    [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:]

        [GRAPHIC] [TIFF OMITTED] T5639.001

        [GRAPHIC] [TIFF OMITTED] T5639.002

        [GRAPHIC] [TIFF OMITTED] T5639.003

        [GRAPHIC] [TIFF OMITTED] T5639.004

        [GRAPHIC] [TIFF OMITTED] T5639.005

        [GRAPHIC] [TIFF OMITTED] T5639.006

        [GRAPHIC] [TIFF OMITTED] T5639.007

        [GRAPHIC] [TIFF OMITTED] T5639.008

        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

    [GRAPHIC] [TIFF OMITTED] T5639.009

    [GRAPHIC] [TIFF OMITTED] T5639.010

    [GRAPHIC] [TIFF OMITTED] T5639.011

    [GRAPHIC] [TIFF OMITTED] T5639.012

    [GRAPHIC] [TIFF OMITTED] T5639.013

    [GRAPHIC] [TIFF OMITTED] T5639.014

    [GRAPHIC] [TIFF OMITTED] T5639.015

    [GRAPHIC] [TIFF OMITTED] T5639.016

    [GRAPHIC] [TIFF OMITTED] T5639.017

        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

    [GRAPHIC] [TIFF OMITTED] T5639.018

    [GRAPHIC] [TIFF OMITTED] T5639.019

    [GRAPHIC] [TIFF OMITTED] T5639.020

    [GRAPHIC] [TIFF OMITTED] T5639.021

    [GRAPHIC] [TIFF OMITTED] T5639.022

    [GRAPHIC] [TIFF OMITTED] T5639.023

    [GRAPHIC] [TIFF OMITTED] T5639.024

    [GRAPHIC] [TIFF OMITTED] T5639.025

    [GRAPHIC] [TIFF OMITTED] T5639.026

    [GRAPHIC] [TIFF OMITTED] T5639.027

    [GRAPHIC] [TIFF OMITTED] T5639.028

    [GRAPHIC] [TIFF OMITTED] T5639.029

    [GRAPHIC] [TIFF OMITTED] T5639.030

    [GRAPHIC] [TIFF OMITTED] T5639.031

    [GRAPHIC] [TIFF OMITTED] T5639.032

    [GRAPHIC] [TIFF OMITTED] T5639.033

    [GRAPHIC] [TIFF OMITTED] T5639.034

    [GRAPHIC] [TIFF OMITTED] T5639.035

    [GRAPHIC] [TIFF OMITTED] T5639.036

    [GRAPHIC] [TIFF OMITTED] T5639.037

    [GRAPHIC] [TIFF OMITTED] T5639.038

    [GRAPHIC] [TIFF OMITTED] T5639.039

    [GRAPHIC] [TIFF OMITTED] T5639.040

    [GRAPHIC] [TIFF OMITTED] T5639.041

        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).

    [GRAPHIC] [TIFF OMITTED] T5639.042

    [GRAPHIC] [TIFF OMITTED] T5639.043

    [GRAPHIC] [TIFF OMITTED] T5639.044

    [GRAPHIC] [TIFF OMITTED] T5639.045

    [GRAPHIC] [TIFF OMITTED] T5639.046

    [GRAPHIC] [TIFF OMITTED] T5639.047

    [GRAPHIC] [TIFF OMITTED] T5639.048

    [GRAPHIC] [TIFF OMITTED] T5639.049

    [GRAPHIC] [TIFF OMITTED] T5639.050

    [GRAPHIC] [TIFF OMITTED] T5639.051

    [GRAPHIC] [TIFF OMITTED] T5639.052

    [GRAPHIC] [TIFF OMITTED] T5639.053

    [GRAPHIC] [TIFF OMITTED] T5639.054