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[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
 Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

                    ------------------------------  

                         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

                              ----------                              

                        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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