[Senate Hearing 105-178]
[From the U.S. Government Publishing Office]
S. Hrg. 105-178
WINNING THE WAR ON CANCER
AND
MEDICARE: PHYSICIAN PRACTICE EXPENSES
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED FIFTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARINGS
__________
MAY 7, 1997--WASHINGTON, DC
MAY 29, 1997--BEVERLY HILLS, CA
JUNE 19, 1997--WASHINGTON, DC
__________
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
WASHINGTON : 1998
_______________________________________________________________________
For sale by the U.S. Government Printing Office
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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, May 7, 1997
Page
Opening statement of Senator Specter............................. 1
Prepared statement........................................... 2
Statement of Senator Connie Mack, cochair, Senate Cancer
Coalition...................................................... 3
Prepared statement........................................... 5
Statement of Senator Dianne Feinstein, cochair, Senate Cancer
Coalition...................................................... 6
Prepared statement........................................... 8
Opening remarks of Senator Reid.................................. 9
Opening remarks of Senator Lauch Faircloth....................... 10
Statement of Richard Klausner, M.D., Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 13
Prepared statement........................................... 15
Newly diagnosed cancer cases..................................... 16
Statement of Helene G. Brown, director of community applications
of research, Jonsson Comprehensive Cancer Center at UCLA....... 17
Prepared statement........................................... 18
Statement of Sherry Lansing, chairman and CEO, Paramount Pictures
Corp........................................................... 18
Prepared statement........................................... 21
Statement of Sam Donaldson, ABC News, Washington, DC............. 22
Remarks of Senator Harkin........................................ 24
Statement of Ellen Sigal, chairman, Friends of Cancer Research... 26
Prepared statement........................................... 28
Funding needed to fight cancer................................... 29
Statement of Donald S. Coffey, Ph.D., M.D., president-elect,
American Association for Cancer Research....................... 35
Prepared statement........................................... 37
Statement of Arnold Palmer, professional golfer, Arnold Palmer
Enterprises, Latrobe, PA....................................... 38
Prepared statement........................................... 39
Cancer survivor.................................................. 40
Statement of Amy Langer, executive director, National Alliance of
Breast Cancer Organizations.................................... 40
Statement of Toni M. Shaheen, breast cancer survivor, Manmouth
Beach, NJ, introduced by Amy Langer, executive director,
National Alliance of Breast Cancer Organizations............... 41
Prepared statement........................................... 43
Statement of Keith L. Black, M.D., professor, department of
surgery, University of California, Los Angeles................. 44
Prepared statement........................................... 46
Statement of Charles A. Coltman, Jr., M.D., president and CEO,
Cancer Therapy and Research Foundation of Southwest Texas and
director of the San Antonio Cancer Institute................... 47
Prepared statement........................................... 48
Testing.......................................................... 49
Thursday, May 29, 1997
Opening statement of Senator Arlen Specter....................... 55
Statement of Sherman Block, sheriff, Los Angeles, CA............. 57
Prepared statement........................................... 58
Mammograms....................................................... 59
Statement of Sally Field, actress, Los Angeles, CA............... 60
Prepared statement........................................... 61
PSA.............................................................. 61
Statement of Stephen J. Forman, M.D., director, department of
hematology and bone marrow transplantation, staff physician,
department of medical oncology and therapeutics research, City
of Hope National Medical Center, Duarte, CA.................... 62
Prepared statement........................................... 65
Statement of Diane Keaton, actress, Los Angeles, CA.............. 69
Statement of Olivia Newton-John, actress, Beverly Hills, CA...... 71
Prepared statement........................................... 73
Funding.......................................................... 68
Improving mammograms............................................. 74
Statement of Mushtaque Jivani.................................... 75
Statement of Dr. Shari Kahane.................................... 76
Statement of Yocheved Rosenthal.................................. 77
Statement of Anissa Ayala........................................ 78
Statement of Dr. Robin Frasier................................... 79
Statement of Harold P. Freeman, M.D., director, department of
surgery, Harlem Hospital Center, New York, NY.................. 80
Prepared statement........................................... 82
Managed care..................................................... 83
Statement of Jack Klugman, actor, Malibu, CA..................... 84
Prepared statement........................................... 86
Abdominal cancer................................................. 87
Statement of Judd Rose, ABC News correspondent, ``Prime Time
Live,'' New York, NY........................................... 88
Prepared statement........................................... 91
Public impact.................................................... 92
Statement of Steven Weber, actor, Beverly Hills, CA.............. 92
Statement of Owen W. Witte, M.D., professor of microbiology and
developmental immunology, UCLA, investigator, Howard Hughes
Medical Institute, Los Angeles, CA............................. 93
Prepared statement........................................... 95
Molecular genetics............................................... 96
Thursday, June 19, 1997
Opening remarks of Senator Specter............................... 101
Prepared statement........................................... 101
Statement of Kathleen A. Buto, associate administrator for
policy, Health Care Financing Administration, Department of
Health and Human Services...................................... 102
Prepared statement........................................... 104
Statement of Christine Goertz, vice president of research, policy
and information services, American Chiropractic Association.... 109
Prepared statement........................................... 111
Statement of Jay H. Kleiman, Governmental Relations Committee,
American College of Cardiology................................. 112
Prepared statement........................................... 114
Statement of Alan R. Nelson, chief executive officer, American
Society of Internal Medicine................................... 116
Prepared statement........................................... 118
Statement of Donald H. Smith, immediate past president, American
Society of General Surgeons.................................... 112
Prepared statement........................................... 124
Prepared statement of Larry Fitzgerald........................... 126
Statement of John C. Bailar III, M.D., Ph.D., department of
health studies, University of Chicago.......................... 134
Prepared statement........................................... 136
Statement of Richard Klausner, M.D., Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 139
Prepared statement........................................... 141
WINNING THE WAR ON CANCER: PROGRESS AND PROGNOSIS
----------
WEDNESDAY, MAY 7, 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 9:20 a.m., in room SH-216, Hart
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Cochran, Faircloth, Harkin, and
Reid.
NONDEPARTMENTAL WITNESSES
Panel 1--Senate Cancer Coalition
STATEMENTS OF:
SENATOR CONNIE MACK, COCHAIR
SENATOR DIANNE FEINSTEIN, COCHAIR
OPENING STATEMENT OF SENATOR SPECTER
Senator Specter. This room, Senate Hart 216, is the major
hearing room in the U.S. Senate, and there are many hearings of
significance in this room, but I believe today we have a
special hearing as we commemorate the 25th anniversary of the
National Cancer Act and talk about where we have been, what we
have accomplished, but more importantly, perhaps, what remains
to be done.
The President and the Congress came to agreement on Friday
on the general outline of a budget, and I believe that is a
great step forward for America, so that the people of this
country can see that at least sometimes there is agreement in
Washington, DC.
We have a budget of $1,700 billion, and I am personally
convinced that we have the funding to do what is necessary on
medical research with the National Institutes of Health and the
focus on cancer with particularity, and it is a matter of
applying those resources.
Early this year, a group of us joined together--Senator
Mack was a principal sponsor, Senator Feinstein, I, others--in
setting a target of doubling NIH funding over the next 5 years.
That is a very, very ambitious target, but it is one that I
think we can meet.
Senator Harkin, who cochairs this subcommittee and I, set
our mark on a 7\1/2\-percent increase for National Institutes
of Health this year, which is another high mark, $952 million.
We have had increases in NIH funding consistently during my
tenure here. Lots of cuts in the budget, but the National
Institutes of Health has been funded with increases whether the
chairman was Senator Weicker or Senator Lawton Chiles or
Senator Tom Harkin, or, since I have become the chairman we
have made those increases year by year, and we have a very,
very strong case because of the advances which have been made
by the NIH in so many diseases.
Cancer strikes 1.2 million Americans a year. In 1971 the
words, ``you have cancer,'' was tantamount to a death sentence.
Well, it is still a very significant pronouncement to hear.
Testicular cancer death rates have dropped some 66 percent
since the early seventies. Hodgkin's Disease death rates have
dropped 57 percent. Survival for bone cancer grew from 20
percent to 60 percent, and the death rate for childhood
leukemia is down 52 percent.
While we have those statistical improvements, there is a
great deal to be concerned about today. Cancer is the second
leading cause of death in the United States, accounting for 24
percent of the total deaths. There were 1,252,000 new cancer
cases in 1995, the last statistical year available, 547,000
deaths in that year. More than 7 million people have cancer in
the United States, and cancer has the highest rate among
African-American men.
I personally have been the beneficiary of the advances in
technology. I had some mild symptoms, found out I had
meningioma. The initial diagnosis was much tougher, so I know
what it is like to hear the alleged death sentence, and it all
worked out fine. When I had an MRI, I did not know until I had
my own MRI that we have only had the MRI since 1984, and we
really can do much, much more if we establish our priorities.
PREPARED STATEMENT
We have a very distinguished list of witnesses today. These
are the impediments to testimony in this room. There is no
unlimited right to speak, as there is on the Senate floor, and
the green light goes on for 5 minutes, and we would appreciate
if our witnesses can complete their testimony within that
limit, but if you go over that is all right, especially for my
senatorial colleagues, but today all the witnesses are
Senators.
At this time I will put my formal statement into the record
without objection.
[The statement follows:]
Prepared Statement of Senator Specter
Just over 25 years ago the Congress and the President
enacted the National Cancer Act. This legislation catalyzed an
unprecedented effort in science and technology to overcome a
disease that strikes 1.2 million Americans each year. In 1971,
the words: ``you have cancer'' was tantamount to a death
sentence. Today, because of the national cancer program, that
is becoming less so. Since the early seventies:
--Testicular cancer death rates have dropped 66 percent;
--Hodgkin's disease death rates have dropped 57 percent;
--Five year survival rates for bone cancer have improved from 20
percent to 60 percent; and
--The death rate for childhood leukemia is down 52 percent.
I can personally attest to the miracles of modern medicine
and the return on our investment in research. Three years ago,
an MRI detected a benign tumor at the outer edge of my brain.
The tumor was removed by conventional surgery with five days of
hospitalization and five more weeks of recuperation. Last June,
a follow-up MRI detected a small amount of tissue remaining
from the previous tumor . On October 11 of last year, it was
treated with high-powered, focused radiation from the ``gamma
knife.'' I entered the University of Pittsburgh medical center
in the morning, and left that same afternoon, ready to resume
my regular schedule. Like the MRI, the gamma knife is a recent
invention, coming into widespread use.
What we have accomplished as a nation in battling cancer in
the past 25 years has been a lasting legacy for all people. The
advent of genetic therapy, new diagnostic techniques like MRI
and CT scans, and high-tech surgical techniques are just some
of the new weapons in our collective arsenal against cancer.
But we still have many more steps, both big and small, to
accomplish the objective of striking down the death sentence of
cancer.
This subcommittee has the primary responsibility for
funding the war on cancer. Over the past 25 years, we have
appropriated $31.5 billion to the National Cancer Institute.
Like the Chairmen who served before me, including Senator
Harkin, I hold this responsibility with highest regard.
On January 21, I joined with my colleague, Senator Mack, in
introducing Senate Resolution 15 which aims for a doubling of
NIH funding over the next 5 years. While committed to this
goal, I recognize its ambitious nature and am working with my
colleagues on alternative methods of financing in order to
reach this objective. Toward this end, on March 13, Senator
Harkin and I introduced S. 441, a bill to establish a National
Fund For Health Research. Monies from the Fund would provide
the NIH with up to $6 billion more annually through a small
assessment on health insurance premiums. We have gotten a good
response to this proposal and I am optimistic that we can make
progress.
In the meantime, I have expressed publicly a commitment to
a 7.5-percent increase for NIH, or $952 million, and I will be
looking closely at the budget agreement to ensure that it is
sufficient for this subcommittee to support our top priorities,
not only in medical research, but in education as well.
We have assembled here today three panels representing
leaders from the public and private sector, physicians,
scientists, and cancer patients who wish to bear witness to the
progress and to the opportunities that remain to be pursued. It
is an impressive array of witnesses with heartfelt interests,
not only for themselves, but for all people. I look forward to
hearing your testimony.
SUMMARY STATEMENT OF SENATOR MACK
Senator Specter. We are here today to hear first from the
distinguished cochairs of the Senate cancer coalition. I guess
we are proceeding with--I do not know why this has listed
Senator Connie Mack first, but Senator, the floor is yours.
Senator Mack. Thank you, Senator Specter, for convening
this hearing today.
I want to express my appreciation to Senator Reid and
Senator Faircloth for being here as well. This is an important
day for many of us, because it does focus the attention of the
country once again on the disease of cancer.
I want to, Senator Specter, express my deep appreciation to
you and to Senator Harkin. Regardless of whether you were
chairman or ranking member or vice versa, the two of you have
made a commitment to the National Institutes of Health which
has been second to none.
I had the opportunity the other day to speak with some
folks in the pharmaceutical field, and the comment was made
that knowledge drives investment, that as we expand the base of
knowledge, ideas are developed to the point that investors see
opportunities to move into new pharmaceuticals, the potential
for a cure, so it is the development of knowledge that is so
vital, and it is the investment that we make as a country in
the National Institutes of Health through basic research that
develops this expanding base of knowledge which drives
investment which will eventually lead us to a cure.
We are today in a sense celebrating what has been
accomplished over the last 25 years, and a great deal has been
accomplished. Senator Specter made the comment a moment ago
about his experience with cancer and the impact of technology
which became available in 1984. There are literally hundreds,
if not thousands of examples of what has been developed over
the last 25 years from the standpoint of technology.
I come to this hearing this morning, though, wanting to
emphasize the personal side of this. Sometimes I guess I have
in working with Dianne Feinstein, Senator Feinstein over these
last several years with the cancer coalition we have had an
opportunity, I think, Dianne, to really make more and more of
our fellow citizens aware of the disease.
We have played our part, if you will, in making America
more knowledgeable about the disease. We know that if people
are made aware of the signs of the early stages of cancer that
truly lives can be saved. That information has been developed
as a result of our commitment this last 25 years through the
efforts of the Congress and NIH.
I would just say to everyone that we should focus today on
the future and the lives that can be saved. My own personal
experience is one that began in the early 1960's, when my
younger brother, Michael, was diagnosed with melanoma, and
Arlen, when you mentioned hearing those words that somebody had
been diagnosed with cancer, clearly in those days it was a
foregone conclusion in everyone's mind that Michael would die,
and truly he was diagnosed in his early twenties, told he had 6
months to live. He was a fighter, and he lived for 12 years,
and the impact he had on people's lives those 12 years cannot
be measured.
When I ran for the Congress in 1982 I dedicated my
political career to my brother, to Michael. I think in 1982,
when I expressed those words, I really had no idea as to how to
go about playing a role in the fight against cancer. I now know
that in fact, at least in my mind, it is possible to find a
cure for cancer, and that we could eradicate cancer.
Think about what has been going through people's minds
years ago when the pursuit of ridding the world of polio. I am
sure there were plenty who said it could never be done, but
look at the impact on the world and on our country and on our
society today because of the fact that polio has been
eradicated.
Norman Schwarzkopf in this room, at a hearing that was held
by Senator Hatfield and Senator Cohen--as a matter of fact,
their last hearing--Senator, or, excuse me, Norman Schwarzkopf
was here and he was testifying on behalf of those who have been
engaged in this fight against cancer, and he is a prostate
cancer survivor. He said the American people would not stand
for military operation which, like the battle against cancer,
has taken 25 years and claimed 10 million lives.
He in essence went on to say that one day when the American
people fully understand what we are capable of doing they are
going to be mad as hell that we have not acted faster, that we
have not provided more resources to fight this disease.
Travis Roy was at that hearing as well. Travis Roy was a
starter for the Boston University hockey team and while this is
not cancer, it, I think, goes to indicate that--someone said to
me earlier this morning, we are not here solely for investments
in the National Institutes of Health for cancer only. We want
to see the investment in the National Institutes of Health
doubled because we believe that this investment in basic
research can have an effect in all kinds of diseases.
This individual suffered a spinal cord injury which
paralyzed him from the neck down. His comment to us that day
was his hope was that one day I simply want to be able to hug
my mother, and if he had made that statement 25 years ago, most
of us would have concluded that there was no way that that
could possibly happen.
I think what has changed now, why this fight is different,
is because most of us honestly believe that we have developed
to the point that we can develop technology in the future that
in fact can cure so many of these diseases that are affecting
our loved ones.
PREPARED STATEMENT
So again I thank the chairman for allowing me to go on
beyond the assigned time and I commend you and compliment you
for the work you are doing, and indicate to you that Senator
Feinstein and I and others will work with you to make sure that
over this 5 years that we double the investments of NIH.
Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Mack.
[The statement follows:]
Prepared Statement of Senator Connie Mack
Mr. Chairman, thank you for the opportunity to testify at
this important hearing.
This year marks the 25th Anniversary of the National Cancer
Act. With the signing of this historic legislation by President
Richard Nixon, America officially declared a ``war on cancer.''
I believe the most significant benefits of the National
Cancer Act can be summed up in these words--hope and
opportunity.
Twenty-five years ago, when patients were told they had
cancer, they were also told there was not much hope for
survival.
Today, thanks to the scientists at the National Institutes
of Health and in academic research centers throughout our
nation, patients have a realistic hope of beating cancer.
Overall cancer death rates have fallen. New technologies for
the detection and diagnosis of cancer are being developed at a
rapid pace. The Human Genome Project is progressing ahead of
schedule, and it is leading biomedical research in to a
revolutionary era. Cancer patients have immediate access to
information about new methods of treatment, including clinical
trials. America has led the world in the development of more
targeted, and less toxic, ways to treat cancer.
And so today, as we commemorate the 25th anniversary of the
passage of the National Cancer Act, there is indeed great cause
to celebrate the scientific advancements which now bring hope
to patients throughout the world who are diagnosed with cancer.
Now, it is up to Congress and the Administration, along
with our friends in the patient community, to take advantage of
the opportunity to build upon this foundation and conquer this
horrible disease.
Our scientific base of knowledge is such that now is the
time for a bold, new commitment to finding the cure for cancer
and other diseases. We now have the opportunity to make
scientific breakthroughs which, only a decade ago, would have
seemed impossible. Scientists have identified key research
areas where they are poised to make significant advances
including the biology of brain disorders; new preventive
strategies against disease; the development of new therapeutics
such as genetic medicine; new approaches to our understanding
of cell and protein structure through 3-D modeling, and state-
of-the-art instrumentation and computers.
The question is whether the Congress will provide the
necessary resources to take advantage of these and other
scientific opportunities.
I have introduced a Senate resolution to double funding for
the National Institutes of Health over the next five years. I
realize how difficult this will be to achieve. It will mean
tough choices. Spending on some government programs will
undoubtedly have to be reduced.
But I am convinced that Americans are willing to make this
commitment, and they are looking to Congress for the leadership
necessary to achieve this ambitious goal.
What could it mean to average Americans if we doubled our
commitment to biomedical research?
I think back to a hearing of the Senate Committees on
Appropriations and Aging which took place last year. One of the
witnesses who testified was a brave young man from Maine named
Travis Roy. All his life, Travis dreamed of being a
professional hockey player. He had the God-given talent and the
strong desire to achieve his goal. He qualified as a starter
for the Boston University hockey team. Eleven seconds into his
first game, he suffered an injury which left him paralyzed from
the neck down.
Travis Roy knows his dream of being a professional hockey
player is probably gone. Now, he has a new goal. As he told
those of us who were there, ``One day, I simply want to be able
to hug my mother.''
A decade ago, doctors could not offer Travis much hope.
Today, given the outstanding progress that has been made in
spinal cord rejuvenation research, doctors are able give him a
realistic sense that he can, one day, achieve this new goal.
The challenge before us is great. But America has always
responded when our people are behind the challenge. America
landed a man on the moon. We pioneered computer technology.
America won the cold war. Now, it is time for America to win
the war on cancer and other diseases.
We have the knowledge. We have the technology. We have the
support of the American people.
Now is the time for leadership. Now is the time for action.
SUMMARY STATEMENT OF SENATOR FEINSTEIN
Senator Specter. We now turn to the distinguished Senator
from California, Senator Feinstein.
Senator Feinstein. Thank you, Mr. Chairman, Senator
Faircloth, Senator Reid. I am very pleased to be here. It has
been a great pleasure for me to work with Connie Mack. We have
held four hearings in the cancer coalition. I think they have
been useful.
We have done some work on genetics to prevent any insurance
company from discriminating against anyone in their policy on
the basis of genetics. That is now part of legislation that
Congress passed, the law of the land.
We held hearings on environmental risk factors, breast
cancer, and tamoxifen.
I think, Mr. Chairman, the good news is the American Cancer
Society's finding that shows that for the first time since 1900
the death rates of cancer are on the decline. That is good
news. There is a lot of bad news. Part of it is that cancer
kills half-a-million Americans a year, that it will overtake
heart disease by the year 2000.
Lung cancer remains the No. 1 killer of women and breast
cancer the No. 2 killer, now impacting more and more younger
women.
Since the signing of the National Cancer Act in 1971 we
have spent $25 billion on cancer research and yet we still do
not have a cure or, in so many cases, a cause.
In 1996 the National Cancer Institute could fund only 26
percent of its grant applications. That is down from 32 percent
in 1992 so they were actually able to fund fewer grant
requests.
Only 3 cents of every health care dollar is used in this
country for medical research, and NIH's budget is less than 1
percent of the Federal budget, and yet we find in independent
polls that 75 percent of the American people would pay more if
their dollars were used for research.
A recent poll this year in California found that 59
percent--this is a proposition 13 State--59 percent of the
people polled support more taxes if those dollars go for this
kind of research.
I want to just speak about three efforts that are going to
take place. Senator Mack and I have joined together in a bill
that will create a tax checkoff for cancer research. Studies
show that 60 percent of Americans would contribute to medical
research in this way. If the average contribution were just
$10, $410 million could be raised through a tax checkoff. If
the average contribution, which has been average in other
areas, were $23, $1.1 billion for research could be raised in
this way.
I know both Senator Mack and I cordially invite the three
Senators on the dias to become cosponsors of this legislation.
We believe its time has come.
This week, I will also introduce a bill to create some
consistent coverage of screening mammography for women over the
age of 40 in commercial insurance, in Medicare and Medicaid,
consistent with the guidelines of the American Cancer Society
and the National Cancer Institute. Lack of insurance coverage
is a major obstacle in getting regular mammography screening
for women.
The third piece of legislation that I will introduce this
week, and again I would urge people to join with me, is a
breast cancer stamp. This initiative is supported by a host of
cancer institutions, and I would like to ask that their names
be incorporated in my written remarks, if I might.
Senator Specter. Without objection, they will be
incorporated.
Senator Feinstein. Essentially, what we are asking is that
the U.S. Postal Service create, instead of a 32 cent stamp, an
additional stamp, a 33 cent stamp, and that that 1 cent go for
breast cancer research. Research has shown that this could
produce anywhere from $60 million to $300 million a year. If
just 10 percent of those who buy first-class stamps were to buy
the breast cancer stamp, this would mean an additional $60
million a year.
So these three initiatives are going to be taking place
this week, and I would very much hope that every Member would
support them.
Also, Senator D'Amato has authored legislation, of which I
am an original cosponsor, which would end the drive-through
mastectomies and set into law the proviso that hospital stays
should only be determined by the physician in consultation with
the patient, not by insurance companies.
I was appalled to learn from a California constituent who
had a mastectomy at 11:30 a.m., and was pushed out the door at
4:30 that afternoon, virtually unable to stand, not really
understanding even where she was. This kind of medical care has
got to end.
PREPARED STATEMENT
So I see my time is up. I really want to thank you. This is
so important. I think it is the one thing that all Americans
agree on. They want to see their Federal Government doing more
research to end life-taking disease, and I thank you very much,
Mr. Chairman.
Senator Specter. Thank you very much, Senator Feinstein.
[The statement follows:]
Prepared Statement of Senator Dianne Feinstein
Thank you for giving me the opportunity to appear before you this
morning. In looking at where we are as a nation in terms of health
care, there is hardly a higher calling than the goal of eradicating one
of humankind's most dreaded and most devastating diseases--cancer. As
Co-Chair of the Senate Cancer Coalition along with my colleague Senator
Mack, I have made cancer research one of my top priorities.
Even though earlier this year the American Cancer Society announced
new data showing that for the first time since 1900, overall cancer
death rates have shown a sustained decline, we all know that death
rates for some cancers, like cancer of the pancreas and chronic
leukemia in the elderly, are going up. We know that childhood cancer
has risen 11 percent over the past decade.
Cancer kills half a million Americans per year. It will overtake
heart disease as the leading cause of death of Americans by 2000. This
year, 44,190 people will die from breast cancer, the second major cause
of cancer death in women. Lung cancer rates continue to rise; lung
cancer accounts for 29 percent of all cancer deaths. Virtually every
family is touched by cancer at some time. Every person fears it. We
cannot rest until we have found a cure for cancer. And I for one will
not.
There are several issues I would like to highlight today.
REDOUBLE RESEARCH EFFORTS
This subcommittee has given important support to cancer research
over the years and I know you agree that we must not let federal health
research decline. Since the signing of the National Cancer Act in 1971,
we have spent over $25 billion on cancer research, but we do not have a
cure.
The facts tell us a sad story:
In 1996, the National Cancer Institute could only fund 26 percent
of grant applications, a rate that has dropped from 32 percent in 1992.
This low funding rates leaves a vast wealth of knowledge unobtained,
many questions unanswered.
Only 3 cents of every health care dollar spent in this country is
used for research. NIH's budget is less than 1 percent of the federal
budget.
As managed health care insurance expands and plans choose not to
affiliate with academic medical centers, our research institutions are
rapidly losing revenues that have traditionally provided core support
for research.
Biomedical science--and especially cancer research--is on the
cutting edge of many important discoveries, a time when we should be
nourishing our research base, not starving it, to maximize these
explosions in scientific knowledge. For example, we have made
revolutionary advances in understanding genetics in recent years that
help us better understand why cells become cancerous.
A June 1995 national survey by Research America found that 75
percent of the public would pay more for medical research. 94 percent
of Americans believe it is important for the United States to maintain
its role as a world leader in medical research. A May 1996 poll found
that 59 percent of Californians would pay more in taxes to support
medical research.
The United States has always been the world's leader in developing
sophisticated treatments for illnesses and diseases, in making
breakthrough medical discoveries and in improving human life
expectancy. We cannot backslide.
FEINSTEIN EFFORTS
I have taken a number of steps to address the scourge of cancer.
Tax checkoff.--This week, Senator Mack and I will introduce a bill
to create a tax checkoff on tax returns so that citizens can contribute
to a Cancer Research Trust Fund. Studies show that 60 percent of
Americans would contribute to medical research in this way and that if
the average contribution were just $10, $410 million could be raised.
Mammography Coverage.--This week, I will also introduce a bill to
create some consistent insurance coverage of screening mammography for
all women over age 40 in commercial insurance, Medicare and Medicaid,
consistent with the guidelines of the American Cancer Society and the
National Cancer Institute. Lack of insurance coverage is a major
obstacle to getting regular screening mammographies, studies show, and
mammograms save lives.
Breast Cancer Stamp.--I will also introduce a bill requiring the
U.S. Postal Service to create a new stamp, adding 1 cent to the price
of a normal, first-class, 32-cent stamp, and directing USPS to transfer
the funds to the NIH and the Defense Department for breast cancer
research.
Senate Cancer Coalition.--Senator Mack and I have held several
hearings on cancer including a hearing on genetic testing for cancer,
one on the status of breast cancer research, one on the drug tamoxifen,
and one on environmental risk factors for cancer. At the March 6
hearing on environmental risk factors, several witnesses presented
compelling testimony about the geographic disparities in cancer rates
and pressed the need for more research. They called for better
coordination among the 14 federal offices that sponsor environmental
health research.
Clinical Trials Database.--On January 21, along with Senator Snowe,
I introduced S. 87, a bill to set up a toll-free service so that people
with life-threatening diseases and the medical community can
conveniently find out what research projects are underway. This
database is needed so that people--often people in desperate, life-
threatening situations, people who have tried everything--can easily
find possible new treatments. Getting information on health research
projects should not require a ``fishing expedition'' of futile calls,
``good connections,'' computer sophistication or access to top-flight
university medical schools to find out about research on treatments of
disease.
Mastectomy, Reconstruction Coverage.--With Senator D'Amato, I have
introduced S. 249, the Women's Health and Cancer Rights Act of 1997, to
require insurance plans to cover medically-necessary hospital stays,
the length of which would be determined by the physician, in
consultation with the patient. The bill also requires plans to cover
breast reconstruction after a mastectomy and for all cancers, to cover
second opinions by specialists, whether the initial diagnosis is
positive or negative.
Anti-Discrimination Now Law.--Last year, Senator Mack and I
introduced the Genetic Fairness Act, and with others, we succeeded in
including in the Health Insurance Portability Act, now law, a provision
prohibiting insurers from denying insurance on the basis of genetic
information.
I salute you for holding this hearing this morning. Hearing from
this distinguished list of witnesses, who have been personally touched
by cancer, can communicate to the public most graphically the need to
make cancer research funding a top priority of this government. In this
difficult budget climate, let us pledge to work together toward that
end.
OPENING REMARKS OF SENATOR REID
Senator Specter. Senator Reid, do you have an opening
statement?
Senator Reid. Mr. Chairman, I have a number of things I
would like to say. First of all, I would be happy to be joined
as a sponsor of the resolution--your legislation, I am sorry,
to have a tax checkoff. I think that is excellent.
My only suggestion with your breast cancer stamp is, I
think it should be on all stamps. I do not think it should be a
choice. I think it should be a penny on every stamp. It should
go to medical research generally, but that lacking, I will join
you in having a special stamp, which I think is better than
nothing, but not much.
Senator Feinstein. Thank you.
Senator Reid. Mr. Chairman, I think that I would first like
to extend my appreciation to you for the panels that you have
gotten together today. Like happens around here, we have a vote
scheduled at 10 o'clock so we will not be able to join in all
of these.
I appreciate the leadership of Senators Mack and Feinstein.
I think it is commendable that you have done the things you
have already done and I think, Senator Mack, I would say that
as I was waiting to hear you testify I was thinking about how,
as a young boy, I was frightened to death of polio.
I lived in a small rural community, was always worried
about polio. There was a man in town that had a real--he was
hunch-backed and grossly handicapped, and he had had polio as a
young boy.
The same feelings that I had as a boy are now present with
cancer. You know, prostate cancer, one out of every five men,
people around the family and friends dying, getting sick with
cancer, and I believe, as do you, that we can do better.
In testimony we will hear today--I have reviewed the
testimony. The experts that will testify say we are very close
with all of our gene research to finding some breakthroughs not
only to finding better ways of treatment, maybe, to stop
cancer. One part of the testimony today talks about a vaccine
for some type of brain cancer that they think is going to work.
So I again commend you for your leadership. Senator
Specter, thank you very much for convening this hearing, and I
will close by saying that, Senator Feinstein, I think it is
important that we do not talk about all the negative things, as
you started off by indicating there is good news. There is good
news with the work that is being done on cancer research, and
even though there is a lot more to do, we have made significant
progress.
Senator Specter. Thank you very much, Senator Reid.
OPENING REMARKS OF SENATOR LAUCH FAIRCLOTH
Senator Specter. Senator Faircloth, do you have an opening
statement?
Senator Faircloth. Yes; I do have a very brief one, and
again I want to thank you for having the hearing and the panel
that you have put together here. It will certainly attract
attention to something that we all feel very strongly about.
Much progress has been made, as we all know, since
President Nixon signed the National Cancer Act 25 years ago. In
the 1990's we have seen some very encouraging news in that the
overall mortality rate for cancer for the first time has begun
to drop since 1990.
But I am old enough to remember when cancer--as Senator
Mack mentioned earlier that when his brother was 20 years old--
that it was a death sentence. In the thirties and forties when
someone had cancer and even into the fifties it was an
automatic death sentence. There really was not anything they
could do. They just tried to make people comfortable and
watched them slowly die, and that was it. So we have done a
lot, but we need to do a lot more to eradicate the disease.
But I am especially proud that so much of the research and
finding a cure for cancer has taken place in North Carolina.
Duke University especially has had a lead role and was named a
comprehensive cancer center in 1973 by the National Cancer
Institute.
Today, clinics at Duke have more than 100,000 cancer
patient visitors each year. I am proud of what they have been
able to do. I want to commend the panel for coming here this
morning and meeting here to share their experience and
knowledge.
It is a tremendous help when people such as Mr. Donaldson
and Mr. Palmer come and show their support, and it encourages
all Americans to use early detection and prevention and methods
that are available to us today. I think so many younger people
tend to forget when these methods of detection were not
available. You just simply went on until the cancer broke
through somewhere and you were too far gone to do anything
about it.
So I want to thank you, Senator Specter, and all of the
panelists, for what they have done to bring this to the
forefront of the American people. I thank you.
Senator Specter. Thank you very much.
Senator Mack. Mr. Chairman, if I could just make one
comment with respect to what Senator Reid said a moment ago, he
is absolutely right to focus us on the positive.
I am reminded that my wife, Priscilla, who is a breast
cancer survivor, just about I guess 10 days ago, 2 weeks ago
had a luncheon here in Washington. It was a luncheon of
survivors. The message is that in fact you can beat the
disease, that, for example, in certain types of breast cancer,
if detected early, 94 percent curable.
So you are absolutely right, we need to keep people focused
on the idea that if you catch the disease early you can whip
it. So thank you for raising that point.
Senator Specter. Thank you, Senator Mack. We do have a vote
at 10 o'clock. My suggestion would be that we limit our
questions to one for the two panels here on the first round.
I am frequently asked a question, and was this morning
earlier, what can be done in a practical sense to increase
funding for cancer, increase funding for the National
Institutes of Health, and I would be interested in a response
from Senator Feinstein and Senator Mack, and the response that
I give is to contact your Member of the House and your Member
in the Senate and to get your peers to do the same thing.
It is much more effective if you are going to try to
influence the Member from Congress in Wisconsin illustratively
to have people from that district contact him. I still have
160,000 unanswered letters from one of the Supreme Court
hearings from out of State. I answer all the ones from in-
State, but get somebody in-State and in the district to do so.
When the 104th Congress came in in 1995 and we had a new
attitude in the House, the funding for the National Institutes
of Health was cut by more than $900 million, and when the
matter came to the Senate on the budget resolution a
characteristic for the majority to have the amendment offered,
and there was a Hatfield-Specter-Kassebaum--Senator Hatfield as
chairman of the Appropriations Committee, I as chairman of the
subcommittee, and Senator Nancy Kassebaum, she chaired the
authorizing committee, and we reinstated those funds.
One of the difficulties, and I think this has to be talked
about and pressed, is the necessity for a center in the Senate
and the House. We do not have Senator Hatfield any more, and we
do not have Senator Kassebaum any more, and that puts a greater
obligation on the part of the American people to tell their
elected representatives where their priorities are.
We have enough money to do the job if we establish the
priorities. Senator Feinstein, I would appreciate your thinking
as to how we can raise enough money in the Federal budget. What
action would you recommend?
Senator Feinstein. The first thing I think of is, will
money really help, will money really solve the problem, and my
answer to that is a resounding yes, because I really believe
that cancer is going to be solved, and we are going to find the
cause, and we are going to find a cure, and that is solidly
dependent on research, and I think what has been done in
genetic research today, the research that is going on on
environmental risk factors for cancer, are really vital.
The immunological studies that are going on that can
produce changes in the immune system to ward off cancer cells I
think is extraordinarily important, and if you think about it,
Government is really where the great bulk of this money has to
come from. I also believe that the kinds of individual
initiatives, whether it is a breast cancer stamp, a tax
checkoff, other things that we can think of to encourage the
private contribution to this kind of major research is also
critical.
But you are right, Senator, people have to rally and say,
we want you to do this, so that there is that solid bulwark of
support to increase the appropriations.
Senator Specter. Senator Mack, what is your best
recommendation?
Senator Mack. I would build on your recommendation, and you
are exactly right, we all know that with all of the different
issues and problems facing our country, if we do not get
focused on something it is very hard to move something here.
So I think what we have to decide, those of us who have
been interested in this issue, is really what is kind of like
our No. 1, No. 2, and No. 3, what are our top priorities, and I
think that the No. 1 top priority, frankly, is the doubling of
research over 5 years. That ought to become the mantra, if you
will.
If we can communicate a clear message to those who are
interested in this fight, then I think it is easier for them to
deliver a clear message to their representative about what to
support.
And of course I would say that I think the key thing to do
is doubling the research in 5 years. That ought to be the
message we deliver. That ought to be the message we encourage
people back home to deliver to their representatives.
Senator Specter. Senator Reid.
Senator Reid. I think that is commendable. If you look at
the number of grants that now are able to be filled, it is I
think 26 percent. It was 32 percent, or a number similar to
that. If we double the funding maybe half the research grants
requested would be able to be met, which would be a significant
increase.
So other than that, Mr. Chairman, I have no further
questions.
Senator Specter. Thank you, Senator Reid.
Senator Reid. Senator Faircloth.
Senator Faircloth. I do not have any questions. Thank you,
Mr. Chairman.
Senator Specter. Thank you very much, Senator Feinstein.
Senator Mack, we will see you at the vote.
Panel 2
STATEMENTS OF:
RICHARD KLAUSNER, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
SHERRY LANSING, CHAIRMAN AND CEO, PARAMOUNT PICTURES CORP.,
INTRODUCED BY HELENE G. BROWN, DIRECTOR OF COMMUNITY
APPLICATIONS OF RESEARCH, JONSSON COMPREHENSIVE CANCER
CENTER AT UCLA
SAM DONALDSON, ABC NEWS
ELLEN SIGAL, CHAIRMAN, FRIENDS OF CANCER RESEARCH
INTRODUCTION OF PANEL
Senator Specter. I would like to call our second panel. Dr.
Richard Klausner, Ms. Helene Brown, who will introduce Ms.
Sherry Lansing, Mr. Sam Donaldson, and Ms. Ellen Sigal.
We are going to lead our testimony today with Dr. Richard
Klausner, who is the Director of the National Cancer Institute.
He took that job on August 1 of this year. Since 1984 he has
been Chief of the Cell Biology and Metabolism Branch of the
National Institute of Child Health and Human Development. Dr.
Klausner was an undergraduate at Yale, medical degree at Duke
University, well-known for his contributions to multiple
aspects of cell and molecular biology.
Welcome, Dr. Klausner. The floor is yours.
SUMMARY STATEMENT OF DR. KLAUSNER
Dr. Klausner. Good morning, Senator Specter. As you said, I
am Richard Klausner. I am Director of the National Cancer
Institute, actually since almost 2 years ago. I am pleased once
again to have the honor of appearing before your subcommittee.
After 20 years of our war on cancer, we have as you have
said some victories to report. Some cancers previously carrying
a rapid and inevitable death sentence are now, incredibly,
curable and, as we have heard, the overall mortality rate from
cancer, the overall rate is falling, yet as we sit here this
morning over 450 Americans will be newly diagnosed with cancer,
and over 150 will die.
The progress we have made is a direct result of research
which has begun to eliminate the causes of cancer, allowing
effective prevention for some cancers, the development of
vastly improved methods of early detection and diagnosis, and
producing new therapies with increasingly real and measurable
efficacy.
The good news is that we have tested the very premise of
the war that this Nation has supported. That premise is that
progress is predicated on research, and we have found that
premise to hold true, but as the grim statistics and the
stories of tens of millions of survivors, the stories of their
families and friends, and the stories of those who have not
survived tell us, we have a long way to go.
I believe, however, we are at a turning point in this war.
It is hard to adequately describe the profound advances in the
science of cancer research and in the revolutionary
technologies that have given us the power to attach these
diseases in ways we could not imagine just a few years ago.
All cancers, we now know, arise because of a slow
accumulation of changes in a small number of the hundred
thousand or so instructions that determine the behavior of each
cell. There is no one cause of these changes, and there is no
one cause of cancer. Chemicals like those found in tobacco
smoke, viruses, radiation, sunlight, and the inevitable
mistakes made each time one of the hundreds of trillions of
cells in our body have to copy the DNA in which those
instructions are written all contribute to cancer.
Identifying the causes is the key to prevention. Diet,
exercise, hormones, and our genetic makeup in ways often still
mysterious profoundly modify the risk of cancer. But cancer is
not something that just happens. It does not happen at the
moment one receives that awful diagnosis. It arises out of a
long process that we are now beginning to unravel.
All cancer evolves from precancer, and we now can begin to
design how to detect and how to treat not cancer, but
precancer.
Let me give you an example. Colorectal cancer is the second
most common killer from cancer in the United States. 145,000
new cases this year. In the vast majority of cases there is a
loss of one of those instructions, one specific gene product
which we call APC, and this happens in 85 percent of those
cases, and very early.
This gene was actually discovered by studying a very rare
familial syndrome of hereditary cancer. This molecular change
results in the activation of another gene, one which encodes an
enzyme which actually is inhibited by anti-inflammatories such
as aspirin.
This, coupled with epidemiologic observations that anti-
inflammatories may reduce the risk of colorectal cancer is
leading to the search for new and more effective drugs that
inhibit this enzyme, and clinical trials are aimed at such
specific targets in hopes of preventing the development and
recurrence of this cancer. This is the type of process we are
ready for for all cancers, for new preventions, and new
therapies.
Will it work? We do not know, but we will not know unless
we try, and we will not know what to try unless we capture the
opportunities that our new discoveries are daily yielding.
We can, I am convinced, as you have heard, develop new ways
to predict the behavior of each cancer and determine how to
design and target therapies the way we do with antibiotics,
with anti-cholesterol-lowering drugs, and with the new protease
inhibitors for HIV.
Some of these new strategies are aimed at getting cancer
cells to commit suicide, others at slowing down the motor that
drive cancer cells, others at getting the immune system to
recognize and attack cancer cells, others at attacking the
unique ways that cancer develops its own blood supply to supply
its own nutrients. All of this is based on specific knowledge.
Imagine engineering a virus, engineering it to only kill
cancer cells. Such a virus has been made. It is now being
tested. It is being tested in clinical trials.
This year, 20,000 patients will be enrolled into one of
over 700 NCI-sponsored clinical trials. These clinical trials
are the only way to test therapies and preventions of tomorrow
which must replace the inadequate approaches we have today.
Despite the enormous size of this process, only 2 percent
of adults with cancer enter into clinical trials, limiting our
ability to test promising leads, and limiting the speed with
which we get these answers.
Senator Specter. Dr. Klausner, we are about to come to a
vote. If you would summarize it, I would appreciate it.
Dr. Klausner. This is a time in cancer research, as I know
you have heard me say, that many of us approach with
extraordinary optimism. We know the road to take. We do not
know how long that road is going to be.
PREPARED STATEMENT
We at the NCI have been planning with all of our
communities about how we must be prepared to make new
investments in the extraordinary opportunities now available.
The challenge before us is to step up to these new
opportunities to make sure that however long that road is we
travel on it at full speed.
Thank you very much.
[The statement follows:]
Prepared Statement of Richard D. Klausner, M.D.
Good morning, Senator Specter. I am Dr. Richard Klausner,
Director of the National Cancer Institute. I am pleased to have
the honor of appearing before the Subcommittee today.
After twenty years of our ``War on Cancer,'' we have some
victories to report--some cancers, previously carrying a rapid
death sentence are now, incredibly, curable--overall cancer
mortality rates are, for the first time, beginning to fall.
Yet, as we sit here this morning, over 450 people will be
newly diagnosed with cancer and over 150 more Americans will
die. The progress we have made is a direct result of research
which has begun to illuminate the causes of cancer--allowing
effective prevention for some cancers, development of vastly
improved methods of early detection and diagnosis and producing
new therapies of increasing efficacy. The good news is that we
have tested the very premise of the war which this Nation has
supported--the premise that progress is predicated on
research--and found that premise to hold true. But as the grim
statistics and the stories of the tens of millions of survivors
and families and friends of survivors and of those who have not
survived tell us, we have a long way to go.
I believe we are at a defining point in this war. It is
hard to adequately describe the profound advances in the
science of cancer research and in the revolutionary
technologies that give us powerful tools to attack these
diseases--but let me try.
All cancer arises because of the slow accumulation of
changes in the set of the 80-100,000 instructions that
determine the behavior of each of our cells. There is no one
cause of these changes and no one cause of cancer. Chemicals,
like those found in tobacco smoke, viruses, radiation, sunlight
and the inevitable mistakes made each time each cell copies the
DNA on which those instructions are written, all contribute to
cancer. Identifying cause is the key to prevention. Diet,
exercise, hormones and our genetic makeup, in ways still
mysterious, profoundly modify the risks of cancer.
Cancer is not something that just happens--it arises out of
a long process that we are only now actually unravelling. All
cancer evolves from pre-cancer and we can now begin to design
how to detect and treat pre-cancer. Let me give you an example.
Colorectal cancer is the second most common cancer killer. In
the vast majority of cases, there is a loss of the function of
one specific gene product called APC. This was actually
discovered by studying a relatively uncommon hereditary colon
cancer syndrome. This molecular change results in the
activation of another gene which instructs the cells to make an
enzyme that is one of the targets of anti-inflammatory drugs
like aspirin. This, coupled with observations that aspirin and
other anti-inflammatories may prevent colon cancer, is leading
to the search for new and more effective drugs and to clinical
trials that are aimed at this specific target in hopes of
preventing the development or recurrence of this cancer. This
is the type of process that we are ready to repeat for new
preventions and new therapies not blind guesses but targeted
choices based upon real knowledge of the machinery of each
cancer. Will it work? We will not know if we do not try and we
will not know what to try if we do not capture the
opportunities for discovery.
We can, I am convinced, develop new ways to predict the
behavior of each cancer, whether it needs to be treated,
whether it will respond to therapy and what therapy will
actually work. This is the new promise of molecular
diagnostics. The explosion of new ideas about the specific
machinery of cancer cells is beginning to result in the design
of therapies against cancer much like the use of antibiotics,
anti-cholesterol agents and the new anti-HIV drugs. Some of
these new strategies are based on turning off the motors that
make cancer cells grow, some are based on strategies to trick
cancer cells to commit suicide, some on harnessing the immune
system to seek out and destroy cancer cells and some on
destroying the unique ways that cancers assure their own blood
supply. All of these are based on specific knowledge about
cancer That is where the research is taking us.
One recent therapeutic advance illustrates how cancer
therapy is being altered by our new understanding of the
molecular characteristics of cancer. Researchers at the NCI, in
collaboration with extramural investigators, have been testing
new treatment regimens for a particularly aggressive form of
lymphoma. A 5-drug regimen resulted in an apparent cure, or
long-term remission in about 50 percent of the patients. The
remainder either failed to respond or rapidly relapsed. What
was different? In virtually all of the relapsed patients, their
cancer cells harbored a mutation in the p53 gene, a gene whose
loss of function is implicated in over 50 percent of all human
cancer. What had been called one cancer was clearly at least
two distinct diseases. Recently, the investigators evaluated a
newer regimen with three additional drugs and have observed
long-term remission, hopefully cure, in 90 percent of all of
these patients. This example illustrates a principle that is
guiding a transformation in oncology. We can begin to identify
the defining characteristics of any cancer. It is this set of
alterations that will define the actual targets for therapy.
Imagine engineering a virus to only kill tumor cells--a
virus tailored to recognize a gene altered in 50 percent of all
human cancers. It has been done and is now being tested in
clinical trials. This year, 20,000 new patients will be
enrolled onto one of over 500 NCI-sponsored clinical trials
This is the only way to test the therapies and preventions of
tomorrow which must replace the inadequate therapies of today.
Despite the size of our national clinical trials system, only 2
percent of cancer patients enter clinical trials limiting the
number of promising leads tested and the speed with which we
answer critical questions.
This is a time in cancer research that all of us approach
with a new optimism. We know the road to take. Unfortunately,
we don't know how long that road is. We, at the National Cancer
Institute, have been planning for how we must be prepared to
make new investments in the extraordinary opportunities now
available. The challenge before all of us is to step up to
these new opportunities to make sure at, however long the road
is, it is one we travel at full speed.
Mr. Chairman, that concludes my prepared testimony. I would
be pleased to answer any questions.
NEWLY DIAGNOSED CANCER CASES
Senator Specter. Thank you, Dr. Klausner. You talk about
450 newly diagnosed cancer cases. I would add an addendum at
this point that those who are diagnosed do not have to accept
that.
I was diagnosed and told I had 3 to 6 weeks to live, and I
did not accept that. We got a second opinion and moved
promptly, and I do believe the doctor was wrong. It was not
true, and I do believe, and I think it is important for
patients to take a very active role in their own care and to
undertake some substantial studies.
Just another parenthetical note. I took a look at what is
called the gamma knife and had to talk to about 35 doctors
around the world, and a lot of doctors did not like the idea
because it was not conventional, but there is a big body of
opinion out there on the periphery which says it is a good
thing, so that a patient ought to be a real activist. I might
say, even if you are dealing with lawyers. [Laughter.]
SUMMARY STATEMENT OF HELENE G. BROWN
We will turn now to Ms. Helene Brown, who will introduce
Ms. Sherry Lansing.
Ms. Brown has been a leading activist in the fight against
cancer, responsible for implementing the mass media approach to
the promotion of the new pap smear in the 1950's and 1960's.
Ms. Brown, why do we not turn to you, and I will introduce
Ms. Lansing myself. [Laughter.]
Ms. Brown. Somehow, Senator Specter, I expected that.
[Laughter.]
Senator Specter. Well, I had not, but it seemed to me a
good thing to do.
Ms. Brown. Thank you.
Senator Specter, Senator Reid and guests here today, I come
as a spokesman for 15 million donors to the American Cancer
Society, the voluntary arm in the community supporting cancer
research as well as the things you just spoke of, Senator
Specter, lifestyle changes, the way in which patients can,
indeed, help themselves.
There are three points that I will make, and you do not
have to fuss with your lights because I will be way under the
5-minute period of time, but first the majority of people in
this country have forever given charitably to cancer research,
to cancer causes.
They do that with what we call leftover dollars, if you
will, not to denigrate the money but to indicate that they
think of it as a charity, and what I would like to do today,
what the 15 million people out there would like to do and all
of us on these panels, is to turn away from Congress looking at
cancer research as if it is a charity and look at it better as
an investment, because we know what kind of an enormous and
beautiful investment it is.
Congress knew this in 1930, 1937 when the first cancer act
was passed, and again in 1971, when the next cancer act was
passed. The result is that since the 1930's life expectancy has
moved from about 48 years to approximately 78 years. Now, if
that is not one beautiful investment in our country, I do not
know what is.
The pharmaceutical industry in this Nation depends upon the
basic science research that is brought about by Government, and
in our view Government is here to do what the private sector
cannot or will not do, and voluntarily they have never given
enough money to do the kind of work that we can get done
through the doubling of the cancer research budget by the
National Cancer Institute, by you, Senator Specter, and the
Congressmen that you represent.
Last, I want to simply say that the monumental explosion of
knowledge that Dr. Klausner has just described to us is
something that has never happened before, only since what we
used to call the golden age of medicine. That was when we
discovered antibiotics and immunizations. There have been
several references made to that this morning.
This is indeed, in our opinion, the second golden age of
medicine that is about to come upon us. A doubling of this
research budget within the next 5 years will give us the
investment in the pharmaceutical industry, in business, in
parents, in children, in the collection of taxes and the buying
of stamps and all of this that we think will make an enormous
difference in this country.
PREPARED STATEMENT
Senator Specter, we join you, Senator Mack, Senator
Feinstein, in stepping up to the plate. We need a home run in
this, and to make this the mantra of the country, the highest
priority possible, is what we are asking of you today.
Thank you so much for listening to us.
[The statement follows:]
Prepared Statement of Helene G. Brown
Mr. Chairman and members of the committee: In most of the
country, people believe that cancer research is a charity that
one contributes to with leftover dollars. In the hall of
Congress, you and we know better. History tells us that
voluntarily people have never and will never give enough to
support the level of scientific discovery that we have
witnessed in the past several decades. Congress knew that in
the 1930's, when Federal expenditures for scientific
advancement began in earnest. Now life expectancy has increase
from 48 years at the turn of the century to the 78 years that
it is today.
We know cancer research to be a major contributor to one of
the most successful business in America, the pharmaceutical
industry. We know that in recent years cancer research has
succeeded in saving more young lives and that the years of life
saved of a young person add considerably to our gross national
product, to our collection of taxes, to the growth of families,
of business, of talent, of scientists, and yes, of our future
politicians and a future President.
We, in this room, know of the potential that is now within
reach in genetic discovery because of what your federal funding
has accomplished in the past. We now know that all diseases
have a genetic component. Cystic fibrosis is viewed as having a
75-percent dependence on genetic makeup, adult diabetes may be
50 percent attributable to genes, and AIDS may be as little as
1 percent genetically based. So, as much as we know and will
know about genes and how they cause cancer, we also know that
treatments will necessarily be combined to include lifestyle
changes and medicine, along with the results of the study of
epidemiology (the study of that which causes cancer in our
lifestyle, like smoking, or in our surroundings, like ionizing
radiation) in order to prevent cancer as well as to cure it.
And please do not forget that an ounce of prevention is still
worth a pound of cure.
We all know that our expectations and limitations are
totally and fully dependent on money. In the final analysis
that's where the rubber hits the road. If we fund cancer
research by doubling the current budget, we will get there and
we will get there sooner. If we do not accept that challenge,
we will literally cripple a monumental effort with every
indication of a monumental payoff that will impact your life,
mine, and that of all our children and grandchildren. I do not
want that pox on my house. And I do not believe you want it on
yours. Please double this budget as soon as you can * * * it is
not a question of should it be but when will it be?
Please accept my appreciation for this time before you and
your patience with these candid remarks.
Senator Specter. Thank you, Ms. Brown.
As I had said earlier, we have a vote on. We vote at
irregular times in the Senate, and votes take precedence over
every other activity, and so I am going to excuse myself for a
few moments. I should be back within 10 minutes, and we will
resume at that time.
[A brief recess was taken.]
SUMMARY STATEMENT OF SHERRY LANSING
Senator Specter. Our hearing will resume, and we will
proceed with the testimony of Ms. Sherry Lansing, the chairman
and CEO of the motion picture group, Paramount Pictures Corp.
She had previously had her own independent production company
at Paramount, and has had an illustrious career in the
industry, movies, and television, in 1980 was president of
production at 20th Century Fox, the first woman to hold that
position in the industry.
She has had a long list of extraordinary achievements in
the industry, ``Indecent Proposal,'' ``Fatal Attraction,''
``Black Rain,'' ``The Accused,'' and the list too long to
enumerate--so we now turn to you, Ms. Lansing. Thank you for
joining us, and the floor is yours.
Ms. Lansing. Thank you. Thank you, Mr. Chairman and members
of the committee. It is truly an honor for me to testify before
you today, and I come here because I believe so deeply in the
importance of cancer research.
I have had a long and personal history with this disease.
Over 30 years ago I remember attending a black tie event which
was to raise funds for cancer research. At that time, a very
articulate representative from the American Cancer Society got
up to speak. He spoke about the horrors of cancer, about the
nature of the disease and the advances that were being made.
I barely listened. I was having too good a time, and I
simply did not want to be interrupted. I certainly did not want
to think about anything as unpleasant as disease or sickness.
He then said that one out of three people get cancer. Turn to
your right. Turn to your left. One of you will get cancer.
At that time, that statistic held absolutely no meaning for
me. I could not relate to it. I did not have cancer, and no one
I knew had cancer. It was simply somebody else's problem.
Then, several months later, my mother, Margot, called and
she told me she was not feeling well. She had a distended
stomach. I laughed, and I told her it must be all the good food
that she was eating. No doubt she had just been careless in
watching her weight.
Margot went to numerous doctors as the pain continued. One
doctor told her that it was diverticulitis. Medicine was
prescribed, but it just did not seem to do any good.
Still, I did not take it too seriously. My mother was such
a healthy and such a happy woman. She was so very young and so
very vital. Nothing bad could happen to her. Nothing bad could
happen to me.
As the pain persisted, my mother went to a specialist at
the University of Chicago, and we were told that my mother,
Margot, had ovarian cancer. Turn to your right. Turn to your
left. One out of three people get cancer. Turn to your right.
Turn to your left. One of you will get cancer.
Suddenly, that statistic was no longer a remote and a
meaningless one. Suddenly my family was no longer invincible,
because that statistic had become a chilling reality.
For the next 18 months, I watched as my mother struggled to
defeat this disease. I watched the pain, the false hopes, the
humiliation, and I watched as the cancer ate her body. My
mother's will to live could not stop this disease. No amount of
positive thinking could save her. No amount of love could
prevent her death.
I hate cancer. I hate it in a way that I have never hated
anything in my entire life. It causes incredible pain and
suffering in an almost random way. It knows no class barriers,
no race, no religion or gender. Rich or poor, we get it. Rich
or poor, we die the same.
Throughout the years, cancer has struck my loved ones, my
friends, and my professional associates. I sometimes feel as if
cancer is really a plague, as I pick up one phone call after
another and I learn of another friend who has been struck by
this disease, but that is just what it is, a disease. As in the
case of other diseases that used to cause fear, it can and it
will be cured.
I, too, remember when we were all growing up and you were
afraid to go to the beach because you were afraid you would get
polio. Similar stories abound about tuberculosis and smallpox,
and some day, I know, in the not-too-distant future we will be
sitting around and we will telling stories about the big C, and
in that not-too-distant future we will no longer hate cancer
and we will no longer be frightened by it. It will no longer
hold power over us, because it will no longer exist.
So I come to you today to ask you to try to finally put an
end to this disease. This year, nearly 1.4 million Americans
will be diagnosed with cancer, and about 560,000 will die of
it, more than 1,500 every day. These statistics are simply
unbearable when you realize that cancer research, when pursued
aggressively, can help diagnose, treat, cure, and prevent this
terrible disease.
Hollywood obviously has not been immune to cancer. In
February, following a meeting with Vice President Gore and NCI
Director Rick Klausner, my colleagues and I formed the creative
community task force which will work in conjunction with
Friends of Cancer Research.
This task force, which Jack Valenti and I chair, includes
all the senior executives at the major studios and broadcast
networks, as well as independent producers, writers, actors,
and directors.
Our task force agenda is an aggressive one. First, we are
committed to use our television, film, and other programming to
communicate what actions people can actually take to fight
cancer, actions such as supporting cancer research, modifying
diet, and scheduling regular diagnostic exams.
At the request of the Vice President, we also are
evaluating how our industry, as well as the Government, can
help in the fight against teen smoking.
Second, we will be public advocates for cancer research
ourselves. We have visibility and the opportunity to talk to
the public about these issues in the media. The task force will
become an important, visible voice, similar to the AIDS lobby.
We intend to mobilize the public as well as the Government for
increased emphasis on cancer awareness and cancer research.
I do not want my mother to have died in vain. I do not want
my friends and my associates to have died in vain. I want, as
we all want, to defeat and eradicate this disease.
So in closing, Mr. Chairman, I would like to thank you for
your leadership in the area of biomedical research. You are one
of the original cosponsors of Senate Resolution 15, introduced
as well by Senator Mack, which calls for the doubling in
Federal funding for cancer research over the next 5 years.
PREPARED STATEMENT
I sincerely hope that all of your colleagues will join you
in supporting this goal, and so it is in that spirit that I
thank you for your time and for the privilege of testifying
before you.
Senator Specter. Thank you very much, Ms. Lansing.
[The statement follows:]
Prepared Statement of Sherry Lansing
Mr. Chairman and members of the committee, it is an honor
for me to testify before you today; I do so because I believe
so deeply in the importance of cancer research.
I have had a long and personal history with this disease.
Over 30 years ago I remember attending a black tie event to
raise funds for cancer research. At that time, a very
articulate representative from the American Cancer Society got
up to speak. He spoke about the horrors of cancer, about the
nature of the disease and the advances that were being made. I
barely listened. I was having too good a time and I didn't want
to be interrupted. I certainly didn't want to think about
anything as unpleasant as disease or sickness. He then said
that one out of three people get cancer. Turn to your right,
turn to your left * * * one of you will get cancer. That
statistic held absolutely no meaning for me, I couldn't relate
to it. I didn't have cancer. No one I knew had cancer. It was
simply someone else's problem.
Then, several months later my mother Margot called and told
me that she wasn't feeling well. She had a distended stomach. I
laughed and told her it must be all the good food she was
eating--no doubt, she has been careless in watching her weight.
Margot went to numerous doctors as the pain continued. One told
her it was diverticulitis. Medicine was prescribed, but it
didn't seem to do any good. Still I didn't take it too
seriously. My mother was such a health and happy woman. She was
so very young--so very vital. Nothing bad could happen to her--
nothing bad could happen to me.
As the pain persisted, my mother went to a specialist at
the University of Chicago, and we were told that my mother
Margot had ovarian cancer. Turn to your right, turn to your
left * * * one out of three people get cancer. Turn to your
right * * * turn to your left, one of you will get cancer.
Suddenly that statistic was no longer a remote and meaningless
one * * * suddenly my family was no longer invincible, that
statistic has become a chilling reality.
For the next 18 months I watched my mother struggle to
defeat this disease. I watched the pain, the false hopes, the
humiliation and I watched as the cancer ate her body. My
mother's will to live could not stop the disease. No amount of
positive thinking could save her. No amount of love could
prevent her death.
I hate cancer. I hate it in a way I've never hated anything
in my life. It causes incredible pain and suffering in an
almost random way. It knows no class barriers, no race or
religion or gender. Rich or poor we get it. Rich or poor we die
the same. Throughout the years cancer has struck my loved ones,
my friends and my professional associates. I often feel as if
cancer is really a plague as I pick up one phone call after
another and learn of another friend who has been struck by this
disease.
But that's just what it is, a disease. And as in the cases
of other diseases that used to cause fear, it can and will be
cured. Remember when we were all growing up and you couldn't go
to the beach because you could get polio? Similar stories
abound about tuberculosis and small pox. And someday in the not
too distant future we will all be sitting around and telling
stories about the big C. And in that not too distant future, we
will no longer hate cancer or be frightened by it. It will no
longer hold power over us because it will no longer exist.
And so I come before you today to ask you to try to finally
put an end to this disease. This year, nearly 1.4 million
Americans will be diagnosed with cancer, and about 560,000 will
die of it--more than 1,500 every day. These statistics are
unbearable when you realize that cancer research--if pursued
aggressively--can help diagnose, treat, cure, and prevent this
terrible disease.
Obviously, Hollywood has not been immune to cancer. In
February, following a meeting with Vice President Gore and NCI
Director Rick Klausner, my colleagues and I formed the Creative
Community Task Force to work in conjunction with Friends of
Cancer Research. The Task Force--which Jack Valenti and I
chair--includes all of the senior executives at the major
studios and broadcast networks, as well as independent
producers, writers, actors, and directors. Our Task Force
agenda is an aggressive one.
First, we will use our TV, film and other programming to
communicate what actions people can take to fight cancer--
actions such as supporting cancer research, modifying diet, and
scheduling regular diagnostic exams. At the request of the Vice
President, we also are evaluating how our industry, as well as
the government, can help in the fight against teen smoking.
Second, we will be public advocates for cancer research
ourselves. We have the visibility and the opportunity to talk
to the public about this issue in the media. The Task Force
will become an important visible voice--similar to the AIDS
lobby--to mobilize the public as well as the government for
increased emphasis on cancer awareness and cancer research.
I do not want my mother to have died in vain. I do not want
my friends and my associates to have died in vain. I want, as
we all want, to defeat and eradicate this disease.
In closing Mr. Chairman, I would like to commend you for
your leadership in the area of biomedical research. You were
one of the original cosponsors of Senate Resolution 15,
introduced by Senator Mack, which calls for a doubling in
federal funding for cancer research over the next 5 year. I
hope that your colleagues will join with you to support this
goal.
And it is in that I thank you for your time and for the
privilege of testifying before you all.
SUMMARY STATEMENT OF SAM DONALDSON
Senator Specter. We turn now to Mr. Sam Donaldson,
distinguished broadcast journalist, a 29-year veteran of ABC
News, coanchor of ``Primetime Live,'' and ``This Week,'' a long
list of accomplishments. It is a special pleasure for me to
welcome Mr. Donaldson here, because this will give me a chance
to question him. [Laughter.]
Mr. Donaldson. I trust you will show me the same deference
that I have shown you when you have come to ``This Week,''
Senator. [Laughter.]
Senator Specter. No; I am going to be a lot nicer to you.
[Laughter.]
I am not sure, but I think this hearing was scheduled
before I was on ``This Week'' recently, and I have to say that
on one occasion Sam let me finish an answer. [Laughter.]
So that may have been in anticipation.
We have been joined by our distinguished colleague, Senator
Cochran. I had a brief chat with Thad at the last vote, and he
said, is Donaldson really going to be there, and I said, yeah,
and when Senator Cochran's turn comes you will see a
distinguished trial lawyer in operation. [Laughter.]
Well, we welcome you here, Sam. You have had your own
experiences and become an outstanding advocate and focused a
lot of public attention, and we look forward to your testimony.
Mr. Donaldson. Senator Specter, thank you for holding this
hearing.
Now, you said that Senators Hatfield and Kassebaum are no
longer with us in the Senate, that is true, but you are here,
and you are on the large side of this one, and we appreciate
that very much.
Senator Cochran, thank you for coming today, too. I know
that you know something about cancer and that you, too, are on
the right side of the Pearly Gates--not yet literally, you
understand. [Laughter.]
In January 1988 a wart on my ankle which I had had for
years and years and years did not look right. I went to the
doctor. He said, we have got to have this off, and I do not
want to frighten you, but we have to check it to see whether it
is melanoma.
Well, he frightened me, and they sent the tissue to three
separate laboratories. The first one said it was not, and the
doctor said, I do not know, we had better check this some more,
and all three said that it had not turned.
Well, I went home happy and go-lucky, jaunting, arrogant as
usual, and then in the summer of 1995 I felt a lump in my groin
in the shower, and to me it had come up overnight. Well, I knew
that was not good, and I went to the doctor, another one, and
he said, what is this on your ankle? I said, it is a scar. It
did not matter. I told him the story and he said, well, I do
not want to scare you, but we are going to have to take a look
at this.
Well, he scared me. They did take a look. The biopsy said
it was melanoma. I went home that night and I sat down with my
wife, and I think I am pretty well informed as a layman, and I
said, dear, I think we have about 3 to 6 months. I knew
something only casually about melanoma, and I knew it was sort
of a Tyrannosaurus rex, normally not responsive to chemotherapy
or radiation, and I was sad. I have been very lucky. Very
lucky. I have enjoyed my life, and I did not particularly want
to leave it.
They sent me out to NCI, I thought as a consultation to see
Dr. Steven Rosenberg. He looked at my scans. It had not spread,
apparently. He examined me, he sat down with me and he said,
``you know, I think you have a good chance of leading a long,
healthy life,'' and I blurted out, ``I don't believe you.'' So
here is one of the foremost cancer authorities in the world,
and I am setting myself up as his master. Well, he said, no, I
really think so, and we can take care of it here.
I said, well, I am not eligible. He said, you are. You are
eligible for a tissue protocol, and I said, Steve--and we were
on a first-name basis now--I had better be eligible,
absolutely. Never mind the melanoma, my press colleagues will
kill us if I am here inappropriately.
They removed what turned out to be one lymph node. The
involvement of only one lymph node in stage 3 in my case means
that I am in a 50-50 bracket statistically. About 50 percent of
the time people like me see it come back, usually then in the
soft organs, and now it is desperate; 50 percent of the time we
never see it again.
I do not know which category I am in. I know which category
I would like to be in. I have tried to learn something about
the disease, and also selfishly what is in store.
In 1984, before then, the cure rate for metastasized
melanoma was zero. In that year, Dr. Rosenberg, having tried 66
times and failed, with the 67th patient he is free of it for 12
years now, and he has freed others, and other great research
institutions have, but it took money to go through those first
66.
We did a program on cancer, and I discovered to my horror
that doctors tell us we have therapies in the laboratory that
work on the rats. Now, they may not work on human beings. Many
of them do not. Some of them do, and we cannot test them on
human beings because we do not have the money.
Well, I thought that is a little silly. I discovered we
have only at least, as of last November, one national breast
cancer protocol, and only one national prostate cancer
protocol. Why don't we have more? We don't have the money, is
the answer.
Well, ladies and gentlemen, I know that all of you are
pressed by special interest good causes. Ours is not the only
worthy cause that you have to deal with as custodians of the
public purse, but to think that this disease, which kills
560,000 Americans every year, is something that we could
conquer sooner if we had more research dollars to increase the
trials and therapies that work in the laboratory, to increase
national trials so that we will have a better idea of how to do
it, is something that really is a little silly.
I want to close not only by saying to Senator Harkin, thank
you for coming--I know you have been a champion of this cause,
too--I want to close by saying something pretty harsh, and I do
not mean to be, but I thought Senator Specter in one of his
opening statements was exactly right. He answered the letters
from Pennsylvania first. That is his constituency. That is
frankly--and again, forgive me, but maybe your reelection
counts on.
Senator Specter. Not a total irrelevancy.
Mr. Donaldson. I want to say to you that when you mark up
this fall, I want you to feel, and I know I am preaching to the
choir, but I want your colleagues to feel that among all the
worthy causes there are just too many letters out there from
the cancer people not to answer, because my old friend, and I
mean that sincerely, Ronald Reagan got it right. You do not
have to make them see the light. You just have to make them
feel the heat.
Thank you.
Senator Specter. Thank you very much, Sam. Thank you very
much indeed.
REMARKS OF SENATOR HARKIN
We have been joined by the distinguished ranking member,
Senator Harkin, and I would turn now to Senator Harkin for an
opening statement or whatever comments he chooses to make at
this stage.
Senator Harkin. Mr. Chairman, thank you, and I apologize to
this panel, and I already did to Senator Mack and Senator
Feinstein, for not being here earlier. It just so happened that
this morning was the markup of the Individuals With
Disabilities Education Act and months of negotiations.
We finally pulled it together and we are able to get it out
of committee, so I had to be present at another committee, at
least up until this moment, but I did not want to miss the
opportunity to be here, and I am sorry I missed some of the
testimony here, but I will read it, I can assure you.
Just picking up on what Mr. Donaldson said, it really does
come down to resources and focus. I have often said that--
President Nixon declared war on cancer. The war on cancer was
what, in 1972, or 1971, and we declared war and beat a hasty
retreat, and that has just been the sum and substance of it.
We have made great progress. I have been an eyewitness to
some of the progress that has been made. People are living
longer that have cancer. There is more hope for people out
there, but it still is a killer, and it is still taking too
many lives every year, and the mortality rate is still
exorbitant.
We have some promising new therapies. The whole gene
program, gene therapy I think holds a lot of progress, but we
are not going to get there if we keep muddling along like we
have been doing in terms of the finances.
I do not know what everyone else said, but I just happened
to hear what Sam Donaldson said, and he is right. You know, I
always think of it like this. You say, well, how much money do
you need, and I say, I do not know, but I always look upon the
research, Dr. Klausner, and we have talked about this before.
It is like you have got 10 doors, and those doors are all
closed, and the answer may lie behind one of those doors.
Well, if you are going to open 1 out of 10 doors your
chances, your odds are what, 10 to 1, 9 to 1 that you are not
going to find it. Those are overwhelming odds.
Right now, we are funding 2 out of 10, 2\1/2\ out of 10,
something like that, of--and those are the research proposals
that have gone through the peer review process, and poor Dr.
Klausner, he can only fund 2\1/2\ out of 10. That is about 25,
26 percent I think last year, if I am not mistaken, so there is
another eight doors that are being shut that we do not know
what is behind those doors.
Now, there are a lot of young people out there, I know, I
see them, that are in colleges, sometimes they are in high
schools now, they are interested in this area, they are
interested in the biology, they are interested in the chemistry
of it, they are interested in the medical approach, they are
interested in the gene research approach, but they have to be
realistic.
They are looking ahead and they say, my odds that I am
going to be a great scientist and I am going to put in for a
grant, and my odds are only 1 in 4 that I am going to get
approved, and if I get approved 1 year I may not get approved
the next year, and sometimes this research has to take a long
period of time, well, that can dissuade me from following that
course of study.
I am going to get on my soap box here. I did not mean to,
but you asked me to make an opening statement, and I will.
Senator Specter. Or briefly a closing statement.
[Laughter.]
Senator Harkin. You see, here is another thing to keep in
mind, and I am going to use this opportunity to say this again.
During the gulf war we saw all of these great TV pictures of
these smart bombs that went down the chimney and these missiles
that intercepted these other missiles. We knocked out what was
it, we knocked out 3,000-some tanks and we only lost 7, and
this was wonderful. I mean, all this wonderful technology that
we have. As far back as I have been able to research the
Department of Defense spends 15 cents of every $1 on research,
15 cents of every $1 on research.
One other thing to keep in mind. In the last 4 years, in
the last 48 months, we have spent more money, your money,
taxpayers' money in 4 years, Sam, we have spent more money on
military research and development than we have on all medical
research since the turn of the century. I say that to people
and they say, you must be nuts, Harkin. I say no, you check it
out. I am right. You add it up. In 4 years.
Sure, that is why we have got smart bombs and missiles.
Thank God they protect us, and I am not downgrading it, but if
you want the smart missile or the smart bomb that is going to
knock out that cancer you have got to put those kind of
resources there now.
And when we spend as much money as we spend on health care
in this country, and we do not put 1 penny out of every $1--we
do not even put 1 penny out of $1 into medical research. What
do we expect? We are going to keep doing just what we have been
doing in the past, and we are not going to find the
interventions, the causes, and the cures.
So that is why I have pushed for so long, first with
Senator Hatfield, now, God bless him, with Senator Specter, to
try to get it in people's minds in this country that when you
spend $1 on health care some of that ought to go to research.
We only ask for 1 penny. My God, you would think the sky is
going to fall.
I have had some of the largest managed care organizations
in America, supposedly there to help the health of America, say
that they are going to fall on their sword to defeat us on this
bill, to try to get 1 penny out of every $1 to put into medical
research.
Insurance companies--oh, no, we can't have that. Well, I
will tell you, it is time that we have a policy in this country
that out of every $1 that an American spends on health care,
some of that is going to go to research. We only ask for 1
penny. That would only give us a 50-percent increase to NIH. We
cannot even get that through.
So you are right. I did not mean to go off, but you pulled
my chain when you started talking about resources, because that
is what it adds up to, and we have got to get those resources,
and we have to have a dedicated fund of money.
I talked about a trust fund that Senator Specter and I have
talked about, where some of that money would come from a health
care bill. If we put 15 cents out of every $1 that goes into
defense into research, my God, we ought to be able to take 1 or
2 cents out of every $1 for health care and put that into
research, and then--then we would win the war on cancer.
Thank you very much, Mr. Chairman.
Senator Specter. Thank you, Senator Harkin.
Senator Cochran, would you care to make an opening
statement?
Senator Cochran. No, Mr. Chairman. I am here to learn from
the witnesses and I just want to express my sincere
appreciation to all of them who have come here today to help us
understand how important it is that we move as quickly as we
can to do more in the research area to try to find the answers
and to try to find the cures that we know are out there to save
the lives that are very important to all of us.
Thank you very much.
Senator Specter. Thank you very much, Senator Cochran.
SUMMARY STATEMENT OF ELLEN SIGAL
We now turn to Dr. Ellen Sigal, Presidential appointee to
the National Cancer Advisory Board and chair of its Budget and
Planning Committee which oversees the board's $2 billion
budget.
Dr. Sigal has had a very distinguished career, and is a
very, very strong advocate in the fight against cancer, and I
want to thank Dr. Sigal for helping us organize today's
hearing. She was really instrumental, along with Bettilou
Taylor and Craig Higgins, and we are going to have a field
hearing commemorating the 25th anniversary of the National
Cancer Act in Los Angeles on May 29, and so we will be paying
tribute again to the same lives, so we very much appreciate
your help, and we welcome you here, Dr. Sigal, and the floor is
yours.
Dr. Sigal. Thank you, Senator Specter, and thank you for
your leadership and support for cancer research. It is deeply
valued. Thank you, Senator Harkin and Senator Cochran for being
here to listen.
My advocacy is based on a personal and very tragic loss. It
is the loss of my younger sister to breast cancer 11 years ago.
I will never forget my niece's first birthday party. My sister
had breast cancer, and she was undergoing chemotherapy, and
when we came to New York to help her prepare for the party her
hair fell out that day, the very day of her daughter's first
birthday party, and it was 10, or 11 o'clock in the morning,
and we had--no, she was not prepared. She was told her hair was
going to come out eventually but not that quickly, and I
remember desperately going out to find a turban or a scarf, or
to do something to protect her so she could have pictures with
her daughter on her first birthday party.
She fought valiantly. She underwent every treatment
imaginable for this disease. When the disease progressed, her
only option was a bone marrow transplant. At the time there was
a very high fatality, and she felt she had no other choice
because it was certain death.
However, they knew that fatality was high, and I was with
her when the psychologist had advised her to take a video of
herself for her daughter in case she did not make it, and she
recorded a video saying goodbye to her daughter. We thought she
would make it. We hoped she would, but indeed she did not, so
we have the video.
So yes, we speak with great passion, because it is our
sisters, it is our brothers, it is our children, it is our
fathers and mothers that we are talking about. I do not think
there is a family in the United States that has not been hit by
this disease or affected by it, and so there is great passion
and great hope in this community.
The burden is felt by all, disproportionately among the
minorities. It is more pronounced on our poor, but there is no
one that is exempt from this, and you know this on this panel.
We are at a point where there is no stopping us now. There
is great progress on this disease. We have enormous leadership.
We are so lucky at the National Cancer Institute to have
someone as brilliant and gifted as Dr. Klausner. It is his
vision. It is his inspiration. It is the opportunity. It is the
ability now, and it is the time to get something done.
It is all over. It is pervasive. It is in the communities.
It is at our cancer centers. We know now that we can, indeed,
do something. There is focus and there is opportunity. What is
stopping us? It is money. We are spending $2.4 billion a year
on this disease. It is not enough. That is the equivalent of a
half-a-tank of gas a year, or $10 per person.
I would challenge you to look at any witness here today or
cancer survivor in the eye and tell them that their quality of
life and their prospects for cure and their chance of survival
is worth the cost of two fast food meals. We cannot do this.
The cancer community is organized. We are together. We are
not going to pit breast cancer against prostate cancer against
ovarian cancer. We are speaking with one voice. We need more
money for this. We can make a difference, and we need you. We
need your support. We need your leadership, because this is
extremely important to all of us. There is no family in this
country that is not affected, and we have the opportunity, and
now we need your leadership.
PREPARED STATEMENT
We are very pleased about Senator Mack's resolution and
Senator Specter, your support for it, for doubling the NIH, and
I would say thank you, and I would only say this is a good
start.
Thank you.
[The statement follows:]
Prepared Statement of Ellen Sigal
Mr. Chairman and members of the Committee, I deeply
appreciate the attention you are giving today to the topic of
cancer research. Mr. Chairman, I salute you for your
leadership, Friends of Cancer Research was proud to honor you
earlier this year. I would also like to acknowledge the long-
time support of Senator Connie Mack and his wife, Priscilla.
They have personally experienced the burden of cancer and are
passionate advocates for change.
You will hear news of medical science here today, and you
will hear budget numbers. But for me and for many of the
witnesses today, this issue is rooted in personal experience. I
lost my own sister to breast cancer. I would venture to say
that nearly everyone in this room has lost someone close to
them because of cancer. And that is why we are here today.
We speak with passion about this subject because it is our
lives and the lives of our fathers and daughters, our husbands,
and our friends that we are fighting for--the lives of half a
million Americans a year. These are young people as well as
old, cut down in the fullness of life, their contributions to
their families and the world cut short by this merciless
disease, a disease that does not discriminate, but strikes
indiscriminately, rich and poor, people of all races and
ethnicities, famous people and common people alike.
We are here because a cause which some called hopeless now
shines with opportunity, as the mysteries of the human genome
yield to brilliant research and astonishing breakthroughs. We
are here because we believe that we now have the tools we need
to make further gains--gains that will save lives and alleviate
suffering and possibly transform our understanding of cancer.
All that we lack is the money to pursue them with the vigor and
passion that this cause deserves.
Some 25 years ago a Committee of Congress came together,
much as you have today, to determine what should be done about
this devastating disease. In their wisdom and in cooperation
with President Nixon, a bipartisan Congress enacted the
National Cancer Act. Now, 25 years later, thanks to that caring
and compassionate Congress, who could not sit by and watch this
disease destroy families nationwide, the overall cancer death
rate in the United States is going down. It has declined 2.6
percent and is falling for colon and rectum cancers, breast
cancer, lung cancer, prostate cancer and cancer for children
due to progress in prevention and research. For men it is down
4.3 percent and for women 1.1 percent.
But despite Congress' action a quarter-century ago, 1.4
million people will be diagnosed with cancer, and about 560,000
will die this year alone. That is more than 1,500 people a day.
In fact, one of every four deaths in the United States is from
cancer. Yet we spend only $2.4 billion in finding a cure,
improving treatments and diagnosis, and preventing cancer--that
breaks down to $10.40 per person per year. I lost my sister and
many dear friends to cancer, and I believe it is inexcusable
that a disease that costs this country $104 billion annually to
treat those afflicted only spends the equivalent of half a tank
of gas per person to eradicate this disease. I challenge you to
look any witness here today or cancer survivor in the eye and
tell them their quality of life, their prospects for cure,
their chance of survival is worth only the cost of two fast-
food meals.
Like the Congress 25 years ago, this Congress has an
opportunity to provide increased funding for cancer research
that will benefit generations of Americans for years to come.
Scientists have opened the black box on cancer and are
beginning to understand what causes this disease and what
treatments offer the best prospects for success. Of the 10
million survivors of cancer alive today, the majority have been
cancer-free for 5 years because of new discoveries in research
that diagnose the cancer earlier, that treat the cancer more
directly with fewer overall toxic effects on the body, and that
enable the cancer patient to live a higher quality of life.
We are not often confronted with an opportunity to make a
decision that will save millions of lives and improve the
quality of living for millions of people currently living. But
we have that opportunity today. It will take the cooperation of
government, public advocacy groups like those represented here
today, and survivors. You hold the key to the resources that
will unlock the door to new treatment and cures for cancer.
I urge your support for a level of investment that will
make that happen, and in particular I want to commend Senator
Mack for his resolution--which I know you have co-sponsored,
Mr. Chairman. On behalf of all the cancer survivors, I urge you
to at a minimum double the federal funding for biomedical
research over the next 5 years.
FUNDING NEEDED TO FIGHT CANCER
Senator Specter. Thank you very much, Dr. Sigal.
We are now going to have a 5-minute round for questions for
the panel.
Dr. Klausner, I'll begin with you. You are the head man.
When we had a hearing in early February I asked you how much
money could be usefully spent. I take a look at the statistics
on grants. There were 4,185 grants for fiscal year 1997. There
were 10 years ago 3,732 grants, so we are 453 up. That is not
very much over a 10-year period.
You talk about resources, and when I commented earlier
about getting the people in your districts and your States to
write your elected representatives, I am a U.S. Senator and I
am also a Pennsylvania Senator, and when Sam Donaldson refers
to election, that is a thought which occasionally crosses the
mind of 535 people up here on Capitol Hill.
A lot of people write me letters from all over, and I am
glad to get them, but they would be a lot more effective in
their district, and people do not think when they come to visit
us and they ask for advice. Take a look at the people who voted
against it. They are all on the record, and get people in their
districts to tell them.
If I get a dozen letters from Pennsylvania with 12 million
people that is a trend. That is a matter of significance.
So Dr. Klausner, you have had several additional months,
February, March, April, 3 additional months. You will be in
next week for the NIH hearings. How much money, not would you
like to have, but could you usefully use to fight cancer?
Dr. Klausner. Sir, you are asking my professional judgment
as to what we can use?
Senator Specter. Well, I am sure I would get it whether I
asked for it or not.
Dr. Klausner. Well, of course, as you know, I am asked by
law to provide a professional judgment budget, which we have
done, created a whole new budget to outlay very explicitly what
we believe the needs and the opportunities are, and exactly
what those investments would mean.
We asked in that for an immediate about 20-percent increase
in the budget to allow us to find what we believe are the
immediately accessible and achievable opportunities, and my
feeling is, is that in order to achieve these opportunities, as
we have laid out in the NCI bypass budget, we really see the
opportunities. We actually see the only way to prevent the
tragic inability to step up to the opportunities, and Senator
Harkin said young people are saying this is not for me. This is
a disaster.
Senator Specter. Dr. Klausner, I ask you for your view
because there is a lot of filtering. After you put your figures
in they go to NIH generally, and there is a lot of filtering in
the Office of Management and Budget, and a lot of times we have
witnesses come into the appropriations process who tell us one
thing, and then they meet us in the back room and they tell us
something else.
Dr. Klausner. Senator, again, I am in the unusual situation
that the law allows the NCI Director to directly produce a
bypass budget to go to both the Congress and the President. We
have done that and have created that. It is in this document,
that lays out a very explicit plan for how to spend what we ask
for in 1 year.
Senator Specter. We will have a chance to do this further
next Tuesday. I want to observe the time limit, because we are
going to have some time problems. We have to conclude a little
in advance of noon.
Dr. Sigal raised her hand, and I will call on her last.
Ms. Lansing and Mr. Donaldson. I was glad to hear Ms.
Lansing comment about what her industry could do and what your
industry could do, Mr. Donaldson, and I would urge you to do
all you can to tell the American people about the support we
need.
Dr. Sigal, on my time the final word is yours.
Dr. Sigal. Thank you, Senator Specter. I just want to tell
you that I serve on the National Cancer Advisory Board. I see
the grants--that is our statutory responsibility--that are not
funded, the science that is not funded. We can do much more.
There is good science out there.
I also serve on the board of cancer centers. There is an
enormous opportunity. That additional funding, and as I said
earlier, double would be a good start, but we could
productively over time use a lot more money.
Senator Specter. Thank you very much, Dr. Sigal.
We turn now to Senator Harkin.
Senator Harkin. Thank you very much, Mr. Chairman.
We know about the bypass budget, and the 20-percent
increase is what you said you could use immediately to actually
get out to the grants that have come through. I just want to
say again, Dr. Sigal--and I am sort of combining two here--you
talked about you do not want to pit breast cancer against
prostate cancer against brain cancer, et cetera. You see, that
is the problem that Senator Specter and I have, and all of us,
and Senator Cochran, that we have on this committee.
It is not pitting one cancer against another. It is pitting
this research against education, Head Start programs, low-
income heating energy programs for elderly who are poor, Pell
grants for college students. And what else is there? We have
got more than I can even remember when I chaired the
subcommittee.
Senator Specter. School-to-Work, drug education.
Senator Harkin. Drug education.
Senator Specter. Therapy.
Senator Harkin. Yes; everything.
So we get one bundle of money. And so it is pitted against
that.
Thus, why I encourage you, I plead with all of you, we need
a dedicated source of revenue so that we are not pitting this
against everything else.
I have worked with Arlen Specter a long time. I know he
agonizes over it, just like I do, trying to figure out how we
are going to fund these things. Every time you go down and put
a tank of gas in your car, some of that money goes into a trust
fund. Every time you buy an airline ticket, some of that money
goes into a fund, to help make safer airways and airports and
things like that.
Yet every time you buy Blue Cross/Blue Shield, Aetna, or
whatever else health plan you have gone to, not 1 cent of that
goes for research. And I am saying that has to change in our
society. That is why I make that point, Ms. Lansing.
Ms. Lansing. And I think we all agree with you 100 percent.
I certainly do not want to take something away from something
else. But I do not think that we have ever been at this point
in cancer research, where we are so close to finding cures, to
finding a way to control the disease. And I think you could
look at what happened with AIDS and see where the money that
went to research really did produce results, where people are
now not dying from AIDS, and they are finding ways to live with
it.
I can only say to you that--you know, I heard Senator
Feinstein speak about various ways so that we could get
alternate income in, you know, the idea of the stamp, the idea
of checking your income tax form. And on behalf of the people
in Hollywood, these are the kind of things we want to do.
Senator Harkin. Ms. Lansing, excuse me. I am all for the
stamp. I am one of the supporters of it. At the most, that is
going to raise about $30 million.
Ms. Lansing. But it is something.
Senator Harkin. That is nothing.
Ms. Lansing. But do not we have to start thinking of
alternate things like that? I mean if you are saying to me----
Senator Harkin. Fine. You can think of that. I am just
telling you that that $30 million is like spitting in the
ocean. I am sorry, I just have to tell you that. I am all for
it. I would get a dollar anywhere I can. But the stamp is not
going to do it.
We are talking about increasing it by billions of dollars a
year, not a few million dollars a year.
Ms. Brown.
Ms. Brown. Senator Harkin, you were gone when I spoke, but
I am here as a spokesperson for the American Cancer Society. We
are the group with the constituency out there. They are willing
to pay more in the taxes to put it into medical research.
Senator Harkin. Absolutely.
Ms. Brown. They are, I will bet you dollars to donuts, that
your 10 cents, 15 cents of every health care will be important.
What we have to beg you to do is to turn a deaf ear to the
lobby that says, ``no.''
In all of World War II, in all of Vietnam, in all of Korea,
in all of the gulf war, we have not lost nearly as many as we
lose in 1 year to cancer.
Now, you found the money for the Persian Gulf war. You
found the money for Vietnam. You found the money for the other
wars. It seems to me that what we have to do in support of you
is to step up to the plate and say to the Blue Cross and to the
other insurers, put some money where the rubber hits the road.
They are making money from health care. I will tell you, an
ounce of prevention still is worth a pound of cure.
And what we are here to express to you is the feeling of
all of your constituents. We want this No. 1 on your agenda. So
if you will say no, we will say yes.
Senator Harkin. Some of us have been saying no.
Did you have something, Sam, that you wanted to say?
Mr. Donaldson. This is a national emergency. And if you put
it on that basis, Americans will respond. Because it is not
something esoteric. Scientists tell us that if we do not get a
hold of the hole in the ozone layer, it may kill us all. But it
is not something people understand. Their mother did not die
immediately, that they can see, from the hole in the ozone
layer. But their mother died of cancer. Their best friend has
it. They themselves may have it.
Now, you gentlemen are on the right track. Here is the
question I would like you to put to Dr. Klausner. Not how much
money can you use. He has got many considerations, as you well
know far better than I, in how he has to frame his answer. Put
the door question to him. Dr. Klausner, if we open all 10
doors, how much money would that take?
He is freed now from having to worry about the other
considerations and the other people that he has to worry about.
Senator Specter. Dr. Klausner, would you answer Senator
Donaldson's question? [Laughter.]
Mr. Donaldson. Dr. Klausner, if these grant requests, that
have gone through peer review, that show some promise, and not
someone saying let us flap a bed sheet at the aurora borealis,
were all funded, all 10 doors, how much money, sir?
Dr. Klausner. We believe that to do that would require a
doubling of the NCI budget in 3 years.
Mr. Donaldson. Then let us do it. Then let us do it.
Ms. Lansing. Three years, not five.
Senator Harkin. OK. The other thing, Dr. Klausner, is this
a doubling, but not a one-shot deal. This has to be something
that we know is going to be there for these young people to
say, hey, I want to get involved in that. I want to spend the
next 10 years or 20 years of my life in this kind of research.
We have got to hold that out there that that money is going to
be there.
If it is just up to the appropriations process, and we are
battling this and battling that and maybe it is there and maybe
it is not, but if we had that dedicated source of revenue that
is going to be there, that can double it, and it will be there
for the next 20 years.
Mr. Donaldson. Americans will support it.
Senator Harkin. I believe they will, Sam, but, darn it, you
have got too many people around here who say, we do not want to
raise another tax on anybody around here. And I am telling you
that I believe the American people would pay that penny. They
would pay 2 cents of every health care dollar if they knew that
that was going to medical research.
Mr. Donaldson. You do these things better than I do every
day.
Senator Harkin. I do not think so.
Mr. Donaldson. We can roll over the people who say no,
because we have the numbers. Not because of me. We have the
numbers out there; 10 million cancer survivors. If you took a
show of hands in this room--and I am not suggesting it--of
people who have cancer or whose family members have died of
cancer, or whose friends, almost every hand--probably every
hand would go up.
We have got the shock power. How many divisions has the
Pope? How many divisions do the cancer people have? We have
unlimited divisions. And we will get behind you through perhaps
a march on Washington that many of us are contemplating.
Senator Harkin. How many people in the audience have had a
family member who has had cancer, how many people? [A show of
hands.]
Mr. Donaldson. My mother died of it. My brother of it.
Ms. Lansing. Well, there you are. That is what we are
talking about.
Mr. Donaldson. I do not want to die of it, but I may.
Senator Specter. We are going to have to move on.
Senator Harkin. Ms. Lansing.
Ms. Lansing. I think we are all saying the same thing. You
know that the constituents, the American people, will support
this. We all, you know, in my industry try and make it more
visible, try and draw more attention to it, but this is a
national emergency. And we are at a time like we have never
been before in cancer research and we have to do something
about it.
Senator Specter. I am reluctant to cut off this very
important dialog, but we have six more witnesses and we have to
finish shortly before noon. And we had made you a senator, Sam,
to ask Dr. Klausner. I did not know we were giving you the
chairmanship to get the show of hands. [Laughter.]
Mr. Donaldson. Excuse me, Senator. I sometimes take the bit
in my teeth. And I apologize.
Senator Specter. Senator Cochran.
Senator Cochran. Well, we all know the cost in lives. We
also are aware that cancer costs $100 billion every year. And
that is an astounding amount of money to lose. When we can
invest more, we will save more, not just lives, but money as
well. So you were talking about the dollars-and-cents aspect of
this.
And I think Senator Harkin touched on an aspect, too, that
cannot be overlooked and should not be underemphasized in all
of this, and that is doing more to try to attract into the
research field medical doctors and others who can help us find
the answer.
We had a hearing here last year--Dr. Klausner, I think, was
in one of the panels--we were talking about orphan drug
research, for example, and the difficulty of not only getting
dollars, but getting people to commit themselves to those areas
of research that are also very important.
But we are limited, I think, in terms of the number of
people who are engaged in this. And that limits how much money
may be effectively used in a research project. You do not have
the people there to use the money and do the things that you
know need to be done.
What is the answer to that? Is there a proposal that we
have before us in terms of research, scholarships or incentives
that we can build into the system that will help us do a better
job of getting people into these fields?
Dr. Klausner.
Dr. Klausner. Yes; we do. Part of this is to significantly
increase the amount of money for training, but also to protect
people who want to do research from the forces that are
preventing them from doing research. With the changing health
care system, clinical researchers are in danger. They cannot
spend the time doing clinical research. That is part of this
budget request.
But I can tell you the people who want to do research, who
want to participate in preventing and curing cancer are there.
They want to do it. The most painful thing, as we have all
talked about, is the number of times, constantly, that we have
to say no.
Senator Cochran. Dr. Sigal, would you add to that or
comment?
Dr. Sigal. Young people today who are inspired, who are
brilliant, who can make a difference have to rethink whether
they can dedicate their lives. They have to feed their
families. They have to know that there are resources available.
There is the will. There is the opportunity. There are the
scientists. There are the brilliant minds that are ready to
make a commitment. But they cannot and will not make a
commitment to this disease and research if there is no funding.
It is what we do well in government. It is what we do well
at the National Cancer Institute. And it is where we can make a
difference. There are too many millions of lives dependent upon
it, and we can do that.
Senator Cochran. Thank you very much.
Thank you, Mr. Chairman, for your leadership in this area
and for having this hearing and for doing all that you are
doing to try to generate support for this new initiative.
Senator Specter. Well, thank you very much, Senator
Cochran.
Senator Cochran has been on the subcommittee, and he is No.
1 in line to become the next chairman of the appropriations
committee.
I would like now to turn to our next panel. Thank you very
much, Mr. Donaldson, Ms. Brown, Dr. Sigal, Ms. Lansing, and Dr.
Klausner.
Panel 3
STATEMENTS OF:
DONALD S. COFFEY, Ph.D., M.D., PRESIDENT-ELECT, AMERICAN
ASSOCIATION FOR CANCER RESEARCH
ARNOLD PALMER, PROFESSIONAL GOLFER, ARNOLD PALMER ENTERPRISES
TONI M. SHAHEEN, BREAST CANCER SURVIVOR, MANMOUTH BEACH, NJ,
INTRODUCED BY AMY LANGER, EXECUTIVE DIRECTOR, NATIONAL
ALLIANCE OF BREAST CANCER ORGANIZATIONS
KEITH L. BLACK, M.D., PROFESSOR, DEPARTMENT OF SURGERY,
UNIVERSITY OF CALIFORNIA, LOS ANGELES
CHARLES A. COLTMAN, JR., M.D., PRESIDENT AND CEO, CANCER
THERAPY AND RESEARCH FOUNDATION OF SOUTH TEXAS AND DIRECTOR
OF THE SAN ANTONIO CANCER INSTITUTE
summary statement of dr. donald s. coffey
Senator Specter. I will turn now to Dr. Don Coffey, Mr.
Arnold Palmer, Ms. Amy Langer, Ms. Toni Shaheen, Dr. Keith
Black, and Dr. Charles Coltman.
We begin with Dr. Don Coffey, who is the president-elect of
the American Association for Cancer Research [AACR], and is a
professor of urology, oncology, pharmacology, and molecular
sciences at the Johns Hopkins University School of Medicine.
For 19 years, Dr. Coffey served as a member of the National
Prostatic Cancer Program of the National Cancer Institute, and
as national chairman from 1984 to 1988.
Welcome, Dr. Coffey. We are going to be compelled to pay a
little more attention to the time lines. And we have changed
the timing from 5 minutes to 4 minutes, because we want to hear
from everybody and we want to leave some time for questions.
Dr. Coffey, the floor is yours.
Dr. Coffey. Senators Specter, Harkin, and Cochran, I am
speaking to three heroes of medical research, and I have very
little that I can really tell you that you do not already know.
In fact, I thought Senator Harkin had given my speech, so I had
to quickly rewrite another one.
But on the serious side, let me start out by saying that
there are three or four things that burn their images into my
mind. And one of them was when I was a young schoolchild in
Bristol, VA-TN, looking into a mirror into the face and the
eyes of a young boy in an iron lung, like being in a coffin,
and helping him to breath, and he succumbed to this. An
epidemic of polio swept through Wythville, VA, and they were
rerouting traffic around U.S. 11 outside of Wythville.
Well, another thing that really burned into my mind when,
40 years later, I stood in Baltimore and watched four large
dump trucks hauling all the iron lungs--75 iron lungs--to the
trash dump because they were obsolete. And this came because my
father stood on the corner ringing bells, he thought research
would do this, raising money. We got those little pieces of
blue cardboard and put our dimes in it.
But it was really Senator Cochran who really--and people
like this--who led the fight in Congress to eradicate this. And
you know what you had to do to do that, and I salute you, sir,
for that.
Now, years later, as a young engineer in 1957, working in
military research with the Westinghouse Corp., we were stunned
when we found out that the Russians had put their research
money into space efforts and a satellite had gone up. Well,
over night--they did not say how much money we could use--it
was not the March of Dimes, it was the march of dollars. And it
was absolutely overwhelming.
And then, again, many years later, I stood in Florida in
the night and watched this scientific marvel hauling American
astronauts to the moon and a car to drive around when they got
on the moon. Is this a good country or what? I could not
believe it.
Well, in 1971, President Nixon pledged and made a contract
with America to eradicate prostate cancer. And it was never a
war. It was only a skirmish. And even though that chart looks
great over there, it would not buy two bombers--the one over
there that shows all the appropriations--it would not buy two
bombers for this war. And still six cancers were cured. But
one-fourth die.
Now, I want to show you on this chart over here, this is
what is going to happen while this session is going on. Seven
people are going to be murdered in this 2\1/2\ hours of this
session, shown on the bottom in red. Eleven of these people are
going to die of AIDS while this conference is going on. And 161
are going to die from cancer.
Now, this is equivalent--and I want this in our minds as we
leave this meeting--to five jumbo jets, fully loaded, crashing
every day, year in and year out--that is what it would take to
kill this number of people. Those five jumbo jets are falling
behind the mountains and we do not see them. It is terrorism
from within. But if it hits you or your family, you certainly
know what we are talking about.
And on the next chart, I want to show you what the real
problem is; 1 penny out of every $10 goes for cancer research;
1 penny out of every $10. Even if we doubled that--that little
red dot down there in the corner is the penny--even if we
doubled that, that would not be one-third of what we are
spending on our space effort.
Now, I am all for the space effort, but we can spend one-
third of that amount here.
Now, as president of the AACR, the American Association for
Cancer Research, which is the largest research organization in
the world and the oldest one in cancer research, I tell you,
ideas abound. And let me just end with this. Three-fourths of
the cup is empty. There is no doubt about it in research. They
are not being funded.
One of those yellow dots on that chart is Janet Luke. And
11 days ago, I stood by her coffin. She is a young nurse. She
is 29 years old. And in 3 years of pain and suffering, she
succumbed to cancer. Standing by her coffin was her little son,
who had the same look in his eye as that little kid in that
iron lung--bewilderment and fear.
PREPARED STATEMENT
And I will tell you, we can do better than that. And if we
cannot get four bombers in this war, let us surrender. And I
think we can do it. And we are not going to surrender. And we
are going to do it one way or the other.
And I want to salute you three Senators, who helped us do
it. You have all sorts of good ideas. We stand behind you. We
will charge up that hill with you. I swear we will.
Thank you very much.
Senator Specter. Thank you very much, Dr. Coffey. Those
charts--we have had a lot of charts around here. I have not
seen one more impressive than the 161 cancer deaths. If we keep
talking too long, there will be more.
[The statement follows:]
Prepared Statement of Dr. Donald S. Coffey
As a young, grade-school student in Bristol Virginia-
Tennessee, I watched in horror as a young child, who was locked
alive in a metal, mechanical coffin, struggled to breathe while
afflicted with poliomyelitis. An epidemic of polio was sweeping
through the neighboring city of Wythville, Virginia. We all
stood by, helpless and frightened, as this unknown killer
maimed its victims. Our national leaders rallied to control
this scourge, but they did not know how. Neither the source nor
the identity of this menace was known. We had to attack polio
with research; it was our only hope. People collected donations
for a cure, standing on street corners ringing bells. Children
in school were given cards in which to place their dimes in
rows? and the March of Dimes was initiated. America and the
world had had enough of polio. The collected research funds
worked. Fifty years later, I stood in Baltimore and watched
dump trucks hauling the last obsolete and unneeded iron lungs
off to the trash dump. A tear of relief and of pride in America
rolled silently down my cheek as I witnessed the end of polio--
conquered by research.
Earlier, I was a young engineer, working in military-
related research with the Westinghouse Corporation in
Baltimore. In October 1957, we awakened to the startling news
that the then feared Russians had silently invested their
research in space and had beat America into orbit. To catch up
would require more than a march of dimes; this would require a
march of dollars. We got it. Almost two decades later, I stood
in the Florida night and watched an unimaginable miracle as the
United States launched a gigantic scientific marvel carrying
American astronauts and a car to drive around on the lunar
surface. Was this a great country or what?
Then, in 1972, we launched another great endeavor--a War on
Cancer. President Nixon pledged the full resources of our
government to conquer this dreaded disease. Unfortunately, only
limited research funding trickled out that could support only a
small skirmish, and not a real war. This was not an American-
style effort to go to the moon, to crack the atom, or to fight
a Gulf War. This effort could only support a few thousand
investigators to fight only a limited engagement. Still, six
cancers were essentially cured, including those that primarily
affect young people, such as leukemia and testicular cancer.
However, today the big six cancer killers (lung, breast, colon,
prostate, bladder, and brain cancer) continue to ravage the
bodies of their victims. Now, 25 years after this country
pledged to go to war against cancer, one half of all American
men and one third of all American women will be struck by the
horror of being diagnosed with cancer during their lifetimes.
One fourth of all Americans will one day die from this most
unpleasant and painful form of death. During the approximately
2\1/2\ hour period that this Senate hearing will be in session,
161 Americans will die from cancer, compared with 11 who will
die from AIDS and 7 who will be murdered. It would take 5
Boeing 747 jumbo jets crashing every day for a year to equal
the half million Americans who die each year from cancer. This
number of cancer deaths per year exceeds all U.S. combat deaths
in all of the wars in this century. This carnage on our people
from cancer must stop, and it will, because of research funded
by this Congress. In the past, medical research has conquered
the pain of amputation, surgery, and dental procedures, as well
as infectious diseases such as typhoid fever and pneumonia; one
day, medical research will conquer AIDS and cancer. We have
already proved that we can cure six cancers through medical
research; now it is tune to eradicate the other major cancers.
However, this will be slow to be realized at the current
funding levels, when only one penny out of every ten tax
dollars is spent to research this tremendously costly disease.
If we doubled our effort on cancer today, it would still cost
less than one-third of our space effort and only one-twentieth
of the cost of the Gulf War. Taxpayers are far more endangered
by a ``berserk'' cancer cell than by a bullet from an enemy,
and they want to be protected against cancer.
As a scientist at Johns Hopkins University who has
dedicated his life's effort to cancer research, and as the
elected President of the American Association for Cancer
Research which is the largest organization of laboratory and
clinical cancer investigators in the world, I can assure you
that exciting scientific opportunities abound. No one can
predict when or where cures or successful prevention strategies
will originate, but all agree that they will only come from
funding a large base of investigations. At present the cancer
research cup is three-fourths empty. Of every 100 grants
approved for funding after critical peer review, less than 25
will receive funding. The other 75 unfunded projects represent
lost opportunity, valuable time in the fight against cancer,
and more lives lost.
On April 26th, I stood by the graveside of my friend, Janet
Luke, a young nurse who was just 29 years old when she died
after suffering for 3 years from the pain and ravages of
cancer. By her coffin stood her husband, Markham, who is in
training as a physician-scientist, and her 3-year old son,
Matthew. I just know that one can do better than this. It would
take only a fraction of the effort that got Americans to the
moon, and it would save so many. We have had enough of the
suffering and death from cancer. Together, with your support of
cancer research, we can conquer cancer. It is time to make a
commitment to the American people to wage a Real War on Cancer.
Thank you for listening to their pleas through my inadequate
words.
SUMMARY STATEMENT OF ARNOLD PALMER
Senator Specter. It is a special pleasure for me now to
turn to a very distinguished American and a distinguished
Pennsylvanian, Mr. Arnold Palmer, an immortal in the golf
world. They brought the statistics up, Arnie: 92 championships
in professional competition, 61 of those in the USPGA Tour, 4
Masters Tournaments, 2 British Opens. He is a native of
Latrobe, PA. He is a father of a breast cancer survivor and
someone who has been diagnosed with prostate cancer himself a
few years ago.
Many of us tried to persuade Arnie Palmer to run for
Governor. I am just glad no one has tried to persuade him to
run for Senator, at least not my seat. [Laughter.]
We are delighted to have you here, Mr. Palmer, and the
floor is yours.
Mr. Palmer. Thank you, Senator. I had a speech here that
was going to last about 1\1/2\ hours, but I saw I was only
allowed 3 to 4 minutes, so I will make it very quick.
I am not an expert in cancer. I have had. I know how it
feels. And I have very strongly felt that we have people,
doctors, and researchers. And if you gentlemen can find the
moneys to fund those researchers, we can really prevent a lot
of the cancers that are happening before they happen.
I have a lot of things here. I was going to talk about how
I found out about cancer and how I found out I had it. And you
know about those things. But we talk about PSA and we talk
about breast cancer and all the cancers--and we are together
and we want this to be cured. We want it to be cured before it
happens. And I think that that is possible, with research.
My purpose here is more not to tell you about cancer and
not to tell you that what I know about it, but to call it to
the attention of the American people. And if I can do that,
then I will feel like I have really helped.
I was taking a physical. And I have been taking physicals
for 35 years. And the doctors have been fantastic. And at one
point, about 2\1/2\ years ago, they said that my PSA was
rising. Well, let me just say something about PSA's. I went to
the Mayo Clinic to be operated on for prostate cancer. And the
doctor told me the night before he operated on me that if it
had not been for the PSA, they would not be operating on me
that next morning, simply because the digital testing was not
satisfactory and they would have not known that I had cancer
without PSA testing. And, of course, that led to further
screening and a final operation.
So I cannot get into the facts about bombers and all the
things, the wars, and all the things that have happened. But I
have a lot of friends that have had cancer, including a
daughter. And I will do whatever I have to do to call attention
to research and further development for the cure of cancers--
and I would like to say that before the fact.
PREPARED STATEMENT
And I have been told by doctors who I have talked to that
that is very possible, with the dollars for research. And what
can happen is something that I would just like to see it
happen.
Thank you.
[The statement follows:]
Prepared Statement of Arnold Palmer
Mr. Chairman and Members of the Committee, it is an honor
for me to testify today before this group. I want to personally
thank you for your attention to the topic of cancer and your
support for research that can save the lives of literally
millions of people.
I consider myself a direct beneficiary of progress made in
research to date. Just a few short months ago, when I arrived
from Florida for the PGA Tour Player Awards Dinner in
California, I had a message to call my wife, Winnie, who is
here with me today When I heard Winnie's voice, I knew right
away--the doctor had diagnosed me with prostate cancer.
Five days later I was operated on at the Mayo Clinic. My
surgery coincided with the first round of the Bob Hope Chrysler
Classic--a tournament I won five times over the years, most
recently in 1973. From the moment of diagnosis, I was
determined to defeat this challenge the same way I had won
tournaments in the past--facing the challenge head on.
While I am not a medical man, I want men nationwide to
understand that prostate cancer is not a death sentence. It's
not the end of life--not even the end of golf. And research
truly is the key. People need to understand the possibilities
of having cancer and the great possibility of cures for cancer.
I am living proof. For a year and a half before I was
diagnosed, I knew I had a high level of risk for prostate
cancer because of a simple blood test that checks for a protein
that is an indicator of the disease. This test called a PSA--
Prostate Specific Antigen--is a recent research discovery that
can alert men that they are at risk for this deadly disease. My
doctor caught my cancer early because of better detection
methods--methods that were not available to men just a few
short years ago.
But this test is not perfect. An elevated PSA may mean
cancer is growing, or it may not be significant at all. In
fact, my doctors monitored my PSA level for several months, and
took 12 biopsies before diagnosing me with prostate cancer.
Clearly, we need more research to give doctors better detection
tools. And once cancer is detected, we need more research to
help us better understand which men are at risk of dying from
prostate cancer and which may not need treatment at all.
Prostate cancer is now the most common cancer in American
men. This year alone, over 200,000 new cases of prostate cancer
will be diagnosed, and 42,000 men will die. Current studies
show that prostate cancer is found mainly in men over age 55,
and it is more common in black men than in white men. But
doctors cannot explain why one man gets prostate cancer and
another does not.
Thanks to important research conducted around the country,
men today have better chances of having this disease detected
and treated than ever before. The death rates from the disease
are already going down.
But that is just the start. Not enough is known about
prostate cancer. More funding for cancer research is
desperately needed to determine which treatments are best for
older and younger men and men in ``different stages'' of the
disease, and to identity new drugs to control or prevent
prostate and other types of cancers.
Now, I am not interested in being a hero over this sort of
thing. But my daughter is a breast cancer survivor, and as you
are well aware, a cure for prostate cancer may come from
research being conducted in any number of other related areas.
If I can help raise awareness that discoveries in cancer
research are and will continue to improve detection methods,
treatment options and the general quality of life for men,
women, and children, I am happy to do that. And I want to join
in with the other witnesses here today to say that we are only
part of the way there. I am not here today to pit one cancer
against another, but to ask you to provide increased funding
for the whole cancer program.
As you might guess after being operated on and resting for
several weeks, I was real anxious to return to the golf course.
And I am happy to report that just 42 days after my surgery, I
swung my first golf club. Two short months after surgery I
competed in my own Bay Hill Invitational. And as I set out to
do from the start, on April 9, I played my 43rd consecutive
Masters.
I have always felt that on the golf course the key to
success is preparation and persistence plus a little luck. This
is as true of cancer research as it is of golf. You have in
your hands a chance to support more research and more clinical
trials that will increase what we know about the disease and
save millions of lives. Increased funding for all cancer
research is truly the key, and I urge you to provide it.
CANCER SURVIVOR
Senator Specter. Well, thank you very much, Mr. Palmer.
Your presence here today is very significant. Americans pay
particular attention to our heroes. And when it comes from
Arnie Palmer, a lot of people will listen to it. So we thank
you for joining us.
Mr. Palmer. Well, if you saw the mail that I received, you
would not believe it.
Senator Specter. No; I would believe it.
Mr. Palmer. It was fantastic. I had one that I will relate
to you. This is a little off the subject, but it is on the
subject. I had a letter from an older man. And he said that he
had gone through the same thing that I had and that he was
doing very well and he was playing golf again. And he said that
the only thing that he had noticed was that his sex life was
not the same as it was before. He said, but it is good enough.
He says, it is not bad for an 88-year-old. [Laughter.]
Senator Specter. I think probably Mr. Palmer only you could
get away with that. [Laughter.]
SUMMARY STATEMENT OF AMY LANGER
Now I want to turn to Ms. Amy Langer, executive director of
the National Alliance of Breast Cancer Organizations. She is a
12-year breast cancer survivor and serves as a lay member of
the Board of Scientific Advisers of the National Cancer
Institute. We welcome you here, Ms. Langer, and the floor is
yours.
Ms. Langer. Thank you very much, Mr. Chairman, for your
attention to this issue, and for the actions we are very
hopeful you will take.
You have started my remarks for me. I am a 12-year breast
cancer survivor, and it is my privilege to appear here before
you with these expert colleagues and also to introduce Toni
Shaheen, a fellow breast cancer survivor who is here today to
speak from the heart.
As I am sure you know, usually my role is limited to breast
cancer issues, but today those issues form a part of a larger
problem that you have the tools to repair. The many mysteries
yet to be unraveled about how cancer works and how it chooses
its enemies are exemplified by breast cancer, a single disease
among hundreds of cancers but the most common form of cancer in
women in this country.
Because of America's familiarity with and fear of this
disease, when women become breast cancer patients they are
astonished that many vast questions remain unanswered, among
them how soon will we know how to prevent breast cancer? So
far, prevention research is still in progress, stalled,
undernourished, or the source of conflicting information.
When will we have true early detection? We cannot yet
diagnose breast cancer cells gone wrong until they cluster in
billions, forming masses big enough to image but also to spread
and kill.
When can we design the right treatment for each patient? As
good as many breast cancer treatments are, we still cannot
predict which patients should receive what treatments or how
much of them, so that thousands of women are routinely
overtreated with drugs they do not need, and others live
unprotected, their cancers ready to resume control.
And can we ever promise a certain cure? Although an
increasing portion of breast cancer survivors remain cancer
free, physicians cannot honestly reassure us that we can take a
deep breath, have our families, make our plans, smell the roses
without the constant counterpoint of cancer that could return.
You have heard today what I feel, too. We need a shift in
national values, a reaffirmation and an unwavering commitment
to bring resources to the fight against breast cancer, and we
need increased funding for basic and clinical research and all
cancers, and a plan to prioritize transitional activities that
will have an immediate impact on prevention and treatment.
We need a scientific environment that attracts the best
minds and nurtures their explorations. We need science to be
responsive to priorities of cancer patients and survivors,
their needs, perceptions, hopes, and fears.
Ms. Shaheen captures this paradox, a strong and admirable
woman who is cancer-free because of advances in treatment but
not worry-free, because research has not advanced enough. I am
honored to introduce Toni Shaheen.
SUMMARY STATEMENT OF TONI SHAHEEN
Senator Specter. We welcome you here, Ms. Shaheen. You,
too, are a breast cancer survivor, cancer-free, according to
the information provided to me, for 6 months after and during a
lumpectomy, lymph node removal, radiation and hormonal
treatments, and subsequently stem cell transplants. Quite a
sequence.
Unfortunately, according to what I have learned here you
lost your identical twin sister, Regina, through breast cancer
in 1966, and you are an outstanding advocate, and we welcome
you here and look forward to your testimony.
Ms. Shaheen. It is an honor for me to testify here today
with the other supporters of Friends of Cancer Research.
The best way for me to express the importance of cancer
research is to share with you my family's experience with
cancer. My first encounter with this disease began in 1989 when
my identical twin sister Jeannie was diagnosed with breast
cancer. She was 36 years old. Her initial treatment at the time
was a lumpectomy followed by radiation and mild chemotherapy.
Just 2 years later, in 1991 I was also diagnosed with
breast cancer, but in those 2 years clinical research had
opened up new protocols for women diagnosed with breast cancer.
I had a lumpectomy and lymph node removal followed by radiation
without chemotherapy. Subsequent to the radiation treatment I
received various hormonal treatments.
About the same time my sister, Jeannie, found a second
tumor in her other breast, and she had another lumpectomy,
lymph node removal and radiation. Chemotherapy followed, and
over the course of the next 4\1/2\ years Jeannie was
continually on and off chemotherapy.
In October 1994 on the advice of her doctors, Jeannie began
an even more aggressive approach, a regimen of high dosage
chemotherapy and a bone marrow transplant.
Being twins, my sister and I were very close, and I found
it devastating to see her undergo the effects of the high
dosage chemotherapy. It was evident to me that research was
needed to make lifesaving treatments less toxic and painful for
patients.
At that time, I told my husband that I would never have
that done, that I am not as strong as Jeannie. In January 1996
however, we realized that various hormonal treatments I had
been taking were not effective, and my doctor had recommended
more aggressive therapy for me also. My options were to begin
traditional chemotherapy regimen or to begin high dose
chemotherapy combined with a new treatment, a peripheral stem
cell transplant, which was a much less risky procedure than a
bone marrow transplant.
Having seen what my twin sister had gone through, I did not
think I could do the high dosage chemotherapy, or high dosage
treatment. With her encouragement and support, however, I
started my preparation for the high dosage chemotherapy in
February 1996. I was still in the early stages of my treatment
when Jeannie died in May 1996. She was only 42 years old.
In the summer of 1996 I began the stem cell harvesting
process. This was followed by three different cycles of high
dosage chemotherapy treatment and the stem cell transplants. I
was released from Columbia Presbyterian Hospital following my
third cycle of high dosage chemotherapy on November 8, 1996.
To my surprise the stem cell transplant program was not
nearly as harsh for me as the bone marrow transplant had been
for my sister just 2 years earlier. Within those 2 short years,
the advances made in breast cancer treatment, which were made
possible by cancer research, meant a great deal to me.
I rebounded quicker after the stem cell transplant and was
home sooner from the hospital than would have been possible
with a bone marrow transplant, but the treatment was still
devastating to my physical well-being. I look forward to the
day when cancer treatment will not subject a person to the
rigors of chemotherapy, a day that I truly hope is not too
distant in the future.
I have a 32-year-old sister and a 14-year-old daughter,
both of whom have seen what my twin sister and I have gone
through, and I would love to live to see the day when advances
in cancer treatment reach the point that neither my sister nor
daughter will ever have to deal with this disease.
I remain optimistic that with continued research if I ever
have a relapse there will be something new for me. I am
presently taking a drug which has had some success in treating
osteoporosis and which may also be beneficial in preventing
bone metastasis. This drug and many other new drugs presently
being tested were not available for my sister just a few short
years ago, so as you can see we are moving forward, but it can
never be too fast for me and for others like me.
Being able to testify before you on this particular day is
very special for me, for tomorrow is the first anniversary of
the day we laid my sister to rest. It is not easy, losing
someone you love to this disease, and it is especially
difficult for my parents.
PREPARED STATEMENT
I do not want my family to have to go through this again,
and that is why I will be speaking out for the need for cancer
research for as long as it takes to conquer this disease. I
believe that we are at a point in time that we are very close
to conquering this disease. That is why I am asking the Senate
to at the very least double the budget for cancer research over
the next 5 years.
Thank you.
Senator Specter. Thank you very much, Ms. Shaheen, for that
very moving testimony.
[The statement follows:]
Prepared Statement of Toni M. Shaheen
It is an honor for me to testify here today. The best way
for me to express the importance of cancer research is to share
with you my family's experiences with cancer. My first
encounter with this disease began in 1989 when my identical
twin sister, Jeanne, was diagnosed with breast cancer. She was
36 years old. Her initial treatment at that time was a
lumpectomy, followed by radiation and mild chemotherapy.
Just two years later, in 1991, I was also diagnosed with
breast cancer, but in those 2 years, clinical research had
opened up new protocols for women diagnosed with breast cancer.
I had a lumpectomy and lymph node removal, followed by
radiation, without chemotherapy. Subsequent to the radiation
treatment, I received various hormonal treatments.
At about the same time, my sister, Jeanne, found a second
tumor in her other breast. She had another lumpectomy, lymph
node removal and radiation. Chemotherapy followed, and over the
course of the next four and one half years Jeanne was
continually on and off chemotherapy. In October 1994 on the
advice of her doctors Jeanne began an even more aggressive
approach, a regimen of high dosage chemotherapy and a bone
marrow transplant.
Being twins, my sister and I were very close, and I found
it devastating to see her undergoing the effects of the high
dosage chemotherapy treatment It was evident to me that
research was needed to make life saving treatments less toxic
and painful for patients. At that time I told my husband: ``I
will never have that done. I am not as strong as Jeanne.''
In January 1996, however, we realized that the various
hormonal treatments I had been taking were not effective. My
doctor recommended more aggressive therapy for me also.
My options were to begin a traditional chemotherapy
regimen, or to begin high dosage chemotherapy with a new
treatment--a peripheral stem cell transplant, which was a much
less risky procedure than a bone marrow transplant. Having seen
what my twin sister had gone through I did not think I could do
the high dosage treatment. With her encouragement and support,
however, I started my preparation for the high dosage
chemotherapy in February 1996. I was still in the early stages
of my treatment when Jeanne died in May 1996. She was only 42
years old.
In the summer of 1961 began the stem cell harvesting
process. This was followed by three different cycles of high
dosage chemotherapy treatment and stem cell transplants. I was
released from Columbia Presbyterian Hospital following my third
cycle of high dosage chemotherapy on November 8, 1996. To my
surprise, the stem cell transplant program was not nearly as
harsh for me as the bone marrow transplant had been for my
sister just two years earlier. Within those two short years,
the advances made in breast cancer treatment, which were made
possible by cancer research, meant a great deal to me. I
rebounded quicker after the stem cell transplant, and was home
sooner from the hospital, than would have been possible with a
bone marrow transplant. But the treatment was still devastating
to my physical well being. I look forward to the day when
cancer treatment will not subject a person to the rigors of
chemotherapy, a day that I truly hope is not too distant in the
future. I have a 31 year old sister, and a fourteen year old
daughter, both of whom have seen what my twin sister and I have
gone through. I would love to live to see the day when advances
in cancer treatment reach the point that neither my sister nor
daughter will ever have to deal with this disease.
I remain optimistic that with continued research, if I ever
have a relapse there will be something new for me. I am
presently taking a drug which has had some success in treating
osteoporosis, and which may also be beneficial in preventing
bone metastasis. This drug, and many other new drugs presently
being tested, were not available for my sister just a few short
years ago. So, as you can see, we are moving forward, but it
can never be too fast for me, and for others like me.
Being able to testify before you on this particular day is
very special to me, for tomorrow is the first anniversary of
the day we laid my sister to rest. It is not easy losing
someone you love to this disease, and it was especially
difficult for my parents. I do not want my family to have to go
though this again. That is why I will be speaking out on the
need for cancer research for as long as it takes to conquer
this disease.
SUMMARY STATEMENT OF DR. KEITH BLACK
Senator Specter. We turn now to Dr. Keith Black, professor
in the Department of Surgery, Division of Neurosurgery at the
University of California at Los Angeles. He has served as
UCLA's head of neurosurgical oncology. He is now codirector of
the comprehensive brain tumor program on the Brain Committee
for the Southwest Oncology Group and National Clinical Research
Group, and he is a member of the Board of Scientific Councils
for the National Institute of Neurological Disorders and Stroke
at NIH.
Welcome, Dr. Black. We look forward to your testimony.
Dr. Black. Thank you, Senator Specter, distinguished
Senators. Let me first express my gratitude for the opportunity
to testify before your prestigious committee.
As a physician specializing in the treatment of cancer I
know of no disease that can strike a patient more tragically
than cancer. However, I can tell you with absolute certainty
that the medical and scientific communities are on the verge of
major breakthroughs in our ability to control this dreadful
disease.
Unfortunately, I can also tell you with absolute certainty
that tens of thousands of Americans will die because critical
research remains unfunded, slowing the development of new
lifesaving treatments by years.
Never in the history of mankind have we had such an
opportunity in medicine. We are literally witnessing an
explosion in our understanding of cancer. Every week, new genes
which regulate the process of cancer are being discovered.
We now have an incredible knowledge of what regulates
cancer, what makes a cancer cell a cancer cell, what cancer
cells need to thrive, what signals cancer cells to self-
destruct and die. We also have a remarkable ability now to
manipulate genes within cells, to actually direct cells to do
what we want them to do.
This combination of increased knowledge and powerful new
techniques to manipulate cells provides opportunities we could
only dream of just a few years ago. Let me give you just one
example of how we are now using this new knowledge.
I specialize in the treatment of malignant brain tumors.
The most common brain tumor, the malignant glioma, is
responsible for 15,000 deaths in the United States each year.
The median survival time from diagnosis to death without
treatment is 12 to 16 weeks. With conventional cancer
treatments, including surgery, radiation therapy, and
chemotherapy, the median survival is 38 weeks.
Because of new research findings we now know that malignant
brain tumors are able to grow and escape destruction by our
immune system because they release a protein that turns off the
immune system. This protein is called TGF beta.
We were able to take tumor cells and genetically engineer
the cells in our laboratory so that they could no longer make
TGF beta, thereby uncloaking these tumor cells to the immune
system.
We showed in laboratory experiments that rats with
untreated brain tumors all died within 25 days. However, rats
treated with the genetically modified vaccine all survived.
Rats given the vaccine were able to develop immunity against
their cancers and completely eradicate the tumors.
Based on these studies, we now have a clinical trial where
tumor cells are removed during surgery, genetically engineered,
then reinjected into patients with brain cancer. Some 6 weeks
ago, we treated our first patient with the vaccine, a 36-year-
old man with three children whose brain tumor was growing
despite two surgeries and radiation therapy. His tumor appears
to have stabilized now after the first vaccine injection.
This is just one of literally hundreds of novel approaches
now being developed for the treatment of cancer. When plans to
start this clinical trial were first announced a year ago, my
office received over 2,000 phone calls, faxes and e-mails from
desperate patients hoping to participate in this trial because
they had failed conventional treatments.
Due in part to limited funding the trial could start only 6
weeks ago, I would venture that most of the patients who called
my office have now died. Even with the study underway, only 12
patients can be entered into the trial out of potentially
thousands who could be treated. This is the painful reality,
knowing that our patients will die because our country has not
made cancer research a higher priority.
PREPARED STATEMENT
Our national budget for cancer research should be twice
current funding levels. We no longer wonder if we will find a
cure for cancer, but when. America has an incredible
opportunity to conquer this deadly disease. Increasing funds
for cancer research now could accelerate this process by years,
saving tens of thousands of American lives.
Thank you.
Senator Specter. Thank you very much, Dr. Black. I will
have a question for you when the dialog begins.
[The statement follows:]
Prepared Statement of Keith L. Black, M.D.
Senator Specter and distinguished Senators, let me first
express my gratitude for the opportunity to testify before your
prestigious committee.
As a physician specializing in the treatment of cancer, I
have had to watch hundreds of patients die from cancer because
current treatments have limited benefit. I know of no disease
that can strike a patient more tragically than cancer. However,
I can tell you with absolute certainty that the medical and
scientific community are on the verge of major breakthroughs in
our ability to control this dreadful disease. Unfortunately, I
can also tell you with absolute certainty that tens of
thousands of Americans will die because critical research
remains unfunded or underfunded, slowing the development of new
lifesaving treatments by years.
Never in the history of mankind have we had such an
opportunity in medicine. We are literally witnessing an
explosion in our understanding of cancer. Every week, new genes
which regulate the process of cancer are being discovered. We
now have an incredible knowledge of cancer, what makes a cancer
cell a cancer cell, what cancer cells need to thrive, and what
signals cancer cells to self-destruct and die. With more
research our knowledge will be even greater. We also now have
the remarkable ability to manipulate genes within cells, to
actually direct cells to do what he want them to do. This
process, one of many new treatments we now have, is called Gene
Therapy.
This combination of increased knowledge and powerful new
techniques to manipulate cells provides opportunities we could
only dream of just 5 years ago. Let me give you just one
example of how we are now using this new knowledge: I
specialize in the treatment of malignant brain tumors. The most
common brain tumor, the malignant glioma is responsible for
15,000 deaths in the United States each year. The median
survival time from diagnosis to death without treatment is 12
to 16 weeks. With conventional cancer treatments, including
surgery, radiation, and chemotherapy, the median survival is 38
weeks.
Because of new research findings, we now know that
malignant brain tumors are able to grow in the brain and escape
destruction by our immune system because they release a protein
into the brain which suppresses or ``turns off'' the immune
system. This protein is called Transforming Growth Factor Beta,
(TGFb).
We are able to take tumor cells and genetically engineer
them in our lab so that they can no longer make TGFb, thereby
uncloaking these tumor cells to the immune system. We've shown
in lab experiments that rats with untreated brain tumors all
died. However, rats with brain tumors treated with the
genetically modified vaccine all survived. We found that rats
given the vaccine were able to develop immunity against these
tumors and their brain cancer was completely eradicated. Based
on these studies, we now have a clinical trial where tumor
cells are removed from patients during surgery, genetically
engineered to make a cancer vaccine, and then re-injected into
patients with brain cancer.
Six weeks we treated the first patient with the vaccine, a
36-year-old man with three young children whose brain tumor was
growing, despite two brain surgeries and radiation therapy. His
tumor appeared to have stabilized after his first vaccine
injection.
This is just one of literally hundreds of novel approaches
now under development for the treatment of cancer. When plans
to start this experimental trial were first announced a year
ago, my office received over 2,000 phone calls, faxes, and e-
mails from desperate patients hoping to participate in this
trial because they had failed conventional treatments. Due
partially to limited funding the trial started just 6 weeks
ago. I would venture that most of the patients who called my
office have now died. Even with the study underway, only 12
patients can be entered into the trial, out of potentially
thousands who could be treated. This is the most painful
reality, knowing that our patients will die because our country
has not made cancer research a higher priority.
To continue rapid progress requires increased funding for
not only basic research to continue our understanding of
cancer, but also for the translation of research into clinical
trials for patient care. Our national budget for cancer
research should be at least twice the current funding levels.
We no longer wonder if we will find a cure for cancer but when.
America has an incredible opportunity to conquer this deadly
disease. Increasing funds for cancer research could now
accelerate by years the development of new and more effective
treatments for cancer, literally saving tens of thousands of
American lives.
Thank you.
SUMMARY STATEMENT OF DR. CHARLES A. COLTMAN, JR.
Senator Specter. We now turn to our final witness, Dr.
Charles Coltman, president and CEO of the Cancer Therapy and
Research Foundation of Southwest Texas, as well as director of
the San Antonio Cancer Institute and chairman of the Southwest
Oncology Group.
He is a graduate of the University of Pittsburgh School of
Medicine, and now is a professor at the University of Texas
Health Science Center at San Antonio. We welcome you here, Dr.
Coltman, and look forward to your testimony.
Dr. Coltman. Senator Specter, honorable members of the
committee, it is my high privilege to speak on behalf of the
subject near and dear to my heart. I have been in the care of
patients with cancer and in cancer clinical trials for the past
34 years.
I chair the Southwest Oncology Group, the largest National
Cancer Institute-supported clinical cancer research
organization in the country. In 1996, this group enrolled 6,359
patients to therapeutic cancer research clinical trials from
all 50 States and completed randomization of 18,867 normal,
healthy men into an intergroup prostate cancer prevention
trial.
Clinical trials are always designed to improve the outcomes
of patients with cancer. However, only 2 to 3 percent of all
eligible patients in this country are treated on these cutting-
edge clinical trials. It is clear that this number must
increase dramatically in order for us to be able to translate
the monumental advances emanating from the basic research
laboratories into effective diagnosis, prevention and treatment
strategies for patients with and at high risk for cancer.
This low accrual is related to multiple factors. First,
managed care has a negative impact related to its refusal to
reimburse for the clinical care aspects of patients on cancer
clinical trials. During my presentation to the President's
cancer panel in San Antonio in September I shared three
thoughts as to what the panel should be asking as they pursued
the question of managed care's role in the war on cancer:
Should managed care bear a portion of the cost of clinical
research as a form of R&D?
What State or Federal legislation is needed to assure that
managed care patients have access to cancer clinical research?
Will there be any future for cancer clinical research when
the managed care tidal wave finally reaches Chicago and New
York?
The NCI-Department of Defense and the NCI-Department of
Veterans Affairs interagency agreements are superb models of
what needs to be done for the rest of managed care.
Second, the Southwest Oncology Group is outstripping its
financial support at its current rate of accrual. Even if the
managed care problem were resolved, there must be more money to
support clinical research to translate this plethora of science
into patients with cancer.
As director of the San Antonio Cancer Institute, an NCI-
designated comprehensive cancer center in San Antonio, recently
one of my investigators had an astonishingly productive breast
cancer program project grant which received a priority score of
one point below the line. While this grant will undoubtedly be
funded by exception, it is representative of a nationwide
problem of insufficient funds to support truly outstanding
research.
The following is a quote from another cancer director who,
like me, is also cooperative group chairman:
Breakthrough
We never know where the next breakthrough will come from.
Every time we discover a new gene we also have a new marker for
early diagnosis, a new predictor of response to therapy, a new
target for chemo prevention as well as for cancer treatment.
Every discovery in a cancer center provides fuel for the
cooperative group program and requires affirmation in large
clinical trials. Thus, the universe of cancer research is a
continuum, where improved funding for any of it impacts all of
it, and improved funding for all of it will hasten the pace of
discovery throughout.
PREPARED STATEMENT
Finally, I would like to paraphrase a futurist that I
recently heard: The present is obsolete. The future has already
been discovered in the laboratories of molecular biologists
throughout this country. We must search among those discoveries
for the keys to cancer cures.
We are confronted with insurmountable opportunities. These
new tools will change the rules of the game. We should not
manage change. We should love change. We should make change our
best friend, as all those involved in cancer research and
Congress must do every day.
Thank you for your attention.
[The statement follows:]
Prepared Statement of Charles A. Coltman, Jr., M.D.
Senator Specter, honorable Members of the Committee, is my
high privilege to speak on behalf of a subject near and dear to
my heart. I have been involved in the care of patients with
cancer and in cancer clinical trials for the past 34 years.
I chair the Southwest Oncology Group, the largest National
Cancer Institute-supported cancer clinical research
organization. In 1996, this Group enrolled 6,359 patients to
therapeutic cancer clinical trials from all 50 states (Appendix
1), and completed the randomization of 18,867 normal, healthy
men into the intergroup Prostate Cancer Prevention Trial.
Cancer clinical trials are always designed to improve the
outcomes of cancer patients. However, only 2 to 3 percent of
all eligible cancer patients in this country are treated on
these cutting edge trials. It is clear that this number must
increase dramatically in order for us to be able to translate
the monumentary advances emanating from the basic cancer
research laboratories into effective diagnosis, prevention and
treatment strategies for patients with and at high risk for
cancer.
This low accrual is related to multiple factors: First,
managed care has had a negative impact related to its refusal
to reimburse for the clinical care aspects of patients on
cancer clinical trials. During my presentation to the
President's Cancer Panel in San Antonio in September (Appendix
2), I shared three thoughts as to what the Panel should be
asking as they pursue the question of ``Managed Care's Role in
the War on Cancer.''
``Should managed care bear a portion of the costs of
clinical research as a form of R&D?''
``What State or Federal legislation is needed to assure
that managed care patients have access to cancer clinical
research?''
``Will there be any future for cancer clinical research
when the managed care tidal wave finally reaches Chicago and
New York?''
The NCI-Department of Defense and the NCI-Department of
Veterans Affairs Interagency Agreements are superb models of
what needs to be done for the rest of managed care.
Second, the Southwest Oncology Group is outstripping its
financial support at its current rate of accrual. Even if the
managed care problem was resolved, there must be more money to
support clinical research to translate this plethora of science
to patients with cancer.
I am also Director of the San Antonio Cancer Institute, a
National Cancer Institute-designated Comprehensive Cancer
Center (Appendix 3). A recent astonishingly productive Breast
Cancer Program Project Grant received a priority score one
point below the pay line. While this grant will undoubtedly be
funded by exception, it is representative of a nationwide
problem of insufficient funds to support truly outstanding
research.
The following quote is from another Cancer Center Director,
Dr. Richard L. Schilsky:
``We never know where the next breakthrough will come from.
Every time eve discover a new gene, we also have a new marker
for early diagnosis, a new predictor of response to therapy, a
new target for chemoprevention, as well as for cancer
treatment. Every discovery in a Cancer Center provides fuel for
the Cooperative Group program, and requires affirmation in
large clinical trials. Thus, the universe of cancer research is
a continuum, (where) improved funding for any of it, impacts
all of it, and improved funding for all of it will hasten the
pace of discovery throughout.''
Finally, I would like to paraphrase a futurist that I
recently heard:
``The present is obsolete.''
``The future has already been discovered'' in the
laboratories of molecular biologists throughout this country!
We must search among those discoveries for the keys to cancer
cures.
``We are confronted with insurmountable opportunities!''
``These new tools will change the rules of the game!''
``We should not manage change, we should love change and
make change our best friend'', as all those involved in cancer
research and the Congress must do every day.--Don Burrus.
Thank you for your attention.
TESTING
Senator Specter. Thank you very much, Dr. Coltman.
The issue of testing is so very, very important. And you
have highlighted that, Mr. Palmer, with your comment about the
PSA. And we are trying to work hard to popularize testing on
all lines as a method of prevention.
Senator Dole had wanted to be here today, because he
recently had an operation for prostate cancer. And he has a way
of characterizing the situation, which is really unique. He
came back as majority leader at a Republican luncheon, where we
had a caucus, announce his successful operation and he said it
strikes one man out of nine, so you eight guys are safe.
[Laughter.]
And he turned to Senator Stevens, Ted Stevens, who had just
had an operation for prostate cancer, he said, you eight are
safe, and he turned over to Strom and he said, and Strom is too
old to get cancer anyway. [Laughter.]
But I thought that his focus in his own lighthearted way
was very effective. And the testing is so very vital. And I
think your voice today is a very important one on that.
Dr. Black, let me turn to you in the very limited time we
have. There are lots of questions I have for everybody, but I
am especially concerned with the research you are doing on
brain cancer. There is a fine line as to what is not malignant
and what is, as I have had some occasion to take a look at the
pathology. It is tough to figure some of that out as to what
the doctors classify as No. 1 and No. 2 and different
categories. But I am concerned to hear about the lack of money
for the clinical application.
Now, where does that fit in to what we can do? How can this
subcommittee and then, ultimately, the Congress help on the
funding for those kinds of trials, those kinds of experimental
operations? You do not have enough money to do it. That does
not quite fit into the research. How can we help you?
Dr. Black. Well, Senator, I think it is important to
increase funding both for basic research to increase our
knowledge of cancer, but it is also critical to increase
funding for what we call translational research--bringing the
research from the laboratory bench to the bedside, so that we
can carry these technologies very rapidly into clinical care.
This is a very critical issue: How do we get research from the
laboratory into our patient armamentarium?
Senator Specter. Well, we will pursue that. Dr. Klausner
will be in on Tuesday when we have the NIH hearings. And I now
know a new term, ``translational research.''
In my limited time, I want to come to you, Dr. Coltman, on
your comment about managed health care. That is a subject which
is being very, very closely followed by the Congress now. And
we legislated against drive-by deliveries last year. And there
is some legislation up as to drive-by mastectomies. And pretty
soon we may legislate on everything. There may not be a need
for any medical judgments. We may handle it all right in the
Congress. And I do say that facetiously, because we really do
not want to micromanage or meddle.
But on managed care, we are looking at a lot of ways to try
to make these medical decisions not exclusively financial
decisions. And you say they are not bearing their fair share in
cancer clinical trials. I would like a brief explanation today
as to what you think we ought to do on that subject, if we
should legislate, and if so, how, and perhaps a followup at a
later time. Because we are going to be getting into that field
and we want to do it right. We want to do it in a very limited
way.
But what is the essence of your thought as to how Congress
might act?
Dr. Coltman. Let me just start by saying that managed care
is not a totally evil organization. They do a lot of good
things. But the fact is that all of their contracts have built
into them that they will not pay for research, and that
includes clinical research. So any time you take a laboratory
tool and take it into clinical research to use it on patients,
which of course is the only way you can validate the concept
from the laboratory, it requires patients.
They repeatedly refuse to pay for those clinical care
aspects--that is, the hospitalization that might be necessary
in a phase 1 or 2 clinical trial--when a patient is getting a
new agent for the first time. And that is the major impediment.
It goes on to phase 3 clinical trials--large clinical trials
that impact on all sorts of malignant diseases. The accrual to
those clinical trials is impeded by that particular aspect of
refusal to pay for quote, ``research.'' It is not laboratory
research, it is research involving humans.
Senator Specter. Well, Dr. Coltman, we would like your
advice as to how we might legislate in the field, if you think
that would be wise.
We have questions for Ms. Langer and Ms. Shaheen, but we
just do not have time to put them to you.
One final question, where is the touch of your Southern
accent from, Dr. Coffey?
Dr. Coffey. Bristol, TN-VA, a State-line city.
Senator Specter. Senator Harkin.
Senator Harkin. I want to thank, first of all, the panel
for being here and for your testimonies.
I want to pick up in one area. I do not know who to direct
this to. Maybe Dr. Coffey. I do not know. But also for the
benefit of Dr. Klausner, who will be here again next week. Just
listening here and in some experiences that I have had in the
past, and not only experiences, but being on this committee for
a number of years, I am concerned that there is evolving, I
think, what I would call a disturbing and I think somewhat
inaccurate perception that the process of new discovery, Dr.
Black, is a one-way street. It starts in the laboratory and it
goes to the bedside for clinical trials.
Now, Dr. Coltman just touched on that. And that is what got
me thinking about this. However, I understand a lot of
discoveries are made by clinical scientists who are observing
diseases out there.
Dr. Black. Absolutely.
Senator Harkin. And some of these are no less profound than
what is happening in the laboratory. And yet, to move this kind
of research from the clinical arena to the laboratory bench
seems not to be working too well. I guess what I would say is,
as it was put to me one time, the path to discovery is
multifaceted. And it really is a two-way street between the
laboratory and the bedside, and the bedside to laboratory.
And yet, this kind of highly innovative type of research
does not seem to compete in this present environment that we
have. I do not know how we move in that direction. And that is
something I wanted to ask Dr. Klausner next week, and perhaps
we will talk about it again. And just listening to this, I am
sorry to have to say this, but listening to a couple of you
talking about going from the laboratory to the clinic--well,
wait, there is another pathway to this, too, and that is from
the clinical to the laboratory also.
Now, Dr. Klausner just testified--I just read--he said that
only 2 percent of cancer patients are in clinical trials. Now,
that is from the laboratory to the bedside. That is woefully
inadequate. Then how about the other end? How about the doctors
who are out there, Dr. Coltman, that you are talking about, and
getting that back to the laboratory for them to look at it?
That does not seem to be working too well. So I just throw
that question out there for digestion.
Dr. Coffey. I would like to comment if you would allow me.
Senator Harkin. Yes; Dr. Coffey.
Dr. Coffey. Special projects on research excellence, called
SPORE grants, were put forth by Congress toward the NCI to
address this very problem. And in those research operations,
you have to have both the clinical and basic plan the grant,
plan the experiments, in a two-way street. These have been
highly successful. And Dr. Klausner can tell you about it.
Unfortunately, let me just give you one example. In the
prostate, many, several dozens of these grants came in. They
could only fund two of them in the first go-around. One of
those SPORE grants from Harvard had three Academy of Science
members on it that did not get funded. The one from M.D.
Anderson, which had the winner of the George Bush Award, did
not get funded. The Mayo Clinic did not. These were beautiful
grants. And each one of them was the size of a New York
telephone directory.
So when I hear statements made that all the good grants and
ideas are being funded, they are not. And in this area of
SPORE's, just what you are talking about is happening and it is
working.
Senator Harkin. Did you have something, Mr. Palmer?
Mr. Palmer. I did.
Senator Harkin. I think Dr. Coltman wanted to respond
first.
Dr. Coltman. Senator Harkin, there is absolutely no
question that this is a two-way street. We are emphasizing this
plethora of science that is standing there, waiting to be
translated into patients. And we have a critical lack of
funding to support that translational research into patients.
But there is no question that the clinical scientists of this
country, of which I represent a diminishing few, are engaged in
feeding back and interacting at cancer centers throughout this
country.
The interaction between the clinicians and the basic
science is the essence of centeredness of the National Cancer
Institute-supported cancer centers. And it happens every day.
We do not happen to be focusing on that today, but it is a
critical aspect.
But in order to assure the supply of young scientists, we
must have a training program available and grant support to
support the physician-scientists, who are out there, the next
generation of Chuck Coltmans, who are prepared to take the
ideas in both directions. And we need support for those young
clinical investigators.
Senator Harkin. Mr. Palmer?
Mr. Palmer. I was only going to bring up the fact that in
the case of prostate cancer, Medicare, for an example, does not
cover a PSA until it is diagnosed.
Senator Harkin. I did not know that.
Mr. Palmer. And a lot of the insurance companies will not
cover PSA's under their medical insurance coverage.
Senator Harkin. That is crazy. I was not aware of that.
That is ridiculous.
Senator Specter. Well, along the same line, on your time,
Senator Harkin, since it is gone----
Senator Harkin. I can see my red light is up.
Senator Specter. On your time, since it is gone, Medicare
does not cover PSA's either.
Senator Harkin. That is what he just said.
Senator Specter. Oh, I see.
Senator Harkin. He said Medicare and the insurance
companies.
Senator Specter. OK, and insurance. Or cholesterol testing.
When you see the kind of funds we have to allocate, it is just,
I think, shocking that you sort of throw away the people on
Medicare. Never mind. Too old. No cholesterol testing. No PSA.
We really have to change that. And we will.
Senator Harkin. On that last question I asked, I really
want to pursue that. If you have any other, Dr. Coltman, Dr.
Coffey and Dr. Klausner, next week when we come up, I would
like to kind of delve into this a little bit more, about how we
get that two-way street going a little bit better.
Senator Specter. Thank you very much, Senator Harkin.
Senator Harkin. Thank you, Mr. Chairman.
SUBCOMMITTEE RECESS
Senator Specter. Thank you, Dr. Black, Dr. Coltman, Ms.
Langer, Ms. Sheehan, Mr. Palmer, and Dr. Coffey. I think it has
been a very productive session, and we are going to do this
again in Los Angeles on the 29th of May.
Thank you all. That concludes our hearing. The subcommittee
will recess and reconvene at the call of the Chair.
[Whereupon, at 11:55 a.m., Wednesday, May 7, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
WINNING THE WAR ON CANCER: PROGRESS AND PROGNOSIS
----------
THURSDAY, MAY 29, 1997
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Beverly Hills, CA
The subcommittee met at 10:18 a.m., in the Beverly Hills
City Hall council chambers, Beverly Hills, CA, Hon. Arlen
Specter (chairman) presiding.
Present: Senator Specter.
NONDEPARTMENTAL WITNESSES
STATEMENT OF SHERMAN BLOCK, SHERIFF, LOS ANGELES, CA
OPENING STATEMENT OF HON. ARLEN SPECTER
Senator Specter. We will now proceed with the hearing of
the Appropriations Subcommittee on Labor, Health and Human
Services, and Education. This is part two of our subcommittee's
hearings on the National Cancer Act, as we celebrate the 25th
anniversary of that historic legislation and the massive
efforts which we have made to try to conquer cancer.
We have scheduled this hearing in Beverly Hills, quite
candidly, because when Hollywood speaks, the world listens;
when Washington speaks, occasionally the world snoozes. And we
have an issue which requires a tremendous public focus if we
are to move ahead on the war against cancer.
This is very current subject, because funding for the
National Institutes of Health and the war on cancer at this
moment is very much in doubt. And that has been occasioned by
the fact that in the budget resolution passed last week by the
U.S. Senate, the account for health services has been reduced
by $100 million. And in Washington, we sometimes have double
speak and sometimes triple speak and sometimes quadruple speak.
But last week, it is a little hard to quantify it, and I will
tell you exactly why.
The U.S. Senate passed a sense of the Senate resolution, to
add $2 billion to the National Institutes of Health; this
followed pronouncements by many of us on the need to increase
funding for NIH.
But this is a meaningless gesture unless there is a
specific offset specifying where the money is going to come
from. So Senator Tom Harkin and I--Senator Harkin is my
counterpart, and we work on a bipartisan basis, and that is the
only way anything ever gets done in Washington, is when
Democrats and Republicans work together--Senator Tom Harkin and
I introduced an amendment to add $1.1 billion to NIH, with a
specific offset.
And it was a modest offset--four-tenths of 1 percent on
discretionary nondefense spending. So a little bit would be
taken in a lot of places to have the funding to add to the
National Institutes of Health. And that amendment was defeated,
63 to 37. I thought it very important, in my capacity as
chairman of the subcommittee, to lay it right on the line so
that the American people would know exactly what was going on.
Because there is a need for significant increases in cancer
funding, and heart disease, and Alzheimer's, and many, many
other very, very important areas of medical research. I did not
want to see a situation prevail, where America thought there
was a $2 billion increase, but it was meaningless, on a sense
of the Senate resolution.
So, ladies and gentlemen, our work is cut out for us, in
terms of what we must do. And this hearing takes on added
significance, as we want to focus the attention of the American
people on the need for funding of the National Institutes of
Health.
I am personally convinced that we have the resources in the
Federal budget to take care of America's needs if we establish
our priorities properly. We have a Federal budget of $1.7
trillion. Now, that is a staggering, incomprehensible sum of
money. If you take a large room this size, there would not be
enough space to stuff $10,000 bills into this room and occupy
that kind of a budget.
In the last 2 years, Senator Harkin and I consolidated or
eliminated 134 programs from our subcommittee to save $1.5
billion, allowing us to put more resources into NIH and into
education, which I personally consider the two top priorities
in America today. And yet, the headlines of the day are
troublesome. The lead story in this morning's USA Today has
this headline: ``$30 billion war on cancer, a bust.''
And a new study is now out from Dr. John Bailar and Dr.
Kevin Gornick of the University of Chicago, published in the
New England Journal of Medicine, which raises real questions
about the success of the war on cancer, and raising real
questions about allocations of resources, as to whether it all
ought to be in research, or so much in research, or in
prevention, with prevention resources having increased from 5
to 10 percent. These are real issues which we are going to have
to tackle, and our subcommittee will have a hearing at a very
early date, to assess the most effective way to deal with this
issue.
We have a very, very distinguished panel today. It has been
assembled with great effort. We will give the kudos at the
conclusion of the hearing, but now I want to move as promptly
as possible to our very distinguished witness list.
I would like to start off with the distinguished sheriff of
Los Angeles County, Mr. Sherman Block, a member of the
department since 1956. He was sworn in as the 29th sheriff in
1982, having been appointed by unanimous decision of the Los
Angeles County Board of Supervisors. He is now in his fourth
elected term of office. He commands the largest sheriff's
department in the world, supervising more than 12,000
personnel.
On a personal note, Sheriff Block and I were reminiscing
about a hearing which the Judiciary Committee held, which I
chaired here in Los Angeles in 1985, when we moved ahead with
the armed career criminal bill, my legislation moving the
Federal Government into the fight against street crime.
Sheriff Block, we welcome you here. And it is appropriate
for me to say at this time that we would appreciate having
statements within a 5-minute limitation. The green light will
go on to start, the yellow with 1 minute remaining, and the red
when time has expired. All statements will be made a part of
the record. To the extent that we can stay within the time
limits, it would be appreciated. If you go over, it is not like
arguing in the Supreme Court of the United States, where they
cut you off in midsyllable.
Sheriff Block, the floor is yours.
SUMMARY STATEMENT OF SHERMAN BLOCK
Mr. Block. Thank you, Mr. Chairman. It is an honor for me
to testify today. And I want to personally thank you for your
attention to the topic of cancer, and your support for research
that can save the lives of literally millions of people.
I am proud to testify here today, because I have survived
cancer not once, but twice; 6\1/2\ years ago, my doctor, while
doing a routine examination, determined that something was not
quite right during a digital exam. He detected a soft spot. My
PSA was not highly elevated, but a biopsy turned up prostate
cancer. I was 66 at the time. And my first reaction to the word
``cancer'' was, am I going to die? But how could I, with a
family and so much left to do?
I had surgery at USC's Norris Cancer Hospital and Research
Institute. And because my cancer was detected early, I have
been prostate cancer-free ever since. Having battled cancer
once, 4 years ago this June, I was shocked to find a lump
between my neck and left shoulder as I shaved for work one
morning. The lump, which was the size of a golf ball, or
perhaps even larger, turned out to be high-grade, fast-moving,
non-Hodgkin's lymphoma, according to my doctor. I was stunned
and somewhat devastated. I had conquered the prostate cancer at
66, but here I was at 68, and considered a high-risk patient
because of my age.
The doctors told me straight out that the chemotherapy
alone might kill me, but that without the chemotherapy, I would
certainly die in 3 to 6 months. This time, I was certainly
concerned, but not fearful. I underwent 7 months of
chemotherapy. And thanks to innovations in research, I was able
to tolerate the chemotherapy and actually go to work every day
except for 2 during that 7-month period. New drugs greatly
minimized the side effects previously caused by chemotherapy,
like nausea and a susceptibility to infection, which would have
prevented me from holding my position as sheriff.
As head of the Nation's largest sheriff's department for 15
years, I was very public about my cancer diagnosis, treatment,
and progress from the start. As a result, the community saw the
progress I was making each month, and many strangers with
similar diagnoses called me for counsel and advice. They saw me
on my good days and my bad days. And I felt real good about the
information I was able to share with these folks, and to help
ease their concerns.
Prostate cancer, of course, is now the most common cancer
among American men. This year alone, over 200,000 new cases of
prostate cancer will be diagnosed and 42,000 men will die. And
there will be an estimated 61,000 new cases of lymphoma in
1997. And since the early 1970's, incident rates have increased
more than 80 percent. And an estimated 25,280 deaths from non-
Hodgkin's lymphoma are expected in 1997; 4,800 in California
alone. That is 13 fatalities per day from just one type of
cancer.
There are fewer than 10 people a day who die from all
homicides in California. Cancer, of course, is one of the
biggest societal menaces we currently face, and we need to find
the resources to put this hazard to rest.
At a recent event, I listened to a large number of women of
color express their fear of getting annual checkups. Their fear
was that they might find something wrong, and since they were
breadwinners, they feared losing their jobs because of a cancer
diagnosis. We need to increase the funding for research, and
get the information out to these and other women that cancer is
not a death sentence. Research has and will continue to make
early detection and better treatments possible.
Like myself, thanks to research, many of these women may be
able to keep their jobs once diagnosed with cancer, because of
improved treatments that are gentler on our bodies.
We also need to make sure that the health care systems that
many of these women and others depend on, like managed care,
provide access to the most innovative treatment and trials. All
Americans should have the chance to receive the best and most
cutting-edge care available.
PREPARED STATEMENT
I will continue my work as a cancer advocate in my
community, to make sure that people know of all the
opportunities to lead a productive life with cancer. But you
have in your hands a chance to support more research and more
clinical trials that will increase what we already know about
the disease and save millions of lives. Increased funding for
all cancer research is truly the key. And I urge you to provide
it.
Thank you.
[The statement follows:]
Prepared Statement of Sheriff Sherman Block
Mr. Chairman, it is an honor for me to testify today. I
want to personally thank you for your attention to the topic of
cancer and your support for research that can save the lives of
literally millions of people.
I am proud to testify here today, because I have survived
cancer not once, but twice. Six and half years ago, my doctor,
while doing a digital exam, determined something was just not
quite right. He detected a soft spot. My PSA was not highly
elevated, but a biopsy turned up prostate cancer. I was 66 at
the time, and my first reaction to the word cancer was ``I am
going to die.'' But how could I with a family and so much left
to do? I had surgery at USC's Norris Cancer Hospital & Research
Institute, and because my cancer was detected early, I have
been prostate cancer-free ever since.
Having battled cancer once, four years ago June, I was
shocked to find a lump between my neck and left shoulder as I
shaved for work one morning. The lump, which was the size of a
golf ball or even larger, turned out to be a high-grade, fast-
moving non-Hodgkins lymphoma according to my doctor. I was
stunned and somewhat devastated. I had conquered the prostate
cancer at 66, but here I was 68 this time, and considered a
high-risk patient because of my age. The doctors told me
straight out that the chemotherapy alone might kill me, but
that without the chemo I would certainly die in 3 to 6 months.
This time I was concerned, but not fearful. I underwent 7
months of chemotherapy. And thanks to innovations in research,
I was able to tolerate the chemotherapy and go to work every
day, except for two. New drugs greatly minimized the side
effects of previously caused by chemotherapy, like nausea and
vomiting and a susceptibility to infections, which would have
prevented me from holding my position as Sheriff.
As head of the nation's largest sheriff's department for 15
years, I was very public about my cancer diagnosis, treatment
and progress from the start. As a result, the community saw the
progress I was making each month, and many strangers with
similar diagnoses called me for counsel and advice. They saw me
on my good days and bad. And I felt real good about the
information I was able to share with folks, and help ease their
concerns.
Prostate cancer is now the most common cancer in American
men. This year alone, over 200,000 new cases of prostate cancer
will be diagnosed, and 42,000 men will die. And there will be
an estimated 61,000 new cases of lymphoma in 1997. Since the
early 1970's, incidence rates have increased more than 80
percent. An estimated 25,280 deaths from non-Hodgkin's lymphoma
are expected in 1997--4,800 in California alone. That's about
13 fatalities per day from just one type of cancer. Do you
realize that fewer than 10 people a day die from all homicides
in California? Cancer is one of the biggest societal menaces we
currently face, and we need to find the resources to put this
hazard to rest.
At a recent event, I listened to a large number of women of
color express their fear of getting annual check-ups. Their
fear was not the fear of finding something wrong, but many were
the breadwinners and feared losing their job because of a
cancer diagnosis. We need to increase the funding for research
and get the information out to these and other women that
cancer is not a death sentence. Research has and will continue
to make early detection and better treatments possible. Like
me, thanks to research many of these women may be able to keep
their jobs once diagnosed with cancer because of improved
treatments that are gentler on our bodies. We also need to make
sure that that health care systems that many of these women and
others depend on, like managed care, provide access to the most
innovative treatments and trials. All Americans should have the
choice to receive the best and most cutting edge care
available.
I will continue my work as a cancer advocate in my
community to make sure that people know of all the
opportunities to lead a productive life with cancer. But you
have in your hands a chance to support more research and more
clinical trials that will increase what we know about the
disease and save millions of lives. Increased funding for all
cancer research is truly the key, and I urge you to provide it.
MAMMOGRAMS
Senator Specter. Thank you very much, Sheriff Block. When
you comment about the diagnoses for women and the concern
factor, we are trying very hard to make mammograms available
throughout the land. And we recently had quite a controversy on
the issue of mammograms for women 40 to 49, with an NIH panel
in January, raising a doubt about that subject. And this
subcommittee held hearings, and we brought the issue to a head.
And a group of specialists concluded that the mammograms were
warranted for women 40 to 49.
There was a concern expressed as to what the impact of what
happened when a question was raised, as to whether that would
discourage so many women from having mammograms. But,
ultimately, it turns on a question of resources. And that is a
decision, as a matter of public policy, the Congress has to
decide. We need the best scientific evidence, but then, when it
comes to the allocation of funding, that is for the
Appropriations Committee to decide and the full Congress.
So we thank you for your testimony.
STATEMENT OF SALLY FIELD, ACTRESS, LOS ANGELES, CA
Senator Specter. I would like to turn now to a very
distinguished actress, Ms. Sally Field, two-time Academy Award
winner for her performance in the films ``Places in the
Heart,'' and ``Norma Rae;'' recipient of an Emmy Award for her
title role as a young woman with multiple personalities in the
television special ``Cybil.'' Her film credits are very long
and include such hits as ``Forest Gump'' and ``Mrs.
Doubtfire.''
We welcome you here, Ms. Field, and look forward to your
testimony.
Ms. Field. Thank you. Mr. Chairman, I want to thank you for
inviting me to testify here today. I am personally grateful for
your attention to this topic that affects so many of us and our
families and our lives.
In my family, frankly, I always thought we were immune to
cancer, because I was not aware of any family member who had
been stricken. All my life, if there was a hidden monster, I
feared it was heart disease and not cancer. My family had a
predisposition to heart disease, and I have always been very
concerned for my health and that of my sons. But that all
changed this last year, when two of my very closest family
members were both diagnosed with and treated for cancer.
Out of respect for their privacy, I will not go into
detail. I only bring it up to make to point that you never know
when, who or why cancer will strike. Yet, when it does, it
turns your life and your family's life upside down.
While I am not a cancer expert, I do know that many cancers
can be prevented. Medical research over the last 25 years has
given insights into how to prevent certain cancers altogether.
This year alone, 174,000 cancer deaths are expected to be
caused by tobacco use. They could have been prevented.
A like number of cancer deaths will be caused by poor
nutrition and dietary factors. As many as 900,000 nonfatal skin
cancers, preventable by protection from the sun, will be
diagnosed this year. We need to do a better job of getting
information out to the public on cancers that are preventable,
and we must make it a national priority to increase funding to
determine the underlying causes of other cancers killing and
afflicting our family and friends.
Research has made the detection of cancers at an early
stage possible as well. I am very grateful that early detection
helped those people that I love so dearly detect their cancers
and get treatment at the earliest possible stage. But we need
to make sure all Americans take advantage of regular screening
examinations to help detect cancer of the breast, tongue,
mouth, colon, prostate, and others. Survival for these and
other cancers is 80 percent if caught early. We must ensure
that all Americans get access to screening. We cannot afford
not to.
We need your support, Mr. Chairman, to help fund research
in prevention, detection and treatment. Because, as we identify
the diseases earlier, our doctors are going to need the best
tools and information available to treat them. They can only
come if our legislators stand up for the 10 million cancer
survivors, their families and friends, and appropriate more
money to cancer research now.
PREPARED STATEMENT
Can there be any American who has not been in some way
touched by cancer? I come here before you today with a message
of urgency. I know my family is not immune to cancer. And I see
the great potential for improved prevention, detection,
treatment, and cure for all cancers. We cannot stand silent as
this disease devastates our lives. Please double the budget for
cancer research, for our families and friends today who are
surviving, and for our children, God forbid, who may be
stricken unexpectedly tomorrow.
[The statement follows:]
Prepared Statement of Sally Field
Mr. Chairman, I want to thank you for inviting me to
testify here today. I am personally grateful for your attention
to this topic that affects so many of our lives.
In my own family, frankly, I always thought we were immune
to cancer, because I wasn't aware of any family members who had
been stricken. All of my life, if there was a hidden monster I
feared, it was heart disease. My family had a predisposition
for heart disease, and I have always been gravely concerned for
my health and that of my sons.
That all changed in the last year when two family members
were both diagnosed with and treated for cancer. Out of respect
for their privacy, I won't go into detail. I only bring it up
to make the point that you never know when, who, or why cancer
will strike--yet when it does, it turns your life, and your
family's life, upside down.
While I am not a cancer expert, I do know that many cancers
can be prevented. Medical research over the last 25 years has
given us insights into how to prevent certain cancers
altogether. This year alone, 174,000 cancer deaths are expected
to be caused by tobacco use--they could have been prevented. A
like number of cancer deaths will be caused by poor nutrition
and dietary factors. As many as 900,000 non-fatal skin cancers,
preventable by protection from the sun, will be diagnosed this
year. We need to do a better job of getting information out to
the public on cancers that are preventable. And we must make it
a national priority to increase funding to determine the
underlying causes of other cancers killing and afflicting our
family and friends.
Research has made the detection of cancers at an early
stage possible as well. I am grateful that early detection
helped those persons I love so dearly detect their cancer and
get treatment at the earliest possible stage. But we need to
make sure all Americans take advantage of regular screening
examinations to help detect cancer of the breast, tongue,
mouth, colon, prostate, and others. Survival for these and
other cancers is 80 percent if caught early. We must ensure
that all Americans get access to screening--we can't afford not
to.
We need your support, Mr. Chairman, to help fund research
in prevention, detection, and treatment--because as we identify
the disease earlier, our doctors are going to need the best
tools and information available to treat them. That can only
come if our legislators stand up for the 10 million cancer
survivors, their families, and friends and appropriate more
money to cancer research now. Can there be any American who has
not been in some way touched by cancer?
I come here before you today with a message of urgency. I
know my family is not immune to cancer. And I see the great
potential for improved prevention, detection, treatment and
cure for all cancers. We cannot stand silent as this disease
devastates our lives. Please double the budget for cancer
research--for our families and friends today who are surviving
and for our children who may be stricken unexpectedly tomorrow.
PSA
Senator Specter. Thank you very much, Ms. Field, for that
very poignant and moving testimony.
We are going to have questions for the panel when everybody
concludes, but may I ask if either of the two family matters
that you referred benefited from early detection?
Ms. Field. I believe their lives, at this point, were saved
from that. They both received very early detection. They were
both operated on, and right now they are cancer-free.
Senator Specter. That is a message which needs to go out
very forcefully. Sheriff Block testified about his PSA, a very
good detection for prostate cancer--methods--mammograms for
breast cancer, and so on. So I think that is something to be
underscored early and often.
STATEMENT OF STEPHEN J. FORMAN, M.D., DIRECTOR,
DEPARTMENT OF HEMATOLOGY AND BONE MARROW
TRANSPLANTATION, STAFF PHYSICIAN,
DEPARTMENT OF MEDICAL ONCOLOGY AND
THERAPEUTICS RESEARCH, CITY OF HOPE
NATIONAL MEDICAL CENTER, DUARTE, CA
ACCOMPANIED BY:
SHARI KAHANE, CANCER SURVIVOR
YOCHEVED ROSENTHAL, CANCER SURVIVOR
CINDY LADIN, CANCER SURVIVOR
ANISSA AYALA, CANCER SURVIVOR
ROBIN FRASIER, CANCER SURVIVOR
MUSHTAQUE JIVANI, CANCER SURVIVOR
summary statement of Dr. Stephen J. Forman
Senator Specter. I now turn to Dr. Stephen Forman, director
of the department of hematology and bone marrow transplantation
at the City of Hope National Medical Center, and president of
the City of Hope Oncology Network. He is the principal
investigator with the $14 million, 5-year National Cancer
Institute bone marrow transplant project grant, and is an
international leader in the field of bone marrow
transplantation.
Dr. Forman, welcome, and the floor is yours.
Dr. Forman. Thank you, Senator Specter.
Before I start, I would like to address the article that
you held up that was in the newspaper today and try to put it
in context. Cancer has had 3 million years of evolution to
evolve to the state where it is a human problem. We have had 30
years of research to address it. It would be naive to think
that we could solve all those problems in 30 years, given what
we have been up against in nature.
Senator Specter. How many years has it been evolving; you
say 30 million?
Dr. Forman. Well, I think 3 million years of evolution, to
have----
Senator Specter. Why do you pick 3 million?
Dr. Forman. Because I think the species has been evolving
over that long a period of time. I think the problems that
exist, the ways that cells have figured out to get around our
therapeutics, have had that long a time to evolve and confront
us with a very large problem.
So to think that in 30 years we will have figured out all
the secrets that a cell holds would be naive.
Senator Specter. So you want to be put down for funding for
research? [Laughter.]
Dr. Forman. Yes; I do. But I also want to address the issue
of prevention. Prevention that we can address now is only
possible because of the last 30 years of cancer research. One
cannot simply go out and make a statement that we want to
prevent it without knowing more about the cancer cell and how
to prevent. All of the innovations that we are ready to make in
terms cancer prevention are on the basis of the research that
we have done in the last 30 years.
Senator Specter. Well, Dr. Forman, since I have taken up
most of your time, we are going to reset the clock for you.
Dr. Forman. Thank you very much. [Laughter.]
Thank you, Senator Specter, for the opportunity to appear
before you today.
As you know, I am physician in chief at the City of Hope
National Medical Center, one of the National Cancer Institutes'
designated clinical cancer research centers. I am the principal
investigator on a grant which supports the work of many
dedicated scientists and physicians whose task it is to improve
our understanding and the therapeutics of cancer; in
particular, leukemia, lymphoma and breast cancer. I have been
caring for patients for over 20 years and conducting research
for that same amount of time.
I would like to make two points about cancer research that
I think are important this morning. First, the progress that
has been made in cancer treatment over the last two decades has
been remarkable. And I say very appreciatively, on behalf of my
colleagues and our patients, that we could not have made many
of the advances without the Federal Government's funding of
cancer research. However, the major obstacle to more rapid
progress in the fight is limited funding. For years, I have sat
on panels where excellent research projects were turned down
for lack of funding.
It is not the absence of ideas that limits the pace at
which we can save lives, it is the absence of funding for those
ideas. And idea unexplored is a life lost.
Second, a new and significant threat to cancer research has
emerged in the form of managed care. Successful cancer
treatment has been a trusting and committed partnership between
physicians, patients, and scientists. The current system
threatens the involvement of patients and discourages the
testing of new ideas. It is this partnership which has led to
breakthroughs made in the laboratories, which have been turned
into treatments that have saved thousands.
Under managed care, patients for whom there is no
alternative but cutting-edge medical treatment are being
refused these treatments because they are considered by some
investigational. Flatly said, many of these companies do not
pay for innovative therapies despite the potential for a better
outcome.
The real illness is a system which considers physicians as
vendors, patients as customers, cancer as a product line, and
scientists as a drag on that bottom line.
Now, I decided, Senator Specter, not to use my time today
to give you dry statistics, but rather to introduce you to six
individuals who are living today thanks to basic and clinical
research, thanks to their courage to participate in clinical
trials, and thanks to their ability to have access to those
trials. Despite the paper this morning, none of them, not one,
would be alive were it not for the support for Federal cancer
research that has been done in breast cancer, leukemia and
lymphoma.
Let me introduce them to you. Shari Kahane, if you would
stand.
Shari is a physician, who developed breast cancer--advanced
breast cancer--4 years ago. She is alive today because of
research that helped us understand the difference between her
breast cancer and that which occurs in other women, and the
specific need for more innovative and intensive therapy.
Studies which have been done in cancer pharmacology, genetics,
and stem cell biology, were combined to develop a new therapy
for breast cancer.
She is alive to continue her work on behalf of other women
with breast cancer, and is alive to raise her children, because
we had the funding to combine research from different areas and
to advance treatment. She is one of thousands of women who are
alive today because of this kind of research.
Yocheved Rosenthal. Yocheved was diagnosed with leukemia at
the time of the birth of one of her children. The moment that a
new life was entering the world, hers was on the line. She
needed a transplant, but transplant was fraught with dangers,
despite our efforts to make it safer. With funding from the
Federal Government, we were able to offer her clinical research
trials, each of which were designed to decrease complications
and prevent the disease from coming back.
One of those complications was pneumonia. In those days, it
claimed one in five patients undergoing that kind of
transplant. An NCI-funded study, however, helped us develop a
therapy that has nearly eliminated this as a complication.
Yocheved had a long and arduous battle, but she has recovered.
And she and her husband adopted another child, who has become a
special part of their family.
Cindy Ladin. Cindy had a disease called chronic myelogenous
leukemia [CML]. When I began my work in oncology 20 years ago,
all patients with CML died. That was before the development of
transplantation, which has cured many other patients with
incurable diseases. It is the single most complicated therapy
we do in oncology. And it is dependent upon research knowledge
that we derive from diverse fields in immunology, tumor
biology, radiation biology, and immunogenetics.
Cindy needed a transplant, but had no donor in her family.
Fortunately, she benefited from the laboratory work that showed
that the genes that control our immune response allow us to
identify donors in the general population--in this room. This
ability to apply research knowledge from one area to another
has meant the difference between life and death. In this case,
it led to the development of the National Marrow Donor Program,
a registry with 3 million people who have helped save many
lives.
In Cindy's case, after 1 year of searching, a woman in New
Hampshire was found to be a match. Because of those scientific
achievements, all of which were federally supported, and a
Samaritan donor, Cindy is alive, in remission, living a normal
life, a mother to her children, a wife to her husband.
Anissa Ayala. Anissa also had CML, but did not have a
family donor. But unlike Cindy, no one could be found in the
registries. However, research which was then being performed
about stem cells showed that these cells are also present in
the umbilical cords of new-born babies. Therefore, after her
father had his vasectomy reversed, her mother, at age 43,
became pregnant and gave birth to a baby girl, who miraculously
was a match. Anissa underwent transplantation utilizing cells
that were collected from the umbilical cord in the hour of her
sister's birth. That was 5 years ago. The sister became a donor
within the first minutes of her life.
Robin Frasier. Like the others whom I have introduced you
to, Robin Frasier had a form of leukemia for which there was no
curative therapy. And she had no donor of any kind. However,
laboratory studies at that time were helping us understand the
molecular abnormalities present in her leukemia. Other research
which was also government funded, showed us how therapy with
interferon can sometimes lead to remissions of her disease.
Five years ago, Robin underwent transplantation utilizing
her own bone marrow that had been put into remission. She was
one of the first patients in the whole world to undergo such a
therapy. Without the work of investigators and laboratories
working together, she would not be alive today, she would not
be practicing medicine, she would not have seen her children
married, nor her grandchildren born.
Mushtaque Jivani. Mushtaque holds a very special place in
the world of cancer research and marrow transplantation,
because he is the longest living transplant patient in the City
of Hope's program, having been transplanted over 20 years ago
for treatment of leukemia. At that time, the therapy was just
developing, and the scientists in laboratories to help design
it were not sure of its outcome. The heroism he showed in
trusting scientists and physicians to develop a therapy to
treat his fatal disease is one reason he is here today. Another
is that there was funding to do that research. And the third is
that the medical care system allowed him access to these
approaches.
In closing, Senator Specter, I appreciate your allowing me
the opportunity to be here today. It says in the Hebrew Talmud
that he who saves a life saves the whole world. You should not
underestimate for a moment the role that the Federal Government
has had in funding cancer research has had on supporting that
observation.
PREPARED STATEMENT
On behalf of my scientific and clinical colleagues, on
behalf of the patients standing before you, and on behalf of
those who love them and still have them in their lives, we all
thank you for your efforts on their behalf, and I would ask
their families to now stand with them. [Applause.]
[The statement follows:]
Prepared Statement of Stephen J. Forman, M.D.
Thank you, Senator Specter, for the opportunity to speak to
you and your committee concerning the important issue of cancer
research and the saving of lives from this disease. By way of
introduction, I am Dr. Stephen Forman, physician-in-chief at
City of Hope National Medical Center, which is designated by
the National Cancer Institute as a Clinical Cancer Research
Center. I direct the Department of Hematology and Bone Marrow
Transplantation and am a staff physician in the department of
Medical Oncology and Therapeutics Research. I am also principal
investigator on a five-year, $14 million NCI program project
grant on transplantation for leukemia and lymphoma, a grant
which supports many clinical and basic investigators devoted to
basic cancer research and innovative cancer therapy.
For 20 years, my colleagues at City of Hope and I have been
involved in research, both in the laboratory and at the patient
bedside, which has focused on understanding cancer in humans
and developing ways to control it and ameliorate the suffering
it causes. When I first began my work, very few, if any,
patients for whom I cared survived. They all succumbed to the
disease. This was a driving force in my choosing a career
dedicated to the development of innovative therapies that
translate into extending and saving lives from cancer.
I am proud to say that the medical community has made great
advances in the past two decades thanks to the partnership
between physicians, patients, and the scientific community.
This progress is directly attributable to the linkage there has
been between basic research into, for instance, the nature of
the cancer cell, as well as the testing of new research
knowledge in clinical trials.
This progress is also directly attributable to the funding
that there has been for such basic and applied research. We
could not have made the advances we have without the federal
government's funding of cancer research. I want to acknowledge
that, to express my appreciation for it--and to emphasize that
continued progress will depend upon continued federal support
for cancer research.
The reality is that limited funding for cancer research is
the major obstacle to more rapid progress in the fight against
this disease. For many years, my colleagues and I have served
on research panels where excellent proposals are turned down
for lack of funding--with the result that promising research
goes undone. It is not the absence of ideas that limits the
pace at which we can save lives from cancer, it is the absence
of funding to examine and test new ideas. An idea unexplored is
a life lost.
The critical factor of funding is of particular importance
now as molecular genetics and the immunology of malignancy are
just beginning to provide remarkable new information, important
to all of us.
What is sometimes difficult to understand is that it often
requires progress in diverse fields of study to develop a
therapy that is the difference between a patient living or
dying--a person who may be our parent, our friend, our co-
worker, our spouse, or our child. The path to a breakthrough
may start in a distant place and take a course we can't
foretell. Sometimes it begins on a blackboard in a laboratory
that leads to a proposal to a research organization, to the
funding of a young post-doctoral fellow whose energy is matched
by his creativity, which leads to a laboratory experiment whose
implications are noted by a physician investigator who works
with that scientist to develop a therapy and a trial which is
then offered to a patient who comes to us for help.
I decided, today, not to present to you cold statistics
about such patients, but rather to introduce you to some of
these individuals; people who would have been doomed by their
disease were it not for research studies that not only saved
their lives but became the basis for therapies that have helped
others.
As I introduce each of these six people and ask her or him
to stand, please be aware, Senator Specter, that the person you
see is alive before you today because of funded basic and
translational medical research and because they had access to
investigational therapies.
SHARI KAHANE
Shari Kahane is a physician who developed advanced breast
cancer four years ago. She is alive today because of research
that helped us understand the difference between her breast
cancer and that which occurs in other women and the specific
need for a more innovative and intensive therapy. Studies which
were done in cancer pharmacology, cancer genetics, and stem
cell biology were combined to develop a new transplant therapy
for breast cancer.
Dr. Kahane is able to continue her work on behalf of other
women with breast cancer--and is alive to raise her children--
because we had the funding to combine research from different
areas to advance treatment.
YOCHEVED ROSENTHAL
Yocheved Rosenthal was diagnosed with leukemia at the time
of the birth of one of her children. As a new life entered the
world, her life was on the line. Yocheved needed a bone marrow
transplant from a family donor. Despite our tireless efforts to
improve the procedure and make it safer, transplantation from
donors is fraught with danger. With funding from the federal
government, she was able to enter several innovative trials,
each designed to decrease complications and reduce the chances
that the disease would come back.
One of the major complications that faced Yocheved and
other patients was pneumonia. At that time, pneumonia claimed
one out of every five patients who was transplanted. However,
an NCI funded study helped us develop a therapy that has nearly
eliminated post-BMT pneumonia.
Yocheved had a long and arduous battle, but she has
recovered. Her life was saved, and in turn she has saved
another life by adopting an unwanted child who has joined her
family--providing a son to her and her husband and a brother to
her other children.
CINDY LADIN
Cindy Ladin had a disease called chronic myelogenous
leukemia. When I began my work in oncology, there was no cure
for CML. All patients with the disease died. That was before
the development of bone marrow transplantation--which has cured
many patients with otherwise incurable diseases. BMT is the
single most complicated therapy we do in medical oncology and
it is dependent upon basic laboratory research knowledge
derived from many fields including immunology, tumor biology,
radiation biology and immunogenetics.
Cindy needed a BMT but she had no donor within her family.
Fortunately, though, she benefited from laboratory work that
had studied the genes which control our immune response--this
research proved to be useful in identifying bone marrow matches
from the general population. Again, this ability to apply
research knowledge from one area to a different area has meant
the difference between life and death for many people. In this
case, it led to the development of the National Marrow Donor
Program, a registry in which there are currently nearly 3
million volunteer marrow donors.
In Cindy's case, after a year of searching, a woman in New
Hampshire was found to be a match and, although she had never
met Cindy, she felt the need to give. They met for the first
time one year after transplant. Because of scientific
achievements and a Samaritan donor, Cindy is alive, in
remission, and leading a normal life as mother to her children
and wife to her husband, Hal.
ANISSA AYALA
Anissa Ayala is someone who taught us what the combination
of scientific investigation and hope can achieve. Like Cindy
Ladin, she had CML and did not have a family donor. Unlike
Cindy, however, none could be found for her in the national
registries.
However, research which was being performed at that time
showed that stem cells that we have in our bodies are also
present in the umbilical cord of newborn babies. Therefore,
after a reversal of her father's vasectomy, at age 43 her
mother gave birth to a baby girl who, miraculously, was a match
to her. Anissa underwent transplantation utilizing cells that
we collected from the umbilical cord of her newborn sister. Her
sister became a donor within minutes of her birth.
That was five years ago.
ROBIN FRASIER
Robin Frasier also had a disease for which no curative
therapy other than transplant was known to exist but, unlike
Cindy and Anissa, did not have a donor of any kind.
However, studies by scientists such as Dr. Owen Witte and
others helped us understand the molecular abnormalities present
in the form of leukemia she had. Other research, which was also
federal government funded, showed us how therapy with
Interferon can, in some patients, lead to remissions of the
disease and offer opportunity for a transplant.
Five years ago, Robin underwent transplant utilizing her
own bone marrow that had been put into remission by Interferon.
At that time, she was among the first patients in the world to
undergo such a therapy. Without the work of many investigators
and laboratories working together to develop a therapy for an
otherwise incurable disease, Robin would not be alive today.
She would not be practicing medicine. She would not have seen
her children married and she would not have reveled in the
birth of her grandchildren.
MUSHTAQUE JIVANI
Mushtaque Jivani holds a very special place in the world of
cancer therapy and marrow transplantation. He is the longest
living transplant patient in our program, having had a
transplant 20 years ago for treatment of leukemia. At that
time, the therapy was just developing and the scientists in the
laboratories that helped design it were not completely certain
of its outcome. The heroism Mushtaque showed in trusting
scientists and physicians to develop the therapy to treat his
fatal disease is one reason he is here today. Another reason is
that there was funding for those scientists and physicians to
follow where their intuition and intellect led them. It is upon
Mushtaque's shoulders that all transplant patients stand
because the success we had with his disease is what led to the
development of curative therapies for all of the patients you
see here today and who are represented in many other cancer
centers around the United States.
Each of the people I have been privileged to introduce to
you are unique and special to us. Sadly, I could tell you
stories of other patients who, because of our ignorance, I am
unable to introduce you to; for each of the patients you see
here today, there are others, had we known what we know today,
would be alive to join us. For us, every breakthrough has an
exhilaration that we can use to save a life but also the
realization that had we only known sooner, how much more we
could have done for others. It is clear to me, in talking with
colleagues around the world, that there are very exciting,
compelling ideas yet to be tested that wait in line for funding
to allow them to do their work. In some cases, good ideas will
never be funded, young investigators will be discouraged, and
we all lose in that process.
It says in the Hebrew Talmud that ``He who saves a life
saves the whole world''. In the people I have had the privilege
of introducing to you today, we all see the truth of that.
Children keep their parents and parents do not lose their
children, husbands their wives, each other, brothers and
sisters and communities, their friends and colleagues.
While the six people you see standing before you now,
Senator Specter, represent the success that can flow from
funded research, I must tell you that I am worried. This is a
difficult time for cancer research. Not only is funding
limited, but the current health care system of managed care is
a very reluctant partner in this process. Some in managed care
think of physicians as vendors, patients as customers, and
scientists as a drag on their bottom line. The current system
implies that we know all we need to know--an attitude that robs
future patients of the hope that research brings.
In the current environment, none of the patients you see
here today would probably be able to get authorization for the
therapy that saved their lives, regardless of its rationale or
the hope it provides. In this callous environment, it is
vitally important not only that research funding is adequate,
but that the health care system does not deny patients access
to something that may save their lives just because it is
investigational. People with potentially fatal diseases should
not have to battle both their disease and a system that bars
them from access to what might help them.
In closing, Senator Specter, I want again to express my
appreciation for this opportunity to testify and for the
federal government's support of cancer research. I hope that
you understand, by the presence of these very heroic people
with me today, how critical and personal is our challenge.
Thank you.
FUNDING
Senator Specter. Dr. Forman, that is indeed impressive. And
you have offered a fair amount to refute the headline in the
USA Today on the questions raised. And we will discuss that
when we conclude the panel. And it is very impressive indeed.
When you talk about funding, we have increased funding on
NIH and on cancer. It has gone up exponentially, to now $2.3
billion, out of the $12.7 billion in NIH. And those increases
have come in the last 15 years, notwithstanding budget cuts in
almost every other area, regardless of Democratic or Republican
administrations.
When Senator Weicker chaired the subcommittee, funding went
up. When Senator Chiles, now Governor Chiles, chaired the
subcommittee, funding went up. When Senator Harkin chaired the
subcommittee, funding went up. And in my first 2 years as
chair, the funding has gone up. I am determined to see it go up
again. But we have our work cut out for us, because the overall
budget allocation for health has been cut by $100 million for
the next fiscal year. It is important to put our spending
priorities back on track.
Dr. Forman. We would be privileged to help you.
Senator Specter. Good.
STATEMENT OF DIANE KEATON, ACTRESS, LOS ANGELES, CA
Senator Specter. We turn now to a very distinguished
actress, director and producer, Ms. Diane Keaton. Her acting
career spans some 25 movie greats. She received an Academy
Award for her spectacular role in ``Annie Hall,'' in the
``Godfather'' trilogy. She has a recent smash hit, the ``First
Wives Club.'' She had her performance in ``Marvin's Room'',
which earned her an Academy Award nomination.
And I withstood the temptation to ask Dr. Forman how the
patient in ``Marvin's Room'' bears on this issue, but we will
let you take it up if you choose to, Ms. Keaton. We are
delighted to have you here, and the floor is yours.
Ms. Keaton. Thank you very much.
Chairman Specter, of course it is an honor to testify
before you today. I think I speak for a lot of people about my
experience with cancer. It started when my grandmother Keaton
got colon cancer, which metastasized into her liver and took
her life. Then my mother's father, who I never met, died of
lung cancer. Then Grammy Hall had a breast removed. Then Auntie
Martha had a form of skin cancer which forced her to have her
nose literally taken off her face.
But the worst of all happened when my sister Robin called
me in Rome, where I was shooting ``Godfather Part 3'', and told
me dad had a brain tumor, something called a glioma, and it
looked bad. It was bad. We did all the things we were told to
do. We went to UCLA. That always sounds good. He was put on
some experimental treatment, which used a combination of
chemotherapy, special chemotherapy, and radiation.
These so-called therapies, which were developed to prolong
life, were terrifying. The cumbersome machine, baking 200 RAD's
twice a day into my father's head for 5 weeks, and his odd
courage while living under the rein of a tumor, rapidly
enveloping his frontal lobe, seemed impossible to believe.
After dad prematurely flunked the program, he was driven home
in an ambulance to be more comfortable. For my family, an air
of disbelief about dad's future filled our lives with the
depressing kind of hope, a stagnant hope, and basically it was
a hope of no hopes.
My sisters, Robin and Dorrie, and my mother, Dorothy, and I
ritualistically watched for any improvement. He might get
better; you never know. But dad was looking more wounded, more
broken, more like the dozens of dazed birds, who, over the
years, had flown into mom's plate glass window, never knowing
what hit them.
My father's failure to live up to the program's
requirements was obvious, as he gently reeled through the
kitchen, his 6-foot frame barely held up under the uneasy steps
his skinny legs took him. Soon he stopped walking altogether.
Dad's death was devastating. I am not ashamed to say that it
was the most overwhelmingly sad experience of my life. But I am
ashamed to say that in the wake of dad's death, I developed a
terrible, horrible fear of cancer. This fear kind of shut me
down. I tried very hard to keep cancer out of my life. But, of
course, it would not go away.
After dad's death, I directed my first feature. It was
about a family struggling with the loss of a mother who
succumbs to cancer. Two years later, I played the part of
Bessie, in ``Marvin's Room'', who learns she has leukemia, and
more than likely will die from cancer. Spending 3 months of my
life pretending to be somebody who has cancer was not fun. It
was not fun. But beyond the suffering required of the part came
a kind of guilty joy, knowing that the movie would end and I
did not have to live with cancer on my back anymore.
But it did not go away. The fear kept creeping back in the
form it always takes with me--avoidance. Do not go to the
doctor, do not get a mammogram, do not even read about ovarian
cancer; you might get it.
I know that there are millions of people like me who wake
up in the middle of the night in a panic, convinced that they
have cancer; then get up in the morning and do nothing about
it. Like me, they know cancer has had the last say all too
often. It is everywhere. It is lurking behind every corner you
turn. It is secretly waiting to jump out at you in order to
take your life away. You do not fight cancer. What is the
point?
Not only does cancer frequently kill the people who have
it, but it also crushes the fighting spirit in those of us who
are too afraid to even think about the word in connection with
ourselves. And that is what fear can do to you. It can squelch
your curiosity. It can strip you of your courage. It can eat
your soul. But, most importantly, it can tear away at your
ability to hope. And without hope, where does the motivation to
fight back come from?
Now, I do not know how many of you know Sherry Lansing, but
she is a very persuasive person. She is seductively persuasive.
We had lunch several months ago to celebrate our good fortune
with the success of the ``First Wive's Club.'' At some point,
you know, I brought up the name of the mutual acquaintance who
had recently been diagnosed with a brain tumor; 1\1/2\ hours
later, Sherry had convinced me to testify before you today. Now
that is an amazing sell job. Because this is the last place I
want to be. [Laughter.]
Since fear obviously is at the core of my speech, I figured
I would just pick out a few of the terrifying highlights that I
forced myself to read in preparation to come to you today, in
hopes that you, Senator Specter--and now I know you--are not
like me, too scared to fight cancer. OK, here we go. I know you
have heard this before, but I am going to say it, because it
just floored me. OK.
One-half of all American men and one-third of all American
women will be struck by the horror of being diagnosed with
cancer during their lives, one-fourth of all Americans will one
day die from cancer; more than 1,500 people every day die from
cancer, and during this period that this Senate hearing is in
session, 161 Americans will have died from cancer.
The number of cancer deaths per year exceeds all U.S.
combat deaths in all wars of this century. And listen to this
one--this is the one that got me--it would take five Boeing 747
jumbo jets crashing every day for a year to equal the half-
million Americans who die each year from cancer. Now that one
really got me. I mean, pick your favorite fear, double, triple,
quadruple the likelihood that cancer is going to get you
instead.
And, finally, this: Obviously, if we doubled our effort on
cancer research today, it would still cost less than one-third
of our space efforts and only one-twentieth of the cost of the
gulf war. I mean, to me, this is not right. This does not cut
it. And even I know that. Even me, in my fear-ridden stupor, I
know that that is not good enough. We all deserve a better
effort. We have got to keep trying and keep spending time,
effort and most importantly, the big M, money, to destroy the
big C, cancer.
I am just saying, to me, do not wait. Do not wait until the
day it strikes you or your family or somebody you care about.
Because then it is going to be too late. So let us spend now
for the future--yours, ours, and everyone's.
Senator Specter. Thank you very much. [Applause.]
Thank you very much, Ms. Keaton. May I ask how old your
father was?
Ms. Keaton. He was 68.
Senator Specter. Well, I had been on the subcommittee for
more than a decade when I insisted on an MRI. I had no
discernible symptoms, according to the doctors. My shirts were
a little tight and I had light pains running up and down the
side of my head. All sorts of tests did not show anything, but
I knew about an MRI and I said I wanted the one. They said,
well, you do not need one. I said, but I want one. They said,
well, you are not going to have one. And I insisted and I got
one.
And I am aware of the fact that I am in a little better
position to insist than most people. And the MRI showed a
meningioma, which was benign. But I was shocked to learn that
we only have had the MRI since 1984. And without going into any
detail, my own personal experience brought me into contact with
many, many details of the evolving wonders of research, which I
had been voting for, for more than a decade. So it comes very
close to home when it is in your head, or in your heart, or in
your family.
Ms. Keaton. Thank you.
Senator Specter. Thank you.
STATEMENT OF OLIVIA NEWTON-JOHN, ACTRESS, BEVERLY
HILLS, CA
Senator Specter. We now turn to Ms. Olivia Newton-John, an
accomplished actress and recording star, recognized throughout
her musical career with numerous awards, including the Country
Music Association's top female vocalist of the year; honored at
Buckingham Palace by Queen Elizabeth II, where she received the
prestigious Order of the British Empire. She is best known,
perhaps, for her starring role in ``Grease.''
In June 1992, she became the spokesperson and goodwill
ambassador for the Children's Health and Environmental
Coalition. And last October, she hosted a cable special,
``Lifetime Applauds the Fight Against Breast Cancer.''
Welcome, Ms. Newton-John, and we look forward to your
testimony.
Ms. Newton-John. Thank you. I am very pleased to be here
and be a part of this panel this morning. In fact, I am pleased
to be anywhere, for I am one of the lucky ones. I am a survivor
of breast cancer, and not everyone is as lucky as I am.
I think that if you told me a few years ago that I would be
discussing something so personal in public, something so
intimate as this, I would have cringed. But I know that I need
to speak out and something must be done. In 1992, I was
diagnosed with breast cancer. There is no history of breast
cancer in my family. I was, I thought, a very healthy person.
So if it can happen to me, it can happen to anybody.
My treatment was a modified radical mastectomy, and I had
reconstruction on the table, followed by a 6-month course of
chemotherapy. Now, 5 years away from surgery and chemotherapy
and breathing a little easier, I am really examining what
caused my cancer. I did not smoke or drink. I exercised, and I
always ate plenty of my fruits and vegetables. But maybe, was
it in my fruits and vegetables, in the enormous amounts of
pesticides sprayed on our crops? Is it in the polluted air that
I breathe when I am running? Is it in the water I drink, from
the estrogen-mimicking hormones from plastics?
I understand that the Government has spent more than one-
quarter of a billion dollars since the official war on cancer
began under President Nixon. Some two decades into this war, we
still do not have a cure for the most common forms of the
disease. In addition, scientists cannot tell us why cancer
continues to strike in children, why more and more women are
diagnosed with breast cancer, and why more young men are
acquiring testicular cancer.
Of course, we need to allocate more money to cancer
research, and we do need more effective treatments for the 1.5
million people who will be diagnosed this year. But we must be
careful to insist that a large part of whatever moneys are
allocated be spent on figuring out how to prevent this disease
and why is it happening.
It is clear that doctors do not know why most women get
breast cancer. Like me, they have none of the known risks of
the disease. Inherited genetic defects only account for about 1
in 10 cases. And experts can only explain about 25 percent of
these cases.
Since 1971, scientists have known that cancer is caused by
changed genes which control cell growth. But my question is,
what causes this gene to mutate in the first place? What
triggers it?
I believe we need to be looking for the causes in our
environment. We know for a fact that smoking can cause lung
cancer. We need to spend research money finding these links in
your daily lives.
There are two key environmental problems that may be linked
to breast cancer. First, radiation. Everything from nuclear
fallout to routine x rays. And, second, carcinogens and toxic
chemicals found in pesticides, fuels, plastics, and even some
therapeutic drugs. We simply must find funds for the research
that will give us the answer to these life and death questions.
I was relatively young when I was diagnosed. And a
mammogram missed my tumor. And we all have to remember that
mammograms, even when done properly and in the best
institutions, simply do not prevent cancer; they only detect it
after the disease is there. And for women like me, mammograms
can miss tumors. It missed mine.
I am first a mother, a survivor, and a woman who cares for
the planet very much. And we are poisoning our Mother Earth,
and we are poisoning ourselves. And there is recent evidence in
animals and wildlife that indicates that a number of widely
used pesticides, fuels and plastics and drugs can disturb the
body's hormones. And these disturbances could also be keys to
hormonal cancers.
Despite the obvious importance of hormone-disrupting
materials, the Federal Government has spent relatively modest
amounts of money on this issue. Not only must more money be
allocated to cancer overall, but this additional money must be
spent on efforts to understand the causes of and to prevent the
disease.
As a mother, I am deeply concerned that we are failing to
protect our children. My dear friends, Nancy and Jim Chuda,
lost their daughter, Collette, at 5 years old, to Wilm's tumor.
This is a cancer that has been shown to increase in children
whose parents have had workplace exposure to some pesticides.
And because of this personal experience, I am the national
spokesperson for CHEC, the Children's Health and Environmental
Coalition, a national movement on behalf of children's
environmental health.
PREPARED STATEMENT
I am not a scientist. I am a concerned mother and a
citizen. And the main reason I am here is to say that we need
to spend whatever it takes to stop cancer. And I know that with
additional support from the government and the private sector,
we can all make this happen. So that when my daughter looks at
me and says, mummy, am I going to get breast cancer, I can say,
no. [Applause.]
[The statement follows:]
Prepared Statement of Olivia Newton-John
I am very pleased to be here and be a part of this panel
this morning--I am very pleased to be anywhere, for I am one of
the lucky ones. I am a survivor of breast cancer. Not everyone
is as lucky as I am.
I think that had you told me a few years ago that I would
be discussing something so personal in public, something so
intimate as this, I would have cringed.
In 1992 I was diagnosed with breast cancer. My treatment
was a modified radical mastectomy with no lymph gland
involvement and I had reconstruction on the table * * *
followed by a 6-month course of chemotherapy.
Five years away from surgery and chemotherapy, and
breathing a little easier, I am really examining what caused my
cancer. I didn't smoke or drink. I exercised and always ate
fruits and vegetables. Was it in my vegetables from the
enormous amounts of pesticides sprayed on our crops? Was it in
the polluted air that I breathe when I go running? Was it in
the water I drank, from the estrogen mimicking hormones from
plastics?
I understand that the government has spent more than a
quarter billion dollars, since the official War on Cancer
began, under President Nixon. Some two decades into this War,
we still do not have a cure for the most common forms of the
disease. In addition, scientists can't tell us why cancer
continues to strike in children, why more and more women are
diagnosed with breast cancer, and why more young men are
acquiring testicular cancer.
Of course, we need to allocate more money to cancer
research. And we do need more effective treatments for the one
and a half million people who will be diagnosed this year. But,
we must be careful to insist that a large part of whatever new
monies are allocated be spent on figuring out how to prevent
this disease.
It is clear that doctors don't know why most women get
breast cancer. Like me, they have none of the known risks for
the disease. Inherited genetic defects only account for about 1
in 10 cases. Experts can only explain about 25 percent of the
cases.
Since 1971, scientists have known that cancer is caused by
a change in genes which controls cell growth. But my question
is, what causes this gene to mutate in the first place? What
triggers it? I believe we need to be looking for the causes in
our environment. We know for a fact that smoking can cause lung
cancer. We need to spend research money finding links in our
daily lives.
There are two key environmental problems that may be linked
to breast cancer. First, radiation--everything from nuclear
fallout to routine x rays and secondly, carcinogens found in
pesticides, fuels, plastics and even some therapeutic drugs. We
simply must find funds for the research that will give us the
answers to these life and death questions.
I was relatively young when I was diagnosed. And a
mammogram missed my tumor. We all have to remember that
mammograms, even when done properly and in the best
institutions, simply can not prevent breast cancer--and for
women like me, mammograms can miss tumors like they missed
mine.
I am first a mother, a survivor and a woman who cares for
the planet so very much and we are poisoning ourselves and our
earth. There is recent evidence in animals and wildlife that
indicates that a number of widely used pesticides, fuels,
plastics, and drugs, can disturb the body's hormones. These
disturbances could also be key to hormonal cancers.
Despite the obvious importance of hormone disrupting
materials, the federal government has spent relatively modest
amounts of money on this issue. Not only must more money be
allocated to cancer over all, but this additional money must be
spent on efforts to understand the causes of and to prevent the
disease.
As a mother, I am deeply concerned that we are failing to
protect our children. My dear friends Nancy and Jim Chuda lost
their precious daughter, Collete, at age 5 to Wilm's tumor.
This is a cancer that has been shown to be increased in
children whose parents have had workplace exposure to some
pesticides. Because of this personal experience I have been
involved in CHEC, (Children's Health & Environmental Coalition)
a national movement on behalf of children's environmental
health.
I am not a scientist, I am a concerned mother and citizen
and the main reason I am here is to say that we need to spend
whatever it takes to stop cancer and I know that with
additional support from the government and the private sector
we can all make this happen so that when my daughter looks at
me and says ``Mummy am I going to get breast cancer?'' I can
say ``no.''
IMPROVING MAMMOGRAMS
Senator Specter. Very impressive. Very impressive. How old
is your daughter, Ms. Newton-John?
Ms. Newton-John. She is 11.
Senator Specter. When you talk about mammograms and
mammograms missing something, a lot of work is being undertaken
to try to improve mammograms. And of course, for the past
several years, we have enlisted the CIA to help--on their
detection of piercing the clouds, with their special
equipment--the program is called missiles to mammograms--to use
that technology.
For the last 2 years, I chaired the Intelligence Committee
as well as this subcommittee, and we brought some extra funding
in. Dr. John Deutch, the Director, was willing to put an extra
$2 million from his funds into trying to improve mammogram
detection, with the special techniques which the CIA had
developed.
Dr. Forman, I am going to ask your patients to come
forward. We have rearranged the hearing room a little bit. I
would like to hear from them. It is a little unusual, but I
think that they might have something to add, which goes to the
issue, which is very topical today, as to what Dr. Bailar has
had to say about research not being significant.
So would, at this time, Ms. Shari Kahane, Ms. Rosenthal,
Ms. Ladin, Ms. Ayala, and Ms. Frasier come forward. We do not
intend to put you on the spot, and we know you are not prepared
to testify, but I think it might be useful.
And Mr. Jivani.
Dr. Forman, I would like to have you give us some insights,
to the extent you can, on the benefits of research, which is
essentially what Dr. Bailar is contesting, as to how it works
out in an application with your own patients who are here
today, and perhaps hear a word or two from them on what has
happened to them.
Dr. Forman. I think in each case that I introduced each
person to you today, we used something in their care that was
derived from a laboratory that was researching cancer.
Senator Specter. Something that was successful on the
cancer research?
Dr. Forman. The phrase we use is translational research,
taking observations in a laboratory and trying to figure out
how they can be incorporated into diagnosis, prevention, or
therapeutics.
Senator Specter. May we start with the gentleman who is the
longest survivor, 20 years, as articulated by you.
Sheriff Block, could you hand him your microphone? Craig
Higgins is ahead of me, as is Bettilou Taylor, as usual, our
committee staff. Tell us a little bit about your case. When did
you first know you had the problem, and what did you do about
it?
STATEMENT OF MUSHTAQUE JIVANI
Mr. Jivani. OK, I was going to school in Indiana, in 1976,
and I was sick and diagnosed with leukemia.
Senator Specter. And could you state your name, please, for
the record.
Mr. Jivani. My name is Mushtaque Jivani.
Dr. Forman told me that you are going to die today,
tomorrow or in a week, and he recommended I go home and see my
family, because there was no treatment at the time in Indiana.
I called my brother here, and he said why do not we bring you
to California, Los Angeles, and we try something. And it
happened that they called the City of Hope, and they admitted
me the very next day. I went through the chemotherapy and then
the bone marrow transplant.
Senator Specter. And you came from?
Mr. Jivani. I came from Pakistan.
Senator Specter. Pakistan.
Mr. Jivani. I was going to school in Indiana.
At that time, I had my transplant in December 1976. They
just started the unit there, and I was like the fourth or fifth
transplant patient at that time. Everything was new. I had to
take a chance of going through it. Things have changed since
then.
Senator Specter. Dr. Forman, would you give us an insight
as to what research did for this gentleman, the cancer
research?
Dr. Forman. The research that we utilized was to figure out
how we could transplant marrow from one individual to another
and have it take. He received a transplant from his brother,
who we, through laboratory tests that had been worked out, was
found to be a match. If we could not identify the match, we
could not have identified that he could have a transplant from
a donor.
He was then able to endure very high doses of radiation and
chemotherapy to kill the cancer and have his own marrow and
immune system replaced by someone else's.
Senator Specter. I would like to go into more detail, but I
want to hear from the others, too. And if we might move to Ms.
Shari Kahane, who is a physician, and developed advanced breast
cancer 4 years ago. What do you mean by advanced breast cancer?
Do you mean it could have been detected earlier and was not?
Dr. Forman. I think the biology of her particular cancer
was very aggressive. So, at time of diagnosis, we knew it was
extensive.
Senator Specter. Research developed an understanding as to
the difference between her breast cancer and that which occurs
in other women, according to your testimony, and the specific
need for more innovative and intensive therapy. What did the
research do specifically there?
Dr. Forman. It showed us that if we could use the
chemotherapy available at that time, her chances of survival
were 20 percent. And by using innovative methods of cancer
therapy that had been developed on research protocols, we were
able to intensify the therapy and increase the survival to 70
percent.
STATEMENT OF DR. SHARI KAHANE
Senator Specter. Dr. Kahane, let us hear from you. You are
a physician yourself.
Dr. Kahane. Yes, Mr. Specter.
Senator Specter. How did you first discover your breast
cancer? What happened to you? How were you treated?
Dr. Kahane. First, I would like to thank you very much for
being able to listen to us. I truly appreciate it.
My breast cancer was misdiagnosed for a long time by
several physicians. I had been nursing my son, who is here with
me today, and it was missed for a long time. Like Ms. Newton-
John, it did not show up on mammography. And at the time of
diagnosis, it was extensive.
Senator Specter. Did not show up on mammography?
Dr. Kahane. It did not show up.
Senator Specter. Do you know why?
Dr. Kahane. I had been nursing a child, and it was thought
at that point that mammography was difficult, in that women
such as myself, who were young and had what would be classified
as dense breasts. At the time, I was told by several community
oncologists and the surgeon that basically I would be lucky to
live 2 years.
Senator Specter. And that was 4 years ago?
Dr. Kahane. That was almost 4 years ago.
Senator Specter. And how are you now?
Dr. Kahane. No evidence of cancer.
We six here are the lucky ones. We have had access to
treatment that 5, 10 years ago, might not have been available
to save our lives. There are many patients out there who do not
have access to clinical trials, because they are not aware of
what is out there. And I really believe that, in addition to
research, we need to work to educate patients so that they can
have access to clinical trials.
Senator Specter. Thank you very much, Dr. Kahane.
I would like to hear more, but I would also like to hear
from others here.
Ms. Rosenthal, diagnosed with leukemia at the time of the
birth of one of her children. Leukemia has always been, Dr.
Forman, an especially dreaded form of cancer, if you can
distinguish among dreaded forms of cancer. Tell us a little bit
about her case and what happened exactly with respect to the
research which was of assistance.
Dr. Forman. When one uses the phrase ``acute leukemia,'' it
means that life is on the line at that moment. Prior to
therapies, patients would die within weeks. The research that
she benefited from was that a transplant is a dangerous thing,
and that we had funding from the Government to look at ways to
reduce the complications. She was on that trial. She avoided
many of the complications, and she looks like any normal person
you might see anyplace.
What, in essence, the research did was spare her the
complications of an intensive therapy designed to cure her
leukemia.
Senator Specter. And how are you today? How is she today?
Dr. Forman. I will let her speak for herself.
STATEMENT OF YOCHEVED ROSENTHAL
Ms. Rosenthal. I am fine, thank you.
Mr. Specter, one thing that Dr. Forman may not remember
about my specific case, where I specifically benefited from
research that was done right at that moment, was one part of
having a transplant is you need to have a bronchoscopy and find
out if you are a carrier of CMV. CMV is an infection that can
potentially cause pneumonia.
Prior to my transplant, just within weeks prior, there was
no medication to treat CMV. Right before I went in for my
transplant, there was a new medication that was developed
thanks to research, called cyclovir. And I benefited from that
because I was CMV-positive. And had I gotten CMV pneumonia, I
would not be here today if not for the research that helped
develop that medication.
Senator Specter. And where did you find your donor?
Ms. Rosenthal. My sister.
Senator Specter. Ms. Keaton, do you have any special advice
from ``Marvin's Room'' as to how to find donors?
Ms. Keaton. How to do what?
Senator Specter. Find donors. Last week you did.
Ms. Keaton. Find donors. In ``Marvin's Room,'' there was no
donor for her. She just--it did not work out for her.
Senator Specter. OK.
And Ms. Cindy Ladin, chronic leukemia. When you began your
work in oncology, Dr. Forman, there was no cure for CML. Tell
us a little bit about what the research did there.
Dr. Forman. The trials we did in transplantation for CML
were to convert it from a disease that was uniformly fatal to
one where up to 80 percent of the patients can be cured under
the age of 50, who have a donor in their family. Cindy did not
have a donor in her family. But there was a lot of research
being done on how our immune system works. And one of the
offshoots of that research was the ability to identify donors.
There is potentially a donor in this room for other patients
around the country.
We used that information to try to find a donor for Cindy.
Senator Specter. How frequently do--is there failure
because you cannot find a donor? It must happen all the time.
Dr. Forman. It happens disappointingly frequently.
Senator Specter. What are the mechanisms set up to try to
find donors or have a reserve of donors?
Dr. Forman. In the United States, there is the National
Marrow Donor Program, which is also federally funded and it
exists in Minneapolis, MN.
Senator Specter. And that is the organ donor organization?
Dr. Forman. That is for bone marrow.
Senator Specter. And bone marrow as well?
Dr. Forman. Yes; it is administrated under UNIS and the
Federal Government. There are international registries, and we
in fact have used marrows that we have gotten from Europe,
South America, the Orient, Canada, and England.
Senator Specter. Well, that is a repository which could
certainly use more publicity and more support.
Dr. Forman. Thank you.
STATEMENT OF ANISSA AYALA
Senator Specter. May we hear from Ms. Ladin?
Ms. Ayala. Hi.
Senator Specter. How do you feel?
Ms. Ayala. I feel terrific. Thank you. I am celebrating my
fifth anniversary in October of this year. And I thank God for
all the research that has been done that I have been able to
come as far as I have. When I was first diagnosed in 1991, I
had two small children, who are now, as you can see--one is 11
and one is 8. And thanks to the research that Dr. Forman and
his group have done, I am here to be able to celebrate with my
children on the fifth anniversary.
Senator Specter. Well, thank you very much.
Ms. Newton-John, we know you have to depart, and we thank
you very much for being with us.
Ms. Newton-John. Thank you very much. I am doing a
documentary on breast cancer, so it is for a very good reason.
But thank you very much for listening.
Senator Specter. Well, leave very promptly then.
Ms. Newton-John. Thank you very much for listening.
Senator Specter. Thank you. Thank you very much.
[Applause.]
Anissa Ayala. A combination of scientific investigation and
hope.
Ms. Ayala, may we hear from you? What was your situation
and how are you feeling?
Ms. Ayala. I am doing great today. I am celebrating my
sixth anniversary coming up in June. And I was diagnosed in
1988, when I was 16 years old. I had CML. That is what my
diagnosis was. At that time, I was given 3 to 5 years to live,
without a marrow transplant. I only had one sibling at that
time. We tested him. He was not a match.
And from that point, we went to the National Marrow Donor
Program, and tried to locate a donor. Unfortunately, for 1\1/2\
years, we did not find a donor. And at that time, my parents
went through extreme measures to try to conceive another child
to see if that child could possibly be a match for myself. At
that time, my disease was treatable through an experimental
drug, called interferon, that would hopefully hold off my
disease for a period of time.
And I was on that until my sister was born. She was a
perfect match at the time of her birth. They did save the cord
blood, and at the time of my transplant--why they save the cord
blood was because she would not have to be large enough--she
would not have to be as large to donate the marrow needed for
me.
So, at 14 months, my sister went in. She donated her
marrow. I also received the umbilical cord blood that was
frozen up until that time. And so I received the cord and
marrow transplant, and I am here today, thank God.
Senator Specter. Well, you have a miraculous story.
According to the information that Dr. Forman has given, a
reversal of your father's vasectomy.
Ms. Ayala. Right, after 17 years.
Senator Specter. Your mother gave birth at the age of 43--
--
Ms. Ayala. Correct.
Senator Specter [continuing]. To a sister who was a match
for you.
Ms. Ayala. Right. And the odds of that are one in four.
Senator Specter. Boy, you sure got a good doctor.
Ms. Ayala. I do. He is great. Thank you.
Senator Specter. And Robin Frasier had a disease for which
no curative therapy, other than transplant, was known to exist.
Tell us about Robin Frasier's case, Dr. Forman, in a little
more detail.
Dr. Forman. Robin had a disease for which, as you pointed
out, there was no cure except a transplant. But she had no
donor in the family or the registry. We were able to use a
medicine, called interferon, to clean up her marrow, if you
will, of leukemia cells, and then take it out, remove it from
her, put it in the freezer, so that we could transplant her
utilizing the normal cells that we could find in her marrow. At
the time that we did that, there were very few, if any, other
people who had undergone therapy in that exact situation.
Had we not known from research that these cells even
existed in the leukemia marrow, we would not have been able to
harvest them for the transplant. And I think it is Robin's
trust in the system, in research and us that led her to that
therapy.
Senator Specter. And she was one of the first patients in
the world to undergo this particular kind of therapy?
Dr. Forman. That is correct.
Senator Specter. How are you feeling today?
STATEMENT OF DR. ROBIN FRASIER
Dr. Frasier. I feel wonderful and very grateful to Dr.
Forman.
I am a physician as well, and when I was in medical school,
I treated a lot of patients with CML. That is to say, I held
their hands while they died, and I thought that that would be
my case when I got my diagnosis.
Senator Specter. And you are the beneficiary of the
research and a good doctor.
Dr. Frasier. Absolutely.
Senator Specter. Well, it is very impressive. I think we
have heard from all of your patients now, Dr. Forman.
Dr. Forman. Yes.
Senator Specter. Well, thank you all very much. It is
important testimony. And my colleagues will be reviewing it on
the subcommittee and the full committee, and I am going to make
a special floor statement on it to summarize--Bettilou Taylor
and Craig Higgins will summarize it, but I will make the floor
statement to acquaint others with exactly what you have
accomplished. It is very impressive.
So thank you very much, Sheriff Block, Ms. Field, Dr.
Forman, Ms. Keaton.
Thank you very much.
Dr. Frasier. May I say one other thing?
Senator Specter. Sure.
Dr. Frasier. I would like to point out that I have had two
grandchildren born since I was ill. And both of them have had
cord blood stored just in case this should ever be a problem.
Senator Specter. How old are your grandchildren?
Dr. Frasier. One is 14 months old. I have three others that
are older: one is 4\1/2\, a 15-year-old, and an 8-year-old.
Senator Specter. OK, thank you very much. I appreciate it
very much. I would like to move now to panel 2. [Applause.]
STATEMENT OF HAROLD P. FREEMAN, M.D., DIRECTOR,
DEPARTMENT OF SURGERY, HARLEM HOSPITAL
CENTER, NEW YORK, NY
Senator Specter. We turn first to Dr. Harold Freeman,
director of the Department of Surgery at Harlem Hospital
Center, and professor of clinical surgery at Columbia
University College of Physicians in New York City. He is the
chief architect of the American Cancer Society's initiative on
cancer for the poor.
Recognizing his contributions, in 1990 the American Cancer
Society established the Harold P. Freeman Award, given annually
to individuals who have made outstanding contributions in the
fight against cancer for the poor. He was appointed by
President Bush as chairman of the President's cancer panel in
1991, and reappointed to the position by President Clinton in
1994.
Dr. Freeman, in a very bipartisan sense, welcome. The floor
is yours.
Dr. Freeman. Thank you. It is an honor to be here, Senator,
and I am going to spend my 5 minutes talking about the effect
of managed care on the war against cancer.
As chairman of the President's cancer panel I have had the
opportunity to look at this over the past year. The panel has
had hearings in four American cities in the four quadrants of
America, and I have heard the testimony of people, not only
consumers but scientists, and we have a deep concern about what
this system has caused.
Indeed, we know that cost is fairly well under control
under this system. However, there is a concern that managed
care is controlling cost but at very high price to the American
people. The system we believe at this point of evolution could
be better characterized as a managed cost system, in
contradistinction from a managed-care system. The system pays
for what it defines as medical care, which often is different
from what doctors believe should be done, and will not pay for
other care. Also it will not pay for research and for training
of scientists.
The previous system, which was traditional health care,
paid for research, and it paid for training, and to a certain
extent helped to pay for indigent care, so the shift from
traditional health care at fee for service, although the other
system had its problems, has left us with a situation where
there is a threat to this system with respect for paying for
research and for training and for indigent care.
There are certain points I want to make in this short
period of time that we consider problematical with the managed
care system. No. 1, often it denies reimbursement for services
provided under a so-called research protocol, even though the
services would have been granted as regular care, but once it
is classified as research, many of the managed care companies
do not pay for the service.
In many instances we found that there was diminished
patient access to clinical trials, patients being shifted to
gatekeepers and generalists instead of being examined by a
specialist, which they should be examined by, and often
patients are referred away from the research centers to get
cheaper care elsewhere.
Researchers themselves are under duress. Sometimes ethical
considerations occur where a researcher has to relate to a cost
concern of a company rather than the human concerns of those
patients. There is less time for physicians to do research, as
they are being forced to spend less time with patients and have
to be accountable for money rather than care.
One of the threats that I think is extraordinarily
important to bring to the table is that, as you know, we have
developed the highest and most advanced system of medical care
in the history of this planet, and we should all be proud of
it. Medical care and research are at the highest level in this
country compared to anywhere else in the world, but these
research institutions, Senator, I believe are being threatened
by this new system.
The academic medical centers are being squeezed by lack of
reimbursement for services, by cutting reimbursement for
services, by increased overhead with the need to develop higher
infrastructures to satisfy the managed care movement, by
decreased referrals, as I said, to the outside, which the
companies do not wish to send these patients to the research
centers themselves.
Another area of concern is that we are spending less money
under this new system for training and education, and I think
the young scientist is rather threatened in this change. The
managed care companies will not pay for research nor for
training.
Also, the percentage of research that is being done in the
centers is more and more being taken up by pharmaceutical and
by medical companies as opposed to investigative simulated
research, which has been so important.
So in general I would summarize by saying that we have a
system that is undergoing change from traditional health care
to so-called managed care, which has so far emphasized managed
costs. We have a system where the managed care companies are
taking significant money out of the system to be distributed to
stockholders and CEO's and not putting money back in for the
research, as was done in the previous system. This is a
dangerous change.
The question is, Senator, what does it profit this Nation
to manage the cost of medical care if it loses its great
research and teaching potential in the process?
If managed care will not pay for this, who will? Should not
the research and development be at built-in expense to the
managed care companies? If an automobile company builds a car,
as General Motors does, you pay a part of the research for the
next year's car when you pay for that car. Why should this
system not do the same thing?
A final concern is that the system called managed care
gives less favorable outcomes to certain segments of the
population, the poor and the less educated. People who have
money and education tend to get into research protocols at a
greater rate than the poor and the people who are less
educated. The system does nothing to confront the problem of
the 41 million uninsured American people who do not get care at
all until it is too late.
PREPARED STATEMENT
So we conclude in general that we are shifting to a system
that has controlled cost to a large extent, but I believe at
too high a price for the American people.
Thank you very much.
[The statement follows:]
Prepared Statement of Harold Freeman, M.D.
MANAGED CARE'S ROLE IN THE WAR ON CANCER: FINDINGS FROM 1996
During 1996, it was the intent of the President's Cancer
Panel to hear first-hand, in four distinct regions of the
country, how changes in health care delivery are impacting the
National Cancer Program and the reduction of the burden of
cancer on the American people. Our primary objective throughout
this process was to determine if and how the shift to a managed
care system dominated by the notion of ``managed cost'' is
impacting the process of bringing cancer advances to individual
patients and to the public as a whole. This process, as defined
by the Panel, embraces the whole spectrum of cancer research,
application in trials, and finally to the delivery of enhanced
cancer care. Clinical research, even narrowly defined, cannot
be isolated from its application in cancer care and all the
issues associated with assuring that the cancer care provided
is the best that science has to offer.
Funding for clinical cancer research has traditionally been
derived from a variety of sources, with a significant portion,
perhaps even half, coming from ``premium'' dollars paid by
individual and corporate subscribers to health insurance
companies. These dollars, as well as State and Federal payments
for services to Medicaid and Medicare beneficiaries, have
traditionally flowed to academic medical centers and other
health care organizations and provided the funding required for
additional investments in clinical cancer research, education,
and training. They have also provided the basis for indigent
care in many parts of this Nation.
These sources of funding are shifting or disappearing
altogether as our health care system changes and Federal
support decreases. Various health care providers, but
particularly managed care organizations, have responded by
instituting policies that curtail costs through restricting
health services utilization, negotiating provider contracts
that may not cover the providers' costs, capping costs, and
denying reimbursement for services provided in connection with
research initiatives. In response, many health care
institutions are adopting cost effectiveness as a standard of
success and re-engineering key processes to enhance efficiency
and improve outcomes. More clinical trial support by
pharmaceutical and biotechnology companies is also being
provided.
Coping with the demands of the changing health care systems
at the institutional level requires new case management
systems, clinical research cost information systems, as well as
intensified clinical trial review processes. The intent of
these changes is beneficial for all participants in the
process. However, building these core resources is expensive
and, with declining revenues from patient care, reinvestment in
clinical infrastructure may be out of reach for many centers.
Many providers are increasing the number of patients they
see and decreasing the amount of time they spend with each
patient in order to maintain the same level of revenue needed
to fund clinical research efforts. Other institutions are
severely curtailing non-patient associated costs, including
training and education. In this scenario, teaching will suffer
most, since no one wants to pay for it. And from an ethical
perspective, physicians are also facing the increasing
challenge of maintaining their roles as patient advocates while
contracting with managed care organizations governed by
economic motivations.
There was consensus that managed care organizations rarely
approve reimbursement for phase I clinical trials, that phase
II trials are occasionally approved, and that while phase III
trials are frequently approved, more time and documentation is
needed to obtain such approval. In all fairness, however, the
fee-for-service policies which formerly dominated the health
care system also carried specific prohibitions against
participation in clinical investigations. But, it is also true
that those policies allowed much greater physician discretion
in requesting medical care deemed necessary for the welfare of
the patient. Such decisions are now impacted by cost
limitations, gatekeeper review and, in some cases, blanket
policies prohibiting reimbursement of any care associated with
research efforts even if the same or similar services would
have been provided as part of a ``standard'' cancer therapy in
the absence of an experimental component.
These issues impact whether patients are offered the best
and most appropriate cancer care, but also impact the validity
of clinical study outcomes. If the only trials that can be
supported become those that are most easy to finance, for
example, shorter outpatient trials, how will that impact
progress toward ongoing aggressive fast moving disease that
requires inpatient support? If personal ability to pay for
health care or intellectual capacity to challenge the decisions
of health care providers become the criteria for entry into
clinical trials, can the results of those trials be
extrapolated to the underserved of this nation, or in a worst
case scenario, will access to appropriately designed cancer
therapy become a privilege of the ``rich and well connected?''
We clearly need strategies to ensure that appropriate cancer
care remains easily and widely available and that a meaningful
clinical research agenda continues to exist at all levels and
that all the beneficiaries of clinical research share the
burden of its cost.
On a positive note, there are mature managed care
organizations plans which are committed to the support of
clinical research. And, despite many of the concerns heard by
the Panel, on a system-wide basis, managed care--not managed
cost--could ultimately lead to significant positive benefits,
such as greater emphasis on prevention, development of better
research guidelines and protocols, clearer measurement of
outcomes, greater consistency across health care delivery
systems, and improved affordability.
We must not overlook these opportunities in a rush to
single out managed care as the cause for all that ails us.
Access, cost containment, and quality of care are currently the
competing priorities with which we are struggling to achieve a
balance. This balance is essential, since without high-quality,
accessible clinical research, progress in the war on cancer
will be undermined. And we cannot forget to bring our focus
back to those we are serving; we must remain humane and caring
at all times to the cancer patients' needs.
MANAGED CARE
Senator Specter. Thank you, Dr. Freeman. You articulate it
very well when you characterize it as managed cost as distinct
from managed care. This is something that we are really
wrestling with in the Congress at the present time, and are
looking for answers. We had the so-called gag rule, which is
really managed care telling family physicians not to refer to
specialists, and we have changed that in the Medicare system.
We had hearings in this subcommittee. Last year we had an
amendment by Senator Wyden which passed by a big vote in the
Senate but did not get enacted into law. I then scheduled a
hearing last November and the head of the Health Care Financing
Administration came in and said, well, we plan to change the
gag rule next year. My response was that we should not wait
until next year.
It happened to be November 13, and I counted the days
remaining in the year. There were 48 of them, and I said a lot
can happen in 48 days or 48 hours or 48 minutes, and I
commented that the President had opposed the gag rule 5 months
earlier, and I know the President was really in charge of HCFA
the last time I looked; as a result, HCFA did change the gag
rule just 12 days later, on November 25, 1996.
I have taken up with Secretary Shalala the issue of managed
care having a share in graduate medical care, because they do
not have any now, and we are looking for answers.
When you say that it denies referrals away from research
centers, could you particularize that a little more?
Dr. Freeman. Yes; the testimony that we heard, Senator,
indicated that throughout the country--and the four regions
that we explored, there was a tendency particularly on the west
coast where the managed care system is more highly developed,
that there was a tendency for the managed care companies, many
of which are for-profit companies, not to wish to send their
patients to the medical centers, the academic medical centers
where the cost is a bit higher, but it is a cost that the
American society needs to pay to keep its advances going.
Senator Specter. So it is not only for the patients, but it
is for the ongoing research.
Dr. Freeman. Yes; that is the key issue, is not only
patients being harmed, perhaps, but research centers threatened
for their very existence, and I think this is a major issue to
be considered, that we have major academic centers that are
being squeezed and threatened to the point where they may not
exist in the future.
Senator Specter. Well, Senator Harkin and I have introduced
legislation, Senate bill 441, where 1 percent of insurance
premiums would go to support medical research. We are trying to
add on the private sector. That would be about $6 billion for
biomedical research. We are very concerned about the problem,
Dr. Freeman, and I would like to pursue it with you in terms of
what suggestions you might have as to how we solve it.
I do not have to tell you that we do not have all the
answers in Washington. We need help from the professionals, who
see it day-in and day-out.
Dr. Freeman. Senator, we are completing a report to the
President, perhaps within the next 30 days, and if you wish I
will be happy to send you that report.
Senator Specter. I would like to see it. Perhaps I can read
it faster than he can.
Dr. Freeman. Yes.
Senator Specter. I would like to see it.
Dr. Freeman. Very likely--thank you.
STATEMENT OF JACK KLUGMAN, ACTOR, MALIBU, CA
Senator Specter. We turn now to a very distinguished
Philadelphian, Mr. Jack Klugman. One of the reasons for coming
here today is to bring him back to south Philadelphia.
[Laughter.]
We need his presence in my home town, and he has enjoyed
tremendous success in films, television, theater, attended
Carnegie Tech in Pittsburgh on the GI bill after his service in
World War II, a three-time Emmy Award winner, including two for
his role in the hit comedy series ``The Odd Couple.''
They have taken your ``Odd Couple'' and have applied it
indiscriminately, Mr. Klugman. Now Hatch and Kennedy are being
called ``The Odd Couple'' I think. I think you may have a cause
of action. You might be able to win a lawsuit on that if you
challenge it.
Senator Hatch said recently in one of his speeches, when
Kennedy and I are on the same bill everybody figures one of us
has not read it.
So your odd couple scenario has gained great fame. We
appreciate your being here, Mr. Klugman, and look forward to
your testimony.
Mr. Klugman. Whenever I get that many compliments I always
wish, as LBJ said, that my mother and father were here, my
father because he would have enjoyed it, my mother because she
would have believed it. [Laughter.]
Really, it is an honor to be here, Senator. When I told
Sherry Lansing that I would be honored to appear before you,
she sent me an enormous packet of very valuable information
about cancer research, facts and figures and statistics which
definitely prove the need and the value of cancer research. But
now I am here, and I know you have heard all these figures over
and over again, so I am going to throw as few statistics as
possible, and I am going to jump right into the fire and get
personal.
But the one word I did not see in the packet is the word,
``miracle,'' and research can perform miracles. For instance,
it is a miracle that research can have a doctor or a scientist
know something about a disease on Friday that he did not know
the preceding Monday. It is miraculous that a doctor can cure a
cancer in 1997 that was incurable in 1987, and he only has one
tool that helps him to do that: research, the only tool.
My father died in 1934, when I was 12 years old. My mother
went to visit him in the hospital and he said to my mother, he
said: ``take me out of here, they do not listen to me, they are
not helping me.'' He was in a ward with 30 other people, big
wards in those days. He died 2 days later, and throughout the
years, when people ask me what did my father die from, I really
answer very bitterly, he died from poverty.
But as years went along I had to appear before--I spoke at
the graduation, at Mount Sinai, of doctors, and I went over
what my father had said. I was going to use the poverty line,
but I realize what he said was, ``they do not listen to me.''
It does not cost anything to listen.
And he said, ``they are not helping me.'' But my older
brother had assured me that doctors had done everything they
possibly could, so he did not die from poverty, and he did not
die from indifference, and he did not die from negligence. He
died from ignorance. Because if the same doctors treated him
today for the same illness, I was told that they could
guarantee him a minimum of 20 more years of quality life. You
see, the flip side of ignorance is knowledge.
I am living proof of why increased investment in cancer
research is so critical. In 1997, this year, almost 11,000 new
cases of larynx cancer will be diagnosed, almost 9,000 new
cases in men alone, and 4,230 people will die from this
devastating disease.
A little over 8 years ago they performed a partial
laryngectomy on me, brought on by cancer caused by smoking, but
I know that is a different congressional committee.
Senator Specter. Not really.
Mr. Klugman. Not really? Well, let me get into that.
Senator Specter. Go ahead.
Mr. Klugman. That light is going to go on.
Had I had the same illness 20 years ago, just 12 years
previous, the doctors would have taken out my entire larynx and
left me with a hole in my throat, and I would be talking to you
on the bubble, or maybe with one of those vibrators, and the
quality of my life would be gone because I would not be able to
act any more, and that has always been my main love.
But because it was a partial, because of research they had
found out how to just take out my right chord and not take the
entire amount. I exercised vocally for 4 years, very hard, and
now my voice is stronger, not prettier, but it is stronger, and
last year--last year Tony Randall and I performed a play, ``The
Odd Couple'', on stage in London in the most beautiful theater
in the world, the Royal Haymarket Theater. We had a 4-month
engagement. I did not miss one performance, and we played to
standing ovations. [Applause.]
So the quality in my cup runneth over, and I swear, you
ain't heard nothing yet. I am 75, and I am going on.
PREPARED STATEMENT
So Mr. Chairman, I beg you--I beg you today to commit to a
doubling of the budget for the National Cancer Institute, and
that will make sure that the best care is available to all
people. We must stop equating money with human life. That
really is an insult to human life.
Thank you. [Applause.]
[The statement follows:]
Prepared Statement of Jack Klugman
When I told Sherry Lansing that I would be honored to
appear before this distinguished panel, she sent me an enormous
packet of valuable information about cancer research. Facts and
figures and statistics which definitely prove the need and
value of cancer research. Now I know you have heard these
figures over and over again, so I will limit the amount of
statistics I throw at you. Instead, I'll jump right into the
fire and get personal.
You see, the one word I didn't see in the packet was the
word miracle. And research can perform miracles. For instance
it is miraculous that a scientist can know more about a disease
on Friday than he did the preceding Monday. Or that a doctor
can cure an illness in 1997 that was incurable in 1987. And the
only tool that helps him to do that is research. The only tool.
My father died in 1934. I was twelve. My mother and I went
to visit him in the hospital. He was in a ward with thirty
other patients. He said to my mother, ``take me out of here.
They don't listen to me. They are not helping me.'' Two days
later he died. I never forgot the size of that ward. And for
years, when anyone asked me what my father died from, I always
answered angrily, ``poverty.''
But a few years ago, I realized I was wrong. He said,
``they don't listen to me.'' Well it doesn't cost anything to
listen. And he said, ``they are not helping me.'' My older
brother assured me that the doctor did everything he could. So
my father didn't die from indifference. And he didn't die from
negligence. He died from ignorance. If the same doctors treated
my father for the same illness today, I was told he could be
guaranteed at least twenty more years of quality life because
of research. The flip side of ignorance is knowledge.
I am living proof of why increased investment in cancer
research is so critical. In 1997, 10,900 new cases of larynx
cancer will be diagnosed. 8,900 new cases in men alone. And
4,230 people will die from this devastating disease.
A little over eight years ago they performed a partial
larynectomy on me brought on by cancer caused by smoking
cigarettes. (but I understand that's for a different
congressional committee).
Had I had the same illness twenty years ago, the doctors
would have taken out my entire larynx and left me with a hole
in my throat. And I never would have been able to act again.
And since acting has always been my main love, my love would
have lost all of its quality. But because of the partial, I was
able to do vocal exercises that made my voice stronger. (not
prettier, but stronger!) As a result, last year, Tony Randall
and I did the play, ``The Odd Couple'' in London at the most
beautiful theater in the world. The Royal Haymarket. We had a
four month run and I never missed a performance. And we played
to standing ovations. And so, ladies and gentlemen, the quality
in my cup now runneth over. And you ain't heard nothin yet!
Mr. Chairman, I beg you today to commit to a doubling of
the budget for the National Cancer Institute and to help make
sure that the best care is available to all people.
We must stop equating money with human life. It's an insult
to human life.
ABDOMINAL CANCER
Senator Specter. Mr. Klugman, may I ask you what your
father died of?
Mr. Klugman. He had abdominal cancer, which could have been
taken today, I understand, because they caught it early. He was
in hospital for such a long time. They just did not know what
to do. He had been in there about 5 weeks.
Senator Specter. Was he in the old Jewish hospital?
Mr. Klugman. Mount Sinai. You are too young to remember
this ward, 30, 35 people on the ward, but they were taking care
of him. The thing is, you hear what you want to hear.
Senator Specter. Well, you had two very powerful
characterizations. He died from poverty, and then you said he
died from ignorance, and I think both are appropriate. In
America, no one should die from poverty. We have great wealth
if we apply it properly.
And smoking, would you tell us a little more about that?
Mr. Klugman. Well, I used to smoke, you know. That is the
way it started. You were talking about Joe Camel now. That is
how I started. There used to be a program called the Lucky
Strike Hit Parade. This was many years ago, almost 60 years
ago. They would have 10 songs, the top 10. If you wrote in the
top three songs that you guessed would be the top three, they
would send you a free carton of Luckys. Well, it was easy when
the same songs were on top for 6 weeks, so all the guys are on
the corner--and I am talking about 50, 60 guys. We would fill
it out.
Senator Specter. Where did you live in south Philadelphia?
Mr. Klugman. Seventh and Morris. We would send it in, and
they would send us a carton of cigarettes, so we said, what
suckers these people are. What fools. We got' em, boy. We did
not realize that we were being hooked, and that is what they do
with Joe Camel, and they have been doing it for years,
something like 60 years, and that is what got me hooked on it.
Senator Specter. Seventh and Morris, was that not just
around the corner from Frank Rizzo?
Mr. Klugman. Yes.
Senator Specter. Did you know Rizzo?
Mr. Klugman. Yes; I knew him quite well--quite well, quite
a character.
Senator Specter. But he did not smoke.
Mr. Klugman. I did not know that. If he did not, he was the
only one in south Philadelphia, I will tell you that. If they
had known they would have thrown him out. [Laughter.]
Senator Specter. Well, thank you very much for your
testimony, Mr. Klugman. You have given some good verbiage for
the Congressional Record. We will put it in.
STATEMENT OF JUDD ROSE, ABC NEWS CORRESPONDENT, ``PRIME
TIME LIVE,'' NEW YORK, NY
Senator Specter. We turn now to Mr. Judd Rose, a
correspondent with ABC News, ``Prime Time Live,'' since May
1989, prior to that a Washington-based correspondent for
``Nightline,'' Emmy Award winner for his contributions to
``Nightline's'' coverage of the Philippine President Marcos,
extensive experience in TV and radio, reported on some of the
most significant news stories of the day, including the San
Francisco earthquake, or one of the recent San Francisco
earthquakes, the crash of Pan Am 103, and the U.S. invasion of
Panama.
Thank you for joining us, Judd, and the floor is yours.
Mr. Rose. Thank you, Mr. Chairman, and like everyone who
has preceded me today, I appreciate the opportunity to speak
here about a subject that is very important to me, and I
appreciate the fact that you are interested in a subject that
is important to so many of us.
You just cited all of my years as a reporter. In those
years I have always gone by the rule that I am not the story,
and I think that that is a rule that is being broken a lot
these days, but I have always tried to adhere to that. But last
fall, when my friend and colleague Sam Donaldson, who had
gotten through a bout with melanoma cancer, came to me and
suggested that we get together and do an hour on ``Prime Time
Live'' television about our stories and then talk about other
people and what they dealt with, I broke my rule and we went on
the air with that last October.
The response that we got, both Sam and I, was phenomenal.
He received thousands of letters, e-mails, phone calls, faxes.
I received hundreds. Clearly, what we did touched people out
there, and I am very proud that we did that.
What we also learned, among many things, in doing that hour
was that there are many potential treatments for brain tumors
and other kinds of cancers that are being worked on now that in
fact could be ready in a very short time if the money is there
to pay for the research. I will get back to that in 1 minute,
but obviously I am not here today as a medical expert or a
scientist. I am neither of those. All I know is basically what
I have reported on, and been told by other people, but I am
here as a survivor, so I would like to tell you briefly about
my story.
In the fall of 1993 I was 39 years old and, like one of the
other people here testified today, Olivia Newton-John, I did
not smoke, I did not drink, other than the occasional beer--I
was a pretty healthy guy, so that was the way I proceeded.
In the fall of 1993 I started getting dizzy spells. They
did not last very long, but they were frequent, and then I
started losing my balance, again not in a serious way, but
enough so that I noticed it.
I went to my doctor, and I was diagnosed as having an inner
ear infection, and so I took the medication. It did not seem to
help at all. Finally, after a few months I went and got an MRI,
and after the MRI it was clear something was going on in my
brain and, after consulting with several neurologists, I got a
biopsy which showed that I had a grade II astrocytoma, a brain
tumor.
Senator Specter. You had a biopsy before surgery?
Mr. Rose. Yes; In fact, surgery, when they took a look they
realized that surgery was not an option, because it had grown
in a place where they could not operate. Surgery was not an
option, chemotherapy was not an option because all of the
doctors that I spoke with told me that what they had available
for my type of brain tumor was not really very effective and
they had terrible side effects.
So basically it came down to radiation, and they were going
to hold that unless and until my tumor began to grow. A grade
II tumor, as you may know, it means that it is there but it is
not necessarily growing at that particular point.
So I did not have a lot of options, and finally when the
tumor did begin to grow late in 1994 radiation was really my
only choice, and I began a 6-week course of radiation at
Memorial Sloan-Kettering Hospital in New York, which as far as
I can tell is about the best in the country for that sort of
thing.
I went in there for 6 weeks, every day of the week for 6
weeks, and by the time I was finished, of course, like
everybody who goes through this I was bald. I used to have a
big bushy head of hair. I was bald, and I was bloated from this
huge amount of steroids that I had been taking, and I was bed-
ridden for more than 1 month after the radiation ended, because
it depletes your energy in such a way that you cannot get out
of bed. You cannot literally get up on your feet.
It is one of those things where you think to yourself at
the time, the cure is worse than the disease. Of course, I
realize that is not the case, but you get the idea.
For months after that--and we are talking now about the
spring of 1995--I had to walk around with a cane. I wanted to
get back on the air. That was my job, and I wanted to get back
to it, and I probably got back to it a little too early, but I
felt that I wanted to show the people I work for that I was not
damaged goods.
I looked like I had put on an enormous amount of weight
because of the bloating from the steroids. I bought a wig to
put on my bald head, and I looked like a guy with a wig, and I
did not have the stamina, but I did go back to work finally.
Of course, as soon as I did go back on camera, anybody who
did not know at that time that I had a brain tumor knew as soon
as they saw it. I looked like a very sick guy.
I am not complaining, you understand. The radiation, as it
happens, ended up saving my life. I stopped getting the
radiation at the end of January 1995, but it continued to work
in my brain for at least a year after that, and my tumor today
has been reduced down to a little tiny, microscopic speck, so I
am today pretty much like my own self, just with a lot less
hair, and I guess at my age, which is 42, I should not be
worried about that.
At the same time, even though I managed to survive, I have
to stress how critical it is that we continue to search for new
treatments that will reduce the damage that I suffered and so
many people suffer in worse ways from the treatments we get.
Obviously, research is the key, and like Mr. Klugman I am
not going to bore you with a lot of numbers, but I do want to
give you a few important ones from the brain tumor side of this
issue.
Some 17,600 Americans will be diagnosed with a brain tumor
this year alone, and also this year 13,200 of us will die from
a brain tumor. It does not take a mathematician to see that
those are not great odds.
For brain cancer patients, it sounds like good news. The
chance of survival for brain cancer patients, survival 5 years
after diagnosis, that keeps going up, actually: 18 percent
survival in the sixties, 20 percent in the seventies, 25
percent in the eighties, and just about 30 percent survival
rate now.
That is good, obviously, but it is not good enough. We need
more money for more research that will greatly improve the odds
for those with brain tumors and, of course, all other types of
cancer.
I can tell you from the reporting that Sam Donaldson and I
did for that show last year that we saw just a few of these
remarkable treatments that are in fact going on at UCLA Medical
Center. There is--of course, you have heard of gene therapy,
and they have been doing a protocol with gene therapy.
There is another thing called RMP-7, which they have been
experimenting with, which would allow the administering of
medicines to a brain tumor that cannot get in there now. All
kinds of things are going on, but of course without the funding
to keep those experiments going, they will not. They will not
go forward. That is a risk we just cannot take.
Senator Specter. Mr. Rose, the biopsy that they did, how
did they do the biopsy?
Mr. Rose. My biopsy was a stereotactic biopsy, in other
words, needle biopsy.
Senator Specter. And what was the finding on that?
Mr. Rose. I had a grade II astrocytoma.
Senator Specter. What does that mean?
Mr. Rose. An astrocytoma is a type of brain tumor that is--
obviously all brain tumors are serious. Mine was not as bad as
some. Grade II, as I said, means that it is not growing.
Brain tumors are graded I through IV. You may know this.
People say was it malignant, was it benign. Well, they do not
really talk about tumors that way in the world of doctors. It
is I through IV.
I is basically just what children get, if children get a
brain tumor, that is a I. II, what I had, you have a tumor, but
it is not growing at that particular point, and hopefully can
be controlled with whatever treatment. III means it is growing
and you have to do something, and do it quickly. IV basically
means it is terminal.
I had a II, which was sort of on the bad side. Then it
began to grow, and since radiation, it is now on the good side,
I would say. It has shrunk down to such a small point.
Obviously, listening to all of the other people who are
testifying here today, my story is not incredibly different
from all the others. I want to repeat the point that some of
them made that this affects all of us. Everyone at least knows
somebody who has cancer.
PREPARED STATEMENT
Let me tell you that the same month that I was diagnosed, I
found out that my mother had breast cancer, and she died a few
months later. It is too late for her, but my survival, the
survival of all of these people and countless others, it
depends on you and the decisions of this committee. I ask for
your help, and I thank you for your time.
[The statement follows:]
Prepared Statement of Judd Rose
Mr. Chairman, I am pleased to testify at this special
hearing on research. I want to personally thank you for your
attention to the topic of cancer, which affects the lives of
millions of Americans, their friends, and families each year.
I am not a very public person about my private life. But I
am here today to share with you how progress in cancer research
has made it possible for me to continue my work and my passion
despite a terminal cancer diagnosis over four years ago.
In the fall of 1993 I started having dizzy spells. My
equilibrium and balance were out of synch as well. I was
originally diagnosed with an inner ear infection, but the
symptoms kept getting worse and not improving. Finally, I
consulted some of New York's top neurologists. My worst fear
was confirmed: I was diagnosed with a brain tumor, also known
as a Grade II astrocytoma.
I was stunned. At that moment, I wasn't depressed or angry,
just shocked. I was always a pretty healthy guy.
Because of the tumor's location, surgery was out of the
question. So I began various types of treatments, including
radiation, chemotherapy, and steroids.
I won't lie to you, the treatments that saved my life were
not pleasant. I lost my hair and experienced severe bloating
throughout my body. I cannot stress enough how critical it is
that we continue to search for new treatments that will
minimize the effects on our bodies. Research certainly holds
the key to discovering gentler antibodies that can destroy the
disease with as little impact as possible on our bodies, minds,
and lives.
But I also don't kid myself in that the discoveries made to
date from research in the last 25 years have saved my life.
Some 17,600 Americans will be diagnosed with a brain tumor
in 1997. And 13,200 people will die of brain tumors the same
year. I'm not a mathematician, but I can understand that those
aren't great odds.
Brain cancer patients are given a 29-percent chance of
survival 5 years after diagnosis. The survival rate has
continually gone up from 18 percent in the 1960's, 20 percent
in the 1970's, 25 percent in the 1980's, and now almost 30
percent in the 1990's. But unless there is an infusion of
funding into cancer research, brain tumor patients only expect
a 30-percent chance of survival--and that is unacceptable. More
money for increased research will greatly improve the hope and
opportunities for those newly diagnosed with a brain tumor and
other types of cancer.
Since 1996 my tumor has shrunk, and I am symptom-free. I am
coming up on my fifth year as a survivor--an extremely
significant benchmark for cancer survivors. But for others as
well as myself, I want to be sure cancer researchers have the
full support of the U.S. Congress to take advantage of every
research opportunity that presents itself.
We cannot rest until the budget for cancer research is
doubled.
I lost my mother to cancer. We have all lost a friend or
family member. My survival depends on you and the decisions of
this Committee. I am confident you will strive to help those of
us afflicted by this terrible disease.
PUBLIC IMPACT
Senator Specter. Well, we can work together, Mr. Rose. Some
might say that ABC-TV has more currency, more distribution,
more impact than the Congressional Record. I am not too sure.
Mr. Rose. Well, certainly. We are planning a sequel, if you
will.
Senator Specter. OK, good. Our appropriations process tops
you, notwithstanding the power of ABC and Disney, but our
public impact is not quite as great as ABC.
Thank you for your testimony.
Mr. Rose. Thank you.
STATEMENT OF STEVEN WEBER, ACTOR, BEVERLY HILLS, CA
Senator Specter. I would like to turn to Mr. Steven Weber,
an accomplished dramatic and comedy actor perhaps best known as
the character, Brian Hackett, on the NBC comedy ``Wings,''
recently seen on the ABC miniseries, Stephen King's ``The
Shining,'' also starred in such films as ``Leaving Las Vegas,''
``Hamburger Hill,'' and in addition to his career in television
and film he has performed in the theater, making his Broadway
debut in 1985 in ``The Real Thing.''
Welcome, Mr. Weber. We look forward to your testimony.
Mr. Weber. Thank you, Mr. Chairman. This is just a brief
story about a surviving family.
In 1958, a daughter was born to a couple. Two years later a
son was born, and they lived as most families live. They tried
in the most basic ways to simply be happy. The parents worked
to support their children and themselves, to provide a home,
food, and as many comforts as they could.
Time, of course, passed, as the parents grew older they
continued to do what most parents seek to do, to watch their
children grow into strong, healthy teenagers, to hopefully
become wise and sensitive adults, and perhaps to go on to have
children of their own, and above all to keep the family strong
and close.
But, of course, the unforeseen happens. In 1990 the
daughter, who was born in 1958, died at age 32 of complications
stemming from lymphoma. She left a family that has not
recovered from her loss, a family that simply wanted to live,
as most families want to live, unburdened by hardship, illness,
and pain.
The family that survived her did not understand why she had
died, nor do they understand it now. They watched and listened
to doctors who tried to explain the complicated puzzle that is
cancer. They struggled to understand why they had to literally
stand helplessly by while the girl was overtaken by the
disease.
They felt ignorant, ashamed, embarrassed that they should
be so ill-equipped to deal with the situation, and in the end
they felt the leaden weight of her loss, the finality of her
absence, and they were left with the image of the beautiful
young woman's eyes wide with terror as infection swept through
her lungs, smothering her.
The doctors had done all they could for her, and despite
the breakthroughs in treatments and research, the care shown by
the physicians and specialists, all working under endless
pressure of trying to help people desperate to simply live, it
still was not enough.
Cancer, of course, still tears families apart and destroys
the most basic dreams that we all have. So this is what is left
for those who are powerless, the surviving families who do not
themselves have the direct resources to take action against
cancer, who have to stand helplessly by and watch their
daughters, their fathers, their mothers, their sons, their
friends, their sisters slip from their grasp utterly and
forever.
This is what is left for the surviving families, to beg
those who have the power to wield it forcefully and wisely and
to commit themselves to the eradication of this most formidable
destroyer of families.
And so, Mr. Chairman, I beg you on behalf of my sister,
Abby Weber, who was born in 1958 and who in 1990 died of cancer
at age 32, to please continue your generous and necessary
efforts to fund cancer research. Millions of families depend on
you to simply live.
Thank you.
Senator Specter. Thank you very much, Mr. Weber.
[Applause.]
That is a very powerful, real life situation. A
longstanding friend of mine, Dick Buterra, who is in the
audience today, has a somewhat similar personal experience with
a daughter, and of course the power is greatest when it is
personal, very obviously, and when we juggle all the figures in
Washington they tend not to be too personal.
We talked about a balanced budget. That is an important
objective, but the step beyond that is to assess priorities,
and as Dick Buterra says when he talks about many of the other
ailments--and there is fierce competition for these NIH dollars
among heart disease and cancer and Alzheimer's and AIDS. Those
other people, most of them are living, but in cancer they are
not. They are not breathing--or hearing disorders, or what-
have-you. We have to make this impact felt on the
decisionmakers, and I am one of them, and I have a key
position.
I am determined to raise NIH funding--I set a target of
providing a 7\1/2\-percent increase this year, which would be
$952 million, and I am not quite sure at this point how I am
going to get there from here, but I am determined to get there.
Hearings like this and airing the kinds of personal experiences
we have heard today are very powerful driving forces.
In your field you have a lot of powers, and cameras have
enormous power, because they tell the story on television.
People watch television, and Members of Congress watch
television and hear from people who do. Hollywood talks and
people listen, very much so.
STATEMENT OF DR. OWEN W. WITTE, PROFESSOR OF
MICROBIOLOGY AND DEVELOPMENTAL IMMUNOLOGY,
UCLA, INVESTIGATOR, HOWARD HUGHES MEDICAL
INSTITUTE, LOS ANGELES, CA
Senator Specter. We turn now to Dr. Witte, professor of
microbiology and molecular genetics, first incumbent of the
president's chair in developmental immunology at Howard Hughes
Memorial Institute at UCLA, a recipient of numerous awards for
leukemia and cancer research, a graduate of Cornell and
Stanford University School of Medicine, completed his
postdoctoral research at the Center for Cancer Research at MIT
not too long ago.
What comes after post doctoral research? I ask that because
Joan and I have a son who is just working on his postdoctoral
research. We thought when he had his Ph.D., he was there, but
where else do you fellows and women go?
Dr. Witte. If the budget of NIH is increased sufficiently
there will be jobs out there for the Ph.D.'s and postdoctoral
fellows that we are training currently.
Senator Specter. Our son has no interest in a job.
[Laughter.]
That is not where he wants to go.
Dr. Witte. Send him to my lab for a couple of years. It
will shape him up.
Senator Specter. OK. He is on his way.
Dr. Witte, we thank you for being here, and we have not
started your clock yet.
Dr. Witte. OK. Thank you very much.
Senator Specter. So the whole time is yours.
Dr. Witte. I just want to connect with some of the other
testimony we heard this morning and to a comment you made,
which is that people talk about research, we talk about new
therapies, we talk about advances. Who does the research? Where
do the new medicines and therapies come from?
It connects to your comment where you said the two things
you are most interested in are (1) advancing the research
agenda in the NIH budget, and (2) education, and they are
intimately related, and that is what I would like to speak to
today about.
I have had the privilege of being supported by the National
Institutes of Health, and in particular the National Cancer
Institute, for over 17 years. My own research and work in the
area of human leukemia has helped to define the genetic basis
of this group of diseases and provided new insights useful in
diagnosis and therapy. In fact, I was delighted that some of
the things we worked on a decade ago have come to be borne out
in some of the stories you heard today from Dr. Forman and his
patients.
As many witnesses have testified, the National Institutes
of Health funding is the most critical resource available to
move our knowledge forward in the fight against these dreaded
diseases. We really could put a great deal more money to use
immediately on needed and valuable research projects.
Today I would like to focus on an item of great concern to
me as an educator and a medical researcher. A not-so-obvious
benefit to added research funding is the impact it has on the
overall process of education for the next generation of
scientists. The excitement caused by the revolution in
molecular biology and biotechnology has led to direct advances
in biomedical research. It has also not surprisingly resulted
in a dramatic surge in the number of students enrolled in our
colleges and universities who major in these subject areas.
At the University of California, Los Angeles, as one
example, within the last 5 years we have seen a huge increase
in the number of majors in such disciplines as biochemistry,
microbiology, neurosciences, cell biology, and molecular
biology. Currently, there are over 5,000 students enrolled in
these areas of study at UCLA. A little simple math across the
board of the number of people interested in these subject areas
around the country comes to an impressive figure.
These students that are interested in these careers in
biotechnology and biomedicine get this excitement both from
what is going on in the field, as well as from the lay press.
In fact, I think it is hard to find a week that either Time,
Newsweek, or other major periodicals do not have a lead story
about what is going on in biomedicine, cancer, and other
subjects.
Now, the hands-on doings of science is a critical component
of science training. Students in our classes want to work with
the advanced technologies necessary to study the important
biological processes associated with cancer and other diseases
and then apply this knowledge as they move from college into
further professional training--that would be your son--or the
job market.
They want to participate in this biological revolution that
will carry us into the 21st century, and at the same time our
biotechnology, pharmaceutical, and health care industries want
better-trained graduates competing for the broad range of jobs
they can provide.
Now, I believe that NIH funding will support not only this
critical research agenda to press forward on the causation of
disease and new therapies, but simultaneously provide the
educational framework for the efficient framework of new
generations of scientists. This will occur by increasing the
opportunities for practical experience before they leave their
undergraduate training and continuing on to graduate school and
post doctoral training.
Our faculty that teach this group of students must also be
critical to practitioners of the art of science, so if we view
our colleges and universities as providers of opportunity, we
must face the issue that classroom teaching alone is not
sufficient to ensure that the most competitive group of young
biological science graduates will be the next generation of
professionals working to define a knowledge of disease and new
cures for such diseases.
PREPARED STATEMENT
So in summary, Mr. Chairman, the increase in funding for
the National Institutes of Health will ensure faster progress
toward the treatment of these dreaded diseases and also ensure
the quality and training of and opportunity for thousands of
students who wish to participate in the biotechnology and
biomedical revolutions.
Thank you.
[The statement follows:]
Prepared Statement of Owen Witte
Good morning, Senator Specter and other distinguished
members. My name is Owen Witte; I am a professor at the
University of California, Los Angeles, and an investigator at
the Howard Hughes Medical Institute. I am pleased to be present
and to provide my testimony concerning the benefits of
increased research funding through our National Institutes of
Health.
I have had the privilege of being supported by NIH, in
particular the National Cancer Institute, for over 17 years. My
own research experience and work in the area of human leukemias
and immunology has helped to define the genetic basis of this
group of diseases and provided, I believe, new insights useful
in diagnosis and therapy. As many other witnesses have and will
testify, NIH funding is the most critical component to move our
knowledge forward in the fight against these dreaded diseases.
We could put a great deal more money to use immediately on
needed and valuable research projects.
Today I would like to focus on an item of great concern to
me as an educator and a professor. A not-so-obvious benefit to
added research funding is the impact it has on the overall
process of education for our next generation of scientists. The
excitement caused by the revolution in molecular biology and
biotechnology has led to direct advances in biomedical
research. It has also, not surprisingly, resulted in a dramatic
surge in the number of students enrolled in our colleges and
universities who major in these subject areas. At the
University of California, Los Angeles, we have seen a dramatic
increase in the number of majors within the last five years.
The number of students declaring themselves interested in
careers in biotechnology and biomedicine has more than doubled.
The tremendous public interest in this subject area, as seen in
the lay press and professional science magazines, goes hand-in-
hand with this increased excitement.
If our colleges and universities are to provide the
appropriate training for these students, we must not only
develop the didactic curriculum for lecture and seminar groups,
but also provide substantive early research experiences in the
professional research laboratory. Most students get the science
bug sometime during junior high or high school, but they only
really experience science when they have the opportunity to
conduct science themselves.
The ``hands on'' doing of science is a critical component
of science training. Students in our classes want to work with
the advanced technology necessary to study the important
biological processes associated with cancer and other diseases
and then apply this knowledge as they move from college into
professional training for the job market. They want to
participate in the biological revolution that will carry us
into the 21st century. At the same time, our biotechnology,
pharmaceutical, and health care industries want better-trained
graduates competing for the broad range of job opportunities
they can provide.
Increased NIH funding will support not only the critical
research agenda to press forward on defining the causation of
disease and new therapies, but will simultaneously provide the
educational framework for the efficient training of new
generations of scientists. This will occur by increasing the
opportunities for practical on-the job experience during the
undergraduate years.
The faculty that teach this group of our brightest students
must also be critical practitioners of the art of science. If
we view our colleges and universities as providers of
opportunity, we must face the issue that classroom teaching
alone is not sufficient to ensure that the most competitive
group of young biological science graduates will be the next
generation of professionals working to define a knowledge of
disease and our new cures for such diseases.
In summary, Mr. Chairman, an increase in funding for the
National Institutes of Health will ensure faster progress
toward the treatment of dreaded diseases and ensure the quality
training of and opportunity for thousands of young students who
wish to participate in the biotechnology and biomedical
revolutions. Thank you for your attention. I would be happy to
answer any questions.
MOLECULAR GENETICS
Senator Specter. Thank you very much, Dr. Witte.
Would you amplify on exactly what molecular genetics is?
Dr. Witte. It is the study of how genes influence either
processes of life or, in the case of diseases like cancer, how
they influence the progression of disease, and it is really an
explosive area of research, and what we know about cancer
causation today really can be lumped under that heading of
molecular genetics.
Senator Specter. How is that distinguished from
microbiology?
Dr. Witte. Microbiology would include the study of
microorganisms, but as we heard earlier today, controlling a
cytomegalovirus [CMV] infection in a cancer patient is just as
important to the outcome of that patient's life as is treating
the primary cancer, so it is hard to segregate cancer research
from any of these disciplines, and in fact we utilize all of
those disciplines in our approach to studying cancer.
Senator Specter. How would you quantify, if you can, the
progress made on finding a cure for cancer? I realize that is a
very broad question.
You have Dr. Bailar articulating the conclusions, which we
see in the morning's press, and I have not had a chance to read
his report, and I suppose you have not either, because it is
hot off the press. How would you respond to what Dr. Bailar has
said in terms of progress which you have seen on trying to find
the cause of cancer with your microbiology, or molecular
genetics, or whatever else there is in the field?
Dr. Witte. This morning we heard from many people who said
they neither smoked nor drank or did anything to any excess,
and we heard about cancer in children. There is much in cancer
for which there is no appropriate preventive cause of action.
Cancer happens. It happens based on genetic principles as well
as things in our environment. That is undeniable by any study,
not just the latest study.
What I sense and what I see is that the progress we make in
cancer research is hard to predict down the line, and in fact
some of the spectacular results we saw today of people standing
and testifying about their disease and treatment--Dr. Forman--
relates to things that at the time we study them we had no idea
there would come to this conclusion.
In fact, the particular piece of work that I did over a
decade ago was to define the molecular genetic change in the
type of leukemia that one of the women today spoke of, called
chronic myelogenous leukemia. It actually comes from something
called the Philadelphia chromosome, which you may have heard
about. It is the only cytogenetic event----
Senator Specter. Why is it called the Philadelphia
chromosome? Is that like the Philadelphia lawyer?
Dr. Witte. No; it is actually like the Philadelphia
Philadelphia in Pennsylvania, because Peter Noel, the man who
first described that, was working at the University of
Pennsylvania.
The convention to name chromosomal abnormalities after
cities started and stopped with the Philadelphia chromosome.
They now have boring numbers that nobody will remember.
But as a young assistant professor at UCLA, without meaning
to we actually stumbled upon the molecular key to what happened
in that disease.
From that point, my laboratory, in cooperation with
biotechnology companies, developed improved diagnostics which
are used, I am sure to this day to monitor patients such as Dr.
Forman's to look for residual disease and an increase in
disease, and subsequently new therapies for this disease based
on a knowledge of how the stem cell, a particular cell in the
bone marrow works, and how it is affected by it.
So I do not think what is in that article about preventing
cancer makes a lot of sense for people who have cancer
currently. I think we need to face the reality.
Senator Specter. Well, what do you think Dr. Bailar's point
is? It is difficult for you to put yourself inside his head,
but----
Dr. Witte. I do not know him and I do not know the study.
Senator Specter. What do you think his point is here?
Dr. Witte. I think his point is that there are some
preventable causes of cancer. I think smoking is one.
Senator Specter. Well, OK, so we ought to do more on cancer
prevention. Smoking, the environmental factors, detection,
early detection, but he fairly slams research very, very hard.
Dr. Witte. Well, having not read his study and only the
excerpts from the USA Today I think probably I should reserve
judgment.
Senator Specter. He came to the conclusion back in 1986.
Now he says it again, on a study that he made up through 1982.
Dr. Freeman, do you have any thinking as to whether--we are
going to ask him to come in and testify in Washington.
Dr. Freeman. Yes; I think it would be fair to let him say
what he really wants to say. I have read the article, and I
have it in my bag right here, and I do believe that the
headline that you read does not depict the article.
Senator Specter. Well, that is the first time that has ever
happened. [Laughter.]
Dr. Freeman. They have taken a sort of editorial view and
try to make a more sensational headline. I think you can
disagree with Dr. Bailar or you can agree, but it is true,
however, that the greatest impact that you can have on an
emanating cancer would be prevention.
If no one smoked, about one-third of cancers, people who
die now would not die. If we could improve education with diet,
another third probably would not die.
But it is not an either-or, Senator. If Dr. Bailar is
saying it is prevention or treatment, then I would disagree
with him firmly. We need to go into research for treatment. We
have made great breakthroughs. We have people here who
represent those breakthroughs.
Senator Specter. Does his article say, as depicted in the
USA Today, that we are not getting value for our research
dollar?
Dr. Freeman. There is an implication that we should have
shifted the money more toward research, in his article.
Senator Specter. Away from research?
Dr. Freeman. If you had a limited amount of money, he
believes you should shift it more toward prevention as opposed
to treatment research, but I think you need to read the
article. The newspaper is a bit unfair to Dr. Bailar.
On balance, there is a need to prevent cancer, and there is
a need to do research to advance treatments for cancer. We have
made great advances in pediatric cancer and Hodgkins disease,
certainly the lymphomas, testicular cancer. Truly, those are
diseases where not many people are affected.
We have not gotten to colon cancer. We have not gotten to
breast cancer in the way that we have to.
Senator Specter. We have not gotten as far on colon cancer
and breast cancer?
Dr. Freeman. As far as being able to treat them for cure.
Senator Specter. Contrasted with the other types of cancer?
Dr. Freeman. Yes; that is correct.
Senator Specter. Why are we behind on breast cancer?
Dr. Freeman. Because we have not done enough research.
Senator Specter. That is a field which at least recently
has come under intense scrutiny, deservedly so.
Dr. Freeman. Yes.
Senator Specter. In my position I have a lot of complaints
about the money we are spending on breast cancer, the money we
are spending on AIDS, believe it or not. People are showing me
statistics about how many people have AIDS and how many women
have breast cancer, how many people have other kinds of
ailments. Of course, you can get the statistics arrayed in
virtually any line, but should we be spending more money on
research on breast cancer?
I asked Dr. Klausner the question on one of our recent
hearings that we had on the mammograms, for women between ages
40 and 49, how much do you need? How much do you want? What is
the figure? I have not really gotten that figure here, because
I think there are some of us who would spend whatever it takes,
like Elizabeth Crew's book, ``Whatever it Takes,'' might even
get foreign contributions for whatever it takes.
Dr. Freeman. Yes; well, Senator, that is a tough question,
but there is good and bad in targeting research toward one
disease. It may very well be that the answer to breast cancer
may come from another line of research. We have to deal with
the fundamental changes that take place called carcinogenesis,
and that might occur in a laboratory of a doctor who is dealing
with a different disease.
Senator Specter. You are gesturing toward Dr. Witte.
Dr. Freeman. Yes.
Senator Specter. More money for Dr. Witte?
Dr. Freeman. Well, perhaps so, but my point is that it is a
controversial issue as to whether you should target money on a
certain site as opposed to putting the money on the very basic
research that might affect all sites.
Senator Specter. Well, thank you very much, Dr. Freeman,
Mr. Klugman, Mr. Rose, Mr. Weber, Dr. Witte, and special thanks
to Ms. Sherry Lansing, chairman and CEO of Paramount Pictures
Corp. [Applause.]
She has had an illustrious career, is having an illustrious
career, and we very much appreciate the work that Dr. Helen
Segal has done, presidential appointee to the National Cancer
Advisory Board and chair of its budget and planning committee
which oversees the board's $2 billion budget. Special thanks to
Ms. Helene Brown, a leading advocate, activist in the fight
against cancer, and responsible for implementing the mass media
approach for many items going all the way back into the fifties
and sixties on the new pap smear. [Applause.]
SUBCOMMITTEE RECESS
I have been at quite a few hearings, and this is one of the
best. I will be sharing this with our colleagues on the
subcommittee, the full committee, and the full Congress, so we
thank you very much for coming. [Applause.]
That concludes our hearing. The subcommittee will recess
and reconvene at the call of the Chair.
[Whereupon, at 12:13 p.m., Thursday, May 29, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
MEDICARE: PHYSICIAN PRACTICE EXPENSES
AND
WINNING THE WAR ON CANCER
----------
THURSDAY, JUNE 19, 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 2:53 p.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter and Harkin.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
STATEMENT OF KATHLEEN A. BUTO, ASSOCIATE ADMINISTRATOR
FOR POLICY
OPENING REMARKS OF SENATOR SPECTER
Senator Specter. Good afternoon, ladies and gentlemen. We
will proceed with the Subcommittee on Labor, Health and Human
Services, and Education. I regret our late start. We have on
the floor the intelligence authorization bill, and it was
necessary for me to be there, and as sometimes happens in the
Senate we are in the midst of a vote now, so I voted and came
right over. We are soon going to have a second vote and then a
third vote, so I am going to have to return there in about 15
minutes. We have a great many witnesses on important subjects,
so we will do the best we can to try to conclude the hearing.
We had scheduled it from 2:30 to 4, and whether we will be able
to maintain that schedule, I do not know, but we will proceed.
PREPARED STATEMENT
I have a lengthy statement which will be made part of the
record.
[The statement follows:]
Prepared Statement of Senator Arlen Specter
The Senate Appropriations Subcommittee on Labor, Health and
Human Services and Education will come to order. Today we will
have three panels to discuss separate, but equally important,
topics.
We will first hear from the Associate Administrator for
Policy of the Health Care Financing Administration followed by
a distinguished group of medical professionals to discuss the
impact of proposed Medicare ``practice expense'' regulations,
that could result in dramatic changes in payments to various
providers. These regulations, scheduled to take effect January
1, 1998, are required by legislation passed by Congress in 1994
to adjust Medicare reimbursement to physicians to better
reflect the actual practice expense costs.
There has been a great deal of controversy about the
accuracy of the data used by the Health Care Financing
Administration in developing the new system of calculating
physician overhead costs. It has taken the Health Care
Financing Administration a long time to issue these
regulations. Many physician groups, including the AMA, have
been critical of the short time they have been given to analyze
the new proposals. Certain specialists are facing severe
reductions in Medicare reimbursements, that when combined with
other fee schedule changes being contemplated by Congress,
could adversely effect quality of care and access to care by
senior citizens.
Even as these regulations are being published for a 60-day
comment period, the authorizing Committees are considering
changes to the law as part of reconciliation legislation which
is on a fast track in Congress. This hearing provides not only
the first opportunity to discuss the proposed regulations, but
also to assess the impact, feasibility, and cost to this
Committee of possible legislative changes requiring the
collection of new data.
The final panel will continue our ongoing series of
testimony examining the national War on Cancer and its progress
and prognosis after 25 years of effort. On two previous
occasions, once here and once in Los Angeles, we heard
compelling testimony from individuals who have survived cancer
and who called for more cancer research. On the morning of our
Los Angeles hearing, May 29, the USA Today newspaper ran a
front page story: ``$30 Billion War on Cancer a Bust?'', based
on an article in the New England Journal of Medicine that
critiques the priorities given to prevention research verses
treatment research in the War on Cancer. Our panel will feature
Dr. John Bailar of the University of Chicago, chief author of
that article, and Dr. Richard Klausner, Director of the
National Cancer Institute and as such, stands as the commander
in chief in the War on Cancer.
SUMMARY STATEMENT OF HON. KATHLEEN BUTO
Senator Specter. We will proceed now to hear Ms. Kathleen
Buto, Associate Administrator for Policy of the Health Care
Financing Administration. And to the extent you can focus, Ms.
Buto, in the 5 minutes you have allotted to you as to what is
happening with the schedule of physician payments due on May 1
and what the proposals are for HCFA to act on that, there are
some proposals now pending to give a year's delay, and what
would that mean and what can we expect from HCFA.
Thank you for joining us. The floor is yours.
Ms. Buto. Thank you very much, Mr. Chairman. I am pleased
to be here today to discuss our proposals for implementing the
fee schedule, the relative-value-based practice expense portion
of the fee schedule. I have a lengthier statement which is
being submitted for the record. I am going to really respond
very directly to your comments and first announce that the
proposed rule was published in the Federal Register on
Wednesday. It does some very important things to begin to
change and make more accurate the relative overhead payments or
the overhead cost payments.
Senator Specter. Any coincidence of that publication
yesterday with this hearing today?
Ms. Buto. No; quite frankly, we have been working toward a
May 1 date, as you noted, and it has just taken us longer than
that to get this work completed. So there was really no
connection.
Senator Specter. No connection. OK.
PHYSICIAN PRACTICE EXPENSE
Ms. Buto. We actually put the reg on Federal Register
display on Friday the 13th, an auspicious date, but it has been
out in the public domain since last week.
The way physicians are now paid, we have a fee schedule
where the work part of the fee schedule is based on physicians'
estimates of their time, skill, and effort typically required
for the service. But practice expenses and malpractice values
in our fee schedule are based on our old historical reasonable
charge system. These are historical charges without a direct
relationship to actual costs.
The inequity in the current system could be seen by
comparing practice expense payments, these overhead payments,
for the most common office visit with, for example, triple
heart bypass surgery. Medicare pays almost 100 times more for
the physicians' practice expense, this overhead payment, for
bypass surgery than for an office visit. This would be about
$1,400 in overhead payments to the surgeon compared to about
only $14 for the office visit overhead. Most observers agree
that the relative values here for practice expenses are out of
line for both services, and our analysis suggests that the
ratio should be closer to 18 times as great for heart bypass
overhead costs as for the office visit, not 100 to 1 as
currently is the case.
So as you pointed out, we have issued a proposed rule. The
rule is supposed to go into effect for fee schedule payments
beginning January 1, 1998. As you noted, the Congress is
considering a number of proposals, both the House and Senate,
to look at an extended implementation schedule for the fee
schedule. As currently in law, the fee schedule changes would
go into effect in one fell swoop beginning January 1, 1998, the
original fee schedule provisions involving the work portion
that is now on a relative value basis.
Senator Specter. So you are prepared to have the schedules
go into effect January 1, 1998?
Ms. Buto. We are prepared to do that. The proposal is put
forward with that schedule still in mind because we do not know
ultimately what the legislation will say. However, I want to
add that the administration is working with the committees to
look at an extended implementation schedule, and we want to
work productively. We agree that in many ways this kind of an
extension would allow the changes to go in more gradually.
Senator Specter. Do you favor an extension?
Ms. Buto. We do. We favor an extended implementation
schedule.
I want to just point out a couple of things about the way
we did the fee schedule. We used extensively the physician
community to help us derive these values. The values are
complicated. I will not go into them here because my testimony
more specifically lays out how direct costs and indirect costs
are computed and what they are and so on. But we did calculate
these values using more than 170 physicians, 15 expert panels,
and we included in those panels, in addition to the 170
physicians, practice managers and nonphysicians such as
registered nurses who would have knowledge of the staffing and
overhead costs associated for each procedure.
I should point out there are about 7,000 procedures that
had to be costed, if you will. In addition to that, since they
are in office and out of office, we are talking in the
neighborhood of 14,000 distinct prices or costs that had to be
associated with these fees. So it is a fairly complicated
process.
Senator Specter. Was the questionnaire of any value to you?
Ms. Buto. The questionnaire, the survey that we
commissioned ABT Associates to put out, which they did last
year, turned out to be very disappointing. We got about a 20-
percent response rate from physicians, and found that we could
not use it. Our hope was that it would help us to make that
judgment about the right share between indirect costs and
direct costs for each of the procedures.
Senator Specter. My question was was it of any value to
you?
PREPARED STATEMENT
Ms. Buto. Well, it was valuable in that we thought we could
get more information than we did. I think if we had not
undertaken the survey we might be under the illusion that we
could do a major survey. We now think major survey is not the
way to go in developing the methodology for indirect costs and
that we ought to use more accounting-based methods for doing
that, and that is what we have proposed in the proposed rule.
Senator Specter. Ms. Buto, would you mind staying with us?
We have five chairs here. What I would like to do now is call
the doctors, because I think we are going to have some
interchange, and we will use the question and answer session as
we move through the doctors.
[The statement follows:]
Prepared Statement of Hon. Kathleen A. Buto
INTRODUCTION
Mr. Chairman and Members of the Subcommittee, I am pleased
to be here today to discuss the Health Care Financing
Administration's proposed plans for implementing the practice
expense relative value requirements which Congress mandated for
physician services under the Medicare fee schedule. Research
performed by the Physician Payment Review Commission (PPRC) and
recommendations made in their 1993 annual report to the
Congress documented the need to change the current practice
expense RVU system and the significant redistributions that
would occur under the new system. Following the PPRC
recommendations, Congress passed legislation requiring HCFA to
implement a resource-based practice expense relative value
system beginning in 1998. The intent of the new system is to
create a more equitable system for physician reimbursement
which better reflects the relative cost of the resources that
are involved when a physician performs a service.
BACKGROUND
Medicare's physician fee schedule, implemented beginning
January 1, 1992, established relative values for three
components of each physicians' service: physician work,
practice expenses, and malpractice insurance. The sum of these
three components represents the total relative value for a
service; this total relative value is used in conjunction with
a conversion factor to establish the Medicare fee schedule
amount for the service. The relative size of the three
components varies for each service, but on average, physician
work represents 54 percent of the overall relative value,
practice expenses 41 percent and malpractice insurance 5
percent.
The relative values for physician work were based on
physicians' estimates of the physician time and effort
typically needed to perform each service. Practice expense and
malpractice expense relative value units, however, were
constructed based on allowed charges under the old reasonable
charge system of paying physicians. Relative values for these
components thus largely reflect historical charge values,
without a direct and explicit relationship to resources used.
One example of the inequity in the current system can be
seen by comparing practice expense RVU's that Medicare
currently pays for the most common office visit and for triple
heart by-pass surgery. Under the existing system, Medicare pays
almost 100 times more for the physician's practice expense
(overhead) for a by-pass surgery than for an office visit. In
other words, a physician practicing in an office would have to
do almost 100 office visits to receive the same amount of
practice expense as performing one by-pass surgery in a
hospital. Most observers would agree that the ``relative''
values for practice expense is out of line for both services.
Our analyses suggest that a ration of about 18 visits to 1
heart by-pass procedure is more appropriate, not 100 to 1.
PROPOSED RESOURCE-BASED PRACTICE EXPENSE RVU
To replace the current system of paying for practice
expenses, Section 121 of the Social Security Act Amendments of
1994 requires the Secretary of Health and Human Services to
develop and implement, effective January 1, 1998, a system of
resource-based practice expense relative value units for each
physicians' service. The law requires that the methodology
recognize the staff, equipment, and supplies used in the
provision of medical and surgical services in various settings.
Let me also point out that our task is to develop a set of
``relative'' values for practice expenses. That is, we need to
determine the resource inputs for one procedure relative to
another. Our task is not to measure the actual practice costs
of any individual physician as we are not designing a cost-
based reimbursement system.
We closely followed the statutory provisions in designing
the resource-based practice expense relative value system. The
approach we are using is one in which we divide practice costs
into direct and indirect practice expense. Direct costs are the
specific resource inputs, such as clinical and non-clinical
labor, medical supplies, and equipment, that can be identified
for a specific service. Indirect costs are overhead costs that
do not obviously relate to specific services but under the fee
schedule must be allocated to individual services. Indirect
costs include rent, utilities, office equipment, accounting and
legal fees, and similar general expenses. Relative value units
are derived separately for direct costs and for indirect costs
and then summed to create practice expense relative value
units. We have proceeded by attempting to identify all the
specific direct costs for individual services and have used an
allocation method to attribute indirect costs to individual
services. As we developed our approach, we sought input from
researchers expert in relevant methodologies and from staff of
the PPRC.
We have attempted to treat as many physician practice costs
as possible as direct costs, explicitly linked to specific
services and thus not requiring allocation. For hospital based
services, we have even included as direct costs the many office
expenses such as services of the receptionist to set up the
appointment, the office billing and collection costs. In the
aggregate, our estimates are that direct expenses are
approximately 55 percent of total practice expenses while
indirect expense are about 45 percent.
The data to establish the direct practice expense relative
value units come from resource profiles furnished by expert
clinical panels composed of practicing physicians, practice
managers and other nonphysicians, such as registered nurses.
These practitioners served on 15 Clinical Practice Expert
Panels (CPEP's), each generally consisting of 12 to 15 members.
These panels estimated the typical amounts of non-physician
staff time, including both clinical and non-clinical staff,
medical supplies, and medical equipment expended in the
provision of each physician service.
Because the physician practice incurs different costs in
the office and non-office setting, the CPEP's reported direct
service inputs for both settings when appropriate. The direct
costs for each service were determined by applying national
standardized wages or prices to the service inputs.
There has been much misinformation claiming that this new
system is not based on accurate data. I wish to be very clear
on this point: We obtained data about the direct resource
inputs from the physician community. We asked physicians
participating on the CPEP's to determine what supplies and
equipment are used for the procedure and how long they are
used. We asked the number and kinds of staff needed and the
time they spend on procedures. We asked physicians how much
staff time it takes to do the paperwork, appointments, billing,
authorizations, reports and correspondence. We obtained all of
these estimates from physicians who perform the procedures,
their nurses and clinical assistants and the administrators who
manage clinics and practices. We added up the costs of the
supplies, equipment and staff to determine the other direct
expense for each service. As I will explain below, we then
allocated part of the overhead (rent, heat, lights, automobile,
etc.) to each code since all codes must have overhead
components.
The allocation of indirect expenses to particular services
is a standard problem in accounting for all industries. The
task we face is to determine how much indirect expenses such as
rent and utilities should be associated with a particular
procedure. Unlike direct expenses where the resource inputs can
be specifically linked to particular services, indirect
expenses by their nature cannot be linked to specific services.
The issue of how much rent or expenses for utilities that
physician's practice incurs should be allocated to a by-pass
surgery or an office visit requires some type of allocation
method. No survey or study could determine the indirect costs
of any of the more than 7,000 individual procedures.
No universally accepted method for allocation of indirect
expenses exists. Accountants look for reasonable proxies and
available data. For example, a reasonable case can be made that
the amount of rent and utilities associated with particular
procedures should depend on the amount of time the physician or
his staff spend doing the procedure. Preliminary impacts we
released to the physician community in January of this year
were based on allocating indirect expenses using these two
approaches.
We have continued to review those approaches to allocating
indirect expenses as well as consider other alternatives.
However, basically all the approaches we considered utilized
formula-based methods in which indirect practice relative
values are assigned to individual codes based on some factor,
such as physician time, nonphysician time, direct practice
expenses, or some combination of these factors. Our Notice of
Proposed Rulemaking selects a method of allocating indirect
costs that is driven by direct costs, an allocation method that
we believe is sound. The proposed rule also discusses other
options and why they were not selected.
Also, I wish to set the record straight about a survey of
physicians that we started but subsequently canceled. We
initiated the survey to obtain data on aggregate practice costs
and case mix of physician practices. However, we canceled the
survey due to unacceptably low response rates. If the survey
response rate had been adequate, it might have provided
additional data on indirect costs for the entire practice that
would have allowed estimation of econometric cost functions
which, if they yielded plausible estimates, would have provided
an alternative approach to the allocation of indirect costs to
particular procedures. However, the survey itself would not
have determined the indirect costs of particular procedures,
nor would it have been a source of data for individual
procedures. The bottom line is that regardless of the physician
practice cost data source, we still have to select a method for
allocating indirect costs to individual procedures.
We believe that the methodology we have used is
fundamentally sound and that the data are not fundamentally
flawed. We believe that our results are the best that can be
achieved, given the information that is, or would likely,
become available. However, we recognize that the proposed
values do contain some anomalies, as one would expect with any
effort of this magnitude. A purpose of the proposed rule is to
solicit procedure-specific comments from physicians about the
practice expense relative value units. We plan to refine the
proposed values in response to comments received.
IMPACT ON PHYSICIANS
The statute requires that the new system be implemented in
a budget-neutral way. This means that there will be both
winners and losers. The general pattern of winners and losers
by specialty is similar to the winners and losers in the 1993
PPRC report, although the magnitudes differ somewhat.
The new system shifts practice expense RVU's from services
performed in the hospital setting to services performed in the
office setting. Physicians in specialties which tend to perform
more services in offices gain and specialties who work mostly
in hospitals experience reductions. Specialties that divide
their time between the office and the hospital would experience
modest increases or decreases.
Hospital based surgical specialists are likely to see the
greatest payment reduction. They would still receive payments
for practice expenses covering the direct costs of the resource
inputs they incur for services performed in the hospital, as
well as direct expense payments for pre- and post-operative
care provided in their offices, and payment for indirect costs
for direct costs in both the hospital and office setting.
Let me explain why the proposed system would result in a
significant shift from hospital based to office based services.
Inpatient hospital surgery provides a good example. A surgeon,
while performing a 3-vessel bypass, may provide hours of
difficult work. Since bypass surgery is always performed in a
hospital, the hospital provides the staff, medical equipment
and supplies provided during the entire hospitalization which
are all covered under the prospective payment system of
reimbursement to the hospital. The surgeon incurs indirect
costs such as setting up appointments, the expense of post-
operative visits, and the administrative expense of creating a
single patient record, obtaining approvals from third party
payers and sending a single bill.
Compare this to the primary care physician who incurs all
direct costs for services performed in ``his'' office. The
physician who removes three skin lesions from three patients in
the office incurs indirect costs such as rent and the costs of
maintaining an office, the administrative cost of creating
three records and sending three bills, the cost of the clinical
staff to prepare instruments and assist in three different
procedures, the costs of other staff, supplies and equipment to
do the service, and the cost of providing follow-up visits.
We believe that the redistributions resulting from
resource-based practice expenses could be difficult for
physicians in some specialties. For this reason we will work
with the Congress to change the law so that resource-based
practice expense payments would be phased in gradually. The
statute does not provide for such a transition. The phased-in
implementation schedule will allow us to refine the application
of our methodology to ease the inequities this legislation was
intended to address.
In order to implement a new system by the statutory
effective date, the Health Care Financing Administration will
publish an NPRM this month. The proposed rule will have a
formal 60 day comment period. We believe that prior
consultations with physician groups and specialty societies
were very comprehensive and contributed greatly to more
accurate relative values for practice expenses. However, we
think there may be anomalies in some of the values and we will
be looking for precise code specific comments from physicians
on these points.
PRACTITIONER INVOLVEMENT
Not only have we sought to keep the physician community
involved and informed on the progress of this initiative
throughout the process, we have obtained the direct cost data
for this new system from them. The data to create the resource-
based practice expense RVU's came primarily from two sources,
both of which were provided by physicians. In 1996 HCFA
convened the 15 CPEP's of practicing physicians, non-physician
clinicians, and practice managers, including 180 members from
more than 61 specialties and subspecialties, to provide data on
direct expenses for about 6,000 CPT codes. The panelists were
nominated by national specialty societies. Ultimately, the
American Medical Association's 1996 Socioeconomic Survey data
were used to divide practice expense relative values into
direct and indirect cost portions. These data are collected
annually from 4,000 practicing physicians.
In addition, HCFA held five open but formal meetings with a
broad array of physician specialty groups. The purpose of these
meetings was to solicit physician input and provide them with
project updates. At the January 1997 meeting HCFA released (1)
preliminary impacts by physician specialty for several
different models under consideration, and (2) preliminary
resource-based practice expense relative value units for the
top 200 procedure codes. Shortly thereafter, HCFA made
available the underlying direct cost data which provided the
basis for the calculations. Thus, in making this information
available prior to publication of the proposed rule, HCFA has
allowed extended time of nearly 6 months for medical
organizations to analyze and provide input into the process.
HCFA staff accepted numerous invitations to meet with
representatives of segments of the medical profession and we
expect to continue meeting with the profession at appropriate
times.
CONCLUSION
We are confident that our basic methodology for
implementation of resource-based practice expense is sound and
we are prepared to implement the legislation in January 1998 as
required. We conducted extensive consultations with physician
groups and specialty societies. This process contributed
significantly to the development of more accurate relative
values for practice expenses. Certainly, we are receptive to
additional consultations and refinements that will improve upon
the provisions of our proposed rule. Finally, we understand the
difficulties that the proposed changes present for some
specialty groups. We look forward to working with the Congress
on the gradual phase-in of the new resource-based practice
payment system.
NONDEPARTMENTAL WITNESSES
Panel 1
STATEMENTS OF:
CHRISTINE GOERTZ, VICE PRESIDENT OF RESEARCH, POLICY AND
INFORMATION SERVICES, AMERICAN CHIROPRACTIC ASSOCIATION
JAY H. KLEIMAN, GOVERNMENTAL RELATIONS COMMITTEE, AMERICAN
COLLEGE OF CARDIOLOGY
ALAN R. NELSON, CHIEF EXECUTIVE OFFICER, AMERICAN SOCIETY OF
INTERNAL MEDICINE
DONALD H. SMITH, IMMEDIATE PAST PRESIDENT, AMERICAN SOCIETY OF
GENERAL SURGEONS
REMARKS OF SENATOR SPECTER
Senator Specter. Would Dr. Christine Goertz, Dr. Kleiman,
Dr. Nelson, and Dr. Smith come forward at this time? And we
begin with Dr. Christine Goertz, vice president of the research
policy and information services for the American Chiropractic
Association, former assistant professor at Northwestern College
of Chiropractic, and coprincipal investigator of the treatment
of hypertension with alternative therapy study, former chair of
the Minnesota Chiropractor Association's legislation and
National Health Care Committee.
Dr. Goertz, welcome. Thank you for joining us, and I look
forward to your testimony. I regret the 5-minute time limit,
but I also regret even more that that is customary.
SUMMARY STATEMENT OF CHRISTINE GOERTZ
Dr. Goertz. Thank you, Chairman Specter and members of the
committee. It is a pleasure to be here this afternoon. It is an
honor for me to be given the opportunity to testify before this
committee, and it is a special privilege for me to have my son
Nathan with me today. Thank you.
Senator Specter. Where is Nathan?
Dr. Goertz. He is the short one right there, I think the
only 10-year-old in the room.
I was asked by this committee to testify regarding the
status of HCFA's current proposal to reform Medicare payment to
physicians for their practice expense costs. It is my opinion
and the opinion of the American Chiropractic Association that
the resource-based methodology used by HCFA to calculate
practice expense is basically sound, and that the new fee
schedule should go into effect in January 1998, as scheduled.
Under the new system proposed by HCFA, practice expense will be
more fairly allocated to those who primarily provide office-
based services, and, therefore, are financially responsible for
their own overhead expenses.
For example, 76 percent of chiropractic physicians are in a
solo private practice. Less than 9 percent of doctors of
chiropractic practice in urban areas of more than 1 million
residents and nearly half practice in communities of less than
50,000. A national survey showed that the mean practice expense
for doctors of chiropractic is just under 60 percent of their
average gross income at present.
While on average, the practice expense under the current
Medicare system comprises about 40 percent of the fee for any
given CPT or HCPCS code that is reimbursed under the fee
schedule, right now for the three codes the doctors of
chiropractic are allowed reimbursement for under the system,
the practice expense comprises only 30.3 percent of the total
RVU's that have been allocated to those codes. Thus, the actual
practice expense for doctors of chiropractic is approximately
twice the practice expense that is reimbursable by Medicare at
this present time.
Although doctors of chiropractic are slated for an increase
of approximately 15 percent in total reimbursement for Medicare
services, under the proposed resource-based practice expense
system the total impact on the net income of the profession is
relatively small on average. Basically doctors of chiropractic
see about 8.4 percent of their income is derived from Medicare
fees. According to HCFA's estimates under implementation of the
fee schedule, as outlined in the preliminary rule that was
released yesterday, the average net yearly income of doctors of
chiropractic would change from just under $94,000 to just over
$95,000, resulting in an increase of just over $1,000 annually.
Now, it has been intimated by some during the debate that
has led up to this testimony today that the increases projected
for nonmedical providers, nonmedical doctors such as
chiropractors, account somehow for the losses that are
projected for some of the other groups, and I want to make the
point that this is just simply not the case. According to HCFA,
reimbursement from nonmedical doctors such as podiatrists,
chiropractors, and optometrists comprise about 4 percent of the
fee schedule. They eliminated our increase that would only make
a 2-percent difference to all of the other groups.
NEW PAYMENT SYSTEM
For example, HCFA has projected that under the new payment
system reimbursement for a CABG, or coronary bypass procedure,
would fall to approximately $1,770. If they eliminated all
nonmedical doctors from the system, it would make a difference
of only $16 in a CABG. It would increase to $1,786 for the
procedure.
The projected reallocation assigned to chiropractic alone
has an almost insignificant----
Senator Specter. Ms. Buto, would you focus on this, because
I am going to ask you in a moment whether you agree with this?
Go ahead, Doctor Goertz.
PREPARED STATEMENT
Dr. Goertz. In summary, we believe that any delay in the
implementation of the practice expense is unwarranted; that the
current system is unfair to those who primarily provide office-
based services, and are responsible for their own overhead; and
that this burden is felt especially by practitioners who are in
solo practice. We also believe that it is unlikely that a delay
in implementation would lead to significantly better data or
significantly improved methodology for arriving at practice
expense.
Thank you.
Senator Specter. Thank you very much, Dr. Goertz.
[The statement follows:]
Prepared Statement by Christine Goertz, D.C.
Chairman Specter, Senator Harkin, Members of the Committee
and ladies and gentlemen present, good afternoon.
My name is Dr. Christine Goertz, Vice President of
Research, Policy and Information Services for the American
Chiropractic Association. I earned my doctor of chiropractic
degree from Northwestern College of Chiropractic in
Bloomington, Minnesota and I am currently a doctoral student at
the University of Minnesota's Institute for Health Services
Research. It is an honor for me to be given the opportunity to
testify before this Committee, and a privilege to have my son
Nathan present here today.
I was asked by this Committee to testify regarding the
status of HCFA's current proposal to reform Medicare payments
to physicians for their practice expense costs. It is my
opinion and the opinion of the American Chiropractic
Association, that the resource-based methodology used by HCFA
to calculate practice expense is basically sound and that the
new fee schedule should go into effect in January of 1998, as
scheduled.
Under the new system proposed by HCFA, practice expense
will be more fairly allocated to those who primarily provide
office-based services and, therefore, are financially
responsible for overhead expenses. For example, 76 percent of
chiropractic physicians are in a solo private practice. Less
than nine percent of Doctors of chiropractic practice in urban
areas of more than one million residents and nearly half
percent of Doctors of chiropractic practice in communities of
less than 50,000. A recent national survey showed that mean
practice expense for doctors of chiropractic is just under 60
percent of average gross income. On average, practice expense
under the current system comprises approximately 40 percent of
the fee for any given CPT/HCPCS code reimbursed under the
Medicare Fee Schedule. However, the practice expense allocated
to the only three CPT codes that can be used by doctors of
chiropractic under the Medicare payment system comprises only
30.3 percent of the total RVU's allocated to those codes. Thus,
actual practice expense for chiropractic physicians is
approximately twice the practice expense reimbursable by
Medicare at the present time.
Although doctors of chiropractic are slated for an increase
of approximately 15 percent in total reimbursement for Medicare
services under the proposed resource-based practice expense
system, the total impact on net income for the profession is
relatively small. The percentage of income received by doctors
of chiropractic from Medicare patient fees in 1995 was 8.4
percent. According to HCFA's estimates, under implementation of
the fee schedule as outlined in the preliminary rule, the
average net yearly income of doctors of chiropractic would
change from $93,956 to $95,032, resulting in an increase of
$1,076 annually.
It has been intimated by some during the debate leading up
to this testimony that the increases projected for non-medical
providers, such as doctors of chiropractic, account for the
losses forecasted for surgical groups. This is simply not true.
According to HCFA, reimbursement for non-medical doctors such
as podiatrists, chiropractors, and optometrists comprise
approximately four percent of the Medicare fee schedule. In
fact, elimination of the increase projected for all of these
provider groups would only reduce surgical losses by two
percent. As an example, HCFA has projected that under the new
payment system, reimbursement for a CABG or coronary bypass
procedure would fall to approximately $1,770. Elimination of
the increases assigned to all non-medical doctors would raise
this to $1,786, a difference of only $16. The projected
reallocation assigned to chiropractic alone would have
significantly less than a one half of one percent impact on the
changes estimated for surgical and other groups.
In summary, any delay in the implementation of the practice
expense is unwarranted. The current system is unfair to those
who primarily provide office-based services and are responsible
for their own overhead. The burden is felt especially by those
practitioners commonly in solo practice. Further, it is
unlikely that delay would lead to better data or a
significantly improved methodology for arriving at practice
expense values.
Thank you for your time.
SUMMARY STATEMENT OF DR. J.H. KLEIMAN
Senator Specter. We now turn to Dr. J.H. Kleiman, assistant
professor of clinical medicine at Northwestern University and
attending physician at St. Joseph's Hospital in Chicago; a
graduate of the University of Michigan's Medical School, Dr.
Kleiman is the immediate past medical director for
interventional cardiovascular service with St. Joseph's
Hospital and serves on the Governmental Relations Committee of
the American College of Cardiology. And one other background
credit, he and I have mothers who are sisters, so I have known
Dr. Kleiman since shortly before he was born. [Laughter.]
I can personally attest to his competence in many lines.
Dr. Kleiman, welcome, and you have 5 minutes.
Dr. Kleiman. Thank you, Mr. Chairman and members of the
subcommittee. I am Dr. Jay Kleiman, a cardiologist and member
of the American College of Cardiology. I would like to thank
you for the opportunity to testify before you today on behalf
of the Practice Expense Coalition.
I have practiced clinical cardiology for more than 20
years, and during this time have cared for numerous Medicare
patients in both academic training institutions and in large
community teaching hospitals. I want to share with you the deep
concerns of members of the Practice Expense Coalition and the
American College of Cardiology regarding changes in the
practice expense component of the Medicare fee schedule
recently proposed by the Health Care Financing Administration.
The concerns of the 40 organizations comprising the
coalition are shared by the American Medical Association and
groups representing hospitals and academic medical centers. We
strongly believe that implementation of these changes will
cause serious deterioration in the quality of care available to
seniors. The data on which this schedule is based are badly
flawed, and must be revisited.
One week ago HCFA made public its notice of proposed
rulemaking, which includes resource-based practice expense
relative value units. It does not create reimbursement equity
within the community of medicine. HCFA's proposal produces new
and damaging distortions that will become effective January 1,
1998, unless Congress takes immediate action.
HCFA has used questionable methodology and inconsistent
data. It has made inaccurate assumptions in allocating the
proportion of direct and indirect practice expenses. HCFA has
incorrectly stated that physicians practicing primarily outside
the office in the office in the hospital setting incur very
limited practice expenses. They have failed to take into
account staff and supply costs which are incurred independent
of where the physician is practicing. HCFA admits that there is
no correct way to allocate indirect costs with their existing
data, so they have arbitrarily ascribed indirect procedure
costs based on what they believe is fair rather than on sound
data, or more importantly, sound cost accounting principles.
The practice expense component for procedures performed in
the hospital begin significantly before a patient enters the
hospital. It ends long after the patient is discharged.
Medicare patients, in particular, need repetition of
instructions and high levels of reassurance to support them
through angioplasties, hip pinnings, bypass surgeries,
gastrointestinal endoscopies, and numerous other interventional
procedures.
In fact, the overhead expenses related to providing these
progressively more intense support services have increased.
Some 10 years ago, two secretarial persons were able to support
my cardiology practice. Now, five staff members are required,
including a nurse clinical specialist, to provide the same
number of physicians with support.
CORONARY ANGIOPLASTY
For example, services related to coronary angioplasty
include detailed outpatient preoperative teaching; dietary
instruction, covering low-salt regimens to prevent heart
failure; dietary instructions, covering low-fat regimens needed
to slow further hardening of the arteries; education and
laboratory monitoring of anticoagulation therapies; monitoring
and refilling prescriptions, for an average of six medications
per patient; and stenographic support to provide multiple
letters to primary care physicians. Staff must be constantly
available. My expenses continue whether I am in or out of the
office. In addition, specialists providing high tech, intense,
and often emergency care must maintain mobile telephone, pager,
and answering service capabilities to provide immediate 24-hour
access.
In its proposed rule, HCFA has made a number of arbitrary
assumptions and edits to its incomplete data. For example, HCFA
staff thought the amount of administrative time required for
many services seemed excessive. They are proposing to cap the
time allowed for these services at a midlevel office visit. In
addition, HCFA assumes that there are economies of scale when a
diagnostic test such as an echocardiogram is done in
conjunction with an office visit. They propose to cut the
practice expense payment for the diagnostic office test by 50
percent in that instance. It makes no sense that the economies
gained for administrative staff time would amount to 50 percent
of the costs associated with a complex test such as an
echocardiogram. These tests require the services of highly
trained clinical technicians, as well as payment for expensive,
state-of-the-art equipment.
I anticipate that the negative fallout of HCFA's proposal
will spread far beyond the physician community to all patients,
not just Medicare beneficiaries. Logic dictates that reductions
of this magnitude cannot fail to have an administrative effect
on physician practices. These will be translated into delays at
every level. Patients will have less time with the doctor and
longer waiting times.
The drop in reimbursement will also delay acquisition of
new and improved technologies which enhance medical care and
ultimately save lives. They will add financial pressure to
teaching facilities. They will target services provided to
patients in the hospital, where these patients are the sickest
and need the care most. At a time when quality considerations
have generated bipartisan legislation to assure patient access
to specialists, HCFA's proposal will impede such access.
Importantly, their effect will inevitably be compounded by
similar adjustments from private insurance carriers.
Mr. Chairman, we urge Congress to delay the implementation
date for resource-based relative values for 1 year; to redirect
HCFA to develop new and verifiable methodologies based on
generally accepted accounting principles to determine these
values; and to phase in the changes over 3 years. Although some
have argued that the distortions of the new practice expense
values could be mitigated by a transition, transition alone
will not correct or prevent the profoundly adverse effects of
changes based on flawed data which grossly undervalue the
overhead costs of an array and tests of procedure.
PREPARED STATEMENT
Transition to a payment system built on incorrect data and
faulty assumptions will not protect patients, hospitals, and
academic medical centers from harm. HCFA must give Congress the
opportunity to restudy this issue and to get it right. We
encourage this subcommittee to provide the appropriate
financial support to HCFA to ensure that congressional mandates
can be met in a way that protects the Medicare constituency.
Mr. Chairman, I appreciate the opportunity to speak before
the subcommittee, and I thank you.
Senator Specter. Thank you very much, Dr. Kleiman. Thank
you very much, indeed.
[The statement follows:]
Prepared Statement of Jay Kleiman, M.D., F.A.C.C.
INTRODUCTION
Mr. Chairman and members of the subcommittee, I am Dr. Jay
Kleiman, a cardiologist and member of the American College of
Cardiology. I would like to thank you for the opportunity to
testify before you today on behalf of the Practice Expense
Coalition.
I have practiced clinical cardiology for more than 20 years
and during this time have cared for numerous Medicare patients
in both academic training institutions and in large community
teaching hospitals. I want to share with you today the deep
concerns of the members of the Practice Expense Coalition and
the American College of Cardiology regarding changes in the
practice expense component of the Medicare fee schedule
recently proposed by the Health Care Financing Administration
(HCFA). We share our concerns with the American Hospital
Association, the Association of American Medical Colleges, the
Medical Group Management Association, the Association of
Academic Medical Centers, the American Medical Association, and
the American College of Surgeons. We strongly believe that
implementation of these changes will cause serious
deterioration of the quality of care available to seniors. The
data on which this schedule is based is badly flawed and must
be revisited.
HISTORY
In 1994, Congress mandated that reimbursement for physician
practice expenses (or overhead costs) be converted from a
charge basis to a resource basis by 1998. To develop new
practice expense relative values in accordance with the
mandate, HCFA convened a series of Clinical Practice Expert
Panels (CPEPs) to develop estimates of direct practice expenses
for about 300 current procedural terminology (CPT)
``reference'' codes. HCFA also was to conduct a complex
national survey of physician practices in order to collect data
on total practice expenses, including both direct (expenses
directly related to the performance of a specific medical
procedure, i.e., cost of supplies) and indirect (expenses that
cannot be traced to a particular service, i.e., rent) practice
expenses. Unfortunately this survey was very cumbersome. In
September 1996 the survey was abandoned due to low response
rates, leaving HCFA without a major source of data on how
practice expenses are distributed across specialities and
divided into direct and indirect expenses. Furthermore, the
CPEP data have never been released in a readable format nor
validated by HCFA. Despite these events, HCFA is still under a
congressional mandate to produce a resource-based payment
system for the practice expense component of the Medicare fee
schedule for implementation on Jan. 1, 1998.
HCFA'S PROPOSED RULE
On June 12, 1997, HCFA made public its notice of proposed
rulemaking (NPRM) of policy changes affecting the Medicare Fee
Schedule, including resource-based practice expense relative
value units. It does not create reimbursement equity within the
community of medicine. HCFA's proposal produces new and
damaging distortions.
It is clear from the proposed rule and comments by HCFA
staff that even the CPEP process was flawed. Until this time,
we were under the impression that HCFA believed that the CPEP
data was the strongest component of their study. HCFA had to go
through several steps to ``normalize'' the data. Agency staff
acknowledge that they could only describe a few of the numerous
edits made to the CPEP data before it was usable. In fact, HCFA
had to construct a whole new ``simplified data set'' from which
to develop the proposed relative value units. HCFA staff have
been unable to say when this ``simplified data set'' will be
available for review by the public. However, they imply that
these data are essential to evaluating the proposed values.
Using questionable methodology and inconsistent data, HCFA
has made an important assumption concerning the proportion of
direct and indirect practice expenses. HCFA has stated that
physicians practicing primarily outside the office incur very
limited practice expenses. However, HCFA has failed to take
into account labor and supply costs which are incurred
independent of where the physician practices. Furthermore, HCFA
does admit that there is no correct way to allocate indirect
costs with their existing data. They have arbitrarily allocated
indirect procedure expenses based on what they believe is fair,
rather than on data or sound accounting principles.
The practice expense component for procedures performed in
the hospital begins significantly before a patient enters the
hospital and ends long after the patient is discharged.
Medicare patients, in particular, need repetition of
instructions and high levels of reassurance to support them
through angioplasties, hip pinnings, bypass surgeries,
gastrointestinal endoscopies, and numerous other interventional
procedures. Thus, overhead expenses related to providing
progressively more intense support services have increased. For
example, such services related to coronary angioplasty could
include dietary instructions covering low-salt and low-fat
regimes, education and laboratory monitoring of anti-
coagulation therapies, and monitoring and refilling
prescriptions for an average of six medications per patient.
Staff must be constantly available. I do not close my office
when I go to the hospital. My expenses continue. In addition,
specialists providing high-tech, intense, and often emergency
care, must maintain a mobile telephone, pager, and answering
service capabilities to provide immediate 24-hour access.
HCFA claims that the current system is inequitable and does
not reflect the actual cost of providing services. For example,
it states that ``a family physician would have to perform
approximately 100 mid-level office visits to receive the same
amount of practice expense reimbursement as a thoracic surgeon
receives for one triple bypass operation.'' This claim has
absolutely nothing to do with the costs physicians incur.
This comparison is like comparing the costs of car makers
and bicycle manufacturers. The car maker sells fewer, more
expensive units but more overhead is put into the price of each
car. The bicycle manufacturer sells many more inexpensive
units, but the amount of overhead per unit is smaller. Should
the payment to the bicycle maker go up just because he has to
sell more units to recover his costs?
HCFA does not identify the costs of the family physician,
nor does it identify the costs of the thoracic surgeon. In
fact, HCFA's data is incomplete and lacks clinical validation.
It cannot realistically sort out what those different costs
really are. HCFA's proposal would reduce its practice expense
reimbursement for a three-vessel open heart surgery by 35
percent down to $400. Surgical payments cover a full 90 days of
care, not just the hospital procedure. HCFA has not validated
its proposed values against data on actual practice costs of a
typical cardiac surgeon.
In its proposed rule, HCFA seems to have made a number of
assumptions and edits to its incomplete data which are
completely arbitrary. For example, HCFA staff thought that the
input on administrative staff time for many services seemed
excessive, so they are proposing to cap the time allowed for
those services to the time allowed for a mid-level office
visit. In addition, HCFA assumes economies of scale when a
diagnostic test is done in conjunction with an office visit and
proposes to cut the already reduced practice expense payment
for the diagnostic test by another 50 percent in that instance.
Does it make sense that the economies gained for administrative
staff time (scheduling, reception, billing) would amount to 50
percent of the costs associated with a complex diagnostic test
requiring the services of a highly trained clinical technician
as well as an expensive piece of state-of-the-art technology?
CONSEQUENCES
If rational allocation of Medicare resources to physicians
was the only issue, that would be reason enough for Congress to
act. However, the negative fallout will spread far beyond the
physician community to all patients, not just Medicare
beneficiaries, if HCFA's proposal is allowed to take effect on
Jan. 1, 1998. Logic dictates that reductions of this magnitude
cannot fail to have an administrative effect on physician
practices. These adjustments cannot be to the patient's
benefit. Patients will be less satisfied with the care they
receive and can expect to experience delays at every level
including appointments, test results and longer waiting room
times. In my office, I know that the patients who are calling
have potentially life-threatening problems. This makes the
first person who answers the phone the most important person in
a cardiologist's office. I am concerned that these inevitable
administrative reductions will have an adverse effect on the
well-being of my patients.
A precipitous drop in reimbursement will delay acquisition
of new and improved technologies that will enhance medical care
and save lives. In some cases, physicians may have to stop
providing certain services, and care will become fragmented as
patients are forced to go elsewhere for those tests. It will
add financial pressure to teaching facilities, which not only
train the next generation of physicians, but also often reach
out to underserved communities. These reductions also target
services provided to patients in the hospital, those who are
sickest and need care the most. At a time when quality
considerations have generated bipartisan legislation to assure
patient access to the services of specialists, HCFA's proposal
will lessen such access, both in the short-term and for the
future. Moreover, an extreme reduction in Medicare
reimbursement to specialists will be compounded by similar
adjustments from private insurance carriers. These reductions
will likely be even more severe in the inner city and rural
areas due to their already limited resources. Congress could
not have foreseen nor intended these outcomes.
ACTION
The HCFA practice expense methodology is based on neither a
reasonable definition of resource-based practice expenses nor
sufficiently accurate data to trust the results. We urge
Congress to delay the implementation date for resource-based
relative values until Jan. 1, 1999, redirect HCFA to develop
new and verifiable methodologies based on generally accepted
accounting principles to determine these values, and phase-in
the changes over three years. Many argue that the distortions
in the proposed practice expense relative values could be
mitigated by a transition. But a transition alone will not
correct or prevent the adverse effects of changes based on
flawed data.
CONCLUSION
Implementation or transition to a payment system built on
incorrect data and faulty assumptions will not protect
patients, hospitals and academic medical centers from harm.
HCFA must be given the opportunity by Congress to restudy this
issue and get it right. We encourage this subcommittee to
provide the appropriate financial support to HCFA to ensure
that congressional mandates can be met.
Mr. Chairman, your leadership in health care is widely
recognized within the physician community, and we thank you for
your attention to this important issue. I appreciated having
the opportunity to speak before the Subcommittee.
SUMMARY STATEMENT OF DR. ALAN NELSON
Senator Specter. We will turn now to Dr. Alan Nelson, CEO
of the American Society of Internal Medicine. He previously
practiced internal medicine in Salt Lake City, where he was
clinical professor at the University of Utah; past Chair of the
Board of Trustees of the AMA; and a member of the first
National Professional Standards Review Council.
Thank you very much for joining us, Dr. Nelson, and the
floor is yours.
Dr. Nelson. Thank you, Mr. Chairman.
My hope is that today's hearing will bring some balance to
what has become a very contentious debate. Unfortunately, the
way the data has been framed to date has put Congress in the
position of having to choose between surgical specialists and
primary care physicians. There is an alternative that does not
require that Congress make such a choice, however. The bill
reported out of the Finance Committee yesterday is a win-win
compromise that responds to the legitimate concerns of both
primary care doctors and surgical specialists. The bill would
begin to make some modest improvements in 1998 in payments for
primary care services whose practice expenses are undervalued
under the current charge-based formula. But it would also give
the critics of the current rule-making process much of what
they have asked for.
Under the Finance Committee proposal, no specialty would be
subjected to extreme cuts in 1998. Another year would be
provided to refine the data. The Secretary of HHS would be
required to consult with a panel of physicians and other
experts and provide for additional data collection if
appropriate. The General Accounting Office would conduct a
thorough examination of the proposed rule. Resource-based
practice expenses would be phased in over 4 years to limit the
amount of redistribution that will occur in any 1 year.
But the Finance Committee alternative also responds to the
concerns expressed by primary care physicians about the
unfairness of the current payment methodology by beginning at
10 percent of the transition to resource-based payments in
1998, and by requiring the full implementation to occur no
later than January 1, 2001. The bill recognizes that we do not
need another huge study to begin correcting inequities. The
recently released notice of proposed rulemaking adds to the
growing body of data in support of the need to improve payments
for primary care services, but it is not necessary to rely on
the specific data and methodology used in the proposed rule to
begin the transition.
SURGICAL PROCEDURES OVERVALUED
It is important to keep in mind that the existing flawed
and inequitable charge-based methodology has already been in
effect for 6 years, and that this formula perpetuates
inequities that have existed since the Medicare Program was
enacted in 1965. I do not believe that any honest assessment of
the practice expense issue could deny that the practice
expenses of primary care services are undervalued, and that
those of many surgical procedures are overvalued. At least five
different studies, each using different methodologies and
sources of data, all concluded that the current practice
expense methodology systematically undervalues primary care
services.
There are serious inequities that the Finance Committee
proposal would begin to address. There simply is no other
proposal on the table that is responsive to the concerns of
both primary care physicians and surgical specialists. The
bills reported by the House authorizing committees would begin
and complete the transition a year later than the Finance
Committee alternative. They would do nothing to begin
correcting in 1998 the inequities in payments that have
disadvantaged primary care.
The Finance Committee bill provides that appropriate level
of direction to HHS on how the proposed rule should be
improved. I caution this committee not to include language in
the appropriation bill that would force HHS to use a single
methodology to the exclusion of all others, or that would
require that the agency start all over in developing an
approach to resource-based practice expense methodologies.
We have no objection to including any additional data on
actual costs to the extent that it is feasible to collect such
data. But we would be concerned about any directive language
that could delay implementation of the final rule by requiring
a massive and costly new study of practice expenses, one that
the Physician Payment Review Commission has said is not needed.
By no means is ASIM suggesting that the proposed rule is
perfect. Far from it. To the extent that other sources of data
on practice expense costs exist, Health and Human Services
should consider such data and make revisions as appropriate.
But we firmly believe that the needed improvements can readily
be accomplished with an additional year. No further delay
beyond that is appropriate. And we also firmly believe that
although the data and methodology can be improved, Congress
should not direct that Health and Human Services start over
again from scratch and dismiss the data and analyses that are
conducted to date.
PREPARED STATEMENT
I urge the members of the committee to express your strong
support for the alternative reported yesterday out of the
Finance Committee. Congress does not have to choose between
providing more time and direction to Health and Human Services
on improving the proposed rule, or making incremental
improvements in payments for undervalued primary care services.
The Finance Committee proposal is the only one under
consideration that satisfies both objectives.
Thank you.
Senator Specter. Thank you very much, Dr. Nelson.
[The statement follows:]
Prepared Statement of Alan R. Nelson, M.D.
I am Alan R. Nelson, MD, executive vice president of the American
Society of Internal Medicine. I appreciate the opportunity to share
with you the perspectives of internists on HCFA's proposed rule on
practice expenses, and on the ongoing debate in Congress on this
important issue.
My hope is that today's hearing will bring some balance to what has
become a very contentious debate. No one likes to put Congress in the
position of having to adjudicate a fight between warring factions of
physicians. Unfortunately, the way that the debate has been framed to
date has put Congress in the position of having to choose between
surgical specialists and primary care physicians. Clearly, any proposal
that would redistribute payments among physicians--and, therefore,
produce winners and losers--is going to produce some degree of division
within medicine. But there is an alternative that does not require that
Congress choose between voting with the surgeons or with the primary
care physicians. This alternative is the one proposed by Senator Roth,
chairman of the Finance Committee, in his mark on Medicare budget
reconciliation.
A better alternative
The Finance Committee chairman's alternative would give the critics
of the current rule-making process most of what they have asked for.
They have expressed concern about ``extreme cuts'' in payments. Under
this alternative, no specialty would be subjected to extreme cuts in
1998.
They have asked for another year to work with HCFA to improve the
data and methodology used in the proposed rule. This alternative would
give them another year to refine the data.
They have asked that Congress provide more direction to HCFA on how
the study should be conducted. The alternative would provide
appropriate direction to HCFA on improving the data used to develop the
proposed rule, with Congress' own General Accounting Office being given
a major role in reviewing the data and methodology used by HCFA.
The critics have asked that Congress direct HCFA to consult more
with physicians. More consultation with physiclans would be mandated.
They have asked that resource-based practice expenses be phased in
over several years to limit the amount of redistribution that will
occur in any one year. The alternative provides for a four-year
transition.
But the Finance Committee alternative also responds to the concerns
expressed by primary care physicians about the unfairness of the
current payment methodology, by beginning 10 percent of the transition
to resource-based payments in 1998. This modest transition would
represent a good faith effort by Congress to begin honoring the
commitment it made in 1994, when it enacted legislation that required
implementation of resource-based practice expense payments in 1998.
The Finance Committee alternative recognizes that it doesn't take
another study to begin correcting inequities that have been long-
documented in every major study of this issue. Studies that support
this conclusion include the Harvard RBRVS study (1990, 1991), Physician
Payment Review Commission (1991, 1992), Health Economics Research
(1996), Pope and Burge (1996), and now the Abt study cited in the
proposed rule (1997). The recently-released notice of proposed
rulemaking adds to the growing body of data in support of the need to
improve payments for primary care services, but it is not necessary to
rely on the specific data and methodology used in the proposed rule to
begin the transition. The modest amount of the transition that would
occur under the Finance Committee in 1998 is actually far less than the
studies suggest is appropriate. In addition, it is important to keep in
mind that the existing flawed and inequitable charge-based methodology
has already been in effect for 6 years, and that this formula
perpetuated inequities that have existed since the Medicare Program was
enacted in 1965. Even under the chairman's mark, full implementation of
resource-based practice expenses would not occur until 2001--9 years
after implementation of resource-based payments for physician work, and
7 years since Congress enacted legislation in 1994 calling for
resource-based practice expense payments. It is simply not reasonable
to delay implementation further so that another study can be done to
confirm what we already know: that the current charge-based formula is
inherently unfair and needs correction.
I don't believe that any honest assessment of the practice expense
issue could deny that primary care services are undervalued, and many
surgical procedures overvalued, under the existing charge-based
practice expense methodology. There may be legitimate differences of
opinion on the best methodologies and sources of data to be used in
developing resource-based payments. But even though the studies cited
above used different methodologies and sources of data, they all agree
that the current practice expense methodology systematically
undervalues primary care services. Further, common sense tells us that
the differences between what Medicare allows for the practice expenses
of many surgical procedures, compared with those of primary care
services, just isn't right. Under the current charge-based methodology,
an internist would have to provide 115 established patient office
visits to receive the amount of reimbursement for practice expenses
that a surgeon gets for a single coronary bypass graft. Yet the
internist assumes the entire overhead costs of the office visit, while
most of the direct costs of the surgical procedure are borne by the
hospital, not the surgeon.
It is this kind of serious inequity that the Finance Committee
proposal would begin to address. But it does so in a way that requires
only very modest adjustments in existing payment levels, until such
time as the final rule is ready to be implemented. As a result, no
specialty would gain or lose more than 3 percent in 1998 as a result of
the 10 percent transition to resource-based practice expenses.
There simply is no other proposal on the table that is responsive
to the concerns of both primary care physicians and surgical
specialists. The bills reported by the House Commerce and Ways and
Means Committee would not start the transition until 1999, a year later
than under the Finance Committee's proposal, and would also mandate
that full implementation occur a year later (2002) than under the
Finance Committee proposal (2001). By beginning and completing the
transition a year later than the Finance Committee alternative, the
House version allows for the existing inequities to remain in effect
for a longer period of time. It does nothing to begin correcting in
1998 the inequities in payments that have disadvantaged primary care.
I urge the members of this committee to express your strong support
for the alternative being offered by Sena or Roth.
Direction to HCFA
Many of you are also being asked to support legislation that would
direct HCFA on how to collect and analyze the data on resource-based
practice expenses. Although some direction to HCFA may be appropriate,
I caution this committee not to include language in the appropriations
bill that would force HCFA to use a single methodology to the exclusion
to all others, or that would require that the agency start all over in
developing an approach to resources-based practice expense
methodologies.
The argument of those who are seeking to direct how HCFA conducts
its study is that the current methodology is fundamentally flawed. As
explained more fully below, ASIM believes that although improvements in
the existing methodology and data may be appropriate, it is not
necessary to reject all of the work that has been done to date. The
objective should be to refine and improve upon the existing data
including incorporating additional data as necessary and feasible,
rather than throwing out everything that has been done to date.
ASIM would be especially concerned about any language that requires
that HCFA conduct a detailed cost accounting of physician practices. We
have no objection to including any additional data on actual cost, to
the extent that it is feasible to collect such data. But we would be
concerned about any directive language that could delay implementation
of the final rule even further by requiring a massive new study of
practice expenses.
The Secretary has already attempted to conduct a detailed survey on
practice costs, but was forced to abandon it because of an inadequate
response rate. Development and implementation of a new survey could
take several more years, with no guarantee that it would produce
sufficient responses. A mandate that would implicitly require a new
survey could make it impossible for the Secretary to meet a January 1,
1999 implementation date. Further, it is difficult to justify mandating
a detailed cost accounting survey that would cost millions of
taxpayers' dollars--especially one that may not be necessary or even
feasible.
Congress should also not enact legislation that would rule out
using other sources of data--such as existing data on indirect costs
and estimates from clinical practice expert panels--that the Physician
Payment Review Commission has reported can produce accurate practice
expense relative value units (RVU's). Although it is appropriate to
require that HCFA consider additional data, to the extent that such
data can practically be collected, it is inappropriate for Congress to
mandate that HCFA disregard source of existing data, including some of
the sources of data used in the proposed rule.
ASIM is concerned that if Congress establishes requirements and a
timetable that may be impossible for Health and Human Services to meet,
this will virtually guarantee that some physician groups will seek an
additional delay next year, on the grounds that HCFA failed to meet
statutory requirements. HCFA should be held accountable. But the
requirements placed on the agency must themselves be realistic.
The committee should consider the question of what is driving the
requests that Congress provide more direction to HCFA. To the extent
that the requests are simply for HCFA to consider additional data
within the one year extension likely to be granted by Congress before
the rule is implemented, then this is appropriate. But some of the
requests may be motivated more by the desire to require that HCFA go
through so many hurdles that RBPE's may never be implemented. One must
question whether there is any amount of data that will convince those
who expect to see reduced fees under RBPEs to accept the inevitability
of the required redistribution.
Preliminary analysis of the proposed rule
During the 60-day comment period, and during any extended comment
period that Congress may grant, ASIM plans to conduct a rigorous
evaluation of the methodology used by HCFA in the proposed rule.
Although we expect to recommend improvements in HCFA's data and
methodology, we believe that some of the data used may well prove to be
valid and appropriate.
The recommendations from the Clinical Practice Expert Panels on
direct costs are among the sources of duties that should be considered
in developing resource-based practice expense RVUs. ASIM recently
surveyed 185 internists on the clinical and administrative staff times
associated with evaluation and management services. Approximately 30
percent responded. Although we are still analyzing the response, it
appears that for most of the codes, the respondents agreed with the
CPEP data. Although admittedly a relatively small sample, this suggests
that it would be inappropriate to simply reject all the CPEP data as
being ``fundamentally flawed'' as some have alleged.
The proposed rule allocates indirect costs on the basis of direct
costs--i.e., the higher the direct costs, the higher the indirect
costs. ASIM will be submitting comments to HCFA on the appropriateness
of this methodology. We concur with HCFA's view, however, that existing
sources of data can be used to determine indirect costs--a view also
shared by the Physician Payment Review Commission. We also concur with
HCFA's view that ``by definition, it is not possible to directly survey
[indirect] costs associated with specific procedures.'' This is because
the indirect costs of running an office--utilities, rent, general
administrative salary costs--are by definition not attributable to a
specific procedure. Therefore, some method of allocating those costs to
a given procedure must be selected. Among the options that are
available are to allocate them based on physician time, staff time, or
on the basis of the direct costs as HCFA has proposed. It is misleading
to suggest that use of these allocation methodologies represent an
arbitrary ``proxy'' for actual data on the indirect costs of each
procedure, since there simply is no feasible way to collect the actual
indirect costs that are attributable to each procedure.
By no means is ASIM suggesting that HCFA's proposed rule is
perfect--far from it. To the extent that other sources of data on
practice costs exist, HCFA should consider such data and make revisions
as appropriate. The agency should also consider analyses that suggest
that the estimates from the Clinical Practice Expert Analyses need to
be revised in some cases. It should consider alternatives to the
approach it recommends on indirect costs. It should consider collecting
additional data on actual costs, to the extent that it is feasible to
collect such data. It should consult more regularly with physicians and
other technical experts.
But ASIM believes that the kinds of improvements and refinements
that are needed can readily be accomplished with an additional year--no
further delay is appropriate. We also firmly believe that although the
data and methodology can be improved, Congress should not direct that
HCFA start over from scratch and dismiss the data and analyses that it
has conducted to date.
Conclusion
In conclusion, ASIM urges the committee:
1. To strongly support the proposal from Senator Roth for a four-
year transition to RBPEs, with 10 percent of the transition beginning
in 1998. Congress does not need to choose between providing more time
to reexamine the data used by HCFA before the final rule is
implemented, and beginning to make improvements in payments for primary
care services in 1998. The Roth proposal is the only one on the table
that does both.
2. To assure that any direction that is given to HCFA on how the
study should be conducted does not lead to additional delay in
implementation of RBPE's, require the collection of data that are not
feasible or practicable to obtain; or set up a series of impractical
conditions that HCFA will not be able to meet. If some additional
direction is given, it should emphasize to the agency the importance of
consulting with physicians and other experts, and of being open to
considering the collection of additional sources of data, to the extent
practicable.
3. To make it clear that Congress expects that HCFA will make a
concerted effort to consider comments on improving the data and
methodology used in developing the proposed rule, both during the
current 60 day comment period and during any extension that Congress
will provide. HCFA should not be required, however, to disregard all of
the analysis and data it has collected to date.
Congress has an opportunity to come up with a winning approach that
begins to address the serious inequities created by the existing flawed
formula, while at the same time assuring that HCFA publishes and
implements a final rule that is based on the best available data. We
urge you not to turn back the clock on correcting the inequities in
payments that have disadvantaged primary care services, by improving
requirements that will further delay or even indefinitely postpone
resource-based practice expenses.
I'd be pleased to answer any of your questions.
SUMMARY STATEMENT OF DR. DONALD H. SMITH
Senator Specter. We will now turn to Dr. Donald Smith,
immediate past-president of the American Society of General
Surgeons, and vice chairman of the Pennsylvania delegation to
the American Medical Association. He is a graduate of Lehigh
and Jefferson Medical College. He has been chief of the
Division of General Surgery at Easton Hospital; clinical
assistant professor at Hahneman, and has maintained a general
practice in Easton over the years.
Dr. Smith, we welcome you here and look forward to your
testimony.
Dr. Smith. Thank you very much, Mr. Chairman. I would like
to thank you for convening this hearing, and for giving me the
opportunity to testify with respect to the Health Care
Financing Administration's plans to revise the practice expense
component. Having practiced in Easton for over 26 years, and
having served as a spokesperson for general surgeons throughout
this country for the past year, I believe I can lend some real
world perspectives to this subject.
When Congress directed HCFA in 1994 to develop these
expense relative values, they specifically asked that the new
relative values recognize the staff equipment, equipment, and
supplies used in the provision of these services. Clearly
congressional intent was for HCFA to construct the values using
data generated by actual resources involved in the provision of
these services, rather than the off-the-shelf estimates that
are currently in use.
Unfortunately, the proposed rule unveiled a few days ago is
not based on a methodology that we agree with, because it does
not measure the actual resources consumed in the provision of a
Medicare procedure, and again, we believe is based on estimates
extrapolated from various data and theoretical sources. It is
inconceivable that a sound practice expense methodology using
actual data could produce the payment reductions of the
magnitude proposed by HCFA for these various specialties. In
fact, some of the proposed reductions appear to assume that
certain specialties have only minimal practice expenses.
In my own specialty, HCFA's proposal would reduce overall
payments to general surgeons by 9 percent. This is compared to
an earlier plan that called for reductions of as much as 19
percent. The fact that there is such a wide variation tells us
that HCFA is simply massaging statistics rather than employing
the sound cost accounting principles that we think are
necessary, and that we believe have been referenced earlier in
the discussion.
Perhaps the most egregious example has already been related
dealing with the thoracic surgeons or the cardiac surgeons by
reducing their payments by 32 percent, which contrasted with
national data that shows that practice expenses for surgeons on
the average are about 41 percent of their total revenues.
Mr. Chairman, we know that the surgeon is not going to
perform as many procedures as office visits by a family
physician, thank God, but consider the different requirements
for office expense to care for an established patient with a
midlevel problem contrasted with the multiple pre- and
postoperative office visits, scheduling, family and physician
contacts, billing, rent, and ancillary office staff involvement
in caring for an elderly patient undergoing a major operation
that may last for several hours, with postoperative attention
often lasting several weeks. I would just make the point that
the office meter never stops running for the general surgeon,
either.
Sound accounting principles, not to mention logic, call for
the overhead costs of the family physician to be spread over
many more encounters with the patient, while the payment to the
surgeon is and appropriately should be on fewer, far more
complex patients. In my estimation, examples such as these
demonstrate what the American Medical Association, the American
College of Surgeons, and many specialists have identified.
The methodology that HCFA is proposing to use, we believe
is fatally flawed. It is unrealistic, and not the product of
actual measurement of multiple resources, but simply more of
the theoretical or estimated inaccurate data that prompted the
1994 mandate from Congress. More to the point, I seriously
doubt that the intent of Congress was to eliminate payments for
legitimate payments, anymore than to base the entire resource-
based relative value system on erroneous estimates and theories
in the late 1980's.
I recognize that HCFA made an effort to collect data, but
they never completed it. Using the clinical practice expert
panels, of which many physicians were composed, they asked
physicians to try and evaluate procedures with which they were
not familiar--point No. 1. What has not been said is the
physician survey took 24 hours to complete, and explains, I
think readily, why only a small percentage of these surveys
were reported. In all candor, Mr. Chairman, there must be a
better way to get a fair and equitable handle on this aspect of
a physician's practice.
Unfortunately, what HCFA has proposed will have far-
reaching effects beyond the Medicare Program. As you know, most
insurance companies utilize some form of the Medicare relative
values in developing their own payment schedules. Thus, the
true impact of this proposal is really not known. However, it
could be very substantial, and it seems unwise to cause such a
major disruption in the health care delivery system using what
we believe is spotty research.
More importantly, this impact could be devastating on one
of the most vulnerable segments of our population, our senior
citizens. No one knows for certain how physicians will adjust
to these charges. A reduction of this magnitude when coupled
with other changes Congress is now contemplating could
dramatically restrict access to and for Medicare patients.
Every time payment reductions to physicians occurs,
organized medicine cries access to quality health care will
suffer. But as you well know, little change has occurred up
till the present time. Coupled with other proposals for the
Medicare conversion factor in 1998 and payments for needed
assistance at surgery, general surgeons could see reduction in
their Medicare income this year of 25 to 30 percent. And I
would only ask is this the threshold that truly limits access
to care.
Last, we must not overlook the impact this change has on
academic health centers which rely heavily on faculty practices
to train medical students and generate the revenue needed to
support medical research. As someone who has a long-standing
record of support for medical research, you should be aware
that if this change is implemented, it will result in dramatic
reductions in research and training at institutions in your
home State of Pennsylvania.
PREPARED STATEMENT
In closing, Mr. Chairman, I urge you and your colleagues to
adopt the recommendations of the American Society of General
Surgeons and our colleagues in the Practice Expense Coalition
to stop the current rulemaking process and allow sufficient
time for accurate methodology to be developed, as well as a
reasonable time for comment and refinement of that methodology.
Instruct HCFA to assemble experts that they will require in
cost accounting and to develop mechanisms for collecting actual
data on physician practice expenses which can be validated and
regularly reported in their progress reports to Congress, and
to provide for an appropriate 3-year transition.
Mr. Chairman, let me conclude by saying that the Medicare
Program is not the place to road-test a very risky theoretical
scheme.
Thank you, sir.
Senator Specter. Thank you very much, Dr. Smith.
[The statement follows:]
Prepared Statement of Donald H. Smith, M.D., F.A.C.S.
Mr. Chairman and members of the committee: I am Donald H. Smith,
M.D., F.A.C.S., the Immediate Past President of the American Society of
General Surgeons. By way of background, ASGS is a national society
exclusively representing 4,000 practicing General Surgeons who
currently make up its membership and all 28,500 board-certified General
Surgeons in the U.S. The Society focuses on educational and
socioeconomic issues affecting the practice of general surgery as well
as the interests of surgical patients regarding cost, access and
quality of care.
Mr. Chairman, I would like to thank you for convening this hearing
and for giving me the opportunity to testify with respect to the Health
Care Financing Administration's (HCFA) plans to revise the practice
expense component of the Medicare fee schedule. Having practiced in
Easton, Pennsylvania for over 26 years, I believe I can lend some
``real world'' perspectives to the subject.
In 1994, Congress directed HCFA to develop resource-based practice
expense relative values for each procedure and service provided under
Medicare. In so doing, the statute specifically directed that the new
relative values ``recognize the staff, equipment and supplies used in
the provision of medical and surgical services in various settings.''
Clearly, congressional intent was for HCFA to construct the practice
expense values using data generated by actual resources involved in the
provision of physician services, rather than the ``off-the-shelf ''
estimates currently in use. Unfortunately, the proposed rule HCFA
unveiled a few days ago is not based on a methodology that measures the
actual resources consumed in the provision of a Medicare procedure or
service, but rather on estimates extrapolated from various data and
theoretical sources. It is inconceivable that a sound practice expense
methodology using actual data could produce payment reductions of the
magnitude proposed by HCFA. In fact, some of the proposed reductions
appear to assume that certain specialties have only minimal practice
expenses.
In my own specialty, HCFA's proposal would reduce overall payments
to General Surgeons by 9 percent, compared to an earlier HCFA plan that
called for reductions of as much as 19 percent The fact that there is
such a wide variation tells me that HCFA is simply massaging
statistics, rather than employing sound cost accounting principles.
Perhaps the most egregious example relates to payments to our
colleagues for cardiac surgical procedures, where HCFA would reduce
payments by 32 percent. Contrast this with national data which shows
that practice expenses for surgeons, on average, account for 41 percent
of total physician revenues. In other words, HCFA would eliminate
reimbursement for three-fourths of that specialty's overhead costs.
Yet another example of how HCFA has missed the mark is contained in
the agency's own press release that accompanied this new proposal. HCFA
calls it inequitable that a family physician has to perform about 100
mid-level office visits to receive the same amount of practice expense
reimbursement as a thoracic surgeon receives for one triple bypass
operation. Mr. Chairman, we know that the surgeon is not going to
perform as many bypass procedures as the number of office visits by a
family physician. Sound accounting principles, not to mention simple
logic, call for the overhead costs of the family physician to be spread
over more encounters with the patient, while the surgeon's payment is
concentrated on fewer patients.
In my estimation, examples such as these demonstrate that the
methodology HCFA is proposing to use is fatally flawed, unrealistic and
not the product of an actual measuring of the multiple resources
required to provide a quality surgical service. More to the point, I
seriously doubt that this was the intent of Congress to eliminate
payments for legitimate practice expenses.
While I recognize that HCFA made an effort to collect data through
Clinical Practice Expert Panels, or CPEPs, and through the use of a
survey of selected physician practices, neither of these tasks were
completed.
In fact, the survey instrument took more than 24 hours to complete
and was so complex that only 27 percent of the practices selected
responded. In all candor, Mr. Chairman, there must be a better way to
get a fair and equitable handle on this aspect of a physician's
practice.
To construct a new set of values, HCFA relies primarily on data
derived from the clinical practice expert panels. But a review of those
findings suggest that they contain a number of errors. In addition,
HCFA has no indirect cost data and thus has no way to validate its
proposed methodology. In its proposed rule, HCFA admits that
``refinements'' will have to be made after the rule is implemented.
Unfortunately, what HCFA has proposed will have far reaching
effects beyond the Medicare Program. As you know, most insurance
companies utilize some form of the Medicare relative values in
developing their payment schedules. Thus, the true impact of this
proposal is really not known at this time. However, it could be very
substantial. It seems unwise to cause such a major disruption in the
health care delivery system using spotty research.
More importantly, the impact this could have on one of the most
vulnerable segments of our population--our senior citizens--is unknown.
No one knows for certain how physicians will adjust to these changes. A
reduction of this magnitude, when coupled with other changes Congress
is now contemplating, could dramatically restrict access for Medicare
patients. Some surgeons certainly would leave the field and others may
eliminate the necessary clinical support they now have in their
practices. In surgery, for example, a substantial portion of the pre-
and post-operative care is provided by the nursing staff. Currently
surgery is paid a ``global fee''. This covers the pre-, the operative,
and the post-operative care. If you take away a substantial portion of
the relative value units, it would seem that the quality of all of
those services currently in the global fee would have to suffer--as
will the patients' access to quality surgical care.
Last, we must not overlook the impact this change would have on
academic health centers, which rely heavily on physician faculty
practices to help train medical students and generate the revenue
needed to support medical research. As someone who has a long standing
record of support for medical research, you should be aware that if
this change is implemented, it will result in dramatic reductions in
research and training at institutions such as the University of
Pittsburgh and the Hershey Medical Center.
In closing Mr. Chairman, I urge you and your colleagues to adopt
the recommendations of ASGS and our colleagues in the Practice Expense
Coalition to:
--stop the current rule making process, and allow sufficient time for
accurate methodology to be developed as well as a reasonable
time for comment and refinement;
--instruct HCFA to assemble experts in cost accounting and to develop
mechanisms for collecting actual data on physician practice
expenses which can be validated, and regularly report their
progress to Congress; and
--provide for a three-year transition to the new payment schedule.
Mr. Chairman, let me conclude by saying that the Medicare program
is not the place to road test this very risky theoretical scheme.
PREPARED STATEMENT OF LARRY FITZGERALD
Senator Specter. The subcommittee has also received a
statement from Larry L. Fitzgerald of the University of
Pittsburgh, the statement will be placed in the record at this
point.
[The statement follows:]
Prepared Statement of Larry Fitzgerald
RVU IMPACT STUDY
We have performed an analysis of the impact of the proposed
reduction to the RBRVS system for the computation of practice
expense on the University of Pittsburgh Physicians.
Collectively the University of Pittsburgh Physicians represent
the faculty physicians of the University of Pittsburgh Medical
Center. The estimated impact to our faculty physicians is a
decrease in net Medicare revenue (collections) of 11 percent
($3 million annually).
Please recognize that other payors such as Worker's
Compensation, auto insurance and many of the managed care
companies follow the Medicare rule. The ultimate overall impact
on the net revenue could be a reduction of as much as $15
million on an annual basis. Needless to say this is potential
revenue loss and a great concern to our practice plans and it
has the potential of impacting negatively on services made
available to the Medicare recipients in Western Pennsylvania
and their health and well-being.
QUESTIONS FROM WITNESSES AND OTHERS IN THE PROFESSION ASKED OF HCFA
Senator Specter. We have 2 minutes left on the clock for
the vote which started a few minutes ago, and there is a 5-
minute grace period, which I can make with about 90 seconds to
spare if I leave immediately. I want to thank you very much for
coming in, and I express my regret that other committee members
were not present because they were over there voting, and they
are not quite able to come back.
What I would like to do is a little different procedure
here. What I would customarily do is have a dialog for about
one-half hour. But I cannot do that because of time constraints
and I have to go vote. You have not had a chance to review the
400 pages which were made available on Friday and filed
formally yesterday. What I would like you to do is to frame
questions which you would like this subcommittee to ask HCFA,
and we will frame questions in addition.
Again, I express my regrets, but these schedules are very,
very difficult. But I did want to have this hearing at this
point. I had expected we would be pressing HCFA as to why
nothing had been filed, but not coincidentally something has
been filed. So we will proceed as I have just outlined.
I will return as soon as I can to hear the next panel.
Thank you all very much.
[The following questions by witnesses and others in the
profession as what ought to be asked of HCFA to respond to. The
questions were not asked at the hearing but were submitted to
HCFA for response subsequent to the hearing:]
I. Questions Pertaining to Resource-Based Practice Expense Relative
Value Units (RVU's) Submitted by American Society of General Surgeons
Question. In the absence of specific data, it is difficult to
analyze HCFA's June 18 proposed rule on practice expenses. Would HCFA
provide the Subcommittee with the data used to develop the proposed
rule? Will the agency also make the data available for review by the
medical and surgical community?
Answer. The Abt data, which includes the resource inputs per code
furnished by the Clinical Practice Expert Panels (CPEP's) and then
priced using national standardized prices, was made available to the
medical and surgical community following a meeting on January 22, 1997,
with the physician specialty groups. As explained in the June 18,
Notice of Proposed Rulemaking (NPRM), the physician community will also
be able to gain access to this data through the HCFA Home page or to
purchase it from the National Technical Information Service. HCFA will
provide this extensive data set, on diskette, to the subcommittee.
Question. HCFA has analyzed the impact the proposed rule would have
on each specialty on physicians' income. Would HCFA provide the
Subcommittee with its best analysis of what impact the proposed rule is
likely to have on Medicare enrollees? In particular, focus on how the
proposed rule might affect access, including the availability of care
in rural areas.
Answer. Although changes in physician payments when the physician
fee schedule was implemented in 1992 were large, we detected no
problems with beneficiary access to care. We do not expect problems
with beneficiary access to care as a result of the change to resource-
based practice expenses. Because some specialties will experience large
changes, we favor a transition to resource-based practice expenses. A
four-year transition (1992-1996) was used for the implementation of the
work component of the physician fee schedule.
Resource-based practice expenses should not have any particular
geographic impact. That is, resource based expenses affect the relative
value of the procedure in all areas. Geographic differences across
areas are recognized by the geographic practice cost adjustment which
applies to whatever relative value is used. We should note that a
larger mix of primary care services are performed in rural areas. Since
the proposed resource-based practice expense produces significant
increases in payments for evaluation and management services and other
office based procedures commonly furnished in rural areas, access to
care by beneficiaries in rural areas should not be adversely affected
and could be enhanced.
Question. Earlier this year, HCFA was reviewing options where
Medicare reimbursement for some procedures was below the Medicaid
reimbursement. Are there any instances where that occurs under the
proposed rule? If so, would you provide the Subcommittee with a list of
procedures where that occurs?
Answer. We have not conducted a comparative analysis of Medicaid
payment rates and Medicare payment rates per code and, therefore,
cannot provide a list of procedures or services where the proposed
Medicare payment rate, adjusted for the resource-based practice
expenses, is less than the corresponding Medicaid rate.
Question. Those initial options were viewed by many to be seriously
flawed since they were derived from studies and extrapolation rather
than actual data. What have you done since then to gather actual data?
How can Congress be assured that your current proposal has validity?
Answer. We obtained actual data about the direct resource inputs
from the physician community. We asked CPEP participants to determine
the number and kinds of staff needed and the time these staff spend on
procedures. We asked about the supplies and equipment for the procedure
and how long they are used. We asked physicians how much staff time it
takes to do the paperwork, appointments, billing, authorizations,
reports and correspondence. We added up the costs of staff, supplies
and equipment to determine the direct expense for each service. We then
allocated the indirect expenses (i.e., rent, utilities, automobile,
other expenses) to each code.
The data we are using to determine the direct nonphysician direct
inputs expended in the provision of physician services are then priced
using national data and used to establish the direct practice expense
RVU's. These data were obtained from the CPEP's whose members were
predominantly physicians but included other practitioners and practice
managers. We have continued to use this data set because it is the best
available source of data on direct resources and expenses. As explained
in detail in the NPRM, our medical staff have applied individual tests
of data reasonableness to the CPEP data to eliminate data anomalies and
to ensure internal data consistency.
The options we have presented in our NPRM differ significantly from
any of the four options that we shared with the physician specialty
groups in January 1997 predominantly with respect to the methods used
to allocate indirect expense to individual physician services. The
options presented in January employed methods that allocated indirect
costs (RVU's) to individual codes based on either physician time or
nonphysician staff time. In the NPRM, indirect costs (RVU's) are
allocated to individual codes based on the sum of the physician work
RVU, malpractice RVU, and the direct practice expense RVU. We believe
this is consistent with a standard accounting approach and also
consistent with recommendations from the Physician Payment Review
Commission.
Question. The proposed rule calls for a 32-percent reduction in
total allowed charges for cardiac surgery. Since practice expenses
account for about 41 percent of practice costs, how does HCFA justify a
reduction of this magnitude--about three-fourths--against allowed
charges?
Answer. The reduction for cardiac surgery can be understood in
context of a typical high volume procedure, bypass surgery (code 33512)
that is performed by cardiac surgeons. Currently, the national fee
schedule (without any geographic adjustment) for this code is $2,748
and this amount is lowered to $1,770 under the resource-based practice
expense system, a 36 percent reduction. Current analysis shows that a
primary care physician must perform over 100 mid-level office visits to
receive the same amount of practice expense payments that the cardiac
surgeon receives through the current practice expense payment for a
three vessel bypass surgery. Under the resource-based practice expense
RVU system, a primary care physician must perform 18 mid-level office
visits to receive the same amount of practice expense payments that the
cardiac surgeon will receive for a three vessel bypass surgery.
For the hospital surgical procedure, the physician utilizes medical
supplies, medical equipment and nonphysician clinical staff, whose
costs are recognized, by law and implementing regulations, as paid only
through the prospective payment made to the hospital. Thus, these
services cannot be paid again through the practice expense payment.
Question. What is HCFA's estimate of actual practice expenses that
would be covered for the average physician practice in each specialty,
assuming that Medicare were the sole payer? This is especially
important because many insurance companies will follow HCFA's lead in
setting reimbursement levels?
Answer. We have analyzed, by specialty, the impact of the resource-
based practice expense RVU's on physician's net incomes. However, we
have not analyzed the percent of the actual practice expenses covered
for the average physician. One of the difficulties with this type of
analysis is that we do not have the specific procedure mix of the
typical specialist across all payers. Moreover, we believe the
statutory mandate was to develop a fee schedule where payments are
based on the resources required to perform each service.
We do not believe there is a statutory requirement or expectation
that the new resource based practice expense payments return a fixed
percentage of ``costs'' to each specialty. In fact, we would expect the
opposite to occur--that practice expense payments would increase or
decrease by specialty based on the specific mix of services performed
and the resources required to produce the service. In any case, there
are no ``cost report'' data available that we know of that would enable
us to compute these type of statistics. (We do not believe that current
expenditures are an accurate estimate of ``costs.'' ``Cost data'' for
other settings typically refers to audited cost reports in which
expenditures have been audited for reasonableness or for other criteria
or limits).
Question. If the proposed values did not cover roughly the same
proportion of each specialty's practice expenses, would they be truly
resource-based?
Answer. Yes, as explained for question 6.
Question. If HCFA cannot estimate the proportion of each
specialty's practice expenses that would be covered by the proposed
values, how can the agency be confident that those values are fair and
accurate?
Answer. We are charged by law with designing a resource-based
relative value system not a system of cost reimbursement for
physicians' services. Consistent with the statutory requirement, our
focus has been on developing payments that reflect the relative
resources to perform each service, not to return a specific percent of
current expenditures to each specialty.
Question. What information does HCFA have about urban-rural
differences in the utilization of medical equipment per unit of time?
What is the risk that the relative values being proposed by HCFA will
underpay rural practices for costs of their equipment because it is not
possible or practical for them to match HCFA's assumed machine
capacity?
Answer. The fee schedule represents relative resources required to
perform a service for the ``typical practice''. Other adjustments, such
as the geographic practice cost indices and the health professional
shortage area bonus have been established by Congress to account for
differences between geographic areas.
We acknowledge in the NPRM that there is no source of data on
utilization levels of equipment across all procedures and all payers.
We have made requests to the medical community for this information,
but it has not been provided. Certainly, the pricing of medical
equipment is critical for those specialties that are significant users
of medical equipment, such as radiology and ophthalmology. However, for
almost all other specialities, medical equipment in the aggregate
represents less than 10 percent of total direct practice costs.
Question. HCFA has estimated that the indirect costs of a practice
average about 55 percent of total costs in a charge-based system. Yet
with respect to surgical practices, the proposed rule does not appear
to make any allowance for continuing indirect costs of maintaining an
office and support staff during the time the surgeon is performing work
in the hospital or operating room. Please explain HCFA's assumptions on
these aspects of practice expenses, and how those costs are accounted
for.
Answer. First, neither of these statements is correct. We estimate
from the AMA SMS data that the indirect costs, which are costs other
than clinical and administrative labor, medical equipment and medical
supplies, are approximately 45 percent of total costs. Further, we do
recognize the practice's indirect costs when the surgeon is performing
surgery in the hospital. We allocate indirect costs to the specific
code based on the sum of the physicians' work, the direct practice
expense and the malpractice expense relative value for that code.
Furthermore, office staff is likely performing direct labor for other
physician services while the physician is performing tasks in the
hospital.
______
Questions From Panel 1
PENDING LEGISLATION
Question. What is your assessment of the additional House and
Commerce Committee and Senate Finance Committee provisions calling for
new studies and reviews of the data?
Answer. We firmly believe that we have sufficient data to establish
resource-based practice expense RVU's. We are very supportive of a well
defined refinement process during which physician panels can address
concerns that code-specific RVU's are missing key inputs or the RVU's
are inconsistent with the values of other codes in the same family or
codes of other specialties. In the proposed rule, we asked for comments
from physicians regarding the refinement process.
Question. You have already spent nearly $3 million on data
development contracts; how much more do you estimate it would cost to
implement the new House and Senate provisions under consideration, and
could you absorb the cost within your fiscal year 1998 budget request?
Answer. The proposed legislation requires that we use, to the
maximum extent practicable, generally accepted cost accounting
principles; use actual data on equipment utilization and other key
assumptions. We believe we have most of the data we need to establish
resource based relative values in accordance with the proposed
legislation. Information we don't have, such as actual equipment
utilization, will be requested as part of the notice of pre-rulemaking
we plan to publish in September of this year.
From the comments we have received so far on our June 18, 1997
proposal in the Federal Register, some physicians have told us they
have information about equipment utilization in their practices. We
plan to request this and other information so we can incorporate it
into the proposed notice which the legislation mandates we publish by
May 1, 1998.
An additional provision of the proposed legislation requires that
the Secretary develop a refinement process for each of the years of
implementation of the new relative values. HCFA is well on the way in
developing a refinement and validation process. In the Fall of this
year, we will be conducting a series of validation panels to review the
practice expense data on about 300 of the most frequently performed
procedures. Members of the validation panels will be comprised, in
part, by physicians nominated by their specialty societies. Although we
haven't scheduled additional validation and refinement activities as
yet, we expect to ask for comments about how this process should work
in our notice of pre-rulemaking.
IMPACT ON HOSPITALS
Question. Have you looked at the impact of your practice expense
regulations on major medical centers across the country?
Answer. In our impact analysis, we did not examine the impact of
the practice expense regulations on major medical centers. Our national
claims data is not structured in a format to allow us to readily
perform an analysis by medical center.
RELIABILITY OF DATA
Question. Ms. Buto, in Dr. Kleiman's testimony, he states that the
data you are relying on for the practice expense regulations, developed
by Clinical Practice Expert Panels, has neither been released in a
readable format nor validated by HCFA. Are you working with the
interested groups to resolve these concerns, and won't more time be
needed than the 60-day comment period allowed by the proposed rule?
Answer. The Abt data, which includes the resource inputs per code
furnished by the CPEP's and then priced using national standardized
prices, is available to the medical community. The data that were used
to determine the relative values were widely distributed in January to
the medical community. The physician community can gain access to the
final data through the HCFA Home Page or can purchase it from the
National Technical Information Service.
The current law requires us to implement the resource-based
practice expense system in 1998. We cannot extend the comment period
and also met the deadline imposed by the current law.
Question. What is your response to Dr. Kleiman's recommendation,
made on behalf of the 40 health organizations that are members of the
Practice Expense Coalition, that Congress should delay implementation
of the regulations until January 1, 1999 and redirect your agency ``to
develop new and verifiable methodologies based on generally accepted
accounting principles?''
Answer. We are working with Congress to pass legislation allowing
for a phased-in implementation schedule. There are different opinions
in Congress on when changes should first take place. A phased-in
implementation strategy will ease the impact of these changes, which
otherwise will take place at the same time as the President's proposal
for a single conversion factor. Phased-in implementation also will
allow us to work with physician groups to refine the relative values
for specific codes. However, we are confident that our methodology is
sound.
LAG TIME GETTING OUT REGULATIONS
Question. Ms. Buto, Congress enacted the legislation requiring your
agency to implement physician practice expense regulations on October
1994, and provided a lead-time of 3 years and 2 months for development
of the regulations before going into effect on January 1, 1998. Why has
it taken 2 years and 8 months to publish the proposed rule in
yesterday's Federal Register?
Answer. The law requires us to develop the resource-based practice
expense RVU system based on the staff, the medical supplies and the
medical equipment for the service furnished in various settings.
To develop this system, we had to collect data on resource inputs
at the code level. This type of data was not available. Consequently,
we published a request for proposal (RFP) and asked the research
community to submit proposals following the design elements and the
criteria in the RFP.
The RFP was published in the Commerce Business Daily in November
1994. The proposals were submitted with respect to the RFP in January
1995 and, in March 1995, the contract was awarded to Abt Associates.
Under the contract, Abt was to perform data collection activities.
Code-specific data on the direct service resource inputs was collected
through two rounds of the CPEP's. The first round of CPEP's was held in
February 1996 and the second round was held in June 1996. Abt provided
the complete draft CPEP data set to us in January 1997. These data were
used to derive the direct component of the proposed relative values.
Question. Do you feel that interested parties are being given
sufficient time to analyze these regulations and provide informed
comments before a final rule is issued this fall?
Answer. In order to meet the deadlines required under current law,
we are giving the medical community and public 60 days to comment on
the NPRM. During the life of the Abt contract, we have conducted
numerous public meetings with the medical community. In January of this
year, we conducted a meeting at HCFA's headquarters during which we
provided an overview of the proposed methodology and various options
being considered, such as whether the CPEP data should be linked or
unlinked and how indirect costs (RVU's) should be allocated to
individual procedure codes. We also shared impacts by physician
specialty on four options that were being considered.
Question. Would you prefer an extension of time to further refine
the regulations?
Answer. We plan to seek input from the physician community and
refine the procedure-specific relative values whether resource-based
practice expense relative values are implemented next year or in a
later year.
Question. Why did it take 6 months after enactment of this law to
award the initial contract with Abt Associates to put together the data
collection survey for developing these regulations?
Answer. See response to question 1 under this subsection. The time
frame for awarding a contract is governed by the competitive
procurement rules that apply to all government agencies.
Question. Why did it take another full year to develop the survey
and get it approved by OMB?
Answer. The survey of practice costs was a very comprehensive
survey of physician practice costs and the procedure mix of the
practice. Because of its complexity and range, we asked Abt to solicit
comments from the medical community. As noted below, the design of the
survey itself and the review and feedback from the medical community
took 5 months and the clearance by OMB took nearly an equivalent time.
In June 1995, HCFA scheduled a public meeting with the specialty
societies to discuss the overview of the project and the planned data
collection strategies. Comments were also solicited on the practice
cost survey. After considering the comments of outside researchers,
medical specialty societies and HCFA, Abt finalized the survey design
in September 1995. In October 1995, the package for clearance of the
Survey was sent to the Department and OMB. OMB approved the survey in
February 1996. The first mailing of the survey began April 1996.
Question. When the survey was finally canceled in September 1996,
due to lack of an adequate response from the physician community, do
you feel 18 months had been wasted?
Answer. We have always attempted to have as many options as
possible. If the survey had been successful, we would have been able to
consider more options for measuring and allocating indirect costs. This
experience has been invaluable to us. We do not believe a survey of
this type is feasible. We are confident we can use the existing data
and more standard accounting methods to allocate indirect costs.
Question. Why weren't the regulations put out months ago?
Answer. Under the timetables that we had presented to the AMA and
the physician specialty groups as far back as April 1996, we had
advised the medical community that we would publish a NPRM in the first
half of 1997. Thus, the publication of the NPRM was not significantly
delayed even from the perspective of the earliest projections.
______
Additional Questions on Practice Expense for Senator Specter
Question. It strikes me that the study of physician practice
expenses and how to fairly reimburse physicians for those expenses
boils down to an accounting exercise. Did HCFA utilize generally
accepted accounting principles in collecting its data?
Answer. We believe that we used generally accepted accounting
principles in our method to develop practice expense relative values.
We divided practice costs into direct and indirect costs attempting to
identify as many costs as possible as direct costs. We obtained
itemized direct inputs for each procedure from the physician community.
We then priced these inputs using standard pricing data. Indirect
expenses, which by definition cannot be directly measured at an
individual service level, were allocated in relation to total direct
expenses, a commonly accepted accounting practice in cost accounting.
Question. Please describe which accounting experts were consulted
in this study and what aspects of the study did they consult on?
Answer. HCFA staff have extensive experience and familiarity with
cost accounting. For many years HCFA payment systems have been based on
cost accounting methodologies.
The RFP also required Abt Associates to assemble several Technical
Expert Groups to provide technical advice on the CPEP process and the
survey. The TEG's included clinicians, and researchers, including
economists and accountants. Included on the TEG were a number of
participants who have done work in this area either for HCFA or
specialty societies, including Allen Dobson, Ph.D., Daniel Dunn, Ph.D.,
Henry Miller, Ph.D., and Gregory Pope, M.S.
Abt Associates engaged subcontractors to provide technical
expertise on the design of the survey instrument itself. These
subcontractors included the Medical Group Management Association, and
Rod Nelson, a CPA and the owner of a firm that specializes in costing
physician practice activities. MGMA had experience with physician
practice surveys including knowledge of accounting information that
physician practices could provide.
Question. I'm not an accountant, but it would seem that there are
some fundamental issues that would impact your proposal.
--(a) For example, how did HCFA's study consider and reconcile the
differences in practice expenses incurred by a specialist
physician practicing at a major research and teaching
institution versus a physician in the same specialty who
practices independently?
--(b) In conducting your study, how did you collect and consider
detailed information about the different practice expense
structures faced by physicians in these rather different
practice settings?
Answer. A relative value scale requires the development of one
number for a procedure, regardless of the various setting in which the
service may be furnished. This is a fundamental premise upon which the
entire physician fee schedule is premised. The same issues are involved
for the physician ``work'' for a procedure. The relative value for
physician work, as well as practice expenses, are based on the
resources for the ``typical'' patient. Separate adjustments under the
fee schedule are made for differences across geographic areas.
However, in developing relative values for a ``typical'' patient
for procedure, we sought input from a wide mix of physician practices.
One of the objectives of the CPEP process was to assemble a panel of
physicians and practice administrators that represent the variation in
physician practices in terms of size, geographic location (urban vs.
rural), and teaching/nonteaching characteristics. Thus, the CPEP's
consisted of both academic and nonacademic physicians and each
contributed to identifying the typical kinds of resources involved in
providing a different code both in and out of the physician's office.
Standard prices were assigned to labor input components principally
using data from the Bureau of Labor Statistics (BLS). Data from the
University of Texas Medical Branch and the Current Population Survey
were used as supplements to BLS data. Prices for medical supplies were
obtained from published catalogues, contacts with medical suppliers,
and CPEP members. Prices for medical equipment were obtained from
medical equipment suppliers (and allocated to individual replications
of services using a relatively straight-forward technique).
Question. I understand that the purpose of the proposed Abt
Associates survey of physician practice expenses was to understand the
actual realities of expenses being incurred by physicians in the
operation of their practices.
--(a) In suspending the Abt study, how can HCFA now assure Congress
that its proposal is based on ``real'', rather than
hypothetical information?
--(b) Please explain how you were able to get real, reliable and
relevant data in lieu of the originally planned study.
Answer. We are able to calculate resource-based practice expense
RVU's without the survey. First, we used the AMA SMS data from
approximately 4,000 physician practices to determine the division, in
the aggregate, between direct and indirect costs. The definition of
direct costs we used for this calculation is the same definition of
direct costs used by the CPEP's.
We relied on the CPEP's to provide us with ``real'' data on the
resource inputs, such as labor staff, medical supplies and medical
equipment, associated with individual services. This information came
from physicians, practice managers and others who are actively
practicing medicine. In addition, prior to the CPEP sessions,
participants were provided with a list of the procedure codes they were
to analyze so they could consult with others about what resources were
required when those services were performed. These inputs were used to
generate the direct practice expense RVU's.
Question. How does HCFA propose to measure changes and collect
information in the future about practice expenses, to ensure, for
example, that changes which occur in the practice expenses being
incurred by physicians are adequately considered in future policy
decision? Have these changes been though through?
Answer. We are considering these matters as part of how we will
structure the refinement process. It is clear that there will be
significant physician involvement in the refinement process. We have
already had and will continue to have discussions with the AMA and the
physician specialty groups about these issues.
Question. What about things like indirect expenses, say electric
utilities? How did HCFA's approach capture basic things like the
allocation of an electric bill to many physicians of different
specialties practicing in a large building? Without a mechanism to
meter each physician's electricity usage separately, how would you know
how much it cost each practice to operate?
--(a) Did HCFA's study allocate these items on a ``per physician''
basis, or did it consider the ``actual consumption'' of
electricity and its cost for each different type of physician
or procedure performed?
--(b) So if in the same building you had a radiologist providing
services that consume large amounts of electricity next to a
primary care physician who consumes much less energy resources,
how did the study consider these differences and build them
into the reimbursement proposal?
Answer. It was not feasible to attempt to collect data at this
level of detail. We did collect information on staff, equipment and
supplies required for each service. Other costs, such as electricity,
heat, telephones, etc. are considered to be indirect costs and
allocated to individual codes on the basis of the sum of the physician
work, direct practice expense and malpractice value for the code. This
is consistent with a standard accounting approach.
Question. What do you feel are the major weaknesses in the approach
used by HCFA to study this issue? What allowances have been made to
deal with these weaknesses to ensure that we do not make an error in
establishing policy?
Answer. We recognize there are some specific areas where additional
work is needed and have asked the public to share their comments and
views with us. One of the areas is the pricing of medical equipment. As
we mentioned earlier, the pricing of medical equipment is not a
significant issue for most specialties since it represents less than 10
percent of total direct costs (which is about 2 percent of total
payments). However, medical equipment pricing is a more significant
issue for some specialties (i.e. radiology) and we need to further
examine the implications of a single uniform approach for these
specialties. The other major issues are the process by which the
practice expense RVU's are refined and the magnitude of the
redistribution for certain specialties. We are supportive of a multi-
year transition so that the changes do not occur in a single year.
______
II. Questions Pertaining to Radiosurgery
Question. It is our understanding that HCFA proposes to reduce the
Medicare reimbursement for radiosurgery to begin October 1, 1997, but
is willing to work with providers to review cost data. Should the
current reimbursement rates be maintained until the cost of the review
is completed?
Will your review of cost data differentiate between clinically
different technology in the radiosurgery area?
Concerns have been expressed that severe reductions in Medicare
gamma knife reimbursement could force many patients back to traditional
surgical approaches at high cost to the government and potentially
resulting in harm to patients due to complications from needless
surgical intervention. Have you investigated these concerns, and if so,
what have you found out?
Can you give us any assurances that no action will be taken on
Medicare reimbursement that could result in limiting patient access to
gamma knife treatment, which could be the only option for patients
unable to withstand conventional surgery?
Answer. This is not an issue for payment under the physician fee
schedule. Rather, it is an issue for the DRG payments to hospitals.
The most recent Medicare data indicate that hospital charges
associated with stereotactic radiosurgery cases are substantially lower
than the charges for other cases in the relevant DRG's. For example, in
DRG 1 (Craniotomy)--which contains most of the radiosurgery cases--the
average charges for the radiosurgery cases are approximately $16,400
compared to approximately $27,800 for DRG 1 overall, and the lengths of
stay are about 3 and 10 days, respectively. Thus, we believe that these
cases are being overpaid. As a result, we are proposing to move these
cases to DRG's 7 and 8 (Peripheral and Cranial Nerve and Other Nervous
System Procedures, with and without CC), with average charges of
$20,500 and $8,240, respectively.
The analysis above is based on hospital charge data from the
standard 10 percent sample of Medicare cases that we use in assessing
DRG issues. We have indicated our willingness to examine a full 100
percent sample of all radiosurgery cases before making a final decision
about DRG assignment. We intend to complete this analysis before
publication of the fiscal year 1998 hospital payment rates that are
scheduled to take effect on October 1, 1997.
Because current ICD-9 codes do not discriminate between the ``gamma
knife'' procedure and other radiosurgery, there is no way to
discriminate between these types of cases in the Medicare database. Any
expansion of the coding would have to be accomplished through the ICD-9
Coordination Committee process and could not take effect any earlier
than October 1, 1998.
We do not believe that the proposed reductions in payment for
radiosurgery cases would jeopardize patients or limit their access to
appropriate care. A basic principle of the hospital prospective payment
system is that payment is based on an averaging process, as each DRG
contains a range of patient costs and lengths of stay. Payment in
excess of cost in one DRG may offset costs in excess of payment in
another DRG. For cases that would now fall into DRG 7 (which contains
nearly 6 times as many patients as DRG 8), radiosurgery cases would
continue to be somewhat overpaid in the aggregate, since average
charges for radiosurgery cases are lower than for other cases in the
same DRG. Similarly, cases that fall into DRG 8 would likely be
underpaid as a whole. Particularly in view of the large profit margins
hospitals now enjoy on Medicare patients, we do not believe it is
necessary to continue to overpay all radiosurgery cases to ensure that
hospitals provide appropriate care, including gamma knife treatment, to
Medicare beneficiaries. We note that a hospital may not refuse to
provide a covered service to a Medicare beneficiary if it provides that
service to other patients.
______
III. Temple University Hospital Ventilation Rehabilitation
Demonstration
Question. Ms. Buto, I understand that your agency has been working
with Temple University Hospital on a Medicare demonstration project for
ventilator-dependent rehabilitation patients to devise a workable
solution for permanent fund for the unit. What is the status of these
discussions? Will HCFA extend the demonstration project for another
year while a permanent fix is developed? Would the Administration
support legislation to permanently extend this project?
Answer. Temple University's ventilator rehabilitation unit (VRU)
was part of a HCFA demonstration project from July 1, 1991 through June
30, 1997. Because of Temple's excellent outcomes in this area, HCFA has
worked with Temple for the past three years to find a way for Temple's
VRU to become permanently eligible for Medicare funding. As of yet, no
mutually agreeable solution has been found. HCFA cannot extend the
Temple VRU demonstration project for another year under its own
authority because the demonstration project is not budget neutral. We
would oppose the creation of a new class of providers for ventilator-
rehabilitation units since the demonstration project showed that the
quality of care across these institutions varies widely, but we would
not oppose permanent continuation of the two sites in the original
demonstration project which have consistently demonstrated high quality
care, Temple University and the Mayo Clinic.
Panel 2
STATEMENTS OF:
JOHN C. BAILAR III, M.D., Ph.D., DEPARTMENT OF HEALTH STUDIES,
UNIVERSITY OF CHICAGO
RICHARD KLAUSNER, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE
Senator Specter. Our hearing will resume.
We have with us two very distinguished doctors and
researchers, Dr. Klausner and Dr. Bailar. We will begin with
Dr. John Bailar, chair and professor of the Department of
Health Studies, University of Chicago, graduate of Yale
University School of Medicine, who began his career with the
National Cancer Institute, and has written extensively on
progress in the war against cancer. The full statement that I
had prepared will be made a part of the record.
As I said earlier, regrettably we are under time
constraints. We have a recent headline from USA Today, ``$30
Billion War on Cancer a Bust?'' That frames the issue about as
well as anything.
Dr. Bailar, the floor is yours.
SUMMARY STATEMENT OF JOHN BAILAR, M.D.
Dr. Bailar. Thank you, Mr. Chairman. I did not write that
headline. I would not have written that. I think there are some
things that we need to be concerned about, but that is a
statement I think that is inappropriate.
In 1986, Dr. Elaine Smith and I reported that cancer
mortality had climbed slowly but steadily over several decades,
and we concluded that the war against cancer should be judged a
qualified failure. My current work with Dr. Heather Gornik
finds little reason to modify that conclusion. The cancer
mortality rate, adjusted for changes in the population,
including changes in the risk of death from other causes,
continued to grow by about 1 percent per year until very
recently. Mortality has now plateaued and started to decline
slightly, but the 1994 cancer death rate was still about 6
percent higher than that of 1970. We expect a slow and partial
decline to continue, primarily because of the delayed effects
of reductions in tobacco usage several years ago.
Of course, cancer is a collection of many different
diseases, and the risk of death from some forms has been
declining, while it has been growing for others. These changes
in cancer mortality, both up and down, have been largely a
result of changes in the occurrence of cancer, sometimes in
earlier detection, rather than a result of the development of
improved treatments.
We are not questioning the value of treatment. Treatments
presently available are already curing about one-half of all
patients, and the best of modern medicine has much to offer
those who cannot be cured. In short, this is not a dispute over
whether the glass is half full or half empty. We agree that it
is half full. The problem is that it is the same half full that
it was several decades ago. There is no substitute for a major
reduction in cancer mortality rates, a reduction which has not
yet occurred despite decades of targeted research focused
mostly on treatment.
I am convinced, as I was in 1986, that a major emphasis on
cancer research must be shifted from treatment to prevention.
The principal counter argument to a new focus on prevention, as
expressed to us, has been that success in treatment is near. We
are almost there, we hear. Persistence will pay off, we have
been told time and time again. I have heard this argument for
41 years, since I entered cancer research in 1956. I heard it
again repeatedly and stridently after Dr. Smith and I published
our paper in 1986. If there are no changes in the broad
direction of our national cancer research strategy, I expect to
hear it again in another 10 years and 20 years and beyond. The
cure is just around the corner argument may have been old in
1956; it is most certainly old now.
Why the relative lack of prevention research? We have heard
arguments that cancer research organizations are dependent on
proposals submitted by investigators. That is, of course, true,
but the agencies are far from helpless in this matter. In
short, prevention research could be moved ahead broadly and
effectively, if the will were there.
Another recent advance for the dominance of treatment
research is the need to deal with the life-threatening problems
of cancer patients now and in the future. We wholeheartedly
agree that these patients must not be abandoned, and that a
vigorous program of research on cancer treatment should
continue, though the level of effort must be balanced with
investment in a prompt major expansion of cancer prevention
research initiatives.
PREPARED STATEMENT
It is time for all of us to stop dreaming and to devise new
and realistic strategies to concur this disease. Prevention is
the key to future progress against cancer, and we hope that
this Congress will employ effective means to support research
toward that end.
Thank you, sir.
Senator Specter. Thank you very much, Dr. Bailar.
[The statement follows:]
Prepared statement of John C. Bailar, M.D.
Good afternoon. My name is John C. Bailar, III. I am Professor and
Chair of the Department of Health Studies at the University of Chicago.
I am here to talk about work I have recently done with my colleague Dr.
Heather Gornik on trends in cancer mortality
I am a retired commissioned officer of the U.S. Public Health
Service. I worked at the National Cancer Institute in Bethesda for 22
years, and since then I have held academic appointments at Harvard,
McGill University, and now the University of Chicago, where I am
Professor and Chair of the Department of Health Studies. For six years
I was Editor-in-Chief of The Journal of the National Cancer Institute.
For 11 years I was the statistical consultant for The New England
Journal of Medicine, and more recently I have been a member of the
Editorial Board of that journal. I have an MD degree (Yale, 1955) and a
Ph.D. in statistics (American University, 1973). I have a license
(presently inactive) to practice medicine in D.C. I was a MacArthur
Fellow from 1990 to 1995, and I have been elected to both the Institute
of Medicine and the International Statistical Institute. I have
published about 250 scientific papers of various kinds, as well as
several books. My 40-plus year career has been devoted to the
interpretation of statistical evidence in medicine, with special
emphasis on cancer.
A report of my research with Dr. Gornik was published recently (May
29, 1997) in The New England Journal of Medicine. In 1986 I published a
similar article in the same journal with Dr. Elaine Smith (314:1226-
1232; May 8, 1986). Both papers are included here as attachments. The
data are not in need of any revision, and our interpretation is up to
date, so Dr. Gornik and I will use this statement to address some
misunderstandings of our paper and to comment on some of the rebuttals
that have been offered.
In 1986, Dr. Smith and I found that cancer mortality rates had
climbed slowly but steadily over decades, and we concluded that the war
on cancer, at that time, should be judged a qualified failure. Our
current study finds little reason to modify that conclusion. The cancer
mortality rate (adjusted for changes in the population, including
changes in the risk of death from other causes) continued to grow
slowly but steadily, at a rate of about 1 percent per year, until very
recently. The cancer mortality rate has now plateaued and has started
to decline slightly (by a total of 1 percent during the three year
period 1991-94), but the 1994 cancer death rate was still 6 percent
higher than that of 1970. We believe that the present decline will
continue (though still at a slow rate), primarily due to the delayed
effects of reductions in tobacco usage several decades ago.
This six percent increase is a serious matter; it corresponds to
more than 30,000 cancer deaths per year beyond what the rates of 1970
would have caused, even after adjustment for increases due to growth
and aging of the population, and declines in deaths from other fatal
conditions.
Though there has been much interest in our findings and
conclusions, we have not heard any serious questions about the data we
present. All of the questions have been related to our interpretation
and conclusions, rather than the data. But we believe that the data
almost speak for themselves: the cancer death rate was increasing until
quite recently, and the small downturn now observed is largely a result
of decreased cancer incidence (primarily of lung cancer in men,
reflecting their turning away from tobacco several decades ago) and in
some cases, earlier detection. On the national level, treatment has had
little impact on total cancer mortality.
Changes in the death rate for all forms of cancer combined do not
tell the whole story. Cancer is a collection of many different
diseases, and the risk of death from some forms has been declining,
while it has been growing for others. Our analyses indicate that these
changes in cancer mortality, both up and down, have been largely a
result of changes in the occurrence of cancer, and sometimes in the
earlier detection of the disease, rather than a result of the
development of improved treatments. Despite some clear successes in
treatment, which we will return to, it is disappointing that the risk
of death from cancer is now so much higher than it was at the time of
passage of the National Cancer Act of 1971, and indeed higher than it
was at the time of the 1986 paper I published with Dr. Smith.
We conclude that past efforts, focused largely on treatment, have
not been generally successful, that there is now reason for skepticism
about whether they will ever be successful, and that it is time to get
serious about cancer prevention, so that treatment will be needed much
less often. Large decreases in the incidence of some forms of cancer
have been occurring with little intervention by the medical and public
health establishment, and targeted efforts to continue and extend these
welcome but unintended changes may produce great benefits. Tobacco-
related cancers are an exception, but the efforts even there fall far
short of advertising and other efforts to promote tobacco use.
We now turn to some of the misinterpretations of our study.
First, we are not questioning the value of treatment for cancer.
Treatments presently available in hospitals nationwide are already
curing about half of all cancers, and we should make maximum use of
whatever is known to work. And, the best of modern medicine has much to
offer all cancer patients--even those who cannot be cured of their
disease. There is no question that knowledgeable medical care can be of
great value to a cancer patient even when the cancer cannot be kept in
check indefinitely and will ultimately causes the patient's demise.
We have consistently tried to keep these advantages of present
cancer therapies in clear focus. In short, this not a dispute over
whether the glass is half empty or half full; we all agree that it is
half full. The problem is that it is the same half full that it was
several decades ago. National progress in reducing cancer death rates
has been spotty and, overall, not very successful.
We also emphasize that we are not attacking any persons. I know
many cancer research investigators, and they are uniformly dedicated
and honest scientists who are fully committed to the public welfare.
Unfortunately, many of them are also wrong, to the extent that they
continue to believe that the present division of effort between
research on cancer treatment and on cancer prevention is the best way
to deal with this dread disease.
We have been accused of unjustified, even destructive, pessimism,
but the real pathology here is unjustified optimism. While false hope
may have its uses, it can waste resources and, more importantly, direct
attention away from what really needs to be done, whether at the
conference table of our leaders in medical research or at the bedside
of a patient. In some ways, Dr. Gornik and I feel that our role has
become similar to that of the independent accountant, a part of whose
job is to curb the excesses of company managers who are fundamentally
sincere, but desperately want to find good news to sustain themselves,
their company, and their stockholders. Similarly, it seems that cancer
research managers and investigators have consistently, though
sincerely, overstated their progress and underestimated the problems
that remain, while the public has been sustained more by hope than by
accomplishment.
What are the successes? First, there has been marvelous progress in
reducing the cancer death rate among children and young adults. Cancer
mortality of persons under the age of 15 is only half of what it was in
1970, and is still declining. We might all agree that if we must begin
reducing the death rate in one place, cancer in children is that place.
To put these data in perspective, however, cancer deaths before the age
of 15 now make up only about one-third of 1 percent of total cancer
mortality in the U.S., and complete elimination of cancer at these
young ages would have little impact on the national death toll.
In addition to more effective care of cancers of children and young
adults, there have been major successes in treatment of some cancers in
adults, such as Hodgkin's disease and cancer of the testis, but all of
these, too, are relatively uncommon. For example in 1993, deaths due to
Hodgkin's disease and testicular cancer combined accounted for less
than one-half of 1 percent of total cancer deaths in the United States.
Past successes of treatment for these particular forms of cancer are
reflected in the present death rate, but further progress can have
little further effect on the national cancer burden.
In addition to these individual treatment victories, there have
been major advances in the palliation of most cancers. Cancer patients
can now live better lives, and in many cases, longer lives, than in
decades past. There is no question that it is better to have cancer in
1997, even incurable cancer, than it was 20 or 30 years ago. This is a
very important improvement.
More broadly, the national dedication to cancer research has
produced major advances in related fields of medical science, including
virology, immunology, genetics, and molecular biology, and these have
important clinical applications to other diseases. It was no accident
that the first major successes in research on AIDS were at the US
National Cancer Institute, where investigators had the knowledge,
skills, and facilities to deal with dangerous viruses. There have also
been important advances in medical imaging technologies and other kinds
of technology as a result of decades of dedication to cancer research.
However encouraging these advances may be, improvements in
scientific knowledge and even in palliation are not what we set out to
do in the ongoing war against cancer, nor should they be our present
goal. There is no substitute for a major reduction in cancer mortality
rates--a reduction which has not yet occurred despite decades of
targeted research.
The principal-counter argument that we have heard is that success
in treatment is near. ``We are almost there,'' we hear, ``Success is
just out of reach'' or ``just around the bend.'' Persistence will pay
off, we have been told, time and time again.
I have heard this argument for forty-one years, since I entered
cancer research in 1956. I heard it again, repeatedly and stridently,
after Dr. Smith and I published our paper in 1986. And if there are no
changes in the broad direction of our national cancer research
strategy, I expect to hear it again in another 10 years * * * in 20
years * * * and even beyond, as Dr. Gornik continues our work. The
``cure is just around the corner'' argument may have been old in 1956,
and it is most certainly old now, as cancer mortality remains near its
all time high. Remember interferon? Remember interleukin-2? Remember
the monthly, sometimes weekly, fanfare about great new advances against
cancer?
Another argument brought forward in response to our data is that
the lack of progress in reducing cancer mortality is because major
advances in treatment have been offset by large increases in cancer
incidence--increases that reflect new exposures to carcinogens. But
this argument in fact supports our conclusion. An increase in the true
incidence of cancer is an unmistakable flag of trouble that merits the
immediate and broad concern of the cancer research establishment and
the reallocation of substantial support to characterize, understand,
and interrupt the increase. Even if increases in incidence have been
largely contained by improvements in treatment, we still have an
obligation to identify and attempt to control the causes of the
increase. In any event, few persons who have had cancer would argue
against the statement that prevention would have been better for them
than treatment, which, regardless of ultimate effectiveness, is at best
inconvenient, and at worst, leaves the patient with painful, life-
altering, and disabling problems, many of which are permanent.
Why the relative lack of prevention research? We have heard
arguments that cancer research organizations are dependent on proposals
submitted by investigators. That is of course true, but the agencies
are far from helpless in this matter. For example, NIH is divided into
institutes precisely to assure attention to specific areas of great
public concern than might otherwise be under-studied. These institutes
have intramural as well as extramural programs, in part so that all
important matters can be covered without regard to what is proposed by
independent investigators. Requests for Applications and Requests for
Proposals, with special funding limited to defined narrow areas of
investigation, are remarkably effective in capturing and directing the
attention of investigators. NIH staff can provide targeted training,
equipment, and other encouragement where they feel that encouragement
is necessary.
Another reason advanced for the dominance of treatment research is
the need to deal with the life-threatening problems of cancer patients
who need care now, or who will need it in the years before a national
prevention program could become effective, or who will continue to get
cancer for reasons that remain beyond prevention. We wholeheartedly
agree that these patients must not be abandoned, and that a vigorous
program of research on cancer treatment should continue, though the
level of effort must be balanced with investment in the expansion of
prevention research.
A prompt, major expansion of cancer prevention research initiatives
at the National Cancer Institute and elsewhere is feasible as well as
needed. This change may be difficult and painful for both investigators
and institutions that have been dedicated to research on treatment, but
it is possible if we all have the will to make it work.
We have not addressed the issue of the overall budget for cancer
research in this country. Instead, we are arguing for a new balance
between prevention and treatment within the constraints of whatever
budget is provided. We have heard some critics say that our findings
should drive a massive expansion of the cancer research budget. That
may be the best way to go. However, we are not certain that anyone
would be harmed by substantial reallocations within the present NCI
budget. We understand the argument that one cannot predict where the
next important research finding will emerge, but we are not convinced
there will ever be such an advance. Further, while all funded research
is judged to be promising, some projects are readily identified as more
promising than others. We trust that decisions to reduce research on
cancer treatment, if necessary, will result in a leaner program that is
more focused on what is most likely to pay off.
We believe that Congress recognizes the need for a shift of
attention to prevention. After more than 20 years of little change, the
Public Health Service Act (Section 417B(d)) was modified in 1993 to
require a reluctant NCI to devote at least 10 percent of its budget to
a range of specified cancer control activities by 1996. This
requirement is being met on paper, but we have no way to tell how much
of the apparent change is real, as opposed to relabeling of ongoing
work, and even the full 10 percent would still be far too low.
What figure would be optimum? We cannot be sure; Dr. Gornik and I
have been working alone, without even grant support, and we have not
had the resources for a full analysis. However, it appears that the
treatment: prevention ratio has been about 4:1 exclusive of
administrative costs and research that is so basic that no direct
implications for prevention or treatment can be discerned (though
relabeling of applied research as basic may again be a problem). My
initial guess is that this should be partially reversed, to a ratio of
at least 1:2 in favor of prevention, but this (or any other) figure
requires detailed and entirely unbiased consideration by a panel of
experts.
After decades of tenacious dedication to treatment research, it is
time for all of us to stop dreaming and to devise new and realistic
strategies to conquer this dread disease. Prevention is the key to
future progress against cancer, and we hope that this nation will find
effective ways to support research toward that end.
Thank you.
SUMMARY STATEMENT OF DR. RICHARD KLAUSNER
Senator Specter. We now turn to Dr. Richard Klausner,
Director of the National Cancer Institute since August 1, 1995.
Since 1984 he has been the Chief of Cell Biology at the
Metabolism Branch of the National Institute of Child Health and
Human Development. A graduate of Duke University School of
Medicine, he began his research career in NIH in 1979.
Welcome Dr. Klausner. The floor is yours.
Dr. Klausner. Thank you, Senator Specter.
I am pleased to have this opportunity to discuss progress
and to respond to the article ``Cancer Undefeated.'' I want to
make eight brief points.
MORTALITY RATES
First is one overarching message that we all agree on.
Overall cancer mortality rates which had been rising all
century have finally begun to fall. The 1- to 3-percent drop in
age-adjusted mortality rates is just a beginning, representing
thousands of lives saved per year that would have been lost.
Second, to understand why mortality rates are changing, we
must move away from lumping all cancers together, and rather
examine each, for each is a different disease. We can look at
four examples.
Lung cancer.--The No. 1 killer, has a death rate that is
finally falling in men and in women under 65. The reason is
indeed prevention, and a drop in smoking rates.
Gastric cancer.--This has plummeted from the No. 1 killer
early in the century to the No. 8 now, and in fact, none of us
really know why.
Colorectal cancer.--This is the No. 2 cancer killer. Its
mortality has been falling for 20 years, due largely to early
detection. We believe that the recent evidence of a 30- to 35-
percent reduction in mortality following adjuvant treatment of
moderately advanced disease is and will continue to contribute
to the drop in mortality from this cancer.
Breast cancer.--There is a significant recent decline in
mortality that is likely the result of both early detection and
the widespread use of adjuvant treatment. All of the data
suggest that it is the latter, that is, treatment that explains
the bulk of this effect.
Third, we must take our victories against cancer where we
can. For that reason, a balanced approach to prevention,
detection, treatment, and the science that underlies all of
them must remain the driving principle of the NCI. Indeed,
prevention and treatment are often not readily separated.
Prevention is a high priority to the NCI. Prevention research
does and must include research into causes of cancer, or else
we cannot prevent it; identifying who is at risk from which
cancer; conducting prevention research; and direct prevention
interventions. It this year will amount to $911 million, or 38
percent of our budget.
Research into early detection of cancer crosses the line
between prevention and treatment. Early detection is of no
benefit unless you have effective treatment. Our investment in
treatment-oriented research, in contrast to what Dr. Bailar
says, amounts to $845 million, 35 percent of our budget. The
remaining 27 percent of our budget is targeted to cancer
biology training and education, which I consider to be part of
the foundation for prevention, treatment, or detection.
Senator Specter. How much of the budget is for prevention,
would you say, Dr. Klausner?
Dr. Klausner. If we define prevention as identifying causes
of cancer, as identifying who is at risk for cancer, conducting
what we call strictly prevention research, and direct
prevention interventions, it amounts to 38 percent of our
budget, and I would be happy to provide you with the details of
those numbers.
Senator Specter. Identifying the cause of cancer, who is at
risk, intervention, prevention----
Dr. Klausner. Yes, both prevention research, and direct
prevention interventions. For example, there is a new
burgeoning of clinical trials where we are now testing a whole
variety of prevention interventions, from behavior research to
new drugs. Many of those drugs began as treatment drugs.
Senator Specter. OK.
CANCER PREVENTION REVIEW
Dr. Klausner. Since I became Director 2 years ago, I have
commissioned a series of critical external reviews, and 2 days
ago I received the first-ever comprehensive report from a very
eminent panel of our country's cancer prevention researchers
that will help guide the invigoration of our cancer prevention
programs.
Fourth, progress is dependent upon knowledge. Our
investment in understanding the causes and characteristics of
cancer is essential if we are to develop effective
interventions, regardless of whether they are treatment or
prevention.
Fifth, progress takes time. The pace of progress against
cancer frustrates all of us. Whether we like it or not, to move
from an insider in observation to a tested successful human
intervention takes time, and there will always be a lag between
our investment and the payoff we are now actually beginning to
see.
Six, success is measured in multiple ways. While the
reduction in cancer mortality should be our ultimate goal,
there have been critical advances in the quality of life for
the 8.1 million cancer survivors; longer survival time after
diagnosis, time to spend with family and community; less
destructive and disfiguring surgery, so that people who would
have lost their voices can speak, people who would have lost
their limbs can walk, and many others can keep the function of
their bowel and bladder; better control of pain and
disabilities. These are all advances that benefit people,
advances that should not be dismissed.
Seven, the drop in mortality that we have recently seen can
be viewed as a fork in the road of our progress against cancer.
What do we do with this fork? I agree with Yogi Berra. When you
come to a fork in the road, take it. This year, over 1.3
million Americans will be diagnosed with cancer. While some
significant fraction of these cases are a failure of
prevention, even if all tobacco use stopped today, even if all
of us instantly adopted a perfect diet, we would still be
confronted with an enormous number of people who would be
diagnosed with cancer. These people cannot and will not be
written off because we have chosen one fork in the road and
decided that if you slip past prevention you are out of luck.
Our broad-based approach is working. It would be foolish to
abandon it.
And eighth, it is dangerous to make predictions, especially
about the future. While the past is prologue to the future, the
future is not easily predicted by the past. Before all of our
breakthroughs critics pronounced that we will never fly, never
wipe out smallpox or polio, or never cure a child with
leukemia. While cancer is still clearly undefeated, defeatism
is simply not supported by the current evidence. The promise of
ideal and total prevention of cancer may well contain as much
hype as Dr. Bailar sees in the over-promise of cure.
PREPARED STATEMENT
I believe that we can and must do better in our fight
against cancer. The past 2 years, I have worked to bring a
spirit of reevaluation and of real change to the NCI, to ensure
that our investment in understanding the causes and nature of
cancer are optimally linked to the development of new
strategies for prevention, detection, diagnosis, and treatment
which this collection of complex diseases demands.
Senator, I thank you very much for having the opportunity
to appear before you today.
[The statement follows:]
Prepared Statement of Richard D. Klausner, M.D.
Senator Specter, Members of the Committee--I am Richard Klausner,
Director of the National Cancer Institute. I am pleased to have this
opportunity to discuss progress against cancer and to respond to the
recent article in the New England Journal of Medicine entitled ``Cancer
Undefeated.'' I wish to make eight brief points.
First, there is one overarching message that we all agree on:
overall cancer mortality rates, which had been rising all century, have
finally begun to fall. The 1-3 percent drop in age-adjusted mortality
rates is, we hope, just a beginning--representing thousands of lives
saved per year that would have been lost.
Second, to understand why mortality rates are changing, we must
move away from lumping all cancers together and rather examine each
cancer, for each is a different disease or, indeed, a different set of
diseases. Let us look at four examples.
--(1) Lung Cancer.--This is the No. 1 killer whose death rate is
finally dropping in men and in women under 65 and the reason is
clear: the drop in smoking that began after the first Surgeon
General's report in 1964.
--(2) Gastric Cancer.--This has plummeted from the No. 1 killer in
1900 to No. 8 now, and we don't know why.
--(3) Colorectal cancer.--This is the No. 2 cancer killer. Its
mortality has been falling for 20 years due largely to early
detection, and we believe that recent evidence of a 30-percent
reduction in mortality following adjuvant treatment of
moderately advanced disease is and will continue to contribute
to the drop in mortality from this cancer.
--(4) Breast cancer.--The significant recent decline in mortality is
likely the result of both early detection and today's almost
universal use of adjuvant treatment. I believe it is the latter
that explains the bulk of the effect.
Third, we must take our victories against cancer where we can. For
that reason, a balanced and constantly re-evaluated approach to
prevention, detection, and treatment must remain the driving principle
of the National Cancer Institute.
Currently, we do have a large investment in prevention. This does
and must include research into the causes of cancer, identifying who is
at risk for which cancer, conducting prevention research and prevention
interventions, and amounts to $911 million or 38 percent of our budget.
Research into detection of cancer crosses the line between
prevention and treatment. Early detection is of no benefit without
effective treatment. Our investment in treatment-oriented research
amounts to $845 million or 35 percent of our budget.
The remaining 27 percent of our budget is targeted to cancer
biology, training, and education which I consider to be part of the
necessary foundation for prevention, detection, or treatment. Since I
became director, I have commissioned a series of critical external
reviews and two days ago, I received a comprehensive report from a very
eminent panel of our country's cancer prevention researchers that will
help guide the invigoration of our cancer prevention programs.
Fourth, progress is dependent upon knowledge. Our investment in
understanding the causes and characteristics of cancer is essential if
we are to develop effective interventions--regardless of whether they
are aimed at prevention or treatment.
Painstaking molecular, genetic and epidemiologic studies in
colorectal cancer are revealing real targets for preventing the
development of polyps, the precursors of colon cancer, and preventing
their progression to cancer. Cellular and molecular studies of the
hormone-dependent growth of breast and prostate cancer are allowing the
design of specific antagonists that are providing the first preventives
now being tested for these cancers.
Fifth, progress takes time. The pace of progress against cancer
frustrates all of us. Whether we like it or not, to move from an
insight or an observation to a tested successful human intervention
takes time, and this is why there will always be a lag between our
investment, the development of the critical knowledge base, and the
pay-off that we are finally seeing.
Childhood leukemia was not cured overnight. It took decades from
the first tentative use of anti-metabolites and genotoxic drugs to
achieve our current 70-80 percent cure rate.
Sixth, success is measured in multiple ways. While the reduction in
cancer mortality should be our ultimate goal, there have been critical
advances in the quality of life for our 8.1 million cancer survivors.
Longer survival time after diagnosis--time to spend with family and
community, less destructive and disfiguring surgery, so that people who
would have lost their voices can speak, those who would have lost limbs
can walk, and many others can keep the function of their bowel and
bladder, better control of pain and other disabilities--these are all
advances that benefit people, advances that should not be dismissed.
Seventh, the drop in mortality can be viewed as a fork in the road
of our progress against cancer. What do we do at this fork? I agree
with Yogi Berra ``When you come to a fork in the road, take it.'' This
year, over 1.3 million Americans will be diagnosed with cancer. While
some significant fraction of these cases are a failure of prevention,
even if all tobacco use stopped today, even if all of us instantly
adopted a ``perfect'' diet (recognizing that we don't know for sure
what the preventive efficacy is of changing diet), we would still be
confronted with an enormous number of people who will be diagnosed with
cancer. These people cannot and will not be written off because we have
chosen one fork in the road and decided that if you slip past
prevention, you're out of luck. Our broad-based approach is working. It
would be foolish to abandon it.
Eighth, it is dangerous to make predictions, especially about the
future. While the past is prologue to the future, the future is not
easily predicted by the past. Before all of our breakthroughs, critics
pronounced that we will never fly, never wipe out smallpox or polio, or
never cure a child with leukemia. While cancer is clearly still
undefeated, defeatism is simply not supported by our current data. The
promise of ideal and total prevention of cancer may well contain as
much hype as Dr. Bailar sees in the over promise of cure. I believe
that we can and must do much better in our fight against cancer. For
the past two years, I have worked to bring a spirit of re-evaluation
and change to the NCI to assure that our investment in understanding
the causes and nature of cancer are optimally linked to the development
of new strategies for prevention, detection, diagnosis and treatment
which this collection of complex diseases demands.
Thank you Senator Specter, for asking me to appear before you
today. I would be pleased to answer any questions.
PERCENT OF BUDGET
Senator Specter. Thank you, Dr. Klausner.
Dr. Bailar, you say you disagree with this headline, ``$30
billion war on cancer a bust,'' but you call it a qualified
failure. A qualified failure, as distinguished from an
unqualified failure. I am not saying you are wrong, but I have
seen few headlines about me that I like or anything that I have
said that I like. I do not know if the headline is too far off
as a real attention-grabber.
The information submitted some time ago by the NCI on
percentages, and I am going to ask you about this in a minute,
Dr. Klausner, is 11.53 percent spent for prevention. If you
have not seen it, let me have it made available to you.
Dr. Klausner. I have it here.
Senator Specter. Dr. Klausner now identifies a number of
prevention items which he says totals 38 percent. I would be
interested, Dr. Bailar, in your evaluation as to whether those
are really prevention items?
Dr. Bailar. I would not classify all of this as prevention
the way I define it. You could take a very comprehensive
definition and smuggle these in. I would not, for example,
include all of the work on the causes of cancer. Understanding
causes of cancer will not lead directly to saving any lives. It
may help in identifying carcinogenic agents that should be
removed, but much of it is focused on molecular processes that
might be of equal value in treatment or in other ways.
Similarly, some of the work on who is at risk of cancer I
think is not directly related to prevention unless those risk
factors are going to be modifiable. My figure is a good bit
less than 38 percent.
Senator Specter. What would your figure be?
Dr. Bailar. My figure would be on the order of 10 percent.
On the other hand, I would be more generous than Dr.
Klausner in the proportion of the budget targeted to cancer
biology, training, and education, which underlies everything.
He mentioned 27 percent. I might say 40 percent.
And I would not touch that 40 percent.
CANCER PREVENTION PERCENTAGE
Senator Specter. Dr. Klausner, how do you interpolate or
justify your current 38 percent estimate with the category
which you provided the committee some time ago, at 11.53
percent?
Dr. Klausner. In talking about trying to understand what is
needed for prevention, I strongly disagree with Dr. Bailar. I
think the idea of preventing something you do not know the
cause of----
Senator Specter. Before you disagree with him, answer my
question about 38 versus 11.5 percent.
Dr. Klausner. If we have the same table, it is broken into
epidemiology, causation----
Senator Specter. Well, that is why I wanted to give you my
sheet.
Dr. Klausner. OK. The epidemiology, causation and
carcinogenesis portion is 28 percent.
Senator Specter. Please do not read the whole chapter. Take
my percent. Well, I have got a sheet here that has 11.53
percent. Take a look at that, and I again ask you what is the
explanation for the difference between that document you
provided a long time ago and the 38 percent on prevention you
are testifying about now?
Dr. Klausner. There is a mandated line in the budget called
cancer prevention and control, which is to be approximately 10
percent.
Senator Specter. Who says it is to be approximately 10
percent?
Dr. Klausner. Ten percent is according to legislation. It
is determined in the law that 10 percent should be in cancer
prevention and control.
Senator Specter. Only 10 percent or a minimum of 10
percent?
Dr. Klausner. It is a minimum of 10 percent.
Senator Specter. It could be more?
Dr. Klausner. That is right. And above this, sir, is called
cancer causation, which is 27 percent.
Senator Specter. OK. So why did you say cancer prevention
was 11.3 and now say it is 38?
Dr. Klausner. Because when you add the about 10 percent for
cancer prevention and control, plus the 28 percent here listed
as cancer causation--that adds up to 38 percent. This budget
table was based upon reporting as we were asked for this, based
upon budget authorities.
Senator Specter. But if you thought cancer research was
really cancer prevention, you could have put it in earlier?
Dr. Klausner. Yes; I think it was for answering a different
question, but yes. We called it cancer causation--asking what
we are investing for our ability to intervene in cancer, I
think requires an investment in understanding the causes of
cancer.
Senator Specter. Now, Dr. Bailar, what would you recommend
as activities that NCI ought to undertake for prevention
research?
Dr. Bailar. It would be largely an expansion of activities
already underway. One is to identify and remove known
carcinogens, so that the cancer never gets started, never gets
a toehold. A second broad area is strengthening natural
defenses against cancer. This may be the most important overall
impact of the gross elements of diet--proportions of the major
dietary fractions, as opposed to trace contaminants.
A third area is what is called hemoprevention. That is the
development of drugs and drug-like materials that one can take
over a lifetime to interrupt the development and progress of a
malignant neoplasm. As I say, all of these things are in
progress. I think they are being done well. But I am calling
for a very substantial expansion in these.
I might add, sir, I take strong exception to the notion
that we must understand causation, that we must approach it as
if our understanding is necessary for any effective action.
This has not been true in a wide range of medical advances. We
knew about the beneficial effects of vaccination and
immunization, put them to good use before we knew how they
worked. The same is true of antibiotics. The early years of the
antibiotic era, we saved thousands, perhaps millions, of lives,
without knowing how antibiotics really worked. We knew that
they did work.
Dietary diseases is another example. We were able to block
the development of beri-beri, rickets, scurvy, and pellagra
without knowing the basic biology behind those. Even in lung
cancer, we knew that smoking was a very serious health threat,
that it caused most lung cancers, before we knew anything about
how it worked. So, in summary, I would say that we do not, in
general, need to know about causation in order to undertake
effective action.
I am not arguing against research on causation, but I think
it has to be kept in this kind of context.
BREAST CANCER ACTION PLAN
Senator Specter. Dr. Klausner, we have had some discussions
about the breast cancer action plan. And I know that there are
many who think that research is the only real line. We have had
the mobile mammograms, which came to Philadelphia. And some
people said, we really ought not to be investing in that kind
of detection. And there has been some revision in what was in
the last appropriations bill on the breast cancer action plan,
a fair amount of which is devoted to prevention.
Will the prevention aspects that are in the breast cancer
action plan be carried out under whatever arrangement has been
worked out? I have not yet resolved that with Secretary
Shalala. I wrote to her months ago, and have not had a formal
response to that. What is happening there?
Dr. Klausner. The action plan, of course, sits in the
Secretary's Office, in the Office of Women's Health. And we
have, and remain, available, and have been working very closely
with Dr. Blumenthal in order to help facilitate the type of
activities that Dr. Blumenthal and the action plan and that
planning process wants to do.
You are right, most are prevention. And we are working very
closely on--I think there are 15 projects that were identified.
Most of which are involved with prevention and education
outreach, that the NCI staff and expertise and mechanisms are
made available to help with the Office of Women's Health
studies.
Senator Specter. As I understand it, there was some concern
that that money ought to be going to research--we talked about
that at an earlier hearing. Do you think it ought to be
maintained in the prevention category?
Dr. Klausner. Oh, yes, I am very comfortable with these 15
projects that were identified, and we are working on them.
Senator Specter. And while it is not a part of the breast
cancer action plan, mobile mammography--digital, as I
understand it--came to Philadelphia. It seems to me that when
you talk about prevention, it does have multiple meanings--
education of women, making services available in the inner
city, as we had with Temple University Hospital. Now, that is
not research, but is that money well spent in your opinion?
OUTREACH
Dr. Klausner. I think it is. And we do much of that. I mean
outreach is very important, and education. And I think this
discussion about prevention is a very interesting one. There
are many ways to think about prevention. You have to define
what is it you are preventing. One can prevent the first
molecular change by preventing exposure to a carcinogen. Not
all of these molecular changes that lead to cancer come from
the outside. Those that do, you try to stop. There is also
prevention, preventing the cancer from developing, or
preventing the cancer from ever expanding or spreading.
As we learn more about cancer, in fact, I think this
knowledge will have the most impact in prevention. But what it
will do is greatly increase our definition and understanding
about multiple places where we can prevent what we want to
prevent, as Dr. Bailar says, which is death from cancer.
Senator Specter. Well, I am going to have to excuse myself
in a moment or two, but I want to ask you one more question,
Dr. Klausner, that we have talked about before; have you
committed yourself to funding for clinical evaluation of MRI
imaging in breast cancer?
Dr. Klausner. Yes; we have.
Senator Specter. That is something that I am particularly
interested in, because I had the benefit of an MRI myself. And
you learn most, I suppose, when you are most directly involved.
Senator Harkin is going to take over and preside. And, as I
said earlier, I had commitments that I am going to be late for
now. We have been very fortunate in having great experts here,
such as Dr. Bailar. You came from Chicago today?
Dr. Bailar. Yes.
CANCER
Senator Specter. Our schedule around here is just
extraordinary, with so many things we have to do. I consider
the work of this subcommittee a very, very high priority. And
cancer is right at the top of the list, as we try to get
additional funding for NIH. I thank Dr. Varmus for taking my
personal call on what the MRI is doing in heart conditions now.
I think you are doing phenomenal work.
I compliment you again, Dr. Klausner, and, Dr. Varmus,
Director of NIH. Senator Harkin and I are determined to find
extra money for NIH somehow, although we are not sure where. It
may be from Riggs National Bank at gunpoint. [Laughter.]
Senator Harkin agrees, as a coconspirator, an active
coconspirator--we are determined to find you the money.
Senator Harkin. I am driving the getaway car, you are doing
the stickup.
Senator Specter. OK. [Laughter.].
And, Dr. Bailar, I compliment you on producing that
headline, whether you agree with it or not. Because I think
that the debate is really very good. And I know your
qualifications as a researcher, and I admire them. And I
believe growth comes out of controversy.
It stimulates thinking. I am just sorry we cannot do more
today. I know that Senator Harkin will have very incisive
questions, and will move the ball along tremendously.
Thank you very much. I yield now to my distinguished
colleague, who has had very substantial experience presiding
over this subcommittee, as its previous chairman.
Thank you.
Dr. Klausner. Thank you, Senator.
Dr. Bailar. Thank you.
Senator Harkin [presiding]. I knew if I waited long enough,
I would get it back. [Laughter.]
First of all, I apologize for being late and not hearing
your testimony, but I have read it over. And I really do not
have a lot of incisive questions at all. I just have a couple
of issues that I want to cover.
I agree with Senator Specter, Dr. Bailar and Dr. Klausner,
I agree that it is good to have this debate. I think we ought
to be taking a look at this. The headline in the USA Today:
``$30 billion war on cancer a bust.'' I mean it is pretty
provocative. I know you did not write the headline, but it is a
provocative headline and it gets people thinking. And maybe we
all ought to think about this, what direction we ought to go
in.
So I agree with Senator Specter in that regard, that out of
this could come a good dialog and debate and discussion about
what avenues of research we ought to be pursuing.
Now, I am all for prevention. And I think my history in
legislation has been one of promoting more prevention in a lot
of programs. I guess the one thing I just have to ask, Dr.
Bailar, if you are going to talk about prevention, though, you
have got to talk about what to prevent--what is causing cancer.
That is a very simple straightforward question. What causes
cancer?
Dr. Bailar. That is an extremely complicated, technical
kind of question, as you recognize.
Senator Harkin. Yes.
Dr. Bailar. On the other hand, as I have already sort of
flagged, I am not sure that we have to understand the causes in
order to prevent cancer. If we are going to identify specific
carcinogens and remove them from the environment, yes. But
strengthening body defenses in one way or another--the cancer
chemopreventive agents that I talked about--can act, I think,
without any real understanding of the individual causes of each
form of cancer.
That is one of their glories, that you do not have to deal
with cancer--I suspect, in the long run, we will find--that you
do not have to deal with cancer as a collection of 100, 200,
300, or 400 diseases if we can work effectively along those
avenues of attack.
Senator Harkin. But it seems to me, if we do not know the
cause, how are we going to prevent it? If we did not know the
cause of smallpox, we could not prevent it. If we did not know
the cause of polio, we could not prevent it. If we are out
there flailing around, we could come up with all kind of crazy
things. I would like to get a better understanding of how are
you going to have a preventative scheme if we do not have some
better understanding of the cause.
Dr. Bailar. Senator, we were preventing smallpox before we
knew the cause.
Senator Harkin. We were?
VACCINATION
Dr. Bailar. A century or more before we knew about the
smallpox virus, vaccination was being effective in saving very
large numbers of lives. Acute clinical observation showed that
persons who had been infected with a related disease, called
cowpox, simply did not get smallpox. And that was the original
source of this notion of vaccination, which----
Senator Harkin. OK, you may have bested me there. How about
polio?
Dr. Bailar. Polio, we did know about the virus at the time
the vaccine was developed.
Senator Harkin. It seemed to me we had to find out what
kind of virus it was. And there was a lot of research--I happen
to know a little bit about this--which Dr. John Enders and
others did at Harvard, to find the intervention. But, first,
they had to understand what was causing it, it would seem to
me.
Dr. Bailar. Well, polio may be a good example of that.
Senator Harkin. OK, so we are even on it. OK, we are even.
[Laughter.]
Let me see if I can think of another one here.
Dr. Bailar. Maybe I can give you one.
Senator Harkin. OK.
Dr. Bailar. Scurvy.
Senator Harkin. What?
Dr. Bailar. Scurvy. Which used to be very devastating in
navies and other populations that were away from fresh fruits
and vegetables for long periods of time.
Senator Harkin. I have read my history, yes.
Dr. Bailar. And an English naval surgeon, John Lent,
discovered that giving sailors lime juice would prevent scurvy.
Senator Harkin. OK.
Dr. Bailar. He did not have the foggiest idea what was
going on, but it worked.
Senator Harkin. OK, fine. I believe that is a good
approach. I have had some arguments with NIH about an approach,
about looking at different ways of saying, OK, if you have a
group of people out there and they have had spontaneous
remissions of cancer, we ought to get a matrix done of who they
are, what they have come from, what they have done, to see if
there is connecting points. We have talked about that before. I
have talked about that before.
But it seems to me, with cancer, though, since there are so
many different forms and varieties and how it starts and how it
spreads, can you show me or can you give me any idea of any
study that has been done to show where, if you do A, B, and C,
you are not going to get cancer? Or if you do this or if you do
not do this, the results will be different?
Dr. Bailar. I think the----
CIGARETTE SMOKING AND LUNG CANCER
Senator Harkin. I know of no valid scientific study that
shows that. And I do not know how you would ever set one up.
Dr. Bailar. I think the history of our understanding about
the relation between cigarette smoking and lung cancer is an
example of that. It was clear that there was a cause-and-effect
relation before 1964, at the time of the first Surgeon
General's report. Nobody knew what the cause was. There was
educated guessing that it was tar or nicotine or possibly just
the heat that was in the tobacco smoke that might damage cells.
But we did not know what was going on at the molecular or
cellular level.
What we knew was that if you get people to stop smoking,
that the rate of lung cancer would, in time, start going down.
And that has happened.
Senator Harkin. OK. We know that smoking does cause lung
cancer.
Dr. Bailar. Yes.
Senator Harkin. But we also know--I have known people that
smoked all their life and never got lung cancer.
Dr. Bailar. Yes.
Senator Harkin. So something else is going on. I mean I can
take some people that live an awful lifestyle, they drink, they
smoke, they eat the worst possible kind of foods, they are
exposed to all the worst kinds of chemicals, they never get
cancer. I can show you people that live virtuous lives, never
drink, never smoke, eat the best kinds of foods--vegetarians--
and they get cancer. See, I do not know of any--what is the
word I am looking for--any cohort of individuals that you can
point to, that because they lived a certain way, ate a certain
way, did not do this or did this, were immune from cancer.
Dr. Bailar. I agree with you. And I am not sure to what
extent this is a result of just random chance--luck--that it
affects groups of people. You may have a group of persons in
whom the risk of cancer, person by person, is increased,
perhaps quite a lot, but still not 100 percent, so some will
get the disease and some will not. There may also be some
element, a substantial element, of individual variation in risk
that we do not know about and might be able to exploit if we
did know.
There has been research to try to identify reasons why some
people are at high risk and others are not. I do not think it
has been applied across the board in the way that it might. But
there certainly are some kinds of cancer where we know a good
bit about the risk of individuals, you know, as opposed to
their neighbors or even their close relatives.
Senator Harkin. I tend to agree to a certain amount that
diet does have something to do with it. There seems to be a lot
of evidence out there about that--not firm, but some. And you
can look at other societies and other countries, where they
have a different diet than ours, and their incidence of certain
kinds of cancer are less than ours.
Dr. Bailar. Yes.
Senator Harkin. And we know that.
Dr. Bailar. Yes.
SKIN CANCER
Senator Harkin. But it is just like skin cancer. They say
to use a sunscreen and do not go out in the sun. Yet there are
countries, high altitude, where people live at very high
altitudes, exposed to extremely high amounts of ultraviolet
radiation, and never get skin cancer.
Dr. Bailar. Yes; the evidence is actually stronger than
what you have indicated. There have been a number of studies
now of populations that have migrated from one area to another.
And what is generally found is that within 15 to 25 years,
those who migrate begin to acquire the cancer risks of the
place they went to.
Senator Harkin. I understand that.
Dr. Bailar. They have been compared with siblings and
others who stayed back in the country of origin, and it takes
about that long before there are major changes in cancer risk.
I think that is abundant evidence that there is something in
our environment, very broadly defined, that is determining most
of our cancer risk. We do not know what it is in most cases.
Senator Harkin. Why is it that, in certain places, the
incidence of skin cancer has gone up? And people say, well, it
is sunlight exposure. Yet, you get to the higher reaches of
Tibet and Nepal and places like that, where people are living
at 12,000 to 15,000 feet, with absolutely no interference
between them and ultraviolet radiation, and they do not have
that problem. Why is that?
Dr. Bailar. Well, first, I think they do have the problem.
It may not be as great as it is here.
Senator Harkin. No; it is certainly not.
Dr. Bailar. It looks like a small problem because large
parts of those populations do not live to the ages where skin
cancer would be common. Beyond that, they have darker skin than
most people of Western European origin, and the skin
pigmentation may be important in this. I suspect that there has
been some degree of natural selection. That is, their
ancestors, who moved to the high altitudes, with very intense
exposure to ultraviolet light. Not all survived to reproduce
and have children because of the skin cancers and other
conditions that might be related to that exposure, so that
their descendants are more resistant.
It is possible to spin out a number of theories about this,
I am sure.
Senator Harkin. Could it be possible, Dr. Bailar, that 100
years ago, 150 years ago, our ancestors, my grandparents and
great grandparents, that had they lived beyond the age of 50
years, that there might have been a lot more cancer in those
days than we are having today?
Dr. Bailar. I am sure that there would have been. I would
like to just inject here that the figures that I have been
talking about--I believe all the figures that Dr. Klausner has
talked about here and elsewhere--have been what is called age
adjusted to remove the effect of the changing age distribution
of the population at the same time to remove the effect of
changes in other causes of death.
Senator Harkin. But that is comparing today.
Dr. Bailar. No; it is comparing over time.
Senator Harkin. I do not understand that.
Dr. Bailar. The age adjustment says if you had a population
under a certain set of cancer risks, with the age distribution
in a specific standard that you choose, what would have
happened? So that your great grandfather, whoever, from an
earlier era, was in a population that was, on the whole, a
great deal younger. Now, the question the age adjustment asks
is, what happens if we allow those people to get older--to have
the current age distribution or the age distribution in 1990 or
whatever, what would we be observing?
Senator Harkin. I guess some of that data I would not
trust. Because I have some personal knowledge of deaths that
occurred in older times and records were not kept that well.
And people died of the consumption. They did not know what it
was. And they died of the ills. And, you know, who knows what
it was? And so I do not accept a lot of that data of previous
times.
Dr. Bailar. I agree, sir. And I do not myself go back
beyond 1950 in any of this.
Senator Harkin. Yes; that is getting into pretty modern
times. I am just saying I am not certain how long the plague of
cancer has been with us. That is my point.
Dr. Bailar. From antiquity.
Senator Harkin. Well, I think so.
Dr. Bailar. Egyptian mummies have had evidence of cancer.
Senator Harkin. And I think so. And I am just saying, if
people lived longer, maybe the incidence would have been just
as high then as it is today. I do not know.
Dr. Bailar. Yes, sir.
PREVENTION
Senator Harkin. I have no way of knowing that. My basic
premise, getting back, is that I am all for prevention. But it
seems to me we still have to--how are you going to prevent what
you do not know is causing something? You can take shots in the
dark, and that is fine. And we can take a shot in the dark. We
can all change our lifestyle and change our diets and hope for
the best. I think changing our diets would help us live better.
It would help us feel better. We would have better lives. We
would be healthier. Our hearts would be better. And we would
probably live longer, and we would have a better life.
But I am not so certain in my own mind that that alone is
where we ought to focus as much resources as I think you are
wanting us to focus in the fight against cancer. And that is
what I am concerned about. I want to find out what is the root
cause. What is causing those cells to go haywire? I think if we
find that out, then it seems to me that is when we can start
finding out the cures and the preventions of them.
Dr. Bailar. With respect to diet, we already have a good
many indications that a class of vegetables that includes
cauliflower, broccoli, brussels sprouts, and so forth is in
some way, somewhat protective. Now, that may be information
that could be more thoroughly checked. I do not regard it as
absolutely established. But if we learn that there is that kind
of correlation, if it appears on further study to be cause and
effect, there is something that we could recommend right now in
a much more vigorous way than we can, without understanding the
mechanisms.
I am not opposed, sir, to understanding mechanisms, but I
think we ought to get on with what we can do now, whether it is
in terms of implementation or research, based on these kinds of
hints that I have mentioned.
Senator Harkin. Well, I think there is room for that.
I do not know the discrepancy, Dr. Klausner, between your
figures and Dr. Bailar's, in terms of what percent of NCI
funding goes for prevention. I do not know what that is all
about. You are saying 38, you are saying 10, I do not know what
that is all about.
Dr. Klausner. Well, you heard it. Dr. Bailar thinks that
doing research into the cause of cancer, whether that is doing
research to originally identifying that tobacco is a cause of
cancer--this idea that cause only means molecular cause or
subatomic cause and cellular cause. What you do is you look for
mechanisms at the level of cause that tells you how to
effectively intervene. It is an operational definition.
The reality is that the more we know about the components
of tobacco, the better we are at effecting the prevention that
Dr. Bailar would like us to do. Even with tobacco, knowing that
nicotine is in tobacco delivery systems and that is addictive
is extremely important in effective prevention. Remember, we
have known that tobacco has been the cause of cancer for quite
some time. The first case-controlled study was in 1939,
published in Germany.
But, actually, what you have to do to effect that
prevention is very difficult. And the more we understand about
who is at risk and why, including aspects of the mechanism,
gives us more and more powerful tools at intervening, whether
it is intervening with addiction, intervening behaviorally.
This all takes research.
If we try to turn this discussion into this type of black
and white, you either just prevent sort of magically, whether
you know or do not know, or you need to know down to the
quarks--we are not saying that. What we are saying is that the
way scientists work is you establish definitively connections
that allow you to predictably act. Whether that means you
totally understand mechanism or very vaguely understand
mechanism, but understand enough of what your intervention is,
whether it is prevention or treatment, that it be predictable
in terms of its outcome. That is what science does for you. And
it is a complete continuum.
CHEMOPREVENTION
Dr. Bailar mentioned chemopreventions, as if we would just
throw chemicals at people without knowing why and how they
work. Now, there are chemicals that we would give to people
because of observational studies, such as aspirin or
nonsteroidal anti-inflammatories, to prevent cancer. But I will
tell you that that is a great example of studying the molecular
mechanisms, which gives us what appears to be the precise
molecular target of aspirin in that pathway--an enzyme we think
is called Cox-2; we think that is the precise target; we think
we can prove it--now allows us to say, well, aspirin does it.
Since that is not a specific inhibitor, only an inhibitor
of that enzyme, if that is the enzyme that gave that
observational effect, knowing that connection allows us now to
design and test, which we are now doing, chemopreventative
agents to prevent colon cancer. That may well be one, two, or
five steps better than this sort of--the information we get out
of these observational studies. And it is just another example
that what we want to do, we want to do well, and we want to
make sure that we optimize it.
It is true what Dr. Bailar said, we did not know how
antibiotics worked when they were discovered. But we very
quickly learned about their structure, where they are made and
how they work. And that allowed us to develop the enormous
explosion of antibiotics. So it is true, it is not a black and
white; we need to know how everything works. But all of our
history tells us, the better we know how it works, the better
we can intervene, with fewer side effects and directed at the
people that most need it. And that is really what we are
talking about.
I mean the more I listen to Dr. Bailar, as he has said to
me, the less we seem to disagree. We need to know things to the
point where we can successfully intervene.
Senator Harkin. I do not know if I have any followup to
that--other than I know a lot of people are frustrated, me
included, because we are not getting some of the answers. But,
again, I would submit, perhaps, Dr. Bailar, something that
Senator Specter mentioned, and that is that we declared war on
cancer in 1971?
Dr. Bailar. 1971.
Senator Harkin. And we immediately beat a hasty retreat.
And so if the war on cancer is a bust, it is because we never
really fought it. People say $30 billion is a lot of money. You
know, in the scheme of things, it really is not.
Dr. Bailar. I agree.
Senator Harkin. And I keep pointing out, and I keep
pointing out to a lot of people I see--those who watched the
gulf war on television and saw all those smart bombs go down
those chimneys and all those missiles intercepting missiles and
all those wonderful things we have to protect our country and
keep us free--it is wonderful. It came about because of
military research.
In the last 5 years--Dr. Klausner is getting sick of
hearing me say this--I say it everywhere I go--you could spread
the gospel; you could spread the word--in the last 5 years, we
have spent more money out of this Congress on military research
and development than we have on all biomedical research since
the turn of the century--cancer, Alzheimer's, diabetes, heart,
polio, everything. Add it all up. More in 5 years--and I can
show you the numbers, I have got them--5 years, more on the
military than we have on all biomedical research since the turn
of the century.
And we have got smart missiles and we have got smart bombs;
we can do anything. But just think what we could do, instead of
opening--what is it now--one out of four doors--if we could
open four out of five. Then maybe we could start making some
advance on this.
So I do not know if the war has been a bust, I just do not
think we ever really fought it. We just kept kind of low-level
combat going on that does not win anything. It just sort of
keeps it going. And we have had some success. People do live
longer. We have had some successes in certain forms of cancer.
There is no doubt about it--that some early intervention
programs and chemo and others--radiation therapy and other
drugs have certainly kept people alive longer and added to the
quality of their life.
I am sorry, I have to go. I am sorry to have to abruptly
end this like this, but thank you both very much. I appreciate
it.
Dr. Klausner. Thank you.
Dr. Bailar. Thank you, Senator Harkin.
Senator Harkin. Thank you, Dr. Bailar, and thank you, Dr.
Klausner.
CONCLUSION OF HEARINGS
Senator Harkin. That concludes our hearing, the
subcommittee will stand in recess awaiting the call of the
Chair.
[Whereupon, at 4:33 p.m., Thursday, June 19, the hearings
were concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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