[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
WOMEN'S HEALTH: RAISING AWARENESS OF CERVICAL CANCER
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
HEALTH AND ENVIRONMENT
of the
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
MARCH 16, 1999
__________
Serial No. 106-4
__________
Printed for the use of the Committee on Commerce
U.S. GOVERNMENT PRINTING OFFICE
55-639CC WASHINGTON : 1999
------------------------------------------------------------------------------
For sale by the U.S. Government Printing Office
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------------------------------
COMMITTEE ON COMMERCE
TOM BLILEY, Virginia, Chairman
W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas RALPH M. HALL, Texas
FRED UPTON, Michigan RICK BOUCHER, Virginia
CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey
Vice Chairman SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee
CHRISTOPHER COX, California PETER DEUTSCH, Florida
NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma ANNA G. ESHOO, California
RICHARD BURR, North Carolina RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California BART STUPAK, Michigan
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
GREG GANSKE, Iowa THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma GENE GREEN, Texas
RICK LAZIO, New York KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio
JAMES E. ROGAN, California DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING,
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland
James E. Derderian, Chief of Staff
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health and Environment
MICHAEL BILIRAKIS, Florida, Chairman
FRED UPTON, Michigan SHERROD BROWN, Ohio
CLIFF STEARNS, Florida HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia PETER DEUTSCH, Florida
RICHARD BURR, North Carolina BART STUPAK, Michigan
BRIAN P. BILBRAY, California GENE GREEN, Texas
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma LOIS CAPPS, California
Vice Chairman RALPH M. HALL, Texas
RICK LAZIO, New York EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING, (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Cox, John Thomas, Student Health Services, University of
California at Santa Barbara................................ 82
Eshoo, Hon. Anna G., a Representative in Congress from the
State of California........................................ 6
Gatscha, Rosemarie, Cytology Manager, American Society of
Clinical Pathologists...................................... 91
Lee, Nancy C., Associate Director for Science, Center for
Disease Control and Prevention............................. 22
Lenhart, Sharyn, Immediate Past President, American Medical
Women's Association........................................ 88
Lowey, Douglas R., Deputy Director, National Cancer Institute 27
Mack, Hon. Connie, a United States Senator from the State of
Florida.................................................... 8
Piker, Linda Grace, Cervical Cancer Survivor................. 73
Trimble, Edward L., Head Surgery Section, National Cancer
Institute.................................................. 26
Valdiserri, Ronald O., Deputy Director, Center for Disease
Control and Prevention..................................... 16
Material submitted for the record by:
Center for Cervical Health, prepared statement of............ 101
Center for Disease Control, responses to questions for the
record..................................................... 132
Lowey, Douglas R., Deputy Director, National Cancer
Institute, letter dated April 8, 1999, enclosing response
for the record............................................. 105
Trimble, Edward L., Head Surgery Section, National Cancer
Institute, letter dated April 8, 1999, enclosing response
for the record............................................. 103
(iii)
WOMEN'S HEALTH: RAISING AWARENESS OF CERVICAL CANCER
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TUESDAY, MARCH 16, 1999
House of Representatives,
Committee on Commerce,
Subcommittee on Health and Environment,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:57 p.m., in
room 2123, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman) presiding.
Members present: Representatives Bilirakis, Stearns,
Greenwood, Bilbray, Ganske, Coburn, Lazio, Bryant, Brown,
Green, Barrett, Capps, Towns, and Eshoo.
Staff present: Lori Wall, majority counsel; Marc Wheat,
majority counsel; Mike Flood, legislative clerk; John Ford,
minority counsel, and Kristi Guillory, minority legislative
fellow.
Mr. Bilirakis. The hearing will come to order.
Today the subcommittee will hold the first in a series of
hearings on women's health concerns by focusing on the issue of
cervical cancer, its causes, and its treatments. Each year
approximately 15,000 women are diagnosed with cervical cancer
in the United States, and almost 5,000 die annually from the
disease. Troubling evidence also shows a higher incidence of
cervical cancer among minority and disadvantaged populations.
The tragedy of these statistics is compounded by the fact that
cervical cancer is readily treatable if caught at an early
stage.
Last year I sponsored legislation which was enacted into
law to reauthorize the National Breast and Cervical Cancer
Early Detection Program at the Centers for Disease Control and
Prevention. This women's health initiative had strong
bipartisan support, including the subcommittee's ranking
member, Mr. Brown, the full committee chairman, Tom Bliley, and
the full committee ranking member John Dingell.
Today we will learn about recent progress in the fight
against this terrible disease. We know that the primary risk
factor and leading cause of cervical cancer is the human
papillomavirus or HPV, a sexually transmitted disease. Experts
estimate that 24 million Americans are infected with HPV, and
the incidence of this virus may be increasing.
The good news is that the human immune system can normally
clear the virus within 18 months. As a result, many women do
not realize they have contracted HPV and they never suffer any
health consequences from it. Unfortunately, that is not always
the case. It is critical that all women understand the threat
of cervical cancer and the importance of regular Pap smear
exams. We must increase awareness of how it is transmitted and
the importance of early detection. We must also improve methods
of detecting the presence of pre-cancerous lesions that develop
into cervical cancer.
Later this year I will be participating in a women's health
fair in my congressional district. I encourage my colleagues to
help educate the public about this disease and other women's
health concerns. In that regard, I want to commend the efforts
of Senator Connie Mack of my home State of Florida, and
Representatives Juanita Millender-McDonald, Rick Lazio, and Tom
Coburn in sponsoring a resolution to raise awareness of
cervical cancer.
Let me also thank our witnesses for taking the time to join
us today, and again extend a special welcome to my Florida
colleague, Senator Connie Mack. Connie, do you have the time to
wait for the opening statements before testifying?
Senator Mack. Sure.
Mr. Bilirakis. Okay. I first want to applaud the work that
you and Priscilla have done in the fight against cancer. You
certainly will be missed in the Senate, but I trust your
leadership in these issues will continue.
I now recognize the ranking member, Mr. Brown of Ohio.
Mr. Brown. Thank you, Mr. Chairman, for arranging this
hearing. I would also like to thank Senator Mack and
Congresswoman Eshoo for their fine work, and our other
distinguished panelists today. While I am pleased that the
subcommittee will hear from a wide range of witnesses, I am
disappointed that it was not possible to include a
representative from the College of American Pathologists. This
organization, representing some 16,000 physicians, offers a
unique perspective on the detection, diagnosis, and treatment
of cervical cancer. Their input would have been extremely
valuable.
The tragedy of cervical cancer is twofold. It is tragic
that hundreds of thousands of women confront this disease, a
profoundly debilitating and deadly illness. It is tragic that
cervical cancer remains such a virulent killer, when it is
within our power to prevent it. Cervical cancer is a national
and international public health issue. It accounts for 6
percent of cancers diagnosed in women in the United States,
taking nearly 5,000 lives. Worldwide, more than 470,000 new
cases are diagnosed each year.
In both industrialized and non-industrialized nations,
cervical cancer takes its greatest toll on those individuals
least able to fight back, minority populations and the economic
disadvantaged. Cervical cancer deaths can be virtually
eliminated through behavioral changes, early detection, and
timely access to treatment, all of which hinge on public
awareness. Public awareness fuels change. It can generate the
individual and collective actions necessary to achieve a
meaningful reduction in cervical cancer rates.
The public needs to know that safe behaviors and proper
screening can reduce cervical cancer death rates dramatically.
We need to get them the facts about screening test accuracy,
new detection methods, and treatment breakthroughs, so they can
play an active role in prevention and treatment decisions. We
need to emphasize the potential inherent in a national
commitment to combat this disease.
The public needs to know about initiatives like the CDC's
Breast and Cervical Cancer Early Detection Program, which has
reached millions of uninsured women with free screening tests.
Public awareness can help us gather the resources needed for
CDC and its State and local partners to do more than scratch
the surface of this problem. As currently funded, the CDC
program reaches only 15 percent of uninsured women. We can do
much better than that.
We need to spread the word about initiatives like H.R.
1070, legislation introduced by Ms. Eshoo, which would ensure
proper treatment for women who are screened under the CDC
program and diagnosed with cancer. Diagnosis is a cruel and
fiscally irresponsible exercise when women diagnosed with
cancer have no access to treatment, as happens all too often in
this society.
Finally, we must all become more sensitive to potential
barriers blocking proper cervical cancer screening. Pap smears
have dramatically reduced cervical cancer deaths, and it is
critical that we do everything in our power to ensure their
continued availability.
In that context, we must be vigilant in evaluating the
adequacy of Federal reimbursement for Pap smears. Medicare and
Medicaid reimbursement directly affects access for two
populations particularly vulnerable to cervical cancer: low-
income individuals and the elderly. Since private reimbursement
is often based on Federal payment rates, our actions indirectly
affect millions of women with employer-sponsored or individual
insurance coverage. It is imperative that Federal reimbursement
accurately reflect the true costs of performing and evaluating
Pap smears.
Inadequate data on cervical cancer incidence rates is one
of our greatest obstacles, a problem to which too little
attention is paid. Our current data lumps different
subpopulations together, potentially masking wide variations in
cervical cancer rates. It is critical to understand these
differences in order to target prevention and treatment
initiatives appropriately. Knowledge fuels advocacy, and in the
case of cervical cancer, advocacy will save countless lives.
That is why today's hearing on cervical cancer awareness is so
valuable.
Mr. Bilirakis. I thank the gentleman. The Chair recognizes
the gentleman from Oklahoma, Dr. Coburn.
Mr. Coburn. Thank you Mr. Chairman. I, too, want to
congratulate you on having this hearing. This is a subject
matter which, unfortunately, I know way too much about. Last
year I treated over 200 women with carcinoma in situ of the
cervix. Seven of those had invasive carcinoma. But there were
thousands that went through our clinic that had cervical
dysplasia.
Not only is the knowledge not out there, the government
entities, in terms of this disease, have done a miserable job,
in my estimation, of raising public awareness of this. We are
not just talking about cervical cancer. There are studies now
that show that the human papillomavirus can be transmitted from
the mother in utero to her child; that, in fact, you can
culture newborn children about 40 percent of the time with this
virus. It is theoretically possible that a young woman never
exposed could die of carcinoma of the cervix because she
contracted that virus in utero or at birth.
There are many studies that are ongoing now to look at
these issues. My fear and my worry is not that we will make
awareness of these issues possible, but that we will somehow
average and marginalize the best public health policy for
preventing this disease.
I look forward to the testimony that we have and I yield
back my time.
Mr. Bilirakis. I thank the gentleman. The gentlelady from
California, Ms. Capps.
Mrs. Capps. Thank you Mr. Chairman. I appreciate that you
are holding this hearing today on such an important topic,
raising awareness of cervical cancer, and I want to welcome all
of the witnesses.
Senator Mack, I know that you are representing Priscilla as
well.
My colleague, Anna Eshoo, a leader in this area, I look
forward to hearing from you.
I want to particularly welcome one of our expert panelists
today, Dr. J. Thomas Cox, who is a constituent of mine from the
University of California at Santa Barbara. An accomplished OB-
GYN, Dr. Cox oversees student health services at UCSB, where he
runs a program that screens thousands of women for cervical
cancer each year. He is an expert in the area of cervical
cancer treating, and will today share his broad knowledge on
the problems associated with present cervical cancer screening
and opportunities to improve this system. I am so proud that
Dr. Cox is here to represent the medical expertise worldwide
and at UCSB in the 22nd district of California.
As a nurse, I have seen firsthand how important it is to
raise awareness of cervical cancer, especially since it is so
highly treatable if caught early. The vast majority of cases of
cervical cancer are caused by the human papillomavirus,
otherwise known as HPV, a sexually transmitted agent that
infects the cells of the cervix and slowly causes cellular
changes that can result in cancer. Women are often infected
with HPV in their teens, 20's or 30's, though the disease can
take up to 20 years after the HPV infection starts before the
development of the disease begins. It starts with an in situ
stage that can be treated, but then as it progresses to an
invasive disease, it can often be fatal.
Cervical cancer prevention efforts worldwide have focused
on screening women at risk of the disease through Pap smears
and treating pre-cancerous lesions. Where screening quality and
coverage have been high, these efforts have reduced invasive
cervical cancer by as much as 90 percent, and that is a
remarkable number. Since pre-cancerous and very early cervical
cancers are nearly 100 percent curable, this test can prevent
nearly all deaths from cervical cancer.
In reading the remarks that Dr. Cox has prepared for
today's presentation, I learned that the decrease in the rate
of cervical cancer in the United States is so dramatic that Pap
smear screening is one of the few interventions to receive an
``A'' recommendation from the U.S. Preventive Services Task
Force, and that is quite an endorsement. Pap smears have
changed the way we approach the problem of cervical cancer, but
even with all of our medical advances, there is so much more
work to do. Women need more education about cervical cancer and
the associated risk factors, including this link with HPV.
Our challenge now is to provide those who have been slow to
seek out screening, very often low-income women, with screening
opportunities and with access to treatment. And so, just this
week, I was honored to join with Congresswoman Anna Eshoo and
Congressman Rick Lazio in introducing the Breast and Cervical
Cancer Treatment Act. This bipartisan bill gives States the
option to provide Medicaid coverage to uninsured or
underinsured women who have been diagnosed through the National
Breast and Cervical Cancer Early Detection Program, a screening
program for low-income, uninsured, or underinsured women. Women
who are screened through this program often cannot afford
treatment. All of the screening in the world won't help if
women who are diagnosed with the disease do not have access to
quality treatment for their condition.
So I look forward to learning more from our experts today
as we seek to raise the awareness of cervical cancer, its
causes, and its treatments. And I hope that we can all work
together to enact the Breast and Cervical Cancer Treatment Act
as quickly as possible.
I yield back the balance of my time.
Mr. Bilirakis. I thank the gentlelady. Does the gentleman
from Florida, Mr. Stearns, have a quick opening statement?
Mr. Stearns. A quick opening statement.
Mr. Bilirakis. You are recognized.
Mr. Stearns. Thank you, Mr. Chairman. I appreciate you
holding this important hearing, and, of course, I look forward
to hearing from our distinguished Senator, who is retiring. I
appreciate the opportunity to see him again.
The average age at diagnosis is 45, but can occur in women
20 to 30 years old. We are not sure what causes cervical
cancer, but we do know that there are a number of pre-disposing
factors. These include multiple sex partners, early sexual
activity, and early child bearing. But the good news is that
routine Pap smears are very effective in detecting abnormal
cells, and if detected in time, can be treated with promising
results.
I look forward to the hearing, Mr. Chairman, and I
appreciate Senator Mack being here.
[The prepared statement of Hon. Cliff Stearns follows:]
Prepared Statement of Hon. Cliff Stearns, a Representative in Congress
from the State of Florida
Thank you, Chairman Bilirakis, for holding this very important
hearing that deals with a very serious women's health issue.
I look forward to hearing from our distinguished panel of
witnesses. In particular, I look forward to hearing from my own
Senator, Connie Mack.
When we think about the various cancers that can afflict women, we
rarely focus on cervical cancer. Yet, 2-3 percent of all women over the
age of 40 will develop some form of cervical cancer. That translates to
about 5,000 deaths per year.
The average age at diagnosis is 45, but can occur in women 20-30
years old. We are not sure what causes cervical cancer, but we do know
that there are a number of predisposing factors. These include:
multiple sex partners, early sexual activity, or early childbearing
(less than 16 years of age).
Another factor that must be mentioned is that women who were
exposed to the drug DES (diethylstilbestrol) might be at greater risk
of developing certain types of cervical cancer due to this exposure.
The good news is that routine pap smears are very effective in
detecting abnormal cells and if detected in time can be treated with
promising results. Because there are no discernible symptoms in the
early stages, it is vital that women see their physician on an annual
basis since early intervention with proper treatment can save 80% of
women. Once this disease progresses and spreads to other organs the
survival rate drops significantly.
I look forward to hearing from our witnesses and believe that
through hearings such as this we can educate the public about this
disease and the need for medical check ups on a regular basis.
Mr. Bilirakis. I thank the gentleman. Unless it is
imperative that the latecomers make an opening statement, I
would like to go ahead. Greg, do you have a quick opening
statement?
Mr. Ganske. In deference to the chairman, I will submit my
opening statement.
Mr. Bilirakis. I appreciate that.
Well, let's go into the first panel then. Joining Senator
Connie Mack in the first panel is a lady who I always refer to
as to the conscience of this subcommittee. She is a very
effective Congresswoman with a fantastic heart. Anna, you are
recognized.
STATEMENTS OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS
FROM THE STATE OF CALIFORNIA; AND HON. CONNIE MACK, A UNITED
STATES SENATOR FROM THE STATE OF FLORIDA
Ms. Eshoo. Thank you very much, Mr. Chairman. Is this on?
Now it is. We are more accustomed to the microphones at the
other side of the table here.
Mr. Chairman and members of the committee, our
distinguished ranking member, it is a special privilege for me
to give testimony today to the subcommittee that I am a member
of, and how proud I am to be a member of the committee. This is
an all important issue, and I think that the entire Nation
should be grateful today that this hearing is taking place.
I am especially proud to be seated next to Senator Mack,
and I want to salute him for his outstanding service in the
Congress of the United States. Everyone will miss your
leadership and your service here. I want to express my
gratitude to him and to California Representative Juanita
Millender-McDonald for their leadership on the cervical cancer
public awareness resolution.
Resolutions are important because I think they set the
foundation on which legislation can follow, and so I am very
pleased to be a part of that resolution because it raises
public awareness. And we know that we can make a difference
when we set our minds to it, to raise the awareness of people
in the country, and in this case about cervical cancer, with
special regards to its risks, certainly the prevention, and
most importantly, treatment.
Why? Because 70 percent of women in a recent study in our
country did not even know what causes cervical cancer. Less
than a quarter of them had ever even heard of HPV, which is the
leading cause of this disease. Cervical cancer is a killer. I
should say that again. Cervical cancer is a killer. Of the
15,000 women who are diagnosed with cervical cancer each year,
5,000 will die. That is a huge, huge number of human beings.
And we know that we can do something about this. That is a
mortality rate of over 30 percent. In this enlightened Nation,
we know we can do better. In fact, we must.
But even more tragic is the fact that this disease is
actually preventable. Since the introduction of the Pap smear,
as Congressman Lois Capps just stated, since 45 years ago,
cervical cancer in our country has dropped 75 percent.
According to the National Cancer Institute, the 5-year survival
rate is 91 percent when cervical cancer is detected and treated
at an early stage.
In 1990, Congress took a very important step. I wasn't here
then, but to those of you that were, I salute you, because you
took a very important step in the fight against this deadly
disease by passing the Breast and Cervical Cancer Mortality
Prevention Act. The law authorized a cervical cancer screening
program for low-income, uninsured, or underinsured women
through the CDC. It was a very important first step, but it was
only a first step. Because while the current program covers
screening services, it does not cover treatment for women who
are found to be positive through the program.
Representative Rick Lazio, Congresswoman Capps, and myself
introduced last week a bill that would address this. The bill,
H.R. 1070, would establish an optional State Medicaid benefit
for the coverage of certain women who are screened and
diagnosed through the CDC program. I don't really think, Mr.
Chairman, that the Federal Government should be saying to
women, ``We are willing to help you be screened and then you
are left to your own devices when it comes to treatment.'' So
this is what the bill seeks to close the gap on.
I set a goal with Representative Lazio when we introduced
this last week--and we missed you, Lois, there, and we
understand why you couldn't be--that by Mother's Day we would
have 218 co-sponsors on a bipartisan basis in the House. And I
hope, Mr. Chairman, that you will have a hearing on the bill. I
think that this is something that we can, indeed, get done for
the American people.
So, this providing breast and cervical cancer treatment to
women who cannot afford it otherwise, we believe should be a
Federal priority. We know that there is not Republican cancer
or Democratic cancer. When we go home to our constituents, we
should have an united voice and a united front on this.
So, we will look forward to taking the next step, not only
on the resolution, but on the bill, and I want to thank you,
Mr. Chairman, for your leadership always, and our distinguished
ranking member, Sherrod Brown. I think it is the real privilege
of my congressional career to be part of this committee,
because we can really make a difference in people's lives. So
thank you for giving me this opportunity.
[The prepared statement of Hon. Anna G. Eshoo follows:]
Prepared Statement of Hon. Anna G. Eshoo, a Representative in Congress
from the State of California
Thank you Mr. Chairman. As a member of this distinguished
committee, I am extremely proud that we are tackling the issue of
cervical cancer. As a witness for the hearing, I am grateful for the
opportunity to contribute my insight into how we, in Congress, might
help to fight this battle.
I also want to express my gratitude to my colleague from
California, Rep. Juanita Millender-McDonald, and Senator Connie Mack
for their leadership on the Cervical Cancer Public Awareness
Resolution.
This resolution seeks to raise public awareness of cervical cancer
among women, specifically with regard to risks, prevention and
treatment.
For instance, 70% of women in a recent survey did not know
what causes cervical cancer and less than a quarter had even
heard of the human papilloma virus (HPV), which is the leading
cause of the disease.
I am an original cosponsor of the Millender/Mack resolution because
I know that knowledge saves lives.
Cervical cancer is a killer.
Of the 15,000 women who are diagnosed with cervical cancer
each year, 5,000 will die. That is a mortality rate of over
30%.
But even more tragic is the fact that this disease is preventable.
Since the introduction of the Pap smear test 45 years ago,
cervical cancer in the U.S. has dropped 75%.
According to the National Cancer Institute, the five-year
survival rate is 91% when cervical cancer is detected and
treated at an early stage.
In 1990, Congress took the first step in the fight against this
deadly disease by passing the Breast and Cervical Cancer Mortality
Prevention Act.
This law authorized a cervical cancer screening program for
low-income, uninsured or uninsured women through the Centers
for Disease Control (CDC).
But this was only the first step. While the current program covers
screening services, it does not cover treatment for women who are found
to be positive through the program.
A bill Rep. Rick Lazio and I introduced last week would fill that
gap.
Our bill, the Breast and Cervical Cancer Treatment Act (H.R. 1070)
would establish an optional state Medicaid benefit for the coverage of
certain women who were screened and diagnosed through the CDC program.
Our bill would replace the current system of providing treatment
through an ad hoc patchwork of providers, volunteers, and local
programs scrambling to find treatment dollars with a consistent,
reliable source of health care coverage.
Mr. Chairman, we have the technology to fight cervical cancer. But
we must pair this with the will to help women fight the battle. Because
women with life threatening diseases should be concentrating their
energies on treatment, not payment.
Mr. Chairman, the federal government should not be in the business
of telling women, ``We've helped you find out you have cancer, now
you're on your own.''
With over 80 bipartisan cosponsors of the bill already, Congress
has sent a message that this bill--the Lazio/Eshoo Breast and Cervical
Cancer Treatment Act--should be a federal priority.
Providing breast and cervical cancer treatment to women who can not
otherwise afford it, should be a federal priority.
So I ask you today, Mr. Chairman, to not allow this to be the only
hearing this subcommittee holds on cervical cancer. Hold a hearing on
H.R. 1070 and take the next step toward helping women fight cervical
cancer.
Thank you Mr. Chairman for this opportunity to testify before my
own distinguished subcommittee on this very important issue. I look
forward to hearing from the other witnesses.
Mr. Bilirakis. Thank you very much.
Ms. Eshoo. I see the red light and I'll shut my microphone
off.
Mr. Bilirakis. Thank you very much. Knowing you, Anna, and
having worked with you these many years, I expect you'll
probably have 218 co-sponsors by your timeline.
It is a great privilege to yield now to Senator Mack.
STATEMENT OF HON. CONNIE MACK
Senator Mack. Well, Mr. Chairman, let me add my voice to
others in expressing not only my gratitude for the opportunity
to speak before this committee, but also to thank you for
highlighting this particular issue. Some of you probably
remember that I was diagnosed with melanoma back in 1989, right
after I was elected to the Senate. I don't have to worry about
that today, because it was detected early. That early detection
probably took place because of the death of my younger brother
Michael, who died of the same cancer. It made me so aware of it
that I was, as I have said before, Priscilla and I check each
other like two baboons looking for--you get the message. I am
alive today because of early detection.
Many of you know that my wife Priscilla was diagnosed with
breast cancer a number of years ago, and she is a survivor
today because she detected the breast cancer early. Most of you
don't know, in fact, probably all of you don't know, that our
daughter Debbie was diagnosed with cervical cancer back in
1990. She is a survivor today because of early detection. She
was aware of the cancers in our family, and as families become
sensitive to that, they are aware of the types of actions they
ought to be taking on their own to protect themselves.
So, I commend you for holding this hearing because, I will
tell you, just as a result of doing the hearing, someone is
going to hear that message. Priscilla and I have already
experienced it, and I suppose that you have as well; that
people will come up to you and say, ``Because I heard such and
such, I did such and such, and as a result today, I am cancer-
free.''
So, I not only commend the chairman, but all of you who
have shown such an interest in this disease. I commend all of
you.
According to the American Cancer Society, nearly 1,000
women in Florida will be diagnosed with cervical cancer in
1999. This year Florida will have the third largest number of
new cases of cervical cancer.
Yet, despite significant progress being made in the war on
cancer, not all segments of the U.S. population have benefited
to the fullest extent from the advances made in the
understanding of cancer. According to the U.S. Institute of
Medicine report, ``The Unequal Burden of Cancer,'' rates of
cervical cancer are significantly higher in Hispanic and
African-American women. We simply must do better. We must
reinforce our effort to eradicate the terrible disease, but we
also must continue and expand our efforts to see that this
information and the knowledge and the education gets to all
women in America.
Research, education, and early detection are the most
effective weapons that we have in the war on cervical cancer.
In an effort to help increase awareness and education about
this disease, today I will introduce a Senate resolution to
designate the month of January as National Cervical Health
Month. I am pleased that Senator Diane Feinstein and 31 other
members of the Senate have agreed to be original co-sponsors of
this Senate resolution. I know from what has been said already
here this afternoon that Juanita Millender-McDonald and many of
you have agreed to co-sponsor similar legislation in the House
of Representatives.
Research is the key to finding a cure for cervical cancer,
and significant progress is being made in this regard. Just
last month, for example, the National Cancer Institute took the
rarely used step of issuing a clinical announcement urging that
physicians should give strong consideration to adding
chemotherapy to radiation therapy in the treatment of invasive
cervical cancer. According to NCI Director Rick Klausner, this
will likely change the standard of treatment for cervical
cancer. Dr. Mitchell Morris of the M.D. Anderson Cancer Center
called this new treatment approach ``the first fundamental
advance in the treatment of cervical cancer in more than 40
years.''
Mr. Chairman, I am proud to say that in our home State of
Florida, there are several studies that are underway.
Scientists at the University of Miami Sylvester Cancer Center
are studying a new type of cervical cancer immunotherapy. Let
me just stop there for a moment.
I guess it was just fate that 1 day, wandering through a
bookstore, I saw a book called Transform Cell, and because it
was about melanoma. it caught my attention. I bought the book
and read through it, and as you made your way through it, you
found there were a couple of terms that we really weren't
hearing. Most of us are familiar with the modalities of
chemotherapy, radiation therapy, and surgery as the means of
addressing cancer. But there were a couple of new words that
were coming into discussion; that was immunotherapy. Dr.
Rosenberg really believes that we could turn on the immune
system to fight cancer--and that for some reason, the immune
system saw cancer cells as just a normal cell in the body. And
so he began an active pursuit, primarily in the area of
melanoma in kidney cancers. The concept now is spreading out
into many other areas.
In addition to immunotherapy, we are hearing people talk
about now gene therapy--again, ideas that just 10 or 12 years
ago didn't really seem to even be on the horizon. And I think
that the Congresses in the past have done a tremendous job in
providing the resources to provide the money for the basic
research that creates the knowledge that then becomes the
magnet for investment to develop new drugs and new treatment.
Again, at the Sylvester Cancer Center, they are developing
killer cells specifically designed to target cancer cells which
express human papillomavirus. By eradicating these cells, the
hope is to kill the tumor, even if the cancer has spread.
At the H. Lee Moffitt Comprehensive Cancer Center in Tampa,
studies are underway to develop a cervical cancer vaccine using
some of the same characteristic of the human papillomavirus.
They are also examining biomarkers to develop cervical cancer
before malignant changes occur.
And just in my last comment, and I do take off my Senate
hat, I take off my political hat, I take off a Republican hat,
I put them aside and I just speak to you all for a moment from
the perspective of a father thinking of my daughter Debbie, of
a husband thinking of my wife Priscilla. I say that I am
stunned, frankly, by the President's budget proposal. Last year
the administration made a major commitment to the fight against
cancer with a commitment of a 55 percent increase over time. If
my memory holds right, I think the President's budget calls for
a 2, maybe 2.6 percent increase in NIH. I would ask all of us,
again setting aside those labels that I used a minute ago,
let's rally around. We made a commitment a couple of years ago
for the effort of doubling the investment that we make at NIH,
which is obviously more than cancer. It is Parkinson's disease;
it is sickle cell anemia; you name the disease and we are
pursuing it. I think this is the greatest investment that we
can make. So I just would appeal to all of you, let's re-
commitment ourselves to this commitment we made less than 2
years ago to double the investment at NIH.
And I thank you again, Mr. Chairman, for the opportunity.
[The prepared statement of Hon. Connie Mack follows:]
Prepared Statement of Hon. Connie Mack, a U.S. Senator from the State
of Florida
Mr. Chairman, I want to commend you for holding this important
hearing, and I thank you for inviting me to testify this afternoon.
The issue of cervical cancer is one which is deeply personal to my
wife, Priscilla, and to me. In 1990, our daughter, Debbie, was
diagnosed with cervical cancer. Because of our family history with
cancer, Debbie was aware that she had an increased risk of cancer and
she made sure to take advantage of early detection screening
procedures. Fortunately, her cervical cancer was detected at an early
stage, and she was treated successfully with surgery. Not long after
her treatment, she gave birth to our third grandson. Debbie's
experience with cervical cancer exemplifies the fact that early
detection saves lives.
According to the American Cancer Society, nearly 1000 women in
Florida will be diagnosed with cervical cancer in 1999. This year,
Florida will have the third largest number of new cases of cervical
cancer. Yet, despite significant progress being made in the war on
cancer, not all segments of the U.S. population have benefitted to the
fullest extent from the advances made in the understanding of cancer.
According to the U.S. Institute of Medicine report, ``The Unequal
Burden of Cancer,'' rates of cervical cancer are significantly higher
in Hispanic and African-American women. We simply must reinforce our
efforts to eradicate this terrible disease.
Research, education, and early detection are the most effective
weapons we have in the war on cervical cancer.
In an effort to help increase awareness and education about this
disease, today I will introduce a Senate Resolution to designate the
month of January as ``National Cervical Health Month.'' I am pleased
that Senator Dianne Feinstein and 31 bipartisan colleagues in the
Senate have agreed to be original co-sponsors of this Senate
Resolution. I understand that Rep. Juanita Millender-McDonald will be
introducing similar legislation in the United House of Representatives.
Research is the key to finding a cure for cervical cancer, and
significant progress is being made in this regard. Just last month, for
example, the National Cancer Institute took the rarely-used step of
issuing a Clinical Announcement urging physicians to give strong
consideration to adding chemotherapy to radiation therapy in the
treatment of invasive cervical cancer. According to NCI Director Rick
Klausner, this will likely change the standard of treatment for
cervical cancer. Dr. Mitchell Morris of the M.D. Anderson Cancer Center
called this new treatment approach, ``the first fundamental advance in
the treatment of cervical cancer in more than 40 years.''
I'm also proud to say that several cutting-edge cervical cancer
studies are taking place in my home state of Florida. Scientists at the
University of Miami Sylvester Cancer Center are studying a new type of
cervical cancer immunotherapy. They are developing ``killer cells''
specifically designed to target cancer cells which express human
papilloma (HPV). By eradicating these cells, the hope is to kill the
tumor, even if the cancer has spread. At the H. Lee Moffitt
Comprehensive Cancer Center in Tampa, studies are underway to develop a
cervical cancer vaccine using some of the same characteristics of the
human papilloma virus. They are also examining biomarkers to detect
cervical cancer before malignant changes occur.
The U.S. Senate and House, working in bipartisan cooperation, have
embarked upon an historic mission to double funding for the National
Institutes of Health over the next five years. Last year, the Congress
overwhelmingly passed, with bipartisan support, a $2 billion increase
for the National Institutes of Health--the largest increase in NIH
history.
With the tremendous progress being made in cervical cancer and
other diseases, I was astonished and extremely disappointed the
President's FY 2000 budget only calls for a meager 2.6% increase for
medical research at the NIH. This is simply unacceptable. The
President's proposed budget means a cease-fire in the war against
cancer, Parkinson's disease, Alzheimer's disease and other illnesses.
In effect, the President's proposal is a formal act of retreat in the
heat of battle.
I was also shocked that the President's FY 2000 budget calls for
not one additional penny of funding for the Breast and Cervical Cancer
Screening program at the U.S. Centers for Disease Control & Prevention.
For FY 1999, the bipartisan Congress provided a $16 million increase.
By contrast, the President's request for FY 1999 was for an increase of
less than $1 million for this life-saving program, and he proposes no
increase for next year.
When it comes to cervical cancer research and screening, the
President just doesn't get it. It's obvious the leadership on these
initiatives will have to come from this end of Pennsylvania Avenue. It
will be through the bipartisan commitment of the Senate and House that
these important research and detection programs will receive adequate
funding. I am here to pledge my support, and to work with my colleagues
in Congress to make sure this happens. Far too many lives depend upon
it.
Again, Mr. Chairman, thank you for holding this important hearing
and for allowing me the opportunity to appear before this committee.
Mr. Bilirakis. And I thank you, Connie.
Yes, I would wager that most of the members of this
subcommittee have basically signed on the pledge of doubling
NIH funding, and that is certainly one of our great big causes,
working with John Porter and Bill young on the Appropriations
Committee.
Connie, I really have no questions of you and Anna. I just
want to endorse all of the great things that were said about
you yesterday in Tallahassee, where we were together for that
legislative summit. Hopefully, you will continue to use your
high profile for this important cause.
Senator Mack. Well, thank you for the encouragement.
Mr. Bilirakis. I commend you both for testifying on this
important issue.
At this point, I would ask unanimous consent that the
opening statements of all members of this subcommittee and the
testimony of Congresswoman Juanita Millender-McDonald be made a
part of the record. Without objection that will be the case.
[The prepared statement of Hon. Juanita Millender-McDonald
follows:]
Prepared Statement of Hon. Juanita Millender-McDonald, a Representative
in Congress from the State of California
Mr. Chairman, I would like to thank you, Chairman Bliley, Ranking
Member Dingell, and Ranking Member Brown for supporting my efforts to
raise awareness of cervical cancer by serving as original cosponsors of
the Cervical Cancer Awareness Resolution. I would also like to thank
all of the Subcommittee members who served as original cosponsors of
this resolution, and in particular, Congressmen Rick Lazio and Tom
Coburn, who have been tireless advocates in our effort to introduce and
pass this resolution to help educate women on this fatal, yet in most
cases, preventable disease.
In 1990, Congress passed the Breast and Cervical Cancer Mortality
Prevention Act, which enabled the CDC to establish the National Breast
and Cervical Cancer Early Detection Program. This Program offers
community-based screening services for women with little access to
health care, education programs on the benefits of early screenings,
quality assurance standards for cancer testing, and surveillance system
on the effectiveness of these programs.
I applaud the efforts of our colleagues on the Committee who are
working to strengthen these programs and create greater access to
screening and treatment for medically underserved communities. It is
this lack of access and poor understanding of cervical cancer that
illuminate the challenge before us today.
More than 50 years ago, Dr. George N. Papanicolaou developed what
is considered the most effective cancer screen in the history of
medicine, the Papanicolaou test or what we call the Pap smear test.
Although it is not perfect and we welcome technological advances in the
field of medicine, it is a remarkable tool in saving lives and
preventing invasive cervical cancer. The real problem is making sure
women understand what cervical cancer is, what steps they can take to
reduce the likelihood of getting cervical cancer, how it can be
detected early and what all of their treatment options are when facing
this disease.
As you know, tomorrow Committee Members Lazio and Coburn, and I
will introduce the Cervical Cancer Public Awareness Resolution because
we want to tackle this problem of misinformation, confusion and
discomfort that too many women continue to feel on this issue. Our
resolution is part of a national campaign to raise awareness on
cervical cancer among women and encourage Americans to become more
educated on related risk factors, prevention and treatment.
An estimated 15,000 women in the United States develop cervical
cancer each year according to the American Cancer Society. The World
Health Organization and the National Institutes of Health state that
the principal cause of cervical cancer is the human papillomavirus or
HPV infection, which is one of the most common sexually transmitted
diseases (STDs). Fortunately, when cervical cancer is detected at an
early stage, the five-year survival rate is 91 percent, according to
the National Cancer Institute. The Centers for Disease Control and
Prevention report that the mortality rate among American women with
cervical cancer declined from 1960 to 1997 in large part due to the
extensive use of the Pap smear test. However, in 1997 the number began
to rise I fear because the message on cervical health has not reached
enough women.
In October 1997, a Gallup survey commissioned by the College of
American Pathologists found that although 87 percent of the women
surveyed know they should have a Pap test every year, nearly 40 percent
of these same women failed to do so in the previous year. One in four
of the women who had not had an annual Pap test said they ``didn't have
the time.'' The reasons include the belief that they are too old,
feeling embarrassed or afraid of tie results, or thinking it is too
expensive. While all of these reasons are valid, they are not
acceptable when one considers that 80 percent of the women who die of
cervical cancer have not had a Pap test in five years or more.
As with other health issues, there is a tremendous chasm between
minority, lower-income and/or less educated women as opposed to
financially stable, employed and/or well educated women. According to
the Department of Health and Human Services (HHS), one out of every
three Hispanic women reported that they failed to get a Pap test in the
preceding three years, compared with about one-quarter of all American
women. In addition, another survey by HHS on Working Women's Health
found that 87 percent of employed women had a recent Pap test within
the past 3 years while 73 percent of women not in the labor force had
done so. Pap testing for women in managed care plans living in certain
regions of the country is also lower, according to the 1998 State of
Managed Care Quality report. For example, 69 percent of women living in
the mid-western Mountain states had cervical cancer screening while
76.5 percent of the women in New England states had cervical cancer
screening.
More women of color are dying from this disease as well. For
instance, the rate of mortality for African American women is nearly
twice that of Caucasian women according to HHS. Equally disturbing is
the high rate of STD transmission within this community since HPV is
the most common STD. In my own district of South-Central Los Angeles,
the County Health Department reports that the rates of STDs among
African Americans are up to 20 times higher than among whites and STD
morbidity (except Chlamydia) is concentrated disproportionately in
Central and South-Central LA. HPV infection and cervical cancer are
serious risks for the inner-city communities I represent.
That is not to say that HPV infection is the only cause of cervical
cancer, but rather, an important part of this health problem that is
far too often misunderstood by women. According to the National Cancer
Institute, other risk factors include smoking although it is not clear
exactly how or why. Women whose mothers were given the drug
diethylstilbestrol (DES) during pregnancy to prevent miscarriage from
approximately 1940 to 1970 are at increased risk as well. There is also
evidence indicating that women whose immune systems are weakened as a
result of an organ transplant where drugs are administered to prevent
rejection of the new organs are at higher risk.
Although the risk factors for cervical cancer can vary, the
cultural, financial and even geographical barriers that complicate the
fluid delivery of quality health care linger as a dangerous indication
of the need for open and honest dialogue on this issue. As Members of
Congress already in the public eye of our communities, we should do our
part in raising public awareness on this critical issue.
Mr. Chairman, I applaud your work today and appreciate your giving
me the opportunity to work with you in meeting this goal. Once again, I
thank you for your support of the Cervical Cancer Public Awareness
Resolution and I look forward to working with you to advance this
cause.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Rick Lazio, a Representative in Congress
from the State of New York
Mr. Chairman, one of my priorities as a Congressman is to fight
cancer by bringing attention to this dreaded disease. We must find
solutions for the women and men in our country who suffer from all
forms of cancer.
I founded the House Cancer Awareness Working Group, a bipartisan
working group which provides an educational forum where cancer
patients, advocates, and scientists can heighten public and
congressional awareness and offer recommendations to address the most
pressing issues in the battle against cancer. We have focused on issues
such as determining the best age for mammography screening, detecting
prostate and ovarian cancer, preventing the onset of cancer through
healthy eating, the cancer disparities between races and ethnic groups,
the progress of genetic research, and the need for anti-discrimination
legislation. Gaining the recognition of more than 40 Members of
Congress, as well as the American Cancer Society and the National
Cancer Institute, the Group will continue to fight cancer here in
Congress.
In addition to the Working Group, I have recently re-introduced my
legislation, The Breast and Cervical Cancer Treatment Act of 1999. This
legislation will complete the CDC's National Breast and Cervical Cancer
Early Detection Program (NBCCEDP) by adding a treatment component to
the extremely successful screening program for low-income women who
have little or no health insurance. We encourage early detection and
screening, but treatment must be coupled with screening if we are ever
going to save lives.
My legislation, introduced with Ms. Eshoo, would create an optional
state program to allow these women to be covered under Medicaid while
they are being treated for cancer. The hallmark of fairness is to
ensure that women stricken with cancer can have the hope of a cure.
This legislation is the right thing to do and I hope that every member
of this committee will support it through cosponsorship.
Also, I have recently partnered with Rep. Millender-McDonald and
Rep. Coburn in introducing a cervical cancer resolution recognizing the
severity of the issue of cervical health and its relation to cancer as
well as encouraging public awareness, education, and early detection.
Mr. Chairman, thank you for having this hearing. I look forward to
working with you in taking the appropriate steps to combat this dreaded
disease in every way we know how!
______
Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
Mr. Chairman, I applaud you for holding this hearing today on the
issue of cervical cancer. I am proud to say this Committee is the first
committee to hold such a hearing on this issue. I have worked very hard
over the years to pass legislation of importance to public health and
especially those related to the special health concerns of women. For
example, I recently sent a letter to Dr. Richard Klausner, Director of
the National Cancer Institute (NCI), on the importance of health
issues, specifically in regards to women's health. One issue that I
addressed was cervical cancer.
In the response to my letter, NCI stated there are 5,000 women who
die from cervical cancer each year. In addition, thousands of others
are diagnosed with the disease and begin treatment. In light of these
alarming numbers, it is somewhat surprising the lack of attention given
to cervical cancer in comparison to other diseases. A recent study by
Wirthlin Worldwide indicated 70% of the women they surveyed did not
even know what causes cervical cancer. Today, we have the sound medical
evidence that demonstrates that human papillomavirus or ``H-P-V'',
while not the only cause of cervical cancer, is the primary cause of
cervical cancer. It is important that we have this hearing today to
raise the awareness of cervical cancer and provide much needed
information on the disease.
There are many new advances being made in cervical cancer
detection, prevention and treatment. Today, we will hear about some of
the new advances and treatments that are being made in the fight
against cervical cancer. Until the day that cervical cancer becomes a
disease of the past, we need to do all we can to make sure women know
about cervical cancer, its causes and its treatments.
I would like to welcome all of our panels here today to testify. I
would especially like to welcome Sen. Connie Mack for being with us
today and for all of his efforts in the fight against cancer. In
addition, I would like to thank Rep. Anna Eshoo, a member of this
subcommittee, for appearing before it today. Thank you all for coming
and testifying before us today.
______
Prepared Statement of Hon. Henry A. Waxman, a Representative in
Congress from the State of California
Mr. Chairman, it is a pleasure to see this Subcommittee return to
such an important issue. This is an area of public health where the
Subcommittee has been aggressive and successful in enacting important
legislation benefitting women's health.
In 1988, Congressman Dingell and I sponsored the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), which protects women
from substandard Pap smears. In 1990 and 1993, I sponsored laws
creating and strengthening the Federal government's programs to screen,
prevent and treat breast and cervical cancers--the Breast and Cervical
Cancer Mortality Prevention Act of 1990 and the Breast and Cervical
Cancer Amendments of 1993.
At the time, we believed that these laws would help reduce cervical
cancer's mortality. We funded comprehensive screening programs for low-
income women, established quality guidelines for cytological screening,
and supported health training and public education.
There are indications that these efforts, in conjunction with
improvements in diagnosis and treatment, have borne some fruit. Deaths
and the incidence of cervical cancer appear to have marginally declined
in this country.
But we must do much more. In 1990, cervical cancer caused 6,000
deaths. Last year, it caused 4,800 deaths--most of them preventable
with proper screening and treatment. Despite the availability of such
services to low-income women, there is evidence that this is not as
widely known as it should be. That is why I strongly support
Congresswoman Millender-McDonald and my colleagues on this Subcommittee
for sponsoring the cervical cancer awareness resolution.
To save more lives, the next step for the members of this
Subcommittee and the Congress will be to determine whether Federal
funding and reimbursement for preventive screening and follow-up
treatment is adequate.
I join my colleagues in welcoming our witnesses and look forward to
their testimony.
______
Prepared Statement of Hon. Gene Green, A Representative in Congress
from the State of Texas
I want to thank Chairman Bilirakis for scheduling this important
hearing so that we can learn more about how to prevent and treat
cervical cancer.
Each year in the United States, 15,000 women are diagnosed with and
5,000 women will die from cervical cancer.
In fact, it is the second most common form of cancer effecting
women today.
The good news is that we have learned a great deal about what
causes cervical cancer.
The bad news is that there is no cure when it is not detected early
on.
With this in mind, there are several steps that Congress can and
should take to help reverse this trend.
First, we need better education of the health risks and behaviors
that can help prevent cervical cancer.
Statistics indicate that while 93% of women with cervical cancer
had the sexually transmitted disease HPV, the overwhelming majority of
women have never heard of HPV--not to mention how to prevent it.
Second, federal health insurance programs should cover not only the
screening to detect and diagnose cervical cancer--but also financial
assistance to treat the women who test positive for this disease.
The federal government should lead by example when it comes to
providing the most comprehensive health insurance for women.
Finally, we need to continue to increase funding for research by
doubling the NIH budget.
Increasing research at NIH will give the thousands of women who are
annually diagnosed with cervical cancer the best chance at finding a
cure.
I look forward to hearing from our distinguished witnesses. Before
Congress can help educate our constituents, we need to be fully aware
ourselves.
______
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
I applaud Mr. Bilirakis for scheduling this hearing on the
important issue of cervical cancer. I also would like to applaud the
bipartisan efforts of my colleagues in sponsoring H. Con. Res. 5, a
resolution to promote public awareness of cervical cancer. This
resolution points out the serious problems associated with cervical
cancer and calls on the country as a whole to learn more about this
disease through public awareness and education.
Last year, H.R. 4683, the Women's Health Research and Prevention
Amendments of 1998, did not address certain important issues that
affect women's health such as sexually transmitted diseases. Left
untreated, sexually transmitted diseases can cause infertility, birth
defects, disease, and can ultimately lead to death.
Perhaps now we can begin open, frank discussions of this topic
since the primary cause of cervical cancer is one of the most common
sexually transmitted diseases, human papillomavirus (``HPV''). Up to 80
percent of women develop HPV at some point in their lives. HPV is
unique in that it is largely asymptomatic, can cause cancer, and is so
widespread.
Each year, an estimated 15,000 cases of cervical cancer are
diagnosed, and 5,000 women die from this disease. Even though the
incidents of death are lower when compared to other cancers, the impact
of cervical cancer is felt worldwide. It is the leading cause of death
among women in developing countries. The sad part about this is that
most of these deaths are preventable.
The pap smear is the most effective tool for detecting cervical
cancer; however, in many cases the results are inconclusive. Studies
indicate that testing for HPV may be a more effective test for cervical
cancer than pap smears. Regular pap smears combined with HPV testing
would be a woman's best defense against cervical cancer.
I am pleased that my colleagues in the majority on this committee
have shown interest in this important issue. We must raise awareness
about cervical cancer if we are to stop women from needlessly dying
from this curable disease. Let this hearing be a first step in enacting
legislation that will ensure that the issue of cervical cancer receives
the attention that it deserves. None of us should be satisfied until
the cervical cancer death rate drops to zero.
Thank you.
Mr. Bilirakis. Call forward the second panel: Dr. Ronald
Valdiserri, Deputy Director, Center for Disease Control and
Prevention; Dr. Nancy Lee, Associate Director for Science, also
with the Center for Disease Control and Prevention; Dr. Douglas
Lowey, Deputy Director, National Cancer Institute, and Dr.
Edward Trimble, Head Surgery Section, National Cancer
Institute.
Welcome to this hearing. I apologize for the late start.
Often when we're scheduled for a hearing, votes take place on
the House floor, and that is why we were delayed in getting
here.
Your written statements are a part of the record, and I
would appreciate it if you could stay as close to the 5-minute
light as you can in the process of complementing your written
statement.
Dr. Valdiserri, we will start off with you.
STATEMENTS OF RONALD O. VALDISERRI, DEPUTY DIRECTOR, CENTER FOR
DISEASE CONTROL AND PREVENTION; NANCY C. LEE, ASSOCIATE
DIRECTOR FOR SCIENCE, CENTER FOR DISEASE CONTROL AND
PREVENTION; EDWARD L. TRIMBLE, HEAD SURGERY SECTION, NATIONAL
CANCER INSTITUTE; AND DOUGLAS R. LOWEY, DEPUTY DIRECTOR,
NATIONAL CANCER INSTITUTE
Mr. Valdiserri. Good afternoon, Mr. Chairman and
subcommittee members. I am Ron Valdiserri, Deputy Director of
the National Center for HIV, STD, and TB Prevention at the
Centers for Disease Control and Prevention. I thank you for the
opportunity to testify today about what we know about the
relationship between human papillomavirus infection and cancer
of the uterine cervix.
Human papillomavirus, otherwise known as HPV, is a virus
that infects the skin and mucus membranes. New laboratory
techniques to identify HPV became available in the 1980's and
revolutionized what we know about the epidemiology of HPV
infection. Over 80 different types have been identified. Some
viral types infect the hands and feet, causing common warts,
while others are sexually transmitted and affect the genital
area. Of the 30 or so types that infect the genital region,
some cause clinically apparent genital warts and also low-grade
Pap smear abnormalities, but are not associated with cervical
cancer; hence, they are termed low-risk types. Approximately 10
types are considered high risks for cancer, in that they are
found in approximately 95 percent of all tissue specimens from
cervical cancer patients.
It should be stated, however, the genital HPV infections,
while they are not curable, that the vast majority are benign.
Definitive studies on prevention strategies, including male and
female condoms and newly developed microbicides, are,
unfortunately, very limited. Most people who are infected with
HPV are asymptomatic and do not develop warts. Infected men and
women who develop genital warts are diagnosed by their typical
appearance, usually without laboratory verification of the
virus. Most women with HPV are diagnosed indirectly by Pap
smear or by biopsy findings rather than having the HPV directly
detected.
It is estimated that at least 50 percent of sexually active
adults will acquire genital HPV infection. As many as 45
million Americans may already be infected, and an estimated 5
million new cases develop each year, making HPV the most common
sexually transmissible disease. Again, more than 90 percent of
people with HPV infections do not have symptoms, although they
are potentially infectious.
Key risk factors for cervical HPV infection in women
include a younger age and the number of sex partners. Cigarette
smoking and oral contraceptive use have also been cited as risk
factors. Unfortunately, risk factors for HPV in men have not
been very well studied.
In most sexually active women who acquire HPV infection of
the cervix, the virus becomes undetectable over time without
specific treatment and causes no problems. However, for women
whose infections persist, these women are more likely to be
infected with the cancer-associated HPV types. Approximately 5
to 10 percent of women with the high-risk types of HPV
infection will develop cervical cancer without Pap smear
screening and early treatment. Large studies comparing women
with cervical cancer to those without it have shown that
infection with one of these high-risk HPV types increases the
risk of cervical cancer by at least 30-fold, a level similar to
or higher than the risk of lung cancer association with
cigarette smoking.
Laboratory and animal experiments also support a causative
role for HPV and cervical cancer. In summary, there is now
widespread consensus among cancer researchers that high-risk
types of genital HPV play a causative role in cervical cancer
and probably other types of anogenital cancer, including cancer
of the penis and anus. Having HPV seems to be necessary for
developing cervical cancer, but just having the infection alone
is not sufficient to produce cancer. Other co-factors such as
smoking, an abnormal immune system, and other genital track
infections may also be important. My CDC colleague, Dr. Nancy
Lee, will present an overview of cervical cancer screening
programs later during this panel.
The recognition that cervical cancer is caused by a highly
prevalent STD has important implications for public health.
Vaccine development is a promising prevention strategy, and my
NIH colleague will be discussing this issue. But even before
the development of a vaccine, we can prevent cervical cancer in
women who are already infected with HPV. For example, it may be
possible to use HPV DNA tests as an adjunct to the Pap smear to
improve the latter's accuracy. Studies are now underway to
determine if these combined modalities would help to identify
women who might otherwise be missed by Pap smear alone.
Several studies have also reported that providing HPV
testing for these women can help determine who is likely to
have a more serious problem, and so these tests might be
combined with Pap smear screening to provide a triage of sorts
to identify these individuals.
CDC is involved in a variety of research and programmatic
activities related to HPV and cervical cancer. However,
additional important activities must be undertaken. These
include determining the clinical usefulness of HPV tests and
their relative costs and benefits, developing appropriate
counseling messages for women who learn that they have a
cancer-associated STD, evaluating the effectiveness of various
primary prevention strategies, and developing systems to track
transient HPV.
Thank you for the opportunity to bring this important
public health issue to your attention, and I will be glad to
answer any questions that you might have.
[The prepared statement of Ronald O. Valdiserri follows:]
Prepared Statement of Ronald O. Valdiserri, Deputy Director, National
Center for HIV, STD, and TB Prevention, Centers for Disease Control and
Prevention, Department of Health and Human Services
human papillomavirus infection and cancer of the cervix: what do we
know and what are the implications?
I am Dr. Ronald O. Valdiserri, Deputy Director of the National
Center for HIV, STD, and TB Prevention at the Centers for Disease
Control and Prevention (CDC). Thank you for the opportunity to present
what we know about the relationship between human papillomavirus (HPV)
infection and cancer of the cervix which was one of the most common
cancers among women in this country prior to the introduction of Pap
smear screening and remains one of the most common cancers worldwide.
For more than a century, there have been suspicions that cancer of the
cervix is caused by an infectious agent and behaves like a sexually
transmitted disease (STD). For example, epidemiologic studies have
consistently shown that cervical cancer is rare in virgins but much
more common in women who are sexually active and at risk for other
STDs--especially so in women who became sexually active at a young age,
who have multiple sexual partners, or who have sexual contact with a
man who has had multiple partners.
Over the past 50 years, there have been many studies attempting to
assess whether a particular infection--such as gonorrhea, syphilis,
chlamydia, or genital herpes--was the sexually transmitted agent that
led to cervical cancer. Many of these studies cast suspicion on one or
more of these infections, but the results remained inconclusive until
the 1980s when, using newly developed laboratory techniques, evidence
began to point to another, less well understood, STD: the human
papillomavirus or HPV. Prior to that time, HPV was known to cause non-
sexually transmitted warts at body sites such as the hands or feet, as
well as sexually transmitted warts around the genitals. But because
warts were rarely found on the cervix, it was thought unlikely that HPV
could be playing a role in causing cervical cancer. The inability to
recognize cervical HPV infection was in large part due to the problem
that, unlike most other STD organisms, there was and still is no way to
culture HPV in the laboratory.
The development of laboratory tests for detection of HPV/DNA, the
genetic material of the virus, helped to overcome this problem and
dramatically increased our estimate of just how frequent HPV infection
of the cervix and other genital sites actually occurs. It is now
estimated that approximately 5,000,000 new cases of genital HPV
infection occur in the United States each year, making it the most
common of all of the STDs. It is further estimated that at least 50
percent of sexually active men and women will acquire genital HPV
infection at some point and that as many as 45,000,000 Americans may
already be infected. As with many STDs, most of these infections are
asymptomatic, so that the majority of those with genital HPV are
unaware of their infection--further contributing to its spread. The
economic burden resulting from these millions of infections has not
been clearly determined, but is likely quite large. One recent estimate
by the Institute of Medicine was over $3 billion per year, more than
that for any other STD apart from HIV infection.
The HPV DNA tests have revealed that there are many different
strains or types of HPV; more than 80 types have been identified.
Approximately 30 of these are found primarily in the genital area and
are considered ``genital HPV''. While some of these 30 types are
considered ``low-risk,'' primarily causing genital warts and low-grade
Pap smear abnormalities, approximately 10 of these types are considered
``high-risk'' for cancer in that they are found in approximately 95
percent of all tissue specimens from cervical cancer. Large
epidemiologic studies comparing women with cervical cancer to those
without it have shown that, even when controlling for other factors
that might make cervical cancer more likely, being infected with one of
these high-risk HPV types increases the risk of cervical cancer by at
least 30-fold, a level similar to or higher than the risk of lung
cancer from smoking. In addition to these human studies, laboratory
experiments provide additional support that HPV causes cervical cancer,
by showing that when inoculated into cell culture systems, HPV causes
the cells to grow in an ``out-of-control'', cancer-like fashion and
that these out-of-control cells can then cause cancer when injected
into mice. Thus, while definitively proving that an infectious agent
causes a disease can be quite difficult, based on a large number of
studies, there is now widespread consensus among cancer researchers
that high-risk types of genital HPV clearly play a causative role in
the development of cervical cancer, and probably other types of
anogenital cancer, such as cancer of the penis and anus.
Having HPV seems to be ``necessary'' for developing cervical
cancer, although having the infection alone is not ``sufficient'' to
produce cancer, and other co-factors such as smoking, an abnormal
immune system, and other infections may be important as well. The role
of the immune system has been most clearly demonstrated in patients
with HIV infection in whom very high rates of HPV infection occur and
in whom both cervical and anal cancer appear to be increased. Although
a large proportion of sexually active women will become infected with
genital HPV, the majority of these infections become undetectable over
time without specific treatment or the development of complications.
Only those women whose infection persist are at risk for developing
cancer, and it has been estimated that approximately 5-10 percent of
women with high-risk types of HPV infection will develop cervical
cancer. Pap smear screening programs and early treatment reduces this
percentage even further.
The recognition that this important cancer is caused by a highly
prevalent STD has important implications for public health. The first
strategy to consider is that of primary prevention, namely, preventing
cancer by preventing infection. Unfortunately, the traditional STD
control strategy of preventing transmission by identifying infected
persons and then treating them and their partners in order to prevent
transmission to other partners currently has limited value for viral
STDs such as HPV because existing therapies do not cure infection. The
therapies available for both genital warts and cervical HPV infection
will eradicate the tissue abnormality, but probably do not eliminate
the infection entirely. Abstinence should be effective for preventing
HPV infections, since the large majority are sexually transmitted.
However, other approaches to prevent HPV infection are also promising.
Latex condoms can be expected to be protective if they cover the
genital skin that is infected and if they are used consistently and
correctly. Several studies have shown condoms to provide some
protection against cervical cancer, and the more recently developed
female condom has promise as a physical barrier in the prevention of
viral STDs because of its greater surface area.
Microbicides, chemicals that inhibit microbial growth and could
potentially function as ``chemical barriers'' also have potential
benefit. Some of these agents currently under investigation have been
shown to inactivate genital HPV in the laboratory. Advantages of
microbicides include both the possibility of inhibiting multiple STDs--
such as HPV and HIV--with one agent, and providing a protective
strategy under the control of the woman, in contrast to male condoms.
The most promising primary prevention strategy would be the
development of an HPV vaccine. There are several animal models in which
papillomavirus infections specific to the particular animal can be
effectively prevented by immunization, which has created great optimism
that vaccines against HPV might be beneficial in humans as well.
Several small studies are now underway in humans to determine
whether the experimental HPV vaccines are sufficiently safe and
effective at producing an immune response to warrant larger, more
definitive studies. Because of the relatively large number of high-risk
HPV-types believed to cause cervical cancer, effective vaccines will
have to contain multiple types of HPV to achieve high levels of
benefit, which increases the complexity and length of time it will take
to develop and test them. Such preventive vaccines would ideally be
given prior to the onset of sexual activity probably in early
adolescence since most people who contract genital HPV infection do so
within the first several years of sexual activity. Because the peak
incidence of cervical cancer are between 35 to 55 years of age, it
would likely be at least 20 years after the initiation of vaccine
programs before we would see reductions in cancer rates. However,
effective vaccines would also reduce the rate of pre-cancerous Pap
smear abnormalities, known as dysplasia. Considering that the
evaluation and treatment of dysplasia is among the most expensive
aspects of the current cervical cancer prevention efforts, reductions
would most likely occur much earlier in cost as well as the avoidance
of anxiety that often accompanies the diagnosis of an incurable STD or
pre-cancerous changes on a Pap smear.
Our current strategy is to prevent cancer in those who already have
HPV infection. In essence, this is what Pap smear screening is directed
toward--the early detection of pre-cancerous changes caused by HPV
infection which can be evaluated and treated to prevent their
progression. With the knowledge that HPV infection causes cancer, it
may be possible to use HPV/DNA tests as an adjunct to the Pap smear to
improve its accuracy. A single Pap smear does not identify all women
who have serious abnormalities, so serial Pap smear screening is the
current standard of care. Studies are underway now to find out if using
HPV/DNA tests, along with the Pap smear, will increase the test
sensitivity (in other words, the likelihood of identifying women with
abnormal Pap smears). If these tests work well enough, they might not
only prevent women with treatable problems from being missed, they
might also allow Pap smears to be done less frequently than annually in
most women, thereby reducing costs of screening. Furthermore, because
samples for HPV testing are easier to collect than Pap smear samples,
they may permit the development of self-collected swab kits for women,
which, by avoiding the need for a full gynecologic exam, might be more
convenient for many women and could encourage many more women to get
tested for HPV. Such self-collected testing also facilitate development
of outreach efforts, where field workers go into non-clinic locations
to do testing, similar to approaches that have been used for community-
based programs to address high blood pressure, high cholesterol,
tuberculosis, and even STDs like chlamydia.
An even more immediate use of HPV tests for secondary prevention is
their use to triage women with low-grade Pap smear abnormalities.
Currently, the large majority of women in the United States with
abnormal Pap smears have early changes that have a very low risk of
progression to cancer, and yet, to be sure an important problem isn't
missed, these women usually need to come back for several follow-up
examinations, creating tremendous anxiety and expense. Several studies
have reported that providing HPV testing for these women can help
determine who is likely to have a more serious problem. If these
reports can be confirmed by larger studies now underway, they may
permit a more cost-effective approach to this very common problem.
Important work remains to be done before these strategies will be
ready for widespread implementation. CDC is currently involved in a
number of applied research and service activities to improve prevention
of genital HPV infection and cervical cancer. Among these are:
studies of the epidemiology and natural history of HPV
infection and cervical cancer.
studies to better define approaches to clinical use of HPV
tests.
studies to assess HPV-related complications in patients with
HIV infection.
studies to determine mechanisms by which HPV causes cervical
cancer.
development and assessment of improved HPV tests.
implementation of a pilot national population-based
serosurveillance study to more accurately assess the extent of
genital HPV infection.
support of health care provider training programs regarding
both cervical cancer and genital HPV infection.
development of clinical practice guidelines for genital HPV
infection.
education of the general public through the CDC National STD
Hotline
implementation of the National Breast and Cervical Cancer
Early Detection Program that provides access to cancer
screening and follow-up for underserved women.
development of the National Program of Cancer Registries that
will enhance surveillance of cervical and other HPV-related
cancers. Currently, serious gaps in our knowledge preclude the
formulation of more effective prevention strategies for genital
HPV infection and cervical cancer:
HPV Testing
If the ongoing studies to assess use of HPV tests for triage
of women with low-grade Pap smear abnormalities find this to be
a helpful strategy, we must determine if this approach works
equally well in all groups of women. For example, because
younger women have much higher background rates of HPV
infection than do older women, HPV testing may be too non-
specific (i.e. likely to test positive when no serious
abnormality really exists) to be helpful in the younger group,
and could turn out to be a ``double-edged sword'', creating
more anxiety and costs than it saves.
Studies to assess the use of HPV tests as an adjunct to Pap
smear screening will also need to demonstrate which groups of
women (such as younger vs older) get the most benefit from this
extra test.
As ``self-test'' kits are developed, program evaluations will
be necessary to find out how best to distribute them and
encourage their use. Any use of such HPV tests will require the
development of approaches both to counsel women who suddenly
discover that they have a cancer-associated STD, and to
evaluate their sexual partners.
HPV Vaccine Development and Use
The development of effective HPV vaccines would be enhanced by
collection of additional surveillance data on the prevalence of
different types of HPV infection in different groups of men and
women, both to determine exactly which types of HPV a final
vaccine should contain and to track early benefit of vaccines
once they are licensed and widely used.
There is virtually no experience in ``marketing'' vaccines for
prevention of STDs and cancer to the general public or to
health care providers. Yet for HPV vaccines to achieve their
promise, their use will need to be as widespread in the
population as is the virus. Sexually active persons in all
socioeconomic groups are at risk for HPV infection; thus,
immunization of all persons who will potentially be sexually
active in the future would likely be the most effective
prevention approach. Behavioral and social marketing research
to explore this issue will be important and such research may
also have benefit for other STD vaccines, including those for
HIV.
To the extent that effective HPV vaccines are developed and
utilized and Pap smear abnormalities prevented, approaches used
in Pap smear screening programs will also likely evolve, since
criteria for what constitutes a suspicious smear may change as
certain types of HPV infection are prevented.
Assessment of Non-Vaccine Strategies for Primary Prevention
Pending the availability of effective vaccines, a better
understanding of how well other primary prevention strategies
may work is important. Understandably, one of the major
concerns of patients diagnosed with genital HPV infection is
how to prevent it from being transmitted to sexual partners, an
issue that will only increase if clinical use of HPV testing
becomes more widespread. To this end, better information is
needed to determine how long someone with genital HPV is
contagious to a sexual partner and which prevention strategies
work best to prevent transmission.
Programs to Assess Burden of Infection
Monitoring systems to provide information about rates of
various types of Pap smear abnormalities and of type-specific
genital HPV infections in targeted populations will be
important in planning and evaluating vaccine programs, as well
as in tracking the distribution of HPV infection in the
population. Such studies may be particularly useful in
clarifying rates and types of infections in men about which far
less is known than for infections in women.
Economic assessments of the costs resulting from HPV infection
are limited and not available for all populations. Furthermore,
existing analyses address only direct medical costs (the costs
of actually providing care), and there is virtually no
information on indirect costs (those resulting from lost
productivity or premature death of someone with a medical
problem) or intangible costs (such as anxiety and distress in
personal relationships). Such information is critical in
determining the potential public health and societal benefit of
various prevention programs.
Programs to Increase Public and Health Care Provider Awareness
While better understanding of the prevalence of HPV and its
relationship to cancer will support better prevention efforts,
messages to educate the general public about HPV will need to
be clearly crafted to avoid undue anxiety, competition with
other public health prevention messages, and the possibility
because of the stigma associated with STD and undermining Pap
smear screening programs.
The issues around HPV are complex ones for health care
providers who must convey messages that are both accurate and
helpful to patients with concerns, often in time-constrained
clinical settings. In addition, because genital HPV infection
is a minor health problem for the vast majority of infected
people, proper education and counseling may be as important as
treatment. More cost-effective means to convey this information
is an important priority.
In April, 1999, CDC and the American Cancer Society will convene a
pivotal meeting of national and international experts, including our
NIH colleagues, to review possible prevention strategies and prevention
research needs for genital HPV infection and its complications. The
goal of this meeting is to develop priorities for a linked programmatic
and research agenda for CDC and other public health agencies.
Mr. Bilirakis. Thank you very much, Dr. Valdiserri.
Dr. Lee?
STATEMENT OF NANCY C. LEE
Ms. Lee. Good afternoon, Mr. Chairman and the subcommittee
members. Can you hear me? I am Dr. Nancy Lee, Associate
Director for Science at the Division of Cancer Prevention and
Control at the CDC in Atlanta. I am pleased to be here this
afternoon to discuss how CDC approaches cervical cancer early
detection through the National Breast and Cervical Cancer Early
Detection Program.
As discussed in the previous presentation, infection with
certain strains of HPV is one of the strongest risk factors we
know for cervical cancer. But the most important risk factor
for developing cervical cancer, at least from the point of view
of what we can do about it now, is the failure to receive
regular screening with a Pap smear.
Cervical intraepithelial neoplasia or CIN is the pre-
cancerous condition that can develop into cervical cancer. With
appropriate treatment, almost all women diagnosed with CIN
should be cured of their condition. From the time a women
develops CIN, it usually takes years before cervical cancer
develops. So we have many opportunities to detect pre-cancerous
lesions with regular Pap screening, treat them, and actually
prevent cervical cancer. Furthermore, even if cervical cancer
has developed, when detected at its earliest stage, the 5-year
survival is over 90 percent.
The accepted screening test for cervical cancer is the Pap
smear. Since introduction 50 years ago, the Pap smear has been
credited with the steady decline in cervical cancer deaths in
the United States. In 1994, well over 90 percent of all women
had received a Pap test at least once in their lives, and 80
percent had one within the preceding 3 years.
In 1990, as many of you have spoken already, Congress
passed the Breast and Cervical Cancer Mortality Prevention Act.
This act authorized CDC to establish a nationwide screening
program to ensure that low-income women who are uninsured
receive regular screening for breast and cervical cancer.
In fiscal year 1999, with appropriations of $159 million,
the CDC entered into the ninth year of the National Breast and
Cervical Cancer Early Detection Program. CDC supports programs
in all 50 States, 5 U.S. territories, the District of Columbia,
and 15 American Indian and Alaska Native organizations. The
national program has provided more than 1.1 million Pap smears
to over 700,000 women. However, with existing resources, it is
able to screen only 12 to 15 percent of the eligible population
annually. Significantly, almost half of the women screened are
from minority racial and ethnic groups. This is the really good
news: More than 31,000 cases of these pre-cancerous lesions
have been detected and only 508 women have been diagnosed with
cervical cancer.
This last set of statistics illustrates a key point that I
always emphasize when I talk about the program. The main
purpose of cervical cancer screening is to find pre-cancerous
lesions, treat them, and cure them so that these women never
have to be diagnosed with cancer.
Our program statistics illustrate the success of Pap
testing and emphasize the proven strategy that can be used to
fight this disease. We consider women who do not receive Pap
tests to be a priority population. The national program
endeavors to provide cervical cancer screening to women who are
hard to reach because of cultural, language, or financial
barriers. Our No. 1 goal must be to reach the largest number of
unscreened women as our resources allow.
For example, many programs are involved with developing low
literacy, bilingual, or culturally appropriate materials that
are used in a myriad of training and outreach programs and
educational campaigns. The various strategies used by different
programs promote screening and increase knowledge and awareness
of cervical cancer.
The Food and Drug Administration has approved three new
technologies for Pap smears: ThinPrep, AutoPap and Papnet.
These technologies all appear to do a somewhat better job of
detecting cervical disease than conventional Pap tests. They
are rapidly being adapted by laboratories nationwide and at
least double the price of the conventional Pap test. However,
there are concerns that the extra costs associated with these
technologies will overshadow their benefits. In spite of the
promise of these new technologies, the American College of
Obstetricians and Gynecologists stated last year that their
routine use, ``could not be recommended based on costs and the
lack of sufficient data demonstrating whether they reduce the
incidence of or improve the survival rate for an invasive
cervical cancer.'' The College also concluded that the main
strategy should be screening women who are not receiving
regular Pap tests, as they account for the majority of new
cervical cancer cases each year.
CDC is committed to increasing the awareness, availability,
and use of cervical cancer screening services for women. We
must also work hard to screen those women who are not receiving
regular screening, as they are at greatest risk for developing
cervical cancer. This is the hardest part of our job, but one
we cannot ignore. The national program will continue to develop
strategies to find those women most in need of the lifesaving
benefit of Pap smear screening.
Thanks for your interest in cervical cancer detection
programs at CDC, and I, as well, am pleased to answer any
questions you may have.
[The prepared statement of Nancy C. Lee follows:]
Prepared Statement of Nancy C. Lee, Associate Director for Science,
National Center for Chronic Disease and Health Promotion, Centers for
Disease Control and Prevention, Department of Health and Human Services
Good Morning, I am Dr. Nancy Lee, Associate Director for Science,
within the Division of Cancer Prevention and Control of the National
Centers for Chronic Disease Prevention and Health Promotion, Centers
for Disease Control and Prevention (CDC) in Atlanta, Georgia. I am
pleased to be here this morning to discuss how CDC approaches cervical
cancer early detection through CDC's, National Breast and Cervical
Cancer Early Detection Program (NBCCEDP).
Background
Cervical cancer is nearly 100 percent preventable, yet according to
the American Cancer Society, an estimated 12,800 new cases of invasive
cervical cancer will be diagnosed in 1999 with about 4,800 women dying
of the disease. The cervical cancer death rate declined 45 percent
between the periods 1972-74 and 1992-94 and the overall incidence of
the disease has decreased steadily from 14.2 per 100,000 in 1973 to 7.4
per 100,000 in 1995. This is largely attributed to the effectiveness of
Pap smear screening for cervical cytology.
Even with this success, there remains significant disparities in
the incidence and mortality of cervical cancer among some racial and
ethnic minority women, when compared to the rate in white women. The
incidence rate for all U.S. women is about 8 per 100,000; however, the
highest age-adjusted incidence rate of 43 per 100,000 occurs among
Vietnamese women, probably reflecting lack of appropriate screening.
Incidence rates of 15 per 100,000 or higher also occur among Alaska
Native, Korean, and Hispanic women. The death rate of 6.7 per 100,000
in African American women continues to be more than twice that of
whites even though their incidence rate is slightly lower.
Early Detection
Cervical cancer occurs at an average age of 54; however, cervical
intraepithelial neoplasia (or CIN), the precursor lesion to cervical
cancer, most often occurs in much younger women. For a woman with CIN,
her likelihood of survival is almost 100 percent with timely and
appropriate treatment. The fact that CIN occurs at a younger age tells
us that it usually takes a substantial amount of time for cervical
cancer to develop. This means that screening younger women is an
important strategy that actually prevents cervical cancer from ever
developing. Furthermore, when cervical cancer is detected at its
earliest stage, the 5-year survival rate is more than 90 percent.
Risk Factors
Studies that have identified risk factors associated with cervical
cancer have shown that cervical cancer is closely linked to sexual
behaviors, human papillomavirus (or HPV) infection, immunosuppressive
disorders such as HIV/AIDS, as well as a failure to receive regular Pap
smear screening. The sexual behaviors specifically associated with
greater risk are intercourse at an early age, multiple male sexual
partners, and sex with a male partner who has had multiple sexual
partners. Experts agree that infection with certain strains of the HPV
is one of the strongest risk factors for cervical cancer, but the most
important risk factor for developing cervical cancer, at least from the
point of view of what we can do about it, is the failure to receive
regular screening with a Pap smear.
Screening Tests
The principal screening test for cervical cancer is the Pap smear.
Since its introduction 50 years ago by Dr. Papanicolaou, the Pap smear
has been widely used and is credited with the steady decline in
cervical cancer deaths in the United States. Nationwide estimates from
1994 indicated that well over 90 percent of all U.S. women had received
a Pap test at least once in their lives and that 80 percent had
obtained one within the preceding 3 years.
Despite the ability of the Pap test to help reduce cervical cancer
mortality, the test is far from 100 percent accurate. Approximately
half of the inaccuracies are due to inadequate collection of the Pap
smear by the health care provider and the other half are due to errors
at the laboratory. Detecting a precancerous lesion such as CIN does not
always mean that a cancer has been prevented because only some of the
early precancerous lesions progress to cancer. Thus, the search for a
more efficient means of screening for cervical cancer and precancer is
ongoing.
The Food and Drug Administration has approved three new
technologies for Pap smears: ThinPrep, AutoPap, and Papnet. The
technologies all appear to do a somewhat better job of detecting
cervical disease than conventional Pap tests. They are rapidly being
adopted by laboratories nationwide and at least double the price of the
conventional Pap test. However, there are concerns that the extra costs
associated with these technologies will overshadow their benefits.
Two evaluations of cervical cytology were released in January: one
done for the Agency for Health Care Policy and Research, and the other
published in the Journal of the American Medical Association. Although
the analyses were independently done, each determined that new
screening technologies were cost-effective only if screening was
infrequent, done every 3-4 years. They also found that the new
technologies increased life expectancy by a relatively small amount
compared with conventional Pap testing.
In spite of the promise of these new technologies, the American
College of Obstetricians and Gynecologists stated last year that their
routine use ``[could] not be recommended based on costs and the lack of
sufficient data demonstrating whether they reduce the incidence of or
improve the survival rate from invasive cervical cancer.'' The college
also concluded that the main focus should remain screening women who
are not receiving regular screening, as they account for the majority
of cervical cancer cases.
Screening Guidelines
There are several different recommendations from national,
professional and governmental organizations on the frequency that women
should receive a Pap test. The American Cancer Society, National Cancer
Institute, American College of Obstetricians and Gynecologists,
American Medical Association, American Academy of Family Physicians,
and others developed a consensus agreement regarding cervical cancer
screening. These organizations recommended annual Pap testing for all
women who have been sexually active, or have reached the age of 18.
After three consecutive annual exams with normal findings, the Pap
test could be performed less frequently at the discretion of the
physician.
The U.S. Preventive Services Task Force recommends regular Pap
tests for all women who are or have been sexually active, or who are 18
or older, and who have a cervix. The Pap test should be performed at
least every 3 years. However, the interval for each patient should be
determined by the physician, based on the woman's history of risk
factors.
National Breast and Cervical Cancer Early Detection Program
Recognizing the value of appropriate cancer screening, Congress
passed the Breast and Cervical Cancer Mortality Prevention Act of 1990
(Public Law 101-354). This Act authorized the Centers for Disease
Control and Prevention (CDC) to establish a national screening program
to ensure that low income women who are uninsured or underinsured
receive regular screening for breast and cervical cancer and prompt
followup when necessary. In fiscal year 1999, with Congressional
appropriations of $159 million, the CDC entered into the ninth year of
the National Breast and Cervical Cancer Early Detection Program
(NBCCEDP). This landmark program brings critical breast and cervical
cancer screening services to underserved women, including older women,
women with low income, and women of racial and ethnic minorities.
CDC supports early detection programs in all 50 states, five U.S.
territories, the District of Columbia, and 15 American Indian/Alaska
Native organizations. The goal of the national program is to establish,
expand, and improve community-based screening services for women at
risk. The goal is achieved by screening medically underserved women for
breast and cervical cancer, providing appropriate and timely diagnostic
evaluations for women with abnormal screening tests and treatment
services if needed, developing and disseminating public information and
education related to the detection and control of breast and cervical
cancer, improving training of health professionals in the detection of
these cancers, and finally, evaluating program activities through the
establishment of surveillance systems.
The program targets cervical cancer screening services to women who
are hard to reach and are unlikely to seek a Pap test because of
cultural, language, monetary or institutional barriers. As a major
public health program, our overall concern must be to reach the largest
number of unscreened, eligible women as possible. Thus, we also
consider all women who do not receive regular Pap tests a priority
population for the program. Currently, the national program follows
cervical cancer screening guidelines that are consistent with the
consensus guidelines developed by the American Cancer Society and
others.
Providing cervical and breast cancer health education and outreach
services is an essential component to the NBCCEDP. With technical
guidance, our funded programs have developed projects that are focused
on specific at-risk populations and cover a wide range of prevention
and research activities. For example, many programs are involved with
developing low literacy, bilingual and culturally appropriate
educational materials that are used in a myriad of unique training and
outreach programs and educational campaigns. These various strategies
used by the different programs result in the common goal of increasing
knowledge and awareness of breast and cervical cancer and promoting
screening for early detection.
CDC partners with many national organizations to address issues
related to breast and cervical cancer screening in priority
populations. For instance, CDC funds the American Social Health
Association to formulate a national model for the prevention of
cervical cancer, using two counties in North Carolina as pilot sites
and focusing upon economically disadvantaged Hispanic and African-
American populations and women living in hard-to-reach urban and rural
areas. This cervical cancer prevention project consists of developing
and delivering culturally appropriate media messages, educational
materials, client support services, and health education workshops in
the community setting.
CDC is committed to increasing the awareness, availability and use
of cervical cancer screening services for women. The main purpose of
cervical cancer screening is not to find cancer, but to find
precancerous lesions. Early detection and treatment of precancerous
cervical lesions identified by Pap screening can actually prevent
cervical cancer; thus, the success of any cervical cancer screening
program depends on the early detection, case management and treatment
of precancerous cervical lesions.
The breast and cervical cancer program has provided more than 1.1
million Pap test to a total of more than 700,000 women. With existing
resources, the national program is able to screen 12-15 percent of the
eligible population annually. Almost half of the women screened are
from minority racial and ethnic groups. Of Pap tests provided, about 3
percent were abnormal; more than 31,000 cases of precancerous lesions
were ultimately diagnosed, and 508 women were diagnosed with invasive
cervical cancer. These statistics illustrate a key point for this
essential public health program. The main purpose of cervical cancer
screening is to find precancerous lesions, treat them, and cure them,
so that these women do not go on to be diagnosed with cervical cancer.
Of all the women diagnosed with cervical disease through our program,
fewer than 2 percent actually had a diagnosis of cancer. The program
has potentially averted cancer in more than 31,000 women! This
underscores the success of Pap testing and emphasizes the proven
strategy that we as public health practitioners can use to fight this
cancer.
As mentioned earlier, the success of any cervical cancer screening
program depends on the early detection and treatment of precancerous
cervical lesions. But we must also work hard to screen those women who
are not regularly screened elsewhere. Research has shown that they are
at the greatest risk for developing cervical cancer. This is the
hardest part of our job, but one we cannot ignore. The National Breast
and Cervical Cancer Early Detection Program will continue to develop
strategies to find those women and provide the life-saving benefit of
Pap smear screening.
Thank you for your interest in the cervical cancer early detection
activities at CDC. I would be pleased to answer any questions you may
have.
Mr. Bilirakis. Thank you very much, Dr. Lee.
Dr. Lowey. Well, all right, Dr. Trimble.
STATEMENT OF EDWARD L. TRIMBLE
Mr. Trimble. Good afternoon, Chairman Bilirakis and
subcommittee members. Thank you for inviting us to speak today.
I am an obstetrician/gynecologist and gynecologic oncologist.
My responsibility at NCI is the development of a new treatment
for women with gynecologic cancer.
As we have heard, cervical cancer is the third leading
cause of cancer deaths for women around the world. In the
United States the number of cases and deaths have dropped
dramatically, primarily due to effective screening and
treatment of pre-invasive disease.
As we have heard, more than 90 percent of cases are due to
infection with the human papillomavirus, but the vast majority
of men and women who have infection with this virus will face
no adverse health consequences.
The other risk factors that have been identified include
cigarette smoking, a higher number of pregnancies, lower socio-
economic status, immunosuppression, multiple sexual partners, a
high-risk sexual partner, and an early age of onset of sexual
activity.
The treatment for pre-invasive cancer is generally surgery
for those with disease confined to the cervix, and radiation
therapy for women found to have cervical cancer grown beyond
the cervix into the pelvic tissues. The 5-year survival rate
for those with disease confined to the cervix is 90 percent
compared to only 50 percent for those whose disease is found to
extend beyond the cervix.
We evaluate new treatment options primarily through the
NCI's Clinical Trials Cooperative Groups, which bring together
doctors and nurses and patients around the country. Recently,
five of these trials--conducted by the Gynecologic Oncology
Group, the Southwest Oncology Group, and the Radiation Therapy
Oncology Group--enrolled 1,900 women with cervical cancer. The
results of these trials showed that chemotherapy given at the
same time as radiation therapy improved survival and decreased
the number of recurrences.
When the NCI became aware of these results, we convened a
jury with doctors and a representative from the patient
advocacy community to review the results. That panel voted
unanimously that the National Cancer Institute should issue a
clinical announcement, as Senator Mack mentioned. This
announcement was sent to 14,000 physicians, was placed on the
NCI website, and we also worked closely with the New England
Journal of Medicine, to whom 300 manuscripts were submitted, to
speed review and publication of these important results.
We continue to work through our cancer centers, through our
cooperative groups, through our grantees, and through
investigators at the National Institutes of Health on ways to
improve treatment. We are working to see whether fertility-
sparing surgery can be useful to see if we can improve our
chemotherapy and radiation therapy as well as to develop
vaccines against the human papillomavirus.
Dr. Lowey will address the issue of vaccine development in
greater detail. We are very excited about his research and that
of other investigators in the field because we have the
potential that we may able to prevent initial infection with
human papillomavirus as well as to improve treatment for women
diagnosed with cervical cancer.
Mr. Bilirakis. Thank you, Dr. Trimble.
Dr. Lowey.
STATEMENT OF DOUGLAS R. LOWEY
Mr. Lowey. Yes, good afternoon, Mr. Chairman and
subcommittee members. I am Douglas Lowey. I am the Deputy
Director of the Division of Basic Sciences in the National
Cancer Institute and also run a research laboratory at the NIH
that studies papillomaviruses. I would like to thank you for
the opportunity to talk with you today about the prospects of
developing a vaccine against HPV infection.
As you have already heard, cervical infection with human
papillomavirus is the most common sexually transmitted
infection of women. Abnormal Pap smears and pre-malignant
lesions represent a manifestation of this infection, and
virtually all cervical cancers arise as a consequence of
infection by these viruses. In addition, there is also evidence
that links HPV infection at other sites in the body to several
other types of cancers.
The demonstration that pre-malignant conditions and cancers
are caused by an infectious agent such as a virus implies that
a safe and effective vaccine which could prevent the infection,
would prevent the pre-malignant adnormalities as well as the
cancers. It is also possible that a vaccine directed against
the virus might have therapeutic effects. However, the history
of virus vaccines indicates it is much more difficult to
develop vaccines that cure established infection than to
develop ones that prevent infection.
The principal message I would like to convey today is that
we believe real progress is being made toward achieving the
goal of developing an effective, preventive vaccine against
HPVs involved in cervical cancer. My reasons for this optimism
are based on vaccine studies of papillomavirus infection in
animals, on early phase vaccine trials in normal human
volunteers, as well as on the composition of the vaccine.
Efforts to develop papillomavirus vaccines with therapeutic
potential are also being pursued, as Mr. Mack mentioned in his
testimony.
The preventive papillomavirus vaccine is a subunit vaccine
that is made by genetic engineering techniques analogous to
those used to make recombinant Hepatitis B vaccine, which is
widely used in the United States and elsewhere. The preventive
vaccine currently in human trials is composed of multiple
copies of just a single viral protein which self-assembles to
form the outer shell of the virus particle in a manner that
faithfully mimics the structure of this shell in an infectious
virus. However, unlike infectious virus, the virus-like
particles in the vaccine are not infectious since they don't
contain any papillomavirus genes. Therefore, the vaccine is
unlikely to be dangerous for normal individuals.
In animal papillomavirus models, vaccination with the
papillomavirus vaccine has been 90 percent to 100 percent
effective in preventing infection. Several pharmaceutical
companies are actively involved in the commercial development
of such a vaccine.
Clinical trials are also being carried out by the National
Institutes of Health. This represents a trans-NIH effort with
important support from the NIH Office of Research on Women's
Health, the NIH Office of Research on Minority Health, the
National Institute of Allergy and Infectious Diseases, and the
National Cancer Institute.
In humans, although only a little more than 100 individuals
have thus far received the vaccine, it has been well tolerated
by those individuals, and almost everyone who has received
adequate doses of the vaccine has mounted a strong immunologic
response against the vaccine. Such an immune response often
correlates with protection against infection, but the early
phase trials cannot determine whether or not the vaccine is
effective. These are encouraging results. However, it remains
possible that the first generation vaccine may not be as
effective in people as we hope.
If additional vaccine studies in normal individuals over
the next year continue to show promise regarding safety and
immune response, the National Institutes of Health would plan
to initiate a large-scale, placebo-controlled efficacy trial in
Costa Rica, a country with high rates of cervical cancer, where
the National Cancer Institute already works closely with a
local research team to study HPV infection in young Costa Rican
women.
An efficacy trial will take a few years to complete since
the vaccine needs to be evaluated in unaffected women, and its
effectiveness can only be learned after HPV has developed in a
reasonable number of those women who receive the placebo.
Therefore, even if the vaccine proves to be effective in trials
conducted by the NIH and by pharmaceutical companies, it will
take several years before the vaccine would become available to
the general public.
I am grateful to you for giving me this opportunity to
discuss this issue with you, and I applaud your efforts and
your concerns about cervical cancer and would be happy to
answer questions. Thank you.
[The prepared statement of Edward L. Trimble and Douglas R.
Lowey follows:]
Prepared Statement of Edward L. Trimble, Head, Surgery Section,
Division of Cancer Treatment and Diagnosis and Douglas R. Lowy, Deputy
Director, Division of Basic Sciences, National Cancer Institute,
National Institutes of Health, Department of Health and Human Services
Good afternoon. We are Edward Trimble, M.D., Head of the Surgery
Section for Division of Cancer Treatment and Diagnosis and Douglas
Lowy, M.D., Deputy Director for the Division of Basic Sciences at the
National Cancer Institute. It is our pleasure to appear today to
discuss the progress we are making in cancer research, specifically
cervical cancer research, and to discuss the importance of conveying an
understanding of these advances to the American public.
We are making real progress against cancer. We measure progress
against cancer in two ways: first, the increase in knowledge about
cancer, and second, the reduction of the burden of this disease on
people. We have made progress in both our fundamental understanding of
this disease and in our efforts to prevent and treat it. This is
already evident in the declining cancer incidence and death rates.
Between 1990 and 1995, these rates dropped for all cancers combined and
for most of the top 10 cancer sites, reversing an almost 60-year trend
of increasing cancer cases and deaths in the United States.
After increasing 1.2 percent per year from 1973 to 1990, the
incidence rate for all cancers combined declined an average of nearly 1
percent per year between 1990 and 1995. The incidence rates declined
for most age groups, for both men and women, and for most racial and
ethnic groups. The exceptions were black males, where the incidence
rates continued to increase, and Asian and Pacific Islander females,
where the incidence rates were level. The overall death rate declined
an average of 0.5 percent a year from 1990 to 1995, with the declines
greater for men than for women. The only racial and ethnic group not
included in the decrease in death rates was Asian and Pacific Islander
females.
From 1950 to 1970, the incidence and mortality rates of invasive
cervical cancer fell impressively by more than 70 percent. From 1970 to
1995, these rates decreased by more than 40 percent. Although cervical
cancer has been steadily decreasing, worldwide it is still the third
most common cancer among women. About 400,000 new cases are diagnosed
each year, predominantly among the economically disadvantaged, in both
developing and industrialized nations. In 1999 an estimated 12,800
cases of invasive cervical cancer are expected to occur in the United
States and approximately 4,800 women will die. We must continue our
research efforts to determine the most effective ways to eliminate
cervical cancer.
Recent Advances in Understanding Cancer
As we understand the nature of cancer, we understand that it is a
complex set of diseases, and that the answers to cancer are related to
the most fundamental mysteries of life itself. We know that cancer is
not one disease, but at least 100 different diseases that share certain
features. Because of this it is unlikely that one magic bullet will
solve the problem.
The most remarkable progress in the past 25 years has been in our
knowledge of cancer biology. We are dramatically extending our
understanding of what is required to turn a normal cell into a cancer
cell. Cancer arises when a single cell changes so that it divides
continuously, released from the controls that constrain the replication
of normal cells. This transformation results from changes in the
function and activity of genes. Of the approximately 100,000 genes
found in the human genome, the altered activities of only a relatively
small number of genes are responsible for transforming a normal, well-
behaved cell into a cancer cell. Identifying these cancer genes defines
the central scientific hunt in cancer biology, and opens an
unprecedented window into the nature of cancer. Up until now, our
detection tools have lacked the sensitivity and the specificity that we
must demand if early detection is to be useful and successful. Our
interventions, despite their success, have, by and large, been the
result of guesswork. But now, we are at a point where we can transform
our approach to cancer.
No one genetic alteration is enough to make a normal, healthy cell
a cancer cell. Rather, an accumulation of changes in a relatively small
number of genes during the lifetime of a cell is required. We have
learned that some individuals carry a very high lifetime risk of
developing cancer. This understanding has allowed us to begin
describing the evolution of specific cancers from predisposition to
precancer to cancer. Each cancer is ultimately defined by its
particular pattern of altered and normal gene activity. This unique
pattern determines the cancer's rate of growth, tendency to spread,
responsiveness to hormones and therapies, and also predicts the ability
of a persons immune system to recognize and respond to the cancer.
Moreover, cataloging these molecular patterns will ultimately tell us
how many different cancers exist, and enable us to distinguish the
differences between a cancer cell and a normal cell.
We also are learning to understand the causes of cancer. Research
on cancer risk--the probability that the disease will occur in a given
population--is identifying populations with a significant probability
of developing cancer. Because cancer is a multistage process, analysis
of risk factors leads to the development of prevention and control
strategies, as well as early detection methods, and in some cases more
precise treatments. Epidemiologic research has identified many factors
that increase cancer risk. Most of these are related to environment and
lifestyle, while others are part of a person's genetic makeup. With the
exception of a few genetic conditions, however, it is still not
possible to predict with any degree of certainty that a person having
one or more of these factors will develop cancer. This uncertainty is
related to the very nature of cancer and the need for many specific
alterations to accumulate in a single cell for that normal cell to be
transformed into a cancer cell.
Understanding Cervical Cancer
The etiology of cervical cancer is similar throughout the world.
Cervical cancer results from a series of genetic changes. The National
Cancer Institute is funding numerous studies to enhance our
understanding of cervical cancer. Epidemiologic studies have
demonstrated that infection with human papillomavirus (HPV) is the
major risk factor for development of preinvasive or invasive carcinoma
of the cervix. The virus contains oncogenes that can cause genetic
changes or mutations in the cells, but further changes are necessary
for cancer to develop. In most women and men with HPV infection, these
other genetic changes do not occur and therefore, the individuals do
not develop cancer or experience other adverse health effects besides
HPV infection. A large study in Costa Rica also aims to understand why
common HPV infections sometimes persist and progress to cervical
cancer. Ethnicity-related host factors such as immune status, genetic
susceptibility markers, parity and nutrition are being studied
intensively. Findings from this investigation are likely to be relevant
to minority populations in the United States since the incidence and
mortality rates for cancer of the cervix are two to three times higher
in Hispanic and African American women compared to White women. Certain
Asian American populations, especially Vietnamese women, also have high
rates of cervical cancer. Ethnic differences exist mainly in women over
50 and are decreasing over time. Other known cervical cancer risk
factors include long intervals since last Pap test, multiple sexual
partners, cigarette smoking and higher number of births.
Cervical Cancer Screening
The majority of cervical cancers develop through a series of
gradual, well-defined precancerous lesions. During this lengthy
process, the abnormal tissue is easily detected by the Pap test. In the
majority of women, the abnormalities will clear up without treatment,
but in some instances a few of these abnormal cells will develop into
cervical cancer. Early detection of the disease through the use of a
Pap test is directly related to survival. The five year relative
survival rate for cervical cancer is 88 percent for women with an early
diagnosis of localized disease. For women initially diagnosed with
later stage cervical cancer, the survival rate is only 13 percent.
Studies have found that the risk of developing invasive cervical cancer
is 3-10 times greater in women who have not been screened. Risk also
increases with longer duration following the last normal Pap test.
Women ages 65 and older account for nearly 25 percent of cervical
cancer cases and 41 percent of cervical cancer deaths in the United
States. A National Health Interview Survey has shown that more than
one-half of all women ages 65 and older have not had a Pap test in the
past three years. The pap test is the most effective screening
procedure for detecting abnormal changes in the cervix but many older
women do not know how often to get a Pap test, and are unlikely to be
tested regularly. Since, many older women do not get regular pap tests,
the older a woman is when cervical cancer is diagnosed, the more likely
she is to be diagnosed with later stage disease.
NCI is conducting a large national study to find the best way to
manage the mild abnormalities that often show up on Pap tests. The
study, called the ASCUS/LSIL Triage Study or ALTS is comparing three
approaches: 1) immediate colposcopic exam and biopsy (the current
standard); 2) repeating Pap test every six months (because most
abnormalities return to normal without treatment); and 3) testing for
cancer-associated types of HPV as a means to differentiate between
abnormalities that need immediate colposcopy and those that can be best
followed with repeat Pap tests. The final results of this study are
expected in three years and could affect the 2 to 3 million American
women each year who learn that their Pap test has uncovered a mildly
abnormal change in cells lining the cervix.
Advances in Therapy
Despite screening, women still get cervical cancer and need
therapy. Forty years ago, it was not clear that cancer, other than that
which could be removed surgically, could even theoretically be cured.
The first proof that cancer can be treated and cured came with
childhood cancers, where survival was once measured in weeks to months
and where now the great majority of children with cancer are cured.
Now, for some cancers, our ability to cure is relatively predictable.
For others, our ability to cure is remarkably unpredictable.
Cancer research is also improving the traditional mainstays of
treatment--surgery, radiation, and chemotherapy. Clinical trials are
instrumental in these improvements. Last month in an important advance
notice, NCI issued a Clinical Announcement to thousands of physicians
who treat cancer, describing the results of five large studies that
have shown that women with invasive cervical cancer have better rates
of survival when they receive chemotherapy that includes the drug
cisplatin along with radiation therapy. Until last month, surgery or
radiation alone had been considered standard treatment for this form of
cancer. The new findings show that the risk of death from cervical
cancer was decreased by 30 percent to 50 percent by combining
cisplatin-based chemotherapy with radiation therapy in women who
require radiation therapy for treatment of cervical cancer. This new
approach to cancer therapy is the direct result of the Nation's
clinical trials system.
Cervical Cancer Prevention
NCI is leading the development of a vaccine to prevent cervical
cancer. This vaccine is based on the concept that almost all cervical
cancers are caused by papillomavirus infections. (HPV type 16 has been
found in more than one-half of cervical cancers, and three other types
of HPV are found in another 30 percent of the tumors.) The vaccine has
proven highly effective in animal trials. The vaccine is likely to be
safe since it is not infectious and does not contain the potentially
cancer causing viral genes. Among prevention vaccines in development,
three early phase trials are in progress and being tested in people.
One of these, developed at NCI in collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID), the NIH Office of
Research on Minority Health and Johns Hopkins University, has been
tested in a phase I trial, and the preliminary results have been very
encouraging, showing that it stimulated production of HPV antibodies
and was safe. If these results are confirmed after further follow up
and analysis, a full efficacy trial will test the NCI vaccine in a
larger group of women in the United States and Costa Rica, leading to a
full phase III trial in Costa Rica. Determining the long term efficacy
of this preventative vaccine will take several years. The NCI is also
working with investigators in universities and industry to develop
vaccines which might improve cancer treatment.
NCI also conducts and supports research into behavioral aspects of
cancer prevention. Smoking cessation is a major research priority at
NCI since exposure to cigarette smoke is associated with increased
rates of many cancers, including cervical. Dietary intervention is
another research priority for the institute since increased intake of
certain micronutrients and other dietary factors such as carotenoids
have been suggested as being associated with a decreased risk for
developing cervical cancer.
Public Understanding
Communicating with cancer patients, individuals at high risk for
cancer, the general public, and the health care community is a central
component of NCI's mission and mandate. Our programs are based upon
needs identified through epidemiologic studies and market research
among specific population groups, resulting in programs that are
relevant and understandable to each group. Our patient education
program, leadership initiatives for special populations, and minority
research networks are all actively involved in spreading state-of-the-
art information about cancer prevention, detection, diagnosis,
treatment, and care.
The primary avenues NCI uses to communicate with the public and the
health care community are:
Clinical Announcements: Important cancer research findings are
released directly to the public and to the thousands of physicians who
treat cancer patients through NCI's clinical announcements.
Announcements of research findings are mailed directly to physicians
and the national press is provided with the announcements so that they
can inform the public.
World Wide Web (http://www.nci.hih.gov): Currently NCI is
redesigning its web site to increase its usefulness as a communication
tool. The new web site will be organized so that clinicians,
researchers, and the public can quickly and easily locate up-to-the-
minute information that is relevant to their needs. A new addition to
NCI's Web site is the Cancer Trials site (http://
www.cancertrials.ncl.gov). Through this site, patients, health care
professionals, and the public can learn about ongoing NCI-sponsored
trials, read about the most recent advances in cancer therapy, and
explore other information resources related to cancer treatment. This
web site was used by many patients and others who wanted information
about treatment advances publicized over the past several months.
Cancer Information Service (CIS): The CIS provides accurate, up to
date cancer information to patients and their families, the public, and
health care professionals in every state through 19 offices located at
NCI-funded Cancer Centers and other health care institutions. By
dialing 1-800-4-CANCER, callers are automatically connected, free of
charge, to the office serving their region. Information on specific
cancer types, state-of-the-art care, clinical trials, and resources
such as support groups or screening and smoking cessation programs is
provided in English or Spanish by specialists who respond to more than
600,000 inquiries annually. The CIS regional offices are NCI's focal
point for state and local cancer education efforts that target
underserved, high risk, and low literacy populations.
The CIS distributes informational resources on cervical cancer free
of charge. In order to reach the ethnic populations that are at
increased risk for cervical cancer, NCI is collaborating with the Food
and Drug Administration in distributing Pap test and cervical cancer
brochures in Vietnamese, Cambodian, Samoan, Laotian, Thai, Chinese, and
Korean. The CIS also distributes an intertribal video on early
detection of cervical cancer for American Indian Women that was
produced in conjunction with the Nebraska Department of Health.
Physician Data Query (PDQ): Patients and health care professionals
want and need access to accurate, up-to-date, comprehensive information
about ongoing clinical trials. Through PDQ, NCI provides information
about NCI-sponsored trials. We are in the process of expanding the
database, with the cooperation of patient advocates, the Food and Drug
Administration, and the pharmaceutical industry, to include all cancer
clinical trials approved by the FDA and to revamp the way information
is presented. This system has served as a model for other institutes at
the National Institutes of Health, and we want to ensure that it
continues to be responsive to the needs of the communities we serve.
Medical choices are increasingly made on an individual basis,
requiring that physicians and their patients have access to the
resources needed to make an informed decision about their treatment and
care. Communicating the importance of research findings to physicians
and patients in a clear and understandable manner is central to making
critical decisions about a patient's treatment and care. NCI has
launched a new national media campaign on cervical cancer screening--
``Pap Tests: A Healthy Habit for Life.'' The first phase of the
campaign is focused on encouraging women, ages 65 and older, to get
regular Pap tests since they continue to be at risk for cervical cancer
although their screening rates decrease with age. The second phase of
the campaign targets health professionals, encouraging them to continue
to screen their older female patients because research has shown that
general and family practitioners are not likely to screen their older
female patients.
NIH Consensus Statement on Cervical Cancer: The objective of this
NIH Consensus Statement is to inform physicians and the general public
of the results of the 1996 NIH Consensus Development Conference on
Cervical Cancer. Following established procedures, the consensus
statement was prepared by a non-Federal, nonadvocate, 13 member panel
representing the fields of obstetrics and gynecology, gynecologic
oncology, radiation oncology and epidemlolgy. The statement provides
state-of-the-art information regarding preventive approaches and
appropriate management of cervical cancer and presents the conclusions
and recommendations of the consensus panel regarding these issues. In
addition, the statement identifies those areas of study that deserve
further investigation such as: studies to assess quality-of-life issues
in patients undergoing therapy for both preinvasive and invasive
lesions of the cervix; research on the modification of high-risk
behavior in young people to reduce the rate of HPV; research on ways to
improve screening in populations that are typically underscreened such
as the elderly, ethnic minorities, and the poor; and research on the
development and testing of prophylactic and therapeutic vaccines
against HPV.
We hope this overview provides you and the members of the committee
a sense of the importance of ongoing research on cervical cancer. Thank
you for your interest in the cervical cancer research activities of the
NCI. We would be pleased to answer any questions.
Mr. Bilirakis. Thank you very much, Dr. Lowey.
In the process of trying to prepare for these hearings, we
always ask that the testimony be submitted as much in advance
as possible. The testimony came in from CDC, as I understand
it, this morning. I know that in your particular case, we gave
you plenty of notice for this hearing.
With all due respect, we would appreciate you help by
submitting testimony promptly in the future.
For years, when Florida's late Governor, Lawton Chiles, was
in the Senate up here, we worked together. I was a co-chairman
with him on the subject of infant mortality. After discussions
and research, we determined that there are adequate resources
available to help reduce the very high incidence of infant
mortality in this country. But, the problem was being able to
get the mothers-to-be to the resources. That was a big problem.
We came up with mobile sources. If we could not get them to
come to us, we would go to them.
If a person qualifies for Medicaid, the program covers the
Pap smear. Medicare, because of recent legislation I wrote with
Mr. Brown and others, covers it now. I believe most, if not
all, private insurance plans do. Now I know that there is a
group of people who don't fall in those particular categories.
What is the roadblock to Pap smear screening? We have
determined that the early detection is so very critical. Can
you address that, Dr. Valdiserri or Dr. Lee?
Ms. Lee. Yes, that is a very good question, and I think
there are many barriers. There has been a lot of research in
this area.
Our program particularly is targeting those women that
don't have any insurance, including Medicaid. Those women are
from that 40 million, and we, of course, only have funds to
cover about 12 to 15 percent of that population.
The research indicates a lot of factors. It is real
important that physicians and other healthcare providers take
the lead in encouraging women because many women take their cue
from their physicians. It is real important for us to encourage
all healthcare providers to add this to the many things they
are supposed to be doing.
We know that cervical cancer is highest in poor women,
uninsured women, minority women, and women who are foreign-
born, and women who don't receive regular healthcare.
Mr. Bilirakis. But, you are talking now of women who may
not be well informed about the nature of this threat.
Ms. Lee. Correct. Exactly. So there are many parts of CDC's
National Breast and Cervical Cancer Early Detection Program
that we are trying to come in and figure out how to get those
women--that is what I talked about in my testimony. That is our
hard job, to get the women who nobody else can seem to get. We
can pay for it, but we would have to find them.
We have given money to many primarily community-based
organizations throughout the country, to farm worker
organizations, migrant health, to organizations that provide
services to Asian immigrants, to Hispanic and Latin American
immigrants, to organizations targeting Hispanic, elderly and
the elderly in the Black community. We go through churches. We
go through community clinics. We have programs that fund lay
health educators, and actual women who themselves have had
cancer, but are not otherwise trained in the health profession
to go out and witness to women about what they need to do. So,
there are many strategies that we are working on identifying.
We actually have a whole set of grants now. I will conclude
my answer with this: a bunch of grants to these community-based
organizations take proven strategies that have been proven
through good evaluation research and disseminate them into the
community or different communities around the country. These
are the efforts that we are trying to do to reach these women
that nobody else can seem to reach.
Mr. Bilirakis. College women would not generally fall
within the category that you described. Yet, I understand that
last year the New England Journal of Medicine released a study
that tracked college women at Rutgers University over a 3-year
period of time and found a high incidence of HPV. So, what is
the explanation, when they don't fall within that category?
Mr. Valdiserri. Two comments on that particular study: I
think that it reinforces what I said earlier in my testimony
about probably as many as 50 percent of all sexually active
adults in America are infected with HPV. I think that, to
follow up on Dr. Lee's comments, this is an important issue
that is not, unfortunately, unique to screening for cervical
cancer. In fact, I remember a very interesting approach to
this, looking at barriers to prenatal care, where a researcher
actually went through and characterized a whole set of
attitudinal barriers, informational barriers, provider
barriers, system barriers, et cetera. So, to follow up on what
Dr. Lee was saying, I think that there are a number of reasons
why; there is no single reason why this is happening. Part of
the complexity of the program and the need to do operational
research is to understand what a particular barrier might be
for a community of women and then to disseminate model
practices to try to address that.
Mr. Coburn. Would the chairman yield for just a second a
follow-up question?
Mr. Bilirakis. The chairman does not have much time, but go
ahead.
Mr. Coburn. Your testimony that 50 percent of sexually
active adults are carrying this, but, if you exclude monogamous
relationships, if you include that, what you are really saying
is that it is a much higher percentage in the population that
is outside of the married monogamous relationships. So, that's
the populations that you are studying. So, the real prevalence
is much higher than 50 percent in terms of the sexually active
non-monogamous relationships. Is that correct?
Mr. Valdiserri. Well, let me, first of all, say that I
don't believe that I stated that 50 percent were carrying it,
because I think several of my colleagues indicated that in many
instances this infection is transient. We don't know a lot
about the natural history, but I think that there is a belief
that in some people the infection clears, or at least it is no
longer detectable.
What I did say was there are estimates that at least as
many as 50 percent may have been infected by HPV. Part of the
difficulty, Dr. Coburn, is that we do not have a lot of good
surveillance information nor incidence information about this.
I think that it is fair to say, as I mentioned, that the number
of sexual partners is a clear-cut risk factor for becoming
infected with HPV. So that the greater the number of sex
partners, the more likely an individual would be exposed to
HPV.
Mr. Coburn. Well, I thank the gentleman.
Mr. Bilirakis. Mr. Brown.
Mr. Brown. Thank you.
Dr. Lee, you talked about the higher rate of cervical
cancer among foreign-born women, and my understanding is that
Asian-Indians, in particular, have a higher incidence, and we
have talked about low-income people having high incidence.
Explain why that is in all of those groups.
Ms. Lee. Maybe can I speculate some? Will you allow me?
Actually, the highest rate in recognized racial and
minority groups in the country is among Vietnamese women.
Alaskan Natives, Hispanics, Korean women, all have very high
rates. I think a whole lot of this has to do with being
recently arrived in this country perhaps from--obviously, not
from Alaskan Natives, but for the Asian women and for Hispanic
women from Latin and Central----
Mr. Brown. Is it all Asian women or especially--not Indian,
but especially Korean and Vietnamese?
Ms. Lee. It is mainly Southeast Asian and Vietnamese. I
think Japanese women actually have a very low rate.
Mr. Brown. And Indian women?
Ms. Lee. I have not seen the rates broken out by Indian.
Mr. Brown. Asian-Indians, I am sorry.
Mr. Lowey. Native American Indians.
Ms. Lee. From the subcontinent.
Mr. Lowey. In India there is a very high incidence.
Ms. Lee. The statistics we have in this country on Asian
women don't break out the Asian-Indian women.
I think that what we have found in this country is that the
most profound predictor of getting cervical cancer in this
country is not having screening. Okay, that does not really
count in South America, for example.
Mr. Brown. Does that account entirely for the high
incidence among low-income people?
Ms. Lee. I would say in this country it is a very important
thing. I am not talking about the pre-cancerous lesions
because, if you are screened adequately, you are then diagnosed
with pre-cancer and that is cured. The pre-cancerous lesions
are also caused by HPV and the other known risk factors.
I think the primary reason that you find high rates, not
the only but the primary reason, in these foreign-born and
Hispanic and Asian subgroups is because they have recently
arrived in this country and came from a place where they were
not being screened regularly, or they are in a culture in this
country where they are not getting screened regularly. That is,
I think, the reason that we see the high rates in those
subpopulations in this country.
Mr. Brown. Talk more about the incidence in low-income
women, please.
Ms. Lee. Now I was talking about the incidence in various
racial and ethnic minority groups.
Mr. Brown. No, I am asking you to discuss why the incidence
is higher among low-income women.
Ms. Lee. I think it is among the same reasons that those
women of low-income predominantly are overrepresented members
in the minority community. When we look at screening data from
national survey data, we are less likely to see women of low-
income and low-educational status having regular Pap screening.
Mr. Coburn. [presiding] Thank you, and I will recognize
myself, if I may.
First thing I would like to do is submit for the record a
study that was recently published in Pediatrics about the
incidence of early dysplasia and carcinoma in situ in teenagers
10 to 19, published March 3, 1999 in New England, and a ratio
of 4 percent of advanced dysplasia among that group. If I have
no objection, I would like to enter that into the record.
[The information referred to follows:]
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Mr. Coburn. I want to spend just a few minutes going
through this. Dr. Valdiserri, you have stated that there are 45
million people perhaps that have been exposed to this virus or
this combination of viruses. We know that it accounts for
somewhere above 90 percent of invasive cervical cancer. We have
not talked about the tremendous outbreak and tremendous
epidemic increase in cervical dysplasia in this country that we
are seeing. Would you care to comment on that?
Mr. Valdiserri. I don't know that I am the best person to
comment on that particular aspect of it. From my focus at CDC,
in my center we are not doing surveillance on cervical
dysplasia. In fact, we have a meeting scheduled in early April
with the American Cancer Society and colleagues from NIH and
other colleagues at CDC to consider a whole host of issues
around HPV, and surveillance will be one of the considerations.
But I think that when we are talking about surveillance in that
context, we are talking primarily about HPV surveillance.
Mr. Coburn. That leads me back to my next question.
You said in your verbal statement--and I have read your
written statement--that we have data that says perhaps this may
be a short-lived infection. Would you care to submit for this
committee all the scientific data that you say are the studies,
the peer-reviewed studies, that are out there that would say
that this is short-lived, and that we can actually have for us
to look at the experience model that you are calling on, to
give us that information?
Mr. Valdiserri. Let me state for the record, Dr. Coburn,
that I am here as a representative of the National Center for
HIV, STD, and TB Prevention. My particular expertise is not in
human papillomavirus. I don't know if that was a rhetorical
question.
Mr. Coburn. No, it really was not.
Mr. Valdiserri. But, through my reading and through my
discussions with some of the experts that we have at CDC, let
me say, first of all, there is much that we don't know about
the natural history of HPV. There are many, many issues----
Mr. Coburn. Right, but let me interrupt you there because
that is exactly where I am going. My whole point is this is the
largest sexually transmitted disease that we have in the
country. It affects more people. It accounts for 90 percent of
the cervical cancer. My question to you is, why is not a
reportable disease?
Mr. Valdiserri. Let me answer that one. But, let me go back
to your first question about why I mentioned that some experts
indicate that this might be short-lived. I think that that is a
reflection of the fact that there is good evidence to show,
although there is not incidence data, there are many, many
studies showing the widespread prevalence of HPV, and this is
linked with the fact that clinically, as my colleague from NCI
stated as well, fortunately, for most men and women who are
infected, this is a benign condition that does not even result
in any kind of symptomatic presentation.
So, I think to go back to your first question, that is why
some of the experts in the field, they don't know for certain,
but think that this may be a short-lived condition.
Your second question, I am sorry now, I have forgotten it.
Mr. Coburn. Why is it not a reportable disease?
Mr. Valdiserri. Why is it not reportable? There are two
ways to answer that. I guess the more direct is that, as you
well know, reportable diseases are determined by States.
Mr. Coburn. As I know, the CDC has a list of 53, I believe,
that mandate to the States to report them of which some of
their funding is dependent upon whether or not they report.
Mr. Valdiserri. That's not my understanding of the way it
works out in terms of the Federal and State relations.
Mr. Coburn. Then let me rephrase the question. Why is the
CDC not making a recommendation that this be a reportable
disease?
Mr. Valdiserri. That is what I thought you might be driving
at. Let me say, first of all, at CDC we would like to go on
record saying that we would clearly like to have additional
surveillance information about HPV, for a number of reasons.
Mr. Coburn. I am going to interrupt just for a minute. Here
is the No. 1 cause of cervical cancer in the country. Five
thousand women, at least, a year are dying from it. It is a
known etiologic agent. It can be identified. It can be
prevented with screening. Why would we not want the Center for
Disease Control to make a recommendation that this is a
reportable disease? Answer that from a logical conclusion.
Mr. Valdiserri. Well, I think there are a number of reasons
why there would be difficulties, in that if a State determined
that it wanted to make a law reporting HPV, first of all, what
test would we use? Would people use abnormal Pap smears as what
constitutes the reporting condition? Given that most instances
of HPV infection, as you well know, are asymptomatic and don't
result in any kind of----
Mr. Coburn. Dr. Valdiserri, my point is that every day when
I am in my practice, I am telling a women she has a cervical
dysplasia and I am explaining to her how she got that. She got
it because somebody gave her human papillomavirus. And, if I
don't follow my obligation as a physician to say you have a
disease that is transmissible--it is 300 times more
transmissible than HIV.
Now, to tell me that I should not make that a reportable
disease, that she should not inform her partners--we recently
had the American College of Pediatricians come out and say we
should not circumcise young men, but they totally ignored human
papillomavirus and the disease characteristics that we are
getting ready to see with cancer of the penis.
Mr. Valdiserri. First of all, we don't tell individuals who
are infected with HPV and have clinical manifestations and know
that they are infected that they should not inform their
partners. That is a misperception.
Mr. Coburn. No, I did not say that.
Mr. Valdiserri. Well, I want to go on record saying that.
Mr. Coburn. But, if it is a reportable disease, then it
becomes an obligation on the part of the physician to do what
we all know----
Mr. Valdiserri. If he or she can report it. What I am
trying to get in the record is that there are some difficulties
with the one family of tests that are available. My
understanding is that they don't identify all the viral
subtypes.
Mr. Coburn. Absolutely not; they don't. You are right.
Mr. Valdiserri. That is correct, and we also went on record
saying that there are a lot of questions about, what does
antibody mean? Do people have antibody or not?
Mr. Coburn. We will spar back and forth here for a minute,
but we also know that they DNA probes for chlamydia and
gonorrhea are not 100 percent accurate either, but we still
report those diseases.
Mr. Valdiserri. Not in every State.
Mr. Coburn. Well, in most States they are reportable
diseases.
I will yield back my time and then I will ask for
additional time when we finish. The gentlelady from California.
Mrs. Capps. I want to go back a little, although this part
of what I want to say is not really a question, because I found
the original discussion, after you made your testimonies and
throughout your testimonies, to be so much about basic
healthcare and health education. And, as a school nurse, it
just resonates with me my bias about cervical cancer, so highly
treatable, so easily preventable, with all these questions
about why aren't women who are poor, who are born in other
countries, and then we are talking about all the barriers to
access, and it comes right back to people who should be
talking. We should be talking about this with our well-child
clinic care providers, pediatricians, and those who work with
young families, because the next generation starts in utero, as
was mentioned, in terms of the risk factors, but, also, for the
education that must go on until we get a climate of being
comfortable seeking help, particularly, when it comes to
sexually transmitted diseases. And, we have a lot of discussing
to do about how we can get to that point in terms of
healthcare--such preventive healthcare, family oriented, really
supporting families at a critical time and young people, and
that is why I am delighted that we are having this hearing.
I hope that we can continue that conversation, and that
whatever we can do here on the Hill to help get some of those
barriers eliminated in our communities--and I am intrigued by
the models that you are using. I would like to find ways to
lift those out, and the ones that work, we should be doing
everywhere because they are not costly. I know that it is
mostly working neighborhood to neighborhood using peers and
survivors, or whatever, the ways that you have found to work.
Mr. Valdiserri. May I make just a statement? I think that
is such an important point, because when we think about an
infectious disease process or an infectious disease-related
cancer like we are talking about here, we obviously focus on
the basic research, which is fundamentally important. But,
there are a whole host of operational and health services
research questions like the ones that you have alluded to and
like to ones that Dr. Lee mentioned that I think are extremely
important that have to take place, sometimes even after some of
the basic research questions have been answered. So, I
appreciate your bringing that point up.
Mrs. Capps. Then, just one final note on that: You are
coming here to the House of Representatives. Each of us has
local constituencies that we represent of interest to you all,
and what you do, the health of our communities depends on
getting this information out. So, that is how I would like to
see this conversation move forward.
What are some of the ways we can help you get the word out,
try new models, and also, what can we bring to you from our
communities in terms of either barriers or models for achieving
success in this area?
I think what we have in the situation with cancer of the
cervix is such an example. It is like a symbol of the good--it
is treatable. There is a low-cost screening technique that is
widely available, and yet, why are so few women taking
advantage of the opportunity? So, that's to be discussed.
One quick one for me: A couple of you alluded to smoking
and the relationship and I am curious. Just a couple of words
about why.
Mr. Trimble. Smoking appears to increase the risk of a
number of epithelial of skin cancers. So we all are now aware
of the association between smoking and lung cancer. But, it
also increases the risk of cancer of the head and neck, cancer
of the esophagus, cancer of the vulva, cancer of the vagina,
cancer of the cervix.
Mrs. Capps. Is there a particular way that this is easily
explained to the lay public?
Mr. Trimble. No.
Mrs. Capps. No. The linkage?
Mr. Trimble. Well, we don't fully understand the mechanism
by which cigarette smoking does increase these risks. We note,
though, that cotinine, which is one of the byproducts of
nicotine, is found expressed in the cervical mucus after a
person smoked a cigarette, but we don't know the specific
mechanism for each of the cancers.
Mrs. Capps. I think we need to disseminate that information
as well.
Mr. Valdiserri. And, I mentioned smoking as an
epidemiologic factor in HPV infection, but that has not been as
consistent a finding as smoking in cervical cancer.
Mrs. Capps. Thank you very much. Thank you for being here
today.
Yield back the balance of my time.
Mr. Coburn. Thank you, and the gentleman from Pennsylvania
is recognized.
Mr. Greenwood. Thank you, Mr. Chairman.
I want to do what Senator Mack did and take off all my
hats, except leave my daddy hat on. My little girls are just
about to be 12, Katie is, and Laura is 13\1/2\. They are not
sexually active. They will be someday. I have encouraged them
to wait until after menopause, but I don't think that I am
going to succeed there.
Mr. Coburn. If the gentleman would yield, there is a study
that shows the incidence of cervical cancer in nuns is zero.
Mr. Greenwood. Nuns. Cervical cancer is zero among nuns.
That is another option for them that I will encourage.
But, realistically, what we just heard about these rates of
43 percent among college coeds, I can assume that if one of my
daughters is off at a college campus and becomes sexually
active, that there is an extraordinarily high likelihood,
particularly if she had more than one partner, if half the guys
out there have HPV, and she would have two partners over the
course of 4 years of college, virtually 100 percent likelihood
that she gets a disease that is a very strong precursor to a
very deadly cancer.
I would be happy to be corrected if my assumptions there
need to be corrected. But, I think, whether they do or not, the
fact is that young people today, being sexually active, as the
huge percentage are, are enormously at-risk for disease that is
enormously deadly.
I would guess that if you went to any college campus, go to
the best Ivy League campus in the country and ask male and
female college students about HPV; I would guess that an
extraordinarily small percentage of them have ever heard of it,
know what it means, know how common it is among their fellow
students and their potential sexual partners--let alone have
knowledge of the fact that it is essentially incurable, and let
alone that it is a precursor to cancer which is fatal.
I have two questions: One, is there any other disease out
there that is as widespread, as incurable, and is potentially
devastating as this one? That is my first question. My second
question is: Two, what are you doing to inform the American
public, particularly the young sexually active Americans, that
every time they get in bed with somebody it is a loaded gun?
Mr. Valdiserri. Let me start out, and I suspect that my
colleagues will want to comment as well.
First of all, in answering your first question, I guess I
would ask you to remember, although we are dealing with an
extremely serious situation here, that most instances of HPV
infection are benign and don't result in cervical cancer. I am
not trying minimize----
Mr. Coburn. If the gentleman would yield, I would like for
you to submit to the committee the scientific peer review data
that says that, because I can't find a whole lot of it.
Mr. Valdiserri. Yes, that is not a problem. There is also a
very good summary in the new STD text that came out that has
hundreds of references that tell what we know about natural
history. So, we can do that.
Mr. Greenwood. Just since I am not a physician in this
triangle here, when you say most cases are benign, tell me what
you mean by that.
Mr. Valdiserri. What I mean is that, based on the evidence
that we've accumulated, there are specific subtypes, specific
types of the virus that are associated with cancer and specific
types of the virus that are not, and maybe my colleagues from
NIH and NCI can speak to this, but, epidemiologically, the
estimates that I have seen are that about 5 to 10 percent
perhaps of women who are infected with the so-called high-risk
or the cancer-associated viruses will go on to develop cervical
cancer if there is not the screening that detects the pre-
cancerous lesions.
Again, that is not to minimize that percentage, because it
is a tragedy each and every time it happens. But, it is
important to keep that in mind when you think about how
widespread this viral infection is in the population.
I think your second point is perhaps a little easier to
talk to. You may be aware of the fact that the Institute of
Medicine published a report on sexually transmissible diseases
in America, I guess it has been about 2 years ago now, and they
called it ``The Hidden Epidemic.'' They talked about this whole
issue of all of the sexually transmissible diseases that
confront sexually active individuals, and I would just like to
go on record saying that you are absolutely right; that we do
have to get this information out there and it is one of the
reasons it is important to stress to individuals that there are
a lot of health benefits that derive from delaying sexual
activity. But we also know that sooner or later people will
become sexually active, and then we have to also provide, to
the best of our knowledge, information about prevention in that
context as well.
Mr. Greenwood. The one part of the question that I did not
get a response to yet was: Is there any other disease that is
this prevalent? For 50 percent of at least a subset of the
population that is sexually active, for that population to have
a particular virus, I can't----
Mr. Valdiserri. Off the top of my head, I don't know, and I
think it reflects the fact that the target organ for HPV is
skin, an epidermal surface, and that's a pretty big target
organ; there are a lot of types of them.
Ms. Lee. Let me say that once infected is not the same as
having the disease; Okay? So, like, I had the flu last year,
and if you went back and you were able to check those
antibodies, I would have it, but that does not mean I am now
affected by it. Let me just say that let's look at the positive
of this. Unlike most cancers, we have a test that works, and we
have dropped the rate of cervical cancer by 70 percent in the
last 50 years. And so, most women who are infected with the bad
kind of HPV virus, and, in fact, go on to develop these
neoplastic or pre-cancerous changes, can be, and are, detected
before they ever get cancer, treated in the physician's office
as an outpatient. Dr. Coburn can do it. They never have to do
the hospital. They don't have to get a hysterectomy. They can
still have children, and then they go on. So, we can put a
good, positive spin on this for this kind of cancer.
Mr. Greenwood. We shouldn't put any spin on it at all, but
my time is out.
Mr. Coburn. Next, I'd like to recognize the gentlelady from
California.
Before I do that, I would like unanimous consent to put
into the record a letter from Dr. Clausner, from NIH Public
Health Service, dated February 19, to the chairman, in
relationship to questions that were asked by the committee--I
believe you all had a copy of this letter--and also a study
published in the New England Journal of Medicine on the natural
history of cervical--I will make sure that you have it--
cervical vaginal papilloma virus infection in young women.
[The information referred to follows:]
Department of Health & Human Services
Public Health Service
National Institutes of Health
National Cancer Institute
Bethesda, Maryland
February 19, 1999
The Honorable Tom Bliley, Jr.
House of Representatives
Washington, D.C. 20515
Dear Mr. Bliley: I am responding to your letter of January 12,
1999, in which you pose fifteen questions about the possible
relationship of induced abortion to breast cancer, the relationship
between human papillomavirus (HPV) and cervical cancer, and the
National Cancer Institute's (NCI) dissemination of research findings on
these topics. I regret that I could not meet your request to provide a
response by January 29, 1999. My staff have worked closely with Mr.
Marc Wheat to keep him informed of our progress.
As requested, the questions have been restated below. The answer
follows each numbered question.
1. At the July 20 hearing on ``The State of Cancer Research,'' the
National Cancer Institute testimony addressed the importance of
epidemiologic research in identifying the factors that increase cancer
risk. How much of the NCI budget is allocated to the funding of
intramural and extramural epidemiologic studies done for that purpose?
NCI funds the bulk of this research through the Division of Cancer
Epidemiology and Genetics (an estimated $60 million for intramural
epidemiologic studies) and the Division of Cancer Control and
Population Sciences (an estimated $147 million for extramural
researchers). Additional funding from other NCI Divisions may be
relevant, but we included only projects that are directly related to
studying factors that increase cancer risk.
2. NCI has a long-standing focus on ``preventable causes.'' Are
there preventable causes for breast cancer that have been identified by
NCI? What preventable causes have been identified for cervical cancer?
After discussion with Mr. Mark Wheat of your staff, ``preventable''
(for the purpose of this inquiry) exposures are those created by human
intervention; i.e., herbicides, diet. In contrast, ``unavoidable''
exposures are those that occur in nature; i.e., genetics.
Breast Cancer
The leading known risk factors for breast cancer are largely
unavoidable. Age is the leading risk factor, with incidence rates
increasing dramatically after age 50. Family history is a strong risk
factor, particularly if a woman's mother or sister has the disease.
Genetic factors play an important role. About 50 percent of women with
a mutation in the BRCA-1 gene will develop breast cancer by age 70. It
is important to keep in mind that only between 5 and 10 percent of all
breast cancers appear to be attributable to an inherited genetic
mutation. Some benign breast diseases increase risk, and a previous
diagnosis of breast, ovarian or endometrial cancer is associated with
risk.
Reproductive events are a strong determinant of subsequent breast
cancer risk. Early menarche and late menopause increase risk, while
removal of both ovaries before menopause reduces risk. Having
additional births after the first is associated with a slightly reduced
risk. The most consistent reproductive factor is the woman's age at
first full-term pregnancy. Women without children and women having
their first child after age 30 have a two- to three-fold increased risk
of this disease, compared with women who give birth before age 20. A
woman with an interrupted first pregnancy, either spontaneously or
through induced abortion, does not reap the protective benefit of a
full-term pregnancy.
Other risk factors may be considered ``preventable.'' Taking oral
contraceptives may increase risk for breast cancer at an early age
(before age 45), and estrogen replacement therapy may slightly increase
risk of breast cancer. Among postmenopausal women, risk increases with
weight, body mass, and distribution of weight. The association with
dietary fat consumption is inconclusive, while recent studies have
shown a fairly consistent though small effect of alcohol consumption on
breast cancer risk. Exposure to high doses of radiation increases risk,
although the effects of low-dose radiation are considered minimal.
Most of these ``established'' risk factors for breast cancer are
associated with only a moderately increased risk, suggesting that
multiple factors may play a role in each woman's disease, and that
unrecognized factors may exist. Further research is necessary, is
ongoing, and remains a high priority for the NCI.
Cervical Cancer
Sexual behavior has been identified as the major risk factor for
cervical cancer. Risk is increased by early age at first intercourse or
numerous life-time sexual partners. The greater the number of sexual
partners, the greater the risk of sexually transmitted disease, which
can be a risk factor. Abundant laboratory and clinical data support a
role for human papillomavirus (HPV) in cervical cancer. Cigarette
smoking is associated with increased risk. Barrier methods of
contraception reduce risk, and the use of oral contraceptives increases
risk. Giving birth multiple times is an independent risk factor, and
vitamin C, beta carotene, or folacin (one of the B complex vitamins)
deficiencies may increase risk.
3. The NIH written testimony for the July 20 hearing states that
``communicating with . . . individuals at high risk for cancer, the
general public, and the health care community is a central component of
NCI's mission and mandate.'' To that end, NCI has identified
preventable target exposures of cancer-causing agents as a key element
in the prevention of cancer. What work has NCI done to coordinate a
Federal response to the prevention of breast and cervical cancer?
Specifically, what work has NCI done with the Department of Health and
Human Services Office of Population Affairs and the HHS Health
Resources and Services Administration to alert women to avoidable
exposure to carcinogenic agents? Who are the liaisons within NCI, HRSA,
and the Office of Population Affairs? Has NCI coordinated activity with
the Title V and Title XX programs within those agencies.?
Federal agencies are designated to serve the United States in
specific ways. The National Institutes of Health (NIH), of which NCI is
a part, is a research agency. In its mission to protect and improve
human health, the NIH (and NCI) conducts and supports basic, applied,
and clinical and health services research to understand the processes
underlying human health and to acquire new knowledge to help prevent,
diagnose, and treat human diseases and disabilities. This may include
developing an information campaign (such as the 5 A Day Program
described below, which was based on scientific evidence that increasing
consumption of fruits and vegetables reduces cancer risk) and
evaluating its effectiveness at achieving its goal (increasing the
daily intake of fruits and vegetables). NCI also has a mandate to
disseminate research findings so that when the development and
evaluation are completed, other Federal and state agencies, and private
sector organizations, may take this information and apply it
accordingly. NCI, therefore, plays an integral role in these
activities. For example, the Steering Committee for the National Action
Plan on Breast Cancer (NAPBC) includes NCI staff as members and working
group chairpersons serving this unique public/private trans-Federal
partnership.
The NCI disseminates research findings widely through scientific
publications, press conferences, press statements, clinical alerts,
patient education materials, meetings of professional societies,
television and radio, the World Wide Web, our toll-free Cancer
Information Service, our PDQ databases, and the Information Associates
Program. Our staff has many contacts within agencies for a variety of
programs and issues. Through these personal contacts, and those
mechanisms mentioned above, Federal agencies and offices have direct
access to information pertinent to their programs. In addition, we
maintain and foster close working relationships with other Institutes
that have formal collaborative relationships with the Office of
Population Affairs--our projects and programs are thus included in that
broad knowledge base. NCI has several partnerships with other federal
agencies and non-federal groups to enhance our information
dissemination activities.
NCI has not formally collaborated specifically on Title V
(Substance Abuse and Mental Health Services Administration) or Title XX
(Adolescent Family Life Demonstration Projects) programs. As a research
agency, NCI's role is to conduct and support research, then disseminate
widely new knowledge gained. Following are examples of specific
information campaigns:
Mammography Screening--Scientific evidence supports NCI's
recommendation that lives can be saved if women in their
forties or older have regular screening mammograms, every one
to two years. Because this constituted a major change in the
level of scientific evidence to support screening mammography,
it was imperative that NCI disseminate this information widely.
Specific information targeting various populations and
constituencies was developed and disseminated using a variety
of mechanisms, such as patient-oriented publications, education
materials, public service announcements, and electronic media.
5 A Day--Because fruit and vegetable intake has been clearly
demonstrated to provide a health benefit beyond cancer
prevention, increasing American consumption has tremendous
potential to improve our Nation's health. Because health
messages can be confusing, NCI set aside special funds for
grantees to find innovative ways to inform the public. In an
unprecedented public/private partnership, grantees and health
departments nationwide participated in a study of new methods
to reach the public and influence behavior. These grants are
completed, and NCI and the Centers for Disease Control and
Prevention (CDC) are evaluating their success. If indeed
Americans increased their consumption, then other public and
private groups will have scientifically proven methods to bring
into their communities.
``Risk Disk''--The Breast Cancer Risk Assessment Tool is a
computer program that women and their health care providers can
use to estimate a woman's risk of developing breast cancer for
two time periods--over the next five years and for her
lifetime--based on several recognized risk factors (see
Question 2 for a discussion of some of those risk factors). The
tool compares these risks (given as a percentage) to those of a
woman of the same age with no risk factors other than her age,
and with the risk of women who were eligible to participate in
the breast cancer prevention trial using tamoxifen.
4. The July 20 NCI written testimony states that ``NCI is actively
pursuing development of a vaccine to prevent cervical cancer . . .
based on the concept that almost all cervical cancers are caused, at
least in part, by papilloma virus infections.' What is the status of
the development of a vaccine for this disease? How long will it be
before a vaccine enters clinical trials? Have any private sector
entities partnered with NCI in the development of this vaccine?
The vaccine is currently being developed in clinical trials. The
Phase I study to determine if the vaccine can prevent infection is
underway at Johns Hopkins University, and preliminary results based on
laboratory tests are encouraging--with no toxicities yet reported.
Following completion of the Phase I trial, a Phase II trial to
determine correct dosage is expected to begin in January 2000. A
planned Phase III randomized clinical trial involving 10,000 women to
test the efficacy of preventing HPV (Type 16) infection is expected to
begin in about 2.5 years. As in many of our drug studies, we have
partnered with a company to manufacture the virus-like particle
contained within the vaccine. The manufacturer will have no role in the
evaluation of its benefit or safety.
5. Earlier this year, the New England Journal of Medicine published
the results of a study on human papillomavirus (HPV). Among sexually
active female students at Rutgers University, approximately 60 percent
tested positive for HPV at some time during the three-year study
period. Given that HPV is an agent of most cervical cancer cases, which
kill nearly as many women each year as AIDS, what does a 60 percent
infection rate suggest to NCI about the long-term consequences of this
virus? Does this infection rate suggest that condom usage is less
effective at preventing HPV infection than it is in preventing
pregnancy? Has NCI sponsored any research as to the effectiveness of
condoms to prevent the transmission of HPV?
Experts estimate that as many as 24 million Americans are infected
with HPV, and the frequency of infection and disease appears to be
increasing. For most women, HPV does not remain in the body. After
initial infection, most women's immune system can clear the virus
within 18 months. Therefore, a high prevalence at a point in time is
not indicative of the numbers of women who will suffer health
consequences. In fact, most women suffer no serious health problems as
a result of HPV infection, nor do they know they have been infected.
Although most HPV infections do not progress to cancer, it is important
for women to have regular Pap smears. Potentially precancerous cervical
disease is readily treatable. By identifying women with persistent
infection through screening, and then treating those with precancerous
conditions (by removing the precancerous cervical tissue affected), we
relieve most of the burden of cervical cancer from HPV infection in the
United States.
Condoms are ineffective against HPV because the virus is prevalent
not only in mucosal tissue (genitalia) but also on dry skin of the
surrounding abdomen and groin, and it can migrate from those areas into
the vagina and the cervix. Additional research efforts by NCI on the
effectiveness of condoms in preventing HPV transmission are not
warranted. However, condom use is extremely important for preventing
the transmission of other sexually transmitted diseases, and in the
prevention of pregnancy. We include the use of condoms as an option in
clinical trials if methods of birth control or disease prevention are
needed.
6. What is the amount of research dollars expended on HPV as
compared to the virus that causes AIDS? What is the ratio between the
two research budgets as compared to the number of women who die of the
respective viruses?
There are over 80 types of HPV, about 15 of which are associated
with cancer of the cervix. NCI estimates that it will spend about $38
million on cervical cancer-related HPV research, and about $235 million
on AIDS-related cancers, in FY 1999.
There are about 5,000 deaths in the U.S. from cervical cancer each
year, and more than 200,000 deaths world wide. Over 90 percent of these
cancers are HPV-related. There were about 4,600 female deaths in the
U.S., and 900,000 worldwide, from HIV-related illness in FY 1997.
7. What action does NCI recommend be undertaken by the Federal
government to address the public health threats of HPV?
Human papillomavirus (HPV) is one of the most common causes of
sexually transmitted disease in the world. The NCI believes that if all
women had pelvic exams and Pap tests regularly, most precancerous
conditions would be detected and treated before cancer develops. At
present, early detection and treatment of precancerous tissue remain
the most effective ways of preventing cervical cancer. This is
communicated in our publications and public information. NCI is working
to develop a vaccine that will prevent the main cancer-causing types of
HPV, and is investigating the use of HPV testing, via more accurate Pap
testing programs, to improve cervical cancer screening and prevention.
8. According to an Associated Press report on a Supreme Court
ruling dated January, 11, 1999, HHS had a hand in the removal of
controversial posters in the Philadelphia public transit authority that
linked abortion to breast cancer. According to this report, in ``Early
February [1996], the authority received a copy of a letter a federal
health official had sent to the Washington Metropolitan Area Transit
Authority. Dr. Philip Lee, Assistant Secretary of Health in the
Department of Health and Human Services, called the anti-abortion ad
`unfortunately misleading' and `unduly alarming,' and said it `does not
accurately reflect the weight of the scientific literature.' Based on
Lee's letter, SEPTA removed the posters on Feb. 16, 1996.'' Please
provide the Committee with a copy of this letter, and copies of all
other letters HHS has sent since 1993 raising concerns about ads making
cancer claims that may be ``unduly alarming.'' On what basis was the ad
found to be ``unfortunately misleading,'' ``unduly alarming,'' and that
it ``does not accurately reflect the weight of the scientific
literature''?
In early 1996, NCI staff drafted a response to requests for
information about the scientific evidence concerning the relationship
between induced abortion and breast cancer risk. The letter was drafted
for Dr. Klausner's signature (Attachment 1), but there are no copies of
other drafts, or of correspondence to SEPTA, signed by either Dr.
Klausner or Dr. Lee in NCI's central files system or with queried
staff. There were several meetings with Dr. Lee and/or members of his
staff to discuss a response. We have suggested to Mr. Wheat that he ask
the Department of Health and Human Services, too, to search for
relevant documents. NCI did issue a press statement (Attachment 2) on
February 14, 1996, regarding the SEPTA campaign's representation of
information from the scientific literature. A search of NCI's central
files, and among files of queried NCI staff, revealed no correspondence
since 1993 concerning other advertisements making other cancer claims.
9. In a line of questioning at the July 20 hearing before the
Health and Environment Subcommittee, the NCI witness was asked about a
very substantial body of research linking cancer to what is clearly an
eminently avoidable exposure which you did not mention in your written
testimony. Fully 25 out of 31 epidemiologic studies worldwide and 11
out of 12 studies in the United States (many of which, I am told, were
conducted or funded by the NCI) show that women who elect to have even
one induced abortion show an elevated risk of subsequent breast cancer.
What studies has NCI conducted or funded related to the link between
abortion and breast cancer?
*Note: The written testimony for the July 20 hearing focused on
recent advances in cancer treatment, as it was our understanding that
this was the intended topic of the hearing.
The body of research conducted before 1997 was, as described in a
systematic review of the literature by respected epidemiologists,
``inadequate to infer with confidence the relation between induced or
spontaneous abortion and breast cancer risk, but it appears that any
such relation is likely to be small or non-existent.'' Three points
stood out in 1996. The first point was that the type of study (case-
control interview study) that dominated the scientific literature at
that time was subject to a demonstrated bias (``recall bias'') \1\ that
tended to create an association where such association might not
actually exist. Also, many of the early studies had no controls for
other important risk factors. The second point was that the published
studies showed no consistency in findings--and those that did showed
what epidemiologists term ``a weak association'' (a relative risk
between 0.7 and 1.3), or difficult to distinguish from bias or chance.
The third point was that it seemed unlikely that the type of study that
was needed--a study design unencumbered by recall bias, such as a
cohort study--could be performed in the United States.
---------------------------------------------------------------------------
\1\ Women under-report abortions, yet breast cancer patients are
more willing to acknowledge a previous abortion than other women--a
difference that produces ``recall bias.''
---------------------------------------------------------------------------
Epidemiologists thus regarded with interest the very large study,
reported in 1997, which examined medical records--not personal
interviews--from the entire female population of Denmark. In Denmark,
routinely maintained population registries of births, deaths, medical
procedures, and cancer make it possible to compile the data required on
a large scale without recall bias and with great statistical precision.
The study found no increased risk of breast cancer in the Danish women
who had recorded abortions, as compared with women with no record of
abortion.
The NCI conducts and funds many epidemiologic studies of breast
cancer. Often included in the surveys and/or questionnaires are
inquiries about a woman's reproductive history which, as stated above
in the response to Question 2, is a strong determinant for breast
cancer. These questions typically address her history of spontaneous
abortion, induced abortion, or full term pregnancy. NCI has funded
three studies directly related to abortion as a possible risk factor.
They are listed below:
Breast Cancer in Relation to Prior Induced Abortion (completed 1990)
(PI: Daling--Fred Hutchinson Cancer Research Center, Seattle)
Induced Abortion and Risk of Breast Cancer in Shanghai (completed 1997)
(PI: Thomas--Fred Hutchinson Cancer Research Center, Seattle)
Induced Abortion and Breast Cancer Risk (expected completion 1999) (PI:
De-Kun--Kaiser Foundation Research Institute, CA)
In summary, the scientific literature does not suggest that women
who have even one abortion show elevated risk. It remains true that a
woman whose first pregnancy is interrupted, either by spontaneous or
induced abortion, does not gain the same degree of protection against
breast cancer as the woman who is pregnant for the first time at the
same age and carries her first pregnancy to term; instead, she has
delayed her age at first birth. The biologic effect of abortion is seen
by comparing two women who give birth for the first time at the same
age, one of whom had a prior terminated pregnancy. These two women have
the same subsequent risk of developing breast cancer, based on the
epidemiologic data available today.
10. Research presented to the Committee shows that induced abortion
has been linked with increased risk of breast cancer. What has NCI done
to alert women that induced abortion has been consistently associated
with increased breast cancer risk? How has NCI focused its public
information on at-risk populations?
Experts at NCI and elsewhere find that the evidence suggests that
induced abortion is not associated with an increased risk for breast
cancer. Our information to women concerned about breast cancer risk
after abortion addresses the research data to date, and includes
discussions about data inconsistencies. We also emphasize the
importance of a woman's discussing her personal risk of breast cancer
with her physician.
In general, NCI reaches out to patients, their families, health
care providers, researchers, and the public to bring them the most
accurate, up-to-date cancer information. The NCI provides that
information by telephone, on the Internet, through the media, in
partnership with other organizations, and through a wealth of printed
and audiovisual materials.
The Cancer Information Service (CIS) answers about 500,000
calls a year at 19 regional offices. The toll-free number, 1-
800-4-CANCER, connects English- and Spanish-speaking callers
with the office that serves their area. The CIS provides
nationwide service to all 50 states and Puerto Rico. It also
has an outreach program that develops partnerships with
nonprofit, private, and other government agencies at national,
regional, and local levels. Two-thirds of CIS partners focus on
reaching minority populations.
PDQ is NCI's computerized database that gives patients, health
professionals, and the public quick and easy access to the
latest treatment, supportive care, screening, and prevention
information, as well as descriptions of clinical trials that
are open for enrollment.
NCI's Office of liaison Activities works with national
advocacy, voluntary, and professional organizations concerned
about cancer to disseminate the latest, most accurate cancer
information, and collaborates with these groups in areas of
mutual interest. These organizations influence their members,
the media, the public, and policymakers.
NCI is developing a publication on genetic testing to help
people decide if testing is right for them. NCI is also working
to increase health care professional awareness and knowledge of
human genetics and related ethical, legal, and psycho-social
issues.
NCI develops media and print materials designed for
distribution to a variety of audiences. Some of these are
designed specially for minorities and the medically underserved
and are often implemented as part of national campaigns. These
materials support the main message of a campaign (for example,
women over age 40 should have regular mammograms) but are
designed to be used by community leaders. For example, some
materials for mammography screening include posters in English
for African-American, Asian, and Native American women, and in
Spanish, Vietnamese, Chinese and Korean. NCI also contributed
to a nationally syndicated Spanish radio show promoting breast
and cervical cancer prevention and detection.
11. I understand that the body of worldwide epidemiological
research on the link between abortion and breast cancer reaches back as
far as 1957. And the first such study conducted in the United States
occurred as early as 1981. Is it not a fact that a majority of these
studies show an increased risk (average about 30%) among women who have
chosen abortion even just once?
The only cohort study published before 1996 found a statistically
significant negative association (that is, abortion was associated with
reduced risk for breast cancer). Of the 18 case-control studies
published through 1996, most found no statistically significant
association, positive or negative. Most of these studies did not
control for known risk factors, or were limited by inadequate or
possibly biased reporting of abortions. Because a very weak overall
association might obscure a stronger one in a subgroup of women
(perhaps young women), investigators also reported any associations
noted in subgroups, even though the number of those subjects was very
small. The subgroups noted to be at risk in one study were not found to
be at risk in other studies. Thus, even before the large Danish cohort
study was published the weight of evidence suggested no association, or
a very weak one. There remains some uncertainty about the relative risk
for women with very late induced abortions. More data on this finding
would be valuable.
12. The NCI website on ``Abortion and Breast Cancer'' states that
``although it has been the subject of extensive research, there is no
convincing evidence of a direct relationship between breast cancer and
either induced or spontaneous abortion. Available data are inconsistent
and inconclusive, with some studies indicating small elevations in
risk, and others showing no risk associated with either induced or
spontaneous abortions.''
A. Please identify and provide copies of the ``extensive research''
to which the website text refers. Was this research peer-
reviewed?
I have attached copies of a systematic review of the literature
published in 1996, a Dutch case-control study published later, and the
large Danish cohort study (Attachments 3, 4, and 5). Each of these
papers contain an extensive bibliography which, when taken as a whole,
represent the body of literature used by NCI experts to develop the
fact sheet to which you refer. All of these papers were published in
peer-reviewed journals.
B. The website states that there is no ``convincing evidence.'' What
are NCI's criteria for identifying research that would be
considered ``convincing''? Are there statistical benchmarks
that NCI uses to distinguish evidence that is convincing and
that which is not? How is this evidence measured that would
control for bias among researchers or program evaluators?
C. Does NCI draw a distinction between ``direct relationship'' and
``indirect relationship'' in determining causality?
D. NCI states that ``available data are inconsistent and
inconclusive.'' Are the data inconsistent, or are the studies
inconsistent? What accounts for data that ``are inconsistent
and inconclusive''? Has NCI attempted to replicate studies that
may have shown a link between breast cancer and induced
abortion?
E. The NCI website states that some studies indicate a ``small
elevation in risk.'' What does ``small elevation in risk'' mean
in this context? By saying there is a ``small elevation in
risk,'' is NCI placing the risk on a continuum between no risk
and high risk? How does the ``small elevation in risk'' rank on
a comparative risk analysis continuum? Based on this continuum,
what action has NCI or other Federal agencies taken to warn
consumers of cancer risk-factors that are comparable to that of
induced abortion? Does ``small elevation in risk'' mean
``acceptable risk''? How does NCI determine that something is
an acceptably small risk?
Epidemiologists use the terms ``weak associations'' or ``small
risks'' to express assessment of whether an association is ``real'';
that is, the probability that a factor causes the development of
disease. Epidemiologic studies can be subject to errors of several
types: biases in selection of study participants; biases in the
observation of comparative data (such as the recall bias so problematic
in collecting interview data on induced abortion); and statistical
imprecision as the study size becomes smaller. Thus, ``small'' or
``weak'' are terms associated with the level of error methodologically
expected for (1) chance occurrence, (2) a particular feature of the
disease or the exposure, and (3) study design. The increased risk of
developing breast cancer associated with each risk factor (see Question
2, above, for examples) varies from 1.5 to 4 times average risk.
An association typically is estimated as the ratio of risks, or the
``relative risk.'' ``Relative risk'' is the ratio of disease incidence
in the exposed population to the incidence in the unexposed population.
A relative risk of ``1.0'' means that women exposed and women unexposed
to a factor have the same risk of developing disease. It is a
mathematical computation well-suited for assessing biologic connection.
It is not intended to address comparison of absolute risk to benefit,
or to judge what is acceptable risk to each individual. The NCI
publishes widely the facts known about possible breast cancer risks,
but decisions about ``acceptable'' risks must be made by a woman and
her health care provider.
For the relationship between abortion and breast cancer, the most
complete current summary of the uncertainty comes from the Danish
population record study. The authors estimate that the relative risk
for breast cancer in women with a recorded abortion is most likely
between 0.94 and 1.06, with a very narrow interval of uncertainty
because the study was very large. If a relative risk of ``1.0'' means
that women exposed and women unexposed to a factor have the same risk,
then the Danish population record study demonstrates that the women
exposed to--and those not exposed to--the risk factor (induced
abortion) have the same risk.
In many case control studies, a relative risk of 1.3 (or
equivalently, a protective effect seen in a relative risk of 0.7) would
be weak, small, or low. A relative risk of 2.0 is moderate. For
example, if the initial research suggestion of an overall relative risk
of 1.3 for developing breast cancer after abortion were supported by
large and well-controlled epidemiologic studies, and otherwise
fulfilled criteria for causality (see Question 12F. below), NCI would,
as with other peer-reviewed information, make that available through
all our mechanisms of information dissemination (see Question 10,
above). NCI takes its responsibility for the public trust very
seriously. All peer-reviewed study data are considered carefully,
continuously, and comprehensively before we will say with certainty
that a factor imparts a cancer risk. As discussed previously, the
scientific literature to date does not suggest that women who have even
one abortion show elevated risk. Our publications currently reflect
this.
F. NCI also states that some studies indicate ``no risk.'' What level
of ``elevation of risk'' is considered to be ``no risk'' by
NCI? How is ``no risk'' distinguished from that of ``small
risk'' when proving causality is so difficult?
Evaluation of causality requires consideration of various types of
evidence. Whether an exposure causes cancer may be assessed via several
similar schema, the most common being the Bradford Hill criteria:
strength of association, consistency, specificity, temporality,
biologic gradient, plausibility, coherence, experimental evidence, and
analogy. In many case control studies, a relative risk of 1.3 (or
equivalently, a protective effect seen in a relative risk of 0.7) would
be weak, small, or low. The authors of the Danish study estimate that
the relative risk for breast cancer in women with a recorded abortion
is most likely between 0.94 and 1.06, with a very narrow interval of
uncertainty because the study was very large. This falls below the
level of risk epidemiologists would consider weak, small, or low.
13. Is it true that epidemiologic research has found no overall
link between spontaneous abortion and breast cancer? Is that not also
consistent with the fact that most pregnancies which abort
spontaneously are characterized by subnormal estrogen levels, whereas
normal pregnancy levels of estrogen are several times higher than non-
pregnant levels? Is it also true that some form of overexposure to
estrogen, which stimulates the growth of both normal and precancerous
breast tissue, is the mechanism by which most of the known breast
cancer risk factors operate?
Yes, it is true that research has found no overall link between
spontaneous abortion and breast cancer. There are many causes of
spontaneous abortion, and not all of them are characterized by
subnormal estrogen levels. Breast cancer is a cancer that is hormonally
responsive, but it is unclear that estrogen is the only hormone
involved. Other hormones may also play an important etiologic role.
14. The NCI website's first paragraph concludes with the sentence:
``The scientific rationale for an association between abortion and
breast cancer is based on limited experimental data in rats, and is not
consistent with human data.'' Is this data to which you refer the Russo
and Russo 1980 study? Is it accurate to summarize that this study,
where rats were all given a chemical carcinogen, most of those rats
which were allowed to bear offspring did not get breast cancer, while
most of those which had their pregnancies surgically aborted did get
breast cancer?
The data referred to in the NCI Fact Sheet on the Web site is the
Russo & Russo study data. For breast cancer studies, suitable animal
models have not been found, so extrapolating from animal data to the
human model may not infer an absolute comparison. Russo & Russo found
that pregnant rats who carried to term developed fewer mammary tumors
than did rats who never were pregnant, or whose pregnancies were
terminated.
15. The NCI website refers to studies finding ``small elevations in
risk'' in the link between abortion and breast cancer. A 1994 Howard
University study on African-American women here in the Washington, DC
area showed a more than three-fold increase in breast cancer risk with
induced abortion. That same study showed that the risk was almost five-
fold for African-American women over 50 years old. Is it accurate to
call that kind of risk elevation ``small''?
Abortion was not a risk factor studied in the project referred to
above. The risk you cite was actually the risk associated with a family
history of breast cancer among women with two or more abortions. This
was not the risk associated with abortion.
Please do not hesitate to contact me if you have further questions.
Sincerely,
Richard D. Klausner
Director
Attachments
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Mr. Coburn. I would make one clarifying point. So it is
important to people that are not medical here. There are non-
aggressive forms of human papilloma virus; those are of no
interest to us, because they have no effect. It is only those
that are aggressive that we are concerned with, and it is only
those that cause cancer. So that, when we discuss them in
total, we diminish the importance of the aggressiveness of
those that do affect humans, and it is important for everybody,
when we are asking a question about HPV, we are talking about
those that are carcinogenic or oncogenic, rather than those
that aren't.
The other point that I would make, and I think our panel
made, that is not the only cancer that they cause. We see
cancer of the vulva, cancer of the rectum, cancer of the larynx
associated with these same HPV subtypes.
And I would yield to the gentlelady from California.
Ms. Eshoo. Thank you for recognizing me, and I want to
thank each one of the witnesses that are here today because you
have given us highly informative testimony. I hope there are a
lot of people that are tuned in or will hear this through a
repeat program, wherever they are in this country, because I
think in listening, that at least part the intent of this
hearing is to educate. Educate, educate, educate.
The first request that I have, before I ask my question,
is, Dr. Lee, Dr. Valdiserri, could you from the CDC provide for
me--and perhaps the rest of the members of the subcommittee
would like this as well--I would love to have a list of who you
contract within my congressional district for the services that
you provide. I was deeply involved in those issues before I
came to the House, and the county board of supervisors, and
established a whole network of clinics in a major county in the
Bay area. So I would like to know who you are working with.
Also, we should all be looking into whether we can do public
service announcements in our congressional districts on this.
Because to the extent that we get this out, and to the extent
that we have something in place right now, and to the extent
that this subcommittee and full committee and the Congress pass
Mr. Lazio's and Congresswoman Capps' and my original co-
sponsorship of the legislation, we can really go after this and
be effective. So if you can do that, we would really appreciate
it.
[The information referred to follows:]
Question. List of recipients (CBOs, etc) of BCCEDP funds in Ms.
Eshoo's District (14th District in CA--includes Palo Alto)
Answer. CDC funds the California Breast and Cervical Cancer Early
Detection Program (CBCCEDP) to:
provide screening to medically underserved women for breast
and cervical cancer
provide appropriate and timely diagnostic evaluations for
women with abnormal screening tests and treatment services if
needed
develop and disseminate public information and education
related to the detection and control of breast and cervical
cancer
improve training of health professionals in the detection of
these cancers
and finally, evaluate program activities through the
establishment of surveillance systems.
The CBCCEDP partners with many organizations throughout the State
to provide specific services for at risk women. One such partnership in
the 14th District of California is the Santa Clara Valley Center in San
Jose, which has breast and cervical cancer screening providers located
in Palo Alto. Women of the 14th District may also choose to receive
services from the CBCCEDP sites of Alameda County Medical Center and
San Francisco Department of Public Health.
Santa Clara Valley Center
P.O. Box 21949
San Jose, CA 95151-1940
Attn: Jennifer Sedbrook, (408) 289-9260
Alameda County Medical Center Fairmont Hospital Administration
15400 Foothill Boulevard
San Leandro, CA 94578
Attn: Carol Oakley, (510) 667-7848
San Francisco Department of Public Health
101 Grove Street, Room 321
San Francisco, CA 95151-1940
Attn: Diane Carr (415) 554-2878
Question. The National Breast and Cervical Cancer Early Detection
Program's legislation (Public Law 101-354) provides states with funds
to offer screening services to women of low-income. What mechanisms are
in place to provide treatment to women who need it?
Answer. Ensuring that all women with abnormal screening results
receive adequate follow-up and a definitive diagnosis is a crucial
component of the National Breast and Cervical Cancer Early Detection
Program (NBCCEDP). Thus, diagnostic services funded through the program
include diagnostic mammography, breast ultrasound, breast biopsy fine
needle aspiration, colposcopy, colposcopy-directed biopsy and
endocervical curettage.
The legislation that authorizes the NBCCEDP does not allow
resources appropriated for the program to be used for treatment.
However, participating health agencies are required to identify and
secure resources for diagnostic follow-up services that the program
does not cover and for cancer treatment services for women in need,
regardless of their ability to pay. CDC provides careful oversight to
assure that women who need treatment receive it.
Analysis of program data for all abnormal screening mammograms
reveals a median of 36 days between the initial screening mammogram and
final diagnosis, and a median of 9 days between diagnosis of breast
cancer and treatment. Additionally, surveillance data show that 96
percent of the women diagnosed with invasive or in situ breast cancer
have initiated treatment. Of the remaining 4 percent, 2 percent
reportedly refused care, 1 percent had a provider recommendation that
treatment was not currently indicated, and 1 percent were lost to
follow-up.
In addition, CDC contracted with Battelle Centers for Public Health
Research and Evaluation and the University of Michigan to document the
range of systems and strategies used by states to obtain resources for
treatment and ensure that women diagnosed with cancer or precancerous
lesions receive timely and appropriate follow-up and treatment
services. Seven state programs (California, Michigan, Minnesota, New
Mexico, New York, North Carolina, and Texas) were studied in depth,
ending in December 1997. Almost 200 people were interviewed; more than
half of them were screening, diagnostic service, and/or treatment
providers in local communities.
The study results show that innovative and creative approaches have
been implemented to identify and secure resources for follow-up and
treatment services. Women diagnosed with cancer through the NBCCEDP are
receiving treatment. Without exception, study respondents reported that
of their clients diagnosed with breast cancer or invasive cervical
cancer, all women who have wanted treatment have indeed initiated
cancer therapy.
Creative partnerships and responses to the lack of NBCCEDP
resources for some diagnostic services and all treatment services have
been developed in programs at the state, local, and provider levels.
Implemented strategies are very similar for breast and cervical cancer,
although funding from state legislatures and private foundations is
more prevalent for breast diagnostic services than for cervical
diagnostic services or for cancer treatment in general. Additionally,
each of the seven states studied currently has some type of fund,
centralized at the state level, that supplements the services provided
by the NBCCEDP. Many financial barriers to diagnostic follow-up and
some for cancer treatment have been reduced.
Findings suggest that state programs and their partners have
invested significant amounts of time and effort to develop systems of
care for diagnostic follow-up and treatment, and that these systems
appear to be working. Tremendous effort is involved in developing,
implementing, and maintaining strategies and systems for these
services. Rarely is there a standardized or set way that a state or
even a facility uses to obtain services women need that are not covered
by the NBCCEDP. Efforts typically are tailored to an individual
client's needs and resources.
The goal of the NBCCEDP is to reduce mortality from breast and
cervical cancers, and the success of this effort hinges on the
identification and treatment of early stage cancers. As they have in
the past, CDC and its state partners in the NBCCEDP will continue to
give priority to this critical aspect of the early detection effort.
Strategies for Providing Follow-Up and Treatment Services in the
National Breast and Cervical Cancer Early Detection Program United
States, 1997
The Breast and Cervical Cancer Mortality Prevention Act of 1990
(Public Law 101-354) authorized CDC to establish the National Breast
and Cervical Cancer Early Detection Program (NBCCEDP) to increase
screening services for women at low income levels who are uninsured or
underinsured (1). Although the NBCCEDP covers most diagnostic services
that women need after receiving an abnormal mammography or Papanicolaou
(Pap) test result, the program does not reimburse for breast biopsies.
In addition, the Act prohibits the use of NBCCEDP funds for cancer
treatment. Participating health agencies must ensure that NBCCEDP
clients receive timely, appropriate diagnostic and treatment services.
In 1996, CDC began a case study to determine how early detection
programs in seven participating states (California, Michigan,
Minnesota, New Mexico, New York, North Carolina, and Texas) identified
resources and obtained diagnostic and treatment services. This report
summarizes the results of the study (2), which indicate that
respondents in these states reported that treatment had been initiated
for almost all NBCCEDP clients in whom cancer was diagnosed. However,
respondents also considered the strategies used to obtain these
services as short-term solutions that were labor-intensive and diverted
resources away from screening activities.
In the seven states, NBCCEDP sponsored screening services had been
provided for 3 years, and breast cancer had been diagnosed
in 60 women. The states were selected to provide a range of
geographic locations, a combination of urban and rural populations, and
racial/ethnic diversity among program clients. Researchers conducted
semistructured interviews with 192 persons affiliated with the seven
state programs. Of these interviewees, 120 (63%) were providers of
screening, diagnostic, and/or treatment services; 58 (30%) were state
program staff; and 14 (7%) were coa-
lition members. Interviews included topics such as guidelines related
to diagnostic and treatment services, strategies used to obtain and pay
for services, level of effort required to secure these services, and
changes in strategies over time. Each interview was tape recorded and
transcribed. Using a systematic scheme derived from the research
questions, three researchers coded the same transcripts until an inter-
rater agreement of 80% was reached. Thereafter, all transcripts were
coded independently. Coding results were entered into text analysis
software that sorts text from transcripts into sets of information,
themes, and evidence relevant to the specific research questions (3).
The results reflect a synthesis of the interviewees' responses.
Respondents described several strategies used to ensure necessary
diagnostic and treatment services for women screened through the
NBCCEDP. State level strategies in all states included 1) computerized
tracking and follow-up systems that used program surveillance data to
identify and manage clients in need of diagnostic and treatment
services; 2) provisions in contracts requiring screening providers to
arrange for diagnostic follow-up and treatment before screening women;
and 3) arrangements with provider groups and state professional
associations for free or reduced cost services for NBCCEDP clients. All
states also had access to public or private funds to help support
services not covered by the program; such revenue sources included
state appropriations from general or tobacco tax revenues or funds from
private foundations. These funds were available primarily for breast
diagnostic services.
Local strategies tailored to the needs of individual clients were
used to obtain diagnostic and treatment services. Common strategies
reported by respondents included the following: providers billed public
or private insurance plans; providers or local health departments
helped clients apply for public assistance programs; providers referred
clients to public hospitals; county indigent care funds and hospital
community benefit programs financed services; clients received services
through individually negotiated payment plans; and clients paid reduced
or full fees for services.
Respondents strongly supported the continued growth of NBCCEDP and
its goals but expressed several concerns. First, considerable time and
effort were involved in developing and maintaining systems for
diagnostic follow-up and treatment. Second, the process of identifying
available resources within states for diagnostic and treatment services
was considered labor-intensive. Third, the lack of coverage for
diagnostic and treatment services negatively affected recruitment of
providers and restricted the number of women screened. Fourth,
respondents believed that an increasing number of physicians will not
have the autonomy, because of changes in the healthcare system, to
offer free or reduced fee services to NBCCEDP clients.Respondents
reported that arrangements for treatment were made for almost all
NBCCEDP clients who received a diagnosis of breast cancer or invasive
cervical cancer. Respondents stated that some women experienced time
delays between screening, definitive diagnosis, and initiation of
treatment. State program officials reported that, according to 1992-
1996 surveillance data, small numbers of clients in whom cancer was
diagnosed (i.e., from three to 13 women in each state) subsequently
refused treatment. Because these clients were not interviewed, it could
not be determined whether financial barriers contributed to their
decisions to refuse treatment or their loss to follow-up.
Respondents were concerned that the NBCCEDP did not provide funding
for all diagnostic procedures and treatment for the diseases for which
clients were being screened; approaches for delivering services were
fragmented; and the process of obtaining resources required substantial
effort at the state, local, and provider levels. Respondents reported
that the continuation of every strategy for diagnostic and treatment
services beyond the next few years is uncertain. Reported by: PM Lantz,
PhD, Univ of Michigan School of Public Health, Ann Arbor. LE Sever,
PhD, Battelle, Centers for Public Health Research and Evaluation,
Seattle, Washington. Program Svcs Br, Office of the Director, Div of
Cancer Prevention and Control, National Center for Chronic Disease
Prevention and Health Promotion, CDC.
Editorial Note: During July 1991-March 1997, the NBCCEDP provided
576,408 mammograms to women aged 40 years, and 3409 cases of
breast cancer were diagnosed. During this same period, the program
provided 732,754 Pap tests; 23,782 cases of cervical intraepithelial
neoplasia and 303 cases of invasive cervical cancer were diagnosed.
These totals included women referred to the program for diagnostic
evaluation of an abnormal screening result. The NBCCEDP internal
estimates suggested that during this period only 12%-15% of uninsured
women aged 40-64 years in the United States had been screened by the
program (CDC, unpublished data, 1997).
Screening alone does not prevent cancer deaths; it must be coupled
with timely and appropriate diagnostic and treatment services. The
Congressional mandate for NBCCEDP requires grantees to take all
appropriate measures to ensure provision of services required by women
who have abnormal screening results. CDC provides funds for case
management to help these women access healthcare services. To increase
the comprehensive nature of the program, CDC recently approved the use
of NBCCEDP funds for breast biopsies.
The results of this study indicate that state health departments
and their partners in the seven states had developed a wide range of
strategies for diagnostic and treatment services in the absence of
program resources. However, the time and effort required to arrange and
maintain these services diverted resources away from screening
activities.
This study was subject to at least two limitations. First, the
results were based solely on the experience and opinions of informed
professionals affiliated with the program and did not include the
perspectives of NBCCEDP clients. Second, the results may not reflect
the program experiences in other states. Case study methods, however,
are an appropriate and well-accepted approach to gaining in depth
understanding of complex programs in realife situations (4). The
validity of the findings was enhanced by developing standard
instruments to guide the semistructured interviews, protecting the
confidentiality of respondents' remarks, using interview transcripts
for data analysis rather than relying on interviewer notes, and
obtaining feedback concerning state summary reports from respondents.
As more women are screened by the NBCCEDP, a greater burden will be
placed on participating health agencies, providers, and other partners
to obtain resources for breast and cervical cancer treatment. Case
management services will continue to be essential in helping
underserved women overcome financial, logistical, and other barriers to
receiving these services. Other long term solutions to ensure that
women in the program receive necessary treatment services are being
pursued.
References
1. Henson RM, Wyatt SW, Lee NC. The National Breast and Cervical
Cancer Early Detection Pro-gram: a comprehensive public health response
to major health issues for women. J Public Health Management and
Practice 1996;2:36-47.
2. Lantz PM, Macklem DJ, Hare M, Richardson LC, Sever LE, Orians
CE. Follow-up and treatment issues in the National Breast and Cervical
Cancer Early Detection Program: results from a multiple-site case
study--final report. Baltimore: Battelle, Centers for Public Health
Research and Evaluation, 1997.
3. Miles MB, Huberman MA. Qualitative data analysis: an expanded
sourcebook. 2nd ed. Thou-sand Oaks, California: Sage, 1994.
4. Yin RK. Case study research: design and methods. Sage: Newbury
Park, 1989.
Strategies for Providing Follow-Up and Treatment Services in the
National Breast and Cervical Cancer Early Detection Program--United
States, 1997. Lantz PM, Sever LE, Henson R, Lee NC. MMWR, March
17,1998; Vol. 47. No. 11. pp 215-218
Ms. Eshoo. When the CDC does the early detection and the
screening and something is found, do you have any certain way
to set women on a path outside of that? Tell me what you do.
Ms. Lee. Yes. Yes, I will. Well, as you know, the 1990 act
specifically forbade the use of Federal Government funds to pay
for treatment.
Ms. Eshoo. Well, we know that. That is why the bill is----
Ms. Lee. Yes, right, and that's why you have introduced
this bill. We are allowed to pay for diagnostic services, and
so we do provide central diagnostic services.
Ms. Eshoo. But once you do what the 1990 legislation set
up, and I'm not suggesting----
Ms. Lee. Okay, so then we diagnose.
Ms. Eshoo. [continuing] for giving you permission to go get
into trouble to go beyond it. Do you have set information for
women or----
Ms. Lee. Yes, we actually have a published paper because we
have done a study on this. We have a partnership with our
health agencies, the health agencies, the American Indian
tribes, et cetera, and as part of that partnership, it is the
responsibility of the State health agency to assure that all
women diagnosed with cancer or a pre-cancerous condition
receive the treatment that they need.
Ms. Eshoo. Well, it is not happening, but that is not your
fault; it is that we haven't taken the next step. But that's
instructive to me, because I don't think it is happening.
Ms. Lee. Well, we actually have a study that was published
last year----
Ms. Eshoo. That says----
Ms. Lee. [continuing] that says, by and large, it is
happening.
Ms. Eshoo. That they all got treatment?
Ms. Lee. Yes, except for the few, less than 10 percent of
women----
Ms. Eshoo. Well, is it on a timely basis?
Ms. Lee. Yes, it is on a timely basis. There are some----
Ms. Eshoo. I'd like to see that.
Ms. Lee. Yes, I would be happy to provide you that.
Ms. Eshoo. I'm not here to question you. I'm here to
question some of the outcomes and the results.
Ms. Lee. Right. We feel very good that we are getting--but
the problem is, it is a very tenuous system. We really need the
kind of help that your bill may provide for us. But because
they have to put it together with a lot of charity, donated
charity case from this provider----
Ms. Eshoo. Well, I think the system, at best, once it comes
to treatment, is unpredictable Dr. Lee. Yes, absolutely.
Ms. Eshoo. It is a patchwork quilt at best--if you even
want to bring the word ``best'' into this. I think that
families and women in this country deserve much better. I mean,
if we can get to the moon, we can do something about this, and
we got to the moon a long time ago.
Let me go to another question, because I think I probably
don't have that much time left. To Drs. Lowey and Trimble, in
section 106 of H.R. 358, the Patients' Bill of Rights, it calls
for the requirement of managed care providers to pay for
treatment provided in the clinical trial. In your view, would
enactment of such a provision expand access to clinical trails
and speed up research aimed at preventing, treating, and curing
cervical cancer? I mean, we are talking about screening; then
we are talking about treatment. We know that a lot of the
treatment isn't there or isn't paid for; there is
underinsurance for it. But the fact of the matter is that we
don't have a cure for this.
So, can you maybe just comment on that part of the
legislation? I think it's a very important section, but I would
like to know what your views are about it.
Mr. Trimble. Only 2.5 percent of adults in the United
States with cancer are enrolled on cancer treatment trials, and
the National Cancer Institute has been working closely with a
number of third-party payers to encourage them to pay for the
patient care costs associated with these clinical trials. The
NCI has never had the funds to pay for patient care costs. We
pay for data management or some of the costs of data
management.
We have had reasonable success with some of the third-party
payers. We have worked out agreements with the Veterans'
Administration and the Department of Defense, so that the
patients that they cover can have access to our clinical
trials. We have not yet been able to reach an agreement with
the Health Care Financing Administration, and we have continued
to work with the HMOs, but certainly we are supportive of all
efforts to gain all Americans access to our trials.
Ms. Eshoo. So this would be----
Mr. Coburn. Would the gentlelady yield for a minute?
Ms. Eshoo. Well, I don't have any time to yield, Mr.
Chairman.
Mr. Coburn. Well, I will be very benevolent with the time
if we can.
We have a cancer patient, a survivor, who is going to
testify, and I would like to ask you all if you would remain
there until the rest of our committee can finish their
questions, and if I can have unanimous consent to have her come
and give her testimony now, because she has her flight in a
very short time; otherwise, we will not be able to obtain her
testimony.
Ms. Eshoo. Absolutely. Thank you for the time and thank you
to the panel for your words and professionalism.
Mr. Coburn. Ms. Piker, would you mind coming forward,
please, and giving us your testimony?
Mr. Lazio. Mr. Chairman, could I just ask for unanimous
consent to make a remark for about 30 seconds?
Mr. Coburn. Yes, sir.
Mr. Lazio. I am so conflicted. I am supposed to be chairing
the committee meeting across the hall right now. Just two quick
remarks and they are: First of all, the need to get more adults
in clinical trial, I think, is made all the more compelling
because of the success in childhood cancer. The amount of
children that are in clinical trials, I think it is up around
the 90's, either in clinical trials or in NIH protocol
hospitals, and the success rates, especially in certain
leukemias, I think really bear out the fact that we need to do
much better in terms of getting adults into clinical trials.
The second point is--this is really in response to Ms.
Lee's comments about care for those women who receive bad news
after they have gotten screening through the CDC program--is
that, actually, the timeliness is much in question by a number
of advocate groups, about whether they are getting the
treatment in a timely manner, and whether it is done in a way
that doesn't accelerate or compound the stress and anxiety that
women are under.
For example, many women that we have talked to have
incurred substantial debt, and we are talking about women,
obviously, who are at the lower-income levels, minimum wage
people, waitresses, people who have no hope of wiping out a
$20,000 debt. And so I would not want to leave the impression
that what we have here is a system of care that is reliable and
that is timely and that does not compound the stress that women
face when they find out that they have a malignancy.
Thank you, Chairman, for your indulgence.
Mr. Coburn. Ms. Piker.
STATEMENT OF LINDA GRACE PIKER, CERVICAL CANCER SURVIVOR
Ms. Piker. Mr. Chairman, thank you for inviting me to share
my experience with cervical cancer with this committee. I speak
today as a cervical cancer survivor, a co-founder of a
gynecological cancer support group, a cancer advocate, the
Chair of the Kentucky Breast Cancer Coalition, which addresses
both breast cancer and other women's cancer in the
Commonwealth, and most of all, I speak as a friend and a
confidante to numerous women who have been touched by this
disease. I have seen the despair and the destruction that
cervical cancer has caused these women, their families, and
their friends. There are some stories that I'll never forget.
I'll never forget the beautiful young woman who was about
30 years old, whose physician called me and asked if I could
talk to her, and when I talked to her, I was totally empty
handed. She had had a pelvic exenteration at age 32. I also
talked to another woman who had received the same treatment who
was 40 years old. I think these are some of the treatments that
nobody has any idea take place. I mean, the majority of the
public does not.
And I'll never forget another beautiful young woman who
came to speak to the Cervical Cancer Advisory Committee just
weeks before her death, and I knew the man that was deeply in
love with her and I know how much despair he went through after
this.
In addition to the original diagnosis of cervical cancer,
these women are at increased risk for vaginal, vulva, and anal
cancers. One woman who was first diagnosed with cervical
cancer, and then vulva cancer a few years later, stands out in
my mind. She had the toughest exterior. But when you got to
know her and you really listened to her, she had despair; she
was embarrassed, and the fears were all there. She fought long
and hard, but eventually she died.
These are only a few of the women I would like to
represent. These deaths were needless. If diagnosed early,
cervical cancer has a 5-year survival rate of approximately 90
percent. Most importantly, with proper screening and with
treatment, cervical cancer is a preventable disease. We need to
educate women on the risk factors for the disease, screening,
and, if necessary, where to find information, treatment, and
support.
In addition to the shock of being diagnosed with cancer in
September 1990 when I was 44 years old, I could not understand
how this could have happened. Since I was 19 years old, I had
received annual Pap tests. I had had no problems. The more I
read about the disease, the more confused I became, and the
more frightening the issue became for me. Did I have an
aggressive tumor? Would I live to see my 10-year-old son grow
up? My gynecologic oncologist kept saying, ``You'll be fine,
Linda. You are going to have a radical hysterectomy with
regular followup.'' Well, for about the next year, I was very
frightened because I couldn't figure out why this would happen;
I did everything you were supposed to do; what was happening?
And then to alleviate my fears, I happened to talk to one
of the fellows who had worked with me from the beginning of my
cancer, and he said, ``Okay, Linda, what you really need to do
is get your Pap smear slides, let's look at them, and I can
tell you if it's aggressive and we will follow you more
closely, and if not, this should give you some peace of mind.''
Well, we had moved to Kentucky the previous year, and so I
had to call my former physician's office and ask for my slides
to be sent to Lexington, Kentucky. I was given the address of a
laboratory in California. When I called, there was no listing
for the lab, and this was even more confusing. I just could not
understand, you know, and so I called back to the physician's
office and I said, ``There's no listing.''
Well, to shorten my long story, I found out that my
physician had been sending the Pap slides to a lab in
California that was allegedly closed because of poor quality
assurance. Had I known the name of the lab my Pap slides had
been sent to, I could have read about it, because they were
named in The Los Angeles Times and The Wall Street Journal.
Physicians were not liable for the Pap test; therefore, it is
my understanding that some physicians decided not to notify
their patients that the physicians had sent the patient's Pap
slide to this lab.
My cancer was diagnosed when I had a Pap test the following
year and my Pap slides were read by a different facility in
Lexington. I spoke to my physician out of State about notifying
other patients. We had quite a long discussion. It took me
three phone calls to get to talk to the person, but my
physician was not receptive to doing this at that time.
I suppose this was the crucial experience of my becoming an
advocate for myself and other women. Not only do women need to
be educated about the risks associated with cervical cancer,
but they also need to know what questions to ask about
screening methods and their laboratories.
Since 1993, I have worked in the public health arena, where
I focus on ways to bring women into local health departments
for breast and cervical cancer screening. I also work with
health departments to eliminate missed opportunities for
screening of current clients. For approximately the last 3
years, I have worked with community cancer coalitions which
have unique ways to target women in their communities for
breast and cervical cancer screening. Cooperative partnerships
and education are key components in their success for
increasing the number of breast and cervical cancer screenings
in the communities.
For any education campaign addressing the issue of human
papilloma virus, or HPV, a clear message will need to be
presented in a sensitive manner; otherwise, an ill-conceived
education campaign might well become a barrier for women
seeking screening.
As I leave here today, I thank you for holding a hearing on
cervical cancer. As a mom of a childhood cancer survivor and
relative to friends or individuals with the various types of
cancer, I often call myself the generic cancer survivor.
Although I am grateful to this committee for addressing the
issue of cervical cancer, I think that a more comprehensive
approach to fighting the war on cancer would be more effective.
I have never been a cancer survivor who wanted to fight the
body part wars. I look forward to the day when we all unite and
fight cancer together. Thank you.
[The prepared statement of Linda Grace Piker follows:]
Prepared Statement of Linda Grace Piker
Mr. Chairman, thank you for inviting me to share my experience with
cervical cancer with this committee. I speak today as a cervical cancer
survivor, confounder of a gynecological cancer support group, cancer
advocate, the chair of the Kentucky Breast Cancer Coalition, which
addresses breast cancer and other women's cancer issues in the
Commonwealth, and, most of all, I speak as a friend and confidant to
numerous women who have been touched by this disease. I have seen the
despair and destruction that cervical cancer has caused to these women,
their families, and friends. There are some stories I'll never forget:
the beautiful young woman in her thirties who had a pelvic exenteration
or the distressing call from a forty-year-old woman who had undergone
the same treatment. I'll never forget one beautiful young woman who
spoke to a cervical cancer advisory committee only weeks before her
death or the young man who was devastated by her death. In addition to
their original diagnosis of cervical cancer, these women are at
increased risk for vaginal, vulva or anal cancer. One woman, who was
first diagnosed with cervical cancer and then vulva cancer, stands out
in my mind. She was alone, had no medical insurance, and had a low
paying job prior to her illness. She had a very tough exterior, but
when you got to know her and listened to her, the despair,
embarrassment, and fears were all there. She fought long and hard, but
she eventually died. These are only a few of the women I would like to
represent. These deaths were needless. If diagnosed early, cervical
cancer has a five-year survival rate of approximately 90%. Most
importantly, with proper screening and treatment, cervical cancer is a
preventable disease. We need to educate women on the risk factors for
the disease, screening, and, if necessary, where to find information,
treatment, and support.
In addition to the shock of being diagnosed with cancer, in
September 1990, when I was forty-four years old, I just could not
understand how this could have happened. Since I was nineteen years
old, I had received annual Pap tests. I'd had no problems. The more I
read about the disease, the more confusing and frightening this issue
became for me. Did I have some aggressive tumor? Would I live to see my
ten-year-old son grow up? My gynecologic oncologist kept saying I'd be
fine. I would have a radical hysterectomy and regular follow-up. To
alleviate my fears of an aggressive cancer, I called my former
physician's office and asked that my slides be sent to my physician in
Lexington, KY. I was given the address of a laboratory in California.
When I called, there was no listing of the lab. I was even more
confused. To shorten this story, I found out that my physician had been
sending the Pap test slides to a lab in California that was allegedly
closed because of poor quality assurance. Had I known the name of the
lab my Pap test slides had been sent to, I could have read about the
lab in the Los Angeles Times or the Wall Street Journal. Physicians
were not liable for the Pap test; therefore, it is my understanding
that some physicians decided not to notify their patients that they had
sent their slides to this lab. My cancer was diagnosed when I had my
Pap test the following year and a lab in Lexington read my slides. I
spoke to my physician about notifying other patients, I did not feel
that the physician was receptive to doing this at that time. I suppose
this was the crucial experience in my becoming an advocate for other
women and myself. Not only do women need to be educated about the risk
factors associated with cervical cancer, but also they need to know
what questions to ask about screening methods and laboratories.
Since 1993, I have worked in the public health arena where I focus
on ways to bring women into local health departments for breast and
cervical cancer screenings. I also work with health departments to
eliminate ``missed opportunities'' for screening our current clients.
For approximately the last three years, I have worked with community
cancer coalitions, which have found unique ways to target women in
their communities for breast and cervical cancer screenings.
Cooperative partnerships and education are key components in their
success for increasing the number of breast and cervical cancer
screenings in their communities. For any education campaign addressing
the issue of human papilloma virus (HPV), a clear message will need to
be presented in a sensitive manner. Otherwise, an ill-conceived
education campaign might well become a barrier for women seeking
screening.
As I leave here today, I thank you for holding hearings about
cervical cancer. As a mom of a childhood cancer survivor and relative
or friend of individuals with various types of cancer, I often call
myself the ``generic cancer survivor.'' Although I am grateful this
committee is addressing the issue of cervical cancer, I think that a
more comprehensive approach to fighting the war on cancer will be more
effective. I've never been a cancer survivor who wanted to fight the
``body part wars.'' I look forward to the day when I can see us all
united to fight cancer. Thank you.
Mr. Coburn. Thank you, Ms. Piker. I will defer any
questions to the ranking member. Do you have any questions of
the witness? Any other members of the committee have questions
for this witness?
[No response.]
Ms. Piker, thank you for being here.
The gentleman from Tennessee is recognized.
Mr. Bryant. Thank you. Let me add my appreciation, Ms.
Piker, before you go back to Kentucky, I assume, for your being
here and also for the very learned panels that we have had
here.
At this time, I have been asked by the chairman if I would
yield my time to the chairman. I would be happy to do that.
Mr. Coburn. I thank the gentleman. I just have a couple
other questions that I kind of want to follow up on. I
introduced into the record a few moments ago a letter we
received on the 19th from Dr. Klausner. The testimony today--we
have two different testimonies. One testimony is that a condom
is effective in HPV, and one that says it is not. I wonder if
any of the panel would help this committee know what this
answer is to that question. Anybody have an answer for that?
Mr. Valdiserri. Let me start. I think it's an extremely
important question, and I think it is easy to understand why
there might be some confusion on it.
What we know in general--and I'm talking generally now; I'm
not talking about HPV--but what we know in general about
condoms and viruses lead us to believe that the condom has at
least a theoretical possibility of preventing transmission if
the lesion is confined to the penis that is covered by the
condom. Now, there are a lot of ``if's.'' Obviously, there are
a lot of ``if's'' and conditions. Given that HPV infection may
not result in a visible lesion and that typically that there
are multiple sites of infection on the genitalia, I think that
what you will see in most of the articles or textbooks or
review articles is the statement that there have not been
definitive studies, prospective studies, that have evaluated
condom efficacy in terms of preventing HPV. So, I think that's
why there is that confusion.
Mr. Coburn. I would quote Dr.--and you don't have the
benefit of this letter, but Dr. Klausner states additional
research efforts by NCI on the effectiveness of condoms in
preventing HPV transmission are not warranted. And he states in
his letter why it's not. It's because if you, in fact, are
infected, the scrotum is infected as well.
If I could make one point, you all are behind the curve on
this. The epidemic is way ahead of you. Is that not really
true? I mean, the epidemic associated with evasive HPV and
cervical dysplasia is ahead of where we are. We really don't
have the knowledge on this sexually transmitted disease that we
have on many others. Is that a fair statement?
Mr. Valdiserri. In some areas, I would agree with certain
aspects of that statement. Definitely in terms of some of the
condom efficacy studies and, as we discussed earlier, in terms
of some of the surveillance information, especially about
specific types of HPV.
Mr. Coburn. I guess if I had my heart of hearts, what I
would want everybody to know is that we really don't know all
the answers right now about HPV and that there is an epidemic
of dysplasia out there. All you have got to do is ask any
pathologist what they are seeing in their Pap labs. I mean, it
is growing like crazy right now. We are seeing tons of
carcinoma in situ, and I know the studies are ongoing in that.
The fact is, we don't know. We have an unknown quality
right now. As we talk about access, there is not one woman that
I don't want to have access to a high quality Pap smear and
physical exam every year. I want that for every woman in this
country, those that have been sexually active and those that
have not. But I also want them to have the knowledge about what
the danger is of this disease.
I mentioned earlier a Green Journal study in 1987 or 1988,
where they did culture HPV, one of the aggressive serotypes
from amniotic fluid, where they do, can culture this same virus
in the reproductive tract of newborn babies, male and female,
it is an important consideration that our highest institutions
have not aggressively researched.
And so, my point--and I'm going to submit a list of
questions, and they will be given to each of you and then I'll
ask that we divide those up to the appropriate--actually, I'll
try to get them divided up to the appropriate expert that we
have here today.
You know, we really ought not to worry about where we have
been, but we really ought to get busy about where we need to go
on human papilloma virus. I have been in practice 16 years. I
have never seen anything like it in my office. And if you go
talk to practicing physicians that are in the middle low-income
and with teenagers and Medicaid patients, we are seeing an
explosion of this disease right now. And it is aggressive
types. I mean, we are seeing a ton of high-grade dysplasia.
So, my wish is that, tell us what we need to do so that we
really know what the science is, because I don't believe it's
out there right now.
Mr. Valdiserri. I don't want to be parochial, but I
couldn't agree with you more. I do want to say, again, that we
have been working at CDC and our center and with our colleagues
on trying to develop a specific plan focused on--we looked
first at herpes, which is not, obviously, not the focus of this
meeting, but now we are doing the same thing with HPV. We have
this big meeting in April with a lot of experts coming in and
we have actually generated close to 45 specific questions that
we want these people to grapple with.
So, I couldn't agree with you more, Dr. Coburn, that there
are still some issues that we have to invest in getting answers
to.
Mr. Coburn. Before I would yield to anybody that would like
additional time--we know that a condom is not preventive. I
mean, we know that right now. Unless we wrap everybody in saran
wrap, we are not going to prevent human papilloma virus.
Mr. Valdiserri. And we also know that there is more than
HPV as a sexually transmissible disease. So we have this
complex issue of--it is not an issue if people are abstinent,
but we have this complex issue for people who are sexually
active, where condoms can be helpful in preventing other STDs.
How do we craft the message so that they know that it might not
necessarily protect against HPV? And then they will say,
``Well, gee, why even bother?''
Mr. Coburn. Very easy. It is a condom won't protect you
from human papilloma virus, the No. 1 cause of cervical cancer
in this country, and it affects 50 percent of those people who
are sexually active, regardless that it might protect you from
HIV. If it won't protect you from the No. 1, then it's a false
safe sex message. It doesn't work. And so we can continue down
that line of false assumptions, but you are going to find the
science that will say it doesn't work, and we know it doesn't.
The practicing physicians out there today know it doesn't work.
So, all I'm saying is, we need to look at the data
completely from a pure scientific--and give us a plan to where
we can give treatment, whatever we do. I treat kids who are
going to be sexually active, if they tell me they are; I give
them very tool I can. But the point is, is we can't send a
false message about HPV.
Mr. Valdiserri. Well, we don't intend to send a false
message.
Mr. Coburn. Thank you. And the ranking member, Mr. Brown.
Mr. Brown. Mr. Chairman, I'm a little concerned about the
sort of exchange and the questions, the letter you have
submitted, and I'm glad that we finally got a copy of it. I
understand, from what you just said, you will submit some more
questions of this panel. I would hope that this subcommittee
would--and I don't lay the blame at your feet and I appreciate
your genuineness about this--but would see fit to share with
the minority some of this information. This letter, it started
off--you posed 15 questions about the possible relationship of
induced abortion to breast cancer; these are pretty volatile
issues that people have very strong feelings about. I know,
it's more than that; I understand that, but that was the lead
sentence in it. We just found out about this a month after it
was received by Mr. Bliley.
I would just like to encourage this subcommittee on the
majority side to make sure the minority, particularly when we
are talking about issues that people care about and the
discussion you had with Dr. Valdiserri, just now, that we have
this information ahead of time.
Mr. Coburn. Mr. Brown, the staff tells me that you all
received a copy of that letter the day it was sent.
Mr. Brown. My understanding from our staff is that we
received the letter that you sent to the doctor, that Chairman
Bliley sent to HHS, but we have not gotten the response until
today.
Mr. Coburn. If, in fact, you didn't, that is a grave error
that should be corrected by this committee, and you should have
the response and any letter that comes to this committee, based
on a letter from it. As you know, I am not in the position to
empower that that happens each time.
I would just like to ask if any of the other members of
this panel would like to offer anything for us, tell us where
we know what we need to do, make recommendations outside of
what you have made in your testimony.
Mr. Valdiserri. May I just again say, please don't forget,
in addition to the basic research needs, don't forget the whole
host of operational research questions; and that's fairly
parochial, because it is what we tend to do at CDC. But our
last interchange about how do you craft a message for sexually
active people, about what condoms can and can't do, given that
in the real world there are many, many STDs, as a perfect
example of the kind of work that is very important--so, I would
like to, again, go on record saying that that is a need that we
have.
Mr. Coburn. The gentlemen from New York is here. Would you
like to ask questions, Mr. Towns? Yes, the gentleman is
recognized for 5 minutes.
Mr. Towns. Thank you very much, Mr. Chairman.
What population is considered to be at high risk for
developing cervical cancer? Anybody?
Ms. Lee. There are lots of risk factors. Probably the
strongest risk factor that is sort of the cause of it is what
we have been talking about today, which is infection with
certain subtypes of human papilloma virus. Another very
important risk factor is failure to be regularly screened with
Pap smears. Then, you find higher rates of cervical cancer
developing, and women dying from it, in foreign-born women in
the United States and women who are Hispanic, who are African-
American, and who are from certain subpopulations from Asia.
You also find cervical cancer to occur, and especially cervical
cancer deaths, to occur more often in older women.
Mr. Towns. Decreasing the incidence of cervical cancer 30
percent, is that dependent on treatment, new treatment methods,
or----
Ms. Lee. Most all of that is probably because of Pap
screening and you identify the pre-cancerous condition. It is
easily treated in almost all instances. You cure it and then
the woman never develops cervical cancer, and therefore, then
she doesn't get counted as a cancer statistic. And she doesn't
have it, either.
Mr. Towns. Are the new treatment methods for cervical
cancer considered experimental, or are the likely to be widely
accepted by the insurance companies as a new standard of
treatment?
Mr. Trimble. There have now been five studies, of which
three have been published in the medical literature. We think
that they will be considered as standard of care, and insurance
companies will reimburse for their use.
Mr. Towns. Any other comments on that from anybody else?
[No response.]
Have we solved the lab certification issue or do we need to
promote something comparable to the mammography quality
standards act for Pap smears?
Ms. Lee. I am not sure any of us are really up on that. I
think that the CLIA Act--I can't even come up with what that
acronym, Clinical Laboratory--oh, yes, you know that; thank
you. It was designed--and I'm not very much up on this--but it
was designed, as one of the motivating reasons for its passage
back, I think last decade, was because of problems with Pap
screening; and whether is solved it or not, I am not equipped
to tell.
Mr. Towns. Well, let me just say, first of all, Mr.
Chairman, thank you very much and let me thank all of you for
your testimony. I am sorry I was not here when you actually
testified, but I did read almost all the testimonies; I want
you to know that, and I do plan to read all of them. I was
involved in another meeting is the reason I was not here;
because I am very interested in this. You know, I come from a
family of four and I lost my entire family, except myself, from
cancer. So, I'm always very interested in terms of learning as
much about this as I possibly can. I lost my mother, father,
and a brother from this disease. So I am very interested in
what you have to say.
So I will be reading all the material, and I really
appreciate the time and the effort you have taken to come here
to share with us, as well. Thank you so much.
Mr. Coburn. The gentleman yields back.
I have two things. Dr. Lee, would you note for the record
when we asked you a question, cancer, under the definition of
those cases, does that include carcinoma in situ or not? In
terms of the incidents that you all are quoting, is that
quoting including carcinoma in situ as well as invasive
cancers?
Ms. Lee. From our program, you mean?
Mr. Coburn. Yes.
Ms. Lee. No.
Mr. Coburn. It is invasive cancer only?
Ms. Lee. The 508 are invasive only, and the carcinoma in
situ's are actually folded in with the CIN-3's.
Mr. Coburn. All right. The other question I would ask, if
you would, in response to Mr. Towns' question, the new
epidemiological data that I am seeing is saying that the cancer
now is occurring in earlier and earlier and younger and younger
women. And, in answer to his question, your response was it is
actually in older women. Would you mind forwarding any new
material that you have to this committee, in terms of trends,
epidemiologically?
Ms. Lee. Sure.
Mr. Coburn. The friends I have across the country that are
practicing medicine, what they are seeing and what they are
saying is that this is a disease that is moving to young women.
Ms. Lee. Actually, what I said was the cervical cancer
deaths are highest in the older women. In fact, the people from
the NCI collect the good data on this, and we have looked at it
quite a bit. The rate of cervical cancer among women under 50,
the new diagnoses are actually going down. I looked at it the
other day. They are going down, based on seer data.
Mr. Coburn. Okay. Thank you very much. We have one
additional question.
Mr. Brown. I'm sorry to keep you here for the rest of the
evening, but, Dr. Lee, you in your testimony mention
approximately half the inaccuracies--you said that the Pap test
is far from 100 percent accurate; approximately half of the
inadequacies are due to an inadequate collection of the Pap
smear by the provider, and the other half are due to errors at
the laboratory. And I know your expertise is not centered
around this, but does it make sense for us to pursue perhaps
the MQSA model, where there is inspection once a year, except
for those who have a record of doing very, very well,
inspection of facilities once a year? I don't know if
inspection is the key, or working with, actually re-training of
the people regularly, the technicians, all of that, re-
licensing, some of the things that MQSA does. Is that something
we should consider here?
Ms. Lee. That's really something that I am not totally
expert in. I will tell you this: that the majority--and some
people might even call the substantial majority--70 to 80
percent of all new cervical cancer cases occur in women who
have not been screened in the last 5 years. The issue: There
are lab errors, and Ms. Piker was one of those unfortunate
people. There are lab errors, but that is not where the bulk of
the problem is. And so I will put to you that I think, until we
have something wonderful like an HPV vaccine, that we can use
to prevent, or other therapies, that our biggest, the most
important thing is to continue to go out and try to find women
who aren't being screened. Because if we spend a lot of time
trying to improve the collection, we are still going to only
maybe be affecting up to 20 percent, and not the other 80
percent.
Mr. Valdiserri. To comment on that, there is a part of CDC
that deals specifically with these issues, our Public Health
Practice Program Office, and when we go back I will talk to
their Division of Laboratory Systems--they have been involved
in the implementation of CLIA--and see if they have any
specific information, both related to what Mr. Towns asked and
what you have asked. There may be some data; we just don't have
it at our fingertips. It does make the point, though, that you
always need to remember provider education, even when you get
all these other issues taken care of.
Mr. Coburn. Let me thank the panel again for being here and
persisting with us. I appreciate your input.
I would just make one last comment, Dr. Valdiserri: that
the providers in this country are way behind where they need to
be in terms of diagnosing STDs. We need to have a good national
effort to bring them back up. And thank you again.
We will bring forward the third and final panel, and I wish
to apologize for the length of your wait. Dr. John Thomas Cox
from the University of California in Santa Barbara California,
and Dr. Sharyn Lenhart, and Rosemarie Gatshca--I like that
name--that's great--from the American Society of Clinical
Pathologists.
Dr. Cox, if you would care to start and, if you could, be
as brief as possible with your testimony, so we can spend as
much time as we can discussing it.
STATEMENTS OF JOHN THOMAS COX, STUDENT HEALTH SERVICES,
UNIVERSITY OF CALIFORNIA AT SANTA BARBARA; SHARYN LENHART,
IMMEDIATE PAST PRESIDENT, AMERICAN MEDICAL WOMEN'S ASSOCIATION:
AND ROSEMARIE GATSCHA, CYTOLOGY MANAGER, AMERICAN SOCIETY OF
CLINICAL PATHOLOGISTS
Mr. Cox. Chairman Bilirakis, Dr. Coburn, members of the
House Subcommittee on Health and the Environment, my name is
John Thomas Cox, and I am director of the Women's Clinic,
University of Southern California in Santa Barbara, Chair of
the steering committee of the National Cancer Institute-
sponsored ASCUS LSIL trial, also known as ALTS, and Chair of
the Practice Guidelines Committee of the American Society of
Colposcopy and Cervical Pathology.
I wanted to express my thanks to you for providing me the
opportunity to present a clinical perspective on the issues
related to women and cervical health as I see it in 1999. In
the interest of time, the following comments are a markedly
shortened version of my written statement, and I will not be
discussing the many positives of the Pap smear screening
program, as has already been mentioned here today. But I do
want to mention some of the factors that we run into as
clinicians, and I know, Dr. Coburn, you run into them as well.
Despite the positives of the Pap screening program, the
following problems loom large: that while the majority of
cervical cancer develops in the segment of the population that
remains unscreened, approximately 6,000 women develop cervical
cancer annually, who have had reasonable, if not all perfect,
Pap smear screening. And, although the incidence of cervical
cancer and associated mortality has decreased over 40 percent
since 1973, these numbers have remained constant for over a
decade. Additionally, since 1986, there has been an annual 3
percent increase in the incidence of invasive cervical cancer
in white women under the age of 50. And now, this is the first
information I have had that that has now ceased to increase.
The risk of missing disease in the screened population is
attributed primarily to false negative cytology. The false
negative rate of the Pap has been variously estimated to be
from 2 to 50 percent. However, the Agency for Health Care
Policy Research just released the evidence report, technology
assessment entitled, ``Evaluation of Cervical Cytology,'' which
estimated the true sensitivity of the Pap to be just 0.51.
Their conclusion was that, ``Despite the demonstrated ability
of the cervical cytologic screening in reducing cervical cancer
mortality, the conventional Pap test is less sensitive that it
is generally believed to be.'' Because of the concern over the
risk of missing disease, the medical community has responded by
pursuing the diagnosis and followup of the most minimal
cellular atypia on the pap. The resulting loss in specificity
brings exceptional numbers of normal women in for further
evaluation. The cost in dollars and distress of evaluation of
approximately 2 million women given the borderline reading of
ASCUS has been very high. The result is an excessively
expensive, approximately $6 billion, screening program fraught
with the risk of over-diagnosis, over-treatment, and increased
psychological burden.
So, I think we need to work on solutions. First, of course,
we need to start with education, which we have talked a great
deal about today. Education and outreach, especially to
populations particularly reluctant to attend screening clinics,
must be placed at highest priority, since the failure to draw
the unscreened portion of the population in for routine Pap
smears remains the most common reason for development of
cervical cancer. The nature of failure of women to get adequate
screening is not well understood, and is likely to be the
result of a complex milieu of cultural, societal, and
educational factors. Intense efforts will be necessary to
understand the reasons women do not get Pap smears, or do not
return, as directed, for followup.
Additionally, women receiving cervical screening should be
educated about the ideology of cervical cancer and the reasons
for doing Pap smears, including the association with HPV.
Education must extend to the healthcare providers as well, as
outreach is doomed to failure without a well-informed and
empathetic health services sector.
Second, we need a more efficient screening system, and
there will be some controversy over this, but I think we need
to talk about it. The limitations of cervical cytology in the
screening system re-
quires a reappraisal, with the following deserving our utmost
attention. We need to ask whether beginning screening at age
18, as now recommended, is the best way to spend our cervical
cancer screen resources, since this is an age in which cervical
cancer is virtually non-existent, but transient HPV
manifestations are very common.
Additionally, the inability of caregivers to accurately
predict which women are low risk continues to foster annual
screening. We will never be able reduce the cost of the
screening system until we can safely increase the screening
interval. In order to safely increase the screening interval,
we will need to reduce the risk of missed disease. New
technologies have been developed to improve the sensitivity and
efficiency of detection of cervical disease. These include
liquid-based thin layer cytology, automated computerized
analyzers, and tests for the presence of HPV. Despite
increasing evidence that many of these new technologies are
already improving the effectiveness of cervical cancer
screening, or hold great promise in the future, availability of
the patient has been severely eliminated.
In order to improve the efficiency of the system, we must
find the most efficient and patient acceptable manner of
evaluating ASCUS paps. The NCI ALTS study is designed to
provide a clear understanding of the advantages and
disadvantages of various options for the followup of women
given the Pap reading of ASCUS or LSIL low-grade squamous
intraepithial lesion. This study should settle the question
once and for all, whether women given this Pap reading are best
referred immediately to colposcopy, best followed by several
repeat paps at accelerated intervals, or best tested for HPV
and referred to colposcopy only if the HPV test is positive.
Finally, the present intense public interest in healthcare
quality issues includes questions regarding who should make
decisions about how effective cervical cancer screening will
be, and by what measure should effectiveness be evaluated.
Until now, new cervical screening technology assessments, which
have influenced public policy, have focused almost entirely on
the single end-point of cost-effectiveness as measured by
cancers prevented and lives saved.
In contrast, women deserve that cervical cancer screening
policy be set by a much fairer model, that encompasses quality-
of-life issues associated with decreasing the ambiguity of
equivocal paps and with earlier detection of disease. This
would include reproductive implications and reductions in
invasive treatments, patient anxiety, and loss of time from
work and childcare.
We must acknowledge the individual patient's interest in
receiving information about the benefits, risks and costs of
traditional Pap followup compared with new cytology screening
enhancements. Women have a right to be routinely informed of
these issues and to participate in decisionmaking regarding
their health choices.
And, thank you for the opportunity to address these issues,
and I will be pleased to answer any questions that you may
have.
[The prepared statement of J. Thomas Cox follows:]
Prepared Statement of J. Thomas Cox, Director, Women's Clinic,
University of California, Santa Barbara
Chairman Bilirakis, members of the House Subcommittee on Health and
the Environment, my name is John Thomas Cox, MD. I am Director of the
Women's Clinic at the University of California in Santa Barbara, Chair
of the Steering Committee for the National Cancer Institute sponsored
ASCUS/LSIL Triage Study (ALTS) and Chair of the Practice Guidelines
Committee of the American Society of Colposcopy and Cervical Pathology.
I want to express my thanks for providing me the opportunity to present
a clinical perspective on the issues related to women and cervical
health as I see it in 1999.
The Positives of Cervical Cancer Screening
In countries without cervical cancer screening, cervical cancer
remains first or second amongst all cancers in women in both incidence
and mortality. The measure of success of the Pap smear screening
program in countries fortunate enough to have such a program, such as
the US, is relegation of cervical cancer to the 6th commonest cancer
amongst women and the 10th leading cause of cancer death. These
decreases in the US are so dramatic that Pap smear screening is one of
the few interventions to receive an ``A'' recommendation from the U.S.
Preventive Services Task Force even though there have been no
randomized trials demonstrating its effectiveness.
Problems with the Cervical Cancer Screening Program
Approximately 14,000 women develop cervical cancer in the US
annually and approximately 5000 die of the disease. While the majority
of cervical cancer develops in the segment of the population that
remains unscreened, approximately 6000 women develop cervical cancer
annually who have had reasonable, if not all perfect, Pap smear
screening. The lifetime likelihood that a women never screened will
develop cervical cancer is 3,748 women per 100,000 (3.7%), but even
with annual screening approximately 305 per 100,000 women (0.3%) will
develop cervical cancer during their life. Although this dramatic drop
in incidence demonstrates the remarkable effectiveness of the Pap
screening program, nevertheless this is a toll that is individually
agonizing for both patient and for care-giver. Even though the
incidence of cervical cancer and associated mortality have each
decreased over 40% since 1973, these numbers have remained fairly
constant for over a decade. Additionally, since 1986 there has been an
annual 3% increase in the incidence of invasive cervical cancer in
young white women under the age of 50.
These statistics highlight both the success of cervical cytologic
screening and the fact that, like any other test, achievement will
never reach a perfect score. The risk of missing disease in the
screened population is attributed primarily to false-negative cytology.
The false-negative rate of the Pap has been variously estimated to be
from 2% to greater than 50%. In January, 1999 the Agency for Health
Care Policy and Research (AHCPR) released the Evidence Report/
Technology Assessment, ``Evaluation of Cervical Cytology''. Using a
stringent meta-analysis of published studies comparing cervical
cytologic diagnosis with clinical diagnosis based on colposcopy or
biopsy, the AHCPR provided an estimate of the true sensitivity of the
Pap to be 0.51. Their conclusion was that ``despite the demonstrated
ability of cervical cytologic screening in reducing cervical cancer
mortality, the conventional Pap test is less sensitive than it is
generally believed to be''.
Such statistics are in direct conflict with the public perception
that the Pap smear is, or should be, an infallible test. The result in
failed expectations is exceptional medicolegal liability related to the
development of cervical cancer in any women with a history of previous
cervical screening. For this reason, failure to diagnose cervical
cancer is the second leading cause of liability losses for
gynecologists and the leading liability for laboratories even though
revenue from cytology accounts for only a small fraction of total
laboratory income.
While false-negative cytology accounts for the majority of failures
in the screened population, the poor specificity of cytology may be a
greater problem for both the individual and society. The low rate of
cervical cancer makes the risk of missing disease statistically small
for each individual patient and for each Pap. However, the reality of
the imperfect nature of the test looms large for both the laboratory
personnel reading the Pap and for the caregiver. When the threshold for
evaluation of a woman with an abnormal Pap is set very high, i.e. a
high-grade or HSIL Pap, the specificity of the Pap is very good. That
means that disease with significant threat to the woman is likely to be
found on further evaluation. However, in order to protect our patients
and ourselves from the vicissitudes of missed cervical cancer, the
medical community has responded by pursuit of even the most minimally
atypical cells. When the threshold for evaluating women with an
abnormal Pap is set low, specificity falls dramatically. This means
that many normal women will be evaluated for minimally abnormal Paps.
The result is an excessively expensive (6 billion dollar) screening
program fraught with the risk of overdiagnosis, overtreatment, and
increased psychological burden. While all who have taken the
Hippocratic Oath de-
sire to do anything and everything possible to prevent an untimely loss
of life, we must admit that much of our response to minor cytologic
abnormalities has developed less out of reason than out of fear of
liability.
Solutions
How can we penetrate this impasse in the further reduction in
cervical cancer incidence and mortality? Will attempts to further
reduce the rate of cervical cancer make the system unaffordable? Should
we ``tinker'' with the present system or is there reason, or promise,
to justify a major re-evaluation of how we approach cervical cytologic
screening and follow-up to abnormal Pap smears? How can we motivate the
unscreened population to obtain good cervical health care? I believe
that the answers to these questions can be found by vigorous pursuit of
the following:
Education
Education and outreach, especially to populations particularly
reluctant to attend screening clinics must be placed at highest
priority since the failure to draw the unscreened portion of the
population in for routine Pap smears remains the most common reason for
development of cervical cancer. While financial barriers are often
cited as a major reason in limiting access to cervical screening, most
studies have concluded that cost plays a minor, almost insignificant
role. For example, Canadians, for whom all health care coverage is
provided, have non-compliance patterns nearly identical with those of
patients in the United States. Additionally, approximately 60% of women
getting cervical cancer in one of the largest prepaid HMOs in the U.S.
had not received adequate Pap smear screening even though a large
percentage of these women had seen their primary care physician in the
recent past. These statistics highlight the complex nature of failure
of women to get adequate screening, which is likely to be the result of
a complex milieu of cultural, societal and educational factors.
Education must extend not only to women in the unscreened population,
but women already being screened and to their caregivers. Intense
efforts will be needed to understand the reasons for failure to attend
screening and to apply the resources necessary to overcome these
barriers.
Additionally, women receiving cervical screening should be educated
about the etiology of cervical cancer. In 1995 the Agency for Research
in Cancer and the World Health Organization (WHO) proclaimed cervical
cancer to be the virtually exclusive result of the long-term
persistence of human papillomavirus (HPV). Education must extend to
health care providers as well, as outreach is doomed to failure without
a well-informed and empathetic health services sector. Women must be
made aware of the etiology of cervical cancer and its precursors, and,
thereby, of the reason for which Pap smear screening is performed.
Discussion of the sexually transmitted nature of the process cannot be
avoided. However, it must be done without prejudice and with great
care, compassion, and reassurance given that although the virus is
extremely common, the risk for the development of cervical cancer is
very low, especially with conscientious Pap smear screening. Clinicians
must be continually reminded of the importance of cervical cancer
screening so that women attending for medical care for other reasons
may yet obtain a Pap smear in what may be their only encounter with the
medical community.
A More Efficient Screening System
Taking a new look at what is generally considered to be a
successful system is never without controversy. However, the
limitations of cervical cytology and the screening system requires a
reappraisal, with the following deserving our utmost attention.
1). Optimal age to begin screening and optimal screening interval:
The pattern of practice in cervical cancer screening has been largely
unchanged for 50 years. Annual Paps beginning at age 18 or within one
year of beginning sexual activity, whichever comes first, remains the
standard of care even though ACS and ACOG guidelines provide the option
to extend the screening interval to 3 years in women considered at low
risk. Concerns regarding false-negative cytology, medicolegal liability
and the improbability of being able to accurately predict which women
are really at low risk has served as the major impediment to
implementation of prolonged screening intervals. Additionally, due to
the high-prevalence of HPV and its induced cytologic changes in young
women, a significant portion of the funds available for cervical cancer
screening are spent on diagnosis and treatment of a commonly transient
manifestation at little to no immediate risk of cervical cancer, and
low long-term risk. While it is very important to test for sexually
transmitted diseases (STDs) in this age group, the peculiar
characteristics of HPV may not make Pap screening in very young women
the most prudent approach.
In order to provide the safest, yet still cost-efficient coverage,
we must consider redirecting the greatest concentration of our cervical
cancer screening resources to those populations at greatest risk and
least likely to be traumatized unnecessarily by medical intervention.
This may require beginning screening at a somewhat later age and
extending the screening interval. However, safely extending the
screening interval would require greater reassurance than that provided
by a screening test with just over 0 .50 sensitivity.
2). Reducing the risk of missed disease: New technologies have been
developed to improve the sensitivity and efficiency of detection of
cervical disease. These include liquid-based thin-layer cytology,
automated computerized analyzers, and tests for the presence of HPV.
False negative Paps are generally very difficult Paps to read, often
with very few abnormal cells, and often compromised by obscuring
inflammation, blood or other exudate. Liquid-based cytology eliminates
much of the potential for obscured Paps and may provide a more
representative sample. Computer analyzers have been approved for both
primary review of the Pap and for CLIA mandated rescreening. HPV
testing as an adjunct to the Pap smear in women over the age of 30, who
are less likely to be positive for HPV in the absence of cervical
disease, would appear to increase the negative predictive value of the
screen to approximately 97% without flooding the system with normal
women. Yet, despite increasing evidence that many of these new
technologies are already improving the effectiveness of cervical cancer
screening, or hold great promise in the near future, availability to
the patient has been severely limited. The reasons for this are quite
clear. In the present managed care environment it is not sufficient to
prove increased efficacy. Increasingly, the interests of third-party
payers have dictated the interaction between clinician and patient.
There is now the opportunity to make a significant impact on both the
loss of life and on the inefficiency of the cervical cytology screening
program if we have the will and the foresight to integrate the best
that these technologies provide. If we do not, the present impasse in
further reduction in cervical cancer will remain, and the commercial
viability and future availability of these major improvements will be
lost. Much not only depends upon the willingness of third-party payers
to cover appropriately effective emerging technologies, but also upon a
full understanding by clinicians of their potential and the willingness
to discuss the new methods with their patients.
3). Providing the most objective and efficient triage of women with
equivocal Paps: The NCI/ALTS Study is designed to provide a clear
understanding of the advantages and disadvantages of various options
for the follow-up of women given the equivocal Pap smear reading of
atypical squamous cells of undetermined significance (ASCUS) and the
more diagnostic reading (for the probability of association with HPV)
of low grade squamous intraepithelial lesion (LSIL). The follow-up
options being evaluated include a). Immediate referral to colposcopy of
all women with ASCUS or LSIL Paps, b). Repeat Pap until the woman has
obtained 3 or 4 normal follow-up Paps with referral to colposcopy if
any repeat is abnormal, or 3). Testing for the presence of HPV and
referral to colposcopy only if the test is positive for an HPV type
known to be associated with high-grade cervical precancers and cancer.
Until this time there has been substantial disagreement amongst the
medical community regarding which of these options is best. Recently,
however, the availability in research settings of Hybrid Capture II, a
new HPV test with improved sensitivity has provided very favorable
results as a triage option for ASCUS. The comprehensive, randomized
protocol of the ALTS Trial should once and for all settle the question
of which follow-up option is most reliable, most cost-efficient, and,
perhaps of greatest importance, most acceptable to women.
4). Evaluating the cost-effectiveness of cervical screening
options: The present intense public interest in health care quality
issues includes questions regarding who should decide how effective
cervical cancer screening will be, and by what measures should
effectiveness be evaluated? Two important technology assessment reports
have recently been released; the report of the Technology Evaluation
Center of the Blue Cross and Blue Shield Association (April, 1998) and
the AGOG Committee Opinion: New Pap Screening Techniques (August,
1998). Both emphasize the group perspective on cost-effectiveness,
almost to the exclusion of, or even acknowledging the individual
patient's interest in receiving information about the benefits, risks,
and costs of traditional Paps compared with new cytology screening
enhancements. Unfortunately, cost-containment analysis has focused only
on reduction in death from cervical cancer. Considering the already
relatively low rate of cervical cancer, this is an endpoint doomed to
show insignificant changes in increased life expectancy when factored
over the entire population of women screened. A much fairer model for
women is one that takes into account all the factors of cervical cancer
screening that affect their lives. This would encompass quality-of-life
issues associated with earlier detection of disease, including
reproductive implications, and reductions in invasive treatments,
patient anxiety and loss of time from work and childcare. In addition,
cost-benefit analysis includes an evaluation of the benefits de-
rived for both patient and caregiver of reducing and clarifying the
nature of borderline Pap readings and obscured or otherwise compromised
specimens that result in unnecessary repeat visits. Women have a right
to be routinely informed of these issues and to participate in
decision-making regarding their health choices.
Again, thank you for the opportunity to address these issues. I
will be pleased to answer any questions that you may have.
Mr. Coburn. Dr. Lenhart.
STATEMENT OF SHARYN LENHART
Mr. Lenhart. Thank you. Good afternoon, Mr. Chairman and
members of the subcommittee. My name is Dr. Sharyn Lenhart. I
am the immediate past president of the American Medical Women's
Association, and I also chair AMWA's Advisory Committee to the
National Cervical Cancer Public Education Campaign.
The American Medical Women's Association or AMWA is a
national multi-specialty organization comprised of more than
10,000 women physicians and medical students. As a leading
advocate for women's health issues since 1915, AMWA members
have advocated for Federal legislation, influenced local
policy, developed physician education programs, and spearheaded
national consumer education campaigns to ensure that women
patients and women physicians maintain a voice in upholding the
highest standards of care as they relate to women's health.
AMWA believes that there is an important role for the
Federal Government to play in improving women's health. We
believe that this role can be fulfilled through Federal
legislation that recognizes the need for women to understand
how they can prevent and detect cervical cancer, and through
legislation which supports adequate coverage of cervical cancer
screening technologies, treatments, and preventative measures.
Medicare reimbursement for Pap tests isn't adequate currently
to cover the costs of providing laboratory services and should
be increased to ensure the continued availability of this
primary screening device.
Each year in the United States approximately 15,000 women
are diagnosed with cervical cancer and 5,000 United States
women die of the disease. Since the introduction of the Pap
test almost 50 years ago, cervical cancer rates have been
reduced by 75 percent. The majority of cervical cancers now
occur in the minority of women who are not adequately screened.
Two-thirds of cervical cancers occur in women who have not been
screened and who constitute minority groups, by and large.
Despite the enormous success of the Pap smear, however,
one-third of preventable cervical cancer occurs in women who
have had a Pap test, at least in the last 5 years. Because
cervical cancer is a slowly progressing cancer, often taking 10
to 15 years to develop, regular Pap smear screening, combined
with new and cutting-edge screening tools, can lead to greater
success in prevention.
The success of cervical screening is that it detects
abnormal cells which can be treated before an actual cancer
develops. Recent clinical studies have confirmed that the human
papillomavirus, HPV, is the primary cause of cervical cancer.
HPV is a very common virus which can infect any man or woman
who has ever had sexual intercourse. In most cases HPV is
harmless and asystematic. It is estimated, however, that up to
80 percent of women in the United States contract the virus at
some point during their lives. Only a few of these women, those
with persistent HPV infection of a high-risk type, will develop
cervical cancer.
Seventy types of HPV have been identified and approximately
13 of those are high-risk. The ability to identify the
precedents of the high-risk cancer groups or HPV groups may be
the key in our efforts to combat this disease. Unfortunately, a
recent survey confirmed that 70 percent of women are unable to
name the cause of cervical cancer. While women should receive
regular Pap smear screening, 2 million of these screenings
produce borderline results, and another 1.5 million produce
abnormal results. Recent studies have shown that as a followup
to borderline Pap smear results, the use of enhanced screening
technologies, including a new test that detects the presence or
absence of the HPV, can give a woman's health provider added
information about the cause of her borderline results. Follow-
up options can then be tailored appropriately.
AMWA believes that cervical cancer can be the first major
victory in the war against cancer. We believe that, in order to
achieve this victory, American women and their providers need
more education about cervical cancer, the importance of regular
Pap smear screening, appropriate enhanced screening
technologies, treatment modalities, and current and cutting-
edge tests for the causes of cervical cancer. As an
organization of women physicians, AMWA recognizes the crucial
role we play in leading the fight against this cancer. We are
more likely to provide Pap smear screening, inform our patients
about cervical cancer, and encourage routine screening.
Essentially, the battle against cervical cancer can only be
won with a twofold strategy of increasing the number of well-
educated, pro-active women consumers and enlisting the help of
physicians who encourage and provide routine screening. AMWA
views the Pap smear screening as a critical device in detecting
cervical cancer. We also regard enhanced screening technologies
and HPV testing, in the event of a borderline Pap smear result,
to be an effective way to provide healthcare providers with
important additional information.
To this end, we have become a lead partner in the National
Cervical Cancer Public Education Campaign. The Campaign is a
collaborative educational effort involving representatives from
leading women's health and civic organizations designed to
inform women about the link between HPV and cervical cancer, to
reinforce the importance of regular Pap smear screening, to
introduce them to new and existing methods to detect cervical
cancer, and to empower them to take an active role in
discussing the disease with their healthcare providers. The
goal of the Campaign is to reduce the number of preventable
deaths caused each year by cervical cancer through increased
education and outreach.
Mr. Coburn. Dr. Lenhart, can you summarize?
Mr. Lenhart. Yes. AMWA calls on Members of Congress to
demonstrate their support for public education about cervical
cancer by signing on as co-sponsors of the Cervical Cancer
Awareness Resolution and the Breast Cancer Treatment Act.
The key to winning the fight against cervical cancer is
early detection. We can screen for it; we can test for HPV, and
we can treat it. No woman in this country needs die from
cervical cancer. If we all do our part, we can make this a
reality. Thank you.
[The prepared statement of Sharyn Lenhart follows:]
Prepared Statement of Sharyn Lenhart, Immediate Past President,
American Medical Women's Association
The American Medical Women's Association (AMWA) is a national
medical organization comprised of more than 10,000 women physicians and
medical students. A leading advocate for women's health issues, AMWA is
dedicated to improving the quality of women's healthcare. Since 1915,
AMWA members have advocated for federal legislation, influenced local
policy, developed physician education programs, and spearheaded
national consumer education campaigns to ensure that women patients and
women physicians maintain a voice in upholding the highest standards of
care as they relate to women's health.
AMWA believes that there is an important role for the federal
government to play in improving women's health. We believe this role
can be fulfilled through federal legislation that recognizes the need
for women to understand how they can prevent and detect cervical cancer
and through legislation which supports adequate coverage of cervical
cancer screening technologies. Currently, Medicare reimbursement for
Pap tests is inadequate to cover the costs of providing laboratory
service. Reimbursement should be increased to adequately cover costs,
ensuring women have access to the most effective technology for
detecting cervical cancer. The majority of deaths from cervical cancer
are unnecessary and preventable.
the scope of the problem
Each year in the United States, approximately 15,000 women are
diagnosed with cervical cancer and 5,000 women die of the disease.
Since the introduction of the Pap test over forty-five years ago, U.S.
incidences of cervical cancer have been reduced by 75%. The majority of
cervical cancers now occur in the minority of women who are not
adequately screened. Two-thirds of cervical cancers occur in women who
have not been screened. Yet despite this enormous success, one third of
preventable cervical cancer occur in women who have had a Pap smear in
the last five years. Because cervical cancer is a slowly progressing
cancer, often taking ten to fifteen years to develop, regular pap smear
screening combined with new and cutting edge screening tools can lead
to greater success in prevention. The success of cervical screening is
that it detects abnormal cells which can be treated before cancer even
develops.
cervical cancer and the human papillomavirus (hpv)
Recent clinical studies have confirmed that the human
papillomavirus (HPV) is the primary cause of cervical cancer. HPV is a
very common virus which can infect anyone who has ever had sexual
intercourse. In most cases, HPV is harmless and people never realize
they have it. It is established that up to 80 percent of women in the
United States contract the virus at some point during their lives. But,
only a few of the women with HPV will develop cervical cancer. Although
infection with certain types of HPV increases the risk of cervical
cancer, most infected women do not develop cancer. In fact, of the more
the 70 types of HPV, only 13 are associated with cervical cancer. The
ability to identify the presence of high risk HPV may be the key in our
efforts to combat this disease. Unfortunately, a recent survey
confirmed that 70 percent of women are unable to name the cause of
cervical cancer. While women should receive regular pap smear
screening, in many cases, these screenings produce borderline results.
Of the 50 million Pap smears performed in the United States annually,
3.5 million produce abnormal results. Recent studies have shown that as
a follow-up to borderline pap smear results, the use of enhanced
screening technologies, including a new test that detects the presence
or absence of HPV, can give a woman's healthcare provider added
information about the cause of her borderline results. Follow-up
options can then be tailored appropriately.
amwa's perspective on cervical cancer
AMWA believes cervical cancer can be the first major victory in the
war against cancer. We believe that in order to achieve this victory,
American women and their healthcare providers need more education about
cervical cancer, the importance of regular pap smear screening,
enhanced screening technologies, and current and cutting edge tests for
the causes of cervical cancer. As an organization of women physicians,
AMWA recognizes the crucial role we play in leading the fight against
this cancer. We are more likely to provide pap smear screening, inform
their patients about cervical cancer, and encourage routine screening.
Essentially, the battle against cervical cancer can only be won with
the two-fold strategy of increasing the number of well-educated,
proactive women consumers and enlisting the help of physicians who
encourage routine screening. AMWA views regular pap smear screening as
critical in detecting cervical cancer. We also regard HPV testing, in
the event of a borderline pap smear result, to be an effective way to
provide healthcare providers with important additional information. To
this end, we have become the lead partner in the National Cervical
Cancer Public Education Campaign. The Campaign is a collaborative,
educational effort involving representatives from leading women's
health and civic organizations designed to inform women about the link
between HPV and cervical cancer, reinforce the importance of regular
pap smear screening, introduce new and existing methods to detect
cervical cancer, and empower them to take an active role in discussing
the disease with their healthcare providers. The goal of the Campaign
is to reduce the number of preventable deaths caused each year by
cervical cancer through increased education and outreach.
conclusion
AMWA calls on Members of Congress to demonstrate their support for
public education about cervical cancer by signing on as cosponsors of
the Cervical Cancer Awareness Resolution that has been introduced by
Representatives Millender-McDonald, Lazio and Coburn. The key to
winning the fight against cervical cancer is early detection. We can
screen for it, we can test for HPV, and we can treat it. No woman in
this country need die from cervical cancer. If we all do our part, we
can make this a reality.
Mr. Coburn. Thank you, Dr. Lenhart.
Ms. Gatscha, please.
STATEMENT OF ROSEMARIE GATSCHA
Ms. Gatscha. Mr. Chairman, members of the subcommittee, on
behalf of the American Society of Clinical Pathologists, I
would like to thank you for inviting me to speak here today. My
name is Rosemarie Gatscha, and I am the Cytology Manager at
Memorial Sloan Kettering Cancer Center in New York City. I am
here representing the ASCP, which is the largest medical
laboratory organization in the world. ASCP represents 75,000
members, including board-certified pathologists, clinical
scientists, and certified technologists and technicians.
I would like to take a moment to explain what I do as a
cyto-technologist. Cells are collected from a woman's uterine
cervix, placed on a smear, sent to the laboratory for
processing and evaluation. Part of my job is processing. Most
of my job is evaluating these Pap smears.
As you can see here, this gives you an example of some
cells that are present on a smear. These cells, in particular,
are cancer cells from cervical cancer. It gives you a feeling
for the numbers of cells that are present on this smear. It
varies anywhere from 30,000 to 200,000 cells. It is important
that a well-trained eye be reviewing these cells, and that is
what a cyto-technologist does, discriminates between normal and
abnormal cells.
While it is difficult to believe more women die of cervical
cancer because they have never had a Pap smear or because they
haven't had a Pap smear in the last 5 years than those that die
of a false negative Pap smear, there are many reasons why some
women do not have Pap smears and there are reasons why they are
less available to some women. Let's look at availability first.
ASCP's Board of Registry, in conjunction with MORPACE
International, based in Detroit, conducts the biennial wage and
vacancy survey of 2,500 medical laboratory supervisors. The
1998 data was just made available, and the information
regarding cyto-technologists is of particular concern. The
current vacancy rate for cyto-technologists working at the
staff level is 10.5 percent. This is a 3 percent increase over
the 1996 rate, which was 7 percent. This is the first increase
in the cyto-technologist staff level vacancy rate in the last 8
years. What is critical to note is that the vacancy rate in
rural areas is 17.6 percent. While the overall vacancy rate for
supervisors, cyto-technology supervisors, has decreased
slightly over the past 2 years, the vacancy rate in small
medium-sized cities is increasing. It is 20 percent.
These data show some cause for concern, and I realize that
sometimes numbers of this type may be meaningless, but to put
it in perspective, you may recall the nursing shortage crisis.
At the height of their crisis, the shortage was 11.3 percent.
Cyto-technologists are highly skilled and trained
individuals. Laboratories rely on certified cyto-technologists
to evaluate Pap smears. With high vacancy rates, there is
concern that some laboratories will not have the appropriate
personnel available to evaluate those Pap smears. This leads me
to a related issue.
Cyto-pathology smears are currently priced at $7.15 on the
Medicare laboratory fee schedule. The actual cost of the
conventional Pap smear is between $13 and $17. This price
includes cyto-technologists' salaries, overhead costs, CLIA-
mandated quality control, and laboratory supplies, and also
supplies that are given to healthcare providers who obtain the
Pap smear. The Medicare payment rate for Pap smears should
increase significantly. This, in turn, will help to alleviate
the personnel shortages that exist which are amongst our most
serious concerns.
Despite increased publicity and a greater emphasis on
cervical cancer screening, a lack of knowledge continues to be
a barrier to women in obtaining a Pap smear. A woman is more
likely to obtain a smear if symptoms are present and if there
is social pressure on her to do so. Barriers to obtaining a
smear also include fear and embarrassment, belief that Pap
smears are unnecessary for older women, economic factors, and
language and cultural barriers.
We look forward to continuing to work with you on the
prevention of cervical cancer by increasing the availability of
trained cyto-technologists, increasing Medicare reimbursement
for Pap smear testing, and minimizing economic and cultural
factors that stop women from having Pap smears. Thank you very
much for your attention. If there are any questions, I would be
pleased to answer them.
[The prepared statement of Rosemarie Gatscha follows:]
Prepared Statement of Rose Marie Gatscha, American Society of Clinical
Pathologists
Chairman Bilirakis, members of the subcommittee, my name is Rose
Marie Gatscha, SCT(ASCP). I am Cytology Manager at Memorial Sloan-
Kettering Cancer Center in New York City. I am here today representing
the American Society of Clinical Pathologists.
The American Society of Clinical Pathologists (ASCP) is a nonprofit
medical specialty society organized for educational and scientific
purposes. Its 75,000 members include board certified pathologists,
other physicians, clinical scientists, and certified technologists and
technicians. These professionals recognize the Society as the principal
source of continuing education in pathology and as the leading
organiza-
tion for the certification of laboratory personnel. ASCP's certifying
board registers more than 150,000 laboratory professionals annually.
the pap smear facts
The Pap smear is a proven screening method of detecting and
preventing cervical cancer. It is the most effective cancer screening
test in medical history as it is largely responsible for the 70% to 80%
decline in death due to cervical cancer over the last 50 years in the
United States.
Approximately 4,900 women die from cervical cancer annually in this
country, making it the tenth leading cause of death from cancer in
women. Approximately 14,000 new cases of cervical cancer are diagnosed
each year.
The Pap smear is a safe, noninvasive, cost-effective medical
procedure. Cells collected from a woman's uterine cervix are sent to a
cytopathology laboratory where the cells are evaluated. The
cytotechnologist prepares the slide and evaluates the specimen, which
is composed of thousands of cells--usually between 30,000 to 200,000
cells in a single specimen. If the specimen is within normal limits, a
report is sent to the woman's health care provider. If an abnormality
is detected, then a pathologist examines the slide and issues a final
diagnosis.
barriers to pap smear testing
While it is difficult to believe, more women (80%) die of cervical
cancer because they have never had a Pap smear or they have not had a
Pap smear in the last five years than those that die of a false
negative Pap smear. We believe this is unconscionable.
There are many reasons why some women do not have Pap smears, or
why Pap smears may be less available to women. I'd like to devote the
rest of my comments to exploring those reasons.
Trained Cytotechnologists Are Needed
The American Society of Clinical Pathologists' Board of Registry,
in conjunction with MORPACE International, Detroit, conducts a biennial
wage and vacancy survey of 2,500 medical laboratory managers. The
survey measures the vacancy rates for 10 medical laboratory positions,
and compares and contrasts these data with that from 1988, 1990, 1992,
1994, and 1996 studies. The 1998 data has just been made available, and
the information regarding cytotechnologists, the professionals who
interpret cellular material such as Pap smears, is of particular
interest and concern.
The current vacancy rate for cytotechnologists (staff level) is
10.5%, an increase over the 1996 rate, which was 7.1%. This is the
first increase in the cytotechnologist (staff level) vacancy rate in
eight years. It is also important to note that for rural areas, the
cytotechnologist (staff level) vacancy rate is 17.6%, and totals 9.7%
for small-medium size cities and 12.1% in large cities. Also, while the
vacancy rate for cytotechnologist (staff level) in large hospitals is
8.3%, the vacancy rate nearly doubles for hospitals with a 100-299 bed
size--up to 15.8%. Hospitals with bed size of 300-499 reported vacancy
rates for these professionals at 14.3%.
Laboratory managers were questioned about the difficulty they have
in filling work shifts. 21% reported problems recruiting
cytotechnologist (staff level) for day shifts, three times higher than
the 8% reporting such difficulties in 1996.
While the overall vacancy rate for cytotechnologist (supervisor)
has decreased over the past two years, 10% down from 12.5%, the vacancy
rate in small-medium size cities for cytotechnologist (supervisor) is
20.0%. Vacancy rates for cytotechnologist (supervisor), while virtually
non-existent in the east north central, west south central, and far
west regions of the country, are explosive in the northeast (16.7%),
south central atlantic (18.2%), and west north central (12.5%) parts of
the nation.
These data show some cause for concern. Cytotechnologists are
highly skilled and trained individuals, who must have at least a
baccalaureate degree followed by a year of specialized training in
cytology. Cytotechnologists must then take a rigorous national
certifying examination, administered by the ASCP, in order to become
certified. Laboratories rely on certified cytotechnologists to evaluate
all Pap smears. With high vacancy rates, there is concern that some
laboratories will not have the appropriate personnel available to
evaluate Pap smears.
Medicare Reimbursement
Cytopathology smears are currently priced at $7.15 on the Medicare
laboratory fee schedule. The actual cost of the conventional Pap smear
(excluding new technology and the professional component for
physicians) is in the range of $13 to $17. The cost of new liquid-based
Pap testing is $28-$32. This price includes cytotechnologist salaries,
overhead costs, CLIA-mandated quality control, laboratory supplies, and
supplies given to healthcare providers who obtain the smear. The
Medicare payment rate for Pap smears should increase significantly.
ASCP and other organizations are working with the Health Care
Financing Administration to increase the Medicare payment rate for Pap
smears. In addition, Representative Neil Abercrombie and Representative
Mary Bono have recently sponsored legislation, HR 976, to increase the
Medicare payment rate to $14.60. ASCP supports this effort to bring
attention to the need for the Pap test and a more appropriate payment
rate.
Liability
With annual screening, the chance of a woman developing cervical
cancer can be reduced to less than 1%. Pap smears have an irreducible
false negative rate (10%-40%) due to sampling errors on the part of
health care providers and screening errors occurring in laboratories.
According to a March 1997 report in the Archives of Pathology and
Laboratory Medicine, the continued availability of Pap cancer screening
test is threatened by lawsuits because the legal system demands a zero
error rate which is mathematically unachievable even in the most
competent professional hands.
Socioeconomic Barriers
According to Healthy People 2000, the National Health Promotion and
Disease Prevention Objectives, there are several key assumptions that
may be used to help overcome barriers to cervical cancer screening. The
objectives state, ``low income, low education and advancing age are all
associated with a decreased likelihood of receiving Pap tests.'' The
report continues that ``age influences both cervical cancer incidence
and survival. While younger women are more frequently diagnosed with
cervical cancer, older women are more often diagnosed at later stages
of the disease and are more likely to die from it than younger women.''
We are also aware that certain populations of women--African American,
Hispanic, Asian, and low-income rural women--often face cultural and
economic barriers to Pap screening.
For example, it is not uncommon for low-income women of Hispanic
descent to refuse Pap testing. Even if the Pap smear is free or of
little cost, these women, whose families may rely on them for income
and support, refuse the test because they do not want to know if they
have cancer. A cancer diagnosis, in this instance, would mean
extensive, and often prohibitive, medical costs to treat the cancer,
and would tear the women away from their families for extended periods
of time. Many women in this situation prefer not to know their
potential cancer status. In addition, a lack of culturally appropriate
materials or information communicated in Spanish is a barrier to
Hispanic women being screened.
In a study compiled by the Centers for Disease and Prevention, it
was determined that transportation and its costs were barriers to Pap
testing for Native American women.
In speaking with public health officials, we are also aware of
examples in certain Asian-American communities where it is considered
shameful for women to have a Pap smear. In this culture, husbands may
not want their wives to be examined ``in that way'' by a male
physician.
solutions
The Pap smear, named for its creator Dr. George N. Papanicolaou, is
one of the most effective cancer screening tools available to women
today. There are ways to lessen the barriers that exist to Pap testing,
so that cervical cancer becomes a less formidable disease to women.
ASCP continues to work with the cytology community to provide
continuing education and certification for these laboratory
professionals. ASCP has also established a scholarship program for
medical technology students, including cytotechnologists. The Society
awards 100 student scholarships each year to assist with educational
finances.
Last year, your Committee reauthorized Title VII of the Public
Health Service Act (Health Professions Education Partnerships Act of
1998, P.L. 105-392), which included a program for Allied Health Project
Grants. This program has been effective in addressing the training and
educational needs of allied health personnel, including
cytotechnologists. However, further strides in funding are still needed
to increase the number of cytotechnologists to an adequate level.
Increasing the Medicare reimbursement for Pap testing to an amount
more in line with current costs would also help to attract and retain
professionals in the field.
ASCP, along with many other organizations, are working to educate
the general public and the priority populations mentioned above about
the importance and effec-
tiveness of the Pap smear. We are particularly proud of the efforts we
have undertaken to help educate other health care providers about the
Pap smear.
ASCP believes it is important to develop and disseminate
educational materials to targetted populations and to the health care
providers that serve them, and develop relationships with community
organizations, such as schools, retailers, employers, social
facilities, and churches, to assist in reaching women that are not
participating in cervical cancer screening programs.
We aim to continue these educational efforts, and look forward to
working with you and others in the prevention of cervical cancer.
I would be pleased to answer any questions you may have.
Mr. Coburn. Thank you, Ms. Gatscha.
I am going to take the first round of questions, if I may.
Dr. Cox, would you tell us a little more about the ALTS study
and what you hope to come out of that, and the implications for
us in terms of health policy?
Mr. Cox. Yes, I would be very happy to. As you know, the
1988 Bethesda guidelines created a new category called ASCUS.
And ASCUS, as an OB-GYN, you know has been probably the hardest
Pap smear reading for us to deal with. That is why many people
say, ``Don't ASCUS,'' because it is an equivocal pap. The
problem with it is that it is the most common Pap smear reading
that is considered abnormal. It is the least risky in terms of
the percentage of those with ASCUS that have high-grade
disease. About 6 to 8 percent will have high grade disease.
However, the total high-grade disease discovered by Pap smear
in the United States, about 30 to 40 percent of it comes from
ASCUS. A great deal of cancer comes from under that Pap smear
reading as well. So, it is our biggest problem, because most
people are normal, but there is this hidden sort of group
underneath that are very, very risky.
So the ASCUS LSIL trial was set up to evaluate whether it
is best to refer women immediately to colposcopy, which is
looking at the cervix with a microscope on the stand in the
doctor's office, whether it is better to do that immediately,
whether it is better to follow ASCUS by repeating the Pap 3 or
4 times, and if any repeat Pap is abnormal, then colposcopy in
those women, and if they are not abnormal, sending them back to
annual exams; or whether it is better to test for the causing
by bringing the woman back in and doing an HPV test on
followup; and colposcopy in those women high-risk positive and
returning the women that are not a high-risk positive either to
a Pap in 6 months and then annual exams, or maybe immediately
to Pap smear annually. So the ASCUS LSIL trial was specifically
set up to determine which triage is most cost-effective, which
detects the most high-grade disease, which is most patient-
acceptable, as a very extensive ongoing patient questionnaire
to see what kinds of issues and anxieties are involved with
each office visit, et cetera, so that we get some kind of an
idea what women want to do the most.
Mr. Coburn. You mentioned, can you explain for the rest of
the panel a little bit, about what the new thin-prep is and how
it works and why it is reported to help us in terms of
diagnostic criteria?
Mr. Cox. In 1996, the FDA approved thin-prep paps, and they
are, I believe, going to be soon approving a liquid-based Pap
for Roche as well called CytoRich. These are Pap smears in
which the sample is taken from the cervix in the same manner as
for a glass slide pap, which is a conventional pap. But instead
of putting the swab in, or with a collection device immediately
on, a slide is put into a liquid media. In terms of the thin-
prep pap, that liquid media is sent to the cyto-pathology
laboratory. A cylinder is put in the liquid media and spun to
disperse the cells. The cells are sucked into a filter, and
when about 70,000 cells hits that filter enough, a vacuum
pressure, the vacuum pressure device determines how many cells
are there. It shuts the vacuum off, and then that little
filter, 2-centimeter filter of cells is turned upside down on a
slide, and a positive pressure puts the cells in the slide.
What it does is it removes potentially obscuring materials,
especially vaginal discharge. It disperses the cells on a slide
in what is called a monolayer, so that the cells are not
overlapping each other. So what it allows is for the slide to
be looked at by the cyto-tech without having the potential of
inability to see individual cells.
I should actually have, Ms. Gatscha, or a----
Ms. Gatscha. Yes.
Mr. Cox. There you are. I couldn't see you there for a
minute. Basically, that would be something for you to comment
on as well.
So that is a thin-prep process, and it has been evaluated
in the ALTS trial as well as HPV testing.
Mr. Coburn. Okay, there's just one followup. Could you let
the panel know that the difference is in cost in your area for
a thin-prep versus a conventional pap?
Mr. Cox. Right. Well, my wife had one recently and it was
$60. I don't know; I think the lab charges for--this is private
paid--the lab charges $32 or $34 for conventional pap. For the
health center, I can say that the conventional Pap is $10. The
thin-prep Pap is $20. Basically, the thin-prep Pap has a set
incremental fee that has to be attached until the prices come
down, and that is that it is $9.75 for the materials that are
disposable in the pap, because of the filter, the liquid media,
and some element of usage of the thin-prep machine which cost
in itself for the lab to get.
Mr. Coburn. The gentleman from Ohio.
Mr. Brown. Thank you, Mr. Chairman.
I think you heard, I think all three of you were sitting
there patiently during the last panel, and I had a discussion
with Dr. Lee about MQSA, what Congress did with that and with
licensing and inspection of mammography facilities, and how
that, I think, has been a true success across the country.
Could you comment, I suppose especially Ms. Gatscha, but really
all three of you, on any thoughts you would have with--
obviously, with mammography facilities there is not the
problem, as Dr. Lee said, as with Pap smears of 50 percent of
errors due to healthcare provider errors, 50 percent lab
errors. I mean, it is obviously a different phenomenon with
MQSA and with mammography facilities.
But could you run through what might make the most sense in
terms of better national licensing or annual inspections or
licensing and training of personnel or what we might want to
do?
Ms. Gatscha. Yes. What I have found to be the most
remarkable thing that has happened is CLIA-88. Many
laboratories that were called into question in all of these
articles that we read in The Wall Street Journal, et cetera,
have been forced to institute quality assurance programs. And
that, in my estimation, has been the strongest avenue to
pulling the test results into place--getting more accurate
results, results that correlate with surgical pathology. I
think that has been the strongest impetus.
Mr. Brown. Dr. Lenhart, do you have any thoughts on it?
Mr. Lenhart. Well, I think you have to take into
consideration more that we are just beginning to regulate those
who read the slides. Because some of the newer techniques
involve less and less technology from the individual
pathologists. The auto-prep and papnet involve computerized
technologies. So that if you were only to look at making sure
that--it is not really analogous to mammography. That is why we
are proposing that the public as well as healthcare providers
start thinking about the best way to use these enhanced
technologies. Because they might eliminate some of those errors
through the enhanced technologies without the regulation. They
also might allow for screening to occur less frequently. They
also might make it clear to those women who are dealing with
borderline paps who is really at risk and who isn't, which
would eliminate a lot of anxiety. So we see it as more
complicated than just looking at how to make sure that those
who read Pap smears do it consistently and well.
Mr. Coburn. Would the gentlemen yield for just a second?
Have there not been a couple of studies that have already
showed those advanced technologies as improving our diagnostic
skills at a lower cost?
Mr. Lenhart. Yes.
Mr. Cox. You know, I think enhancing regulation will not be
very helpful. I think it is clear CLIA-88 has had a major
impact on lab quality in almost every area except Pap smear.
There have been several good studies on the 10 percent
rescreening, and it has shown that really the amount of disease
picked up by 10 percent rescreen is very, very little. I think
that if we are going to really look at how to make the system
work better, we have to realize that a false negative pap, only
about 30 percent are screening or interpretive errors. There is
the other 70 percent that are sampling or preparation errors or
cells just not on the slide, for whatever reason. And if we are
going to make a major impact in this problem, we need to try to
improve the Pap upfront, if that is possible.
Now, I think the thin-layer cytology does improve the Pap
smear upfront, but on a year-to-year, on an annual basis of
using it annually, it probably is not cost-effective, unless we
are willing to put that extra money into it and just say it is
a better test and that we are willing to fund it. But if we
really look at the ability of a better Pap to potentially allow
us to increase the screening interval, and realizing that many
people have an increased screening interval anyway--many people
only go in every two or 3 years. So if we have a better Pap
applied to that, then in the end, we don't have to do paps
every year, that would save substantial money down the road.
Part of the reason it would save substantial money is that
you have to remember that 5 to 10 percent of women that go in
and get paps every year on an annual basis will get either an
equivocal Pap or a Pap that is limited in quality; both of
those require a physician response, bringing the patient back
for some response. So, those are in many instances false
positives. If we don't have to do that on a yearly basis and
bring all of those in, but only have that risk, say, every 3
years, our system will get much more cost-efficient than it is
right now, and we can still, I think, pick up as much or more
cancer than we are picking up under the present system.
Mr. Coburn. The gentlelady from California.
Mrs. Capps. Thank you. I want to acknowledge--first of all,
thank you for your testimony, and I would like to address it
briefly. I know the hour is getting late, but we have sitting
through this whole discussion this afternoon Dr. Wanda Jones,
from the Women's Health Office, Department of Health and Human
Services. I think that is a credit to what they are doing in
their office and also bears a lot on what we are talking about
today.
It calls to mind for me the United States Public Health
Service, in combination with the Department of Defense, this
wonderful mobile unit for a mammogram, the state-of-the-art
that I was able to, when I was a congressional spouse, had a
tour of. There are innovations happening in cancer detection
here, in our Nation's Capital, but also all throughout the
country. That is what I find intriguing about it.
So I want to commend the efforts of the Women's Health
office for what you do, and also the three of you are touching
on--and I know that it must be frustrating for you because we
are barely getting into the topics that you care so deeply
about. But that is the nature of what we do here. And right
now, at this late hour, we are getting to part of the
discussion that we could really sink our teeth into and say,
you know, what is the next thing to do?
Here I feel such an dichotomy. We have a treatable disease,
and I have had a personal experience now. My daughter was just
diagnosed with cancer, not this kind, within the last month. So
I am entered into a world that I didn't think I would have to
learn about this way.
But here we have a preventable disease, according to a
screening device, which is fairly routine, and I hear from you,
Ms. Gatscha, the reimbursement rate has something to do with
how effective this is going to be and we need to be addressing
that here on the Hill. Also, we have the challenge of getting
this screening out to more women and having them know more
about--well, not just women, our society in general. I don't
want to pin it all onto women--to know what to do about our
bodies and how to prevent preventable diseases. So we don't
want to lose that track.
Yet, you are saying we should be going the next step. We
shouldn't be content with the Pap smear that was around 50--I
know it has been improved, but maybe there is different
concepts.
So, with the little tiny bit of time, can you tell me how
we should proceed here on the Hill with this topic now? And
thank you.
Mr. Cox. Where I have a hard time answering that is I am
not sure what laws or power you have in terms of making changes
in this. My personal feeling is that the agencies that have
been set up to explore cost-effectiveness and cervical cancer
screening have taken only a single end-point and used a model
that was made in 1985 or made in 1990, but used 1985,
International Agency for Research on Cancer data. The model
uses a $3 cost for Pap smears. It uses a false negative rate of
Pap smears of 2 to 3 percent. It uses as the only end-point
years of life saved, which if you divide the number of lives
lost in the United States per year by 50 million women
screened, comes out to very small numbers, especially when you
talk about enhancements that might improve that.
So, what I would really like to see you all encourage is
that, in those situations in which there are official
assessments of cost-effectiveness, that really we take into
account cost-benefit analysis and quality-of-life years.
Because those are what really matter to women. Women are not at
huge risk over their lifetime of dying of cervical cancer, but
they are at huge risk of getting anxiety and distress over
being diagnosed with something that may have little adverse
effect on them either now or in the immediate future.
I think that we can utilize cost-benefit analysis in a way
in which we can find that this system can be organized in a
much better way than it is, and that it can be still as
effective, and probably more so, with not nearly so much
trauma, both physical and psychological, to women.
So that is where I would like to take it. I would also
mention maybe not starting the screening interval at 18, and I
figured I'd get some real hackles out of people for that. I am
basically in a center where I see 18- to 22-year-olds, and I
have never seen a cancer in this age group, not an epithelial
cancer. I've seen rabdomile sarcomas, et cetera, but not
epithelial cancers. And, indeed, epithelial cancers are
extremely uncommon in women under the age of 24.
So I think that we could consider, if we have to save money
in the screening system to put elsewhere, to higher-risk
groups, et cetera--maybe we don't--but if we do, I think we
could consider looking at what the rest of the world does and
make that screening start a little bit later, especially in
terms of the trauma that occurs with young people considering
the very high positive rate of HPV in that group, the very high
positive transient nature of the HPV effect in that age group.
Mrs. Capps. Thank you. More flexibility then, or----
Mr. Lenhart. I would like to add two thoughts that we
learned through the AMWA campaign that might be utilized on a
more Federal basis. The first is the importance of involving
multi-specialty groups in formulating policy. Our advisory
committee not only included pathologists, cytologists, and some
experts in virology, but also practicing clinicians, both
primary care physicians, obstetrician, gynecologists. It was a
very variable group. And if you want to really tease out cost-
effectiveness, and the complexity of the issue, you want to
develop policy based on a consensus group that is more variable
than is often involved.
The second thing that we learned was not to underestimate
the low cost in high efficiency of women's capacity to be pro-
active and to communicate. The cost of our campaign is
relatively low because, essentially, we took our multi-
specialty advisory committee, said, what are the key things
that women should know that they don't know about both what's
new and about what they should be doing more of? Then we gave
that information free of charge to a number of women's
organizations, many of them minority organizations, and said to
them, ``This is what is important. You figure it out.'' We gave
them suggestions. ``But you figure out the best way to get this
information across to your groups.'' That is pretty cheap.
Mr. Coburn. Dr. Lenhart, let me interrupt and give Mr.
Towns his time, if we may. We are running way over, and many of
us have to be in other places about 10 minutes ago. The
gentleman from New York.
Mr. Towns. I will definitely try to respect that, Mr.
Chairman, and be as brief as possible.
You know, I guess I want to ask each panelist this. In your
opinion, what is the greatest constraint for women to get
access to quality Pap smears? What is the greatest constraint?
Mr. Cox. There is a whole slew of studies and literature on
this right now. And, unfortunately, they are not going to help
answer that question very much because most of them have
indicated the cost is not the primary issue. And, in fact, you
can look at the Kaiser system, and you can look at the Canadian
system, where cost is not a factor--women get free access to
Pap smears--and, yet, this same percentage of women that get
cervical cancer in that system are those women that don't get
screened. So, it is not, it doesn't appear to be a cost issue.
There really are societal, cultural issues, especially
cultural, that we have a harder time penetrating, and
especially in our wonderfully diverse society we have so many
cultures come in, in which really something that is in that
part of the human anatomy is really not something that is shown
even for exam. And, it is those kinds of issues that we have a
hard time getting beyond. If we can find ways to overcome the
cultural and societal issues, then I think that we may be able
to get many, many of these women in. But that is the hardest
thing to crack, I believe.
Mr. Towns. Let me ask you, Doctor, if they come in--I am
not sure that I am hearing that the medical staff encourages
them, even when they come in. Then when they come in for
something else, do they actually encourage them to take a Pap
smear? Is that going on? I get the feeling that there is
something missing here.
Mr. Cox. I agree. I think that what you are alluding to is
that there are often visits to the medical practitioner by
patients, by women, who have never had a Pap or have not had
one in many, many years, and they are there for some other
reason and the Pap smear is not done. And I think that is one
of the things that we have to do. We have to educate physicians
to always be wary of the fact that when a woman comes in, a Pap
needs to be done.
Kaiser published a good study in the Green Journal this
year in which they showed that 60 percent of the cancers in
their population were in women that had not had a Pap smear or
not had one in the last 5 years, and the majority of those
women had been in the Kaiser system for some other reason and
had just not had a Pap when they were there. This is a real
tragedy and something that has got to be corrected.
Mr. Lenhart. We would agree with that. We think that a lot
of the new information, as well as a lot of vital women's
health information in general, is often missed in the doctor's
office. So we have sponsored a number of physician education
programs that are targeted at getting the information out, as
well as converting the doctors into advocates and better
communicators, but also patients into advocates and better
communicators with their physicians. We think that dialog is a
very important one to monitor.
Mr. Towns. Do you want to add to this?
Ms. Gatscha. Yes, well, just one thing really, because
those are the cruxes of this matter. But I think, also, this
information has to be disseminated at other levels because
there are lots of people who don't go to a doctor. They are
just well. They don't go and no one says, ``Hey, have you had a
Pap smear?'' I think that at the community level, churches,
schools, this information has to be part of health programs in
elementary and high schools. Hopefully, by college, when many
young women do become sexually active, then they will have
these tools to use to help them prevent this disease.
Mr. Towns. Thank you. Just one other question which is sort
of really bothering me: Is it realistic to expect that women,
and particularly low-income women, will have access to new
cervical cancer treatment? Is it realistic to think that they
will.?
Mr. Cox. Well, I think that resources are available in most
States. I can only answer for my State--that that there are
resources for almost all women to get Pap smear screening.
There is Medical/Medicaid. There is State Office of Family
Planning, which provides Pap smears to women coming in for
family planning. I think that it is uncommon in the State of
California for there to be women totally outside the system,
unaffordable. Even for women that are caught between the really
low-income level and the job level where they have insurance
coverage, there are some women that are not rich and not poor
and don't have insurance. Those are the ones that often have
the hardest time, but paps are available through Planned
Parenthood, for instance, and other agencies on a sliding scale
that can be very helpful for those women.
I think one of the things we forget is that Planned
Parenthood provides about 2.5 million paps in the United States
per year. It provides more paps than any other organization in
the United States, and so that is a very important function for
it, that women that might otherwise slip through the cracks
would have access to.
Mr. Coburn. Would the gentleman yield?
Dr. Lee did testify--she was asked that specific question
by Ms. Eshoo, and her response was, they are getting the care,
you know, which surprised me. I will just admit to you I was
surprised at her answer, and I am going to ask her for that
data, which leads me to the next question.
I would like unanimous consent to add to the record and
leave the record open until the questions are formulated for
our panel.
Other then that, I want to thank each of you for being here
and for your contribution and your time.
Mr. Cox. Thank you very much.
Mr. Coburn. The meeting is adjourned. I guess you do this:
[using gavel].
[Whereupon, at 5:45 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
Prepared Statement of Carol Ann Armenti, Director, Center for Cervical
Health
It is my privilege to contribute to these proceedings on cervical
issues as a cervical cancer survivor, a patient advocate and a
healthcare professional. In a recent media interview I was asked with
how many women did the Center for Cervical Health have direct contact
over the past year. I was surprised to find that our website, which we
are proud to say has been reviewed, approved by and linked to such
pres-
tigious organizations as Yale University, the Women's Cancer Network,
and the Society of Gynecological Oncology, receives several thousand
accesses a week, and that I personally counsel and refer for treatment
as many as a dozen women in a week.
It has been my distinct pleasure and honor this past year to be the
first patient advocate appointed to the American Medical Association
National Patient Safety Council, to serve as the New Jersey State
Cervical Chair of the Center for Disease Control Breast and Cervical
Program, and to be cervical cancer survivor representative to the
National Cancer Institute Survivorship Research Conference. I served on
the National Institute of Health cancer survivorship grant funding
panel which--for the first time--permitted advocates a full vote on
funding proposals. It was a similar honor to testify before the Food
and Drug Administration, this past year, on new technologies in the
detection of cervical disease.
I am blessed with the support of the print and broadcasting media,
advocacy organizations, medical groups and private industry. But I am
most blessed with this opportunity to represent to you the courage of
those suffering from cervical disease in this country, it is with
frustration and anger on their behalf that I advise you of their unmet
needs, and it is with hope that I ask for the increased support they
deserve.
I call to your attention that fourteen per cent of all cancer
survivors are those surviving cervical cancer. Other than breast
cancer, it arguably represents the largest group surviving any form of
cancer in this country yet relatively little is done to support these
women who have had what is unique to their being, their reproductive
organs, mutilated and destroyed. This past week at a National Cancer
Institute Survivorship Research Conference not one research project
which focused on cervical cancer was presented in two days of lecture.
Of the nearly eighty grant proposals on cancer survivorship
submitted to the National Institute of Health not one--other than a DES
follow-up study--focused on cervical cancer. Indeed, I was recently
contacted by a cancer center in Colorado which was attempting a study
on cervical cancer survivors. The researchers were disconcerted because
they could not find more than two dozen cancer survivors eligible and
willing to participate in a study. I immediately contacted two
prominent cancer advocates whom I know to be surviving cervical cancer
and I was told that they did not wish to become ``public.''
Our society has branded these women pariahs. They are ashamed to
discuss their disease, and even worse, they are so embarrassed to
discuss their symptoms that they frequently do not seek detection of
early precursor conditions or obtain effective treatment of disease. It
is incumbent upon us as a nation to provide women with the education
they need in their earliest, as well as their latest, years to protect
their lives and their reproductive system. It is further incumbent upon
us as a nation to provide adequate funding and assurances that women
who seek detection and treatment will receive it.
Strides are currently being made in the areas of detection, new
technologies which may prove successful in determining the genesis of
disease. New treatments and vaccines are showing great promise for the
reduction in morbidity and mortality of cervical disease. Yet I see
little improvement in the education of young women which may help them
make better choices. We must see programs which will inform all women
on the damage to their reproductive systems caused by smoking, and
inform young women especially of the increased risk to which they
expose themselves by relations in their teenage years when their immune
systems may be especially unable to fight disease.
Similarly, I see little in this country done to educate physicians
to the symptoms of cervical disease and even less done to inform them
on new methods of detection and treatment.
Nearly two years ago because of the great silent suffering of these
women who were willing to share their experiences with me both as a
sister survivor and psychologist, I began my efforts to increase public
awareness. Part of those efforts resulted in the declaration of January
as Cervical Health Month by this administration. Our reward was dozens
of programs across the country encouraging women to protect themselves
by having Pap tests, the single most successful cancer screening device
ever devised, and to have pelvic examinations. Part of our efforts is
the Resolution, consistent with its predecessor sister resolution for
breast cancer survivors, currently before the Senate declaring Cervical
Health Month and conveying the sense of the Senate that these women and
their families deserve support.
I further ask this Committee to support increased funding programs
for the detection of cervical disease. It is oftentimes said that fully
half of the women who develop cervical cancer did not receive a Pap
test. This statement is made as an indictment of those women who
develop the disease as if they were somehow responsible for their own
illness. In the State of New Jersey we are both proud and saddened to
say that we gave a party and everyone came. That is, not only did we
achieve our goals in the numbers of women who responded to our CDC
underserved program, more women came than we had funds to test. We must
ensure that all women who wish to be tested, are tested.
I ask that this Committee encourage studies which will ease the
burden of those surviving cervical cancer. We can learn from these
women how best to treat future disease with less destruction and less
mortality. I call to your attention that while the death rate of other
cancers has declined, the mortality rate of cervical cancer is expected
to increase this year.
Finally, I ask that you encourage the education of both women and
physicians on causes, symptoms and treatments of this disease, and that
we do so without the moral judgment which has made women too ashamed in
the past to seek detection and treatment.
I once again thank you for this opportunity to address this
Committee.
______
Department of Health & Human Services
National Cancer Institute
April 8, 1999
The Honorable Michael Bilirakis
Chairman, Subcommittee on Health and Environment
Committee on Commerce
House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman: I am responding to your letter of March 19,
1999, in which you pose five questions as a follow-up to my testimony
before the Subcommittee on Health and Environment on March 16, 1999.
As requested, the questions have been restated below. The answer
follows each numbered question.
Question 1. What are some of the side effects of various forms of
cervical cancer treatment?
Response. Three kinds of treatments are used for cervical cancer:
surgery, radiation therapy and chemotherapy and side effects vary
depending on the type of treatment chosen. There are also several
different types of surgery that are used to treat cervical cancer. The
stage of cervical cancer at the time of diagnosis determines the type
of treatment and will determine possible side effects.
Methods for removing or destroying small cancers on the surface of
the cervix include: cryosurgery which kills the cancer by freezing;
cauterization (burning) or laser surgery which destroys the abnormal
area without harming nearby healthy tissue; a loop electrosurgical
excision procedure (LEEP) may be preformed in which an electrical
current is passed through a thin wire loop that acts as a knife to
remove the abnormal tissue; and conization in which a cone-shaped piece
of tissue is removed where the abnormality is found. These treatments
may cause cramping or other pain, bleeding, or a watery discharge.
Hysterectomy is another surgical procedure used in the treatment of
advanced cervical cancer. Women who have a hysterectomy may experience
pain in the lower abdomen for a few days following surgery. They will
no longer have their menstrual periods and can no longer have children.
Sexual dysfunction is another possible side effect. Women who undergo
hysterectomy also face the risks of major surgery, including bleeding,
infection, and damage to other organs.
Side effects of radiation treatment can include infertility, sexual
dysfunction, fatigue, hair loss, skin conditions, diarrhea, and
frequent and uncomfortable urination.
Side effects of chemotherapy depend on the drugs and doses the
patient receives. Side effects can include increased susceptibility to
infections, bruising, low energy, hair loss, poor appetite, vomiting,
and mouth sores. Side effects gradually go away during the recovery
periods between treatments. Women treated with cisplatin can also
develop chronic neuropathy and renal damage.
Question 2. How can screening methods for cervical cancer be
improved?
Response. The Pap test is currently the accepted method used to
screen for cervical cancer and has been very successful in reducing the
death rate from cervical cancer. However, as with any medical test, the
Pap smear has limitations, particularly with respect to false-negative
screening results. Recently, interest has focused on development of
technologies to enhance the accuracy of cervical cancer screening. Some
of these techniques are directed at improving the sampling and specimen
quality, others are focused on improving the laboratory microscopic
screening process, and some techniques are visual or molecular rather
than microscopic.
Methods to improve sampling and specimen quality include the use of
liquid-based collection techniques. Liquid-based collections offer
improved fixation and presentation of the material in a more uniform
manner than traditional smears which could make detection of abnormal
cells easier. This technique also has the ability to test for HPV
infection if there is a low-grade or equivocal cytology result which
eliminates additional patient visits for testing.
Computer image analysis has been approved to screen cervical
cytology specimens in an effort to reduce false-negative results. While
this technology increases the screening sensitivity for atypical
squamous cells of undetermined significance and low grade squamous
intraepithelial lesion diagnosis it comes at a significant cost. Used
in a secondary screening mode, these technologies are cost-effective
only if incorporated into a less frequent screening strategy.
Question 3. What type of education campaign has the National Cancer
Institute (NCI) sponsored to increase the awareness of cervical cancer?
Please be specific in describing how NCI has coordinated its activities
with other Federal agencies and programs.
Response. Federal agencies are designated to serve the United
States in specific ways. The National Institutes of Health (NIH), of
which NCI is a part, is a research agency. In its mission to protect
and improve human health, the NIH (and NCI) conducts and supports
basic, applied, and clinical and health services research to understand
the processes underlying human health and to acquire new knowledge to
help prevent, diagnose, and treat human disease and disabilities. This
may include developing an information campaign such as the Pap Tests: A
healthy habit for life campaign and evaluating its effectiveness at
achieving its goal. NCI also has a mandate to disseminate research
findings so that when the development and evaluation are completed,
other Federal and state agencies, and private sector organizations, may
take this information and apply it accordingly. NCI, therefore, plays
an integral role in these activities.
The NCI disseminates research findings widely through scientific
publication, press conferences, press statements, clinical alerts,
patient education materials, meetings of professional societies,
television and radio, the World Wide Web, our toll-free Cancer
Information Service, our PDQ databases, and the Information Associates
Program. Our staff has many contacts within agencies for a variety of
programs and issues. Through these personal contacts, and those
mechanisms mentioned above, Federal agencies and offices have direct
access to information pertinent to their programs. In addition, we
maintain and foster close working relationships with other Institutes
that have formal collaborative relationships with the Office os
Population Affairs-our projects and programs are thus included in that
broad knowledge base. NCI has several partnerships with other federal
agencies and non-federal groups to enhance our information
dissemination activities The following are examples of two specific
information campaigns on cervical cancer:
Pap Tests: A healthy habit for life: In May 1998 the Office of Cancer
Communications began a campaign to alert the public of the
results of a survey that showed that older women were unaware
of their continued risk for cervical cancer. National
activities have included the distribution of a media packet
that focused on cervical cancer and older women. Additionally,
NCI collaborated with the Health Care Financing Administration
(HCFA) to reprint an NCI cervical cancer publication with
Medicare information for older women. Other activities have
included conducting research with physicians to identify their
attitudes and perceptions of Pap test screening among women 65
and older. Based on this research, a print public service
announcement and newsletter article are being developed that
encourage physicians to talk to their older patients about Pap
test screening. These materials will be promoted through
physician publications and newsletters.
The Pap Test and Cervical Cancer Video: An intertribal video on the
early detection of cervical cancer for American Indian women
was produced by the NCI in conjunction with the Nebraska
Department of Health. The video comes with educational material
to help inform American Indian women of the importance of
regular Pap tests.
Question 4. What is being done to improve the quality of life for
women who are diagnosed and treated for cervical cancer?
Response. Improving the quality of life for cancer patients is a
very important part of research at NCI. Currently, NCI is working to
evaluate interventions which can reduce sexual dysfunction caused by
radiation therapy. In addition, the NCI has ongoing research on ways to
reduce damage to normal tissue from radiation therapy. The NCI also has
plans to study fertility-sparing surgery for women with early stage
cervical cancer.
Question 5. In your testimony, you discussed clinical trials that
NCI is conducting on cervical cancer. What is the percentage of
cervical cancer patients who participate in these trials?
Response. Approximately 2-3% of women diagnosed with cervical
cancer are enrolled on cancer treatment trials sponsored by the NCI.
This figure is consistent with other adult cancer sites.
Please do not hesitate to contact me if you have further questions.
Sincerely,
Edward L. Trimble, M.D.
Head Surgery Section, Division of Cancer Treatment and Diagnosis
______
Department of Health & Human Services
National Cancer Institute
April 8, 1999
The Honorable Michael Bilirakis
Chairman, Subcommittee on Health and Environment
Committee on Commerce
House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman: I am responding to your letter of March 19,
1999, in which you pose twelve questions as a follow-up to my testimony
before the Subcommittee on Health and Environment on March 16, 1999.
As requested, the questions have been restated below. The answer
follows each numbered question.
Question 1. The National Cancer Institute (NCI) is in the process
of conducting a randomized trial to establish the best way to manage
abnormalities that are discovered during Pap smear tests. This study is
often referred to as ASCUS/LSIL Triage Study or ALTS. Please explain
the purpose and significance of this trial?
Response. NCI is conducting a large randomized trial to find the
best way to manage the mild abnormalities that often show up on Pap
tests and may, in rare instances, progress to cancer if left untreated.
The ALTS trial is comparing three approaches: 1) immediate colposcopy
(a procedure in which a physician examines the cervix through a
magnifying instrument and biopsies any abnormal area; 2) repeating the
Pap test every six months (because most abnormalities return to normal
without treatment); and 3) testing for cancer-associated types of HPV
as a means to differentiate between abnormalities that need immediate
colposcopy and those that can be best followed with repeat Pap tests.
Researchers will compare the three different groups to assess the
effectiveness of each management option in detecting the serious
abnormalities that can progress to cancer, the acceptability of each
option to patients, and the cost effectiveness of each option.
Question 2. When do you estimate the NCI will develop a vaccine for
human papillomavirus (HPV)? Can you describe all of the different HPV
vaccines that are being tested?
Response. There are both preventative and therapeutic HPV vaccines
which have been developed by the NCI that are currently being tested in
clinical trials. They seek to prevent infection or to induce regression
of established infection via immune recognition of specific HPV-encoded
proteins or peptides. Such vaccines can be delivered either directly as
a protein or by viral vectors derived from organisms of a different but
related species.
Question 3. What effect, if any, does HPV have on men?
Response. Scientists have found an association between several
types of HPV and the development of anal cancer and cancer of the penis
(a rare cancer). HPV also frequently causes benign warts.
Question 4. In addition to cervical cancer, what other effects can
HPV have on the body?
Response. Genital warts (condylomata acuminata or venereal warts)
are caused by only a few of the many types of HPV. Other common types
of HPV infections, such as those that cause warts on the hands and
soles of the feet, only rarely cause genital warts. In women, the warts
occur on the outside and inside of the vagina, on the cervix, or around
the anus. In men, genital warts are less common. If present, they are
seen on the tip of the penis or the urethra; however, they also may be
found on the shaft of the penis, on the scrotum, or around the anus.
Rarely, genital warts also can develop in the mouth or throat of a
person who has had oral sexual contact with an infected person.
Question 5. Please provide the number of HPV cases in the U.S. Is
this number increasing or decreasing? To what can this trend be
attributed?
Response. It is important to remember that estimating the
prevalence of HPV is difficult. Prevalence depends on many factors
which include: the population screened, the sexual habits of those
screened, what is classified as HPV infection at the time of screening,
etc. Estimates for the number of HPV cases varies. In November of 1996
the CDC estimated that 24 million Americans were infected with HPV. The
incidence of HPV infection has increased with changing sexual mores
starting in the 1960's. It is difficult to know whether variations in
incidence and prevalence reported during the 1990's represent an actual
change in the number of cases of HPV.
Question 6. What, if any symptoms are associated with HPV? If it is
asymptomatic, how would one know one is infected?
Response. HPV may cause warts with many different characteristics.
They may appear small or large, flat or raised, single or multiple;
sometimes the warts may not even be visible to the naked eye. The most
common places to notice genital warts are outside the vagina, on the
penis, and around the anus. In women, HPV can lead to the development
of warts inside the vagina and on the cervix as well. For many people
who have HPV infection, there are no obvious signs of infection.
However, if warts are present, a doctor can diagnose HPV infection by
their characteristic appearance and the history of how they developed.
In women, to look for warts on the cervix or in the vagina, a doctor
may use a colposcope, which is like a telescope. In addition, Pap smear
results may be suggestive of HPV infection. There is currently no blood
test that has proven reliable in the diagnosis of HPV infection and it
is not possible to routinely culture HPV. However, there are sensitive
DNA based assays which can be used to diagnose symptomatic and
asymptomatic HPV infection.
Question 7. How widespread or common is HPV? Of the women who have
HPV, what is the percentage of those women who will develop cervical
cancer?
Response. More than 80 types of HPV have been identified. However,
approximately 25 types infect the uterine cervix; of these, only some
are associated with invasive cervical cancer. They are therefore
classified into low-risk types, HPV 6 and 11, and high-risk types, most
commonly 16, 18, 31, and 45, which account for more than 80 percent of
all invasive cervical cancers. Less than 15 percent of women infected
with HPV will develop either low-grade squamous intraepithelial lesions
(LSIL) or high-grade squamous intraepithelial lesions (HSIL). At least
one-third of all grades of SIL will fade, whereas less than half
persist and approximately one-quarter progress. Of lesions that
progress, approximately 10 percent progress to carcinoma in situ and 1
percent to invasive cancer.
Since the virus is transmitted primarily through sexual
intercourse, there seems to be a peak prevalence of infection in
sexually active women who are younger than 25 years of age. The
prevalence of infection decreases with increasing age, suggesting that
most infections in women and men resolve over time through host immune
responses.
Question 8. The NCI has identified risk factors, such as the human
papillomavirus, in the development of cervical cancer. What work has
NCI done to coordinate a Federal response to the prevention of cervical
cancer? Specifically, what has NCI done to coordinate with the
Department of Health and Human Services (HHS) Office of Population
Affairs and the HHS Health Resources and Services Administration (HRSA)
to alert women concerning the risk factors associated with cervical
cancer?
Response. Federal agencies are designated to serve the United
States in specific ways. The National Institutes of Health (NIH), of
which NCI is a part, is a research agency. In its mission to protect
and improve human health, the NIH (and NCI) conducts and supports
basic, applied, and clinical and health services research to understand
the processes underlying human health and to acquire new knowledge to
help prevent, diagnose, and treat human disease and disabilities. This
may include developing an information campaign such as the Pap Tests: A
healthy habit for life campaign and evaluating its effectiveness at
achieving its goal. NCI also has a mandate to disseminate research
findings so that when the development and evaluation are completed,
other Federal and state agencies, and private sector organizations, may
take this information and apply it accordingly. NCI, therefore, plays
an integral role in these activities.
The NCI disseminates research findings widely through scientific
publication, press conferences, press statements, clinical alerts,
patient education materials, meetings of professional societies,
television and radio, the World Wide Web, our toll-free Cancer
Information Service, our PDQ databases, and the Information Associates
Program. Our staff has many contacts within agencies for a variety of
programs and issues. Through these personal contacts, and those
mechanisms mentioned above, Federal agencies and offices have direct
access to information perti-
nent to their programs. In addition, we maintain and foster close
working relationships with other Institutes that have formal
collaborative relationships with the Office os Population Affairs-our
projects and programs are thus included in that broad knowledge base.
NCI has several partnerships with other federal agencies and non-
federal groups to enhance our information dissemination activities.
Following are examples of two specific information campaigns on
cervical cancer:
Pap Tests: A healthy habit for life: In May 1998 the Office of Cancer
Communications began a campaign to alert the public of the
results of a survey that showed that older women were unaware
of their continued risk for cervical cancer. National
activities have included focusing on minority media outreach
and the distribution of a media packet that focused on cervical
cancer and older women. Additionally, NCI collaborated with the
Healthcare Financing Administration (HCFA) to reprint an NCI
cervical cancer publication with Medicare information for older
women to be distributed through HCFA and NCI networks. Other
activities have included conducting research with physicians to
identify their attitudes and perceptions of Pap test screening
among women 65 and older. Based on this research, a print
public service announcement and newsletter article are being
developed that encourage physicians to talk to their older
patients about Pap test screening. These materials will be
promoted through physician publications and newsletters.
The Pap Test and Cervical Cancer Video: An intertribal video on the
early detection of cervical cancer for American Indian Women
was produced by the NCI in conjunction with the Nebraska
Department of Health. The video comes with educational material
to help inform American Indian women of the importance of
regular Pap tests.
Question 9. Please name the NCI liaisons with CDC, HRSA, and the
Office of Population Affairs. Has NCI coordinated activity with the
Title V Abstinence Education Grant Program or the Title XX programs
within those agencies?
Response. As previously stated, NCI staff has many contacts within
agencies for a variety of programs and issues. Liaisons with CDC, HRSA
and the Office of Population Affairs vary on the program and issue
involved.
NCI has not formally collaborated specifically on Title V
Abstinence Education Grant program or the Title XX programs. As a
research agency, NCI's role is to conduct and support research, then
disseminate widely, new knowledge gained. This is done through
information campaigns like the Pap Tests: A healthy habit for life
campaign.
Question 10. What is the amount of research dollars spent by NCI on
HPV as compared to the virus that causes AIDS? How many women die
annually in the United States from cervical cancer? How many women die
annually in the United States from AIDS?
Response. There are over 80 types of HPV, about 15 of which are
associated with cancer of the cervix. NCI estimates that it will spend
about $38 million on cervical cancer-related HPV research, and about
$235 million on AIDS related cancers, in FY 1999. There are about 5,000
deaths in the U.S. from cervical cancer each year, and more than
200,000 deaths world wide. Over 90 percent of these cancers are HPV-
related. There were about 4,600 female deaths in the U.S., and 900,000
worldwide, from HIV-related illness in FY 1997.
Question 11. On January 12, 1999, Chairman Bliley sent a letter to
the NCI on women's health issues, including cervical cancer. In
response to that letter, NCI estimated the number of Americans with HPV
to be 24 million. In testimony before this committee by Dr. Ronald
Valdiserri, of the Centers for Disease Control and Prevention (CDC), on
March 16, 1999, he indicated that number is 45 million. Can you explain
the discrepancy in numbers?
Response. The NCI estimated number of Americans with HPV came from
the CDC website. The entry title is ``The Challenge of STD Prevention
in the U.S.'' and it was written in November 1996. CDC was not
contacted by NCI for verification of this number and the CDC testified
using an estimated number that may be more current than the one posted.
Once again, it is important to remember that estimating the prevalence
of HPV is difficult. Prevalence depends on many factors which include:
the population screened, the sexual habits of those screened, what is
classified as HPV infection at the time of screening, etc.
Question 12. In the above referenced letter from NCI to Chairman
Bliley, NCI stated that, ``Condoms are ineffective against HPV because
the virus is prevalent not only in mucosal tissue (genitalia) but also
on dry skin of the surrounding abdomen and groin and it can migrate
from those areas into the vagina and cervix.'' That letter went on to
say that ``additional research efforts by NCI on the effectiveness of
condoms in preventing HPV transmission are not warranted.'' To the
contrary, Dr. Ronald Valdiserri of CDC testified on March 16, 1999 that
``Several studies have shown condoms to provide some protection against
cervical cancer . . .'' Can you explain the difference in conclusions
made by CDC and NCI?
Response. The NCI conclusion that condoms are ineffective against
HPV infection is based on the results of several long term studies
which have failed to show that barrier contraceptives prevent cervical
HPV infection, dysplasia, or cancer (Attachment 1, 2, 3). Dr.
Valdiserri's testimony might be based on studies that show that while
condoms are ineffective in preventing transmission of HPV, they are
quite effective at preventing transmission of HIV and other sexually
transmitted diseases. CDC would be able to provide insight into the
basis of Dr. Valdiserri's statement.
Please do not hesitate to contact me if you have further questions.
Sincerely,
Dr. Douglas Lowy
Deputy Director, Division of Basic Sciences, NCI
Enclosures
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CDC Responses to Questions on HPV and Cervical Cancer from the
Subcommittee on Health and Environment
Question: 1. How does CDC decide for which sexually transmitted
diseases it will compile surveillance data? Please provide a list of
all sexually transmitted diseases for which CDC currently recommends
that states compile data. Please provide the number of female deaths
per year associated with the sexually transmitted diseases for which
the CDC has surveillance data.
Answer: Notifiable diseases are determined by individual state
laws, not by CDC. All reports of notifiable diseases to CDC are
voluntary on the part of the states. Generally, CDC compiles
surveillance data for sexually transmitted diseases that are notifiable
in all 50 states (gonorrhea, syphilis, chancroid; chlamydia is reported
in 49 states). CDC also monitors non-notifiable diseases such as
genital herpes by conducting special prevalence studies in the U.S.
population (e.g., the National Health and Nutrition Examination Survey)
and in smaller subpopulations. These kinds of special studies define
the disease burden in the U.S. and often establish the need for
diseases to become notifiable at the state level.
According to a CDC study, there were 2,665 female deaths
attributable to HIV, 99 to syphilis, and 3 to gonorrhea in 1992, the
latest year for which comparable data are available (Ebrahim et al.
Mortality related to STD in US women, 1973 through 1992. American
Journal of Public Health 1997;87:938-944).
Question: 2A. Can the human papillomavirus (``HPV'') be transmitted
in non-sexual manner? 2B. How can someone prevent its transmission?
Answer: A. Of the approximately 80 different types of HPV
infection, about 50 are considered to be non-genital (i.e., almost
never occur on genital skin) and are almost always transmitted in a
non-sexual manner. Of the approximately 30 genital types, sexual
intercourse appears to be the predominant route of transmission.
However, it has also been suggested that in rare cases, infection of
genital skin with HPV can result from vertical transmission (mother-to-
child during vaginal delivery); ``autoinoculation'' of non-genital
types of HPV to the genital skin from another body part (such as the
hand); inoculation through casual contact with genital skin, such as
bathing; or transmission by inanimate objects (such as towels). (Cason,
1995).
B. The most reliable means of preventing sexual transmission of
genital HPV infection is likely to be abstinence, although, as noted
above, non-sexual routes of transmission are possible. Other means of
protection are more uncertain. The protection provided by condoms has
been difficult to evaluate because current laboratory tests for HPV
infection cannot determine whether an infection is new or acquired
months or even years before. Latex condoms should provide protection if
they cover the infected genital skin and if used consistently and
correctly. The greater surface area of the female condom may provide
even greater protection, although there are no data evaluating its
effectiveness in this regard. Finally, microbicides under development
may provide some protective benefit (Howett, 1999). The most promising
approach for prevention of transmission will be the development of
preventive vaccines. Carefully designed studies of all of these
transmission prevention approaches will be important in designing more
effective prevention strategies.
Question: 3A. Can the body eliminate HPV from its system? 3B. What
can be done for those people who have compromised immune systems?
Answer: A. Whether the body can eliminate HPV from its system, that
is, totally eradicate it (which is what we think happens with
respiratory viruses such as those which cause influenza or the common
cold) has been difficult to determine. There is good evidence that in
most people genital HPV infections become ``undetectable'' by even
highly sensitive lab tests for detection of HPV DNA (such as PCR) over
the course of a few months to a few years (Ho, 1998), and it appears
that such people do not have an increased risk for development of
dysplasia or cancer. On the other hand, people with persistently
detectable HPV infection appear to be at higher risk for dysplasia, and
probably also cancer.
Evidence which suggests that undetectable HPV infection might not
be totally eradicated from the body comes from patients with
compromised immune systems, such as those taking immunosuppressive
medication after an organ transplant or those with HIV infection, in
whom the rate of detectable HPV infection is much higher than it is in
patients whose immune systems are normal (Sun, 1997; Halpert, 1986).
While some of this difference could be attributed to a greater risk of
acquiring a new HPV infection among those with greater sexual risks
(such as those with sexually acquired HIV), the fact that the rate of
detectable HPV increases directly with declining immune function, even
among patients who become less sexually active due to their illness,
suggests that at least some or most of this excess level of infection
is due to reactivation of previously undetectable infection which was
quiescent but not completely eradicated. The similar experience in
older, and probably less sexually active transplant recipients, is also
consistent with such a process.
B. For those with compromised immune systems, there are two current
approaches to help them with potential HPV-related problems. The first
is to be sure that women undergo Pap smear screening at recommended
intervals (which for those with HIV infection is every 6 months for a
year and then annually thereafter), as well as follow-up evaluation of
any abnormalities, in order to prevent what may be an increased risk of
cervical cancer. The second approach is to attempt to maintain and
improve immune function if possible, such as with the use of highly
active antiretroviral therapy in those with HIV infection, which has
the potential to reduce the risk of HPV-associated dysplasia and
cancer. Better studies are needed to help develop management approaches
in people with compromised immune systems.
Question: 4. On January 12, 1999, Chairman Bliley sent a letter to
the National Cancer Institute (NCI) on women's health issues, including
cervical cancer. In response to that letter, NCI estimated the number
of Americans with HPV to be 24 million. In testimony before this
committee on March 16, 1999, you indicated that number is 45 million.
Can you explain the discrepancy in numbers?
Answer: Because HPV infection is not diagnosed in most people who
are infected and because there are no systems in place for reporting of
HPV infection, assessment of prevalence can only be based on very
general estimates. This issue is further complicated, as noted in the
answer to Question 3, by the problem that it has not yet been
determined whether infection no longer measurable by sensitive HPV DNA
detection tests such as PCR have truly resolved or are simply quiescent
but still present, which is the assumption made for other viral
sexually transmitted diseases such as genital herpes.
With these complexities in mind, there have been several attempts
to quantify the prevalence of what are considered to be active genital
HPV infections. Prior to 1999, the most widely quoted estimate of
active genital HPV infection was 24 million (IOM Report). As of 1999,
new revised estimates for the prevalence of the various sexually
transmitted diseases stated that ``a conservative estimate of the
prevalence of productive HPV (persons with active shedding of HPV DNA)
is approximately 20 million'' (Cates, 1999).
Estimates of viral sexually transmitted disease prevalence based on
serologic studies (assessments based on the presence of antibody in the
blood) are much higher. For genital herpes, the estimated prevalence is
45 million, and the number of cases of genital HPV infection appears to
be at least as great as the number of cases of genital herpes. However,
estimates of the number of people who have been infected (and might
still be at least quiescently infected) with genital HPV based on
serologic studies are as high as 100 million (Koutsky, 1997).
Clearly, a very large number of Americans have genital HPV
infection, and better studies are needed to further refine these
estimates.
Question: 5. NCI stated that ``additional research efforts by NCI
on the effectiveness of condoms in preventing HPV transmission are not
warranted.'' CDC's testimony stated ``Several studies have shown
condoms to provide some protection against cervical cancer.'' Please
explain the difference in conclusions and also cite the studies to
which you refer.
Answer: NCI statement refers to genital HPV infection, not cervical
cancer. Two case-control studies documented a strong protective effect
of condom use and cervical cancer. In one study in Utah, condom use was
associated with a lower risk of cervical cancer in women who had more
than one sex partner; these women had a 47% lower risk of cervical
cancer compared to women who did not use condoms (Slattery ML, Overall
JC, Abbott et al: Sexual activity, contraception, genital infections,
and cervical cancer: support for a sexually transmitted disease
hypothesis. American Journal of Epidemiology 1989;130:248-258). In
another study conducted in Los Angeles, women who used condoms for 2-9
years had a 50% reduction in risk of cervical cancer, and those who
used condoms for 10 or more years had a 60% reduction in risk, compared
to women who had 0-2 years of condom use (Peters RK, Thomas D, Hagan
DG, et al. Risk factors for invasive cervical cancer among Latinas and
Non-Latinas in Los Angeles County. Journal of the National Cancer
Institute 1986;77:1063-1077).
Other studies have not shown a protective effect (Hildeshim A,
Brinton LA, Mallin K et al. Barrier and spermicidal contraceptive
methods and risk of invasive cervical cancer. Epidemiology 1990; 1:226-
272 and accompanying editorial Daling JR, Weiss NS: Are barrier methods
protective against cervical cancer? Epidemiology 1990; 1:261-272.)
Question: 6. The CDC has identified risk factors, such as the human
papillomavirus, in the development of cervical cancer. What work has
CDC done to coordinate a Federal response to the prevention of cervical
cancer? Specifically, what has CDC done to coordinate with the
Department of Health and Human Services (HHS) Office of Population
Affairs and the HHS Health Resources and Services Administration (HRSA)
to alert women concerning the risk factors associated with cervical
cancer? Who are the liaisons with CDC, HRSA, and the Office of
Population Affairs? Has CDC coordinated activity with the Title V and
Title XX programs within those agencies?
Answer: CDC has developed effective partnerships with HRSA and OPA
on a local level. HRSA directs national health programs which improve
the health of the nation by assuring quality health care to
underserved, vulnerable and special-need populations. Under HRSA's
direction, a nationwide network of 643 community and migrant health
centers, and 144 primary care programs for the homeless and residents
of public housing serve 8.1 million Americans each year. CDC's National
Breast and Cervical Cancer Early Detection Program (NBCCEDP) contracts
with many local HRSA health centers to provide services. Women eligible
for CDC's program are referred to HRSA services for screening,
diagnostic and treatment services as needed. To assist this effort, CDC
and HRSA partnered on a successful conference, ``Cancer Institute on
Prevention and Treatment Strategies for Underserved Minority
Populations,'' to focus effective outreach, prevention, screening,
diagnosis, and cancer treatment services for underserved minority
populations.
The OPA, within the Office of Public Health and Science of the
DHHS, provides resources and policy advice on population, family
planning, reproductive health, and adolescent pregnancy issues. OPA
also administers two grant programs, the national Family Planning
Program, authorized under Title X of the Public Health Service Act
(PHSA) and the Adolescent Family Life Program, authorized under Title
XX of the PHSA. In Fiscal year 1999, Title X Family Planning Clinics
expect to serve nearly 5 million persons through a nationwide network
of 4,600 clinics. Priority is given to persons from low-income
families; services are provided at no cost to persons at or below the
poverty level and on a sliding fee scale up to 250 percent of the
poverty level. Many of CDC's NBCCEDP programs collaborate with Title X
programs and share information with Title XX demonstration projects on
a local level. Certain Breast and Cervical Cancer programs contract
with family planning programs for screening services and some OPA's
Title X programs refer women to NBCCEDP's contracted facilities for
additional follow-up and diagnostic care when Pap testing detects
abnormalities. These special partnerships are arranged on a local,
State-by-State or program-by-program basis.
Finally, CDC's Division of Reproductive Health (DRH) is currently
examining the effects of parity (the number of children born alive to a
woman) and age at first birth on risk of invasive cervical cancer. CDC
is using data from a population-based, case-control study of cervical
cancer in Costa Rica collected between 1982 and 1984. Preliminary
results suggest that risk of cervical cancer increased with increasing
parity and decreased with increasing age at first birth.
The liaisons for the respective agencies are Nancy C. Lee, M.D.,
Division Director, CDC/NCCDPHP/DCPC; Marilyn H. Gaston, M.D., Associate
Administrator, DHHS/HRSA/BPHC; and Thomas Kring, Deputy Director, DHHS/
OS/OPHS/OPA.
Question: 7A. What is the amount of research dollars spent by CDC
on HPV as compared to the virus that causes AIDS? 7B. How many women
die annually in the United States from cervical cancer? 7C. How many
women die annually in the United States from HIV-related illnesses?
Answer: A. During FY98, CDC spent approximately $1.25 million
dollars for research on HPV and $41.356 million for research on HIV and
AIDS.
B. In 1996, the latest year for which complete data is available,
4,552 women died of cervical cancer in the United States (CDC, National
Center for Health Statistics, Deaths: Final Data 1996, National Vital
Statistics Reports; Volume 47, Number 29).
C. In 1996, the latest year for which complete data is available,
there were 5,853 HIV-related deaths among women in the United States
(CDC, National Center for Health Statistics, Deaths: Final Data 1996,
National Vital Statistics Reports; Volume 47, Number 29).
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