued support
for breast cancer research is clearly needed. I know that you
have been a strong leader in promoting increased funding for
NIH research in general as well as funding for breast cancer
research in particular. Your efforts are greatly appreciated by
me and my colleagues at the University of Pennsylvania Medical
Center. As a result of these investments, the mortality rate
for breast cancer has finally started to decline in recent
years among white women, although the same cannot be said for
African-American women. This increase in survival undoubtedly
reflects gains from screening mammography, as well as
improvements in breast cancer treatment. Nevertheless, we need
more information about the basic biology of breast cancer; we
need breakthroughs in terms of real prevention of breast
cancer; and we need to understand why the improvements in
survival are not reaching all segments of our population.
Second, legislative protection for access to mammography
for all women is necessary. We know that third-party payers are
not consistent with respect to their willingness to reimburse
for mammography screenings. Over the past 10 years, many
states, including Pennsylvania, have passed laws mandating that
third party payers cover mammography. The provisions of these
laws vary from state to state, and some states have no such
law. Congress should consider legislation to make this
protection uniform across the country.
One of the disadvantages of mammography is the number of
false positive interpretations that lead to additional tests
and procedures for what turns out to be benign disease. There
are several factors that contribute to the false positive rate,
all of which need attention. The quality of the images and
their interpretation are important factors. The FDA acting
under the Mammography Quality Standards Act of 1992 is key to
improving the technical quality of mammographic images and
addressing the issue of radiologist variability in mammogram
interpretation. However, even with optimal technical and
interpretative mammographic quality, the technique still has
limitations and some false positives are inevitable.
Alternative or adjunctive non-invasive diagnostic techniques
resulting from current and future research may help to reduce
this problem. Once again you have shown your leadership in this
area by supporting a study underway at the University of
Pennsylvania Medical Center to explore the use of defense
technologies in the early and accurate detection of breast
cancer I am pleased to say that I am part of the team involved
in this important work.
Yet another contributor to the problem of false negative
interpretations is a heightened fear of lawsuits. Delayed
diagnosis of breast cancer is one of the most frequent causes
of malpractice suites in this country. This causes many
radiologists to practice defensive medicine, contributing to
the number of false positive interpretations. It is my view
that meaningful tort reform might have some impact on reducing
the false positive rate.
One final area where the Federal Government could be
helpful is facilitating implementation of the National
Mammography Database (NMD). A committee of the American College
of Radiology proposed the NMD some years ago. The intent was
that all radiologists in the country would interpret mammograms
with standard terminology and would transfer the results to a
central database. The aggregated data would be an enormously
important resource for research, and for the quality
improvement activities of the FDA. A few problems have hindered
widespread implementation of the NMD. One is the question of an
appropriate ``home'' for this resource. It should not be within
the FDA or the American College of Radiology. Perhaps there is
an entity within the NIH that would be an appropriate base for
the NMD. Second is the issue of funding and long-term
stability. Perhaps some combination of public and private
funding could be developed. Third, is a concern about the
protection of the patient, radiologist, and practice data from
disclosure. Clearly, this would need legislative protection at
the Federal level.
In conclusion, many people, both men and women, want to
have clear, understandable information about choices open to
them for health maintenance. Others rely on their trusted
health care providers to make recommendations for them. Both
are valid approaches. I support the call for clear,
understandable information about the efficacy of mammography so
that women can make informed decisions. It is equally important
to provide similar information to physicians and other health
care providers who will be advising their patients. Guidelines
or recommendations from professional organizations that have
studied the issue are entirely appropriate and necessary. Such
informed guidelines will assist health care providers who may
not have the background or time to evaluate all the available
evidence. For women who ask my advice, I reply that annual
mammography is likely to be of significant benefit for women in
their mid and late forties. I hope and expect that this opinion
will be the recommendation of most, if not all, organizations
that study this issue. And I am working to ensure that this
viewpoint is adequately reflected in the final statement of the
NIH Consensus Panel
Thank you very much for giving me this opportunity to
testify. I would be happy to answer any questions you may have.
summary statement of dr. robert c. young
Senator Specter. We now turn to Dr. Robert C. Young,
president of the Fox Chase Cancer Center, Philadelphia. Dr.
Young came to Fox Chase in 1988 from the National Cancer
Institute, where he was associate director of the Community
Oncology Program. Before that, he served as chief of the NCI's
Medicine Branch for 14 years. He was recently appointed to the
National Cancer Policy Board as director at large of the
American Cancer Society's national board of directors.
Dr. Young, we thank you for coming, and the floor is yours.
Dr. Young. Thank you, Senator Specter.
Albert Einstein once said, ``Things should be made as
simple as possible, but no simpler.'' This is the crux of the
problem with mammography for women 40 to 50 years of age. For
women above 50, the message is clear and unequivocal: regular
mammography reduces breast cancer mortality by 30 percent.
Simply put, mammography saves lives. For women in the 40-to 50-
year age group, the scientific data are less clear. The results
of the studies done to date have been, at best, murky. Several
of the smaller studies show little benefit. Others show none at
all.
The most positive results derived from a large Swedish
study, which demonstrated a 12-percent reduction in mortality
for women in this age group who were screened every 2 years.
That mortality reduction did not become apparent until 8 years
after the randomized trial began. No one wants it to be this
murky, but neither should anyone be surprised.
The risk of breast cancer increases steadily with age. For
women under 40 without any other risk factors, the risk is
quite low, and there is no convincing argument for mammography
screening at all. At the other end of the age spectrum, for
women over 50, the case for screening is open and shut. It is
inevitable, however, when dealing with a rising increase in
risk, that at some point there will be a gray area.
For mammography screening that gray zone occurs between the
ages of 40 and 50. The factors which contribute to the
confusion are the low incidence of breast cancer in women of
this age, difficulty in detecting disease because of the nature
of the breast tissue, and differences in the biology of the
tumors themselves.
Because of these compounding factors, small or short-term
studies yield equivocal and even misleading results. It takes
much larger, longer-term trials to demonstrate the smaller
effect anticipated in this age group. In that regard, it is
noteworthy that the largest and longest trials show the most
positive result. We should not, however, allow ourselves to be
paralyzed or to become equivocal just because not all of the
trials demonstrate that mammography reduces mortality in women
age 40 to 50. Nor do I think it is adequate for the medical
profession to throw the issue back at women and tell them to
make their own decisions.
A number of very well-designed large studies, most notably
those done in Sweden, have shown a small but definite
improvement in survival. To my mind, that is sufficient
justification for not only continuing screening women in this
age group, but also for encouraging them to be screened
regularly. The reality is that public health guidelines cannot
and should not ever be based exclusively on the existence of
unequivocal scientific data. Guidelines are just that--
guidelines.
Even when reasonable people disagree, as they frequently do
in science, the purpose of guidelines is to give people the
best advice, not the purest. But prudent guidelines should
always balance benefit with risk. In the particular instance of
mammography in 40- to 50-year-olds, while the benefit is small,
the risks appear to be minuscule. There is little or no
evidence that screening inflicts any physical harm on the women
who undergo it.
The argument against mammography screening then becomes
largely economic--the dollars spent for mammograms and followup
examinations to detect a relatively small number of breast
cancer cases. From this perspective, most women and the doctors
would opt for the small but well-defined benefit. And, as a
society, I believe we have already made the choice to invest in
mammography as a means of saving the lives of our wives,
mothers, sisters and daughters. I believe this investment
should also include those women 40 to 50.
There are other investments we need to make as well. We
need to continue to improve mammography technology to make it a
more sensitive and valuable tool than it already is. But even
the best applications of mammography will not solve the breast
cancer problem, and it will not save those women whose disease
cannot be picked up by mammography. For these women with breast
cancer, we need new tools and better understanding of the basic
biology of breast cancer so that we can identify those
individuals who are truly at risk, and develop better
screening, prevention and treatment techniques.
prepared statement
The concerns about the efficacy of mammography screening in
women 40 to 50 will not be solved by more of the same studies.
Ultimately, the solutions will be found in research that
addresses the more fundamental questions and leads to new ways
to prevent or eliminate this terrible killer of women.
Thank you for your time and attention.
Senator Specter. Thank you very much, Dr. Young.
[The statement follows:]
Prepared Statement of Robert C. Young, M.D.
Albert Einstein once said, ``Things should be made as
simple as possible, but no simpler.'' This is the crux of the
problem with mammography for women 40 to 50 years of age. For
women above 50, the message is clear and unequivocal. Regular
mammography reduces breast cancer mortality by 30 percent.
Simply put, mammography saves lives.
For women in the 40 to 50 year age group, the scientific
data are less clear. The results of the studies done to date
have been at best murky. Several of the smaller studies show
little benefit; others show none at all. The most positive
results, derived from a large Swedish study, demonstrate a 12-
percent reduction in mortality for women in this age group who
were screened every 2 years. That mortality reduction did not
become apparent until 8 years after the randomized trial began.
Prior to that, screened and unscreened women had identical
breast cancer death rates.
No one wants it to be this murky, but neither should anyone
be surprised. The risk of breast cancer increases steadily with
age. For women under age 40, without other risk factors, the
risk is quite low and there is no convincing argument for
mammography screening at all. For women over 50, the case for
screening is open and shut. It is inevitable, however, when
dealing with a rising increase in risk, that at some point
there will be a gray area, an intersection at which the
convergence of various factors make it difficult to arrive at
clear cut, unambiguous conclusions. For mammography screening,
that gray zone occurs between the ages of 40 and 50. The
factors which contribute to the confusion are lower incidence
of breast cancer in women of this age, difficulty in detecting
the disease because of the nature of the breast tissue, and
differences in the biology of the tumors themselves. Because of
these compounding factors, small or short-term studies yield
equivocal and even misleading results. Much larger, long-term
trials are required to demonstrate the smaller effect
anticipated in this age group. In that regard, it is noteworthy
that the largest and longest trials show the most positive
result.
We should not, however, allow ourselves to be paralyzed or
to become equivocal because not all of the trials demonstrate
that mammography reduces mortality in women age 40 to 50. Nor
do I think it is adequate for the medical profession to throw
the issue back at women and tell them to make their own
decisions. A number of very well designed, large studies, most
notably those done in Sweden, have shown a small, but definite
improvement in survival. They even suggest that the more
aggressive nature of breast cancer in younger women might
require annual rather than biannual screening in order to be
most effective in extending lives. To my mind that is
sufficient justification for not only continuing screening for
women in this age group, but also for encouraging them to be
screened regularly.
The reality is that public health guidelines cannot and
should not ever be based exclusively on the existence of
unequivocal scientific data. Guidelines are just that--
guidelines. Even when reasonable people disagree, as they
frequently do in science, the purpose of guidelines is to give
people the best advice, not the purest. Guidelines must be
clear and understandable and not weighed down by the
conditional statements and conflicting conclusions. But prudent
guidelines should always balance benefit with risk. In the
particular instance of mammography in 40- to 50-year-olds,
while the benefit is small, the risks appear to be minuscule.
There is little or no evidence that screening inflicts any
physical harm on the women who undergo it. The argument against
mammography screening then becomes largely economic--the
dollars spent for mammograms and follow-up examinations to
detect a relatively small number of breast cancer cases. From
this perspective, most women and their doctors would opt for
the small, but well defined benefit. And as a society, I
believe that we have already made the choice to invest in
mammography as a means of saving the lives of our wives,
mothers, sisters, and daughters. I believe this investment
should include those women 40 to 50.
There are other investments we need to make as well. We
need to continue to improve mammography technology to make it a
more sensitive and valuable tool than it already is. But even
the best applications of mammography will not solve the breast
cancer problem, and it will not save the women whose disease
cannot be picked up by mammography. For these women with breast
cancer, we need new tools and better understanding of the basic
biology of breast cancer so that we can identify those
individuals who are truly at risk and develop better screening,
prevention and treatment techniques. The answers to the
questions posed here today about the efficacy of mammography
screening in women 40 to 49 are not likely to come from more of
the same studies. Ultimately, the solutions will be found in
research that addresses the more fundamental questions and
leads to new ways to prevent or eliminate this terrible killer
of women.
Thank you for your time and attention.
medical institutions
Senator Specter. Our region is really very fortunate to
have such phenomenal medical institutions. I recently was with
Dr. Young at Fox Chase, January 23, at an outstanding
symposium. We had Dr. Klausner there, and the work with his
group is really outstanding. The hospital at the University of
Pennsylvania, under the direction of Dr. Bill Kelly, there have
been marvelous results. I recently had the occasion to benefit
from the medical services there.
Just yesterday I was at Allegheny speaking to the group, a
wonderful amalgam. It is a little hard to articulate the name
of Allegheny Medical College of Pennsylvania. It is my
neighborhood hospital. I reminisced yesterday about going there
on the initial occasion when my younger son had his stomach
pumped many years ago, after swallowing mothballs. Allegheny is
my neighborhood hospital wherever I go, because I spend a lot
of time in Pittsburgh with my newer responsibilities.
Jefferson is an extraordinary institution. Our two sons
were born there. I have benefited from the treatment there. And
Temple, under the leadership of Dr. President Hunduly. And we
do not have someone here from Einstein, another extraordinary
institution, but we are very, very fortunate in having the kind
of leadership that we have in medicine here.
That also brings us a great many problems about how we are
going to pay for the care of the poor, which these hospitals
render, and how we are going to pay for medical education, with
so much funding going through managed care today. So there are
rewards and there are problems. Again, I thank all of you for
coming and for your testimony here.
Let me focus at the outset on a statement which was made by
Dr. Falkner, which may be at the core of the issue. That is
where Dr. Falkner says that others--referring to doctors--
choose to err on the side of caution and recommend annual
mammograms for all women in their forties. Does that
essentially mean, Dr. Falkner, that it is the cautious thing to
do and it may produce results, and ultimately is the best
course to have mammograms for women in their forties?
Dr. Falkner. Well, I think what I was reflecting on was the
practice of some physicians who are hearing the mixed messages
from the national guidelines and have concerns about the
possibility of missing the diagnosis. And so, as a caution,
what they will do in their practices is recommend to their
patients annual mammograms.
Senator Specter. What is the essential problem? What is the
downside? The downside is there may be a false positive and
there may be a biopsy which should not have occurred? Is there
any other downside? May I address that to the panel generally?
What other problem may arise in addition to costs, which I am
going to come to, which obviously is a factor? But aside from a
false positive and then a biopsy which would be unnecessary if
you did not have a false positive, is there any other problem
from a mammogram given to a woman in her forties?
Dr. Feig, I see you leaning forward.
Dr. Feig. Well, actually, the fact is that 75 percent of
women with breast cancer have no major risk factors. If we were
only to screen women who are at risk for breast cancer, we
would miss 75 percent of the cancers. The downside, Senator,
are really very minuscule. The panel overplayed these.
Senator Specter. Now, wait a minute. Very minuscule. What
are they? As minor as they may be, what are they?
Dr. Feig. Additional procedures. Now, most people would
think, from additional procedures, you mean biopsies. That is
not the case at all. Most additional procedures mean an extra
mammographic view or a breast ultrasound. Only about 3 percent
of women coming for mammography each year are in their forties.
Senator Specter. Neither of those is invasive?
Dr. Feig. Neither is invasive.
Senator Specter. So what is the harm?
Dr. Feig. Among women in their forties coming for
mammographies, only about one-half of 1 percent will need to be
biopsied. So that is very, very slight.
Senator Specter. Is there any harm besides the false
positive which leads to a biopsy which proves to be
unnecessary? But of course you do not know that until you have
done it.
Dr. Feig. That is right. That is the gold standard, which
is the biopsy.
Senator Specter. I had three biopsies on my nose the other
day. I was madder than hell after I got them back. They were
all negative. And sometimes I think that I am overly diagnosed,
but I would rather be overly diagnosed. There is no such word
as ``underly'', but underdiagnosed. But what I am trying to
zero in on is what is the problem. Are there any problems?
Dr. Feig. No; there is really no objective problem. I think
that there is anxiety from getting an additional mammographic
view or ultrasound. I do not know of anyone who would not
rather have that really minimal anxiety to the anxiety of dying
from breast cancer.
Senator Specter. Well, we had two hands up. Dr. Young, I
will come to you first. But before the comment, I want to ask
you a question. You made the comment about no mammograms for
economic reasons. And I am personally very much opposed to
rationing, very much opposed to decisions made on grounds of
dollars, because I know we are a very, very wealthy nation.
I think the question is whether we have enough doctors,
hospitals, mammogram machines, and MRI's to do the job. When I
had an MRI a few years ago and found out the high cost of it,
the thought came to my mind that you could do MRI's at 3 a.m.
The marginal cost would be very minimal, and people would be
very well served to have MRI's at a time that might be a very
low cost. Because in my case, it was a life-saving procedure.
And as many of you know, I had pains on the side of my head
and my shirt collar was too tight, and they could not find any
symptoms or anything serious. And I wanted an MRI because I had
heard of it and I knew it was not invasive. And the doctor told
me I should not, could not and would not have one. And, with
enough persistence, I got one. And it proved to be lifesaving--
with a meningioma in my forehead--and that gave me a little
different slant on things.
One of the items which your profession has difficulty in
doing is getting attention from the Congress. Everybody has
problems getting attention from the Congress. I think the issue
of breast cancer in women has gotten attention from the
Congress for some time. But it is only the personal
experiences.
If we had taken a closer look at mental health--because
Senator Domenici, our leader, has had two children who have
mental problems, and we are trying to get that included in
insurance rates. On fetal tissue, for a long time, it was in a
prohibited range until Senator Thurmond had a daughter with
diabetes and understood the advantages and very carefully not
to have abortions to produce fetal tissue, but once you had the
availability, to utilize it. So when the people in Washington
have the problems, then we start to understand the issues a
little better.
Dr. Young, before your own comment, I would like to ask you
to pursue the question: Do we have enough mammogram machines in
America to test all the women who might possibly be benefited
from those tests?
Dr. Young. Yes; I think there is no doubt that we do. My
point in my conversations and my presentation was that I think
that the relative risk of mammography in this age group, as I
stated, were I think minuscule, as Dr. Feig mentioned as well.
There are several--I mean, first of all, men should not ignore
the fact that having your breasts squeezed to get a mammogram
is for some women quite uncomfortable. I consider that, on
balance, not a big enough risk. It is a theoretical risk.
Senator Specter. Tell us about the procedures on that. I do
not know the details of it. I would be interested to know the
level of discomfort and the comment about squeezing.
Dr. Young. I think it is variable and I think the vast
majority of women find it not an extraordinarily unpleasant
experience. Some women, for a variety of reasons, including
their breast tissue and size and so forth, find it
uncomfortable--occasionally very uncomfortable. The number of
women that have that problem I think are very small indeed. I
think when you are talking about the survival benefit versus a
short-term discomfort, they are easily balanced.
One of the things that the consensus conference spent a lot
of time on is the theoretical radiation risk of mammography.
And of course mammography radiation exposure has declined over
the years, so it is getting safer and safer. No one has ever
reported a single woman in the United States who ever developed
breast cancer from mammography. So while it may be a
theoretical risk, it must be extraordinarily small. And those
are the other things, in addition to the things that were
mentioned before, that are theoretical risks.
On balance, I do not believe that the risks outweigh the
potential benefit for the discovery of breast cancer in this
age group of women and what I view as a clear-cut small but
definite decrease in mortality associated with mammography
screening in this age group.
Senator Specter. Thank you very much.
Dr. Caroline, you had a comment?
Dr. Caroline. I just wanted to reaffirm the comments before
about the psychological effects. Everybody understands the
anxiety and psychological stress of having a false positive
diagnosis. But, again, as you said, and which was subsequently
said, nobody in their right mind would ever trade having a
false positive biopsy, even if it came to that, and a very
small percentage of people that do, than having missed a real
breast cancer and the problems that would ensue from that. And
I think that that is something that we are all willing to
accept.
We are working--and by having more percutaneous biopsies as
opposed to surgical biopsies, this is a less invasive
procedure. And then you reduce some of the anxieties, some of
the aftereffects. And I think everybody is willing to accept
those. I do not understand people who would not be able to. I
think I can also address a little bit about the comfort and
discomfort of mammography.
It is something which, again, is uncomfortable, but should
not be a painful procedure. We need further development, of
course, even in the bioengineering of the mammography machines.
But people in the American College of Radiology and other
groups have been working to try to make it as comfortable as
possible, given the fact that in order to get an optimum
radiograph you need to compress the breasts in order to get the
optimum x-ray picture from it. But this has been developed in
such a way that it can be somewhat uncomfortable, but should
never be unduly painful. And even on that very small issue,
progress is being made.
I just wanted to make one more quick comment about some of
the economic issues we were talking about when we were talking
about the need to ration medical care, but even the medical
care guidelines for women who are over 65 and other medicare
patients in Pennsylvania are only allowed to have screening
mammograms every other year. Even for the women over 50, it is
not covered every year.
Senator Specter. On the subject of the false positive, at
the risk of being intrusive into the medical profession, I had
a personal experience with a false positive many years ago,
which was very distressing. And it came to my attention at that
time that a little more care could have been exercised by my
doctor in not telling me so much at an early stage when the
false positive was false but not very positive, and a little
farther down the line it turned out not to be positive.
My father used to say to me: ``Arlen, know what you say; do
not say what you know.'' And there could be just a little less
disclosure until there is a little more of a scientific basis
for it. Patients do not need to know all of the possibilities
until it is fairly well narrowed. And I understand the
difficulties of the psychology of the medical profession and
the so-called bedside manner, but I just wanted to make that
one brief comment.
I want to go back to medicine now, instead of homespun
philosophy.
Dr. Feig emphasized the point about it is better on an
annual basis. There have been a number of comments to that
effect. There had been a conclusion some time ago that at least
the annual for women in their fifties. And I believe that, and
you can correct me on this, we have not seen that come about
from Medicaid or Medicare. To the extent that Medicare covers
women in their fifties, and it does to some extent, but is
there a concurrence or a unanimity view on this opinion that
women in their fifties ought to have mammograms every year?
Dr. Feig, you have already testified to that. Is that your
conclusion?
Dr. Feig. Yes; annual screening will always be better than
screening every other year, because cancers can arise and grow
between the screenings. If you have 2 years between screenings,
there is a greater chance that a cancer will grow to an
incurable size during that time.
Senator Specter. Does anyone disagree with that analysis on
the table, that we ought to have annual mammograms?
[No response.]
Senator Specter. That leads us to a question as to what is
the congressional role in this kind of determination. Dr.
Sullivan testified that we ought to mandate mammogram payments
by third-party carriers for women 40 to 49. And that raises
some difficulty as to what intervention there ought to be by
Congress on mandates, contrasted with what ought to be the
interaction of the market and medical profession and the
insurance companies.
We are seeing a great many problems, as we all know, with
managed health care now on the so-called gag rule, which HHS
took action to change as to Medicare and Medicaid. We had a
hearing last November 13 on that subject. And we are seeing
some changes by managed care on the so-called drive-by
mastectomy. We legislated on drive-by deliveries. There is a
real danger, if Congress starts to legislate ailment by
ailment. I am working on legislation now which will try to set
an overall structure, so that there is a medical decision
without it being an insurance company dollars consensus issue.
But there is a question as to how far Congress should go in
making mandates or in making decisions.
I would be interested in the followup question. I think
everybody on the panel thinks there ought to be mammograms for
women in their fifties. Do you think we ought to go so far as
to have a congressional enactment to that effect if HHS does
not administratively make that determination?
Dr. Feig, let us start with you.
Dr. Feig. Yes; I think that women find themselves in a
quandary if they follow medical guidelines and their physicians
recommendations in asking for mammograms annually after age 50
and find that Medicare cannot pay for it. Certainly it places
physicians in a quandary as well. We certainly do not want to
violate any Medicare rules by advising screening.
Senator Specter. Why not? Why do you care about violating
Medicare rules?
Dr. Feig. For reimbursement purposes.
Senator Specter. What do you mean for reimbursement
purposes? How about your patients?
Dr. Feig. Well, are they allowed to pay us on their own
every other year?
Senator Specter. Well, now we have three alternatives. So
far, Medicare will pay for it and the patient will pay for it,
and maybe nobody will pay for it. And I do not wish to
emphasize your response, but this is a good point of issue as
to the doctor's judgment on a matter aside from who was going
to pay. And what we need to get to, I think, is so that the
medical judgment dominates and we find a way to work out the
payment.
Now, if the doctor has a record of not being professional,
or reckless in recommendations--and there are some complaints
about doctors to that effect, and some of the insurance
companies do complain--but, aside from that, how do we
structure our delivery system so that it is a medical judgment
which directs it, aside from the issue of who is going to pay?
Doctor Feig, you brought the subject up.
Dr. Feig. Well, I think that we should perform mammography
every year for women in their fifties. But I do not think that
physicians should be held in violation of Medicare if we advise
screening or to get screening that is not reimbursed by
Medicare: And so I think if there could be some mechanism by
which women could get mammography and if she pays on her own--
it is certainly not fair for the hospital to take up this cost
itself. If there were such a mechanism, I think that certainly
would be preferable to the situation that we may now have.
Senator Specter. Well, I think that is a very good answer.
And then it becomes a judgment for Congress.
Recently, when we had the hearings on the panel's findings,
Senator Snowe brought a sense of the Senate resolution to the
floor, which passed 98 to nothing. And then it so happens,
schedule-wise, that our subcommittee hearings were the next
day.
There was an op-ed piece in the Washington Post criticizing
politicians--that is a derogatory profession--from getting
engaged in this subject and meddling with the doctors. But when
you come to an issue like whether there ought to be Medicaid
payment for two or more mammograms annually, maybe we have to
decide it.
I was not sure what the standards were for mammography, as
to payments by the Federal Government, but for women over 35
and under 40, a limit of one test during that 6-year period.
For women over 39 but under 50 at high risk, one test annually.
Not at high risk, one test biannually, every 2 years. For women
over 49 but under 65, one test annually. For women over 64, one
test biannually. And so it is a fairly complicated schedule.
And I think it is one that we need to reconsider.
Let me run a little overtime on what we had allotted for
this panel to take up another subject. And that is the subject
of gene therapy of, or rather, determination by the genes as to
a predisposition for breast cancer and what use could be made
of that. There has been considerable comment about the problem
of testing for gene predisposition on the ground that a person
cannot get insurance if the insurance company knows there is a
predisposition for breast cancer. And if someone knows that
they have a medical problem and they do not answer it on a
questionnaire, the insurance company can later decline payment
on the ground of falsification, of fraud, and the inducement of
the policy. And we are working on legislation which would grant
primacy to that area. No reason why a person should be
precluded, in a practical sense, from finding out about a
predisposition, because that then gives them knowledge which
would preclude insurance coverage.
But the question which I would like your comment on is,
what do we now know that we can do for a woman if we find out
from a determination of the gene that there is a predisposition
to cancer?
Dr. Falkner, would you give us your view on that?
Dr. Falkner. I think that identifying the gene does not
offer anything new in terms of the specific treatment. But it
does give a very strong--I mean it is the highest risk one can
have is to have the gene. In my mind it is useful information.
But we do not quite know what use to make of it yet.
Senator Specter. Well, then how is it useful? There is no
point in having the gene test and letting women know that,
which causes obviously a lot of psychological stress, unless we
can make some use of it.
Dr. Falkner. Well, the use at present is identifying
someone at a very high risk who then can be followed very
vigilantly for early intervention.
Senator Specter. Dr. Young, you have had your hand up. You
made a comment about we need new tools.
Dr. Young. Well, I think one of the most extraordinary
things that is happening in medicine as it relates to cancer is
the discovery of genes that both cause and predispose people to
various kinds of cancer. We are in a discovery phase of this,
and one of the most paralyzing events would be the insurance
companies' willingness to exclude such individuals from
coverage on the basis of evolving knowledge. There are many
things that are going to emerge from the discovery of genes
that predispose to breast cancer.
First of all, you can look within families and find women
who have an intense family history of breast cancer but do not
harbor the gene, and, therefore, that individual and that
individual's descendants have a risk that is the same as
everybody else in the community. So there are powerful pieces
of information that could be generated out of this. We may need
vastly different screening technologies for people who are
genetically predisposed to risk. And there are a variety of
strategies that can be used to reduce breast cancer risks.
Senator Specter. Do you think it is useful to know if a
woman has a gene which makes her predisposed to breast cancer?
Dr. Young. I think it is in several ways. One, this is
certainly a patient who would want to learn carefully how to do
breast self-examination. This is an individual who would
certainly want at least yearly mammograms, probably beginning
at 40 years of age and continuing throughout.
Senator Specter. Perhaps earlier?
Dr. Young. Perhaps earlier. We do not have data on that.
But it is certainly something that is now studiable, because we
have discovered a population that are genetically predisposed
to risk.
Senator Specter. Dr. Sullivan.
Dr. Sullivan. I think the answer to the question might also
be we are not really sure yet whether this would be a useful
thing for all women. Certainly, for many women, as Dr. Young
just said--and this is not an area of my expertise, but, for
example, Dr. Barbara Webber at the University of Pennsylvania
is an expert in--and she would suggest to those women that they
get mammograms every 6 months. There are no studies to indicate
that this is more valuable than getting it every year, but that
is what her recommendation would be, even starting at a younger
age. As you said, in addition, she has a study to look at the
value of MRI in those patients. And so there are other
techniques that could be used potentially to find cancer
earlier in these women.
Another much more extreme option or choice for some women
with this family history and this gene would be to consider a
prophylactic mastectomy. That is not an acceptable choice for
many women, but for a few women it is.
Senator Specter. Under what circumstance? That seems very,
very harsh and very extreme to me. Under what circumstance
would that be chosen?
Dr. Sullivan. I do not think we can say from a medical
point of view it is warranted, but if a woman comes from a
family history of mother, sisters, grandmother, and if that
woman herself has a strong fear of breast cancer, that might be
her choice. But that would be a very small number of women.
Dr. Young. One of the other strategies that is less
aggressive than that might be to put these women on tomixifen,
an antiestrogen. There is a study that is underway now that has
actually accumulated the number of women necessary to resolve
the question. And we just need a few more years to find out
whether tomixifen reduces breast cancer development in women at
predefined high risk. They are retrospectively going back and
looking within the population to identify women who have the
RCS-1 and BRCS-2 defects to see whether tomixifen can also
reduce their risk.
So there are a number of strategies that become possible
once you learn about this kind of genetic information.
Senator Specter. Dr. Feig, would you care to make a comment
about the value of having this determination as to
predisposition through gene detection?
Dr. Feig. Well, I think all of us would agree that
screening is effective at age 50 and over. And most of us would
agree it is effective beginning at age 40. If we were to be
able to say that a woman with a breast cancer gene had the same
risk at age 30 as the average woman does at age 40 or age 50,
then, by inference, we should begin screening that woman at the
earlier age at which her breast cancer risk is the same as the
risk of the average woman at an older age.
Senator Specter. Do you care to make a comment on this, Dr.
Caroline?
Dr. Caroline. I concur with what Dr. Feig said. And I also
think that what you said about trying to protect people with
nongenetic defects is extremely important. And that may be the
single issue right now that is hampering a tremendous amount of
forward research that is possible.
Senator Specter. Do you think just that factor?
Dr. Caroline. Absolutely.
Senator Specter. I think we can legislate on that. I think
there would be a consensus in the Congress to do that, to
guarantee that primacy.
A final question for you, Dr. Sullivan. You said the panel
was a draft study. It certainly has caused quite a lot of
concern. Part of the concern I have is that it will go beyond
women 40 to 49 and discourage mammograms if people do not read
the fine print too closely. There is a comment publicly about
mammograms not being useful for women 40 to 49, and many will
read it more broadly. Why did the panel come out with a draft
conclusion before they had a chance to refine it and come to a
final judgment?
Dr. Sullivan. Well, before answering directly to that
question, I should say my answer should not be taken as being
critical of the office at NIH that organized the conference,
because I think they did it--they were well intentioned in
doing it. But the format for the NIH Consensus Development
Conference followed the format they used earlier for a variety
of other questions, and the format is to have a 2-day
conference, ending with a press conference with a draft
statement, and then following up with a final statement after
that. For most of the earlier questions and earlier
conferences, the draft statements adequately reflected the
consensus of the panel at that time.
I think, for this question, it was much more complex, with
a much larger body of data to analyze. And I think, in
retrospect, the format used was not appropriate for this
conference or for this question.
Senator Specter. Well, I do not raise the issue in a
critical context. We have experience and we move on to the next
issue. But I think it is like the physician telling an
individual patient you have got a false positive. It may be too
soon to say that until you do some more tests, which I
personalize by my own tests. While it may be a practice to have
a draft report, it might be a better idea to take a step
backward and say, what is this draft report going to do in a
public context and, what is going to happen?
That is what some of us in political life have a little
more experience with--what the public reaction will be. When
somebody in public life makes a statement that is out of bound,
we hear about it in a big hurry, and have some better ways to
judge that, in terms of public reaction.
Dr. Sullivan. Can I add another comment to that?
I think the panel members themselves were not--having not
been through this process before, were not familiar with the
process and the ultimate implication. One of the things that is
part of the process was for the public relations department
from OMAR to prepare a press release for the press conference.
And following the public session on Thursday at 11 o'clock, the
press offer officer distributed that press release for the
panel to review. And the panel refused to review it at that
time because they felt they had not reached a consensus and no
press release could reflect that.
And after some further discussion, at 5 minutes to 1, 5
minutes before the press conference, the press officer asked
the panel again to review the press statement and see if any of
it was useful. They did at that time, and very quickly said, in
a moment of consensus, that that press release did not--was not
adequate and should not be released, and no part of it was
useful, even though that press release did in fact reflect what
the draft statement said at that time. And so I think the panel
members felt that a public statement should not be made and did
not realize the implications in fact that the draft statement
would be available to the press and the implications of that.
Senator Specter. Well, that is an illustration of do not
put anything in writing if you do not expect to see it on the
front page. Well, thank you very much, Dr. Young, Dr. Falkner,
Dr. Sullivan, Dr. Feig, and Dr. Caroline. We very much
appreciate your testimony.
The subcommittee is going to have a similar hearing in
Pittsburgh on Monday, and one in Harrisburg a week from then,
on the 3d of March, and we will be doing more of this work in
Washington, and we appreciate what you are doing. We are
determined to try to give you the kind of financial support you
need on research in this very important field. We have asked
Dr. Klausner and the others, what do you need, what would be
useful, as we try to assess the priorities in Washington, to
give appropriate funding for these very, very important
research projects. So, thank you.
Panel 2
STATEMENTS OF:
LU ANN CAHN, REPORTER, WCAU-TV, NBC-10
BARBARA DELUCA, EXECUTIVE DIRECTOR, LINDA CREED BREAST CANCER
FOUNDATION
BARBARA MALLORY, M.S.N., R.N., NURSE CONSULTANT, PHILADELPHIA
DEPARTMENT OF PUBLIC HEALTH
LAWRENCE ROBINSON, M.D., M.P.H., PHILADELPHIA DEPARTMENT OF
PUBLIC HEALTH
FRANCES M. VISCO, ESQ., PRESIDENT, NATIONAL BREAST CANCER
COALITION
opening remarks of senator specter
Senator Specter. I might call our next panel, Ms. Lu Ann
Cahn, Ms. Frances Visco, Ms. Barbara DeLuca, Ms. Barbara
Mallory, and Dr. Lawrence Robinson. We are going to proceed
with this distinguished panel, again, in alphabetical order.
And we welcome, first, Ms. Lu Ann Cahn, who reports for TV 10.
I can never be sure what network that is, Ms. Cahn.
Ms. Cahn. NBC.
Senator Specter. That is extra advertising. We are going
out live over Pennsylvania cable. We thank you for joining us
today. I am just joking, but we were used to channel 10 for so
many years, it is a little hard. But channel 10 is 10, NBC, and
channel 3 is channel 3, KYW. It does not say CYS, so that adds
to the confusion.
Ms. Cahn reports for channel 10 and has coanchored the
weekend edition of News 10 Today. Prior to coming to
Philadelphia, she was a reporter in Miami, well known to the
viewers of Philadelphia for her personal story of battling
breast cancer. She was diagnosed at the age of 35, and her 1992
special report, ``Breast Cancer: My Personal Story,'' won her
two Emmy Awards. She has campaigned both in Harrisburg and
Washington for additional funding for breast cancer research
and mammography testing. And she has been successful.
The floor is yours, Ms. Cahn. And you have more than a
sound bite.
summary statement of lu ann cahn
Ms. Cahn. Good morning, Senator. Thank you. Thank you for
inviting me here.
Of course you know me as a reporter, but this is a subject
that I am not objective about at all, and so I am going to take
off my journalist hat and speak as a breast cancer survivor.
As you said, 5 years ago, I was told I had breast cancer. I
was 35 years old. I had a mammogram, but it did not detect the
tumor in my right breast. I found the lump with regular breast
self-exams. So I know full well mammograms are not perfect,
especially for younger women. Still, I am absolutely appalled
the NIH decided not to recommend regular mammograms for women
in their forties. It reminds me very much of the way I was
diagnosed with breast cancer. I was 34 at the time, when I had
my first mammogram, because I felt a lump in my breast. The
mammogram again detected nothing.
Several months later, I went to my doctor and she felt the
lump and she too said it was nothing. But she also said, if you
are worried about it, here is the name of a breast surgeon.
Well, I left thinking only a hypochondriac would pursue this
any further, and I believe this is the same message the NIH is
sending to American women in their forties. It is up to you if
you get a mammogram, but we are not worried about it.
I was finally diagnosed with breast cancer by the breast
surgeon several months after being told not to worry. This
year, almost 6,000 women in their forties will die of breast
cancer while NIH is relaying a very confusing message, which
will be interpreted by many women in their forties that they do
not have to worry. Now, you may say this is a very odd story to
use for an analogy, considering it shows again mammograms do
not always work for younger women. Often they do not. My breast
cancer did show up on a second mammogram as I was being
diagnosed. I was then 35.
My point is this: As a reporter and a breast cancer
survivor, I have spoken to thousands of women about breast
cancer. Many in their forties have told me they believe a
mammogram saved their life. If only 2 out of every thousand
women screened have their lives extended because of regular
mammogram screening, I believe that makes a fairly low-cost
procedure well worth it. I am sure you would feel that way if
it was your mother, sister, daughter, or wife.
I have spent countless hours over the last 5 years
informing women that getting mammograms is not enough. We also
have to do breast self-exams. We also have to see our doctors
every year for checkups. We also have to fight to make sure we
are working on developing something better than a mammogram as
an early detection tool. I have absolutely no scientific data
or study to back up this belief, but I would bet that those
women who get regular mammograms are better informed about
breast exams and other things they need to do to make sure that
if they do get breast cancer they find it early.
I believed in the last 5 years that we made great progress
in getting women in for mammograms and informing them that you
could not rely on this one test. But now, with one outrageous
decision, I feel that NIH has undone much of that work, giving
women in their forties who want to stick their heads in the
sand every reason to continue to do that. It pains me to sit on
a panel with women I respect a great deal, who I know are on
the opposite side of this issue.
I wish we all could come here with a united consensus. I
unfortunately believe that this may confuse the issue even
further. But I cannot buy the argument at this point that
perhaps an early diagnosis would probably make no difference in
the outcome anyway. I believe it does make a difference. It
gives that woman more time to fight, to know there is a killer
in her body, to make decisions on how to battle her own
disease. If she loses that battle, at least she would not die
wondering if she had only done this, if she had only done that,
if she had only had a mammogram.
Surely, years from now, there will be a group of women who
will say, I did not go get a mammogram because I saw headlines
saying I did not need to, and now I am dying of breast cancer.
I cannot believe that NIH wants to take on that responsibility
at a time when there is no better screening tool available to
women in their forties. Mammograms are not what we want for the
future, but it is really all we have right now. And I believe
that NIH, as a whole, made a decision for the public that
individually they probably would not recommend for their own
family members.
prepared statement
I personally do not care what NIH says. Any woman who asks
me, in their forties, what she should do, I would tell them to
get a mammogram.
Thank you.
[The statement follows:]
Prepared Statement of Lu Ann Cahn
Five years ago, I was told I had breast cancer. I was 35
years old. I had a mammogram, but it did not detect the tumor
in my right breast. I found the lump with regular breast self-
exams.
So, I know full well mammograms are not perfect, especially
for younger women. Still, I am absolutely appalled the NIH
decided not to recommend regular mammograms for women in their
40's.
It reminds of the way I was diagnosed with breast cancer. I
was 35 when I had my first mammogram because I felt a lump in
my breast. The mammogram detected nothing. Several months later
I went to my doctor and she felt the lump. She, too said it was
nothing, but she also said, ``* * * if you are worried about
it, here is the name of a breast surgeon * * *''. I left
thinking only a hypochondriac would pursue this any further. I
believe this is the message the NIH is sending to American
woman in their 40's. ``It is up to you if you get a mammogram,
but we are not worried about it.''.
I was finally diagnosed with breast cancer by a breast
surgeon several months after being told not to worry.
This year, almost 6,000 women in their forties will die of
breast cancer while the NIH is relaying a confusing message,
which will be interpreted by many women in their forties that
they do not have to worry.
Now, you may say, this is an odd story to use for an
analogy considering it just shows mammograms do not work for
younger women.
My breast cancer did show up on a second mammogram as I was
being diagnosed. I was 35.
My point is this--as a reporter and a breast cancer
survivor I have spoken to thousands of women about breast
cancer. Many in their forties have told me they believe a
mammogram saved their lives. If only two out of every thousand
women screened have their lives extended because of regular
mammogram screening, I believe that makes a fairly low-cost
procedure well worth it. I am sure you would feel that way if
it was your mother, sister, daughter, or wife.
I have spent countless hours over the last five years
informing women that getting mammograms is not enough. We also
have to do breast self-exams. We also have to see our doctors
every year for checkups. We also have to fight to make sure we
are working on developing something better than a mammogram as
an early detection tool.
I have absolutely no scientific data or study to back up
this belief, but I would bet those women who get mammograms are
better informed about breast exams and the other things they
need to do to make sure that if they get breast cancer, they
find it early.
I believed in the last five years we made great progress in
getting women in for mammograms and informing them that you
could not rely on that one test alone. Now, with one outrageous
decision, I feel the NIH has undone much of that work--giving
workmen in their forties who want to stick their heads in the
sand every reason to continue to do that.
I do not buy some of the arguments from some of those I
respect the most who are leading the battle against breast
cancer. How can you believe an early diagnosis would probably
make no difference in the outcome anyway? It makes a
difference. It gives that woman more time to fight, to know
there is a killer in her body, to make decisions on how to
battle her own disease. If she loses that battle, at least she
would not have to die wondering if she had only done this, if
she had only done that, if she had only had a mammogram.
Surely, years from now there will be a group of women who
will say I did not go get a mammogram because I saw headlines
saying that I did not need to and now I am dying of breast
cancer.
I cannot believe the NIH wants to take on that
responsibility at a time when there its no better screening
tool available to women in their 40's.
It is not what we want for the future, but it is all we
have now. I believe the NIH, as a whole, made a decision for
the public that individually they probably would not recommend
for their own family members.
medical determination by nih
Senator Specter. Thank you very much, Miss Cahn. I know you
have to depart shortly and cannot be with us for the dialog,
the questions and answers later, so I would like to ask you a
question or two now.
When you make the comment, as you said, that as we have
been told, if you are 40 to 49 and you want to get a mammogram,
it is up to you. While the individual may choose to get a
mammogram, the consequence will be, if there is a medical
determination by NIH or the Department of Health and Human
Services that, as a generalization, women 40 to 49 do not
benefit from mammograms, we are going to find the insurance
companies not paying for them. And that is going to be a major
discouraging factor, as we heard from the last panel. Who is
going to pay? What advice do you have to women who hear the
insurance company is not going to pay?
Ms. Cahn. I would tell them to find a way to get a
mammogram. There are organizations, like Linda Creed right here
in Philadelphia, that will help you find a low-cost mammogram.
I believe it has become a screening tool, readily available. It
is unfortunate that it is not being paid for by insurance
companies. I personally think it should be, until we find
something better.
I also would like to see a lot of money going toward
something better, because this will not do. But, in the
meantime, I think women still have to do it--also understanding
it is not the only thing they have to do. But I do not think
they can ignore this. And even if their insurance company does
not pay for it, I think that if you were my friend, I would
say, find a way.
Senator Specter. Why did you seek a mammogram at the age of
34?
Ms. Cahn. I actually started feeling a lump. And at the
time the recommendation would say get a baseline at 35, and I
was 6 or 7 months away from becoming 35. And in fact, my doctor
said to go ahead and get one, you are almost 35. And it was
really supposed to be a baseline.
Senator Specter. So you had already felt a lump?
Ms. Cahn. I had started feeling something, and told the
people who were doing the mammogram that I felt something. And
they took special--or they took extra x rays of that spot and
still told me nothing was there. A lot has happened since that
time. A lot more information has come out. I mean I think, at
the time, doctors relied more on mammograms and did not
understand how imperfect they were for younger women. And
again, I think we have done a lot in terms of educating women
to do this, but do not just do this; understand it does not
mean you can just rely on this and it does not mean that you
have done everything you are supposed to do.
Senator Specter. In our shower at home, there is a little
card hanging there about self-testing, with a diagram. It would
be useful, I think, both for the record and for television if
you made a brief description--nobody has in this hearing or any
hearing I have been at--as to just what is involved in a self-
examination. I think it would be useful for women to hear about
that.
Ms. Cahn. Right. And this is the way that I found my breast
cancer. I found it myself, despite the negative mammogram, and
it should be done once a month, about a week after
menstruating, because that is when the breast is less lumpy and
you can find something that was not usual. I think a lot of
women still feel uncomfortable doing this, but it just takes a
few minutes and it could save your life. It involves using
three fingers--and the American Cancer Society has a great
program to teach you how to do it. Your doctor should be able
to teach you how to do it. Not only should you be doing it
every month, but you should go to your doctor.
Senator Specter. Can you talk a little bit more about it
now, to teach women how to do it?
Ms. Cahn. I would like to, but basically it involves a
circular motion. There are a couple of different methods of
doing it, and I am sure someone from the American Cancer
Society might be a better teacher. But I can tell you it
involves going around the breast with three fingers in a
circular motion. At least that is the way I do it. There are
other methods of doing it.
But the most important thing--and you go around the whole
breast to see if you feel a lump, something that you did not
feel the month before. And the reason why it works is that you
become very familiar with your breasts. If something is there
that was not there before, chances are, if you do a breast
exam, you will catch it, and maybe have a better chance than
your doctor, who only sees you once a year.
And most women do find their breast cancer that way. So I
would highly recommend it. And I know I did not give a great
description. The shower is a good place to do it; standing up
or laying down on the bed is a good place to do it. And again,
it only takes a few minutes. It is not that complicated a
thing. It is just something we need to do.
Senator Specter. Well, thank you. Thank you very much, Ms.
Cahn. We very much appreciate your being here.
summary statement of barbara de luca
We turn now to Ms. Barbara DeLuca, who is executive
director of the Linda Creed Breast Cancer Foundation and has
served in that capacity since 1991. Ms. DeLuca was diagnosed
with breast cancer in June 1990, and her experience has
motivated her to put her substantial energies into fighting for
compassionate health care and abolishing breast cancer.
Welcome, Ms. DeLuca.
Ms. DeLuca. Thank you, Senator Specter. I am pleased to be
here today as executive director of the Linda Creed Breast
Cancer Foundation. Our organization provides free mammograms
for needful women, breast health education, support for those
affected by breast cancer, and actively works to secure
necessary funding and legislation. I appreciate your holding
this special hearing. And thank you for the opportunity to
provide testimony today. The opinions and concerns of
Pennsylvanians on the frontlines of the current breast cancer
debates need to be heard.
The question concerning us today: Should women in their
forties be given screening mammograms every year or every other
year? The answer arrived at by the NIH Consensus Conference is
every other year is enough. The reason: There is no clear
indication that yearly mammograms save lives in this age group.
An unspoken reason is that mammograms cost dollars.
I believe that women must be afforded each and every
screening tool that can rule out or discover breast cancer as
early as possible. After 25 or 30 years, mammography is still
the standard and most widely used screening tool, but it is not
perfect. There is a 10- to 15-percent false negative or false
positive failure rate.
A quick survey of six members of our foundation, women who
were diagnosed with breast cancer in their forties, yielded
very interesting results. Five of these six women said they had
just had a mammogram a week or two before their cancer was
discovered by a palpation or a biopsy. But nothing had shown up
on the film. Yet, despite her own experience, each person felt
strongly and reiterated this very loudly, that women in their
forties need a screening mammogram every year.
Seven years ago, a mammogram failed to diagnose breast
cancer in my dense tissue. Since that time, new modes of
detection have been undergoing testing in clinical trials. The
MRI is a three-dimensional image that provides great detail,
but is still far too expensive to be used as a screening tool.
It has the added benefit of not using radiation. Digital
mammography produces a sharper picture with better resolution,
using one-third less radiation. And technology developed for
star wars and detection devices used in Desert Storm to check
troop movements are now being tested for adaptation to medical
imaging.
The argument is not whether to recommend mammograms every
year or every other year. That answer is easy. Yes; we need to
use any tool available to us. The issue needs to be resolved
and put to rest. As an activist and educator, I strive to get
women to take control of their health and be consistent with
their examinations and tests. I trust them to question, to
comprehend medical advice, and to make wise decisions for
themselves.
prepared statement
Information that is equivocal only complicates the ability
of women to make informed decisions. But the larger truth is
that we must find ways to make the MRI more useful, more
available, and less expensive. We must find a blood test. Such
a test could indicate 6 years in advance if a man is likely to
get prostate cancer. We must find ways to turn off cancer
cells, arrest the disease development, so that early detection
really does mean cure. And, most importantly, we must truly
learn how to prevent breast cancer so we no longer have to live
in fear of it.
Senator Specter. Thank you very much, Ms. DeLuca. I want to
come back, when we have the dialog and questions and answers,
and ask you as to your thinking of the MRI. It really is more
expensive.
[The statement follows:]
Prepared Statement of Barbara DeLuca
I am Barbara DeLuca, Executive Director of the Linda Creed
Breast Cancer Foundation. Thank you for the opportunity to
provide testimony today. I appreciate Senator Specter's holding
this special hearing. The opinions and concerns of
Pennsylvanians on the front lines of the current breast cancer
debates need to be heard.
The question concerning us today: Should women in their
forties be given screening mammograms every year or every other
year?
The answer arrived at by the NIH Consensus Conference is
``Every other year.'' The reason: There is no clear indication
that yearly mammograms save lives in this age group. An
unspoken reason is that mammograms cost dollars.
I believe that women must be afforded each and every
screening tool that can rule out or discover breast cancer as
early as possible. After twenty-five or thirty years,
mammography is still the standard and most widely used
screening tool, but it is not perfect. There is a 10 to 15
percent false negative or false positive failure rate.
A quick survey of six members of our foundation, women who
were diagnosed with breast cancer in their forties, yielded
interesting results. Five of these six women said they had just
had a mammogram a week or two before their cancer was
discovered by palpation or biopsy, but nothing had shown up on
the film. Yet, despite her own experience, each person felt
strongly that women in their forties need a screening mammogram
every year.
Seven years ago a mammogram failed to diagnose breast
cancer in my dense tissue. Since that time new modes of
detection have been undergoing testing in clinical trials.
The MRI is a three-dimensional image that provides great
detail but is still far too expensive to be used as a screening
tool. It has-the added benefit of not using radiation.
Digital mammography produces a sharper picture with better
resolution, using one-third less radiation.
Technology developed for Star Wars and detection devices
used in Desert Storm to check troop movements are now being
tested for adaptation to medical imaging.
The argument is not whether to recommend mammograms every
year or every other year. That answer is easy. ``Yes. We need
to use any tool available to us.''
This issue needs to be resolved and put to rest. As an
activist and educator, I strive to get women to take control of
their health and be consistent with their examinations and
tests. I trust them to question, to comprehend medical advice
and to snake wise decisions for themselves. Information that is
equivocal only complicates the ability of women to make
informed decisions.
But the larger truth is that we must find ways to make the
MRI more useful, more available and less expensive. We must
find a blood test. Such a test can indicate six years in
advance if a man is liable to get prostate cancer. We must find
ways to ``turn off '' cancer cells, arrest the disease
development so that early detection can really mean ``cure.''
And most importantly, we must truly learn how to prevent breast
cancer so we no longer have to live in fear of it.
summary statement of barbara mallory
Senator Specter. I would like to turn now to Ms. Barbara
Mallory, Community Health and Public Nurse Consultant with the
Philadelphia Department of Public Health and staff nurse at
Memorial Hospital in Bergen County, NJ. Ms. Mallory serves on
the executive board of the Nurses of Pennsylvania,
headquartered in Philadelphia, and also is a member of the
board of directors of healthy cities, and affiliated with the
World Health Organization. She received her master's and
bachelor's degree in science and nursing at Thomas Jefferson
University.
Welcome, Ms. Mallory, the floor is yours.
Ms. Mallory. Thank you, Senator Specter, my distinguished
colleagues. Good morning. I am Barbara Mallory, here today
representing nurses of Pennsylvania, an advocacy group for
nurses and patients. I thank you for this opportunity to add
comment to the NIH consensus statement, which suggests that
screening mammography does not benefit women in the 40 to 49
age group.
I should warn you, I do not intend to focus on statistics
and numbers, particularly not numbers provided by dollar signs.
Every cancer professional I have spoken to suspects, as I do,
that too much consideration has already been given to financial
rather than human costs.
Recently, my organization has participated in the drafting
of legislation that would end drive-by mastectomies. One of my
roles was to speak with women who have had breast surgeries.
Through my conversations, I met many women, as young as 33
years old, who have had breast cancer diagnosed as a result of
breast self-exams or by routine mammographies. These women and
their families have certainly benefited from screening.
One woman, and we will call her Joan, is a 24-year-old
mother of three children. Although she practiced breast self-
exams faithfully every month, neither she nor her physician
were able to detect the small lesion which was identified by
mammography. After further tests, the tumor was removed with a
lumpectomy. The lesion was cancer, but it was identified early,
and thankfully, so far, it has not recurred. Had it not been
for her routine screening, the lesion probably would have gone
undetected until it reached the palpable stage--a more
dangerous stage.
Hers is not the only story which points to the need for
regular screening. There are countless other women with names
and faces which may not be considered statistically
significant; however, the significance of these women's lives
cannot be discounted.
Also, the debates stem from the attention given to ductal
carcinoma in situ, otherwise known as DCIS. Since the mid-
1980's, there has been a 200-percent increase in the number of
DCIS lesions detected by mammography. Approximately one-half of
these lesions are found in women under the age of 50. Up to 25
percent of these lesions will lead to invasive cancers.
Researchers argue that the 25-percent risk of progression to
invasive cancer does not warrant aggressive surgical
intervention and does not warrant routine screening. Now, I
said I was not going to focus on statistics, but I feel
compelled to inform you that I would not want to be one of the
women with a 25-percent chance of having a form of cancer which
would prematurely end my life.
I suppose this is another case of, is the glass half full
or half empty? Except the consequences here are far more
deadly.
I think most women would agree that a 1-in-4 chance of
developing metastatic cancer represents a significant risk.
Without mammography, women with these lesions will be missing
an important opportunity for the early identification of this
potentially life-threatening disease. True, the technology is
not perfected, but it is the best we have to offer. How can we
contemplate limiting this opportunity?
As this debate continues, we are opening the door for a
great deal of miscommunication and subsequent back-stepping. We
should anticipate that insurance companies will feel
comfortable in stripping women of the option to obtain
screening mammograms.
We have seen a growing ominous trend in health care to
balance financial cost by rationing the quality and quantity of
health care services offered. Yes; health care is expensive in
dollars, but inadequate health care is infinitely more
expensive. As advocates for our patients, health care providers
are challenged to control cost not by rationing services and
technology, but by functioning efficiently. We as health care
professionals cannot continue to allow for these types of
ambiguous messages to be passed on to the public.
It is a good thing that mammography is able to detect
small, unpalpable lesions. The technology has been helpful. The
fact that most lesions are treated aggressively represents the
choice of women and their physicians. And this is a choice they
must be permitted to make.
There are two salient points that I would like to stress.
While women are dying, we are disputing whether to recommend
and encourage the use of the best efforts we have to offer.
Breast cancer remains the leading cancer cause of death among
women 15 to 54 years of age. Admittedly, our best efforts have
not gone far enough. Mammography techniques remain unable to
reliably provide clear pictures on younger, denser breast
tissue. Perhaps the use of missile technology will solve this
deficiency in the near future.
Second, since the health care industry will continue to
transform itself into a system which exploits opportunities to
increase the bottom line, we need to examine the full
implication of our messages. Will that message improve upon
what we have done, or will it merely give women cause to think
that they are not at risk after all? Can we afford that
message?
prepared statement
In closing, I would like to extend my gratitude as well as
the appreciation of women who are impressed and moved by your
commitment to remember the human implications of this
controversy. As you know, there are many other dimensions to
health care that require investigation, and I feel reassured to
know that you have an appreciation of women's health issues.
Thank you, Senator Specter, and I welcome any questions you
have.
Senator Specter. Thank you very much, Ms. Mallory. We will
have questions.
[The statement follows:]
Prepared Statement of Barbara Mallory, MSN, RN
Mr. Chairman, members of the committee, distinguished
panelists and colleagues, good morning. I am Barbara Mallory,
here today representing Nurses of Pennsylvania, an advocacy
group for nurses and patients. I thank you for this opportunity
to add comment to the NIH consensus statement which suggests
that screening mammography does not benefit women in the 40-49
age group. I should warn you, I do not intend to focus upon
statistics and numbers, particularly not numbers preceded by
dollar signs. Every cancer professional I have spoken to
suspects, as I do, that too much consideration has already been
given to financial rather than human costs.
Recently, my organization has participated in the drafting
of legislation that would end drive-by mastectomies. One of my
roles was to speak with women who have had breast surgeries.
Through my conversations, I met many women, as young as thirty-
three, who have had breast cancer diagnosed as a result of self
breast exams or by routine mammographies. These women and their
families certainly have benefited from screening.
One woman, we'll call her Joan, is a 42 year old mother of
three children. Although she practiced self breast exams
faithfully every month, she nor her physician were able to
detect the small lesion which was identified with mammography.
After further tests, the tumor was removed by a lumpectomy. The
lesion was cancer, but it was identified early and, thankfully,
so far it has not recurred. Had it not been for her routine
screening, the lesion probably would have gone undetected until
it reached a palpable stage--a more dangerous stage. Hers is
not the only story which points to the need for regular
screening. There are countless other women with names and faces
which may not be considered statistically significant; however,
the significance of these women's lives cannot be discounted.
Also, this debate stems from the attention given to Ductal
Carcinoma In Situ (DCIS). Since the mid-1980's there has been a
200 percent increase in the number of DCIS lesions detected by
mammography. Approximately one half of these lesions are found
in women under the age of fifty. Up to 25 percent of these
lesions will lead to invasive cancers. Researchers argue that
the 25 percent risk of progression to invasive cancer does not
warrant aggressive surgical intervention and does not warrant
routine screening. Now, I said I would not focus on statistics,
but I feel compelled to inform you that I would not want to be
one of the women with the 25 percent chance of having a form of
cancer which may prematurely end my life.
I suppose this is another case of ``is the glass half full
or half empty?''--except the consequences here are far more
deadly. I think most women would agree that a one in four
chance of developing metastatic cancer represents a significant
risk. Without mammography, women with these lesions will be
missing an important opportunity for the early identification
of this potentially life threatening disease. True, the
technology is not perfected, but it is the best we have to
offer. How can we contemplate limiting this opportunity?
As this debate continues we are opening the door for a
great deal of mis-communication and subsequent backstepping. We
should anticipate that insurance companies will feel
comfortable in stripping women of the option to obtain
screening mammograms. We have seen a growing, ominous trend in
health care to balance financial costs by rationing the
quantity and quality of health care services. Yes, health care
is expensive in dollars; but inadequate health care is
infinitely more expensive. As advocates for our patients,
health care providers are challenged to control costs not by
rationing services and technology but by functioning
efficiently.
We, as health care professionals, cannot continue to allow
for these types of ambiguous messages to be passed on to the
public. It is a good thing that mammography is able to detect
small unpalpable lesions, the technology has been helpful. The
fact that most lesions are treated aggressively represents the
choice of women and their physicians. This is a choice they
must be permitted to make.
There are two salient points I would like to stress:
While women are dying, we are disputing whether to
recommend and encourage the use of the best efforts we have to
offer. Breast cancer remains the leading cancer-cause of death
among women 15-54 years of age. Admittedly, our best efforts
have not gone far enough. Mammography techniques remain unable
to reliably provide clear pictures on younger, denser breast
tissue. Perhaps the use of missile technology will solve this
deficiency in the near future.
Second, since the health care industry will continue to
transform itself into a system which exploits opportunities to
increase the bottom line, we need to examine the full
implications of our messages. Will that message improve upon
what we have done? Or will it merely give women cause to think
that they are not at risk after all. Can we afford that
message?
In closing, I would like to extend my gratitude as well as
the appreciation of women who are impressed and moved by your
commitment to remember the human implications of this
controversy. As you know, there are many other dimensions to
health care that require investigation, I feel reassured to
know that this committee has appreciation of women's health
issues. Thank you Senator Specter for your continued dedication
to the promotion and protection of women's health. Thank you
for this opportunity to address this committee, I welcome any
questions you may have.
summary statement of dr. lawrence robinson
Senator Specter. We now turn to Dr. Lawrence Robinson,
deputy health commissioner for the Philadelphia Department of
Public Health. He is responsible for the coordination of
programs for comprehensive medical and health education
services. He is a graduate of Harvard and the University of
Pennsylvania School of Medicine. Both Harvard and the
University of Pennsylvania School of Medicine; how did you work
that out? [Laughter.]
Dr. Robinson. Thank you, Senator Specter, for the
opportunity to speak today.
It is interesting, in addition to that, some of the other
things that I do as the deputy health commissioner for the city
of Philadelphia, I also work for the American Cancer Society as
a volunteer. I am a board member of the State Cancer Society,
and also I am the chairman of the national black leadership
initiative on cancer, which is a program funded out of the
National Cancer Institute. I am here today to support
mammography screening for women between the ages of 40 and 49.
I think that this is particularly important for minority women.
I know, Senator, that you are a supporter of minority
health, and this is of particular interest, particularly in
terms of the city of Philadelphia. We are one of the largest
providers of ambulatory health care. We have over 125,000
patients in our ambulatory health centers. And of course the
majority of the people served in that situation are minorities
and from lower socioeconomic conditions.
Not only does early screening initiate the start of healthy
behaviors, which I heard discussed at the other end, but it
also identifies cancers. I think one of the things that we need
additional research in is the fact that cancer seems to be a
different disease in minority populations, particularly among
African-American women. We find that the death rate or risk of
death from cancer, breast cancer, is much greater in that
population. And also the cancer seems to be more aggressive in
that population.
We need, of course, to know a lot more about it. Because,
in terms of our clinical trials, the majority of the trials
that you have heard expressed today have been done on the
majority population, mostly on white women. So when you look at
the clinical trials, trying to separate out the issues, it is
difficult, because the participants in the trials do not have
the right percentage of minority representation.
I would like to also tell you something else, too, which I
think really explains the situation from a case study that we
did. Every year we have a major health fair here in
Philadelphia, and it is called Operation Health. We do it in
conjunction with the National Guard. And we literally set up a
MASH unit in the middle of the park, and we open that to
screenings, all different types of screenings, immunizations.
And we had a mobile mammography unit there. The interesting
thing about this particular setup is that it was open to people
just to walk off the street and get a mammography. All they had
to do was sign up. We really did not even require
preregistration for things like that.
This project was supported by the National Guard, Fox Chase
Cancer Center, which provided us with the mobile mammography
unit, and of course the health department. The event drew over
5,000 participants. As I said, it targeted lower socioeconomic
residents of Philadelphia. We did 43 mammographies during this
particular screening session. And I think it is very
interesting to note that many of the women who took advantage
of this were under 50.
During the screening program, we identified six abnormal
results that were confirmed by the mammography technologists.
Of course, this is a very high percentage, and it is much
higher than we would have expected if we had done screening in
the general populations. I think that this particularly points
out the need to do screening in targeted populations,
particularly populations that have a lower socioeconomic
condition, and of course have a much higher prevalence of these
diseases.
prepared statement
I have the breakdown of the ages for those six. It was 52,
46, 48, 78, 46, and 46. So there were two of the individuals
who were found positive who were under 50 in this case. And I
think that, just as a case study, I think that really points
out the need for us to continue to offer screening for women
under 50, particularly in populations that are minority.
Senator Specter. Thank you very much, Dr. Robinson. I have
looked at the summary of your curriculum vitae, which said a
graduate of Harvard and the University of Pennsylvania School
of Medicine. And Bettilou Taylor gave me the details of your
impressive record. You received your bachelor's at Harvard
College and your M.D., from the University of Pennsylvania, and
also a master of public health from Johns Hopkins. Very, very
distinguished institutions.
[The statement follows:]
Prepared Statement of Lawrence Robinson, M.D.
My name is Dr. Lawrence Robinson, MD, MPH. I am currently
Deputy Health Commissioner for the City of Philadelphia, Health
Promotion and Chronic Disease Prevention are my areas of
specialties. I concentrate on the area of Cancer Prevention and
work as a Board member of the American Cancer Society and the
Chairman of the National Black Leadership Initiative on Cancer.
I support mammography screening for woman between the ages of
40 to 49. I think this is particularly important for minority
women, black, Hispanic, etc. Not only does early screening
initiate the early start of healthy behaviors but it identifies
cancers.
I will relate to you a case study which I believe supports
this assertion. The Philadelphia Health Department, The
Pennsylvania National Guard and the Fox Chase Cancer Center
participated in an annual health event entitled Operation
Health. This event drew over 5,000 participants targeting lower
socioeconomic residents of Philadelphia. A mobile mammography
unit sponsored by Fox Chase Cancer Center performed 43
mammograms. Many of the women who received these mammograms
were under 50. During this screening 6 abnormal results were
confirmed by mammography technologist. The percentage of
abnormal results (15 percent) is much higher than expected.
This points out the need to do screening particularly when
it involves outreach to underserved areas. Also it is possible
to find cancer in women who are under 50.
summary statement of frances m. visco
Senator Specter. We now turn to our leader in the field of
breast cancer, Ms. Frances M. Visco. Ms. Visco is both a lawyer
and a health activist. She is the first president of the
National Breast Cancer Coalition, and a member of its board of
directors. She also serves on the board of the Linda Creed
Breast Cancer Foundation, and was appointed the president and
one of the three members of the President's Cancer Panel. She
also sits on the Department of Defense Breast Cancer Research
Program, which reviews the Department of the Army Research
Program. And she cochairs the national action plan on breast
cancer.
Ms. Visco graced us with her presence when we had the
hearing in Washington recently, and we thank you again for
coming today and for your leadership in this field. The floor
is now yours.
Ms. Visco. Thank you, Senator. I would like to start by
focusing on the question that you asked in Washington, and some
of you alluded to in your remarks, and that is the dollars that
are needed for breast cancer research. As we are all aware in
this room, we do not know how to prevent breast cancer. We do
not know how to cure it in every woman. And we do not know how
best to detect it. We need more research dollars to find those
answers.
And as you know, the national breast cancer coalition, this
year, is asking for $590 million in the National Institutes of
Health and $150 million in the Department of Defense Breast
Cancer Research Program, to continue high-quality,
investigative research. I know that you are concerned on how
the money is being spent that we have.
And as I have told you in the past, the coalition last year
held a think tank meeting at the Aspen Institute, where we
began to look at that very issue and began to look at the
design of research decisionmaking in this country. This June,
we will again bring together a diverse group of experts to look
at a plan, over the next 5 years, on how much money we actually
need for breast cancer in this country and how this money
should be spent.
We are looking forward to your input in the process, and I
will bring you all the information we have to date. I hope you
will participate with us throughout this process. I also want
to move to the issue that you raise about mandating medical
coverage.
I agree that mandating coverage by body part is not the
best public policy and that it is actually not very good public
policy. However, women in this country are left with nothing
else. The problem is that we failed to overhaul the health care
system in this country when we had the opportunity a few years
ago. And as I have said many times in the past, while we can
argue over whether mammography for women in their forties will
save lives, there is no argument that if every woman and her
family has access to health care in this country, that, without
question, will save many lives.
This is a wealthy nation, and yet we have 50 million
individuals who are uninsured. And of the millions who have
insurance, most of them are underinsured. We need to focus on
that problem. We need to not only get mammograms for women, we
need to make certain they have the followup treatment.
As you know, the CDC, the Center for Disease Control, has
the Breast and Cervical Cancer Prevention Act, which is a
misnomer, because neither of those things prevent. Neither
mammography nor a Pap smear prevent the disease, but they have
hundreds of millions of dollars, and enter into sharing
agreements with States, Pennsylvania being one of them, to
provide screening mammography and Pap smears for underserved
women.
The problem is that these women often fall through the
cracks, because there is no treatment for them. What we want
them to do--and we will be coming to you and to other Members
of Congress with a plan--to enact legislation so that there is
a treatment component with the CDC screening program. I just
want to briefly talk about the mammography issue, because, as
you know, I was diagnosed with breast cancer at age 39 by a
screening mammogram.
I had a lumpectomy. I had radiation and chemotherapy. And
yet, I do not believe that the data show that we should do
population screening of women age 39 to 49. What I want to talk
about, though, is the issue that women in their fifties, for
whom we all agree there is a reduction of mortality, the
majority of those women are not getting mammograms. And we need
to devote resources and attention to those women, and make
certain that they get the message that mammograms do save
lives--followed by treatment, of course. We need to get more
and more women in for mammograms in that age group.
prepared statement
For women in their forties, I believe strongly that women
are entitled to know the risks and benefits, entitled to know
the data, and that they should make a decision, in conjunction
with their medical provider. I do not think physicians should
make the decision. I do not think we have enough data on which
to make public health pronouncements or population screening
generally. I think women are entitled to the data, and then
they need to make up their own mind about their health care.
Thank you.
[The statement follows:]
Prepared Statement of Frances M. Visco
I would like to thank Senator Specter and the members of
this committee for holding these public hearings and furthering
the public's education about the faces behind mammography
screening for women under 50. My name is Fran Visco, I am a
breast cancer survivor, an attorney and the President of the
National Breast Cancer Coalition, a grassroots advocacy
organization of more than 350 organizational and 50,000
individual members. We have a network of activists in each
state who are trained on the issues and equipped as effective
advocates to achieve our goal of eradicating breast cancer
through action and advocacy. But now I would like to speak
personally.
I was diagnosed with breast cancer in September 1987, when
I was 39 years old. My breast cancer was diagnosed through
screening mammography. I had lumpectomy, radiation and
chemotherapy. But I am here personally to speak in support of
the findings of the consensus panel.
I have been following the coverage of the consensus panel
in the papers and on television since shortly before the panel
convened. I am amazed at the attention given to this question
and frankly appalled at the resources we continue to devote to
this question and at the outrage that met the panel's
conclusions. In the past month I have lost two very close
fiends and great activists to breast cancer. They were both
younger than fifty when they died. A mammogram did not save
their lives. Where is the outrage over that fact?
We are acting as though this issue--whether to recommend
population screening of women 40 to 49, is the most important
question in breast cancer. Let's save our outrage for the fact
that we don't know how to prevent this disease, how to cure it,
how to detect it truly early, or what to do for an individual
woman once we do find it. Let's save our outrage, our
resources, our energy, our time, for the 44,000 women who die
each year. For the tens of thousands of women who have no
access to health care.
What happened here? The Consensus Panel brought together a
well regarded and diverse group of experts; scientists, doctors
and consumers to consider the data in a thorough and open
forum. They reached their conclusions without bias or
interference. Specifically, the consensus panel looked at the
data--from trials not designed to answer the question we're
asking and that don't ask any question about minority women--
and saw that a meta-analysis of the trials shows a 16 percent
decrease in mortality for women under fifty, but the decrease
does not begin to show up for ten years, raising the question
among others, of whether the women, who are by now in their
fifties, are actually benefiting from mammography at that age.
Nothing new really. But we keep asking the question. I don't
think we're really looking for the answer anymore. I think
we're chasing after statistical significance--and we're going
to get it no matter what, if we have to play with confidence
intervals, wait a long enough time, throw out the trials that
don't fit our preconceived notions, get lost in the details.
But the big picture doesn't change. We all admit the numbers
are not overwhelming. Whatever benefit may exist is small.
Some seem to argue that should not matter, that public
policy should be driven by the fear that we will ``confuse
women.'' Well, I have more faith in women's ability to
understand the truth. What is our goal here? Is it to avoid
confusing women or to save women's lives? A simple message is
less confusing--but in this situation the simple message is
wrong. We all want it simple--we want mammography to work in
all women. It doesn't. We want breast cancer to be reduced to a
sound bite. It can't be. We can't continue to sell women false
hope, simply because we don't want them to be confused.
What should we do? Rather than worrying about confusing
women, let's devote our resources to designing mechanisms to
empower women to understand the message--if you are under fifty
there are certain things you should know about mammograms. Get
the information and discuss it with your health professional.
Let's focus our resources and energy on getting women over
50 to get mammograms--the majority do not. Let's make certain
these women have access to quality mammography and to follow up
treatment if needed.
Let's fund the research that will find the cure,
prevention, truly early detection. And if we really want to
save women's lives, let's focus our outrage, our energy, our
commitment on guaranteeing access to quality health care for
all women and their families. There is no dispute that that
public policy will save many lives.
Senator Spector, you have been a leader in Congress on
issues breast cancer. The NBCC has often asked you to support
policy that is not popular, but that is right. I hope you'll do
so now. Let's not continue to give women false hope; let's face
the truth--the data to support population screening in this age
group are simply not there. Let's give women the tools they
need to understand and then let them decide the course of their
own care.
treatment component
Senator Specter. Thank you very much, Ms. Visco. I am very
much interested in your approach as to the treatment component,
which you talk about. And I will be working with you. I am very
much interested in the activities of the various groups which
you are working with. You cover a great many lives, and there
is a lot of input there.
To the extent that you would care to now particularize how
you arrived at your figures, I would be interested to know. We
are going to be in the budgeting process soon. We do not make
all the decisions for NIH. We do not manage them to that
extent. I am committed, as you know, to a very major increase
for NIH this year again. I know that Congressman Porter, who is
chairman on the other side, and Senator Harkin is. And how far
we are going to go, we are going to have to see.
I am going to be taking this to the floor of the Senate in
the budget process. And I am going to be asking the Senators
for a ringing endorsement of the 7.5-percent increase for NIH.
Because we will need that allocation for our subcommittee in
order to have the money, and because we also have a heavy
responsibility on education and drug care in our subcommittee.
But I would be interested to know, analytically, how you
arrived at the figure of $590 million for NIH and $150 million
for the Department of Defense.
Ms. Visco. I can start with the Department of Defense. I
sit on the integration panel, so I have seen the proposals that
come to our panel, which makes programmatic decisions. I have
seen the proposals that have fared very well in the peer review
process, and yet we do not have the funds to cover them.
We simply do not have enough dollars to cover all of the
proposals that should be funded. So we base that figure on a
percentage of those fundable proposals in areas of importance
to research. And if we had that much money for this coming
year, we believe we would be able to fund a more appropriate
percentage of the fundable proposals.
As you know, the DOD Breast Cancer Research Program is
looking at areas where NIH does not have funding to look at.
For example, we fund a great deal of idea grants. A large
percentage of our money goes to idea grants. And those are
scientists who have ideas that are scientifically valid ideas,
but they may lack preliminary data. It is the idea they need to
test in order to form the basis of the larger traditional
proposal that they will submit to NCI later on.
Senator Specter. How about the $590 million for NIH?
Ms. Visco. The $590 million for NIH is based upon the
comparable analysis, looking at what we see that has come to
NIH in the fundable range in particular areas and has not been
funded.
Senator Specter. Ms. DeLuca, you commented about the MRI's.
I would be interested in your thinking as to whether the MRI is
a better test, or might be. They are fancy machines, but they
are not used much of the time. They could be made available if
we had some systematized way. That is a subject I took up with
Mr. Clinton, as a matter of fact, after I had my experience, to
make those MRI's usable around the clock. If they could save a
life, people would be willing to go there at 3 a.m.
Ms. DeLuca. I think that is so. I have spoken to physicians
who have given me indications that the quality of the pictures
that are received from an MRI is so much superior and so much
clearer, and things that would be very impossible to detect on
a mammogram become clear on an MRI. That is from the medical
side. I do not pretend to be able to make that judgment.
But I also understand that an MRI test can be at least 10
times more than the cost of a mammogram, and I understand that
is prohibitive. It is probably not reasonable to make that a
screening tool, unless we can find some criteria to make it
reasonable for certain people under certain circumstances.
Senator Specter. What we really need to find out is how
many MRI's are unused and at what times, and to see what the
availability is. And we may find that the criterion does not
have to be too high. If they are available and if the marginal
cost of operating them are minimal, it is not convenient to do
it in the middle of the night. But I would urge people to line
up around the blocks to have an MRI in the middle of the night
if they could get one.
Ms. DeLuca. I think women would do that. I have no doubt
that they would if they think they could get the answers.
Senator Specter. I think we need to get that determination.
I am going to ask the Secretary of Health and Human Services to
conduct that survey.
Ms. Mallory, do you think we ought to legislate on drive-by
mastectomies? I think we may well do that. We did that on
drive-by deliveries. How far should we go down this road of
drive-by congressional decisions? Do you have a lot of
confidence in the Congress?
Ms. Mallory. I actually have much more confidence in the
Congress than I do the health care industry.
Senator Specter. That may be thanking us by damning praise.
[Laughter.]
Ms. Mallory. I am pleased to hear that you will be
expecting to have some legislation passed to end the drive-by
mastectomies.
Senator Specter. What I want to do, and I have talked to my
staff about this and I will put this on the record now, because
I want to develop it, there is some legislation which has been
proposed on drive-by mastectomies. And we legislated last year
on drive-by deliveries. It is now a requirement of 48 hours.
And it is a very tempting field politically, when one of
these amendments is offered. Hardly a member will vote against
something that comes up. But we do not have the competence to
micromanage medicine. And what I think we need to do is to have
an overall legislative package which will make the decision a
medical decision and not a dollars-and-cents decision.
Now, the dollars and cents are not irrelevant, but the
doctors ought not to be gagged in recommending a specialist,
and they ought not to be penalized for exceeding the capitation
rate. But we have to find it for all problems, not just for
specific problems. Because we are not going to be able to
particularize all of them. And there have to be provisions for
a second opinion, and there have to be provisions for the
managed health care. They have got to make decisions about what
they pay for, because there are qualifications.
Specialists should not have to be dealing with someone who
is not qualified, but with an administrator. And there have to
be appeals procedures. And that is what we are going to be
looking for, something that goes beyond the specific ailment.
But we are working on that, right, Ms. Taylor? That is
where all the work is done.
Dr. Robinson, let me ask you a question which goes in a
little bit different direction, and that is how we do a better
job on minority care. We have 10 million children who are not
covered in health care, and I have a comprehensive health bill.
This is the third Congress that I have put it in, starting in
the 103d Congress, with Senate bill 18, and again in the 104th,
to work toward universal coverage, and on an incremental basis,
following up on Kassebaum-Kennedy from last year.
A number of the Senators on the other side of the aisle
have approached me on cosponsorship, and we have to find a way
to pay for it. I would be interested in your view of the
differences between the kind of care available in America to
minorities contrasted with other citizens, other residents.
Dr. Robinson. I think it is very interesting you mention
that. I always think of myself as being different when I
predict that ultimately we will move toward a universal care
program. I think it is inevitable, when we look at it from the
standpoint of what every other major industrialized country has
already done.
Senator Specter. Dr. Robinson, I think there is care
available actually if you go to the emergency ward. People are
not turned away on care, but it is very expensive to go to the
emergency ward. We need to find a way that people can get the
care without that very high societal cost. And the ultimate
question is whether we have enough doctors and hospitals and
MRI's and mammogram machines and pharmaceutical equipment to do
the job, and then to work out the delivery system.
My health care bill analyzes costs. And where there are
savings--for example, on low birthweight babies, a child as big
as my hand, they come into the world every day weighing 1 pound
or less, and they carry scars for a lifetime, and they are very
expensive. Prenatal care could save billions of dollars on
thousands of children who are born, and that could be applied
in other ways--just as an illustration. A nurse care physician
assistant could be a tremendous help, a tremendous savings, but
we have to find a way to deliver it without being unduly
intrusive with the Federal Government, so that we do not
establish a bureaucracy that puts it in the Government's hand.
At least that is my opinion.
Dr. Robinson. It is interesting also that the city of
Philadelphia actually is the main provider of care; 52 percent
of the patients at our ambulatory health centers are
uninsured--have no insurance at all. And so certainly there is
a need to provide access to care, because I do not think that
the issue is capacity. Because I think that we have the
capacity to offer the care. It is how we reach the access or
how the people get to that care.
subcommittee recess
Senator Specter. Well, thank you very much, Dr. Robinson.
Thank you, Ms. Mallory, Ms. DeLuca, Ms. Visco, again, for your
help today. We have a record as to what we have done here. This
will be reviewed by others who are members of the committee,
and we are going to be pursuing this matter in other field
hearings, as I say, and in Washington. And we appreciate your
input.
This is a big subject. I think we are making progress. But
I think we have to do a great deal more. So we will work
together on it.
That concludes our hearing, the subcommittee will recess
and reconvene at the call of the Chair.
[Whereupon, at 11:30 p.m., Thursday, February 20, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
MAMMOGRAPHY
----------
MONDAY, FEBRUARY 24, 1997
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Pittsburgh, PA.
The subcommittee met at 9:30 a.m., in the Allegheny County
courthouse, Pittsburgh, PA, Hon. Arlen Specter (chairman)
presiding.
Present: Senator Specter.
NONDEPARTMENTAL WITNESSES
STATEMENTS OF:
THOMAS S. CHANG, M.D., ASSISTANT PROFESSOR OF RADIOLOGY,
UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE AND STAFF
RADIOLOGIST AT MAGEE-WOMEN'S HOSPITAL
HOWARD A. ZAREN, M.D., DIRECTOR, MERCY BREAST CENTER, MERCY
CANCER INSTITUTE, THE MERCY HOSPITAL OF PITTSBURGH
VICTOR G. VOGEL, M.D., M.H.S., PROFESSOR OF MEDICINE AND
EPIDEMIOLOGY, DIRECTOR, COMPREHENSIVE BREAST CANCER
PROGRAM, UNIVERSITY OF PITTSBURGH CANCER INSTITUTE
D. LAWRENCE WICKERHAM, M.D., ASSOCIATE CHAIRMAN AND DIRECTOR OF
OPERATIONS, NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL
PROJECT AND FACULTY MEMBER, DEPARTMENT OF HUMAN ONCOLOGY AT
THE ALLEGHENY UNIVERSITY OF THE HEALTH SCIENCES
opening statement of senator specter
Senator Specter. Good morning, ladies and gentlemen. The
hearing of the Appropriations Subcommittee of Labor, Health and
Human Services, and Education and Related Agencies will now
proceed. We thank you for coming, especially our distinguished
panels of witnesses.
This hearing will focus on the issue of mammography, and it
arises from a report of the panel of the National Cancer
Institute which made a conclusion that mammograms for women in
the age category of 40 to 49 were not warranted. That is a
shorthanded statement for their finding.
And as I have noted in the morning newspaper, that message
has resonated from Pittsburgh to Washington and back again.
Walking through the airport this morning, I saw the national
publication with mammograms as the feature, and it has caused a
tremendous amount of interest and a tremendous controversy.
We have had a series of hearings on this subject in
Washington and field hearings in Pennsylvania with a view to
gathering expert opinions from the physicians who are experts
and also the sense from women who have been breast cancer
victims to see if that finding by the panel is well founded.
When I see the report in the morning press about saving the
lives of 2 women out of 10,000 or perhaps, as they put it, only
2 women out of 10,000, it seems to me that those are 2 lives
which ought to be saved.
I have an especially strong feeling about the subject
because not too long ago the doctors counseled me against an
examination, an MRI, and I finally got it after being very
insistent upon it, and it produced a life threatening
disclosure for me, a meningioma, which I would not have known
about had I not insisted on having the MRI.
I am not insensitive to the fact that I can get
examinations a little more easily than some people in our
society can get them.
When I see the reports about mammograms only assisting 2
women out of 10,000, the thought which comes to my mind is,
should we engage in rationing even to that extent.
I personally am very much opposed to rationing. I believe
that the question is whether we have enough doctors and
hospitals and machines like mammogram machines or MRI's or
pharmaceutical equipment to provide health care for all
Americans.
[Child crying.]
Senator Specter. There is another protesting voice. There
is a voice against rationing also. Now, let us not have both
cameras go there. One camera is sufficient. [Laughter.]
I made a political announcement not too long ago and I had
my granddaughter who was about 14 months at the time, and right
in the middle of my very important speech, she started to crawl
across the grass. You may not have noticed the announcement. I
ran for president last year. Not too many people noticed that.
[Laughter.]
At any rate, I am well attuned to items of priority
attention like children, which do warrant the extra attention.
So that what we really have to decide, in my opinion, and I
serve as chairman of the Appropriations Subcommittee of Health
and Human Services, is whether we have the facilities, the
personnel and the equipment to provide health care for all
Americans.
I believe that we do, and the complicated part is finding a
mechanism to deliver health care to all Americans, and that is
what I think we have to work out in cooperation among the
doctors and hospitals and even sometimes Senators or Members of
the House of Representatives.
I am very much concerned that government not play too heavy
a hand. I was very much opposed, as I think you know, to the
President's health care plan on the ground that there was too
much bureaucracy.
I am very much concerned with what is happening with HMO's
now, on a lot of limitations, the gag rule and limitations on
what referrals may be made. I note that that is a lead
editorial in this morning's press as well.
But this issue of mammograms is one of enormous importance.
The Director of the National Cancer Institute said that he was
shocked by the panel's findings, but the more recent
information out of the NCI is that they are not going to
overrule the panel, at least not yet. They are going to try to
find more information.
So this hearing is very important as we listen to experts
from this area where we have preeminent medical researchers and
preeminent hospitals.
We are going to have testimony from Secretary Shalala next
week, I think on March 5, and I am going to try to persuade
Secretary Shalala or maybe the facts will persuade Secretary
Shalala to have Medicaid and Medicare pay for mammograms for
women 40 to 49, because we know as a practical matter, if there
is any basis for the insurance carriers not to pay for
mammograms, they will take that course.
I do not say that in a critical way of the insurance
carriers. That is the way business is conducted. If they have
some basis for taking that approach, they do.
So our job is to see to it that we bring the best of
medical science to view on it. We hear from the women who are
victims. We know that breast cancer is a terrible killer in
America, striking one out of eight women. Thousands of women
die each year from breast cancer.
The funding has gone up. It now exceeds some $400,000,000 a
year. That funding has been increased, notwithstanding who has
been the chairman of the committee, Senator Weicker, Senator
Chiles, or Senator Harkin, and I am now the chairman.
And I have already made a pledge to have a 7.5-percent
increase on NIH funding which would be an additional
$952,000,000. That always brings smiles from the doctors.
Well, that is, believe it or not, relatively short as
opening statements go. I now want to welcome our very
distinguished panel of medical experts: Dr. Thomas Chang, Dr.
Howard Zaren, Dr. Victor Vogel, and Dr. Lawrence Wickerham.
Our practice is to proceed in alphabetical order because of
the difficulty of doing anything else with the kind of a
distinguished array of participants that we have here.
summary statement of dr. thomas chang
So we turn first to Dr. Thomas Chang, an assistant
professor of radiology at the University of Pittsburgh School
of Medicine and Magee Women's Hospital.
Dr. Chang graduated from MIT and Washington University
Medical School in St. Louis, did his training at Pennsylvania
Hospital, Thomas Jefferson University in Philadelphia, and the
Western Pennsylvania Hospital.
Dr. Chang, we welcome you here. We have an array of lights.
To the extent that you can keep your statement within 5
minutes, we would appreciate it. All written statements will be
made a part of the record in full, but if you could maintain
the 5 minute opening, that will allow us the maximum time for
dialog, questions and answers.
Welcome, Dr. Chang. The floor is yours.
Dr. Chang. Thank you very much.
First, I would like to point out that there is an amended
written statement. The one that has the line across the middle
of the page is the amended one. For those of you who have the
unamended one, please get the amended one at your earliest
convenience.
I appreciate your interest in the controversy over breast
cancer screening for women ages 40 to 49. We in the field of
women's health care thank you for the positions you have taken
in the past to promote women's health issues and thank you now
for convening this timely hearing.
I am a radiologist specializing in women's imaging, with a
significant portion of my practice devoted to breast radiology,
including mammography, breast ultrasound and needle biopsies of
the breast. I am an active member of the breast care team at
the University of Pittsburgh Medical Center and at Magee-
Women's Hospital, one of only several specialty women's
hospitals in the country.
For the past few years, I have closely followed the debate
that, as you mentioned, Newsweek magazine just last week dubbed
``The Mammogram War.'' I had the opportunity to attend the NIH
conference on mammography last month and left the meeting with
several thoughts and observations.
First, I was disappointed that the panel's main
recommendation was so inconclusive. By telling women in their
forties to make their own decision about mammography, the
conference did nothing to clear up the confusion about whether
they should have regular mammograms.
Although the panel did say that insurance companies should
pay for mammograms for women who want the test, I am concerned
that without a strong recommendation for mammography, insurance
companies will interpret the panel's decision as a decision
against mammography and stop paying for it. Many women might
then decide not to have a mammogram simply because they cannot
afford it. The ironic end result of the panel's decision would
then be not to let women in their forties make up their own
minds, but to have financial constraints make that decision for
them.
What I find most disturbing about the panel's conclusions
was the apparent disregard of much of the new data supporting
mammography that was presented at the conference. Having heard
the new evidence, I was impressed with the strength of the case
in favor of it. It is clear that routine mammography is
effective, beyond any reasonable doubt, at reducing breast
cancer deaths for women in their forties. The pertinent
question is no longer, Does mammography save lives? but rather,
How many lives does mammography save?
The eight research studies that looked at this question
showed that women in their forties who were offered mammography
have, on average, 18 percent fewer breast cancer deaths than
those who were not offered the test. For various reasons, the
18-percent figure actually underestimates the real benefit that
women who have yearly mammograms can expect. When the
limitations of the studies are taken into account, the benefit
is estimated to be around 30 to 40 percent.
Contrary to what some have implied, breast cancer is
relatively common in this age group. In fact, in 1996, there
were more breast cancers diagnosed in women in their forties
than in their fifties. At Magee-Women's Hospital, the 40- to
49-age group accounts for 36 percent of all patients and 24
percent of all breast cancers.
Just looking at these statistics, however, really does not
do justice to the real life consequences of breast cancer in
younger women. In terms of the number of years of life lost to
breast cancer, the 40- to 49-age group is affected far more
than any other decade. What makes breast cancer even more
tragic for younger women is that many of them die while they
still have young children. Because of the profound effect
breast cancer has on these women and their families, early
detection with mammography is imperative.
Some critics argue that too many women in their forties
with benign conditions have to have additional tests and
biopsies for every cancer that is detected. Whenever I bring up
this topic with my patients, they almost always say that
finding a cancer early is much more important to them than the
drawbacks associated with any additional tests or biopsies.
They realize that the earlier a cancer is found, the better the
chances of survival. Although it is true that women in their
forties have extra tests and biopsies than older women, I
disagree with the objections that there are too many. When it
comes to breast cancer, women would rather be safe than sorry.
Senator Specter. Dr. Chang, could you summarize the balance
of your statement, please?
Dr. Chang. I am sorry. OK. In conclusion, there is no doubt
that mammography saves lives and is a medically effectively
screening test for women in their forties. In terms of the cost
per year of life expectancy gained, it is cost effective as
well, costing less than tests that screen for osteoporosis or
cervical cancer.
prepared statement
Based on all the available information, I advise all my
patients aged 40 to 49 to have regular mammograms once a year.
I strongly urge your committee to make the same recommendations
and to ensure that financial barriers do not prevent women of
any age from having a mammogram whenever it is necessary. Thank
you.
Senator Specter. Thank you very much, Dr. Chang.
[The statement follows:]
Prepared Statement of Thomas S. Chang, M.D.
Senator Specter, I appreciate your interest in the
controversy over breast cancer screening for women ages 40-49.
We in the field of women's health care thank you for the
positions you have taken in the past to promote women's health
issues and thank you now for convening this timely hearing.
I am a radiologist specializing in women's imaging, with a
significant portion of my practice devoted to breast radiology,
including mammography, breast ultrasound, and needle biopsies
of the breast. I am an active member of the breast care team at
the University of Pittsburgh Medical Center and at Magee-
Women's Hospital, one of only several specialty women's
hospitals in the country.
For the past few years, I have closely followed the debate
that Newsweek magazine, just last week, dubbed ``The Mammogram
War.'' I had the opportunity to attend the National Institutes
of Health (NIH) conference on mammography last month and left
the meeting with several thoughts and observations.
First, I was disappointed that the panel's main
recommendation was so inconclusive. By telling women in their
40's to make their own decision about mammography, the
conference did nothing to clear up the confusion about whether
they should have regular mammograms.
Although the panel did say that insurance companies should
pay for mammograms for women who want the test, I am concerned
that without a strong recommendation for mammography, insurance
companies will interpret the panel's decision as a decision
against mammography and stop paying for it. Many women might
then decide not to have a mammogram simply because they cannot
afford it. The ironic end result of the panel's decision would
then be not to let women in their 40's make up their own minds,
but to have financial constraints make the decision for them.
What I found most disturbing about the panel's conclusions
was the apparent disregard of much of the new data supporting
mammography that was presented at the conference. Having heard
the new evidence, I was impressed with the strength of the case
in favor of it. It is clear that routine mammography is
effective--beyond any reasonable doubt--at reducing breast
cancer deaths for women in their 40's. The pertinent question
is no longer, ``Does mammography save lives?'' but rather,
``How many lives does mammography save?''
The eight research studies that have looked at this
question showed that women in their 40's who were offered
mammography had, on average, 18 percent fewer breast cancer
deaths than those who were not offered the test (23 percent if
the flawed Canadian study is excluded). For various reasons,
the 18 percent figure actually underestimates the real benefit
that women who have yearly mammograms can expect. When the
limitations of the studies are taken into account, the benefit
is estimated to be around 30-40 percent.
Contrary to what some have implied, breast cancer is
relatively common in the 40-49 age group. In fact, in 1996,
there were more breast cancers diagnosed in women in their 40's
(33,400 or 18 percent of all breast cancers) than in women in
their 50's (30,900 or 17 percent of all breast cancers). At
Magee-Women's Hospital, the 40-49 group accounts for 36 percent
of all patients and 24 percent of all breast cancers.
Just looking at these statistics, however, really does not
do justice to the real-life consequences of breast cancer in
younger women. In terms of the number of years of life lost to
breast cancer, the 40-49 age group is affected far more than
any other decade. What makes breast cancer even more tragic for
younger women is that many of them die while they still have
young children. Because of the profound effect breast cancer
has on these women and their families, early detection with
mammography is imperative.
Some critics argue that too many women in their 40's with
benign conditions have to have additional tests and biopsies
for every cancer that is detected. Whenever I bring up this
topic, my patients almost always say that finding a cancer
early is much more important to them than the drawbacks
associated with having additional tests and biopsies. They
realize that the earlier a cancer is found, the better the
chances of survival. Although it is true that more women in
their 40's have extra tests and biopsies than older women, I
disagree with the objections that there are ``too many.'' When
it comes to breast cancer, women would rather be safe than
sorry.
Some contend that mammography is not effective in the 40-49
age group because it saves ``only'' one or two lives out of
every 1,000 women who have mammograms. My job as a health care
professional is to help save lives, including those one or two
lives, not to trivialize them.
Critics also charge that too many of these women are
diagnosed with what they call ``pseudodisease'' or
``precancer.'' While many of these cases of ductal carcinoma in
situ (DCIS) never become lethal, others eventually kill.
Unfortunately, there is no way of telling, at present, which of
them will be the inactive ones that can be left alone. Until
the time comes when it is possible to separate the inactive
cases from the deadly ones, we owe it to all women to detect
and treat DCIS before it spreads into surrounding breast tissue
or other parts of the body.
In conclusion, there is no doubt that mammography saves
lives and is a medically effective screening test for women in
their 40's. In terms of the ``cost per year of life expectancy
gained,'' it is cost-effective as well, costing less than tests
that screen for osteoporosis or cervical cancer.
In accordance with the established guidelines from the
American Cancer Society, all women in their 40's should have
regular mammograms. Although current guidelines suggest an
interval of 1-2 years between mammograms, recent studies show
that if screening is to be done at all, it should be done
yearly to achieve maximal benefit. In part, this is because
cancers in this age group tend to be faster growing and more
likely to spread.
Based on all the available information, I advise all my
patients aged 40-49 to have regular mammograms once a year. I
strongly urge your committee to make the same recommendation
and to ensure that financial barriers do not prevent women of
any age from having a mammogram whenever one is necessary.
summary statement of dr. victor g. vogel
Senator Specter. We now turn to Dr. Victor G. Vogel,
professor of medicine and epidemiology and director of the
Comprehensive Breast Cancer Program at the University of
Pittsburgh Cancer Institute and Women's Hospital.
Prior to the current appointment, Dr. Vogel was associate
professor and deputy chairman of the Department of Clinical
Cancer Prevention at the University of Texas. He did his
undergraduate work at Johns Hopkins and is a graduate of the
Temple University Medical School.
I was scanning the morning paper on the turn sheet to see
how extensively Dr. Vogel was quoted on the turn sheet before
coming to his testimony. I did not want to miss anything.
But what appears to have been your prepared statement for
today has already given significant currency to your views, Dr.
Vogel. We welcome you here and look forward to your testimony.
Dr. Vogel. Thank you, Mr. Chairman. Thank you for the
opportunity to present my views to the committee.
There are approximately 16 million white women and more
than 3 million women of color between the ages of 40 and 49 in
the United States. Each year, 18 percent of all breast cancer
cases occur in these women. Collectively, they will develop
more than 33,000 cases of breast cancer this year, or more than
330,000 cases during this decade. Importantly, incidence among
African American women between the ages of 40 and 44 is 9
percent greater than in white women.
Mammographic screening holds the promise of early detection
of breast cancer in a curable stage. Eight prospective,
randomized, controlled comparison studies are available in the
world's medical literature that examine whether screening
reduces a woman's chance of dying from breast cancer.
These studies show unequivocally that mammographic
screening reduces the chance of dying from breast cancer by
approximately 30 percent among women aged 50 to 69 years.
Unfortunately, only one study was designed specifically to
investigate the efficacy of screening in women between the ages
of 40 and 49, and that study was seriously flawed by
methodological deficiencies. Nevertheless, and in spite of the
limitations of the data, meta-analysis of all studies
demonstrates a 24-percent reduction in breast cancer mortality
attributable to screening for women in their forties.
Because of the faster growth rates of breast cancer in
younger women, screening should be done annually rather than
every 1 to 2 years as suggested by some experts.
There are nearly 1 million women in Pennsylvania between
the ages of 40 and 49, and almost 2,000 will be diagnosed with
breast cancer this year. Tragically, as many as 1,000 of these
women may die. It is my opinion that we could reduce that
number by approximately 250 deaths if women between the ages of
40 and 49 years were screened annually.
Available data also indicate that the risk of inducing
breast cancer by mammographic radiation in younger women is
exceedingly small, if it exists at all.
Not all experts believe that we should screen women during
their forties, and they offer various justifications for their
position. Opponents of screening claim that only 2 lives will
be saved among a hypothetical group of 10,000 women screened
for a decade. Yet, for all the women in that age group in the
United States, as many as 35,000 lives can be saved each
decade.
It is difficult for me as a clinician to withhold screening
mammography from my patients in this age group in light of the
very probable, although modest, benefit. Furthermore, the cost
per year of life saved by screening is estimated to be
approximately $20,000. This is comparable to published median
costs of $19,000 per year of life saved for chemotherapy given
to premenopausal women after a diagnosis of breast cancer.
The NIH Consensus Panel recommended that each woman make
her own decision about screening on the advice of her
physician. In my clinical experience, this will lead to a
selective screening strategy in which only women with risk
factors for breast cancer will seek screening, and half of the
cases of breast cancer occur in women with no identifiable risk
factors for the disease.
In a 1994 publication of the Journal of the National Cancer
Institute Monographs, I estimated that a selective screening
strategy conducted only among women who are at increased risk
of breast cancer or about 20 percent of the population might
prevent 3,000 deaths annually but would miss the opportunity to
prevent at least 2,000 deaths each year among women without
risk factors.
My recommendation at that time was to reject a screening
strategy based on risk alone because of the large number of
deaths that such a strategy would fail to prevent. I am
unwilling to change that recommendation now. If we had
treatment that reduced the death rate of breast cancer by 24
percent as screening mammography appears to do, it would be
hailed as a significant achievement. Indeed, a hypothetical 30-
percent reduction in the number of deaths due to breast cancer
by the drug tamoxifen was considered ample justification for
initiation of the breast cancer prevention trial by the
National Cancer Institute. Why, then, is a similar 24-percent
reduction in mortality by screening viewed as unconvincing?
When treatment can cure all women with breast cancer,
screening may become unnecessary. It is my hope that practical
and efficient preventive strategies may obviate the need for
screening in the future. For now, however, primary prevention
remains investigational, it is expensive, and available
strategies are neither 100 percent effective nor completely
safe.
To conclude, there is some concern that the sensitivity of
screening mammography needs to be improved in younger women.
Senator Specter. Excuse me, Dr. Vogel. Did you say you were
concluding?
Dr. Vogel. Yes; I did.
Senator Specter. Thank you.
prepared statement
Dr. Vogel. There is some concern that the sensitivity of
mammography needs to be improved in younger women with dense,
difficult to image breasts, and there is no doubt that we need
improved screening methods. Those solutions will be found with
continued funding support for basic and clinical research. In
the interim, to do nothing while we can do something, albeit
imperfect, is to deny thousands of women each decade the
opportunity to be spared the tragedy of dying from breast
cancer. Thank you.
Senator Specter. Thank you very much, Dr. Vogel.
We will come to the dialog and the questions. These are
very profound statements by both Dr. Vogel and Dr. Chang, and
we will pick up some of the specifics.
[The statement follows:]
Prepared Statement of Victor G. Vogel, M.D., MHS
There are approximately 16 million white women and more
than 3 million women of color between the ages of 40 and 49 in
the United States. Each year, 18.1 percent of all breast cancer
cases occur in women of these ages. Collectively, these women
will develop more than 33,000 cases of breast cancer this year,
or more than 330,000 cases during this decade. Incidence is
rising each year, but we do not yet understand the reason for
this increase. Importantly, incidence among African-American
women between the ages of 40 and 44 is 9 percent greater than
in white women.
Mammographic screening holds the promise of early detection
of breast cancer in a curable stage. Eight prospective,
randomized, controlled, comparison studies are available in the
world's medical literature that examine whether mammographic
screening reduces a woman's chance of dying from breast cancer.
These studies show unequivocally that between the ages of 50
and 69 years, mammographic screening reduces the chance of
dying from breast cancer by approximately 30 percent.
Unfortunately, only one study was designed specifically to
investigate the efficacy of screening in women between the ages
of 40 and 49, and that study was seriously flawed by
methodological deficiencies. Nevertheless, meta-analysis of
available data, from all the screening studies demonstrates a
24-percent reduction in breast cancer mortality attributable to
screening when women in their forties are compared with women
of the same age who are not screened.
There are nearly 1 million women in Pennsylvania between
the ages of 40 and 49, and nearly 2,000 will be diagnosed with
breast cancer this year. Tragically, as many as 1,000 of these
women may die. It is my opinion that we could reduce that
number by approximately 250 deaths if women between the ages of
40 and 49 years were screened annually with mammography.
Not all experts believe that we should screen women during
their forties, and they offer various justifications for their
position. Opponents of screening claim that only 2 lives will
be saved among a hypothetical group of 10,000 women screened
for a decade. Yet, for all the women in that age group in the
United States, as many as 35,000 lives can be saved each
decade. Yet, for all the women in that age group in the United
States, as many as 35,000 lives can be saved each decade. Even
though it is true that only 2 women of every 1,000 in their
forties will develop breast cancer in a single year. It is
difficult for me as a clinician to withhold screening
mammography from my patients in this age group in light of the
very probable, although modest, benefit. Furthermore, the cost
per year of life saved (YLS) by screening is estimated to be
approximately $20,000. This is comparable to published median
costs of $19,000 per YLS for chemotherapy given to
premenopausal women after a diagnosis of breast cancer.
The NIH Consensus Panel recommended that each woman make
her own decision about screening on the advice of her
physician. In my clinical experience, this will lead to a
selective screening strategy in which only women with risk
factors for breast cancer will seek screening, and half the
cases of breast cancer occur in women with no identifiable risk
factors for the disease. In a 1994 publication in the Journal
of the National Cancer Institute Monographs, I estimated that a
selective screening strategy conducted only among women who are
at least at 3-fold increased risk of breast cancer (about 20
percent of the population) might prevent 3,000 deaths annually
but would miss the opportunity to prevent at least 2,000 deaths
each year among women without risk factors. My recommendation
at that time was to reject a screening strategy based on risk
alone because of the large number of deaths that such a
strategy would fail to prevent. I am unwilling to change that
recommendation now even in light of newly available genetic
methods to identify women at highest risk, again for the reason
that those genetic risk factors are found in only 1 to 2
percent of the general population and in only 5 to 10 percent
of breast cancer patients.
If we had treatment that reduced the death rate of breast
cancer by 24 percent (as screening mammography appears to do),
it would be hailed as a significant achievement. Indeed, a
hypothetical 30 percent reduction in the number of deaths due
to breast cancer by the drug tamoxifen was considered ample
justification for initiation of the Breast Cancer Prevention
Trial by the National Cancer Institute. Why, then, is a similar
24 percent reduction in mortality by screening viewed as
unconvincing?
When treatment can cure all women with breast cancer,
screening may become unnecessary. It is also my hope that
practical and efficient preventive strategies may obviate the
need for screening in the future. For now, however, primary
prevention remains investigational, it is expensive, and
available strategies are neither 100 percent effective nor
completely safe.
There can be no doubt that we need improved screening
methods, better treatment, and novel preventive strategies for
breast cancer. Those solutions will be found with continued
funding support for basic and clinical research. In the
interim, to do nothing while we can do something, albeit
imperfect, is to deny thousands of women each decade the
opportunity to be spared the tragedy of dying from breast
cancer.
references
1. Lindfors, KK, Rosenquist J. The cost-effectiveness of
mammographic screening strategies. JAMA 274:881-884, 1995.
2. Tengs, TO, et al. Five-hundred life-saving interventions
and their cost-effectiveness. Risk Analysis 15:369-384, 1995.
3. Vogel, VG. Screening younger women at risk for breast
cancer. Monographs of the National Cancer Institute 16:55-60,
1994.
summary statement of dr. howard a. zaren
Senator Specter. We now turn to Dr. Howard A. Zaren,
director of the Mercy Breast Cancer Center, Mercy Cancer
Institute. He is a surgical oncologist and chief of the
Department of Surgery of the Pittsburgh Mercy Health System.
Dr. Zaren, we welcome you here, and the floor is yours.
Dr. Zaren. Thank you, Doctor--Senator Specter.
Senator Specter. Thank you for the promotion.
Dr. Zaren. I am not sure it is a promotion or a demotion.
[Laughter.]
Before coming to Pittsburgh, I was chief of surgical
oncology at the Medical College of Pennsylvania, which you know
well, and used to be called the Women's Medical College.
Senator Specter. It was my neighborhood hospital. Now my
neighborhood is expanded so much, they all are. [Laughter.]
Dr. Zaren. Before that, I was a surgical oncology fellow at
the N.D. Anderson University in Texas where I received my
surgical oncology training.
The Pittsburgh Mercy Health System and the Mercy Breast
Center appreciate the opportunity to address this important
women's subject with you. My view is not much different than
you have heard today, Senator Specter.
There will be almost 11,000 new cases of and 2,700 deaths
from breast cancer in Pennsylvania in 1997. These figures place
Pennsylvania within the top five States for highest incidence
and mortality from breast cancer. It has been estimated that
almost 20 percent of all breast cancer deaths and 34 percent of
all breast cancer deaths and 34 percent of all years of life
expectancy lost result from cancers that are found among women
younger than the age of 50 years.
During this period of life, the incidence of breast cancer
will double from 1 in 50 at age 40 to about 1 in 25 at age 49.
These facts make the detection and treatment of breast cancer
in women aged 40 to 49 of paramount importance.
The NIH consensus statement on screening for breast cancer
in this group of women received widespread publicity and may
give women the general impression that there is no consensus
opinion on this issue, or may be perceived as a change from
current screening practice. Additionally, women may also
interpret the statement to mean that they should now
individually evaluate and act on scientific evidence that
appears to have confounded scientific experts.
This unfortunate situation may be the result of a lack of
foresight by those who should construct and plan screening
studies to answer such specific questions. Only one of the
eight randomized controlled trials that provides data on this
problem was performed in the United States, and this was
initiated in 1963. Unfortunately, more data on this issue will
not be forthcoming from American sources, and we will have to
wait on the maturity of these randomized clinical trials in
less well financed and socialized health systems in Europe.
Epidemiologic studies in this country, however, show a
shift toward diagnosing breast cancer at earlier stages in
women 40 to 49, and this is regarded as indirect evidence of a
possible benefit from screening these women.
No randomized clinical trial using mammography as the sole
screening modality has by itself included enough women aged 40
to 49 years with sufficient number of years of followup to
establish a statistically significant mortality reduction. The
most recent meta-analysis by Smart et al., of the seven
randomized clinical trials including women aged 40 to 49 with
inclusion of the most recent and longest followup data, and the
exclusion of data from the Canadian NBSS1 trial which was
alluded by my colleague here because of the substantial
differences from all other trials in terms of its design and
implementation, showed a statistically significant mortality
reduction of 24 percent from screening women in this younger
age group.
This finding is not surprising when it is noted that the
meta-analysis for these seven trials for the full age range, 40
to 74, or for the over 50 age group also show a statistically
significant benefit for mammography.
The reasons for delayed demonstration of reduction in
mortality in the 40 to 49 age group include lower instance of
mortality rates for this age group as compared to women 50 and
over.
Feig estimates--and this is my conclusion, Senator--Feig
estimates that a mortality reduction of up to 35 percent can be
expected if annual screening mammograms are performed in the 40
to 49 age group with current mammographic techniques and two
views per breast. We at the Mercy Cancer Institute support this
position. We also emphasize that at the present time, there is
really no alternative modality for early detection of breast
cancer.
The rapid evolution of new technology may improve the
future accuracy of screening mammography and the application of
new, minimally invasive surgical techniques may also help to
reduce anxiety associated with surgical procedures.
Finally, it should be noted that screening mammography
essentially only detects radiological differences, and
mortality as a measure of success of screening is to a great
part dependent on the results of treatment.
prepared statement
The randomized trials referred to above by colleagues and
by myself were done between the years 1963 to 1982. Since then,
significant advances in adjuvant therapy for breast cancer have
been made, and this will have a positive effect in reducing
mortality from screen detected breast cancers in the future.
Thank you, Senator.
Senator Specter. Thank you very much, Dr. Zaren, and we
thank you all for observing the lights. The subcommittee is not
quite as tough as the Supreme Court of the United States. They
interrupt in midsyllable.
I had occasion to argue a case there in 1994, about 3 years
ago this time, and they were a little more punctual with me
than they were with others, since seven of them had been before
the Judiciary Committee. [Laughter.]
But when you looked over at the light, Dr. Zaren, I noted
your attentiveness, and thought about being interrupted in
midsyllable.
Dr. Zaren. Oh, I am a surgeon, Senator, so my approach is
slightly different. [Laughter.]
Senator Specter. Well, I doubt that Chief Justice Rehnquist
would treat you any different.
Dr. Zaren. I am sure of that.
[The statement follows:]
Prepared Statement of Howard A. Zaren, M.D.
Senator Specter, there will be almost 11,000 new cases of
and 2,700 deaths from breast cancer in Pennsylvania in 1997.
These figures place Pennsylvania within the top five states for
highest incidence and mortality from breast cancer. It has been
estimated that almost 20 percent of all breast cancer deaths,
and 34 percent of all years of life expectancy lost, result
from cancers that are found among women younger than the age of
50 years. During this period of life, the incidence of breast
cancer will double, from about 1 to 50 at age 40, to about 1 to
25 at age 49. These facts make the detection and treatment of
breast cancer in women aged 40-49 of paramount importance.
The NIH consensus statement on screening for breast cancer
in this group of women received widespread publicity and may
give women the general impression that there is no consensus
opinion on the issue, or may be perceived as a change from
current screening practice. Additionally, women may also
interpret the statement to mean that they should now
individually evaluate and act on scientific evidence that
appears to have confounded scientific experts.
This unfortunate situation may be the result of a lack of
foresight by those who should construct and plan screening
studies to answer such specific questions. Only 1 of the 8
randomized controlled trials (RCT's) that provides data on this
problem was performed in the United States, and this was
initiated in 1963. Unfortunately, more data on this issue will
not be forthcoming from American sources, and we will have to
wait on the maturity of RCT's, in less well financed and
socialized health systems in Europe.
Epidemiologic studies in this country however, show a shift
toward diagnosing breast cancer at earlier stages in women 40-
49, and this is regarded as indirect evidence of a possible
benefit from screening these women. No RCT using mammography as
the sole screening modality has, by itself, included enough
women aged 40-49 years with a sufficient number of years of
follow up to establish a statistically significant mortality
reduction. The most recent meta-analysis by Smart et. al., of
the seven RCT's including women aged 40-49, with inclusion of
the most recent and longest follow-up data, and exclusion of
data from the Canadian NBSS 1 trial because of substantial
differences from all other trials in terms of its design and
implementation, shows a statistically significant mortality
reduction of 24 percent from screening women in this age group.
This finding is not surprising when it is noted that the meta-
analyses for these seven trials for the full age range (40-74),
or for the over 50 age group also show statistically
significant benefits for mammography. The reasons for delayed
demonstration of reduction in mortality in the 40-49 age groups
include lower incidence and mortality rates for this age group
as compared to women 50 and over, a deficient number of women
in this age group included in trials, shorter lead time, lower
sensitivity of mammography, higher rates of ductal carcinoma in
situ with concomitant slower rates of clinical progression and
fewer women with positive lymph nodes.
These trials indicate that stringent conditions must be met
for successful future screening trials in this age group. These
conditions include larger study populations with longer follow
up, two view mammography with high technical quality and
optimal interpretation, shorter screening integrals and
aggressive biopsy policy, and low tolerance for non-compliance
in study groups since this is a confounding factor. Tabar et.
al estimated that the Swedish Two-County Trial could have
resulted in a 19 percent mortality reduction as opposed to the
12 percent actually observed if for example women 40-49 had
annual mammograms. A 24 percent mortality reduction for the
active study group in the Ostergotland arm of the Two-County
trial would also have been seen as opposed to a 2 percent
increase, because death from breast cancer among women refusing
screening was a confounding factor.
Feig estimates that a mortality reduction of up to 35
percent can be expected if annual screening mammograms are
performed in the 40-49 age group with current mammographic
techniques and two-views per breast. We at the Mercy Cancer
Institute support this position. We also emphasize that at the
present time there is really no alternative modality for early
detection of breast cancer. The rapid evolution of new
technology may improve the future accuracy of screening
mammography, and the application of new minimally invasive
surgical techniques may also help reduce anxiety associated
with surgical procedures. Finally, it should be noted that
screening mammography essentially only detects radiological
differences, and mortality as a measure of success of screening
is to a great part dependent on results of treatment. The
randomized trials referred to above were done between 1963-82.
Since then significant advances in adjuvant therapy for breast
cancer have been made and this will have a positive effect in
reducing mortality from screen detected breast cancers in the
future.
summary statement of dr. lawrence wickerham
Senator Specter. We now turn to Dr. Lawrence Wickerham,
associate chairman and director of operations for the National
Surgical Adjuvant Breast and Bowel Project, a project to
evaluate new therapies in the treatment and prevention of
breast and bowel cancers.
He graduated from Washington and Jefferson College and the
University of Pittsburgh School of Medicine, and he serves as a
faculty member in the Department of Human Oncology at the
Allegheny University of the Health Sciences.
Welcome, Dr. Wickerham, and the floor is yours.
Dr. Wickerham. Thank you, Senator. I appreciate the
opportunity to testify before you today.
The National Surgical Adjuvant Breast and Bowel Project is
indeed a cancer research group that is funded primarily by the
National Cancer Institute. The group's headquarters are located
here in Pittsburgh at both Allegheny University and the
University of Pittsburgh. Our membership includes more than
6,000 medical professionals, physicians, nurses and related
health professionals located in more than 200 medical centers
throughout the United States and Canada.
Since 1958, the NSABP has entered more than 40,000 women in
studies that have dramatically altered the ways that we treat
breast cancers today. Perhaps the most visible result was that
demonstrating that lumpectomy plus radiation therapy was an
effective option in the surgical management of breast cancer.
Today's topic relates to screening mammograms in women 40
to 49. We know from randomized clinical trials that mammograms
in women 50 and older reduce the risk of dying from breast
cancer by as much as one-third. Unfortunately, despite this
established benefit, there are still women 50 and older who
have never had a mammogram. There are probably multiple reasons
for this, including fear, costs and access to care, but my hope
is that this recent consensus statement will not be added to
that list. In addition, we are only talking about screening
mammograms today, not diagnostic mammograms which are done to
evaluate breast lumps or other breast abnormalities.
The consensus panel of experts reviewed a substantial body
of data regarding the use of screening mammograms in women 40
to 49 and reached a conclusion. Other experts reviewing the
same data have differing views, and I do not think we are going
to resolve all those differences here today.
It is not unusual in science for knowledgeable individuals
to disagree. I am not aware of data that demonstrates screening
mammograms inflict physical harm. The discussions surround the
magnitude of benefit if any that can be obtained by the use of
mammograms in this group.
In the absence of clear, unequivocal data, as judged by the
consensus panel, they chose to not make a single recommendation
for mammograms for all women in their forties. The consensus
statement directs women to decide for themselves whether or not
to undergo mammography, and I do not disagree with that goal.
In order to make an informed choice, women and their health
care providers need to have the best possible educational
materials to aid them in those decisions. I would hope that
such educational materials would include information
documenting that the vast majority of mammographically detected
breast cancers allow that woman the option of choosing a
lumpectomy.
The consensus panel focused on the conventional measures of
benefit, that is reduction in breast cancer mortality. An
expanded definition of benefit is likely to be important in the
individual woman, however.
There is nothing magical about turning 50, and just having
a birthday certainly does not result in a benefit from
screening mammograms. There is likely to be a sliding scale of
benefit during the forties, and the potential benefit can be
assessed by the woman in consultation with her health care
providers based on her individual circumstances.
prepared statement
My greatest concern is that the consensus statement not be
used by the insurance carriers as a reason to deny coverage for
mammograms. I would hope that Congress can prevent a
controversial consensus statement from being used as a
rationale for improving the balance sheet of the insurance
industry.
Thank you for the opportunity to discuss this with you
today.
Senator Specter. Thank you very much, Dr. Wickerham, for
your testimony. Thank you all.
[The statement follows:]
Prepared Statement of D. Lawrence Wickerham, M.D.
Mr. Chairman and members of the Committee, I am D. Lawrence
Wickerham, M.D., Associate Chairman and Director of Operations
for the National Surgical Adjuvant Breast and Bowel Project. I
am also a faculty member in the Department of Human Oncology at
Allegheny University of the Health Sciences. I appreciate the
opportunity to testify before you today.
The National Surgical Adjuvant Breast and Bowel Project is
a cancer research group funded primarily by the National Cancer
Institute. The group's headquarters are located in Pittsburgh
at Allegheny University. Our membership includes more than
6,000 physicians, nurses, and other medical professionals
located in more than 200 medical centers throughout the United
States and Canada.
Since 1958, the NSABP has entered more than 40,000 women on
studies which have dramatically altered the ways in which
breast cancer is treated today. Perhaps the most visible result
was the demonstration that lumpectomy plus radiation therapy
was an effective option in the surgical management of breast
cancer.
Today's topic relates to the use of screening mammograms in
women 40-49. We know from randomized clinical trials that
mammograms in women 50 and older can reduce the risk of dying
from breast cancer by as much as one-third. Unfortunately,
despite this established benefit, too many women who are 50 or
older have never had a mammogram. There are multiple reasons
for this including fear, costs, and access to care, but I would
hope the confusion surrounding this recent Consensus Statement
would not be added to that list. We are also talking only about
screening mammograms, not about diagnostic mammograms which are
done to evaluate a breast lump or other breast abnormalities.
The Consensus Panel of Experts reviewed a substantial body
of data regarding the use of screening mammograms in women 40-
49 and reached a conclusion. Other experts reviewing the same
data have differing views and we are not going to fully resolve
these differences today. It is not unusual in science for
knowledgeable individuals to disagree. I am not aware of data
that demonstrates screening mammograms inflict physical harm.
The discussions surround the magnitude of benefit, if any that
can be obtained by the use of mammograms in this age group.
In the absence of clear unequivocal benefit the Consensus
Panel chose to not make a single recommendation for mammography
for all women in their forties. The Consensus Statement directs
women to decide for themselves whether to undergo mammography,
and I do not disagree with that goal. In order to make an
informed choice, women and their health care providers need to
have the best possible educational materials to aid them in
these decisions. I would hope that such educational materials
would include information documenting that the vast majority of
mammographically detected breast cancers allow the woman the
option of choosing a lumpectomy. The Consensus Panel focused on
the conventional measure of benefit, i.e., mortality reduction.
An expanded definition of benefit is likely to be important to
individual women. There is nothing magical about turning 50. A
woman doesn't have a birthday and suddenly develop a benefit
from screening mammograms. There is likely to be a sliding
scale of benefit during the 40's. This potential benefit can be
assessed by a woman in consultation with her health care
providers based on her individual circumstances.
My greatest concern is that this Consensus Statement not be
used by insurance carriers as a reason to deny coverage for
mammograms. I would hope that Congress can prevent a
controversial Consensus Statement from being used as a
rationale for improving the balance sheet of the insurance
industry.
Thank you for the opportunity to appear before you today.
This concludes my prepared statement. I would be happy to
answer any questions you may have.
national cancer institute
Senator Specter. When you talk about the lack of magic of a
birthday, I am reminded of Senator Glenn's statement last week
when he announced he was not running again, and I think we have
lost a great Senator. He has been a colleague of mine for the
past 16 years plus and an outstanding man.
He said--and this is something which even the mighty
medical profession cannot solve--he said, ``There is no cure
for the common birthday.'' [Laughter.]
And Senator Glenn commented about how old he would be at
the end of his next term and decided not to run again, which I
think is a loss for the country.
Let me begin at the core issue as to how many lives would
be saved. And as I hear the testimony of this panel, and we had
a similar hearing in Philadelphia last Thursday and we are
going to have a similar hearing next Monday in Harrisburg, all
in advance of the testimony of Dr. Shalala--Secretary Shalala,
I just about promoted her, too.
We are going to file a report--this is news to Bettilou
Taylor, who is my key staffer on this--of what you have
testified here to. We will put it in the Congressional Record
and make a floor statement of it, because I think that the
information which I heard last week and what I am hearing today
warrants broader circulation, really, to the country as a whole
and for the focus of Secretary Shalala.
I am concerned that the National Cancer Institute may not
take prompt action to contradict what the NIH consensus panel
has done here, as I listen to the testimony and have read on
the subject generally.
But the question is how many women are saved. And Dr.
Vogel, as you have outlined the statistics, when you talk about
2,000 Pennsylvania women being diagnosed with breast cancer
this year and that 1,000 will die, and that 250 could be saved
with prompt mammography, to what extent, Dr. Vogel, would that
impact be felt by mammography in the 40-to-49 age category?
Dr. Vogel. Those figures, Mr. Senator, refer totally to
that age group.
Senator Specter. So when you say 2,000 will be diagnosed
this year----
Dr. Vogel. Between the ages of 40 and 49.
Senator Specter. In the category of 40 to 49 alone?
Dr. Vogel. Yes; now, that represents only 18 percent of the
cases. It is true that breast cancer is largely a disease of
older women. The average age is in the sixties. But 2,000
Pennsylvanians will be diagnosed this year while they are in
their forties.
Senator Specter. Why do we see the statistics published as
they are present in the morning press about saving the lives of
only 2 women out of 10,000, then?
Dr. Vogel. It is a little bit complex. It is based on the
assumption that approximately 2 in a 1,000 per year will
develop the disease, so in a decade, there would be, if you had
a hypothetical group of 10,000 women, you would have 20 deaths
that perhaps would be reduced by 10 percent by mammographic
screening.
The problem with that is, it is a very pessimistic estimate
of the benefit of screening mammography. And as Dr. Wickerham
said, it is likely that the benefit is a sliding scale.
Senator Specter. It somewhat underestimates or
significantly underestimates or enormously underestimates the
number of women who will die out of that 10,000, does it not?
Dr. Vogel. I think it does, and I think one has to be
careful in how one mixes the picture. Now, we want to remain
optimistic about a woman's chances of surviving breast cancer,
but there is no doubt that breast cancer detected late,
particularly breast cancer detected with symptoms, has a far
worse outcome and a much greater chance of mortality than does
breast cancer that is mammographically detected.
And as I and the others tried to point out, even though
every single study is flawed and unable to answer the question,
the meta-analysis, that is when you combine all the data
together, I think a very reasonable estimate of the benefit in
this group of women is a 25- to 30-percent reduction in
mortality.
And that benefit is not insignificant, and it is comparable
to the benefits we achieve with other things that are accepted
as standard practice such as chemotherapy.
Senator Specter. Well, that is a very large swath of women
who will die who could be saved.
Dr. Chang, in your testimony, you characterized the
mammograms for women 40 to 49 as cost effective. That runs
counter to a good bit of the literature in the field and,
again, the morning press reports.
Dr. Vogel has testified in absolute numbers to the women
who would die as a result of breast cancer if undiagnosed and
untreated. Dr. Chang, how do you draw the conclusion about cost
effectiveness which you testified about?
Dr. Chang. Clearly, the definition of cost effectiveness
can be debated left and right. What you really have to do is,
as Dr. Vogel did, weigh what is the absolute cost. That is one
way of looking at it.
Another way is the way Dr. Feig in Philadelphia has looked
at it, which is looking at the cost per year of life expectancy
saved. And that is actually a common method of assessing cost
effectiveness.
The fact of the matter is, for women in their forties,
breast cancer affects their lives profoundly because they have
many decades of life that they lose as opposed to, for example,
prostate cancer where the vast majority of men who die are
elderly and do not have as many years of life that they lose.
Senator Specter. Let us not undercut the importance of
diagnosis prostate cancer.
Dr. Chang. Absolutely not. But I think I would like to
emphasize that this is a very important goal, to try to prevent
cancer in younger people because they are at the peaks of their
lives. They have younger families. The effect on them and their
families is very great.
Senator Specter. Dr. Zaren, let me take up with you the
issue of what harm comes to women. The consensus panel of NIH
emphasized the problem of false readings and then unnecessary
biopsies.
Is there any factor beside that one which is harmful from
having a mammogram for women 40 to 49?
Dr. Zaren. Let us just talk about the radiation harm. This
occasionally gets raised. The harm from that is minuscule
compared to the harm in not making the diagnosis early in
breast cancer.
Senator Specter. When you are on the issue of radiation,
let me digress for just a moment to the MRI. The MRI does not
use radiation. Is there any problem with repeated MRI exams?
Dr. Zaren. We at this point do not use MRI's in a screening
situation in the breast.
Senator Specter. I know you do not, but some other people
do.
Dr. Zaren. I realize they do, and there is no radiation
difficulty.
Senator Specter. Any harm that you know of from MRI's?
Dr. Zaren. Not that I am aware of.
Dr. Chang. Could I address that point, please?
Senator Specter. Sure.
Dr. Chang. As far as we know, MRI does not cause any
untoward effects. I would like to make one correction. MRI does
use radiation, but it is not ionizing radiation, which is what
x rays are.
Senator Specter. What kind of radiation does it use?
Dr. Chang. It is a magnetic sort of radiation.
Senator Specter. So that is not the kind that is a problem,
that dentists put the big lead shield on you?
Dr. Chang. No lead shield. In fact, that would be
contraindicated. The kind of radiation that is used is
magnetic, which is the kind that has been debated, actually, in
neighborhoods where they have power lines.
Senator Specter. There is some feeling about power lines,
that they do cause cancer.
Dr. Chang. Right.
Senator Specter. A lot of people think that in Scranton,
for example.
Dr. Chang. Exactly. That is another controversial issue
where there is tremendous debate.
Senator Specter. So there may be some debate as to whether
the MRI has some quality which could cause medical problems?
Dr. Chang. There is always that chance for debate.
Senator Specter. I do not want to know about a chance for
debate. I want to know about--[Laughter.]
I am serious, now. I want to know about any evidence, any
evidence.
Dr. Chang. None so far.
Senator Specter. Dr. Zaren, back to you, and the question
is on problems. You discounted radiation?
Dr. Zaren. Yes.
Senator Specter. Go ahead.
Dr. Zaren. I think, Senator, if you look at problems
encountered in radiation, second malignancies or causing
problems with radiation, it is minuscule compared to missing
the early diagnosis of breast cancer.
As it turns out, we at least in Pennsylvania have dedicated
breast centers with equipment that is the state of the art now
for detection, minimizing the amount of radiation given to a
patient during mammography, a two-view mammogram.
As far as biopsy is concerned, I alluded to newer
techniques that we are looking at in order to minimize biopsy,
open biopsy, open surgical biopsy.
Senator Specter. Well, you do not have to have a biopsy
simply because the mammogram shows you something.
Dr. Zaren. Well, if the mammogram does show you an
abnormality or a change from the last mammogram and has
specific changes that look like there may be an abnormality
there, there are ways to do biopsies now that do not require
open surgical techniques.
Senator Specter. So are you saying that the biopsy issue is
not a real problem, just like the radiation issue is not a real
problem?
Dr. Zaren. I am saying that as we develop these newer
techniques for minimally accessing breast masses----
Senator Specter. How about right now, aside from developing
newer techniques? How about right now?
Dr. Zaren. The approach right now is, again, a biopsy can
be done through a small needle, mammographically detected, to
take a core biopsy of a piece of tissue.
Senator Specter. So is that a significant risk?
Dr. Zaren. It is a much less risk than open surgical
biopsy, much less discomfort.
Senator Specter. And how do you compare that as a potential
harm? It has been identified in the consensus panel as a harm.
Is it really a harm?
Dr. Zaren. Well, any surgery, that requires general
anesthesia. Most of these procedures require local anesthesia.
Senator Specter. So you are saying in effect that it is
some harm, but what you are saying is it is minimal, again,
like radiation, contrasted with the benefits?
Dr. Zaren. I think it is minimal harm.
Senator Specter. Let me turn to the issue which you brought
up, Dr. Wickerham, of discouraging women from having
mammograms. That is one of the things that really concerns me
about the NIH consensus panel.
If people have any reason not to have an examination, they
will follow that reason. People, understandably, do not like
examinations or tests because they may show that there is
something wrong with you.
When you have this headline, ``Mammograms Unnecessary, Age
40-49,'' many people, most people do not read the fine print.
To what extent do you think it is dissuading women generally
from having mammograms?
Dr. Wickerham. My greatest concern was in the group 50 and
older where we know this test to be of value, that they not
misinterpret the headlines as well and avoid mammograms.
I have been warning patients that I see each week for
several months that this consensus panel was coming down the
road, and that they should be aware of it, read it carefully,
and I would be happy to answer any questions that they might
have.
I was very concerned that this information might be
misinterpreted not only by the medical community but also by
the lay public.
Senator Specter. On the issue of cost effectiveness, that
really is a public policy judgment, a political judgment, much
more so, it seems to me, than a medical judgment, although
obviously the medical inputs are important on cost
effectiveness. But that is something which we all have to make
a determination as to how to deliver medical services.
But with respect to the availability of mammograph
machines, is there any shortage, any reason why every woman in
the 40 age bracket up could not have one mammography a year,
that is with respect to the available physical equipment?
Anybody?
Dr. Vogel. Perhaps I can address that. There have been
studies to examine the number of machines available in the
country. Larry Kessler and others at the NCI have done those
studies, and to my satisfaction they have answered that
question that the access to mammography is not limited by the
availability of machines.
And the FDA program with the Mammography Quality Standards
Act has assured that those machines that are available are up
to technical standards.
I think the problems are those that have been alluded to by
Drs. Wickerham and Zaren and Chang, and that is that the
message be confused. And when our studies done 10 years ago and
others looked at the reasons why women did not get mammograms,
the two reasons they cited most often were that their physician
did not tell them to have one, and they cost too much. And I
think those are my concerns.
Senator Specter. How much does a mammogram cost?
Dr. Vogel. They are variable, but $60, $70 in round
numbers.
Senator Specter. Are they available free of charge?
Dr. Vogel. To some women, they are, and there are many
programs in the city that make mammography available.
Senator Specter. We are getting a lot of nods from the
audience. We may have to take some more sworn testimony here.
One thought which occurred to me on the MRI, which is a
good deal more expensive, is that MRI's might be given in the
middle of the night. The marginal cost for doing one at 3 a.m.,
would not be high, and it would be a lot cheaper at 3 a.m. And
I think a lot of people would be well advised to have one any
time they can get one in some situations. So that on the issue
of availability of medical resources, we do have them.
Dr. Zaren. Senator, just one more point. You raise an
excellent point here about the cost and cost benefit, but we
cannot forget--and again, my colleagues have said it--we cannot
forget that if you do not diagnose breast cancer early, the
cost of treating that patient is monumentally increased.
Senator Specter. I am thinking about our report here.
Bettilou is writing ferociously. Can you give me a ballpark
analysis as to the cost of diagnosis contrasted with the cost
saving once diagnosed?
Dr. Zaren. If a patient needs to have not just a needle
aspirated biopsy but go on to have a surgical removal of a
breast lesion and then is found to have a cancer that needs to
be treated with chemotherapy, I cannot give you a direct cost
for that. We can determine that. We do it every day.
Senator Specter. Would you please do that, Dr. Zaren? I
would be interested to know that, when you talk about cost
effectiveness, a lot of my colleagues are more impressed with
that factor than any other, so I would like to be able to lay
that on the line.
Dr. Zaren. It is something we can do.
Senator Specter. May I ask all of you on the panel to study
that issue for me and supplement your testimony? We will put it
in the record.
There have been some concerns expressed that, on a
comparison as to where we ought to be spending our money, that
much more of the money ought to be spent on research as opposed
to screening. My response to that is we do not have to limit as
to one or the other.
We have a Federal budget of $1,700,000,000,000, which is a
staggering sum of money that people cannot comprehend. And I am
personally convinced that if we established priorities, we
could cover the needs of our nation and have a balanced budget.
Senator Harkin and I cut out some 134 programs for our
subcommittee, enabling us to reallocate $1,500,000,000 to what
we consider to be the high value items like NIH research and
like scholarships and like worker safety.
We have in our subcommittee three departments, not only
Health and Human Services, but also the Department of Education
and the Department of Labor.
I would be interested in your research. I asked the head of
the NCI, how much money would he like to have. And I know this
is not your field. We now appropriate more than $400,000,000 a
year for cancer research. The NIH makes that allocation.
I would be interested in any sense any of you may have as
to what the right figure is. You may be more competent than
either Senator Harkin or I in determining that.
Dr. Zaren. That is a dangerous question.
Dr. Vogel. Yes, Mr. Senator. The answer is always more.
Senator Specter. I know it is a dangerous question, but I
am only two spots from being chairman of the full
Appropriations Committee, and I need to know things like that.
There is a lot of danger to my job. [Laughter.]
Go ahead, doctor.
Dr. Vogel. The pay line at the NCI over the last several
years has been as low as the 10th percentile. That means that
as many as 90 percent of approved grants go unfunded.
Dr. Klausner has done a yeoman's job at improving that
somewhat, but the pay line is still only in the vicinity of the
20th percentile.
It is particularly difficult to get new investigators
started because of the limited funds available for them. And I
have no data, but I have the impression that a number of
capable young physicians are leaving the sphere of medical
research because of the difficulty in securing funding.
There has been a welcomed increase in attention toward
funding of breast cancer specifically with the Department of
Defense initiatives and those increases at the NCI.
Senator Specter. Let me ask the four of you to study this
question for you and give me a figure as to what you would like
to see done here, bearing in mind the debate that cancer takes
more than it ought to in the overall budget from Alzheimer's
and heart disease, AIDS, et cetera.
Dr. Zaren. Just before you move on, Senator, I think it is
important, and Dr. Vogel put it very well. In fact, Dr. Vogel
says the 10th percentile, but at times it has been as low as
the 4th percentile in research dollars.
Senator Specter. Well, would you fund them all, Dr. Zaren?
Dr. Zaren. I would love to fund them all, but I would not
want to pay for it and neither would the rest.
I think it is important to know that there are two aspects
to the research. One, represented here at this table, is very
important and that is the clinical trial expertise and support
of that kind of research.
The clinical trials I alluded to here, most of the clinical
trials that have looked at this question have been done outside
of the United States of America. They have been done in England
and Sweden and other areas.
Senator Specter. Why is that? Why are those tests not done
in the United States?
Dr. Zaren. Well, first is the accrual of patients for
clinical trials. It is much more difficult in the States than
it is out of the States.
Senator Specter. Why?
Dr. Zaren. Because of our legal system and because of the
need for informed consent and not the need for informed consent
in other situations.
Senator Specter. Wait a minute. What about our legal system
impacts on this issue?
Dr. Zaren. We have very stringent rules and regulations for
accrual of patients in clinical trials.
Senator Specter. Why? Informed consent I understand. That
is something you could get.
Dr. Zaren. Yes.
Senator Specter. How many women turn down a request to have
their cases studied with a view to helping other women?
Dr. Zaren. Not so much turn down their case's study, but
when you present to women whether they can participate in a
clinical trial or not, we very fully explain, ``we'' meaning
the U.S. of A., clinical trials, very fully explain to the nth
degree the dangers as well as the benefits of participating in
a clinical trial.
And for a patient to make that decision sometimes is very
difficult from the information we need to give them, because we
give them both sides of the coin very thoroughly.
Senator Specter. Do you talk them out of it?
Dr. Zaren. I beg your pardon.
Senator Specter. Do you talk them out of it?
Dr. Zaren. Not talk them out of it, but very, very, very,
very, very carefully explain the risk-benefit of being involved
in a clinical trial.
Senator Specter. Are there risks in being involved in a
clinical trial?
Dr. Zaren. There are risks in being involved in a clinical
trial depending on that clinical trial, yes. But more
importantly, Senator, it is not just the funding of basic
research in cancer, but we need to fund clinical trials and we
need to fund clinical trials because that is where the answers
lie, at multiple phases of clinical trials, from phase 1 to
phase 3. That is the only point I wanted to make.
Senator Specter. There are a couple of other subjects I
want to move to, and we are running late on the panel. But I
would like you to address this subject as well. If there is
some problem on informed consent or if there is some problem
with the legal system, that is something we can legislate
about.
It is a little distressing to me to see all the tests
coming out of Sweden. I mean, more power to them, but
considering our budgets, why do we not have more clinical
information on this question? One test on women 40 to 49 since
1963 is hardly where we ought to be.
Let me move on to another subject, and that is this issue
of gene research. The research and what your profession has
done has been so astounding that there is so much sentiment in
the Congress to increase the funding.
And we hear a lot about gene research, identifying the gene
which predisposes a woman to cancer. One of the items we are
giving consideration to now is to legislation which would
protect privacy, because you have a curious situation.
If a woman takes a test and finds she has a gene which
predisposes her to cancer, she may rule herself out as being
insurable.
And if she knows about it and is asked a question and does
not tell the insurance company, the insurance policy will not
cover her if that is determined as fraud in the inducement.
So it is worse than catch-22. It is a catch-44 situation.
People do not want to find out what their medical problems are
because they will be barred from getting insurance coverage on
it.
So I think we can legislate at the Federal level to provide
privacy, but that raises the question that I have not heard a
good answer to yet as to, what will you be able to do for the
woman if you find out that she has a predisposition from the
gene beyond, say, more mammograms at an early age? What kind of
treatment can you give, if any, once there is a determination
that a woman has a predisposition from a gene test?
Dr. Wickerham. Senator, the group that I work for, the
NSABP since 1992 has been conducting a very large breast cancer
prevention trial, and one of the goals is to do just what you
have described, give an option for women at risk for this
disease beyond watchful waiting and mammograms and physical
exams and the other extreme, prophylactic mastectomies, removal
of the breast prior to the onset of the disease.
Senator Specter. A pretty tough procedure, pretty tough
remedy.
Dr. Wickerham. We have over 12,700 women who have
volunteered.
Senator Specter. For prophylactic mastectomies?
Dr. Wickerham. Who have entered this prevention trial.
Senator Specter. Oh, pardon me, OK.
Dr. Wickerham. All of them at increased risk for developing
the disease.
Senator Specter. What is the incidence of women who will
undertake a prophylactic mastectomy, if you can comment on
that?
Dr. Wickerham. I cannot.
Senator Specter. One of the things that concerns me is, is
it desirable to have a determination on gene predisposition if
there is nothing you can really do with it?
You are going to worry a lot of people in our society if
you tell them they have a predisposition to it.
Dr. Wickerham. In addition to searching for potential
benefits from the particular therapy we are looking at, it
would also allow for those individuals to be targeted for
structured evaluations, so that they would be certain to comply
with the screening procedures that we do have in place.
Are those perfect? Far from it, nor is the genetic testing
perfect at this point in time.
Senator Specter. May I ask you all to give me a
supplementary answer on that point, as to what you think about
pursuing the gene research determination and what you expect to
do with it, and your evaluation as to how hard we ought to push
it?
Let me raise one final question with you, which is not
within the purview of our hearing today, but I would be
interested in your views, with the disclosure in the news in
the last day or two about cloning of the mammals and the
ethical issues which are posed by that, and that is something
which we might be taking a look at for a hearing in Washington.
When I have four distinguished researchers, although it is
not exactly your field, Dr. Chang, does this raise any
questions in your mind that the Senate ought to be studying?
Dr. Chang. As you point out, that is not one of my areas of
expertise. In terms of cloning, what exactly are you referring
to?
Senator Specter. I am not sure. That is what I am asking
you. What I am referring to, according to the news report, is
that you have had the first mammal cloned, sheep, an exact
replica.
What would you say about the consequences of cloning
another Dr. Chang? You make quite a contribution to our
society, Dr. Chang. Should we clone you?
Dr. Chang. That is difficult to say.
Senator Specter. Dr. Zaren, should we clone Dr. Chang?
Dr. Zaren. We should definitely clone Dr. Chang, but not
Dr. Zaren. He has got enough of his own problems. [Laughter.]
Senator Specter. Wait a minute. Will Dr. Zaren have
problems if he is cloned? The clone may have a problem.
Dr. Zaren. The world may have, Senator Specter, if you
clone another Dr. Zaren. [Laughter.]
Senator Specter. What are the problems? One is enough?
Dr. Zaren. One causes enough problems.
But let me say this, Senator. Again, I am not an expert in
this area, but anything that would forward gene research in any
aspect may help us change what happens in breast cancer and
cancer in general.
So it is very frightening to think that you actually can do
this now, but it should not be any great surprise that we are
able to do this.
We are moving at lightning speed in certain areas, and one
of the areas is gene research. Now, at the University of
Pittsburgh, this is a major area of research for them. I am not
speaking for them, but it is a major area that they have been
in the forefront of.
I am sure Dr. Vogel will have something to say about this,
but I am not an expert in this area.
Senator Specter. Well, this is a subject which comes up
when you talk about genes and you talk about the research. Now
you talk about cloning, and this is a breathtaking conclusion
on cloning of mammals.
Dr. Vogel is next. Would you care to comment, Dr. Vogel, on
this issue?
Dr. Vogel. Well, as you know, Mr. Senator, we could be here
a long time talking about this, but very briefly----
Senator Specter. Do you think the Senate, and our
subcommittee ought to be inquiring into any aspect of this
issue?
Dr. Vogel. With great respect for the Senate, I think we
run the risk here of trying to control scientific inquiry. Now,
I hope I am as moral and as ethical as the next person, and I
would certainly want to seriously examine all the ethical
ramifications of cloning experiments that would involve human
beings.
On the other hand, as a scientist, I would be very
reluctant for any legislation that would impede substantially
scientific inquiry. But in my own mind, that is a tension.
There will be great difficulty in resolving scientific freedom
and ethical appropriateness in this area, but I think we should
move very slowly and have very open deliberations about this so
that scientific inquiry is not impeded.
The sheep cloning that was reported in the New York Times
and the Pittsburgh Post-Gazette yesterday was initiated in the
hope that sheep mammary gland, a curious irony with our topic
today, sheep mammary gland would produce large quantities of
proteins beneficial to human beings.
I would not want to see ethical concerns that may be
initially appropriate in protecting humans from research that
might ultimately benefit human beings.
Senator Specter. Well, how about the Congress establishing
priorities? We are only funding 10 percent of the grants. One
thing we are supposed to do is establish priorities. I keep
hearing all the time, just give us one B-2 bomber for my
project, just one B-2.
Dr. Vogel. I only need a wing, Senator. [Laughter.]
Senator Specter. Dr. Wickerham? I am not going to get into
that one. Do you want to make a comment on this last irrelevant
question? [Laughter.]
Dr. Wickerham. With all due respect, not really.
[Laughter.]
Senator Specter. OK. I am only joking that it is
irrelevant, because it is not irrelevant. The ethical questions
will be analyzed at every level of our society, but when it
comes to the question of priorities, that is a fair question
for our subcommittee as to where we put the money. We recently
had a hearing on Ebonics, because there is a question. We give
a lot of money for education.
Dr. Chang, you have the last word. I see you straining
forward in your chair. Maybe you want to answer that question
about whether Dr. Chang should be cloned.
Dr. Chang. I think it is fine and good that we are talking
about gene research and cloning, but I think we really have to
get back to the central question of what can we do for women
now in terms of preventing and treating breast cancer so that
we can save lives.
The only proven method right now is mammography that we can
offer to help in that goal, and I think that is where we have
to concentrate at the present time.
Senator Specter. Well, it has broad ramifications to the
gene issues, to the mammillary issues that Dr. Vogel raised on
what has turned into cloning.
This has been a very, very useful panel. I have given you
some extra work to do which I would appreciate it if you could
let us have responses by the end of the week, because I do want
to try to file a report sometime next week so that our
colleagues can have the benefit of the thinking.
We have found out too much in the brief hearings we have
had, perhaps comparable or at least supplemental to what the
consensus panel had done. So we thank you very much.
We are going to take a 5 minute recess before the next
panel.
[A brief recess was taken.]
Panel 2
STATEMENTS OF:
DIANE F. CLAYTON, BREAST CANCER SURVIVOR
YVONNE D. DURHAM, PROGRAM COORDINATOR, AMERICAN CANCER SOCIETY,
MAMMOGRAM VOUCHER PROGRAM
LAURIE S. MOSER, EXECUTIVE DIRECTOR, THE SUSAN G. KOMEN BREAST
CANCER FOUNDATION, PITTSBURGH RACE FOR THE CURE
JUDY POTTGEN, VOLUNTEER, AMERICAN CANCER SOCIETY
opening remarks of senator specter
Senator Specter. We will proceed with our hearing.
We have a very distinguished panel of witnesses: Ms. Diane
F. Clayton, Ms. Yvonne D. Durham, Ms. Laurie Moser, and Ms.
Judy Pottgen.
We thank you very much for being with us. If I may make
just a brief comment about the 5 minute recess, we lost a
camera, which was going to leave us in any event.
I said I was reluctant to take a break and lose a camera,
and I was told they were leaving in any event to make the noon
news, and that they had already interviewed some of you ladies.
And I told them the reason I did not like to break was I
did not want them to miss any of this second panel, although I
do not control what they do, obviously.
But I think one of the real benefits from these hearings is
that it sensitizes the public as to the issues, so they reach
more people by breaking at this point, and they said they had
already interviewed some and would interview others. But I
wanted to make that brief word of explanation.
We now turn to this very distinguished panel, and in
alphabetical order, we will hear first from Ms. Diane F.
Clayton, a strong advocate for mammography screening and early
detection.
She was diagnosed with breast cancer at the age of 46,
which obviously puts Ms. Clayton in a category affected by this
precise issue.
She is the mother of a 13-year-old son and resides in
Wexford where she lives with her husband who is a decorated
Vietnam veteran.
summary statement of diane f. clayton
We welcome you here, Ms. Clayton, and look forward to your
testimony. We have, as I think you heard, a 5-minute light.
Green is 5 minutes, yellow is 1 and red is stop to the extent
that you can, leaving the maximum amount of time for dialog,
questions and answers. So, the floor is yours, Ms. Clayton.
Ms. Clayton. Thank you, Senator Specter.
I appreciate this opportunity to speak on behalf of
American women who I believe have been sent a confusing message
by the National Institutes of Health. It is a special privilege
for me to be here this morning to share my story with you and
its relationship to the debate surrounding mammography for
women in their forties. I am here with no ax to grind and I
represent no professional or other special interest group. I am
here only as an ordinary citizen.
I am a breast cancer survivor mainly due to early
detection. My breast cancer was found during a routine
mammogram almost 4 years ago. I was 46 years old and never had
the first lump to indicate anything was wrong, nor was I aware
of any family history of breast cancer. The ductile carcinoma
in situ was discovered only by mammography. It was described to
me as if someone had thrown pebbles in a pond throughout my
duct.
I was told by the radiologist who looked at my mammogram
that I had cancer and probably needed chemotherapy. A biopsy
followed several days later and cancer was confirmed. The bad
news was that I had cancer. The good news was that if I had to
have cancer, mine was the best kind to have, especially since
it was at such an early stage.
The next weeks were spent taking what little control I had
and running with it, becoming educated on the subject,
obtaining second and third opinions and determining the best
procedure for me for the best possible outcome. Rational
decisions needed to be made in a totally emotional and
irrational situation. I likened it to standing on my tongue.
After a grueling 5 weeks of waiting, a total mastectomy was
performed and lymph nodes were taken. Fortunately, there was no
lymph node involvement and, therefore, I did not have to suffer
the ravages of radiation and/or chemotherapy. I was, indeed,
very fortunate.
I have read the NIH consensus statement, but I do not
understand how they could have reached their conclusions. If I
might, let me quote from their statement relating to my type of
breast cancer: ``Because some cases of ductile carcinoma in
situ may not progress to invasive cancer, a risk of
overtreatment exists.''
May not progress? Would you want to take the chance that it
may not progress? What is the risk of no treatment? Their
findings defy logic, common sense and simple observation. I am
offended by them. When I joined a breast cancer survivor's
group called Looking Ahead, I was one of the very few members
who did not have invasive cancer. Of the approximately 100
victims in my group, over 90 percent of them were under the age
of 50. Even more distressing, many were in their twenties and
their thirties. Some of those special women have since died.
I have tried to assess the committee's motives. Was it
money driving their direction? It does not seem logical, since
early detection and aggressive treatment have been shown to
reduce the total costs of treating this horrible disease.
Was it ignorance? This hardly seems likely when you examine
the outstanding credentials and backgrounds of those members.
Was it politics? Who could be against preserving and
extending the lives of mom, sis, Aunt Mary, and grandma? No; it
could not have been politics.
Could it have just simply been a big mistake, a wrong
conclusion, an honest effort that just went bad? I hope so. I
cannot fathom that an organization known as the National
Institutes of Health could have maliciously concluded that
women's health is not important. It really must have been a big
mistake. Let us simply admit it and go forward by doing the
right thing, advise and counsel women in their forties to have
routine mammograms, even if they do not feel a worrisome lump.
Ignorance is not bliss in this situation. I thank the Senate
for attempting to rectify this egregious error.
I am living, breathing proof that early detection can save
lives. If it had not been for my routine mammogram, again, let
me stress, at the age of 46, I believe I might not have been
able to share my story with you today.
I know that mammography is not a perfect science, but I
also know that it probably saved my life. I am happy to tell
you that I had cancer, although I will always belong to what I
call the C club. I also do not mind telling you that 3 days
ago, I joyfully celebrated my 50th birthday.
prepared statement
Thank you for letting me share my thoughts with you and why
I am a proponent of early mammography. It worked for me and
will continue to work for women like me if focus on early
detection is promoted and maintained. My simply being here is
proof.
[The statement follows:]
Prepared Statement of Diane F. Clayton
I appreciate this opportunity to speak on behalf of
American women who I believe have been sent a confusing message
by the National Institutes of Health. It is a special privilege
for me to be here this morning to share my story with you and
its relationship to the debate surrounding mammography for
women in their forties. I am here today with no ax to grind and
represent no professional or other special interest group. I am
here only as an ordinary citizen.
I am a breast cancer survivor mainly due to early
detection. My breast cancer was found during a routine
mammogram almost four years ago. I was 46 years old and never
had the first lump to indicate anything was wrong, nor was I
aware of any family history of breast cancer. The ``ductile
carcinoma in-situ'' was discovered only by mammography. It was
described to me as if someone had thrown pebbles in a pond
throughout my duct.
I was told by the radiologist who looked at my mammogram
that I had cancer and probably needed chemotherapy. A biopsy
followed several days later and cancer was confirmed. The ``bad
news'' was that I had cancer. The ``good news'' was that if I
had to have cancer, mine was the best kind to have, especially
since it was at such an early stage.
The next weeks were spent taking what little control I had
and running with it, becoming educated on the subject,
obtaining second and third opinions and determining the best
procedure for me for the best possible outcome. Rational
decisions needed to be made in a totally emotional and
irrational situation. I likened it to standing on my tongue
After a grueling five weeks of waiting, a total mastectomy
was performed and lymph nodes were taken. Fortunately, there
was no lymph node involvement and, therefore, I did not have to
suffer the ravages of radiation and/or chemotherapy. I was,
indeed, fortunate.
I have read the NIH consensus statement, but I don't
understand how they could have reached their conclusions. If I
might, let me quote from their statement relating to my type of
breast cancer: ``Because some cases of Ductal Carcinoma In Situ
may not progress to invasive cancer, a risk of overtreatment
exists.'' May not progress? Would you want to take the chance
that it may not progress? What's the risk of no treatment?
Their findings defy logic, common sense, and simple
observation. I am offended by them. When I joined a breast
cancer survivor's group called ``Looking Ahead,'' I was one of
the few members who did not have invasive cancer. Of the
approximately 100 victims in our group, over 90 percent were
under the age of 50. Even more distressing, many were in their
twenties and thirties. Some of those special women have since
died.
I have tried to assess the committee's motives. Was it
money driving their direction? It doesn't seem logical, since
early detection and aggressive treatment have been shown to
reduce the total costs of treating this horrible disease.
Was it ignorance? This hardly seems likely when you examine
the outstanding credentials and backgrounds of the members.
Was it politics? Who could be against preserving and
extending the lives of mom, sis, Aunt Mary and grandma? No, it
couldn't have been politics.
Could it have just simply been a big mistake? A wrong
conclusion? An honest effort that just went bad? I hope so. I
can't fathom that an organization known as the National
Institutes of Health could have maliciously concluded that
women's health is not important. It really must have been a big
mistake. Let's simply admit it and go forward by doing the
right thing; advise and counsel women in their forties to have
routine mammograms, even if they don't feel a worrisome lump.
Ignorance is not bliss in this situation. I thank the Senate
for attempting to rectify this egregious error.
I am living, breathing proof that early detection can save
lives. If it hadn't been for my routine mammogram, again, let
me stress, at the age of 46, I believe I might not have been
able to share my story with you today. I know that mammography
is not a perfect science, but I also know that it probably
saved my life. I'm happy to tell you that I had cancer,
although I'll always belong to what I call the ``C Club.'' I
don't mind telling you that three days ago, I joyfully
celebrated my 50th birthday.
Thank you for letting me share my thoughts with you and why
I am a proponent of early mammography. It worked for me and
will continue to work for women like me if focus on early
detection is promoted and maintained. My simply being here is
proof.
nih panel consensus
Senator Specter. Well, Ms. Clayton, that is powerful,
powerful testimony. You are precisely the kind of person who
would not be getting a mammogram under the NIH panel consensus,
because you would have no reason to. You had no lump, you had
no family history, you had no indication.
And as you testified, you had a total mastectomy.
Ms. Clayton. That is correct.
Senator Specter. You made a very forceful comment about not
wanting to hear about the risk of overtreatment. You wanted to
be sure.
Ms. Clayton. At that stage, there was no choice for me
because it was the type of cancer that it was, the ductile
carcinoma in situ, as if someone had thrown pebbles in a pond.
Senator Specter. As I understand it, aided by staff here,
what you had is an early form of breast cancer in which the
cancer cells are still located in the ducts and have not spread
into the surrounding breast tissue or other parts of the body.
But what you are saying is, the kind of breast cancer you
had was susceptible to spreading to the rest of the body.
Ms. Clayton. It was maintained within the breast.
Senator Specter. Yes; but had you not had the mastectomy,
it was the kind that would have spread?
Ms. Clayton. Correct. As far as my understanding is, that
is correct.
Senator Specter. Well, you are, as I say, a powerful story
on this subject.
Ms. Clayton. Thank you, Senator.
summary statement of yvonne d. durham
Senator Specter. I would like to turn now to Ms. Yvonne
Durham, program coordinator for the Mammogram Voucher Program
for the American Cancer Society, affiliated with the African-
American Cancer Awareness Coalition sponsored by the University
of Pittsburgh Cancer Institute, active in numerous
organizations which increase cancer awareness, promoting cancer
screening and early detection, providing community based breast
health education.
Welcome, Ms. Durham, and the floor is yours.
Ms. Durham. To the Honorable Arlen Specter and subcommittee
members: First and foremost, I would like to thank you for
extending to me the opportunity to participate in this special
hearing to discuss the problems of the NIH Consensus
Development Conference on Breast Cancer Screening in Women Ages
40-49.
As an African-American breast cancer survivor, diagnosed at
age 46, I was deeply troubled by the consensus panel's decision
not to recommend regular mammogram screening for women
beginning at age 40.
The consensus statement that each woman should decide for
herself whether to undergo mammography sends a confusing
message to the public.
As the coordinator of the American Cancer Society's
mammogram voucher program and the YWCA ENCOREplus program, I
have witness that women unfortunately cannot always make
informed decisions about health issues. This is evidenced by
information reported in Healthy People 2000, citing findings
that only 25 percent of women age 50 and above reported having
had a mammogram in the preceding 2 years, even though it is
widely accepted that mammography can reduce breast cancer
deaths by 30 percent in this age group.
My work in the African-American community has made me more
aware of the uniqueness of breast cancer disease among black
women. I have personally met and spoken with several black
women who were diagnosed with breast cancer between the ages of
27 and 35.
Published research findings also support that breast cancer
occurs in black women at an earlier age. Based on data from
1987, African-American women ages 35 to 44 had a breast cancer
mortality rate two times that of white women of the same age.
Yet African-Americans as well as Hispanic Americans have some
of the lowest mammogram screening rates in the United States.
As an outreach worker, one of my goals is to educate women
about the importance of mammography in detecting breast cancer.
A clear statement by NIH is important in giving credibility to
our outreach efforts. While I understand that mammography is
not 100 percent reliable, I can say that I personally would
prefer to have the information provided by this screening test
when being faced with making a decision about my breast health.
It has been estimated that 25 percent of breast cancers are
missed by mammography. I was one of those women in that 25
percent category. However, my treatment was not based solely on
mammography results. Because I had had a screening mammogram at
age 38, I was fortunate to have been taught breast self-
examination [BSE]. My breast cancer was detected by BSE, and I
credit that to my exposure to BSE technique during a screening
mammogram. No; mammography did not directly contribute to my
early diagnosis, but it did play an important role in my
survivorship.
The clinical importance of mammography for all women
starting at age 40 may not be clear at this time, but what is
clear is that we still have an underutilization of this most
effective screening tool. We still continue to see women with
advanced disease at diagnosis, and we are still losing our
mothers, sisters, grandmothers, aunts, and friends to the
disease of breast cancer.
No; a mammogram will not detect all breast cancers, but it
will detect many. Instead of limiting its availability, we need
to look at ways for making this screening test more reliable.
For many women, even those women under age 40, mammography has
provided the opportunity for early diagnosis, less extensive
surgical procedures and an added sense of control over our
breast health. The risk of discomfort or inconvenience
certainly pales in comparison to the benefits realized.
prepared statement
I urge you to reconsider your position in regards to this
matter. Recommend mammography starting at age 40 until there is
conclusive evidence of no benefit. I also urge you to support
research efforts that may offer a clearer understanding of how
breast cancer disease affects minority populations. By failing
to support mammography starting at age 40, you will jeopardize
our ability to obtain this screening test. This is especially
true for women who are uninsured or underinsured.
In conclusion, I would like to say that the benefit of
mammography far outweighs any risk associated with this
screening test. Please continue to make this test available to
all women beginning at age 40. Thank you.
[The statement follows:]
Prepared Statement of Yvonne D. Durham
Senator Spector and subcommittee members: First and
foremost, I would like to thank you for extending to me the
opportunity to participate in this special hearing to discuss
the findings of the NIH Consensus Development Conference on
Breast Cancer Screening in women ages 40-49. As an African
American breast cancer survivor, diagnosed at age 46, I was
deeply troubled by the consensus panel's decision not to
recommend regular mammogram screening for women beginning at
age 40. The consensus statement that, ``Each woman should
decide for herself whether to undergo mammography'', sends a
confusing message to the public. As the coordinator of the
American Cancer Society mammogram voucher program and the YWCA
ENCOREplus program, I have witnessed that women unfortunately
cannot always make informed decisions about health issues. This
is evidenced by information reported in Healthy People 2000
citing findings that only 25 percent of women, age 50 and
above, reported having had a mammogram in the preceding 2
years. Even though it is widely accepted that mammography can
reduce breast cancer deaths by 30 percent in this age group.
My work in the African American community has made me more
aware of the, uniqueness of breast cancer disease among black
women. I have personally met and spoken with several black
women who were diagnosed with breast cancer between the ages of
27 and 35. Published research findings also support that breast
cancer occurs in black women at an earlier age. Based on data
from 1987, African American Women, age 35-44, had a breast
cancer mortality rate 2 times that of (30 per 100,000 vs 16 per
100,000) white women of the same age.\1\ Yet African Americans,
as well as Hispanic Americans, have some of the lowest
mammogram screening rates in the United States.
---------------------------------------------------------------------------
\1\ National Center for Health Statistics. Prevention profile.
Hyattsville, MD: Public Health Service, 1990:135.
---------------------------------------------------------------------------
As a outreach worker, one of my goals is to educate women
about the importance of mammography in detecting breast cancer.
A clear statement by NIH is important in giving credibility to
our outreach efforts. While I understand that mammography is
not 100 percent reliable, I can say that I personally would
prefer to have the information provided by this screening test
when being faced with making a decision about my breast health.
It has been estimated that 25 percent of breast cancers are
missed by mammography. I was one of those women in that 25
percent category. However, my treatment was not based solely on
mammography results. Because I had a screening mammogram at age
38, I was fortunate to have been taught breast self-examination
(BSE). My breast cancer was detected by BSE, And I credit that
to my exposure to BSE technique during screening mammogram. No,
mammography did not directly contribute to my early diagnosis,
but it did play an important role in my survivorship.
The clinical importance mammography for all women starting
at age 40 may not be clear at this time. But what is clear, is
that we still have underutilization of this most effective
screening tool; we still continue to see women with advanced
disease at diagnosis; and we are still losing our mothers,
sisters grandmother, aunt and friends to the disease of breast
cancer. No, mammogram won't detect all breast cancers, but it
will detect many. Instead of limiting it's availability we need
to look at ways for making the screening test more reliable.
For many women, even those women under age 40, mammography has
provided the opportunity for early diagnosis, less extensive
surgical procedures, and an added sense of control over our
breast health. The risk of discomfort or inconvenience
certainly pales in comparison to the benefits realized.
I urge you to reconsider your position in regards to this
matter. Recommend mammography starting at age 40 until there is
conclusive evidence of no benefit. I also urge you to support
research efforts that may offer a clearer understanding of how
breast cancer disease affects minority populations. By failing
to support mammography starting at age 40, you will jeopardize
our ability to obtain this screening test. This is especially
true for women who are underinsured or uninsured.
In conclusion I would like to say that the benefit of
mammography far out weighs any risk associated with this
screening test. Please continue to make this test available to
all women beginning at age 40.
mammography
Senator Specter. Ms. Durham, did I understand you to urge
me to reconsider my position?
Ms. Durham. Yes.
Senator Specter. Because my position is that women 40 to 49
ought to have mammography. You do not want me to reconsider
that position, do you?
Ms. Durham. No.
Senator Specter. The testimony this morning by the panel of
experts was in line with what you had said, Ms. Durham, about
greater susceptibility for African-American women. Do you have
any idea why that is the case?
Ms. Durham. No; other than by the time the disease is
detected, that the prognosis is so poor and the disease is
advanced so.
Senator Specter. Well, you have testified that you know
women of the age category 27 to 35. May I ask you how many
women you know in that age category who have had breast cancer?
Ms. Durham. Those several women between 27 and 35 were
women that were diagnosed with breast cancer, that had breast
cancer.
Senator Specter. Well, the issue which you raise, which I
had not heard about, the 27 to 35 category, would suggest there
ought to be some special tests for African-American women where
there are some indications, the doctors have already testified,
that more African-American women have breast cancer, to see if
that incidence also impacts at an earlier age category.
We really have not talked about mammograms for women 30 to
39. We are talking now about mammograms for women 40 to 49.
Now, women do have mammograms where there is an indication in
an earlier category, in an earlier age category, but what you
are suggesting is that there ought to be some surveys made to
see if any special group of people have a greater
susceptibility which ought to lead to different screening
procedures.
Ms. Durham. Well, one of the things I wanted to say was,
you pointed out that African-American women have a higher rate,
the incidence of breast cancer is higher than in the Caucasian
population, but the mortality rate is higher in the African-
American community.
Senator Specter. You would think that would follow, if the
incidence is higher.
You had the mammography, did you say, at the age of 38?
Ms. Durham. Yes.
Senator Specter. But you were not diagnosed until 46.
Ms. Durham. I insisted to my doctor to have the mammogram.
Senator Specter. Did you have another mammogram at 46?
Ms. Durham. Oh, yes, I had it every 2 years after that.
Senator Specter. But you detected it with your own breast
screening examination?
Ms. Durham. Yes; eventually I did.
Senator Specter. Thank you very much, Ms. Durham.
summary statement of laurie moser
We now turn to Ms. Laurie Moser, executive director of the
Susan G. Komen Breast Cancer Foundation, Pittsburgh Race for
the Cure.
She is a middle school teacher at the Hillel Academy here
in Pittsburgh, a member of the board of directors for the
American Cancer Society's Greater Pittsburgh unit, affiliated
with the United Jewish Federation of Greater Pittsburgh and
past director of the National Council of Jewish Women for
Pittsburgh.
Welcome, Ms. Moser, and the floor is yours.
Ms. Moser. Thank you.
Thank you, Senator, for the opportunity to testify today.
The Pittsburgh Susan G. Komen Breast Cancer Foundation Race for
the Cure is an annual race, a 5-K walk and run on Mother's Day,
that raises awareness about breast cancer and provides
mammograms and followup diagnostic services to medically
underserved women in 22 counties of western Pennsylvania and
supports the Komen National Research Program.
In 4 years, we have raised $1.25 million and have provided
over 7,600 vouchers to underinsured women. Fifty-six cancers
have been diagnosed. While the race is a once a year event, our
education and our early detection programs continue throughout
the year, reaching out to the African-American community,
senior citizens, new Americans, native Americans, and breast
cancer survivors.
We at the Komen Foundation strongly disagree with the
latest decision from the NIH Consensus Development Conference
on Breast Cancer Screening for Women Ages 40 to 49 that stated
that: ``The available data does not warrant a single
recommendation for mammography for all women in their
forties.''
It is estimated that in 1996, women in their forties
accounted for 18 percent of newly diagnosed invasive breast
cancers, while women in their fifties were estimated to make up
16.8 percent of these new cases.
Significant data has been presented that indicates regular
mammography screening of women in their forties, when combined
with appropriate intervention, leads to a significant decrease
in mortality.
We firmly believe that the panel's position overstated
potential risks and understated the benefits of mammography.
Although imperfect, mammography screening is presently the most
reliable tool for detection of breast cancer. Mammography
facilitates early detection and intervention which decrease
mortality and can lead as well to an improved quality of life
for those diagnosed by allowing for breast conservation surgery
and less aggressive treatment options.
My personal story twice underlines the importance of
mammography and early detection. In 1987, for my fortieth
birthday, I treated myself to a mammogram. I had no history of
breast cancer in my family. I was in great shape. I ran 7 to 8
miles a day.
To my great surprise, the doctor called and told me that
there were signs of calcification, that 85 percent of them were
benign, and that I should come back in 6 months.
I was not satisfied with that report, and I insisted on a
biopsy. The biopsy turned out to be malignant. I had ductile
carcinoma in situ, DCIS, and I had to have a lumpectomy. The
lymph nodes were removed and they found that they were not
involved, and thankfully I just needed to have 30 radiation
treatments, no chemotherapy.
I had a mammogram every single year after that, and last
September I was diagnosed once again with breast cancer in the
same breast. The DCIS had returned. I knew more about breast
cancer then than I did 9 years ago and I was not frightened by
the diagnosis, but I was very saddened by it.
I had a mastectomy at that point. I did not need any chemo
or any radiation, and I am now recovering from reconstruction.
I strongly feel that all women in their forties should have
full information in order to make informed personal decisions
about mammography. Many consumers, however, look to the opinion
of a body of experts such as the consensus panel to interpret
data and provide recommendations which they can weigh as they
make decisions. The present NIH statement does nothing more
than confuse the public about an extremely important issue. A
strong consensus would also help to guarantee women in their
forties the necessary insurance coverage for mammography.
prepared statement
When the Race for the Cure began in Pittsburgh in 1993, a
woman died every 11 minutes from breast cancer. Today, a woman
dies every 12 minutes. Over 2,000 additional lives are saved
each year with early detection. Our mutual goal should be to
add 1 minute each year in the hope that more and more women
will survive breast cancer. Mammography can help.
Thank you, Senator.
[The statement follows:]
Prepared Statement of Laurie S. Moser
My name is Laurie S. Moser, and I am Executive Director of
the Pittsburgh Susan G. Komen Breast Cancer Foundation Race for
the Cure. The annual race, a 5-K walk and run on
Mother's Day, raises awareness about breast cancer, provides
mammograms and follow-up diagnostic services to medically
underserved women in 22 counties of western Pennsylvania and
supports the Komen National Research Program. In 4 short years
we have raised over $1.25 million and provided 7,600 vouchers;
56 cancers have been diagnosed. The RACE is a once-a-year
event, but our education and early detection programs continue
throughout the year, reaching out to the African-American
community, senior citizens, new Americans, Native Americans and
breast cancer survivors.
We at the Komen Foundation strongly disagree with the
latest decision from the NIH Consensus Development Conference
on Breast Cancer Screening for Women Ages 40-49 that stated
that: ``the available data does not warrant a single
recommendation for mammography for all women in their
forties.'' It is estimated that in 1996, women in their forties
accounted for 18.1 percent of newly diagnosed invasive breast
cancers, while women in their fifties were estimated to make up
16.8 percent of the new cases. Significant data was presented
that indicates regular mammography screening of women in their
forties, when combined with appropriate intervention, leads to
a significant decrease in mortality. We firmly believe that the
panel's position overstated potential risks and understated the
benefits of mammography. Although imperfect, mammography
screening is presently the most reliable tool for detection of
breast cancer. Mammography facilitates early detection and
intervention which decrease mortality and can lead, as well, to
an improved quality of life for those diagnosed by allowing for
breast conservation surgery and less aggressive treatment
options.
My personal story twice underlines the importance of
mammography and early detection. In 1987, for my fortieth
birthday, I treated myself to a mammogram. This was an optional
procedure after a physician casually recommended that I have a
baseline. I had no symptoms; there was no history of breast
cancer in my family and I was in perfect health. I ate well and
ran seven to eight miles each day. To my great surprise the
doctor called and told me I had calcifications in my left
breast, but 85 percent of calcifications are benign, he assured
me. He recommended that I come back in six months. I was not
satisfied and called a surgeon, who told me the same
statistics. At that point I was not interested in national
numbers and requested a biopsy. He agreed and we found that the
calcifications were malignant--ductal carcinoma in-situ (DCIS)
and I had a lumpectomy. The margins were cleaned and,
thankfully, there was no lymph node involvement. As follow-up I
received 30 radiation treatments; no chemotherapy was
necessary. Each year I returned for mammograms and sonograms;
all was well until this past August (1996). Many calcifications
had returned all over my left breast; even with my uneducated
eye I could tell by looking at my mammogram that a mastectomy
was necessary. After a stereo-tactic biopsy it was confirmed
the DCIS had returned and a mastectomy was indeed in order. The
good news was the cancer had not spread and that it had been
detected early, once again. The first time around my then 13-
year-old son asked me if I was going to die. I replied, ``Yes,
but not from breast cancer and not for a very long time,'' was
my reply. This summer, using the same information, I reassured
him again. I firmly believe that my life has been saved twice
by the benefits of early detection--and I am not yet 50 years
of age.
In addition, because I was diagnosed at such an early age,
my recovery was relatively quick and the cost of treatment was
significantly less if the cancer had been more advanced.
I strongly feel that all women in their forties should have
full information in order to make informed, personal decisions
about mammography. Many consumers, however, look to the opinion
of a body of experts, such as the consensus panel, to interpret
data and provide recommendations which they can weigh as they
make decisions. The present NIH statement does nothing more
than confuse the public about an extremely important issue. A
strong consensus would also help to guarantee women in their
forties the necessary insurance coverage for mammography.
When the Race for the Cure began in Pittsburgh
in 1993, a woman died every 11 minutes from breast cancer.
Today, a woman dies every 12 minutes. Over 2,000 additional
lives are saved each year with early detection. Our mutual goal
should be to add 1 minute each year in the hope that more and
more women survive breast cancer.
With your help we can ``race for the cure.''
statistics
Senator Specter. Thank you very much, Ms. Moser. When you
cite the statistics about a women dying every 11 minutes, now
every 12 minutes, is that a national figure?
Ms. Moser. Yes; it is.
Senator Specter. The statistic which you cite about 18
percent being detected in the forties contrasted with between
15 and 16 percent in the fifties, what is the basis for that
statistical study?
Ms. Moser. That comes from the American Cancer Surveillance
Statistics, 1995.
Senator Specter. One of the questions which we are going to
put to the panel of the NIH is what they did with that kind of
information. It looks like fairly persuasive evidence for
screening in the forties.
You say that you had a mammogram at 40 and it showed signs
of calcification. They told you to come back in 6 months?
Ms. Moser. Yes.
Senator Specter. What did the doctor say to you when you
went back sooner?
Ms. Moser. Actually, I changed doctors.
Senator Specter. You changed doctors. I did, too.
Ms. Moser. I am glad. It was good for both of us.
I decided to get a second opinion. The second doctor, I
should say, also said 85 percent calcifications, we can do this
in 6 months, and I said, ``Why? So that it can get worse? Let
us find out what it is now.'' And he was willing to play ball
with me.
Senator Specter. And when did you have the later exam to
show recurrence?
Ms. Moser. Well, I had a yearly mammogram after that,
yearly, and then this past September, the calcifications
reappeared all over the breast.
Senator Specter. And may I ask you how old you were last
September?
Ms. Moser. I was 49.
Senator Specter. And may I ask you what you are doing about
that? What sort of treatment are you having?
Ms. Moser. I have had a mastectomy. I have had
reconstruction since then as well, and I am racing for the cure
every day.
Senator Specter. Well, at 40, how many miles did you run
every day?
Ms. Moser. Seven.
Senator Specter. How many miles are you running now?
Ms. Moser. Eight. [Laughter.]
Senator Specter. Very impressive, Ms. Moser. Thank you very
much. There are 7,600 vouchers that you have provided for women
who could not afford mammography?
Ms. Moser. Yes; that is through the mammogram voucher
program. Some 75 percent of the money that the Race for the
Cure raises stays in the Pittsburgh area and we provide the
mammograms and followup diagnostic services to women who cannot
afford them.
Senator Specter. And 56 detections from the 7,600?
Ms. Moser. Yes.
Senator Specter. Do you have a breakdown as to how many of
those women were in their forties?
Ms. Moser. No; I do not. I certainly could get that.
Senator Specter. Could you? The subcommittee would be very
interested in that. Now, 75 percent of the money stays in
Pittsburgh. Where does the other 25 percent go?
Ms. Moser. It goes to the Komen Foundation in Texas for
national research. The Pittsburgh race is 1 of 77 that take
place all over the country. There is a Mother's Day race in
Philadelphia as well.
Senator Specter. I have been in it.
Ms. Moser. I am sure you have.
summary statement of judy pottgen
Senator Specter. We now turn to Ms. Judy Pottgen, an active
volunteer with the American Cancer Society, a 4-year breast
cancer survivor, mother of three daughters.
She was diagnosed with breast cancer when she was 43. She
now tours high schools in Allegheny County teaching junior and
senior class girls how to do self-breast examination.
Welcome, Ms. Pottgen, and the floor is yours.
Ms. Pottgen. Thank you very much.
I am a 47-year-old woman who is a wife and mother of three
wonderful daughters ages 23, 17, and 13. Other than my
daughters, I feel my greatest accomplishment is having survived
breast cancer for nearly 4 years.
In April 1993 when I was 43 years old, I found a lump in my
right breast while doing self-breast exam. I had a mammogram
and the radiologist referred me to my surgeon.
I was told I needed a biopsy, and when the results came
back, my greatest fear became reality. It was cancer. I had a
modified radical mastectomy in May of that year, and adjuvant
chemotherapy that lasted for 3 months.
When my treatment was completed in August, I felt in my
heart that it was the beginning of the rest of my life. What a
wonderful feeling, to know that you have been one of the lucky
ones to have faced possible death and knocked it flat on its
bottom.
Battling this disease has certainly given me a new outlook
on life. I now appreciate all the wonderful things around me--
my family, nature, especially a beautiful sunset--and I do not
take any day for granted anymore.
There are three very important aspects to maintaining
breast health. Breast self-exam is the first phase of breast
health and should be taught to all teenage girls. No one knows
their own bodies better than themselves.
I am very passionate about this because self-exams are
every woman's first line of defense against breast cancer.
Because I found a lump in my breast at a very early stage, it
saved my life.
I have been very passionate also about educating my three
daughters and educating other young women about breast health
care. We have a wonderful program here in Pittsburgh called
Check it Out. This is a 3-year-old project sponsored by the
American Cancer Society of which, as you said, I am a very
active volunteer; by Hadassah, which is a Jewish women's
organization, and the Allegheny County Board of Health.
This program teaches junior and senior high school girls
the proper way to do self-breast exam. We have visited almost
40 high schools so far. We are providing these young women with
the knowledge and proper procedures they need to detect changes
in their breasts and to seek medical attention, God forbid,
should they later in life be faced with the same thing I was.
The second aspect of good breast health is a clinic examination
done by a physician. Through training and experience, doctors
can tell what some lumps are just by touch. The last part of
preventive breast care and arguably the best is the mammogram.
Mammography can detect a lump long before a woman can feel it
or even before her doctor can detect it. What is the best cure
for breast cancer? Early detection. And early detection must
include mammography.
For some reason, incidence of breast cancer is higher in
Allegheny County than the national norm. As the mother of three
daughters, I feel a woman should have her initial baseline
mammogram taken at the age of 40 if not even at the age of 35.
I know I will insist that my daughters have their baseline at
the age of 30, then repeated at 35, and every year from the age
of 40. Breast cancer used to be called a disease of older
women, but I am aware of younger women in their twenties and
thirties who are developing this terrible disease. I was only
43, and I really do not think of that as old.
prepared statement
Preventive medicine is a lot cheaper than therapeutic
medicine. It is cheaper to have a mammogram than to have major
surgery and radiation or chemotherapy. Years ago, the National
Institute of Health concluded that a yearly pap smear was
unnecessary. How many women unnecessarily developed cervical
cancer and died because of this policy? Is it going to be the
same story with a mammogram? Will more women have to lose their
breasts or be disfigured or will they have to die from this
dreaded disease before NIH realizes the tremendous diagnostic
benefit to preventive care they have with a mammogram? A
mammogram cannot hurt us, but it can save our lives.
[The statement follows:]
Prepared Statement of Judy Pottgen
My name is Judy Pottgen, I am a 47 year old woman who is a
wife, and mother of three wonderful daughters ages 23, 17, and
13. Other than my daughters, my greatest accomplishment is
having survived breast cancer for nearly 4 years. In April
1993, when I was 43 years old, I found a lump in my right
breast while doing self-breast exam. I had a mammogram, and the
radiologist referred me to my surgeon. I was told I needed a
biopsy and when the results came back, my greatest fear became
reality, it was cancer. I had a modified radical mastectomy in
May of that year, and adjuvant chemotherapy that lasted for 3
months. When my treatment was completed in August, I felt in my
heart that it was the beginning of the rest of my life. What a
wonderful feeling to know that you have been one of the lucky
ones to have faced possible death, and knocked it flat on its
bottom. Battling this disease has certainly given me a new
outlook on life. I now appreciate all the wonderful things
around me, my family, nature, especially a beautiful sunset and
I don't take any day for granted anymore.
There are three very important aspects to maintaining
breast health. Breast self-exam is the first phase of breast
health and should be taught to all teenage girls. No one knows
their own bodies better than themselves. I am very passionate
about this, because self-exams are every woman's first line of
defense against breast cancer.
Because I found a lump in my breast at a very early stage,
it saved my life. I have been very passionate about education
my three daughters and education other young women about breast
health care. We have a wonderful program in Pittsburgh called
Check It Out. This is a 3-year-old project sponsored by the
American Cancer Society, of which I am an active volunteer,
Hadassah, a Jewish women's organization and the Allegheny
County Board of Health. This program teaches Junior and Senior
high school girls the proper way to do self-breast exam. We
have visited 40 high schools so far.
We are providing these young women the knowledge and proper
procedures they need to detect changes in their breasts and to
seek medical attention. God forbid, should they later in life
be faced with the same thing I was. The second aspect of good
breast care is the clinical examination done by a physician.
Through training and experience doctors can tell what some
lumps are just by touch. The last part of preventive breast
care, but arguably the best, is the mammogram. Mammography can
detect a lump long before a woman can feel it, or even long
before her doctor can detect it. What is the best cure for
breast cancer? Early detection. And early detection must
include mammography. For some reason, incidence of breast
cancer is higher in Allegheny County than the national norm. As
the mother of three daughters, I feel very strongly that a
woman should have her initial base line mammogram taken at the
age of 40, if not even at 35. I know I will insist that my
daughters have their base line at the age of 30, and then
repeal it at 35, and then every year from the age of 40. Breast
cancer used to be a disease of ``older women'' but I am aware
of younger women, in their twenties and thirties who are
developing this terrible disease. I was only 43, and I
certainly don't think of that as ``old.''
Preventive medicine is a lot cheaper than therapeutic
medicine. It is cheaper to have a mammogram than to have major
surgery and radiation or chemotherapy. Years ago, the National
Institute of Health concluded that a yearly pap smear was
unnecessary. How many women unnecessarily developed cervical
cancer and died because of this policy? Is it going to be the
same story with a mammogram? Will more women have to lose their
breasts or be disfigured or will they have to die from this
dreaded disease before NIH realizes the tremendous diagnostic
benefit to preventive care they have with a mammogram? A
mammogram can't hurt us, but it can save our lives.
self-examination
Senator Specter. Thank you very much, Mrs. Pottgen, for
that testimony. You found the lump through self-examination at
the age of 43?
Ms. Pottgen. Right.
Senator Specter. And when did you begin that self-
examination?
Ms. Pottgen. I started when I was 38. My obstetrician
gynecologist taught me how to do it, and really that was very
late. I should have been doing it from the age of 18, 19, or
20.
Senator Specter. Well, you are counseling high school young
women about self-examination. What does the evidence show as to
the incidence of breast cancer in women at that age?
Ms. Pottgen. They are really not at a very high risk. The
statistics that I have heard doing this program is maybe one in
25,000 girls between the ages of 18 and I guess 21, 22. It is
not a high risk.
Senator Specter. How about earlier than 18? Because you are
counseling young women who are younger than 18.
Ms. Pottgen. I really do not think they are at a high risk
at all. However, the sooner they become familiar with their
bodies, the better off they will be able to determine, God
forbid, that they do have a change in their breast, they would
be able to determine it earlier.
Senator Specter. The thought crosses my mind as to whether
they might be discouraged from maintaining it all their lives
until they get to be at an age where it really becomes very
germane.
Ms. Pottgen. Hopefully, it becomes a habit like brushing
your teeth every morning when you get out of bed. When these
girls are due for their monthly self-exam, hopefully it will
just become habit and it would be an automatic thing.
Senator Specter. I find your testimony interesting where
you say you should have a baseline at 40 or maybe at 35.
Ms. Pottgen. Yes.
Senator Specter. Your children at 30?
Ms. Pottgen. Absolutely, because I had breast cancer, and I
have three girls.
Senator Specter. Why not for everybody at 30?
Ms. Pottgen. Oh, I am a full proponent of that, but I am
just talking about my own children, and since they cannot
decide that we really need it before the age of 50, I really do
not believe that the NIH would make a proposal to bring it down
to 30. That would be terrific.
Senator Specter. The question is, what would the cost be?
Why not? If you can take them in off hours, we have enough
mammogram machines, take them late at night, take them at a
time when they are very low cost, marginal cost, why not?
Ms. Pottgen. I agree.
Senator Specter. If we have the machines.
Ms. Pottgen. I did hear you ask about the cost, if somebody
would have breast cancer how much would it cost to have the
followup therapy.
I did have a mastectomy and I did have chemotherapy, and I
did see my doctor bills, and it was outrageous.
Senator Specter. Well, there you are as to the cost. If it
is not detected early, the costs go up and up and up.
Ms. Pottgen. Yes.
Senator Specter. Let me pose a question to the panel
generally. There have been debates as to whether there ought to
be a mammogram every year, even some challenges to a mammogram
for women over 50.
How often do you think there ought to be a mammogram for
women 50 and older, Ms. Clayton?
Ms. Clayton. For 50 and over, Senator?
Senator Specter. Yes.
Ms. Clayton. I think by the time a woman is 50 years old, a
routine annual mammogram.
Senator Specter. Forty and over?
Ms. Clayton. Forty and over, absolutely.
Senator Specter. How often?
Ms. Clayton. I will give my own story. I had my first
baseline when I was 40 years old. I had a mammogram the
following year when I was 42. I didn't go back for 4 years. I
cannot beat myself up about not having caught it even earlier,
but there was a 4-year interim.
Senator Specter. Too long?
Ms. Clayton. Probably, although I advocate every year.
Senator Specter. How often do you think women over 40
should have it? Forty to fifty, how often?
Ms. Clayton. Every year.
Senator Specter. How about under 40? Should we have
mammograms for women under 40 who are not with a family
history?
Ms. Clayton. I did not have a family history.
Senator Specter. That is why I am asking you.
Ms. Clayton. I would and will encourage all my nieces to
have their first baseline earlier than 40 if they can do that.
Senator Specter. Does anybody here disagree with Mrs.
Clayton's testimony?
Ms. Moser. I do not disagree with it, Senator. I would like
just to reinforce what the American Cancer Society has said for
years, that a woman 50 and older should have one every year, a
woman 40 to 49 without risk should have it every 1 to 2 years,
and then women younger than that if there is families at great
risk.
Senator Specter. Do you think 1 to 2 years is often enough,
Ms. Moser, for women 40 to 49?
Ms. Moser. I think if a women is showing no risk, I think
that that is ample. I think it is also interesting that the NIH
used to follow those guidelines and has given them up, and that
is what is causing so much confusion.
Senator Specter. I would like your sense on this gene
therapy at the current stage of what can be done with it. You
have heard the doctors' testimony that it leads to screening,
but I would be interested in your evaluation.
Ms. Pottgen, what kind of anxiety do you think would be
present for a woman who finds at the age of 15, she has a gene
which shows a propensity for breast cancer?
Ms. Pottgen. When I first heard about the gene and that
they would probably be able to tell somebody if they would be
at high risk, needless to say the first thing I thought about
were my 3 girls, and I did debate the issue with my oldest
daughter, who is now 23. She was maybe 20, 19 at the time.
Senator Specter. How did the debate turn out?
Ms. Pottgen. Well, I said to her, ``Would you want to know?
Would you want to have this blood test done so you would
know?'' And she said, not really, because the fear of
developing breast cancer, even though there's a good
possibility that she would not, would be great.
Senator Specter. She has substantial concern, naturally,
from your experience.
Ms. Pottgen. Right, right. She still said that doing self-
breast exam and having a mammogram, that that would be enough
for her.
Senator Specter. Ms. Durham, what do you think about having
young women told about positive genes, that a gene shows them
positive for breast cancer?
Ms. Durham. If I was the young woman, it would be an
overwhelming burden, worrisome trouble for me. I do not think
that I would want to know beforehand. It would just cause me to
be too anxious all the time.
Senator Specter. You would rather not know?
Ms. Durham. I would rather not know, yes.
Senator Specter. Ms. Clayton, you talked about ignorance
not being bliss. What do you think about the gene detection for
very young women?
Ms. Clayton. I think it is real tough.
Senator Specter. Excuse me?
Ms. Clayton. I think it is tough. I think it would be very
difficult to know. I think it would be harder to know who has
access to that information.
Senator Specter. Suppose we could guarantee the privacy?
There are no absolutes, but suppose we had a Federal law which
said insurance companies could not find it, and if they found
it, they could not act on it, death penalty for anybody who
invades your privacy or something more severe.
Ms. Clayton. Personally, I would want to know, having been
through it. You do not know until you have been there. I
personally would want to know.
Senator Specter. Ms. Moser, what do you think about that
question?
Ms. Moser. I would like to know so that I could follow
myself more closely, yes.
Senator Specter. Well, thank you very much for your
testimony. You are all survivors. I compliment you on your
activism and on your battle.
We have a very major problem here. It is a little
inconceivable to me on the face of the evidence how the
consensus panel could make a public declaration that women 40
to 49 are not warranted for mammogram in that age category.
We have pursued why they made the disclosure, and they have
tried to explain it, saying they did not really come to that
conclusion, they only had a draft report. Why did they get it
into the public domain? There is no good answer for that.
A press release had been prepared which should not have
been disclosed and it was disclosed, and now we face a
situation where apparently the National Cancer Institute is
reluctant to overturn what the panel said, and a lot of people
are saying, ``Well, let us not pressure science.''
Senator Snow introduced a sense of the Senate resolution,
essentially calling for mammograms at 40 to 49, and there is an
op-ed piece in the Washington Post criticizing Senator Snow for
trying to push scientists.
So it is quite an issue, and I find these hearings to be
very informative as to what the doctors have to say and how
women are feeling about it.
I know from before this issue came, how the terror is
present from my own family, from my wife who was concerned
about the issue going back for many, many, many, years.
And the medical profession has to do a better job in
informing people as to what is going on. And I know, when I had
my problem, I got bad information from a doctor, and it scares
you to death when you get bad information.
Doctors have to know enough to perhaps defer a statement at
least for a few days until they have a followup test before
they give you false information. They cannot be faulted for
giving false information under some circumstances, but giving
it prematurely is a real problem.
So these are very, very big issues for sensitizing all of
us, and the subcommittee will be pursuing it. We are going to
have some more hearings.
Usually when we have these hearings, I say I want to find
out what the facts are. I said at the outset of our hearing in
Washington a couple of weeks ago that I had a fixed opinion.
That is a legal expression, when jurors cannot serve if you
have a fixed opinion, but I wanted to say at the outset that I
did. Even a fixed opinion can be altered, but what I have heard
just confirms the opinion that I started with.
Does anybody want to make a closing statement?
Ms. Durham. I just wanted to make a comment, Senator,
because I spoke to your staff person, Sharon Wagner, a couple
times. And I can assure you, I did know your position. I even
asked her, was your wife a breast cancer survivor. So I got a
little nervous. I do not want it to be thought that I did not
know your position.
subcommittee recess
Senator Specter. Well, I appreciate that. Joan is not a
survivor, but she was very concerned with one troubling
incident. Back in 1971, I will never forget the day. It was a
negative, but real terror. When you look at the statistics,
there is cause for the concern.
Thank you, and that concludes our hearing, the subcommittee
will recess and reconvene at the call of the Chair.
[Whereupon, at 11:30 a.m., Monday, February 24, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
MAMMOGRAPHY
----------
MONDAY, MARCH 3, 1997
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Hershey, PA.
The subcommittee met at 10:30 a.m., in the Hershey Medical
Center, Hershey, PA, Hon. Arlen Specter (chairman) presiding.
Present: Senator Specter.
NONDEPARTMENTAL WITNESSES
STATEMENTS OF:
JAMES F. EVANS, M.D., DIRECTOR, SURGICAL ONCOLOGY AND ASSISTANT
DIRECTOR, GENERAL SURGERY, GEISINGER CLINIC
MARY A. SIMMONDS, M.D., CHIEF, DIVISION OF HEMATOLOGY AND
MEDICAL ONCOLOGY, PINNACLE HEALTH SYSTEMS
DAVID M. VAN HOOK, M.D., ASSISTANT PROFESSOR OF RADIOLOGY,
CHIEF OF MAMMOGRAPHY, THE MILTON S. HERSHEY MEDICAL CENTER,
PENNSYLVANIA STATE UNIVERSITY
opening remarks of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. The
hearing of the Appropriations Subcommittee on Labor, Health and
Human Services, and Education will now proceed. This hearing
has been convened as an official subcommittee field hearing to
inquire specifically into the issue of the advisability of
having mammograms for women age 40 to 49.
This issue has come upon the scene as the result of a panel
determination of an NIH panel, raising a question about the
advisability of such mammograms. Immediately after the panel
report was filed, Dr. Richard Klausner, Director of the
National Cancer Institute, said that he was shocked by the
findings of the NIH panel.
The subcommittee then convened a hearing in Washington, DC,
this is the third of our field hearings. Earlier hearings
having been held in Pittsburgh and Philadelphia.
The essential question is whether the mammograms are useful
for women 40 to 49. The question has been raised as to whether
cost is the determinant. My own view is that the U.S. medical
profession has enough doctors, hospitals, mammogram machines,
pharmaceutical equipment, MRI's, et cetera, to bring health
care to all Americans and that it is a matter of delivering it
and paying for it.
I chair the Subcommittee on Health and Human Services. And
last year Senator Tom Harkin, who is the ranking Democrat, and
I, worked together on a bipartisan basis. That is the way
things get done in Washington, DC, when Democrats and
Republicans work together.
Senator Harkin and I working together consolidated or
eliminated some 134 programs so that we were able to reallocate
$1\1/2\ billion to priority items, such as funding for the
National Institute of Health and Pell grants and guaranteed
student loans with our views being that two of the highest
priorities, if not the highest priorities of America were
education and NIH research.
I recently had a medical problem and after some travail got
an MRI. The doctors said I did not need one. And I got one. I
understand that I am in a little better position than many to
get an MRI if I want one. The doctors did not think I should
have one. And it disclosed an meningioma which was life
threatening and it, in effect, saved my life. So, you can see
my point of origin on this issue, that if we can save lives it
is very important.
We have had statistical evidence produced which suggests
that many women's lives can be saved in the age category 40 to
49. And we are here today to hear testimony from medical
experts and also from women in the field.
Tomorrow in Washington, we will have a hearing where
Secretary of Health and Human Services, Donna Shalala, will
testify. It may be that there will be an administrative
decision by the Secretary of Health and Human Services with
coverage for women 40 to 49 in Medicaid and Medicare. And that
would be an enormous step forward.
It is my hope that the legislation will not be necessary,
we will not have Congress micromanaging the health care field,
but if it is necessary we will consider it in due course.
With that introduction, I want to now turn to our
distinguished panel, Dr. James F. Evans, Dr. Mary A. Simmonds,
and Dr. David Van Hook. It is our practice with a panel of this
caliber to go alphabetically and not to try to make any
judgments among the panelists.
So, in alphabetical order, we turn to Dr. James F. Evans,
who is director of surgical oncology at the Geisinger Clinic
and an assistant professor of surgery at Jefferson Medical
College. Dr. Evans received his medical degree from Columbia
University's College of Physicians and Surgeons. He has been a
fellow in surgical oncology at Memorial Sloane Kettering Cancer
Center and is a principal investigator for the national
surgical breast project. He is also past chairman of the
American Cancer Society breast cancer detection task force.
summary statement of dr. james evans
We welcome you here, Dr. Evans. Your full statement will be
made a part of the record as is our custom. And I ask also, as
is our custom, that there be a limit to 5 minutes on opening
statements to allow the maximum opportunity for dialog,
questions and answers as we proceed. Dr. Evans, the floor is
yours.
Dr. Evans. Thank you. Mr. Chairman, members of the
committee, members of the Pennsylvania Breast Cancer Coalition
and guests, I am honored to have the opportunity to provide my
personal opinion to the subcommittee today.
I believe you all have my written comments and I have tried
several times to read them aloud to myself within 5 minutes. I
could never get under 15. So, therefore, I will summarize them
and hope that there will be questions which will provide the
chance to correct the misconceptions that I have created with 5
minutes of testimony.
These comments are my personal opinion and do not represent
any official position of Geisinger. I have studied the issues
over the past 20 years. I am familiar with the data. I am
familiar with the policy statements of the National Institutes
of Health and the American Cancer Society. My comments are not
intended to reflect the position of either organization.
However, I am amused by the disclaimer of the NIH consensus
panel that their statement, ``does not provide recommendations
for public policy or personal action.'' Of course, we all
understand that the statement will be used for both of these
purposes.
We, as advisers to women and to policymakers, cannot just
throw up our hands and say, decide for yourselves, as the panel
seemed to do. Most women and most of their primary care
providers do not have the time or background to analyze the
data that the medical community has been debating for decades.
It is right to express our uncertainty, but we must provide our
opinion.
The panel stated: ``the available data do not warrant a
single recommendation for mammography for all women in their
forties.'' If I were to write my own consensus statement, it
would state that the available data does warrant a single
guideline recommendation for women between the ages of 40 and
70 years, namely annual screening. In fact, this is the only
firm conclusion to be drawn from the randomized clinical
trials.
However, guidelines are not recommendations for individual
women. And this is a point to be stressed. Before I give you my
abbreviated views of the randomized trials, there are a few
caveats that will be more important perhaps than the actual
data from the trials.
No. 1, policy decisions, guidelines and personal decisions
should be based on science, not on rhetoric. In the press and
even in announcements of hearings such as this one, there is
frequently more heat than light. Trying to influence the
thinking of policymakers with emotional arguments and
polarizing one liners rather than with data may be effective in
the short run but ultimately detracts from credibility.
Careful analysis of randomized clinical trials data is the
best hope for progress. I must parenthetically note that of the
eight randomized trials conducted on the question of breast
cancer screening, only one, the first one, was conducted in the
United States. Perhaps we can explore this issue during
questions, but this is not a record of which we should be
proud.
No. 2, data are not available to answer all the questions
about breast cancer screening. Uncertainty is omnipresent.
Therefore, experts may legitimately disagree. Experts must,
however, explicitly acknowledge the areas of uncertainty and
emphasize that what we conclude today may be altered in the
future by new data.
No. 3, setting public policy and writing clinical
guidelines is a very different activity from making a
recommendation to an individual patient with her unique risk
profile and personal life history. Guidelines should derive
from clinical trial data. No clinical trial, however, can
account for the number of variables and special circumstances
which must be accounted for in a decision for an individual.
To re-emphasize this point, what we conclude about the
effectiveness of screening for a population, in this case women
between the ages of 40 and 70, will not apply equally to all
subsets or individuals within the population. Subsets based on
age, which is our current focus, is only one such example. This
large population could also be divided by family history,
personal history, genetic profiles, or characteristics that we
have not yet considered. Such subsets may benefit more or less
from the recommended generic screening policy.
Turning to the clinical trials, I would make the following
points. No. 1, all except one of the randomized clinical trials
in breast cancer screening have been designed to answer a very
specific question and the question is, does breast cancer
screening result in lower death rates from breast cancer for
women aged 40 to 70 years. The answer from all the trials is
``yes.''
I would emphasize that the trials consistently show
survival benefit for screening beginning at age 40. When we try
to get trial data to answer a question for which the trial is
not designed, such as does breast cancer screening result in
lower death rates for breast cancer for women 40 to 49, the
conclusions are less secure.
No. 2, retrospective subset analysis, for example, going
back to look at the benefit in women 40 to 49 from a trial that
was designed to study women 40 to 70 is too tempting to avoid.
It is also useful. However, subset analysis of the data can be
appropriately used or it can be abused. Unfortunately it has
been used----
Senator Specter. Dr. Evans, would you seek to summarize,
please?
Dr. Evans. I certainly will. No. 3, the only randomized
clinical trial that was designed to answer the question about
women 40 to 49, as you know, was a negative trial. In fact, the
screened women did a little worse. The trial has been severely
criticized for design and execution flaws. And these flaws as
well as the meta-analysis support those that claim a benefit in
women 40 to 49.
My written testimony includes more data on these points and
several additional points, but given the time constraints, I
will conclude that, No. 1, guidelines for screening mammography
should include women 40 to 70 years for annual screening.
No. 2, clinicians and women must adjust these guidelines
based on personal characteristics and circumstances. We must
recognize these adjustments are based upon best guesses until
future clinical trials allow a more precise definition of the
correlation between breast cancer risk and screening benefit.
And, No. 3, health care funding should support clinical
research, especially randomized clinical trials.
prepared statement
Again, I would like to thank the committee and the
Pennsylvania Breast Cancer Coalition for the opportunity to
express my opinion. I welcome the opportunity to answer
questions and discuss the issues.
Senator Specter. Thank you, Dr. Evans. During the questions
and answers, we will pick up some of the points you have
referred to.
[The statement follows:]
Prepared Statement of James F. Evans, M.D., FACS
Mr. Chairman and members of the Committee, I am honored to have the
opportunity to provide my personal opinion to the subcommittee today.
Geisinger Clinic and Medical Center has not taken an official position
on the subject we are discussing today or on the recent National
Institutes of Health Consensus Development Conference Statement. The
opinions expressed are strictly my own. I have studied the clinical
research data on this subject over the last twenty years. I have
reviewed the randomized clinical trial (RCT) data numerous times. I
have reviewed the abstracts of the testimony recently presented to the
NIH and have read the consensus statement. As co-chair of a consensus
development conference sponsored several years ago by the Pennsylvania
Department of Health and the Pennsylvania and Philadelphia Divisions of
the American Cancer Society, I am familiar with the position of the
Cancer Society. My comments are not intended to specifically support
the position of either of these organizations.
Every week in the clinical setting, I must advise women on this
subject. My recommendations have not changed as a result of the NIH
Consensus Statement. I was amused by the conclusion the Consensus
Statement that stated, ``This consensus statement * * * does not
provide recommendations for public policy or personal action.'' Of
course, we all understand that it will be used for both of those
purposes. The statement goes on to state that ``the available data do
not warrant a single recommendation for mammography for all women in
their forties. Each woman should decide for herself whether to undergo
mammography.'' Of course, women will decide for themselves. That is
inherent in our system of informed consent. However, many of them are
not well positioned to understand the nuances of randomized clinical
trials, meta analysis, subset analyses and surrogate markers.
In all honesty, neither are their primary health care providers. It
is asking too much of women and their providers to evaluate and weigh
the data themselves when the ``experts'' themselves cannot reach
consensus. Those women and their providers who do not have the time or
expertise to make independent assessments are legitimately asking the
NIH, the ACS, and other experts for guidance and specific
recommendations. We must provide our opinion even while we admit that
there are areas of uncertainty. If I were to write my own consensus
statement, it would say that the available data specifically does
warrant a single guideline recommendation for women between the ages of
40 and 70 years, namely annual screening.
However, guidelines are not recommendations for individual women.
This is a point I will stress. We would all like to have enough data to
make specific recommendations for each individual based on personal
profiles and highly specific and reliable research data. We must be
honest and admit that this sort of data does not exist. The best data
that we have comes from randomized clinical trials and that data
supports a guideline recommendation for annual screening beginning at
age 40. Clinicians and women themselves should then use additional but
less reliable data that we have to make decisions for individuals.
Ongoing and future research has the potential to refine these
recommendations.
Before I complete my testimony, I will give you my abbreviated
views of the randomized clinical trials and I will tell you again what
I would currently recommend. Before that, however, several caveats are
important:
1. Policy decisions, guidelines, and personal decisions should be
based on science, not on rhetoric. Clinical research, particularly
randomized clinical trials, are invaluable source of information. As
incomplete as the data is at the present, the randomized clinical
trials that have been conducted over the past thirty years have
provided most of what we know about breast cancer screening. Only one
of these eight trials has been performed in the U.S., the country with
the best and most extensive systems for breast imaging in the world.
Support for clinical research is the best hope for answering the
remaining questions about breast cancer screening. It is worrisome that
consensus conferences sometimes stifle new creative approaches. If we
claim to know what we really do not know, the ethical conduct of
clinical research is hampered. It is more worrisome that most managed
care organizations have not made clear commitments to clinical
research.
2. If we increase our commitment to clinical research and
randomized clinical trials, new data will accrue. New clinical trials,
longer follow-up of older trials, and new technology all contribute new
data. Therefore, what we conclude today will require alteration in the
future.
3. Data are not available to answer all of the questions about
breast cancer screening. Decisions, therefore, must be made on less
than complete and perfect data. This has always been true in medicine
and will always remain true. There is always some uncertainty and
``experts'' may legitimately disagree, recognizing that they are
sometimes making their ``best guess''. It is important, however, to be
explicit about which conclusions are secure and which are uncertain,
and which justify further research. It is also important to try to
quantify the degree of uncertainty.
4. Setting public policy and writing clinical guidelines are very
different activities from making a recommendation to an individual
patient with her unique risk profile and personal life history. The
current changes in health care delivery systems are tending to blend
these activities for better or for worse. For the purposes of
understanding the issues that we are discussing today, they should be
kept distinct. I think you will hear two kinds of testimony today. You
will hear from three breast cancer clinicians. I believe they will
provide testimony that tries to interpret the data that has accrued
from clinical trials, to put this data in perspective, and to give a
personal opinion and recommendation. This sort of testimony is useful
for setting policy and writing guidelines. You will also hear from
three women who are equally dedicated to influencing the outcomes for
women with breast cancer. I believe that they have personal or family
experiences with breast cancer. I suspect that their testimony will add
some narrative that will demonstrate the clear limitations of the use
of policy and guidelines as the sole instrument for making decisions
for individuals. The personal risk profile and personal life story of a
woman in her forties who has cared for a mother or sister dying of
breast cancer should not and cannot be ignored in making her choices.
To re-emphasize the point, what we conclude about the effectiveness
of screening for a population (e.g., women between the ages of 40 and
70) will not apply equally to all subgroups in the population (e.g.,
women 40 to 49, or women with strong family histories) and certainly
not equally to all individuals. I will come back to this point.
5. The emphasis on mortality data and survival benefits may make us
forget that there are other benefits to early breast cancer diagnosis
even if the survival benefit is marginal or non-existent. Earlier
diagnosis correlates with a greater potential for breast conservation.
Turning to the clinical trials, I would like to make the following
points:
1. Six or seven (depending on whether the Swedish Two County Trial
is counted as one or two) randomized trials have been conducted to test
the effectiveness of breast cancer screening in women between the ages
of 40 and 70 years. Some of the trials included women over 45 and
others only included those under 65. All of these trials were designed
to answer a specific question. The question was, ``Does breast cancer
screening result in lower death rates from breast cancer for women ages
40 to 70?'' The answer from all the trials was and continues to be
``yes''. I would emphasize that the trials show a survival benefit for
screening beginning at age forty. This is the most secure conclusion
that we can draw from the randomized clinical trials. Admittedly, it is
incomplete. But it is the only one that should, in my opinion, be part
of a clinical guideline.
2. So called ``subset analysis'' is too much of a temptation to
avoid during the analysis of data from a randomized trial. It is an
attempt to provide evidence for adding to the conclusions for which the
trial was initially designed. Once we have determined that the group of
women between 40 and 70 years, benefit from screening, we want to know
whether subsets of women within the total group benefit more or less.
Those subsets could be based on age, family history, prior biopsies,
the presence of the BRCA gene, etc., etc. Because subset analysis was
begun based on age, we have been arguing that point for the past 15
years.
Subset analysis can be used properly or it can be abused. The
results of subset analysis are never as secure as the analysis of the
question for which the trial was originally designed. Subset analysis
introduces bias that may lead to erroneous conclusions. Subset analysis
is best used to get ideas for further research. These trials were not
designed to answer thee question of whether breast cancer screening is
effective in the specific age group of 40 to 49.
3. Only one randomized trial was specifically designed to answer
the question, ``Does breast cancer screening in women 40 to 49 years of
age result in fewer breast cancer death?'' NBSS trial conducted in
Canada was specifically designed based on the results of subset
analysis of HIP and Swedish trials. As you know, it did not show a
benefit. However, it did not settle the debate for two reasons (leaving
out the political ones). First, a single trial is rarely enough to
provide a definitive answer and usually requires confirmation (witness
the number of trials done for women 40 to 70). Second, the trial has
been a target of severe criticism based on design and execution flaws.
4. Although drawing conclusions from subset analysis entails
greater risk of being wrong, subset analysis from multiple trials that
shows similar trends provides additional credence to subset analysis
results. The meta-analysis of the 40 to 90 age subsets from multiple
trials suggest a survival benefit in this group. Each of the trials
individually have ``confidence intervals'' that include a relative risk
of ``1''. Translated, this means that the improved survival seen has a
5-percent probability of being due to ``chance''. However, all of the
trials show a benefit. If the differences between screened and non-
screened populations were non-existent, we would expect to see some
individual trials showing a small benefit (by chance) and some a small
worsening of survival (by chance). The fact that the ``trend'' in every
trial is toward benefit suggests that the relatively small differences
are real. It appears to be smaller than the benefit for women age 50 to
70 and it appears to be delayed. This would not be unexpected given the
lower incidence of breast cancer in the 40 to 49 year age group. The
question of whether the benefit in women 40 to 49 years is a result of
screening after the age of fifty is a legitimate question. However it
is not definitively answered by these trials. I suspect the answer will
be: ``partially''. This is a legitimate question for future research. A
survival benefit is also supported by the use of ``surrogate markers''
(tumor size and nodal status) from non-randomized trials. This data
demonstrates that mammography seems to diagnose small and node negative
breast cancers as well in women 40 to 49 as in older women. Although
not as strong as data from randomized trials, it adds to the weight of
evidence.
5. We must not forget that subset analysis based on age is only one
of several subset analyses that could be done. Women could also be
divided based on family history, personal history, genetic markers,
etc. Age just happens to be the one chosen first and, therefore, began
this controversy through the misuse of subset analysis. There are
probably subsets of women in their forties who based on other subset
criteria (e.g., family history) derive more benefit from screening than
some women in older age groups.
6. Little analysis and discussion has been based on ``potential
years of life lost'' (PYLL). A woman in her forties who avoids a
premature death from breast cancer may derive a large benefit than a
woman cured of breast cancer at the age of eighty five. Therefore,
although the number of deaths avoided per 1,000 women screened in the
40 to 49 age group may be smaller, the years of additional life per
individual will probably be larger.
7. Given a survival benefit, the risks of mammography (radiation,
false positives, anxiety, pain) are real but justifiable. These risks
provide justification for research to find more accurate, less painful,
and less anxiety producing methods, but do not provide justification
for abandoning an effective diagnostic test.
Conclusions
1. Guidelines for screening mammography should include women ages
40 to 70 for screening. The screening interval in the guideline should
be annual.
2. Clinicians and women will need to adjust the guidelines based on
personal characteristics. Clinicians and women must recognize that the
adjustments are based on ``best guesses'' until research allows a more
defined correlation between breast cancer risk and screening benefit.
3. Health care funding should support clinical research, especially
randomized clinical trials.
Again, I wish to thank the committee for the opportunity to express
my opinion and welcome the opportunity to answer questions.
summary statement of dr. mary simmonds
Senator Specter. We turn now to Dr. Mary Simmonds, chief of
the division of hematology and medical oncology with Pinnacle
Health Systems and a clinical associate professor of medicine
with Penn State University. She is a member of the board of
trustees for the Pennsylvania Breast Cancer Coalition and
serves on the national board of directors for the American
Cancer Society, former chair of its Pennsylvania Division's
Breast Cancer Detection Awareness Task Force. We welcome you
here, Dr. Simmonds. The floor is yours. Your full statement is
a part of the record. And we ask for your similar summary
within the 5-minute time period.
Dr. Simmonds. Thank you. Mr. Chairman, I am grateful to
have the privilege to be here today to speak as a practicing
oncologist and as a woman in her forties. I support the
American Cancer Society recommendations that women in their
forties should undergo screening mammography every 1 to 2
years.
A perfect screening tool is accurate, acceptable as a
procedure, safe, widely available, and inexpensive. Such a tool
should be applied to detect a prevalent disease when early
detection will avoid suffering and costs if not found until a
more advanced stage.
As medicine is practiced, decisions must be made on an
individual basis. The perspective of relative risk factors and
incidence of disease within the population must somehow be
integrated into an individual health plan. Thus, practice
guidelines play an important role in guiding the practitioner
and the individual consumer.
Unfortunately, no screening tool is perfect. Mammography
included. You have already heard expert testimony analyzing the
scientific data, so I will not reiterate these points in my
limited time today. Rather, I would speak about the need to
accept these limitations, and to endorse a more liberal
recommendation to screen women in their forties for the early
detection of breast cancer.
Breast cancer is a serious health problem for this age
group and the potential impact in suffering and premature death
is relatively greater for a younger woman and her family.
The economics of health care are an important and
undeniable aspect of this debate. Policymakers are struggling
with the issue of the cost effectiveness of mammography. Dr.
William Kissick, a leading health economist and professor of
public health and preventive medicine at the University of
Pennsylvania captures the essence of this issue, I believe, in
the title of his book, it is, ``Medicine's Dilemma: Infinite
Needs versus Finite Resources.'' In other words, if there were
infinite resources, then there would be no debate.
Where the guideline is drawn in the real world is a value
judgment. Rational individuals will disagree even with
conclusive data. I would argue that the standard needs to be
more inclusive, hoping to capture the detection of breast
cancer in those women who develop the disease in their forties.
The incidence of the disease is great enough in this age
group and furthermore the application of mammography as a
screening tool fits the standard criteria. That is, it is
accurate, an acceptable procedure to most women, it is safe,
widely available and relatively inexpensive compared to the
costs of treatment of advanced disease.
Finally, as part of my testimony, I would like to share
with you a copy of recommendations for a Statewide plan for the
early detection of breast cancer. And your staff already has
the booklet.
This was formulated in October 1991 as a result of
deliberations of a Pennsylvania Breast Cancer Awareness
Consensus Conference. This conference was convened by the
Pennsylvania and Philadelphia divisions of the American Cancer
Society and the Pennsylvania Department of Health.
Expert testimony was heard about the benefits and
limitations of screening for breast cancer. With this
background, invitations were issued to organizations and
individuals who represent all aspects of the implementation of
screening procedures, such as consumers, government agencies
and legislators, insurers, and professional groups.
While some of the statistics in this publication might be
updated, many of the recommendations are indeed still relevant.
A list is included with this report.
One recommendation stands out. And that is four simple
unambiguous consistent messages should be communicated to all
women concerning mammography. That is, first, mammography saves
lives. Second, you should get mammograms even if you do not
have symptoms. Third, ask your doctor for information about
mammography and for access to mammography. And finally, follow
the American Cancer Society guidelines for the frequency of
mammography and physical examination.
prepared statement
This recommendation underscores the need for guidelines.
These guidelines must be clear for the sake of both the
provider and the consumer. It is time to see this debate for
what it is, and to stop sending mixed messages to women who may
develop breast cancer.
Thank you for the opportunity to present this statement.
And I will be glad to answer any questions.
Senator Specter. Thank you very much, Dr. Simmonds. And we
will have some questions for you on this very impressive
publication.
[The statement follows:]
Prepared Statement of Mary Simmonds, M.D.
Mr. Chairman and Members of the Committee, I am grateful for the
privilege to be here today to speak as a practicing oncologist and as a
woman in her forties. I support the American Cancer Society
recommendations that women in their forties should undergo screening
mammography every 1 to 2 years.
A perfect screening tool is: accurate; acceptable as a procedure;
safe; widely available; and inexpensive.
Such a tool should be applied to detect a prevalent disease when
early detection will avoid suffering and costs if found at a more
advanced stage.
As medicine is practiced, decisions must be made on an individual
basis. The perspective of relative risk factors and incidence of
disease within the population must somehow be integrated into an
individual health plan. Thus practice guidelines play an important role
in guiding the practitioner and the individual consumer.
Unfortunately, no screening tool is perfect, mammography included.
You have already heard expert testimony analyzing the scientific data,
so I will not re-iterate these points in my limited time today. Rather,
I would speak about the need to accept these limitations and to endorse
a more liberal recommendation to screen women in their forties for the
early detection of breast cancer. Breast cancer is a serious health
problem for this age group, and the potential impact in suffering and
premature death is relatively greater for a younger woman and her
family.
The economics of health care are an important and undeniable aspect
of this debate. Policy makers are struggling with the issue of cost-
effectiveness of mammography. Dr. William Kissick, a leading health
economist and Professor of Public Health and Preventive Medicine at the
University of Pennsylvania captures the essence of the issue, I
believe, in the title of his book Medicine's Dilemma: Infinite Needs
vs. Finite Resources. In other words, if there were infinite resources,
then this debate would be resolved.
Where the guide-line is drawn is, in the real world, is a value
judgment. Rational individuals will disagree, even with conclusive
data. I would argue that the standard needs to be more inclusive,
hoping to capture the detection of breast cancer in those women who
develop this disease in their forties. The incidence of the disease is
great enough in this age group. Furthermore, the application of
mammography as a screening tool fits the standard criteria. That is, it
is accurate, an acceptable procedure to most women, safe, widely
available, and relatively inexpensive compared to the costs of
treatment of advanced disease.
Finally, as part of my testimony, I would like to share with you a
copy of Recommendations for a Statewide Plan for the Early Detection of
Breast Cancer formulated in October, 1991 as a result of deliberations
of a Pennsylvania Breast Cancer Awareness Consensus Conference. This
conference was convened by the Pennsylvania and Philadelphia Divisions
of the American Cancer Society and the Pennsylvania Department of
Health. Expert testimony was heard about the benefits and limitations
of screening for breast cancer. With this background, invitations were
issued to organizations and individuals who represent all aspects of
the implementation of screening procedures such as consumers,
government agencies and legislators, insurers, and professional groups.
While some of the statistics in this publication can be updated, many
of the recommended actions are indeed still relevant. The list of these
recommendations is attached to this report.
One recommendation stands out; four simple, unambiguous, consistent
messages should be communicated to all women concerning mammography:
--mammography saves lives;
--you should get mammograms even if you don't have symptoms;
--ask your doctor for information about mammography and for access to
mammography; and
--follow the American Cancer Society guidelines for the frequency of
mammography and physical examination of the breast as well as
the performance of breast self examinations.
This recommendation underscores the need for guidelines These
guidelines must be clear for the sake of both the provider and the
consumer. It is time to see the debate for what it is, and to stop
sending mixed messages to women who may develop breast cancer.
RECOMMENDATIONS FOR A STATEWIDE PLAN FOR THE EARLY DETECTION OF BREAST CANCER
[Pennsylvania breast cancer consensus conference--action groups]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Department of Professional Health
Health and associations Primary care services and
Recommended actions Consumers Government Legislators Insurers Media and American physicians Radiologists radiology
agencies Cancer Society facilities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Review and, if necessary, change regulations and
legislation to insure uniformly high quality
mammography services throughout the State...... .............. X X .............. .............. .............. .............. .............. ..............
Introduce into the legislature, legislation to
improve quality assurance...................... .............. X X .............. .............. .............. .............. .............. ..............
Encourage mammography facilities throughout the
Commonwealth to obtain American College of
Radiology accreditation and to comply with
State regulations for radiation protection..... .............. X .............. .............. .............. X .............. .............. ..............
Distribute an updated list of American College
of Radiology accredited facilities to referring
physicians and the general public.............. .............. X .............. .............. .............. X .............. .............. ..............
Develop and promulgate a standardized
classification format for screening mammograms. .............. X .............. .............. .............. X .............. .............. ..............
Promote continuing education programs for
radiologists and technicians involved in
mammography.................................... .............. X .............. .............. .............. X .............. X X
Encourage regional consortia of mammography
providers in which community facilities have
close, supportive relationships with cancer
centers........................................ .............. X .............. .............. .............. .............. .............. .............. X
Communicate the four, simple, unambiguous,
consistent messages to all women concerning
mammography.................................... .............. X .............. .............. X X X X X
Develop educational programs and messages that
target older and minority women and other
groups who are less likely to receive
mammograms or breast examinations or to do
breast self-examination........................ .............. .............. .............. .............. .............. X .............. .............. ..............
Develop a clearinghouse for breast health
education materials............................ .............. X .............. .............. .............. X .............. .............. ..............
Include presentations concerning the need for
and conduct of regular breast screening in
medical school, residency, and fellowship
training of physicians......................... .............. .............. .............. .............. .............. X .............. .............. ..............
Promote continuing medical education programs in
breast cancer education, screening, and
detection for all health professionals......... .............. X .............. .............. .............. X .............. .............. X
Encourage innovative programs which utilize the
best available technology...................... .............. .............. .............. .............. .............. X .............. .............. ..............
Disseminate information about the value of
breast cancer screening and mammography through
physician, American Cancer Society and/or
radiologist generated newsletters.............. .............. .............. .............. .............. .............. X .............. .............. ..............
Develop a standardized reporting system for
results of screening mammograms................ .............. X .............. .............. .............. X X X ..............
Encourage mammography facilities to offer
flexible hours, mobile technology, reasonable
costs, sliding fee scales, child care,
acceptance of self referrals, and offering free
mammograms periodically........................ X .............. .............. .............. X X .............. X X
Institute dedicated mammography programs at
radiology facilities that are designed to
provide services to a maximum number of
patients both for initial mammograms and for
periodic re-examinations as recommended by the
American Cancer Society........................ .............. X .............. .............. .............. X .............. X X
Encourage employers to subsidize worksite
screening programs............................. X .............. .............. X X .............. .............. .............. ..............
Lobby State and Federal legislators to extend
coverage, using public funds, to pay for
mammograms for uninsured and underinsured women X .............. X X X X .............. X X
Review Medicare reimbursement schedules
periodically to ensure they reflect the latest
scientific data and the best standards of
practice at the lowest-possible cost........... .............. X X .............. .............. X .............. .............. ..............
Compute trends in cancer incidence, stage at
diagnosis and deaths from the Pennsylvania
Cancer Registry and the Pennsylvania Vital
Statistics files to permit effective
epidemiological surveillance................... .............. X .............. .............. .............. .............. .............. .............. ..............
Study breast cancer screening practices among
residents of Pennsylvania in order to determine
the characteristics of women who are and are
not receiving screening mammograms as well as
reasons for their behaviors.................... .............. X .............. .............. .............. .............. .............. .............. ..............
Study the distribution and characteristics of
mammography equipment in the Commonwealth to
determine the quantity, quality, and location
of mammography services available.............. .............. X .............. .............. .............. .............. .............. .............. ..............
Develop ongoing data collection systems that
would permit an evaluation of screening results
and accuracy................................... .............. X .............. .............. .............. X X X X
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
summary statement of dr. david van hook
Senator Specter. We turn now to Dr. David Van Hook,
assistant professor of radiology and chief of mammography here
at the Hershey Medical Center, graduate of the University of
Missouri School of Medicine and a member of the Radiological
Society of North America and the Society for Breast Imaging.
Welcome, Dr. Van Hook. Your full statement will be made a part
of the record, and you are aware of our time limitations, so
the floor is yours.
Dr. Van Hook. Thank you, Senator Specter, members of the
panel and members of the Pennsylvania Breast Cancer Coalition.
Breast cancer is a terrible disease. Today in the United
States breast cancer is the single most common malignancy in
women ages 40 to 49. It is the leading cause of death in women
ages 40 to 49. In the United States today, more than 10,000
deaths per year occur among women who develop breast cancer
between the ages of 40 and 49.
Population screening for breast cancer is a good thing if
early intervention leads to overall benefit to the population
as measured by reduced mortality or by overall savings for the
health care system or both.
For women over the age of 50, there seems to be little
doubt that these benefits can be achieved by screening with
mammography. In 1995, the National Cancer Institute reported
for the first time ever a 5-percent reduction in breast cancer
mortality which occurred from 1989 to 1992. They acknowledge
that to some degree this reduction was likely due in part to
the increased utilization of screening mammography.
But in January 1997, the NIH announced that there was
insufficient scientific evidence to justify a recommendation
for breast cancer screening for women under the age of 50.
Although an analysis of combined data from seven population-
based randomized control trials which included over 170,000
women in their forties and published in 1995 demonstrated a
statistically-significant benefit in reducing mortality from
breast cancer, and data from several other nonrandomized
screening studies also support a benefit to women ages 40 to
49, the problem seems to be that thus far there has been no
single randomized control trial which has shown statistically
significant proof of benefit of mammography screening for women
ages 40 to 49.
It seems intuitive that a screening test designed to
minimize the impact of a disease on members of a population by
early detection and treatment would benefit that population.
But the process of determining the most appropriate strategy
for screening is enormously complex and expensive. And it
should be equally intuitive that not every screening test will
be beneficial or cost effective for all members of the
population in all cases.
It may be, in fact, that there really is no such thing as
the perfect study to assess the benefits of screening to the
satisfaction of everyone, especially in this age of cost
containment. If this is true, then is it right to ignore the
significance of the accumulated evidence that does support the
benefit from screening? Do we say, well, this is prevention, we
are not forced to act when many, if not most, of the decisions
that are made in daily medical practice are not made on the
basis of statistically significant scientific proof?
The controversy over screening mammography has continued
for 20 years and seems no closer to resolution today. But if
anything is clear as a result of this latest random debate, it
is that there is far more at stake here than just dollars spent
to save lives, that there is far more involved here than just
having to try to make some sense of the statistical mumbo-jumbo
required for scientific proof of something.
prepared statement
The decisions regarding health care and intervention which
affects our society perhaps involve not only science but should
also take into account the willingness of those most affected
by those decisions to accept some degree of uncertainty,
especially when there is controversy or less than scientific
proof of benefit. The beneficiaries of breast cancer screening,
those who stand to gain or lose the most from it, our mothers,
wives and daughters, are willing to do just that.
We the remainder of society should respect that and act
accordingly. Thank you.
Senator Specter. Thank you very much, Dr. Van Hook.
[The statement follows:]
Prepared Statement of David Van Hook
1. Today, in the United States, breast cancer is:
--the single most common malignancy in women ages 40-49; and
--the leading cause of death in women ages 40-49.
2. In the United States, more than 10,000 deaths per year occur
among women who develop breast cancer between the ages of 40-49.
3. Population screening for breast cancer is a good thing if early
intervention leads to overall benefit to the population, as measured by
reduced mortality, or by overall savings for the health care system, or
both. For women over the age of 50 there seems to be little doubt that
these benefits can be achieved by screening with mammography.
4. In 1995, the National Cancer Institute reported, for the first
time ever, a 5-percent reduction in breast cancer mortality, which
occurred from 1989 to 1992. They acknowledge that to some degree this
reduction was likely due in part to the increased utilization of
screening mammography.
5. But, in January 1997, the NIH announced that there was
insufficient scientific evidence to justify a recommendation for breast
cancer screening for women under age 50.
6. Although an analysis of combined data from seven population-
based randomized-controlled-trials, which included over 170,000 women
in their forties, published in 1995, demonstrated a statistically
significant benefit in reducing mortality from breast cancer, and data
from several other non-randomized screening studies also support a
benefit to women 40-49. The problem seems to be that thus far there has
been no single randomized-controlled trial which has showed
statistically-significant ``proof'' of benefit from mammography
screening for women ages 40-49.
7. It seems intuitive that a screening test designed to minimize
the impacts of disease on members of a population by early detection
and treatment would benefit that population.
But, the process of determining the most appropriate strategy for
screening is enormously complex and expensive, and, it should be
equally intuitive that not every screening test will be beneficial or
cost-effective for all members of a population in all cases.
8. It may be, in fact, that there really is no such thing as the
``perfect'' study to assess the benefits of screening to the
satisfaction of everyone, especially in this age of cost containment.
9. If this is true, then is it right to ignore the significance of
the accumulated evidence that does support a benefit from screening?
Do we say, ``ah, well, this is prevention, we are not forced to
act'', when many, if not most of the decisions that are made daily in
medical practice are-not-made on the basis of statistically-
significant-scientific-proof.
10. The controversy over screening mammography has continued for
over 20 years, and seems no closer to resolution today.
11. But, if anything is clear as a result of this latest round of
debate, it is that there is far more at stake here than just dollars
spent to save lives, that there is far more involved here than just
having to try to make some sense of the statistical ``mumbo-jumbo''
required for scientific proof of something.
12. The decisions regarding a health care intervention which
affects our society should, perhaps, involve not only science, but
should also take into account the willingness of those most affected by
those decisions to accept some degree of uncertainty, especially when
there is controversy or less than scientific ``proof'' of benefit.
13. The beneficiaries of breast cancer screening, those who stand
to gain or lose the most from it, our mothers, wives, and daughters are
willing to do just that.
14. We, the remainder of society, should respect that and act
accordingly.
impact of mammography
Senator Specter. Let me begin with the question as to the
impact of mammography. We had some very impressive testimony in
Pittsburgh on this subject from a number of doctors, including
Dr. Victor Vogel, who said this, there are nearly 1,000,000
women in Pennsylvania between the ages of 40 and 49. And nearly
2,000 will be diagnosed with breast cancer this year. As many
as 1,000 of these women may die. It is my opinion that we could
reduce the number by approximately 250 deaths if women between
the ages of 40 and 49 were screened annually with mammography.
Now, I realize that you do not have any scientific data,
but starting with you, Dr. Evans, would you say that that was
within the ballpark figure as to what your expectation would
be?
Dr. Evans. Yes; I think it is. The randomized trials
suggest there is no proof but certainly strongly suggest a
benefit for women in this age group. And it may be smaller than
the benefit for women in the older age groups, but the data
would suggest that perhaps 1 or 2 lives per 1,000 women
screened might be a ballpark figure in terms of the expected
benefit from screening in this age group.
Senator Specter. Dr. Vogel is suggesting substantially
more, suggesting that if you have 1 million women you may save
as many as 250 lives. Dr. Simmonds, what would your sense be as
to Dr. Vogel's statement?
Dr. Simmonds. I would agree with his statistics. I trust
the numbers on the population of Pennsylvania and then the fact
that he quoted that one-half the women will die of breast
cancer. One point that I wanted to make to you, Senator, is
that----
Senator Specter. One-half the women who are diagnosed with
breast cancer will die?
Dr. Simmonds. Will die----
Senator Specter. Yes.
Dr. Simmonds. While we are making great strides in the
treatment of this disease once it is diagnosed, we have a long
way to go. The best thing we can do at this point is to catch
it in its earliest possible stage.
Senator Specter. Dr. Simmonds, let me ask you a question
which may be unduly personal, and if it is, you do not have to
answer. Do you have mammograms?
Dr. Simmonds. Absolutely, every year.
Senator Specter. And another question which goes to what
Dr. Van Hook has testified to about having mammograms, whether
or not there is any indication. Is there any specific warrant
or indication for you to have the mammograms?
Dr. Simmonds. Are you asking?
Senator Specter. Yes; I am asking you.
Dr. Simmonds. The indication for my mammograms?
Senator Specter. Do you have a history in your family of
breast cancer? Any special reason for you to have the
mammograms?
Dr. Simmonds. I do, in fact, have an aunt who died of
breast cancer. But I would get the mammograms regardless of
that. I believe that any woman in her forties is at risk.
The other point that I want to make, Senator, a point that
I do not hear made very often, but medically we know. We have
this label, is what I tell my patients, called breast cancer.
That is what it is. It is a name. And, you know, as a disease
entity, it is really a spectrum. It is maybe various diseases,
maybe of various causes. And so some of them are very
aggressive and some of them are very indolent. And that goes
into the mixture of what we are picking up with mammography.
As a general rule, the disease in a woman in her forties
might be more aggressive. So that is another factor that bears
in screening women at that age. In other words, if you did not
pick it up early, they would surely die.
Senator Specter. Now, Dr. Van Hook, let me shift the ground
slightly to the question about how often on mammograms. There
has been some controversy as to whether even women 50 and over
should have annual mammograms. What is your evaluation as to
the frequency of mammograms in women 40 and up?
Dr. Van Hook. My recommendation for every woman over the
age of 40 is annually.
Senator Specter. When we talk about the issue of, as you
characterize it, Dr. Simmonds, from the book ``Infinite Need:
Finite Resources,'' how expensive is it to get a mammogram, Dr.
Simmonds?
Dr. Simmonds. That is a very good question. There is a
variable cost. In a true screening procedure, you can cut the
cost to maybe $50 in that you streamline the procedure. You
have a facility that does not have a lot of fancy overhead. You
have a radiologist that can batch the reading of this, so that
there is a limited amount of time of the professional involved.
That gets very confused sometimes with what are diagnostic
mammograms, which Dr. Van Hook can answer as well, where the
radiologist must be there one-on-one with the patient.
But a true screening mammography, we could cut the costs
somewhat.
Senator Specter. Could the costs be cut by having
mammograms given at inconvenient hours? When I had my MRI, it
was very expensive to do during the day. There have been some
suggestions, you might run MRI's around the clock. Would it be
less expensive on the marginal cost to do a mammogram, say, at
10 o'clock at night or even 1 a.m., in the morning to reduce
the cost? Dr. Evans, what do you think about that?
Dr. Evans. I really would defer that one to Dr. Van Hook as
the radiologist.
Senator Specter. OK. Dr. Van Hook?
Dr. Van Hook. The way you achieve economy in screening is
by volume of patients seen. Here at the Hershey Medical Center,
we do what we call online reading, which means that virtually
every woman who comes in for a mammogram, her examination is
read at that time and the interpretation, the results of the
exam, is given to the patient directly by the interpreting
radiologist.
This is not terribly cost effective, but it is a good
service for the patients. I think most of our patients really
appreciate that.
The way to make it economical is to have patients come in
in volume, do their exams, have them leave and read the
examinations at a later time, perhaps even at another site. And
then those women who need to be recalled for more workup would
be notified.
Senator Specter. Let me shift ground back to a more primary
question about more research. We have added enormous funds to
breast cancer research. And this has come regardless of who the
chairman has been, whether it is Senator Weicker in the early
1980's, later Governor Weicker, Senator Lawton Chiles of
Florida, later Governor Chiles. Senator Harkin chaired the
committee. I have chaired the committee. We have added funds
all the time on NIH research.
And this year, I laid down a marker of a 7\1/2\-percent
increase of $952,000,000 for extra breast cancer research. And
I did that at the outset of the session, because I wanted my
colleagues to know what I thought about it and what we were
going to be looking for.
The question is, if you doctors can shed some light on a
collateral--a corollary question as to whether more can be done
on research to find the causes of breast cancer. Dr. Simmonds,
what do you think?
Dr. Simmonds. That is absolutely what needs to be done and
we have made progress. I think there is a demonstrated track
record. As you probably know, we are on the verge of some very
exciting understanding through the genetic markers. Then there
are advances in the various medical oncology treatments of the
disease, new drugs.
Senator Specter. Dr. Evans, what do you think about the
adequacy of funding on research for breast cancer, if you care
to express an opinion?
Dr. Evans. Absolutely. I do not think there is any doubt
about the fact that research will add to our knowledge and
improve outcomes. Research into basic causes is one area of
research. I suspect that in the short run, that sort of
research, we are going to see less result in the short-term
than we will from research, for example, in mammography, how to
make it more accurate, how to make it less anxiety-producing,
how to make it less painful for women so that compliance rates
go up. All those are important components.
My concern is that with the increasing pressures on the
Federal and State budgets that there has not been a clear
commitment from managed care organizations to support clinical
research. And I think we need to see that.
Senator Specter. Well, you raised a very good question as
to managed care organizations, as to the cost of medical
education, which is a big issue here at Hershey, big issue
across the country, research, what is--this is a complicated
question. Let me ask you to supplement your testimony, if any
of you can give us a hand on how we structure managed care to
make a contribution. I would be very interested in your
thinking on that.
Dr. Van Hook, let me move over to this issue as to tests.
Although this was Dr. Evans' testimony, let me ask you the
question. Why is it that, considering our NIH budget, there are
so few tests? With eight tests having been conducted in this
field, only one in the United States?
Dr. Van Hook. I really do not know.
Senator Specter. Are the recipients or are the grantees
spending their money wisely?
Dr. Van Hook. I am not an expert in that area. I am really
not qualified to answer that.
Senator Specter. OK. Dr. Simmonds, I appreciate your making
this very interesting booklet available to us. It looks like an
impressive study which was undertaken here.
Dr. Simmonds. Yes; right here in Pennsylvania.
Senator Specter. In 1991. What have the benefits been on
this, if any?
Dr. Simmonds. In the center are the recommended actions.
Some of them are indeed hard to measure, but the Department of
Health has in particular, used the results of the consensus
conference. I picked out the one message about communicating
the simple message and then corollaries of that, are
educational programs, a clearinghouse for breast health
education, and indeed the Pennsylvania Breast Cancer Coalition
has made a lot of progress in some of these aspects.
Senator Specter. Let me shift ground--were you finished,
Dr. Simmonds?
Dr. Simmonds. Yes; I was.
Senator Specter. Let me shift ground here again to a
somewhat related subject. And that is, I have heard from a
number of constituents that Medicare has sent out notices about
reduction in payments, some projected to be lower than Medicaid
payments, some reduced as much as 35 to 40 percent. We are
trying to contain the costs of rises in Medicare costs, not to
cut Medicare, but to restrain the rate of growth, say, to 7
percent instead of 10 percent, which is somewhat more than
twice the inflation rate.
Have any of you doctors received such notification about
Medicare reductions in payments to you? Proposed cuts? Dr.
Evans?
Dr. Evans. I personally have not.
Senator Specter. Dr. Van Hook.
Dr. Van Hook. No.
Senator Specter. Dr. Simmonds.
Dr. Simmonds. No; I have not.
Senator Specter. OK. Let me turn to an avant-garde
question, which is not directly related but one which I would
like your opinions on with respect to the cloning which was
disclosed just last week. This may be the subject of a hearing
in Washington. It brings more animation than any of my other
questions. What do you think about it, Dr. Van Hook? Would you
care to get involved in that deep philosophical issue?
Dr. Van Hook. No; not at all. [Laughter.]
Senator Specter. OK. Dr. Evans, would you care to?
Dr. Evans. Well, I think, my guess is that this came like a
lightning bolt to the public, but I suspect it did not come as
a lightning bolt to the scientific community. And I am not part
of the scientific community in cloning, so it came perhaps as
much of a surprise to me as it did to the public.
I think, though, the scientific community was a little bit
behind the eight ball in setting out, discussing, dialoging
some of the ethical implications that would derive from cloning
of animals or ultimately humans.
The most recent news release would suggest that we are even
closer and that the technology is perhaps closer than we
thought.
Senator Specter. Dr. Simmonds.
Dr. Simmonds. Senator, I would like to bridge your question
back to breast cancer, actually, to pick up on the genetic
aspects, which is not quite cloning. I recognize, a concern
that a lot of people have, and I alluded to this in the
questions as far as the breast cancer genes. And imminently
this test will be widely available, that a woman may find out
if she is carrying this gene, was born with this gene, or not.
There are a number of ethical questions that I do not
believe we are fully prepared in our society to deal with. Just
one example would be, what is an insurance company going to do
with that individual? Are they going to deny her insurance,
because she is now at risk for a disease? I would like to
highlight that.
Senator Specter. Well, I was about to move to that next.
That is a much more restricted question than cloning. We have
commented about that in our hearings. I believe that
legislation is necessary to protect the privacy of women, so
that they can get the benefits from an identification of a gene
which predisposes to breast cancer without losing insurance.
Because if you know you have a preexisting condition, and do
not disclose it to the insurance company, they can cancel your
insurance policy on what the lawyers call fraudulent
inducement.
So, we ought not to preclude people from finding out about
predisposition which could help in the medical care. That is on
our agenda to work on.
Well, this is only the beginning. We have another panel
which we wish to hear from, but I would very much appreciate
your staying in touch on additional suggestions that you may
have. The question of how to get a fair share contribution on
research from managed care facilities and also on graduate
medicine and also education and also on caring for the poor is
something that if you care to give some supplemental testimony,
we would be pleased to have it.
OK. Thank you very much, Dr. Evans, Dr. Simmonds and Dr.
Van Hook. I appreciate your being here.
Panel 2
STATEMENTS OF:
LOIS A. ANDERSON, COFACILITATOR AND FOUNDER, SURVIVING BREAST
CANCER SUPPORT GROUP AND COCAPTAIN, PENNSYLVANIA BREAST
CANCER COALITION, YORK, PA
LORENE KNIGHT, PENNSYLVANIA BREAST CANCER COALITION
HON. KATIE TRUE, STATE REPRESENTATIVE, 37TH LEGISLATIVE
DISTRICT
introduction of witnesses
Senator Specter. I would now like to turn to our next panel
of Ms. Lois Anderson, Ms. Lorene Knight, and Representative
Katie True. If you ladies would step forward.
Again, in alphabetical order, we will turn to Ms. Lois
Anderson medical technologist at Mercy Medical Center in
Baltimore. She has served as a medical technologist at Memorial
Hospital and the Hillcrest Women's Medical Center in York and
at Columbia Hospital in Columbia, PA. She is York County
cocaptain of the Pennsylvania Breast Cancer Coalition and is a
member of the surviving breast cancer support group for breast
cancer survivors. Her breast cancer was diagnosed when she was
39 years old.
Welcome, Ms. Anderson. We would like, again, to limit
opening statements to 5 minutes. And any written statements
will be made a part of the record in full. The floor is yours.
summary statement of lois anderson
Ms. Anderson. Thank you, Senator Specter. The Honorable
Arlen Specter and subcommittee members, I would like to thank
you for extending an opportunity to testify at this special
hearing on the NIH Consensus Conference's decision on
mammography for women between the ages of 40 and 49.
As a breast cancer survivor, I was outraged by their
decision to not recommend screening mammography for all women
in this age group. My own breast cancer experience began
October 12, 1992, just 6 days after my 40th birthday; 3\1/2\
months earlier, I received a blow to my right breast while
roughhousing with my then 12-year-old son.
After the initial injury, the bruise would come and go at a
specific point in my menstrual cycle. Because I was turning 40
in the fall, I had a doctor's order for a baseline mammogram.
That mammogram, done on September 14, 1992, was reported as:
``benign mammographic findings of dense fibrocystic change,''
meaning that I had dense breast tissue.
However, because of my experience and savvy as a medical
technologist and my husband's work as a registered nurse, I
knew the bruise needed treatment. The radiologist who spoke
with me after the mammogram strongly suggested I return to my
gynecologist for an exam.
The night before this scheduled appointment, I decided to
do a self-breast exam which I previously practiced monthly, and
I found a lump. I saw the gynecologist and was referred to a
surgeon for an excisional biopsy of the lump, which revealed a
poorly differentiated infiltrating ductal carcinoma with
osteoclast-like giant cells, an extensive ductal carcinoma in
situ of comedo and cribriform subtypes.
A right mastectomy was performed 1 month later and
macrometastasis were found in 5 of 11 lymph nodes. These
findings made me a stage III breast cancer patient with less
than a 40-percent chance of surviving 5 years.
At 39 going on 40, no woman is expected to have breast
cancer and this diagnosis devastated me. It took me several
weeks to work my way through my emotions and decide what I had
to do. I went through 6 months of chemotherapy, 6 weeks of
radiation therapy and all the while continued physical therapy
for a frozen shoulder that occurred after surgery.
I am now on tamoxifen for the rest of my life or until I
develop a recurrence. Some 2 years after this initial
experience, a lesion was found on the mammogram of my remaining
breast, which was removed and turned out to be a benign cystic
lesion. From this, you can see how my own breast tissue changed
mammographically in only 2 short years.
The incidence of breast cancer in younger women is
increasing. And the NIH's decision to not recommend mammograms
for women below 50 years of age will certainly cause an
increase in the death rate from breast cancer. As a breast
cancer support group founder and facilitator, I have watched as
several younger group members struggled in vain with this
disease and eventually succumbed to it.
Premenopausal breast cancer is usually more aggressive than
breast cancer in older women. To deny mammograms to younger
women is handing them a death sentence. This decision comes at
a time when statistics are showing us a slight decrease in the
overall rate of breast cancer, partially attributed to early
screening mammograms.
Mammography is our only tool other than self-breast exams
and professional breast exams to combat this disease. No other
technology has proven itself as reliable as a mammogram. The
mammogram is not a perfect test. No test is ever perfect. No
test will detect disease 100 percent of the time. However, in
the hands of a practicing, skilled radiologist who consistently
reads mammograms day in and day out, mammography becomes our
best tool for early detection when breast cancer is in its
nonpalpable stages.
As a Pennsylvania Breast Cancer Coalition member, I have
collected over 226 stories from women under the age of 50 who
have been diagnosed with breast cancer through the use of a
mammogram. And I would like these stories entered into the
record. They are here.
Senator Specter. They will be admitted into the record in
full. Thank you.
Ms. Anderson. These stories continue to flood my mail, my
e-mail, and my fax. Copies were sent to Dr. Alan Rabson and Dr.
Richard Klausner, Deputy Director and Director respectively of
the National Cancer Institute for presentation at the NCI's
Advisory Board meeting February 25 and 26 of this month in the
hopes that this anecdotal evidence would persuade the NCI to
change its mammogram recommendations.
Since women represent 52 percent of the population in the
United States, I think we as younger women deserve better
direction in our breast health care. Specific guidelines for
the use of mammography, especially in women 40 to 49 years of
age, need to be set down and followed. Women need to be told
that a mammogram is not perfect, but it is the best tool we
have for detecting breast cancer early.
Deadly confusion over screening mammography will result
from the NIH's decision if these guidelines are not changed.
Senator Specter. Thank you very much, Ms. Anderson. We will
come to the questions and answers later, but let me just ask
you preliminarily now how are you feeling?
Ms. Anderson. As far as the NIH's decision or my health or
what?
Senator Specter. That is a very good----
Ms. Anderson. My health is great right now.
Senator Specter [continuing]. That is a very good request
for specification on the question. I usually am sufficiently
specific not to do that.
prepared statement
Ms. Anderson. I am still very upset about the NIH's
decision.
Senator Specter. OK. But your personal health is fine?
Ms. Anderson. My personal health is good, very good.
Senator Specter. It is important how you feel about the
NIH. It is more important how your health is.
[The statement follows:]
Prepared Statement of Lois A. Anderson
Hon. Arlen Specter, and subcommittee members: I would like
to thank you for extending an opportunity to testify at this
special hearing on the NIH Consensus Conference's decision on
mammography for women between the ages of 40 and 49. As a
breast cancer survivor, I was outraged by their decision to
recommend screening mammography for all women in this age
group.
My own breast cancer experience began October 12, 1992,
just 6 days after my 40th birthday. Three and one-half months
earlier I received a blow to my right breast while rough
housing with my, then, 12 year old son. After the initial
injury the bruise would come and go at a specific point in my
menstrual cycle. Because I was turning forty in the fall, I had
a doctor's order for a baseline mammogram. That mammogram, done
on September 14, 1992, was reported as, ``benign mammographic
findings of dense fibrocystic change,'' meaning that I had
dense breast tissue. However, because of my experience and
savvy as a Medical Technologist and my husband's work as a
Registered Nurse, I knew the bruise needed treatment. The
radiologist who spoke with me after the mammogram strongly
suggested I return to my gynecologist for an exam. The night
before this scheduled appointment I decided to do a self-breast
exam, which I previously practiced monthly, and I found a lump.
I saw the gynecologist and was referred to a surgeon for an
excisional biopsy of the lump, which revealed a poorly
differentiated Infiltrating Ductal Carcinoma with Osteoclast-
like Giant Cells and extensive Ductal Carcinoma In Situ of
comedo and cribiform subtypes. A right mastectomy was performed
one month later and macrometastasis were found in 5 of 11 lymph
nodes. These findings made me a Stage III breast cancer patient
with a less than 40 percent chance of surviving 5 years. At 39
going on 40 no woman is expected to have breast cancer and this
diagnosis devastated me. It took me several weeks to work my
way through my emotions and decide what I had to do. I went
through 6 months of chemotherapy, 6 weeks of radiation therapy
and all the while continued physical therapy for a frozen
shoulder that occurred after surgery. I am now on Tamoxifen for
the rest of my life or until I develop a recurrence. Two years
after this initial experience a lesion was found on the
mammogram of my remaining breast, which was removed and turned
out to be a benign cystic lesion. From this you can see how my
own breast tissue changed mammographically in only two short
years.
The incidence of breast cancer in younger women is
increasing and the NIH's decision to not recommend mammograms
for women below 50 years of age will certainly cause an
increase in the death rate from breast cancer. As a breast
cancer support group founder and facilitator I have watched as
several younger group members struggled in vain with this
disease and eventually succumbed to it. Premenopausal breast
cancer is usually more aggressive than breast cancer in older
women. To deny mammograms to younger women is handing them a
death sentence. This decision comes at a time when statistics
are showing us a slight decrease in the overall rate of breast
cancer, partially attributed to early screening mammograms.
Mammography is our only tool, other than self-breast exams
and professional breast exams to combat this disease. No other
technology has proven itself as reliable as a mammogram. The
mammogram is not a perfect test. No test is ever perfect. No
test will detect disease 100 percent of the time. However, in
the hands of a practicing, skilled radiologist who consistently
reads mammograms day in and day out, mammography becomes our
best tool for early detection when breast cancer is in its non-
palpable stages.
As a Pennsylvania Breast Cancer Coalition member, I have
collected over 226 stories from women under the age of 50 who
have been diagnosed with breast cancer through the use of a
mammogram. These stories continue to flood my mail, e-mail, and
fax. Copies were sent to Dr. Alan Rabson and Dr. Richard
Klausner, Deputy Director and Director respectively of the
National Cancer Institute for presentation at the NCI's
Advisory Board Meeting February 25th and 26th in the hopes that
this anecdotal evidence would persuade the NCI to change its
mammogram recommendations.
Since women represent 52 percent of the population in the
United States, I think we, as younger women deserve better
direction in our breast health care. Specific guidelines for
the use of mammography, especially in women 40-49 years of age
need to be set down and followed. Women need to be told that a
mammogram is not perfect, but it is the best tool we have for
detecting breast cancer early. Deadly confusion over screening
mammography will result from the NIH's decision if these
guidelines are not changed.
summary statement of lorene knight
Senator Specter. OK. We now turn to Ms. Lorene Knight,
logistics distribution analyst for the New Holland North
American Inc., a member of the NAACP of Lancaster County, the
Urban League of Lancaster County and a volunteer for the
American Cancer Society's Reach to Recovery Program and a
member of the Pennsylvania Breast Cancer Coalition. Ms. Knight
was diagnosed with breast cancer when she was 47 years old.
We welcome you here, Ms. Knight, and look forward to your
testimony.
Ms. Knight. Thank you. My name is Lorene Knight. I am a 54-
year-old African-American single woman, no children, and I am a
7-year breast cancer survivor as of Wednesday, March 19. I am a
member of the Pennsylvania Breast Cancer Coalition and a very
active volunteer with the American Cancer Society.
I found a lump in my breast through self-breast
examination, followed by a mammogram and a sonogram. It turned
out to be breast cancer. At the age of 47, I had a modified
radical mastectomy on my right breast followed by 6 months of
chemotherapy and 5 years of hormone therapy by the way of the
drug tamoxifen.
Had I not had a mammogram that verified my suspicion of
breast cancer, I may not have had the opportunity to be here
today and participate in this special hearing. I had my first
mammogram at the age of 36 because of the presence of
fibrocystic tissue in my breast and because of my family
history with breast cancer and my sister's death at age 43,
just 9 years ago, due to complications from this disease, it
was never a question that my mother, my three sisters and I
would have yearly mammograms. And my mother, by the way, is a
5-year breast cancer survivor.
I am most disturbed by the findings of the NIH's consensus
development program that the available data do not warrant a
single recommendation for mammography for women in their
forties. Therefore, the burden of decision for a woman in her
forties is hers alone. This kind of statement would no doubt
lure entirely too many women of all races and in their forties
into a false sense of security about the odds that breast
cancer would not likely happen to them during this decade of
their lives.
Because I am an African-American woman, I know how private
my race is about certain illnesses and how reluctant we all too
often are, to seek medical attention because of fear of the
unknown and economics. The NIH's statement is only sending a
negative message to these women that will reinforce these
feelings.
I am living proof that breast cancer does happen to
African-American women in their forties and that we can survive
it when it is found early. As a member of the Breast Cancer
Detection CORE Team at the Lancaster County unit of the
American Cancer Society, I know how busy this team of
volunteers is with numerous patient service, early detection,
education and advocacy projects with regards to the issue of
breast cancer.
I am very proud to share with you today a portion of some
new statistics that our CORE Team is currently compiling for
Lancaster County. There are four hospitals in Lancaster County
and two of them to date have pulled figures that show us
details about recent breast cancer patients. At one hospital
during the 1995-96 fiscal year, 104 women underwent breast
cancer surgery. Nearly 36 percent of these were under the age
of 50.
At a second Lancaster County hospital during the same
fiscal year, 21 women underwent breast cancer surgery; 8 of the
21 women were under 50 years of age, and 1 of the 8 was in her
thirties.
We are working with other hospitals to get similar figures
that will enable us to soon have a complete Lancaster County
percentage of the 40 to 49 age group for the 1995-96 fiscal
year.
Also for 2 years, I have been a volunteer with the American
Cancer Society's Reach to Recovery Visitation Program. I have
yet to visit one recovering breast cancer patient that is
African-American. Why is this? In my heart, I believe it is
because not enough African-American women are having early
detection procedures such as mammograms at an early enough age
to detect the breast cancer at an early enough stage to survive
it.
In fact, the American Cancer Society's Breast Cancer
``Facts and Figures 1996'' clearly states, and I am now quoting
from that publication, from 1973 to 1988 breast cancer
mortality rates increased 1.1 percent among white women and
19.4 percent among African-American women. Between 1989 and
1992, mortality rates among whites declined approximately 5.2
percent, while rates among African-American women increased 2.6
percent.
So, while a decline in deaths from breast cancer is
wonderful news, we must keep these numbers going down until we
hit zero. Conversely in my mind, any increase in deaths from
breast cancer is just not acceptable. This year an estimated
180,200 new invasive cases of breast cancer are expected among
women in the United States. An estimated 43,900 of these women
will die from it. This is too many lives lost.
Every woman of every race in every community should have
access to earliest possible detection methods, such as
mammograms combined with monthly self-breast exams and regular
physician's exam. And every woman of every race in every
community should have it available to her at age forty if that
is what she determines to be necessary for her, dictated by
family history, her physician's recommendation and any other
personal health factors pertinent to her well-being and
longevity in this world.
prepared statement
Thank you for allowing me this time today to share my story
and to personally request that you do not lend your support to
the NIH's recent findings and public statement. Thank you.
Senator Specter. Ms. Knight, you may be sure I will not
lend my support to the NIH's recent findings. May I ask you the
status of your health now?
Ms. Knight. I am doing wonderfully well. I am fine.
Senator Specter. OK. Thank you. We will get more questions
and answers later.
[The statement follows:]
Prepared Statement of Lorene Knight
My name is Lorene Knight. I am a 54-year-old African-
American single woman--no children--and I am a 7-year breast
cancer survivor as of Wednesday, March 19, 1997. I am a member
of the Pennsylvania Breast Cancer Coalition, and a very active
volunteer with the American Cancer Society.
I found a lump in my own breast through Breast Self
Examination (or BSE), followed by a mammogram and a sonogram.
It turned out to be breast cancer. At the age of 47, I had a
modified radical mastectomy on my right breast, followed by 6
months of chemotherapy and 5 years of hormone therapy by way of
the drug Tamoxifin. Had I not had the mammogram that verified
my suspicion of breast cancer, I may not have had the
opportunity to be here today and participate in this special
hearing.
I had my first mammogram at the age of 36 because of the
presence of fibrocystic tissue in my breasts. And because of my
family history with breast cancer and my sister's death, at age
43 (just 9 years ago) due to complications from this disease.
It was NEVER a question that my mother, my three sisters and I
would have yearly mammograms. And my mother, by the way, is a
5-year breast cancer survivor.
I am most disturbed by the findings of the NIH's Consensus
Development Program ``that the available data do not warrant a
single recommendation for mammography for all women in their
forties. Therefore, the burden of decision for a woman in her
forties is her alone.'' This kind of statement will no doubt
lure entirely too many woman--of all races and in their
forties--into a false sense of security about the odds that
breast cancer will not likely happen to them during this decade
of their lives. And because I am an African-American woman, I
know how private my race is about certain illnesses and how
reluctant we, all to often are, to seek medical attention
because of fear of the unknown and economics. The NIH's
statement is only sending a negative message to those women
that will reinforce these feeling, and I am living proof that
breast cancer does happen to African-American women in their
forties, and that we can survive it when it's found early.
As a member of the Breast Cancer Detection CORE Team at the
Lancaster County Unit of the American Cancer Society, I know
how busy this Team of volunteers is with numerous patient
service, early detection, education, and advocacy projects with
regard to the issue of breast cancer. And I'm proud to share
with you today a portion of some new statistics that our CORE
Team is currently compiling for Lancaster County.
There are four hospitals in Lancaster County and two of
them, to date, have pulled figures that show us details about
recent breast cancer patients. At one hospital, during the
1995-96 fiscal year, 104 women underwent breast cancer surgery
nearly 36 percent of them were under the age of 50. At a second
Lancaster County hospital, during the same fiscal year, 21
women underwent breast cancer surgery--8 of the 21 women were
under 50 years of age, and 1 of the 8 was in her 30's. We are
working with the other hospitals to get similar figures that
will enable us to soon have a complete Lancaster County
percentage of the 40-49 age group, for the 1995-96 fiscal year.
Also, for 2 years, I have been a volunteer with the
American Cancer Society's Reach To Recovery visitation program.
I have yet to visit one recovering breast cancer patient that
is African-American. Why is this? In my heart, I believe it is
because not enough African-American women are having early
detection procedures such as mammograms at an early enough age
to detect the breast cancer at an early enough stage to survive
it. And in fact, the American Cancer Society's Breast Cancer
Facts & Figures 1996 clearly states that, I am now quoting from
that publication.
``From 1973 to 1988, breast cancer mortality rates
increased 1.1 percent among white women and 19.4 percent among
African-American women. Between 1989 and 1992, mortality rates
among whites declined approximately 5.5 percent, while rates
among African-American women increased 2.6 percent.''
So, while any decline in deaths from breast cancer is
wonderful news, we must keep these numbers going down until we
hit ``zero.'' Conversely, in my mind, any increase in deaths
from breast cancer is just not acceptable.
This year, an estimated 180,200 new invasive cases of
breast cancer are expected among women in the United States. An
estimated 43,900 of these women will die from it.\1\ This is
too many lives lost.
---------------------------------------------------------------------------
\1\ American Cancer Society Cancer Facts and Figures--1997.
---------------------------------------------------------------------------
Every woman of every race, in every community should have
access to the earliest possible detection methods such as
mammograms, combined with monthly Breast Self Exams and regular
physician's exams. And every woman, of every race, in every
community should have it available to her at age 40 if that is
what she determines to be necessary for her, dictated by family
history, her physician's recommendations and any other personal
health factors pertinent to her well-being and longevity in
this world.
Thank you for allowing me this time today to share my
story, and to personally request that you do not lend your
support to the NIH's recent findings and public statement.
summary statement of state representative katie true
Senator Specter. Now turning to the Honorable Katie True,
Representative of the Pennsylvania State Legislature having
been elected in 1992, representing the 37th legislative
district. She currently chairs the Subcommittee on Drugs and
Alcohol and has founded several drug and alcohol programs for
children and parents.
She is a strong supporter of cancer research and someone
whose family has been affected by breast cancer. Representative
True introduced legislation to provide a State income tax
refund checkoff for breast and cervical cancer research. The
legislation has already passed the House and is currently
pending in the Senate.
Welcome, Representative True, and the floor is yours.
Ms. True. Thank you, Senator. I appreciate being asked to
participate in this hearing. And I thank you for the
opportunity to lend my voice to the findings of the NIH
Consensus Development Conference on Breast Cancer Screening in
Women Ages 40 to 49. As a legislator, I am proud to be an
active participant in the fight against breast cancer. As a
woman, wife, mother, grandmother, and daughter, I feel it is my
responsibility to pick up the gauntlet.
I fight for the women who suffer mental anguish and
physical pain when they lose their breasts, for the women who
endure major medical procedures, chemotherapy and radiology,
and the women who have died from this dreadful disease. One of
the weapons I have chosen to battle breast cancer is House bill
134, the State income tax checkoff for breast cancer research.
Research requires money.
This bill that I have prime sponsored will help provide
some of the funds needed for cancer research. I feel very
strongly that a second weapon used to battle breast cancer is
education. We are making great strides in getting the word out
that breast self-exams combined with mammograms can save many
lives.
Women still hesitate to look after themselves first,
usually putting others and their needs before their own. Sadly,
the findings of the NIH Consensus Development Conference on
Breast Cancer Screening takes us a step backward instead of
moving us forward.
Until we find a cure, women need to understand that it is
imperative that they have a mammogram early on and not wait
until after age 50. They need to have encouragement through
education that mammography is not harmful and can save their
life. This is a case where good far outweighs the bad.
I would like to digress just for a moment from my written
remarks to say I read the proposal that was faxed to me from
the NIH, and noticed that one of their concerns was minimal
radiation and discomfort. And I think what mammograms can do
far outweighs those concerns.
The recommendation of the NIH Consensus Development
Conference on Breast Cancer Screening Panel in my opinion is
irresponsible. And I question, I really question, the motives
behind such a recommendation. Plain and simple, their message
is wrong. And I think it is deadly.
prepared statement
We need to stop this disease. We need to join forces,
support research and make others aware of how devastating
breast cancer is. And we need to battle for all those women who
lost the fight and for all those fighting the battle now.
Thank you, Senator.
Senator Specter. Thank you very much, Representative True.
[The statement follows:]
Prepared Statement of State Representative Katie True
I appreciate being asked to participate in this special
hearing of the Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies. Thank you for
the opportunity to lend my voice to the findings of the NIH
Consensus Development Conference on Breast Cancer Screening in
Women Ages 40-49.
As a legislator I am proud to be an active participant in
the fight against breast cancer. As a woman, wife, mother,
grandmother, and daughter, I feel it is my responsibility to
pick up the gauntlet. I fight for the women who suffer mental
anguish and physical pain when they lose their breasts, for the
women who endure major procedures, chemotherapy and radiology,
and the women who have died from this dreadful disease.
One of the weapons I have chosen to battle cancer is House
Bill 134, the State income tax ``checkoff'' for breast cancer
research. Research requires money. This bill that I have prime-
sponsored will help provide some of the funds needed for cancer
research. The donation is deducted from the tax refund to which
an individual is entitled and does not constitute a charge
against the income tax revenue's due to the State.
I feel very strongly that a second weapon used to battle
breast cancer is education. We are making great strides in
getting the word out that breast self-exams combined with
mammograms can save many lives. Women still hesitate to look
after themselves first, usually putting others and their needs
before their own. Sadly the findings of the NIH Consensus
Development Conference on Breast Cancer Screening takes us a
step backward instead of moving us forward.
Until we find a cure, women need to understand that it is
imperative that they have a mammogram early on and not wait
until after age 50. They need to have encouragement through
education--that mammography is not harmful and can save their
life. This is a case where Good far outweighs the Bad. The
recommendation of the NIH Consensus Development Conference on
Breast Cancer Screening panel is irresponsible, and I question
the motives behind such a recommendation. Plain and simple--
their message is wrong and deadly.
We need to stop this disease. We need to join forces,
support research and make others aware of how devastating
breast cancer is. We need to battle for all those women who
lost the fight and for all those fighting the battle right now.
motive of money
Senator Specter. Let me begin and ask you what you think
their motive is?
Ms. True. Money. I think the motive has to come somewhere,
somehow from finances and how a lot of this is going to be paid
for. Again, this is my opinion. I really do not believe a group
of people wake up one day and decide to have a hearing on a
panel like this and come up with recommendations like that if
there is not a real driving force behind it.
And the only thing in political life I can think of, it
must have something to do with finances.
Senator Specter. Well, Representative True, the money, of
course, is a matter of assessing priorities. My own sense is
that with a Federal budget of $1,700,000,000,000, if we
allocate the funding properly, we can find the money and still
candidly have a balanced budget. As I said earlier, Senator
Harkin and I found 134 programs we could either consolidate or
eliminate as a matter of priority. It is not that we did not
like them, but they just were not as important as other
programs.
And we have not come to grips really with what these
mammograms cost. But my sense is that we can find the money for
them.
Let me just ask you women one after another, how high a
priority do you put here? I know what the answer is, but let me
put it on the record. Representative True, start with you.
Ms. True. Well, I think it is a very high priority and I
would agree with you, that is, the whole ballgame is putting
priorities on it. I do not know if you could put a dollar
amount on a woman's life. And so, I would feel that compared to
what we spend our money on, and I certainly know on a State
level where a lot of the money goes, I think we could find a
way to make this work.
Senator Specter. Ms. Knight, what is your sense of that?
Ms. Knight. I think it is a big priority. And the thing
that I wish I could really get out into the African-American
community is how important it is that they do go once a year
for a mammogram or every other year. And I wish we could be
more open with it, because I do think that mammograms can save
lives.
Senator Specter. Ms. Knight, certainly the statistics and
you referenced this very accurately show that African-American
women currently experience 32.2 deaths per 1,000 women compared
to 26 per 100,000 for white women. And what do we need to do?
Do we need more publicity in the African-American community on
the availability and importance of mammograms?
Ms. Knight. Yes; I think that would probably be one step.
And we need to make sure that mixed messages are not sent out
into the community that it is not necessary to have a
mammogram. For a woman that is faced with an illness and she
suspected a lump in her breast and she is already fearful of
going in because she has many fears. She may not have the money
to pay for it, and sometimes you just do not want to know that
there is something there. And we need to educate the people to
go in and to have it done. A mammogram does not hurt. You know,
it only takes a few minutes and what is a few minutes when it
can be for the rest of your life, to save your life.
Senator Specter. Well, I said at the hearing in Washington
that the report by the NIH panel set this back a long way, not
only for women 40 to 49 but for women generally. People do not
like to take tests----
Ms. Knight. Right.
Senator Specter [continuing]. Because we are all fearful of
what they are going to show. We are going to make some more
inquiries into this issue about availability of mammograms to
women who cannot afford them. I think this is something that
has to rank very, very high on our scale of values.
Mrs. Anderson, I know from your answer to my first
question, inartfully phrased, what your temperature level is
here. These hearings are very important not only for facts but
for temperature. I get a very good reading on temperature when
I have these hearings or open house town meetings. The other
elected official here, Representative True, can confirm that, I
am sure.
And I congratulate you for assembling those statements to
send to the Director and Deputy Director. Let me ask you what
you think we can do to raise the level of awareness of the
National Cancer Institute and the panel of NIH on this subject,
how women feel about it?
Ms. Anderson. More public meetings, committee hearings such
as this. I hate to get the politicians involved in health
issues, but if that is what it takes then we have to do it.
That is all there is to it. It is just to put it out in front
of the public eye and keep it in front of the public eye. The
whole issue of breast cancer itself has been kept in a closet
for too long, way too long.
And it has only been until, I would say, my generation has
come along that it has come out of the closet. There are women
that I speak to, and I am a reach to recovery volunteer also,
who are 60, 70 years old who want to deny that they have breast
cancer.
Senator Specter. Well, the statistics are overwhelming that
breast cancer is the No. 1 killer of women ages 40 to 49. Some
184,000 women, and you recited this, Ms. Knight, were diagnosed
with this disease last year and nearly 44,000 of them will die
from breast cancer.
This is something very high on the radar screen of our
subcommittee, I can assure you of that.
One final question for you, Representative True. Bettilou
Taylor advises me that your mother has--this is Bettilou, who
is our chief architect, advises me that your mother has breast
cancer. How is she?
Ms. True. My mother was diagnosed and had surgery 20 years
ago. She is now 83 years old and she is doing very well, but I
would like to add my voice again. The fact my mother would not
come with me today. My mother did not tell any of the people
that we live near. She went to Baltimore to have her surgery
done, which is our hometown. And she did not want to share it
with her friends. She was embarrassed. And she literally went
through--what little I could do, I had three small children,
running back and forth to Baltimore, she went through it alone
for that very reason.
And she is absolutely fine, I am very happy to say now. But
what a devastating thing to have to go through by yourself
without ever telling her neighbors, which is why she would not
come. I begged her to come with me today, but she would not do
it.
If I could just add one other thing.
Senator Specter. Looks like we may have to issue a subpoena
for her. [Laughter.]
Ms. True. Yes; I do not know. She is 83. I do not know if
it would work. If I could just add one other thing, Senator.
Senator Specter. Please do.
Ms. True. My whole background on the drug issue deals with
prevention. And on that issue, I know how cost affordable
prevention is. And what we are talking about today,
particularly when we get into the cost of mammograms and
preliminary findings, it cannot match what we spend on health
care if someone has been diagnosed or they have waited too
long.
So, I really, in our quest as political people as we go
down the road and talk in town meetings, to emphasize
prevention. I mean, that is where you save money. It might take
money, but you save a great deal more and that is my message.
Senator Specter. Well, thank you very much, Representative
True, for your leadership and for your presence here today.
Ms. True. My pleasure.
Senator Specter. And give our records to your mother.
Ms. True. Thank you.
Senator Specter. Ms. Knight, do you have anything you want
to say in conclusion?
Ms. Knight. No; but I think I mentioned earlier that my
mother is also a 5-year breast cancer survivor. My mother is 76
years old.
Senator Specter. How does she react to what Representative
True says about her mother's embarrassment?
Ms. Knight. My mother is an Alzheimer's patient. So, when
my mother had her breast cancer, it is because we took her in
to be examined. My mother had 6 months of chemotherapy
treatment. She is still on the pill tamoxifen. And her
prognoses were not as good as mine. Out of 14 lymph nodes, 13
were positive. So, for the average woman, she would have died
many years ago.
But my mother being an Alzheimer's has no stress. She does
not know that she has had breast cancer or that she has it. So,
there is no worry. And she will probably live for a very long
time. And she is doing well, even being with Alzheimer's.
Senator Specter. Well, that is a remarkable concurrence, I
would say, on that. Mrs. Anderson, anything further you would
care to say?
Ms. Anderson. Let me say one fact to get it on the record.
When I heard the NIH's decision, I started crying, because I
knew what this meant to women. My husband also wrote a letter
to the editor of the York Dispatch. And when that letter to the
editor appeared in the Dispatch, there was this political
cartoon depicting the deadly confusion of women ages 40 through
49 regarding having a mammogram. Do you have it? Do you not
have it? Do you do this? Do you do that? Whatever. It was just
so poignant that that came out at that point in time.
It is just this whole decision has just set medical history
back so far. And we are trying our best to come forward with
this disease and we are not. Unless women 40 through 49 are
able to have screening mammograms on a yearly basis, we will
not be detecting breast cancer early. And there is no way that
you can tell me that by not having these mammograms, you are
going to detect it early.
conclusion of hearings
Senator Specter. Well, thank you very much, Ms. Anderson,
Ms. Knight, Representative True. This is very helpful. Your
testimony is part of our record for the full subcommittee to
see and for all of Congress to see. I believe that we will be
successful in having mammograms available to women 40 to 49.
That is the preponderant weight of the testimony. And my sense
is we will get there.
So, thank you all very much.
Ms. True. Thank you.
Ms. Knight. Thank you.
Ms. Anderson. Thank you.
Senator Specter. That concludes our hearing, the
subcommittee will recess and reconvene at the call of the
Chair.
[Whereupon, at 11:30 a.m., Monday, March 3, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]