[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]



 
                CERVICAL CANCER AND HUMAN PAPILLOMAVIRUS

=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON CRIMINAL JUSTICE,
                    DRUG POLICY AND HUMAN RESOURCES

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                             MARCH 11, 2004

                               __________

                           Serial No. 108-206

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpo.gov/congress/house
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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana                  HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut       TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana              CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California                 DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky                  DANNY K. DAVIS, Illinois
JO ANN DAVIS, Virginia               JOHN F. TIERNEY, Massachusetts
TODD RUSSELL PLATTS, Pennsylvania    WM. LACY CLAY, Missouri
CHRIS CANNON, Utah                   DIANE E. WATSON, California
ADAM H. PUTNAM, Florida              STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia          CHRIS VAN HOLLEN, Maryland
JOHN J. DUNCAN, Jr., Tennessee       LINDA T. SANCHEZ, California
NATHAN DEAL, Georgia                 C.A. ``DUTCH'' RUPPERSBERGER, 
CANDICE S. MILLER, Michigan              Maryland
TIM MURPHY, Pennsylvania             ELEANOR HOLMES NORTON, District of 
MICHAEL R. TURNER, Ohio                  Columbia
JOHN R. CARTER, Texas                JIM COOPER, Tennessee
MARSHA BLACKBURN, Tennessee          ------ ------
PATRICK J. TIBERI, Ohio                          ------
KATHERINE HARRIS, Florida            BERNARD SANDERS, Vermont 
                                         (Independent)

                    Melissa Wojciak, Staff Director
       David Marin, Deputy Staff Director/Communications Director
                      Rob Borden, Parliamentarian
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

   Subcommittee on Criminal Justice, Drug Policy and Human Resources

                   MARK E. SOUDER, Indiana, Chairman
NATHAN DEAL, Georgia                 ELIJAH E. CUMMINGS, Maryland
JOHN M. McHUGH, New York             DANNY K. DAVIS, Illinois
JOHN L. MICA, Florida                WM. LACY CLAY, Missouri
DOUG OSE, California                 LINDA T. SANCHEZ, California
JO ANN DAVIS, Virginia               C.A. ``DUTCH'' RUPPERSBERGER, 
EDWARD L. SCHROCK, Virginia              Maryland
JOHN R. CARTER, Texas                ELEANOR HOLMES NORTON, District of 
MARSHA BLACKBURN, Tennessee              Columbia
                                     ------ ------

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                     J. Marc Wheat, Staff Director
                Roland Foster, Professional Staff Member
                         Nicole Garrett, Clerk
                    Sarah Despres, Minority Counsel



                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on March 11, 2004...................................     1
Statement of:
    Coburn, Tom A., M.D., Muskogee, OK; Freda Bush, M.D., FACOG, 
      Jackson, MS; John Thomas Cox, M.D., Santa Clara, CA; 
      Margaret Meeker, M.D., Traverse City, MI; and Jonathan M. 
      Zenilman, M.D., Baltimore, MD..............................    92
    Thompson, Ed, M.D., Deputy Director for Public Health 
      Services, Centers for Disease Control and Prevention; 
      Edward L. Trimble, M.D., Gynecologic Oncologist, National 
      Cancer Institute National Institutes of Health; and Daniel 
      G. Schultz, M.D., Director, Office of Device Evaluation, 
      Center for Devices and Radiologic Health, Food and Drug 
      Administration.............................................    38
    Weldon, Hon. Dave, a Representative in Congress from the 
      State of Florida...........................................    25
Letters, statements, etc., submitted for the record by:
    Coburn, Tom A., M.D., Muskogee, OK, prepared statement of....    95
    Cox, John Thomas, M.D., Santa Clara, CA, prepared statement 
      of.........................................................   107
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    12
    Meeker, Margaret, M.D., Traverse City, MI, prepared statement 
      of.........................................................   119
    Schultz, Daniel G., M.D., Director, Office of Device 
      Evaluation, Center for Devices and Radiologic Health, Food 
      and Drug Administration, prepared statement of.............    74
    Souder, Hon. Mark E., a Representative in Congress from the 
      State of Indiana, prepared statement of....................     4
    Thompson, Ed, M.D., Deputy Director for Public Health 
      Services, Centers for Disease Control and Prevention, 
      prepared statement of......................................    41
    Trimble, Edward L., M.D., Gynecologic Oncologist, National 
      Cancer Institute National Institutes of Health, prepared 
      statement of...............................................    61
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................    18
    Weldon, Hon. Dave, a Representative in Congress from the 
      State of Florida, prepared statement of....................    27
    Zenilman, Jonathan M., M.D., Baltimore, MD, prepared 
      statement of...............................................   123


                CERVICAL CANCER AND HUMAN PAPILLOMAVIRUS

                              ----------                              


                        THURSDAY, MARCH 11, 2004

                  House of Representatives,
 Subcommittee on Criminal Justice, Drug Policy and 
                                   Human Resources,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 11:05 a.m., in 
room 2247, Rayburn House Office Building, Hon. Mark E. Souder 
(chairman of the subcommittee) presiding.
    Present: Representatives Souder, Cummings, Waxman, Davis, 
Norton, Sanchez, and Ruppersberger.
    Staff present: J. Marc Wheat, staff director and chief 
counsel; Roland Foster, professional staff member; Nicole 
Garrett, clerk; Phil Barnett, minority staff director; Sarah 
Despres and Tony Haywood, minority counsels; Jean Gosa, 
minority assistant clerk; and Naomi Seiler, minority staff 
assistant.
    Mr. Souder. Good morning. Thank you for being here.
    Today's hearing will examine the latest medical science 
regarding cervical cancer and ongoing Federal efforts to treat 
the disease and prevent infection from the virus that causes 
it.
    Each year in the United States, over 12,000 women develop 
cervical cancer and more than 4,000 women die of the disease. 
By way of comparison, about the same number of women die from 
HIV/AIDS ever year.
    In 2001, cervical cancer was estimated to be the 12th most 
commonly new diagnosed cancer among women in the United States. 
According to the American Cancer Society, non-invasive cervical 
cancer may be four times as widespread as the invasive type.
    Experts agree that the infection by certain strains of 
human papillomavirus [HPV], is the primary cause of nearly all 
cervical cancers. HPV infection is also associated with other 
cancers and more than 1 million pre-cancerous lesions.
    About 20 million Americans are currently infected with HPV. 
An estimated 5.5 million Americans become infected with HPV 
every year, and 4.6 million of these are acquired by young 
Americans between the ages of 15 and 24.
    In 1988, Dr. Stephen Curry from the New England Medical 
Center said HPV ``is rampant. If it weren't for AIDS, stories 
about it would be on the front page of every newspaper.''
    Fifteen years later, most Americans still have never heard 
of HPV, and most are unaware of the dangers the virus can pose 
or how to protect themselves against infection, and it is still 
rampant.
    On Monday of this week, researchers reported that an 
alarming one-third of women in a recent study were found to be 
infected with a strain of HPV linked to cervical cancer.
    In January of this year, the Centers for Disease Control 
and Prevention issued its first-ever comprehensive HPV 
prevention report. The CDC report states: ``Because genital HPV 
infection is most common in men and women who have had multiple 
sex partners, abstaining from sexual activity (i.e., refraining 
from any genital contact with another individual) is the surest 
way to prevent.''
    It continued: ``For those who choose to be sexually active, 
a monogamous relationship with an uninfected partner is the 
strategy most likely to prevent future genital HPV infections. 
For those who choose to be sexually active but who are not in a 
monogamous relationship, reducing the number of sexual partners 
and choosing a partner less likely to be infected may reduce 
the risk of genital HPV infection.''
    The CDC reports that ``The available scientific evidence is 
not sufficient to recommend condoms as a primary prevention 
strategy for the prevention of genital HPV infection.''
    The CDC's findings echo a 2001 report entitled ``Scientific 
Evidence on Condom Effectiveness for Sexually Transmitted 
Disease (STD) Prevention'' prepared by the National Institute 
of Allergy and Infectious Diseases in consultation with the 
Food and Drug Administration, the U.S. Agency for International 
Development, and CDC, which evaluated all published data on 
latex condoms and STD prevention and concluded that ``there was 
no evidence that condom use reduced the risk of HPV 
infection.''
    These scientific findings are important because Public Law 
106-554, signed by President Clinton on December 21, 2000, 
requires the CDC to educate the public and health care 
professionals about HPV prevention and directs the FDA to 
``reexamine existing condom labels . . . to determine whether 
the labels are medically accurate regarding the overall 
effectiveness or lack of effectiveness of condoms in preventing 
sexually transmitted diseases, including HPV.''
    Because of the lack of awareness of HPV, there has been 
much confusion about the virus. I would like to emphasize two 
important points.
    First, not everyone infected with HPV will develop cancer, 
but those with persistent, high risk strains of HPV are at 
increased risk. And second, while treatment can prevent the 
progression of cervical cancer, treatment should not be 
confused with HPV prevention. Treatment is often invasive, 
unpleasant, and costly, and does not include the necessity for 
additional treatments or adverse side effects.
    Today I look forward to learning what efforts Federal 
agencies are taking to protect the public against HPV and 
cervical cancer, and, in particular, what actions the CDC is 
undertaking to promote the agency's HPV recommendations.
    I also look forward to an update on the status of Federal 
programs to diagnose and treat cervical cancer and to develop 
an effective HPV vaccine. Congress has passed a number of laws 
over the past decade to increase access to testing and 
treatment. Because deaths from cervical cancer are largely 
preventable, it is vitally important that women have access to 
and are routinely screened for HPV and cervical cancer, and, if 
necessary, treated.
    Finally, I look forward to hearing from the experts on our 
second panel, who are on the front lines every day treating 
patients with HPV and learning what advice they may have for 
Federal policymakers for improving efforts to educate, prevent, 
and treat HPV and cervical cancer.
    Thank you all for being here today, and we look forward to 
your testimony and insights on this very important issue.
    [The prepared statement of Hon. Mark E. Souder follows:]
    [GRAPHIC] [TIFF OMITTED] 96225.001
    
    [GRAPHIC] [TIFF OMITTED] 96225.002
    
    [GRAPHIC] [TIFF OMITTED] 96225.003
    
    [GRAPHIC] [TIFF OMITTED] 96225.004
    
    [GRAPHIC] [TIFF OMITTED] 96225.005
    
    [GRAPHIC] [TIFF OMITTED] 96225.006
    
    Mr. Souder. I would now like to yield to our distinguished 
ranking member, Mr. Cummings.
    Mr. Cummings. I want to thank you, Mr. Chairman, for 
holding this hearing today on this women's health issue, 
cervical cancer.
    Fifty years ago, cervical cancer was a leading cause of 
cancer death among women in the United States and around the 
world. Thanks to advances in cancer screening and treatment, 
the threat of mortality from cervical cancer has been 
dramatically reduced in the United States. Still, thousands of 
women are newly diagnosed each year and the American Cancer 
Society estimates that nearly 4,000 women will die from it in 
2004.
    The risk of illness and death from cervical cancer is 
spread unevenly among women in the United States. Despite 
improved screening rates enabled by congressionally authorized 
CDC screening programs, unequal access to screening remains a 
problem that contributes to significant disparities in cervical 
cancer rates along the lines of race, educational level, 
income, and age.
    Women who belong to racial and ethnic minority groups are 
disproportionately represented among the new cases of cervical 
cancers. Asian, African-American, and Hispanic women have 
significantly higher mortality rates from cervical cancer than 
White women; women with less than a high school education are 
less likely to have testing than more highly educated women; 
and despite the peak in incidence of cervical cancer among 
women 40 to 55 years old, women in this age group are less 
likely to have been screened than a younger woman.
    As chairman of the Congressional Black Caucus, I am 
particularly disturbed that African-American women are 60 
percent more likely to have cervical cancer and 33 percent more 
likely to die from it as compared to White women.
    The great tragedy in the American Cancer Society's 
estimates of thousands of lives that will be lost is that these 
deaths are indeed avoidable. The Department of Health and Human 
Services notes in its Healthy People 2010 initiative that the 
likelihood of cervical cancer survival is nearly 100 percent if 
early detection is followed by appropriate treatment and 
followup. But cost remains a barrier to access to Pap tests and 
DNA tests for HPV that, when used together, can accurately 
determine whether a woman is or is not at risk for cervical 
cancer or precursor conditions.
    Any discussion of cervical cancer must involve HPV because 
genital HPV infection is a necessary precursor for cervical 
cancer. But, too often, discussions about HPV devolve into 
discussions of the merits of abstinence-only education. Some of 
my colleagues believe abstinence-only education is the answer 
to transmission of HPV and STDs in general, despite the lack of 
evidence that such programs are effective and the accumulating 
body of evidence to the contrary.
    I expect that we will hear a lot of discussion today about 
condoms and the CDC's recent report finding that condom use is 
not supportable as a primary prevention strategy for genital 
HPV transmission. Far more relevant to the lives of women at 
risk of cervical cancer is CDC's finding in the same report 
that condom use is effective in reducing the risk of cervical 
cancer. This finding speaks to the bottom line question, which 
is: How do we effectively preserve and protect the lives of 
women?
    HPV, when it doesn't lead to cervical cancer, is not life-
threatening. An estimated 75 to 80 percent of Americans will 
have an HPV infection at some time during their lifetime. In 
the vast majority of cases the infection will resolve 
spontaneously. A tiny percentage will be at risk of developing 
cervical cancer or pre-cancerous conditions, however. 
Identifying these women and, where necessary, providing 
treatment is critical.
    The most important message that can come out of today's 
hearing is that cervical cancer can be prevented, detected, 
treated, and cured, and that health screening and condom use 
are essential components of a sound, realistic public healths 
strategy for combating cervical cancer and the spread of 
sexually transmitted disease.
    Until we have done all we can to expand access to screening 
and treatment, and until there is evidence that abstinence-only 
education programs are effective, conversations about condom 
efficacy for HPV will continue to be an unconstructive sidebar 
to the important matter of erasing the threat of cervical 
cancer.
    Indeed, it is worth keeping in mind that we made enormous 
strides in reducing cervical cancer deaths even as the so-
called sexual revolution was occurring. Ensuring that cervical 
cancer death rates continue to go down for women in all parts 
of American society is what matters most. The only certain way 
to do that is by devoting more resources to what we know works: 
providing screening and treatment for women at risk. This 
should remain the foundation of a public health strategy for 
cervical cancer that puts health and wellness before religious 
and social ideology, and science before politics.
    Thank you again, Mr. Chairman, for holding a very important 
hearing. I sincerely hope that we will have an opportunity to 
listen to our witnesses very carefully and make progress with 
regard to this illness that affects so many women in our 
country.
    I yield back.
    [The prepared statement of Hon. Elijah E. Cummings 
follows:]
[GRAPHIC] [TIFF OMITTED] 96225.007

[GRAPHIC] [TIFF OMITTED] 96225.008

[GRAPHIC] [TIFF OMITTED] 96225.009

[GRAPHIC] [TIFF OMITTED] 96225.010

    Mr. Souder. Thank you.
    I would now like to recognize Mr. Waxman. I was going to 
recognize you next, because you are the senior ranking member 
on the full committee. Then I would go over to this side.
    Mr. Waxman. Well, you are all very kind to let me proceed 
with my opening statement.
    I am pleased to be here with the members of this 
subcommittee.
    When it comes to human papillomavirus [HPV], public health 
policy must start with a single question: How can we reduce the 
rate of cervical cancer in the United States?
    And this is a critical question because HPV causes cervical 
cancer and cervical cancer kills nearly 4,000 women in this 
country every year.
    So I think to address this question we have to look at what 
works.
    First, evidence demonstrates that the Pap test works. It is 
a simple test that can find precancerous lesions, pointing the 
way for treatment that can prevent invasive cervical cancer 
from ever developing.
    It is a tragedy that about half the women with newly 
diagnosed cervical cancers have never had a Pap test. Expanding 
access to this service is an important public health priority.
    Second, evidence demonstrates that condoms work to prevent 
cervical cancer. The CDC has found that condom use is 
associated with lower rates of cervical cancer. It is 
critically important that the public be aware of this 
potentially life-saving information.
    Third, evidence demonstrates that comprehensive education 
can reduce sexual risk-taking that may lead to sexually 
transmitted diseases like HPV. These education programs 
typically stress the importance of abstinence, but also provide 
information on other options as well.
    It is important to look at the question of how we can 
reduce the rate of cervical cancer in this country. I am 
concerned, however, that today's hearing will not focus, as it 
should, on this question. Instead, I am concerned that this 
hearing will, instead pursue a different question entirely: how 
the science of HPV can be used to advance the ideological 
agenda of abstinence only education.
    This is neither a useful question, nor a new one. For 
years, those who have argued that teenagers should not be 
taught about the full range of options available to prevent 
unwanted pregnancy and sexually transmitted diseases, including 
abstinence and the proper use of condoms, have used the example 
of HPV to try to undermine public confidence in any other 
approach other than abstinence.
    The main argument is to point out again and again and again 
that condoms are not proven to reduce the number of HPV 
infections. Therefore, the argument goes, condoms should carry 
warning labels and, ideally, should not be used at all.
    Well, it is true that condoms have not been proven to 
reduce the risk of HPV infection. However, what is more 
significant is that condoms are associated with less cervical 
cancer, which is, after all, the key reason we care about HPV 
infection.
    Moreover, and this is very important, condoms, when used 
consistently and correctly, are very effective in preventing 
HIV infection, and can also reduce the risk of transmission of 
other sexually transmitted diseases, such as gonorrhea and 
chlamydia, as well as prevent unwanted pregnancies. Anything 
that undermines the effectiveness of condoms for these uses 
will have serious public health consequences. Are condoms 
perfect? Of course not. But reality requires us not to measure 
public health strategies against perfection, but rather to ask 
a key question: compared to what?
    There are those on this committee and in this Congress who 
insist that abstinence-only education is the solution to teen 
pregnancy and sexually transmitted diseases because 
``abstinence works each time.''
    Well, the evidence, however, indicates that abstinence-only 
education works rarely, if at all. Independent reviews have 
failed to find any significant impact of abstinence-only 
education on real outcomes. And recently, for example, an 
independent study commissioned by the Minnesota Health 
Department found that sexual activity doubled among junior high 
school students who participated in an abstinence-only program. 
And earlier this week, a study of 12,000 teens presented to the 
National STD Prevention Conference found that those who pledge 
to remain virgins until marriage have the same rate of sexually 
transmitted diseases as those who do not take this pledge.
    These studies are inconvenient for those who want to argue 
exclusively for abstinence-only approaches to public health 
problems, and I am concerned that we will not hear much about 
them at the hearing today.
    So I urge my colleagues on this committee and in this 
Congress not to let wishful thinking take the place of facts. 
We must listen to experts, not try to pressure them to saying 
what we expect to hear. We must hear the evidence, not be bound 
by preconceived agendas.
    And to do all this well, we must start with the right 
question: How can we reduce the rate of cervical cancer in the 
United States?
    I thank you, Mr. Chairman, for this hearing, and I thank 
the witnesses particularly for coming and participating, and I 
look forward to their testimony.
    [The prepared statement of Hon. Henry A. Waxman follows:]
    [GRAPHIC] [TIFF OMITTED] 96225.011
    
    [GRAPHIC] [TIFF OMITTED] 96225.012
    
    [GRAPHIC] [TIFF OMITTED] 96225.013
    
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    [GRAPHIC] [TIFF OMITTED] 96225.015
    
    Mr. Souder. Thank you.
    Ms. Davis, do you have an opening statement?
    Ms. Davis. Yes, Mr. Chairman. Thank you so much for holding 
this hearing on what I think is a very important issue. And you 
have already stated, as others have, the statistics of the 
number of new cervical cancer cases, and how many women in 
America die from cervical cancer. And I will just tell you that 
the percentage of women dying in Africa with HPV is even higher 
than the percentage here in the United States, where we sent 
condoms over to protect them from AIDS, but don't bother to 
tell them they could die from HPV; and I am really concerned 
about this alarming news.
    And my colleagues have said that CDC has not proven that 
condoms prevent HPV, but they have proven that they might help. 
Well, this is not about a social ideology or a religious 
ideology, it is about informing women, letting them know. And 
to let our young girls and the women think that they are 
protected from these diseases by saying condoms are fine, go 
ahead, use them, when truly the only way they can be protected 
is abstinence, and that is not an ideology, it is a fact. And 
to hear the argument that if we let the American public know 
that condoms don't protect you from HPV, then people will stop 
using condoms, to me that explanation is totally unacceptable. 
We are still putting women at risk because we are not letting 
them know that HPV is a factor, it is a problem.
    And I am looking forward to hearing the testimony of the 
witnesses and trying to get some of the facts, and I really, 
truly appreciate your having this hearing. Thank you, Mr. 
Chairman.
    Mr. Souder. Thank you.
    Ms. Norton, thank you for being here. Would you like to 
make an opening statement?
    Ms. Norton. Thank you, Mr. Chairman, for shedding light on 
an important precursor to cervical cancer. I do want to say to 
my good chairman of the Civil Service Subcommittee, I don't 
think anybody here was making or would make the argument that 
women should not be informed of their risks that HPV bring, as 
well as other risks. My goodness, HPV is very, very common. 
Eighty percent of sexually active people show HPV. Obviously, 
not all HPV leads to cancer, or we would really have a cancer 
epidemic on our hands, but the fact that it is a precursor or 
means that you could get cancer is very important information.
    The CDC report that has been referred to here seems to me 
has made clear that condoms should not be the major strategy 
for preventing HPV infection. That is important information to 
shout from the hilltops. But the CDC report was also clear that 
condoms reduce cervical cancer. So what we have here is what we 
have often in medical science, we have a preventative that 
doesn't prevent everything, and we better tell people about it.
    Let me go on record right now as being for a better condom. 
Perhaps the first thing we ought to be doing is encouraging 
research so you get a condom that people will use and that, in 
fact, prevents HPV. And I say so because we all know that 
condoms are here to stay; they are one of the oldest, one of 
the cheapest, and one of the most effective methods of birth 
control and of disease prevention. That is a fact. They ought 
to be improved, because something so cheap and something so 
generally effective is not going to be wiped out even by 
telling people about the risk of HPV, and certainly not by a 
very important hearing.
    I was impressed with the study that Mr. Waxman referred to 
and my staff had brought to my attention, that the teens who 
pledged to be abstinent showed the same rate of sexually 
transmitted diseases as those who did not. These are teens, in 
good faith, trying to do what is right. Interestingly, one of 
the problems, according to the study, was the so-called 
virginity pledgers were less likely to use condoms. Here we 
come back to abstinence only and to the failure to understand 
what we must do to in fact be where we want to be. All 
children, all children should abstain from sex. And disease is 
only one of a dozen reasons why no child should be engaged in 
sex. This society has failed utterly to make that point, and I 
don't think that anyone believes we will ever be truly 
successful there.
    The other point, of course, is that adults should be 
monogamous. I regret to say we have failed to make that point 
as well.
    With these two giant failures on our hands, we need to talk 
about abstinence, and we need to talk about it clearly so that 
children understand why. That, yes, it is for religious and 
moral reasons; yes, it is for preserving yourself for a mate; 
and, yes, it is for preventing disease, which may have a 
greater effect than some other reasons. But all together the 
information needs to be transmitted.
    But if we are going to have a hearing today on cervical 
cancer, we certainly must say that whether you abstain or not, 
every woman should have a Pap smear. If you want to look at why 
we have reduced the incidents of cervical cancer over the last 
several years, you will turn to the Pap smear. So we have to 
have a range of interests if we are truly interested in 
cervical cancer.
    And I thank you, Mr. Chairman.
    Mr. Souder. Thank you.
    I would now like to ask unanimous consent that all Members 
have 5 legislative days to submit written statements and 
questions for the hearing record, and that any answers to 
written questions provided by the witnesses also be included in 
the witness. Without objection, it is so ordered.
    I also ask unanimous consent that all exhibits, documents, 
and other materials referred to by Members and the witnesses 
may be included in the hearing record, and that all Members be 
permitted to revise and extend their remarks. Without 
objection, it is so ordered.
    Our first panel is composed of our colleague, Dr. Dave 
Weldon, a representative from Florida. Welcome home, former 
member of this subcommittee.
    It is the tradition of this committee to administer an 
oath, but we do not do that for Members of Congress, because we 
already took the oath.
    So you will now be recognized for 5 minutes. Thank you for 
taking the time to join us today.

  STATEMENT OF HON. DAVE WELDON, A REPRESENTATIVE IN CONGRESS 
                   FROM THE STATE OF FLORIDA

    Mr. Weldon. Thank you very much, Mr. Chairman. It is 
certainly a pleasure to be in what was previously, I believe, 
my hearing room when I was on the committee. And thank you very 
much for calling this hearing; it is a very, very important 
subject. And I certainly want to thank the ranking member as 
well, Mr. Cummings.
    Sexually transmitted diseases are one of the most important 
health issues facing our Nation today. According to the CDC, 3 
million new cases of chlamydia, 1 million new cases of herpes, 
5 million cases of trichomoniasis, and 5.5 million new cases of 
HPV occur every year. Unfortunately, women and adolescents seem 
to bear disproportionately the burden in this epidemic.
    Just recently, the Alan Guttmacher Institute's perspective 
on sexual and reproductive health published data demonstrating 
that almost half of all STD infections were among 15 to 24-
year-olds; and HPV, trichomoniasis, and chlamydia accounted for 
88 percent of all these new cases.
    What is worse is that our agencies entrusted to protect 
public health have been slow to act effectively to prevent 
further spread of these costly and harmful infections. After 
over a decade of increases in HPV incidence, the Centers for 
Disease Control and Prevention only just recently determined an 
effective prevention policy for HPV.
    The CDC's recent report states ``Because genital HPV 
infection is most common in men and women who have had multiple 
sexual partners, abstaining from sexual activity (i.e., 
refraining from any genital contact with another individual) is 
the surest way to prevent infection.'' While the CDC is to be 
commended for promoting abstinence as a sure means to avoid HPV 
infection, it has taken a long time for this common sense and 
science-based conclusion to be reached.
    Other agencies have been quick to spend some $6 billion on 
research to advance methods of identifying and treating 
cervical cancer, but little on true primary prevention and risk 
avoidance. I believe this inattention to abstinence as a 
positive public health approach is only a symptom of a larger, 
more troubling phenomenon, a phenomenon that places science 
behind politics and social agendas. That phenomenon I am 
describing promotes the notion that technology can effectively 
mitigate our problems and that individual behavior is fixed-
particularly with respect to sexual activity.
    Doctors like myself are great friends of technology because 
it allows us to help millions who are sick and in need of 
treatment. Technology is good medicine because it aids in 
diagnosis and treatment, and can help reduce risks and costs. 
Nonetheless, technology is still no match to that simple ounce 
of prevention. Eating properly can stave off obesity and all 
its consequences like diabetes and heart disease; not smoking 
can prevent emphysema and lung cancer; and avoiding excessive 
alcohol can prevent liver disease. An equally important message 
today is avoiding sexual promiscuity can prevent not only 
unplanned pregnancies, but a host of incurable diseases, some 
of which lead to cancer and death.
    We have known for years that STDs, including HIV/AIDS and 
HPV, are closely associated with promiscuous sexual behavior, 
but most of our public health approaches have sought to employ 
intervention modalities that reduce the rate of infection 
instead of true preventive strategies. Instead of seeing 
reductions in HIV and AIDS, chlamydia and HPV, we have seen 
significant increases year after year. In fact, after hundreds 
of millions of dollars to eliminate syphilis, an easily 
preventable and treatable infection, we are now seeing syphilis 
incidences on the rise, particularly in many communities where 
specific prevention efforts were implemented. This is because 
we have not been engaging in true prevention; we have, in 
reality, been engaging in risk reduction programs. 
Unfortunately for millions of young people, this has resulted 
in neither prevention nor risk reduction, as the rate of these 
STDs has continued to increase.
    Certainly, as a physician who has practiced full-time for 
15 years before coming to Congress, and who still sees 
patients, I have seen on a personal level the consequences of 
what we are talking about today. The heartache of infertility 
caused by chlamydia scarring of the fallopian tubes, chronic 
recurring cycles of pain from herpes, and even disability and 
death from HIV and from metastatic cervical cancer due to HPV.
    As a policymaker and as a physician, my objective is to see 
fewer STD infections. Currently, the predominant method to 
achieve that objective is clinical. The clinical approach seeks 
to screen and counsel as many people as possible, and to 
provide them with a condom in the hopes of reducing STD 
infections. Certainly, many of these pursuits are worth 
continuing and expanding aggressively.
    However, as a physician, I can only see one patient at a 
time. A much better public health approach, particularly for 
behavioral risks, is to reduce the need for patients to enter 
my office in the first place. That is why education is so 
important.
    My former colleague, Tom Coburn, introduced legislation 
that became law mandating that the CDC and the FDA educate the 
public about the risk of contracting chlamydia and other STDs 
through sexual contact. I have seen little evidence to indicate 
the CDC and the FDA are in compliance with this important law. 
Even in the area of public education, Federal programs are, for 
the most part, doing very little to prevent people from coming 
into my office.
    Mr. Chairman, I believe that we need to continue to 
aggressively promote accurate information to all young people 
and adults on the true efficacy of the condom in preventing the 
transmission of sexually transmitted diseases and, as well, the 
best methods for preventing these diseases in the first place.
    I thank you. I will submit my entire written statement for 
the record, and I would be very happy to field any questions.
    [The prepared statement of Hon. Dave Weldon follows:]
    [GRAPHIC] [TIFF OMITTED] 96225.016
    
    [GRAPHIC] [TIFF OMITTED] 96225.017
    
    [GRAPHIC] [TIFF OMITTED] 96225.018
    
    Mr. Souder. Thank you. I appreciate your comments very 
much. I think it is very important that we aren't defeatists. 
The primary role of this subcommittee is really to work with 
narcotics issues, and clearly in narcotics we work at 
prevention in the schools, we work at interdiction, we work at 
eradication. We have all sorts of things, in addition to 
treatment questions. And if we just said, oh, well, we can't 
stop drug abuse, we better just treat the victims, we would 
have a tremendous problem. And we are seeing the same challenge 
here with HPV.
    We have heard twice referred to in opening statements this 
study that recently came out. Yesterday the New York Times 
reported that most teenagers who pledge to remain abstinent 
until marriage did not keep this pledge. When compared to those 
teens who chose condoms, the teens who took the pledge were 
more likely to delay the age of sexual debut; they were more 
likely to be married at a younger age; they were more likely to 
be virgins when they married. They were also less likely to be 
infected with three STDs that the researchers used as markers. 
I would note that the researchers did not screen the study 
subjects for HPV. Despite the lower STD rates of those who took 
the virginity pledges, as compared to those who chose safe sex, 
opponents of abstinence education claim this study proves that 
abstinence education is a failure.
    Could you comment on these findings and this conclusion 
that we have already heard here this morning?
    Mr. Weldon. Well, let me start out by saying I have not 
seen the study in question. From what I gather, it appears to 
be a followup from an earlier study published by the same 
author, which was looking at 12,000 teenagers and showed a 
significant delay on the onset of sexual activity of 18 months. 
As I understand it, though, based on the numbers he did report, 
there was a reduction in the incidence of sexually transmitted 
diseases in the group that took the pledge. In Whites it was 
2.8 percent versus 3.5 percent; Hispanics, 6.7 percent versus 
8.6 percent; and in the Black community it was 18.1 percent 
versus 20.3 percent.
    Clearly, the trend is a lower incidence, and what I think 
we need here is more research on this subject. But the fact 
that sexual activity was delayed significantly I think should 
not be discounted. Many of the people who are criticizing 
abstinence, I don't think they would recommend that I, as a 
physician, stop telling my patients to stop smoking because it 
is bad for you simply because the majority of them continue to 
smoke. As a matter of fact, in clinical practice it was 
determined that when doctors do that, a certain percentage do 
actually quit; and though it is very small and many doctors get 
discouraged, so they stop telling their patients to stop 
smoking, when you multiply that over hundreds of thousands of 
dollars over the millions of people in this country, the end 
result, and this is what the public health officials concluded, 
you can prevent hundreds of thousands of people from going on 
to develop lung cancer or emphysema, even though the response 
rate was fairly low.
    Now, what I think this study is actually telling us is that 
you need more followup with these young people. But certainly 
to give up on the notion that abstinence works in preventing 
the onset of teen sexual activity, abstinence education, flies 
contrary to what the science is actually telling us. Certainly 
there is some very excellent data on this issue out of Africa 
in Uganda, that you can significantly delay the onset of sexual 
activity through abstinence education programs.
    Mr. Souder. So in effect, if I understand what you are 
saying, if this would be like a high school class took a no 
smoking pledge without background or other types of things, no 
followup with it, you would have some who might actually follow 
through, which is a gain.
    Mr. Weldon. Right.
    Mr. Souder. But you would have some who wouldn't, some who 
might do it less frequently, some who might not change their 
behavior at all. But you certainly gained in two different 
groups from the pledge. What you are saying is the study didn't 
prove any failure of abstinence education, or even of the 
pledge. In fact, the pledge, from their own data, did work, but 
that it didn't work 100 percent. And what that should suggest 
is that a broader abstinence education program might even get 
more results than just a pledge.
    Mr. Weldon. I am not sure I would go as far as what you 
just said. I think the way I would interpret this agrees 
initially with what you said, that some kids will delay the 
onset of sexual activity. The way I interpret this is that more 
research is needed, and if you are going to have an effective 
intervention, you may need to have some kind of significant 
followup from the original pledge.
    Mr. Souder. We certainly find that true in alcohol, 
tobacco, and in other narcotics, that you have to have more 
than just an initial pledge. That would be no surprise.
    Mr. Weldon. Absolutely. Absolutely.
    Mr. Souder. Mr. Cummings.
    Mr. Cummings. Just to piggy-back on what was just said, 
when you say followup, what do you mean?
    Mr. Weldon. Well, I am not intimately expert on the True 
Love Waits, the pledge program, but the researcher that has 
been tracking these kids, he was originally at Columbia and I 
think he is now at Yale, Dr. Berman. He originally published 
some data 3 years ago that showed this was working very, very 
effectively in getting kids to delay the onset of sexual 
activity. And what he did was a very nice followup study which 
showed, yes, they did delay, but if you actually do a 
surveillance study, at least in the three markers that he used, 
you see only a very small reduction in the incidence of these 
diseases in the pledge takers.
    And so my question is does that mean we throw the whole 
concept out the window? And I say no. We need to go back and 
look at is there a way to make the program better, is there a 
way to make the program work better?
    But the other point I was trying to make is if you see a 1 
percent reduction in the incidence of these diseases, if you 
translate that over the entire population of the United States, 
from this study, then you may be getting into hundreds of 
thousands of kids that are avoiding these diseases. So does 
that mean we abandon it? And I would say no. I would say more 
research is badly needed in this, but I think it is certainly 
an accurate statement to be telling these kids that the best 
way to prevent these diseases is through abstaining from sexual 
activity and, in particular, abstaining from having multiple 
sexual partners. The data is actually the more partners you 
have, the more likely you are to acquire these diseases. And 
when you look at the fact that some of the diseases they can 
contract can be fatal, I think it is a message that is 
definitely worth giving our young people, because we are 
telling them the truth.
    Mr. Cummings. Well, I want to go back to something Ms. 
Norton said, because I don't want us to be confused here. I 
don't see that there is anything wrong with saying you should 
abstain. I think the question becomes for that person who does 
not decide to abstain. I have gone into high schools, and I 
remember one time I went to a middle school, and I thought I 
was pretty hip.
    Mr. Weldon. I thought you were too.
    Mr. Cummings. And I was telling these young people that it 
is very difficult to progress when you have a baby on your 
back. And after the thing was over, and this was in middle 
school, some kids came to me and said, Mr. Cummings, we like 
you and everything, but you don't know, but a lot of these 
folks are already involved in sexual activity, and you really 
didn't sound too hip up there. And I continue to say those 
things, but while we may want a certain thing, I think we also 
have to deal with a dose of reality, too, in some other 
instances. And I think that is one of the points Ms. Norton was 
making. And I use the analogy that when my 21-year-old daughter 
was 3 years old, she used to like to play hide and go seek. And 
she would come up to me and she would put her hand up to her 
face, and she would say, daddy, you cannot find me; and she was 
right in front of me. And I think we have to deal with the 
reality that as much as we might like to see our young people 
abstaining, that simply is not always the case, and so then I 
think you then have to say, OK, if they are not abstaining, 
then what advice do you give.
    Mr. Weldon. Well, that is a great question. I think, as a 
policymaker, that should be the purview of local school 
districts, parents, teachers, churches to get engaged on that 
issue. The primary concern that I have had for years is an 
over-aggressive emphasis on a condom as a solution to the 
problem ignores the scientific fact that compliance with condom 
use amongst 15 to 24-year-olds is extremely poor. You can't 
take the condom data based on HIV discordant couples in their 
30's and 40's, where you are talking about one spouse has it, 
one doesn't, where you get compliance rate with condom use at 
99 percent, you cannot take that data and extrapolate it to 
these kids, the ones we are really talking about now, because 
that is when they contact HPV, it smolders for years, and then 
it becomes cervical cancer later in life.
    And so I think you need to give the kids the full message, 
and the full message is that the condom, No. 1, is not a sure 
way to prevent some of these diseases; and the best way to 
prevent all these diseases is through abstinence, understanding 
that a significant number of them will not be able to comply. 
At least we should give them the message.
    Mr. Cummings. Thank you.
    Mr. Souder. Mrs. Davis.
    Mrs. Davis. I think Dr. Weldon just said what I would say. 
It is very disturbing to me that you have 4.6 million of the 9 
million new STD cases were 15 to 24. And, to me, when we send 
the money down to the local schools, or what have you, to make 
the condoms available to these kids, and that is what they are, 
kids, and, yes, reality is they are sexually active, but I 
think we need to, to quote Ms. Norton, we need to yell it from 
the top of the rooftops that these condoms we are sending down 
to you don't protect you. And I don't think we are doing that. 
I think what we are doing is saying, well, you should abstain, 
but just in case you can't, here is the condom. And we don't 
tell them what the possible effects will be using the condom, 
so they have a false sense of security. So I think we are 
sending the wrong message when we use taxpayer dollars to give 
condoms out to these kids and we don't tell them, by the way, 
you are probably going to be dead maybe at age 24 by cervical 
cancer, but we are giving you the condoms, so go do your thing. 
To me, abstinence is the only way.
    Mr. Weldon. If I could just add one more thing. You know, 
this is a social problem that goes beyond sex education. There 
are some dynamics here that we have little or no control over, 
specifically, some of the messages that come through our 
culture, particularly on the television, in the movies, out of 
Hollywood, and the truth is the sexual revolution is a bit of a 
lie in that totally unfettered sexual liberty indeed can lead 
to significant disability and death and poverty, as Mr. 
Cummings was alluding to with the burden of trying to raise a 
child as a single mother. However, we have first amendment 
issues there that run contrary to us trying to constrain those 
kinds of bad messages getting out in our culture.
    Mr. Souder. Would the gentlelady yield to me for a second?
    I wanted to followup with your smoking example. I have 
certainly been to schools where the majority of the kids were 
smoking, and increasing numbers in some schools, particularly 
younger ages and young girls. And I certainly favor more 
treatment for the results of that smoking, but I don't back off 
my message because it is going younger and increasing. I don't 
understand the philosophy that says we should not deliver the 
primary message.
    Mr. Weldon. Well, you are absolutely right. And I haven't 
looked at the more recent data, but as I understand it, smoking 
rates are going down.
    Mr. Souder. Overall.
    Mr. Weldon. Overall. And the incidents of smoking-related 
diseases in some categories, I believe, appears to be trending 
downward. And when you think about it, this is a phenomenon 
that we are finally starting to see based on 30 or 40 years of 
effort in the public health arena, which began with the little 
labels on the cigarette boxes and now employs some very, very 
sophisticated Madison Avenue-type messaging going out to young 
people, a lot of the money for that coming through this tobacco 
settlement.
    I believe if we earnestly apply ourselves, we can turn this 
problem around. Certainly, to turn our back on it and ignore it 
would be a tragedy. And to continue to do what we have been 
doing in the past is equally a tragedy, because the rates are 
going up. And so we need to step back and say what we are doing 
is not working; we need to try something new. And I think the 
abstinence messaging, and if you look at the experience in 
Uganda, where I think you had a very nice national program to 
get out a message of abstinence and you did see a significant 
reduction in at least HIV that was tracked, I think there is 
plenty of reason to continue to pursue this agenda.
    And if you read the news reports on that study that has 
been quoted by some of the people on the minority side, 
published in the New York Times, if you read deep into the 
study, people acknowledge that we need more research on this 
issue, and I think we certainly do. And the people who are 
giving an abstinence message need to really look at this 
research very, very closely and see how they can modify their 
message, expand their message in a way so that it can be more 
effective.
    Mr. Souder. Any further questions?
    Ms. Norton.
    Ms. Norton. You know, there is a developing consensus here, 
I think, that the more people, including young people, know, 
the better off they are. I happen to be really for telling them 
about disease because I think you might frighten them away from 
sex, and particularly since I believe that young people should 
not have sex. Of course, when we are talking about abstinence, 
we better be careful here that we are talking about young 
people, yes, but we are also talking about adults here. And, of 
course, the message of abstain doesn't make a lot of sense in 
today's adult world.
    So if you are telling them that condoms don't work, for 
example, should you also tell them that abstinence doesn't also 
work? Also sometimes doesn't work?
    Mr. Weldon. Well, abstinence is 100 percent effective when 
it is practiced 100 percent of the time.
    Ms. Norton. Yes, the day it is practiced. How about the 
next day when it is not?
    Mr. Weldon. That is a scientific fact. Ms. Norton, I did 
physical exams on elderly women going into nursing homes, and 
maybe this is a different era, who confessed to me that they 
had never had sex in their entire life. People can abstain. It 
is something that actually goes on. It may be totally 
disbelieved by Hollywood.
    Ms. Norton. Well, you are not advocating abstinence for 
adults, are you?
    Mr. Weldon. Well, here is what I really wanted to say. If 
you look at the success in the condom in preventing the 
transmission of diseases like gonorrhea, syphilis, and they 
haven't studied HPV, but the data on gonorrhea and syphilis is 
pretty clear in this age group that we are talking about.
    Ms. Norton. What age group are you talking about, sir?
    Mr. Weldon. Fifteen to 24-year-olds. The efficacy on the 
condom in preventing the transmission of gonorrhea from the man 
to the woman is, I think, about 40 percent or 50 percent; and 
from the woman to the man it is slightly better, 60 percent, in 
that range. And I think the syphilis data is somewhat similar. 
And I don't want to get into the excruciating details of the 
path of physiology of the transmission of these diseases, but I 
think we owe it to young people to tell them those facts, that 
the data on the efficacy of the condom is not 100 percent.
    Now, part of the problem, and this is something else that 
we need to explain to young people, with this issue of how well 
these things work is that it is very hard to get into 100 
percent compliance mode. They will use the condom some of the 
time.
    Ms. Norton. And they will use abstinence some of the time.
    Mr. Weldon. Well, basically, anybody who is engaging in 
being sexually promiscuous is just not being abstinent.
    Ms. Norton. How about having sex once and getting HPV? I 
mean, the notion of calling everybody who falls off the wagon 
for abstinence promiscuous is, I think, an insult to human 
nature. Sometimes people fail. We all fail sometimes.
    Mr. Weldon. I am not doing that. What I am talking about is 
if you look at who gets these diseases, the correlation is the 
increased number of sexual partners you have. OK? As you have 
more sexual partners, you are much more likely to contact HPV, 
HIV, and a whole host of other diseases. And if you are doing 
it without, obviously, the use of any type of contraceptive or 
a condom, the incidence rates go much, much higher.
    Ms. Norton. The notion of letting the information flow is 
something that, particularly on this part of the isle, we have 
been for sometimes meeting, if I may say so, concerns on the 
other side of the isle when business comes and says they don't 
want certain kinds of things on labels. So, indeed, I would 
like to ask you do you think it would be a good thing to put on 
the labels of condoms that it does not prevent HPV?
    Mr. Weldon. Yes, I do. And I think it would also be 
appropriate to put the label that it is not 100 percent 
effective in preventing the transmission of gonorrhea and 
syphilis. That would be another reasonable thing to put on 
there.
    Ms. Norton. You know, I knew that if we kept this up, Mr. 
Weldon, you and I could find our points of agreement. We just 
found it. Thank you very much.
    Mr. Souder. Thank you.
    We have been joined by Congresswoman Sanchez from 
California, and I will yield to her for any statement and 
questions.
    Ms. Sanchez. Thank you very much. I just want to have a 
brief sort of comment, and then I will get ahead to my 
question.
    I think sort of the analogies that are being drawn here, 
between smoking and sex and abstinence, I don't think the 
messages need to be mutually exclusive, either or. I think when 
you arm young people, and there are responsible young people, 
and educate them about abstinence, and if abstinence is 
practiced 100 percent, it is 100 percent effective. However, 
for those who don't practice abstinence, to suggest condom use 
may reduce significantly their chances of contracting a 
sexually transmitted disease, I think that is also valid. It is 
like saying, OK, look, I don't want to buy my kid a motorcycle 
and say go ride the motorcycle, but if my kid is 18, has saved 
up the money and bought the motorcycle, I don't want to just 
say wear a helmet and you will be safer. While that is true, I 
would want my kid, if he or she bought a motorcycle, I would 
want to say, OK, you need a helmet you need to take training 
classes, you need to understand all of the risks involved. And 
I think with condom use, yes, it probably is sporadic among 
kids that are 15 to 24 years old, because they are not given 
all of the information about the proper way to use it and the 
small risks associated with the fact that they can contract 
sexually transmitted diseases through improper use or for 
whatever failures.
    But from everything that I understand, the most important 
risk factor for cervical cancer is not the presence of HPV 
infection, but it is really a failure to receive timely Pap 
screening and followup care. So I am interested in knowing what 
your thoughts are on this, because we seem to have sort of 
focused in on HPV and condom use, but from everything that I 
have read and everything that I have heard, HPV is not the 
biggest determinant of who will ultimately fall victim to 
cervical cancer.
    Mr. Weldon. Well, I am not a gynecologist, I am a general 
internist, and so I only did probably three or four Pap smears 
a day in my clinical practice, where gynecologists, and I think 
you are going to hear from Tom Coburn, did maybe 40 or so a day 
in their clinical practice. And I promoted it in all of my 
patients in the age group at risk, to have it done every year.
    The new findings have been that HPV is the cause of 
cervical cancer, and this has precipitated a tremendous amount 
of discussion within the public health community and at CDC, 
and as well, obviously, in the halls of Congress about primary 
prevention. Because when you are doing Pap smears, you are 
doing surveillance; you are saying we know there are millions 
of women out there who now have this virus, so we are going to 
do surveillance and we are going to catch it early using the 
Pap smear technology, and respond in a way that prevents them 
from developing metastatic cervical cancer and dying early. And 
we need to continue to do that, and we need to continue to do 
that aggressively.
    Mr. Cummings' comments about access to timely health care 
are extremely important. We need to do more in that arena as 
well. But I think it is very, very interesting, can we do more 
in the arena of primary prevention? And what has emerged is 
data that suggests that you do not prevent the transmission of 
this disease by wearing a condom. And when I say disease, I am 
talking about HPV. The condom does appear to lower the 
incidence of cervical cancer in the group of women who are 
affected with HPV.
    So I think what Ms. Norton was referring to, full 
disclosure to young people is the way we really should be 
going, that is the path we should be going down, and telling 
these kids all the facts and not just assuming a posture of, 
well, we can't change behavior, and give them condoms and, 
therefore, we will lower the incidence of these conditions. I 
think we need to go several steps beyond that.
    The message that I have always liked has been the Ugandan 
message, which is try to abstain from sex and be faithful in 
marriage. If you cannot do those things, then, minimally, you 
should wear a condom, even knowing that the condom is not 100 
percent effective for preventing many of these diseases.
    Ms. Sanchez. Might I suggest a radical notion? That perhaps 
those two messages, in addition to you might want to get 
regular Pap smears and screening, could be a three-pronged 
attack toward trying to reduce the overall incidences of 
cervical cancer for many women in this country.
    Mr. Souder. Mr. Ruppersberger.
    Mr. Ruppersberger. Excuse me for not being here. A lot of 
committee hearings today, and after my questions I have to go 
to another committee hearing. I know you understand that.
    Mr. Souder. Right.
    Mr. Ruppersberger. We are on the same side of the isle 
sometimes.
    Mr. Souder. Mr. Ruppersberger, Congressman Weldon has a 
similar problem, so if you could just ask short questions.
    Mr. Ruppersberger. I will be very quick.
    First, and I am not sure whether you can answer this 
question, is the rate of sexual activity or STDs among 
teenagers who have received abstinence-only education lower 
than among teenagers who have received comprehensive sex 
education? Would you be able to answer that question?
    Mr. Weldon. The one thing I can tell you is that the teens 
that received abstinence education appear to delay the onset of 
sexual activity. And so the way you asked me that question, you 
get into the science of how you want to measure what you are 
talking about, and one of the measures that were used in one of 
the studies we were talking about previously, looking years 
later at the prevalence of certain sexually transmitted 
diseases, the difference between the abstinence group and those 
who didn't receive abstinence did not appear to be significant.
    So I am not sure I can answer your question exactly, but it 
is a very well established fact that children who receive an 
abstinence-based education message will delay the onset of 
sexual activity as much as 18 to 24 months, which I think is a 
worthwhile accomplishment.
    Mr. Ruppersberger. Well, it is my understanding the median 
age of marriage for women is 25 years of age, and for men I 
believe is 26, and that 90 percent of Americans are sexually 
active before age 25. Now, with that in mind, is it safe to 
base public health policy on strategies that require behavior 
that is so far outside today's normal cultural norms? And I 
think that is an important question, because we need to cut 
through all our ideological issues, wherever we are, and get to 
the bottom line on how we deal with the issue.
    Mr. Weldon. Yes, I think there is a good rationale for 
providing teenagers an abstinence message, and one of the 
reasons is the female genital tract in teenagers is 
anatomically slightly different than in adults. Teenagers are 
much more prone to complications of sexually transmitted 
diseases, and so to abandon a message for teenagers simply 
because we don't expect adults to fully comply I think is 
misguided.
    Mr. Ruppersberger. Well, I agree with you. I don't debate 
that with you, I agree with you on that.
    Mr. Souder. Thank you very much.
    Thank you for staying and taking the questions this 
morning.
    Mr. Weldon. Pleasure.
    Mr. Souder. If the second panel could come forth. Dr. Ed 
Thompson, Deputy Director for Public Health Services, Center 
for Disease Control and Prevention; Dr. Edward Trimble, 
Gynecologic Oncologist, National Cancer Institute, National 
Institutes of Health. And if you could remain standing as you 
come forward, because we will also do the oath in a minute. Dr. 
Daniel Schultz, Director of the Office of Device Evaluation, 
Center for Devices and Radiologic Health, Food and Drug 
Administration.
    If you would each raise your right hand.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    Well, thank you all for coming to this wonderfully non-
controversial subject.
    Dr. Thompson, we appreciate it, and we will have you give 
your testimony first.

  STATEMENTS OF ED THOMPSON, M.D., DEPUTY DIRECTOR FOR PUBLIC 
 HEALTH SERVICES, CENTERS FOR DISEASE CONTROL AND PREVENTION; 
   EDWARD L. TRIMBLE, M.D., GYNECOLOGIC ONCOLOGIST, NATIONAL 
 CANCER INSTITUTE NATIONAL INSTITUTES OF HEALTH; AND DANIEL G. 
 SCHULTZ, M.D., DIRECTOR, OFFICE OF DEVICE EVALUATION, CENTER 
FOR DEVICES AND RADIOLOGIC HEALTH, FOOD AND DRUG ADMINISTRATION

    Dr. Thompson. Thank you, Mr. Chairman. I am Dr. Ed 
Thompson, Deputy Director for Public Health Services.
    Mr. Souder. I think you are going to have to, just like we 
are struggling with the mics, get as close as you can.
    Dr. Thompson. I will try to swallow it. Here, how about 
that?
    I am the Deputy Director for Public Health Services of the 
Centers for Disease Control in Atlanta. It my privilege to 
represent the CDC here today. I have two goals. One is to 
provide you with information, and the second is as I always do 
at hearings of this sort, I intend to convince you that 
southerners do not speak slowly.
    Members of the committee and Mr. Chairman, we appreciate 
your holding this hearing, and we appreciate the depth of your 
understanding that has been reflected in the comments that you 
have already made about this complex issue. We have little 
additional knowledge to bring to you on this subject, and we 
acknowledge that. All of us are troubled by the number of 
sexually transmitted diseases and infections occurring in this 
country, and this problem is most disturbing when it occurs, as 
it too often does, among America's youth. We are absolutely 
convinced, and it is clear to us, that the first line of 
defense against STDs for this particular population is 
abstaining from sexual activity. We appreciate the committee's 
interest in the health of America's youth, and women in 
particular, and we welcome this opportunity to discuss CDC's 
activities with regard to prevention of cervical cancer and 
human papillomavirus infection.
    As has been clearly noted, although HPV infection is known 
to be associated with a number of diseases, the one of, by far, 
the greatest public health importance is cancer of the uterine 
cervix, for which HPV has a causal relationship. Cervical 
cancer, as has been noted, and as my colleagues from the 
National Cancer Institute can elaborate on, can be prevented 
largely through screening and early detection and treatment of 
precancerous lesions. And when it does occur, with screening 
and early treatment, the success rate of treatment for cervical 
cancer is in excess of 90 percent.
    If you will take note of the chart to my left, this shows, 
in the large bar, which, if it were not cut in half to fit the 
screen, would go above the ceiling of this room. We see the 
number of human papillomavirus infections occurring in American 
women annually in excess of 2 million. And then we see a bar 
representing the number of cervical cancer diagnoses occurring 
each year in this country, and a bar representing, for the year 
for which this chart was prepared, the number of cervical 
cancer deaths. As noted, that number of cervical cancer cases 
is in excess of 10,000, and the number of deaths is 
approximately 4,000.
    Now, the important thing that this chart shows, however, is 
that in spite of the preventability and the treatability of 
cervical cancer, we still have over 10,000 occurrences and 
approximately 4,000 deaths. Even more important, of these 
women, approximately one half have never been screened, and an 
additional 10 percent have not been screened within the last 5 
years.
    If you will look at the next chart that we are putting up 
over here, this shows you information from CDC's behavioral 
risk factor surveillance system, and it indicates clearly that 
as we continue to find that millions of American women still 
are not receiving adequate screening for cervical cancer and 
its precursors, this is the number of women or the percentage 
of American women who have been screened for cervical cancer in 
the last 3 years, and it has not only not reached 100 percent 
by a long shot, it has continued relatively the same over the 
last decade.
    HPV infection is, as has been noted, the most common 
sexually transmitted infection in the United States, and, as 
noted, approximately 20 million Americans are infected at any 
given point in time, and about 5.5 million new infections do 
occur each year.
    As illustrated on the next chart, a recent estimate 
suggests that as many as 80 percent of sexually active American 
women will have developed HPV infection at least at some point 
by the time they reach age 50. And you see that graphically 
depicted here.
    A genital HPV infection is transmitted primarily through 
sexual intercourse, and since it is almost always asymptomatic, 
the usual source of transmission is someone who has no idea he 
or she is infected. The most important risk factor for HPV 
infection is clearly the number of sexual partners. For both 
men and women, the risk of acquiring a genital HPV infection 
generally increases with increasing numbers of lifetime male 
sex partners.
    CDC has been involved in a variety of clinical laboratory 
and epidemiological studies of genital HPV infection for over 
20 years. Public Law 106-554 included new provisions for CDC 
with regard to HPV, and since the enactment of that law we have 
undertaken additional activities. These have included sentinel 
surveillance to determine the prevalence in various age groups 
and populations of specific types of HPV; the collection of 
additional national prevalence and surveillance information 
using CDC's National Health and Nutrition Examination Survey 
[NHANES]; the initiation of several formative research 
activities to assess knowledge and attitudes of the public and 
of HPV-infected individuals about HPV; and the completion of 
formative research to develop a survey to assess knowledge, 
attitudes, and practices of health care providers regarding HPV 
diagnosis and treatment.
    The status of these activities and timeline for this 
completion were outlined in August 2003 in a report to Congress 
titled ``Human Papillomavirus: Surveillance and Prevention 
Research.'' A copy of that report was sent to the committee, 
along with the written testimony we provided to you early this 
week.
    Now, the photograph that you see here shows one of many CDC 
laboratory activities conducted on HPV. CDC has conducted 
laboratory research on clinical outcomes of HPV disease, 
prevalence and risk factors for HPV, biological markers of 
cervical cancer and HPV, and development of sensitive HPV 
diagnostic tools.
    CDC's National Breast and Cervical Cancer Early Detection 
Program provides cancer screening for under-served and 
uninsured women. Approximately one-half of the women receiving 
services through this program are from racial and ethnic 
minority populations. Since its inception, this program has 
identified over 55,000 women with cervical cancer precursors, 
and approximately 1,000 with cervical cancer.
    In January of this year, CDC submitted a report to Congress 
titled ``Prevention of Genital HPV Infect,'' summarizing 
available science and making recommendations about strategies 
to prevent HPV infection and cervical cancer. A copy of that 
report was provided to the committee as well, along with the 
testimony that you have received.
    I can summarize the recommendation from that report if it 
is the committee's pleasure. If not, I would like to thank the 
committee again for this opportunity to describe CDC's 
activities with regard to HPV and cervical cancer, and I am 
prepared to answer any questions the members may have at the 
appropriate time.
    [The prepared statement of Dr. Thompson follows:]
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    Mr. Souder. Thank you very much. You did prove southerners 
can talk really rapidly, but not like we Yankees.
    Dr. Trimble.
    Dr. Trimble. Chairman Souder, on behalf of Dr. Andrew von 
Eschenbach and the National Cancer Institute, we would like to 
thank you for this opportunity to testify on HPV and cervical 
cancer. I am Edward Trimble, an obstetrician-gynecologist and 
gynecologic oncologist working at the National Cancer 
Institute.
    A hundred years ago, cervical cancer was the leading cause 
of cancer deaths among women in the United States. Since the 
identification and adoption of effective screening for cervical 
cancer with the Pap smear, based on our understanding of the 
natural history of precancerous changes in the cervix, we have 
been able to reduce both incident and death rates from cervical 
cancer dramatically in the United States and elsewhere in the 
developed world.
    Over the past century, we have learned much about the 
natural history of cervical neoplasia or abnormal cell growth. 
We have learned that cervical cancer is preceded by 
precancerous changes in the cervix. We have learned that 
treatment of these precancerous changes can prevent the 
development of cancer. We have learned that a Pap smear taken 
from the cervix can identify these precancerous changes. More 
recently, we have identified the human papillomaviruses as the 
major cause of cervical cancer. Studies also suggest that HPVs 
may play a role in cancers of the anus, vulva, vagina, and 
penis, and some cancers of the throat. There are more than 100 
types of HPVs, of which only 30 can be transmitted by sexual 
contact. HPV is one of the most common sexually transmitted 
viruses. Only rarely does an infection with high-risk HPV 
develop into pre-cancer or cancer. The majority of HPV 
infections go away on their own and do not cause any abnormal 
cell growth.
    The NCI has made a strong commitment to understanding the 
causes of cervical cancer and the relationship of HPV viruses 
to the development of cervical cancer. In fiscal year 2003, we 
spent $79 million for research on cervical cancer. We have 
funded extensive research to understand why most adults exposed 
to the HPV virus do not develop cancer or any other health 
problems resulting from that infection. NCI scientists have 
developed a new vaccine approach to prevent infection with HPV 
and are also working to develop a therapeutic vaccine to 
protect women already infected with the virus from developing 
cancer. In addition, NCI has worked extensively to improve the 
reliability of Pap tests, to evaluate new methods of screening 
for cervical cancer, and to combine testing for HPV with Pap 
tests. NCI is also committed to working to improve treatment 
for women diagnosed with cervical cancer. In 1999, we issued a 
clinical announcement to alert women and their doctors of a 
major treatment advance, combining chemotherapy and radiation 
in cervical cancer. NCI investigators are also working to 
preserve fertility in women with early cervical cancer, as well 
as to reserve bladder, bowel, and sexual function after 
treatment for cervical cancer. Finally, we have increased our 
support for research to address the gaps in the delivery of 
treatment research advances to all populations. We are building 
long-term relationships between research institutions and 
community-based programs to learn more about the causes of 
cancer disparities across the United States and develop ways to 
eliminate these disparities. In the future, as part of NCI's 
challenged goal to eliminate the suffering and death due to 
cancer by 2015, we plan to continue our close collaboration 
with our sister agencies, to make available effective vaccines 
for HPV, to reduce the emotional and economic costs of 
screening for cervical cancer, to improve the accuracy of 
screening, and to find more effective treatment for cervical 
cancer.
    My written testimony contains additional details on our 
research program. I would be happy to answer any questions you 
might have.
    [The prepared statement of Dr. Trimble follows:]
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    Mr. Souder. Thank you very much.
    Dr. Schultz.
    Dr. Schultz. Good morning, Mr. Chairman and members of the 
subcommittee. I am Dr. Dan Schultz, Director of the Office of 
Device Evaluation in the Center for Devices and Radiological 
Health at the FDA. I am pleased to speak today about FDA's 
implementation of Public Law 106-554 with respect to the 
labeling of condoms.
    FDA has conducted an extensive literature and labeling 
review. Based on these reviews, we are developing a draft 
guidance document on condom labeling and proposed rule which 
would make the guidance a special control for condoms.
    FDA regulates all medical devices in the United States, 
including condoms. Since 1987, FDA has issued a series of 
guidance documents that addresses specific elements of condom 
labeling related to protection against sexually transmitted 
diseases. The typical condom package contains a front panel on 
the external box that is referred to as the principal display 
panel. Current FDA guidance recommends that the display panel 
of the package for condoms include a statement regarding 
contraception and a statement on STD risk reduction, and that 
labeling emphasize the need for proper use.
    Public Law 106-554, enacted in December 2000, directs the 
Secretary of HHS to determine whether the labels are medically 
accurate regarding the overall effectiveness or lack of 
effectiveness of condoms in preventing sexually transmitted 
diseases, including HPV. Although the interest of this hearing 
targets HPV, we complied with the law by exploring the labeling 
regarding other STDs as well.
    To fully accomplish this task, we conducted a comprehensive 
systematic review of the published literature and other 
relevant information, and are now looking at how the results 
from this review might impact condom labeling. Our basic 
conclusions are as follows.
    One, the protection a condom may provide against different 
STDs will vary depending on the transmission vectors of a 
particular STD, the specific infectivity of the virus or 
bacteria, and the biological mechanisms of progression from 
infection to disease. The law asks particularly about HPV 
infection, which can manifest as lesions, symptomatic or 
asymptomatic, on a man's penis, scrotum, a woman's vulva, 
cervix, or either's peri-anal areas. Because condoms do not 
cover all these areas, they may not provide the same protection 
as they do against STDs transmitted through bodily fluids like 
HIV or gonorrhea.
    Two, condoms are highly effective against HIV and other 
STDs that are transmitted by genital secretions.
    Three, studies on STDs characterized by genital ulcers, 
such as genital herpes and syphilis, are inconclusive as to 
whether condoms lower the risk of these diseases. We believe 
that the condom will provide some measure of protection when it 
covers the lesion or ulcer.
    Four, clinical studies evaluating the relationship between 
condoms and HPV-related disease have not been consistent. 
However, even though the biologic mechanism has not been 
conclusively demonstrated, women whose partners use condoms 
seem to be at reduced risk for genital warts and cervical 
cancer compared to women whose partners do not use condoms. 
Therefore, there does appear to be a benefit from condom use 
for prevention of HPV-related disease.
    As a result of these findings, CDRH has developed a 
regulatory plan to provide condom users with a consistent 
labeling message about STDs and the protection they should 
expect from condom use. FDA is preparing new guidance on condom 
labeling to address these issues. FDA anticipates proposing to 
amend the classification regulations for condoms to make such 
labeling guidance a special control.
    FDA is also committed to helping bring safe and effective 
technologies to the market, including new tests for the 
detection of HPV and improved methods of evaluating Pap tests. 
FDA is reviewing a number of investigational new drug 
applications for vaccines for the prevention of HPV infections, 
several of which are in advanced clinical development. In 
addition to efforts directed at HPV infection, treatment of 
cervical cancer is a very active field for clinical research, 
and several novel technologies are currently being evaluated 
for the treatment of this disease.
    In conclusion, FDA is working to present a balanced view of 
condom performance, being careful neither to overstate 
effectiveness, nor to discourage use where it is appropriate.
    Mr. Chairman, I want to reiterate that FDA is committed to 
monitoring closely the body of scientific evidence related to 
the degree in which male condoms offer any protection from HPV, 
HPV-related disease, and other STDs. We will continue to 
exercise our regulatory responsibilities to ensure accurate, 
clear, and understandable labeling in accordance with the best 
available science. I am happy to answer any questions that you 
may have.
    [The prepared statement of Dr. Schultz follows:]
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    Mr. Souder. Thank you.
    I wanted to start with Dr. Thompson at CDC. Could you put 
the first chart back up again?
    What do you estimate would be the number of women with 
abnormal Pap smears who require invasive treatment? Do you have 
any idea? You have high risk, general infections, the 
diagnosis, but do you have any idea of the number of women with 
abnormal Pap smears who require invasive treatment?
    Dr. Thompson. Certainly. Virtually any woman with an 
abnormal Pap smear certainly requires medical attention. How 
many of those will require invasive treatment versus 
observational treatment and other types of treatment I would 
not be able to speculate on, although there might be some 
knowledge of that with my colleagues from the National Cancer 
Institute.
    Mr. Souder. Do you have any idea of that?
    Dr. Trimble. Our surveillance methods do not capture pre-
invasive disease very well, so our best sources cannot give you 
information.
    Mr. Souder. Obviously, a cancer diagnosis is very severe. 
Part of the question is in how much we stress things related to 
HPV. In the category that I just was referring to, as far as 
invasive treatment, can that be painful, when somebody is doing 
that? In other words, is that something you would rather not 
have, presumably? In other words, we definitely don't want to 
get death, but what I am trying to say here, because this is a 
sexually transmitted disease that many people don't talk about 
or aren't familiar with, and we are looking at cervical cancer 
and you say, well, that is very extreme. But how hard we hit 
prevention is like are there a larger group of people even more 
than 12,000, and 4,000 who are exposed to invasive procedures 
that could in fact be painful, and we don't even know the 
number of them. So we don't even know the scope of the problem 
of what we have to prevent. Because we are not trying to just 
prevent cancer if in fact there are other painful things that 
could be avoided.
    Dr. Thompson. I would not disagree with that at all. The 
important message that the chart is intended to convey is that 
two of those bars should not appear at all. We can prevent 
virtually all cervical cancer, and almost any cervical cancer 
death represents a failure of the system.
    Mr. Souder. But the sole goal isn't to prevent cancer, 
because, while we want to prevent cancer, and obviously saving 
life is a primary, that would be, like I mentioned earlier, 
when we deal with a narcotics issue, is saying our sole goal is 
to prevent overdose deaths of heroin, as opposed to merely 
somebody who beats his wife, has other kinds of problems 
related to heroin. The problem with HPV is beyond just cervical 
cancer, it is a huge problem that we need to address, but it 
has somewhat of a difference here, how we focus on prevention 
as opposed to just treatment. Are those numbers just available 
or you just don't know them?
    Dr. Trimble. We have no national surveillance system for 
capturing the number of Pap smears done each year in the United 
States. The data that Dr. Thompson cited is based on a 
telephone survey, so it was restricted, obviously, to women 
with telephones. So we don't know for sure the number of Pap 
smears done each year in the United States.
    Mr. Souder. So you don't know how many abnormal either?
    Dr. Trimble. We can estimate it based on some large 
samples. We know that, obviously for women who undergo a Pap 
smear, it is an uncomfortable procedure, as I think any woman 
in this room would be able to tell you. Women who are found to 
have an abnormal Pap smear then will undergo a repeat 
gynecological examination and colposcopy, which is 
uncomfortable, and can be painful if biopsies are taken. But I 
can't tell you the number of, let us say, colposcopies done 
each year in the United States; there is no data source for 
that.
    Mr. Souder. Obviously, I have had a number of friends who 
would have preferred not to have gone through that procedure; 
not necessarily related to HPV, but there are other things here 
other than just the final stages that we prefer to avoid if we 
can.
    And given that premise, I also wanted to ask Dr. Thompson, 
how do you see the CDC, then, proceeding with HPV prevention, 
both to avoid the ones you have on the chart and also this 
probably much larger interim group that has precancerous 
lesions and other things that need to be treated?
    Dr. Thompson. Well, we have a number of activities, some of 
which are already underway, and others will be guided now by 
some of the findings that we have made from this new report. I 
think as the report reflects, there is a need to educate 
providers more about some of the things that we have learned in 
this report. There is a need to educate the public to a greater 
degree about human papillomavirus, its relationship to cervical 
cancer, and the fact that it does require a variety of followup 
measures such as Pap smear screening; but, in addition, it can 
be prevented by certain behavioral decisions if the person 
chooses to make those decisions. And we are in the process of, 
in some cases, already reflecting in our documents for the 
public this new information. The other cases we are in the 
process now of gathering information about people's current 
knowledge so we can tailor messages to that current knowledge 
and so we can deliver it in ways that people will understand it 
and take it to heart.
    Mr. Souder. Several members here referred, in a kind of a 
side comment way, to this, and so I wanted to clarify this 
question in a number of ways. The CDC HPV prevention report 
claimed that ``The use of condoms may reduce the risk of 
cervical cancer.'' The first part of this question is how many 
of the studies on HPV showed that there was a possible 
reduction in cervical cancer?
    Dr. Thompson. There were three studies that were 
identified, among the published studies, that addressed this 
particular issue, and of those, if my recollection is correct, 
five identified a reduction in the risk of cervical cancer that 
was associated with consistent condom use, or at least with 
condom use as best it was measured by the survey. Of those 
five, two were statistically significant. So you have some 
statistically significant findings and a definite trend in all 
of the studies.
    Mr. Souder. I missed what you said. There were five?
    Dr. Thompson. I have been corrected, there were nine. And 
of those, seven showed positive results, but only two of those 
were statistically significant.
    Mr. Souder. And when you say statistically significant, at 
what range, minimal significance or very statistically 
significant?
    Dr. Thompson. The typical study value that we use, and I 
can't speak to these in particular, is at the 95 percent 
confidence level.
    Mr. Souder. Ninety-five percent confidence level, which 
would be 5 percent deviation. And then how significant was that 
95 percent? In other words, you are confident that there was a 
statistical differential. Was it like a 1 percent difference or 
two? We heard earlier, when we were talking about the 
abstinence education, that it was statistically significant, 
and it was also a 30 percent differential between those who 
signed the pledge and not. So there are two parts. The 
statistical question is statistically significant; and then now 
that we have granted a statistically significant, was it a 
major, minor?
    Dr. Thompson. How large was the difference itself?
    Mr. Souder. Yes.
    Dr. Thompson. In some cases the difference was small; in 
other cases the difference was relatively large and it showed a 
pretty substantial preventive impact.
    Mr. Souder. OK, if you can give us maybe some followup 
data.
    Dr. Thompson. If you would like the exact numbers, we can 
provide you those in followup.
    Mr. Souder. I just need it for the record.
    Of those who were found, what proportion of the women and 
girls are likely to require treatment for precancerous? You 
don't necessarily have that in those studies or do you have 
that?
    Dr. Thompson. If you would clarify just a little bit what 
you are asking. Of the women in the studies how many required 
additional followup and treatment?
    Mr. Souder. Yes.
    Dr. Thompson. We don't have that information.
    Mr. Souder. You don't have that. That is what we were 
talking about earlier. Is there any evidence that the women who 
use condoms do not develop cervical cancer?
    Dr. Thompson. Yes. In the studies I just referred to, that 
was the end point that was being evaluated, cervical cancer.
    Mr. Souder. And we have already addressed are there other 
threats to that.
    I heard the discussion both in the written testimony and 
your verbal that you are working toward things, but I wanted to 
make sure that it is in the record. I ask it to Dr. Schultz. Is 
there currently an effective vaccine to prevent HPV infection 
or cervical cancer?
    Dr. Schultz. Not to the best of my knowledge. But there may 
be other people who are more able to answer that question.
    Mr. Souder. Dr. Trimble.
    Dr. Trimble. The Merck Corp. has presented the results of a 
phase 3 randomized trial demonstrating that they were able to 
prevent infection with HPV-16. So that was a prophylactic trial 
targeted at one of the subtypes, the subtype which is the most 
common cause of cervical cancer.
    Mr. Souder. So it is being developed, but it is not on the 
market.
    Dr. Trimble. Right. The study has been published. They are 
currently studying a multivalent vaccine targeting additional 
three subtypes to HPV-16, but my understanding is nowhere in 
the world is there an HPV vaccine that is licensed and on the 
market.
    Mr. Souder. How many subtypes are there?
    Dr. Trimble. There are more than 100 subtypes of HPV.
    Mr. Souder. So if this vaccine were effective, it would 
address, potentially, three of them.
    Dr. Trimble. Four, actually. It is HPV-16 and 18, which are 
the most common cancer-causing viruses, as well as 6 and 11, 
which are most commonly associated with genital warts but not 
cancer.
    Mr. Souder. Is there currently a microbicide that is 
available that would prevent transmission of HPV?
    Dr. Trimble. Not to my knowledge.
    Dr. Thompson. There is not one currently licensed for use.
    Mr. Souder. Dr. Schultz, you agree with that?
    Dr. Schultz. I would agree that there is nothing currently 
indicated for the prevention of that disease.
    Mr. Souder. Do you believe condoms provide complete 
protection?
    Dr. Schultz. No, I don't think they provide complete 
protection. I think a lot of people have addressed that 
question, and we would agree that they provide some protection, 
but not complete protection.
    Mr. Souder. Do you agree with that, Dr. Trimble?
    Dr. Trimble. Yes, we concur with the CDC's review of the 
issue.
    Mr. Souder. I was a little confused, and I want to make 
sure because, Dr. Schultz, in your testimony you used 
``appear'' and other things that were less decisive, and my 
understanding from your testimony, our current guidance 
recommends that the package insert for condoms contain the 
following statement: ``If used properly, latex condoms will 
help reduce the risk of transmission of HIV infection and many 
other sexually transmitted diseases, including'' and then you 
list about seven. Does that FDA guidance for condom labeling 
contradict the FDA scientific studies for this reason: that 
earlier you also said that some of the studies on STDs, I think 
it was the statement before that, were inconclusive? So if the 
studies are inconclusive, why would you list some of them as 
far as that it will help?
    Dr. Schultz. I think the answer is that when those 
statements were formulated, we had a certain body of data to 
look at. I think what we have tried to do, again, over the last 
3 years, along with our colleagues in the other agencies, is to 
examine that data more closely, which is why we are currently 
engaged in the effort that we are, to see about ways to improve 
that labeling. So I am not sure I can answer your question any 
better than that, but I think that we believe that the 
statements do have some value. We think that there are better 
ways and more informative ways to provide that information.
    Mr. Souder. Because, at a minimum, anything beyond ``may'' 
seems a pretty big stretch at this point. Would you agree?
    Dr. Schultz. I think that there are some areas where the 
word ``may'' is a stronger may, and then there are some areas 
where the word ``may'' is probably a weaker may. And, again, I 
think that is our goal, is to try to see if we can do a better 
job differentiating between those and providing, again, more 
informative information to the user.
    Mr. Souder. I wanted to clarify for myself; I think Mr. 
Cummings isn't here right now. Did I understand you to say, Dr. 
Thompson, that over 50 percent of the cervical cancer cases 
were minority?
    Dr. Thompson. No. No, what I said, that in CDC's Breast and 
Cervical Cancer Screening Program, which is aimed primarily at 
under-insured and uninsured women, where you will find a lot of 
minorities, that approximately half the women served by that 
program are racial and ethnic minorities. We do not have 
figures, at least at hand, and I am not sure we have them at 
all, as to what percentage of the women found to have cervical 
cancer or cervical cancer precursors in that program are 
minorities and which are not. We can get those figures for you, 
but I would caution that since this is a safety net program, 
meant only to serve those women who have no other source of 
cervical cancer screening, that it is not going to reflect the 
larger U.S. population.
    Mr. Souder. What would be interesting is if a percentage is 
40 percent African-American is the rate of cervical cancer 
higher than 40 percent. In other words, do they have a rate 
proportionate to the number of people being served that are 
disproportionately hitting certain communities, because that 
would suggest where we have to do outreach targeting. Not that 
there wouldn't be a higher incidence in the population as a 
whole, but what is the incidence relation to their proportion 
of the people being screened?
    Dr. Thompson. These figures do exist, and, if you would 
like, we will provide you with those.
    Mr. Souder. I think that would be helpful for the 
committee.
    Dr. Schultz, in the labeling, which is one of the reasons, 
if not the primary reason, we are having this hearing, because 
some of us have been concerned, why has it taken so long? It 
has been nearly 4 years since we first passed legislation in 
Congress; there have been lots of studies coming that we do all 
kinds of labeling things that we put on, and then if additional 
information comes, you might have to adjust it. But there seems 
to be a certain body of information that has been here and it 
has been 4 years since we passed the act. Why has this taken so 
long?
    Dr. Schultz. I think that is a fair question, and I think 
that the best answer that I can give you, Mr. Chairman, is that 
we felt that this was a very important request and something 
that we needed to pay careful attention to. I think what we 
have heard today, and as is included in all of our testimony, 
there have been a number of studies, a number of meetings, a 
number of interactions that have occurred in those 3 years. We 
are certainly committed to looking at this and making the 
requisite changes, but we felt that our first responsibility 
was to attempt to gather the information and do it in a 
systemic and comprehensive way. So I would agree with your 
statement. I think that we have done that now, and our plans 
are to move ahead.
    Mr. Souder. Well, I don't pretend to be as informed on 
these subjects as Dr. Coburn and Dr. Weldon, who were very 
active in this original piece of legislation, though I 
supported their efforts. One does 200 and one may do 4 Pap 
smears. I do zero. So I don't intend to be somebody who is 
expert on it, but I find it frustrating when people are dying 
and many others are going through painful treatments, and 
others are getting diseases they are going to have the rest of 
their life, it takes 4 years to respond, when we have many 
other labeling type requests that also are very complicated, 
that required lots of research, that are very delicate, that 
are politically controversial, but seem to move faster than 4 
years.
    And one thing I would like for our record, you said there 
were meetings, there were different processes. We would like 
that for the record. We are an oversight committee. Part of our 
job is very specific. This committee is supposed to see that 
the laws of Congress are enforced by the executive branch. 
There was a time period that allowed the development of the 
studies, but that, to be generous, would be probably 2 years, 
not 4 years. And we want to see this move forward, but we would 
also like to see the evidence, as we have asked of the last 
administration, when we had lots of conflicts as a Republican. 
But also as a Republican administration, we want to see the 
evidence that the meetings took place, what they were, when 
they were, and why this process is taking so long.
    Would any of you like to hear anything here? Because I am 
going to go vote and then we will be back, and I know Mr. 
Cummings is planning to be back too. Anything you would like to 
add?
    With that, I am going to assume that we are done with this 
panel, and we will move to the panel. If Mr. Cummings, when he 
comes back, has any questions, if you could remain.
    Just a second, let me find out how many votes there are 
before I ask you to do that.
    I think, since he is not here, we are going to go ahead and 
dismiss, because we have three votes, so it will be quite a 
while. Thank you very much for coming. He will submit any 
written questions, Mr. Waxman and any of the other Members who 
do. Thank you for your time.
    [Recess.]
    Mr. Souder. The subcommittee now stands reconvened.
    And if the third panel will come forth, Dr. Tom Coburn, a 
former Member of Congress, from Muskogee, OK; Dr. Freda Bush 
from Jackson, MS; Dr. John Cox from Santa Barbara, CA; Dr. 
Barbara Meeker from Traverse City, MI; Dr. Jonathan Zenilman 
from Baltimore, MD.
    I am going to briefly recess the subcommittee again.
    [Recess.]
    Mr. Souder. The subcommittee is reconvened.
    If you could each stand and raise your right hand.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    I thank you each for coming, and if I can again say for the 
record, in addition to Dr. Coburn from Muskogee, OK; Dr. Bush 
from Jackson, MS; Dr. Cox from Santa Barbara, CA; Dr. Meeker 
from Traverse City, MI; and Dr. Zenilman from Baltimore, MD. We 
thank each of you for coming and participating in our 
discussion today, and we will start with Dr. Coburn.

 STATEMENTS OF TOM A. COBURN, M.D., MUSKOGEE, OK; FREDA BUSH, 
 M.D., FACOG, JACKSON, MS; JOHN THOMAS COX, M.D., SANTA CLARA, 
 CA; MARGARET MEEKER, M.D., TRAVERSE CITY, MI; AND JONATHAN M. 
                 ZENILMAN, M.D., BALTIMORE, MD

    Dr. Coburn. Mr. Chairman, thank you. I need to make some 
corrections. I am not a member of the American Academy of 
Otorhinolaryngology, but the American Academy of 
Otorhinolaryngolic Allergy. And I need to make that correction.
    I am happy to be here. I am going to summarize my testimony 
and ask that my written testimony be made part of the record.
    This is a disease that is very dear to my heart. I have 
delivered in excess of 3,500 babies, close to 4,000. I have 
handled every complication of sexually transmitted disease 
there can be, and there is no question that we have an 
uncontrolled epidemic in this country, worse now than when this 
bill was offered, and it is not being dealt with appropriately 
by the Government and the agencies in regard to that.
    And I want to just describe an 18-year-old girl this last 
month who came in for treatment from me who has had one sexual 
partner. It hasn't been 10 or 15 years since she was exposed to 
this virus, she became sexually active at the age of 16. And 
through her testing and Pap smear, she ended up losing a good 
portion of her cervix to prevent her from having invasive 
cancer. That is not the end of the story, because what in fact 
it will do is decrease her likelihood of ever achieving a 
pregnancy, and, if she does achieve a pregnancy, increase the 
likelihood of pre-term delivery, which the average pre-term 
delivery in this country now costs us as a Nation about 
$200,000. So this disease is not without consequences.
    I think it is also very important that we not just limit it 
to the sexually transmitted disease aspect of it, because there 
is a new study out just this year. Twenty to 25 percent of all 
head and neck cancers now are associated with this virus, can 
be directly associated with exposure of this virus. Rectal 
carcinoma, especially in the gay population, is 100 percent 
attributable to this virus. So there is tremendous costs 
associated with this virus that we need to look at and ask why 
the Government hasn't responded in the way it should in terms 
of prevention.
    And I also interestingly note, and I think this is part of 
the culture that needs to be looked at, when we hear the CDC 
mentioned, we don't ever hear the complete name of the CDC 
mentioned anymore; it is the Center for Disease Control. We 
heard Dr. Thompson, who I have a great deal of respect for, but 
the fact is the Center for Disease Control is not their name. 
It is the Center for Disease Control and Prevention. And 
although they dropped the name of Prevention, in this case they 
dropped that aspect of the responsibility, because they failed 
miserably in terms of the prevention of this disease.
    I also would make a couple comments outside of my written 
testimony. We heard several times today about statistically 
significant reduction in cancer of the cervix associated with 
condoms. There are 20 studies in that. Two may show, and the 
word is ``may''; it is not does, it is not ``is,'' it is not 
``will'', it is may show a reduction. There are 15 that 
statistically say there is no reduction in cervical cancer. So 
it is important to have a balanced look. There are two that may 
show a reduction.
    The other thing that I would say is what Congresswoman 
Norton had to say is right on. We need access for the women in 
this country to make sure they are screened. There is no 
question about that. And there is no question that the minority 
population has the greatest risk for not being screened. Of the 
two cancers of the cervix in my practice in the last 2 years 
who have gone on to die were both minority women who presented 
late with an advanced stage of the disease.
    Finally, I would make a point that the CDC did not address. 
There is over 1.350 million procedures done every year in this 
country for cervical dysplasia, and that ranges all the way 
from just doing a simple microscopic exam with biopsies of the 
uterine cervix, to cryotherapy, to laser surgery, to what we 
call leap electrical excision, to hysterectomy. And those 
aren't even counted in the numbers that the CDC are looking at. 
So the minimum we are spending, the minimum we are spending in 
this country on this disease on a gynecological aspect is $3 
billion. That doesn't have anything to do with all the late 
stage carcinoma of the vulva, which is out there that CDC isn't 
following. Nobody is looking at a young lady who gets treated 
by HPV and then 35 years later ends up with a carcinoma of the 
vulva, of the reproductive system; and nobody has gone back and 
nobody has looked forward to see what that cost is. So if you 
look at the overall cost of what we are paying in terms of 
health care dollars for the lack of prevention for HPV, what we 
see is a cost greater than what HIV is costing this Nation; and 
we ought to talk about it frankly.
    And then the final point that I would make, as my time is 
just about out, is our young people aren't stupid. They may 
make immature decisions, they may make wrong decisions, but to 
say we should not give them every bit of information about this 
disease, and to say that a condom shouldn't be labeled 
appropriately to warn them that this will not protect them, and 
the fact that a condom, in the best hands of an adolescent, 
fails about 13 to 20 percent of the time for pregnancy, so it 
is not a cure-all that we hear so blatantly stated; and in 
terms of sexually transmitted disease it is even less than 
that, of many of the other diseases.
    So I would like to see the committee look at the total 
aspect of this disease, also to follow the public law that I 
authored before I left Congress, and to hold accountable the 
CDC and the FDA. To think that the FDA may not, and I thought 
it was very peculiar. I thought may meant may, I didn't know 
may meant strong or soft or weak. I thought may meant may. And 
the fact is condoms do not offer significant protection against 
this virus, and the packaging ought to label it, because our 
children have a right to know. If they want to make a bad 
decision, they will. And I routinely advise patients in my 
practice that if they are going to be sexually active, and if 
they are going to be outside of monogamous relationships, they 
ought to always use a condom. I am not anti-condom, but I am 
pro-truth and pro-science. And this isn't a bias, this is 
inter-
rupting a health pattern that costs us dearly, impacts lives 
tremendously, and the social and emotional costs of this 
disease cannot be measured.
    And with that I thank you.
    [The prepared statement of Dr. Coburn follows:]
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    Mr. Souder. Thank you very much.
    Dr. Bush.
    Dr. Bush. Thank you, Mr. Chairman, for the opportunity to 
speak here today to this very important issue. I am Dr. Freda 
McKissick Bush from Jackson, MS. I have been practicing 
obstetrics and gynecology for the last 21 years, and I have 
been in women's health for about 35 years helping women to have 
positive childbirth experiences, because I think it is great to 
be a woman, but also helping them make good choices for their 
gynecologic health.
    Through the years, the hidden epidemic of human 
papillomavirus [HPV], has been a challenge to them achieving 
that ideal. HPV is the most prevalent of all viral sexually 
transmitted infections, as we have heard this morning, and it 
is estimated that 5.5 million women are infected by HPV every 
year in the United States, 3.5 million have abnormal Pap 
smears; 13,400 are diagnosed with cervical cancer, and 4,100 
die.
    Of the more than 100 HPV strains identified, around 35 can 
infect the human genital tract. Infection with benign strains 
that do not cause cancer may lead to genital warts, which may 
be associated with itching, burning, or pain. In contrast, most 
infections with cancer-causing strains may have no symptoms at 
all. Unlike non-sexually transmitted viral infections such as 
the common cold, influenza, or measles, that only last a week 
or two, HPV infections can last for months, and occasionally 
for years.
    Recent estimates indicate that 50 to 75 percent of sexually 
active adults are HPV-positive. In general, that puts sexually 
active people at risk for HPV. This includes age at onset of 
sexual activity, at least age, less than 16 years; multiple 
sexual partners; sex with partners who engage in high-risk 
sexual behavior; adolescent and young adult females are 
biologically more susceptible to HPV disease because their 
cervix has not yet matured. So you have younger people getting 
infected and suffering greater consequences because of the 
immaturity of their bodies.
    The incubation period between HPV infection and the 
development of genital warts ranges from 30 days to 9 months. 
These changes resulting from cancer-causing strains are usually 
not visible to the naked eye. Once a person is infected, the 
virus persists for an average of 8 months. Approximately 10 to 
12 percent of women will have persistent infections. The 
persistence of infection has been identified as a significant 
risk factor for the development of cervical dysplasia and 
cancer.
    With current Pap smear screening technology, it is possible 
to sort abnormal specimens into low-and high-risk categories. 
Patients with high-risk types require microscopic evaluation of 
the cervix to identify the abnormal areas so that cervical 
biopsies can be obtained for pathologic evaluation.
    In the United States, more than 50 million Pap smears are 
evaluated annually. The question was asked earlier what does 
this translate into as far as pre-cancerous lesions. According 
to the American Cancer Society, 1.2 million Pap smears have 
low-grade squamous interepithelial lesions; 300,000 have high-
grade lesions. Sadly, 13,400 cases of cancer are diagnosed.
    Approximately two-thirds of males whose female sexual 
partners are diagnosed with cervical dysplasia have microscopic 
HPV lesions of the penis. Infection of the penis or anus with 
high-risk HPV types predisposes these men to cancer of those 
organs.
    Because HPV is a viral infection, no curative treatment is 
available. In 2000, a national panel was convened by NIH to 
investigate condom effectiveness. This panel found that condoms 
do not provide any protection for HPV infection in females, 
although it may reduce the risk for HPV-associated diseases. 
Because genital warts and asymptomatic HPV infection may be 
outside the area covered by a condom, consistent and correct 
condom use leaves a significant chance for transmitting these 
and other sexual diseases.
    Obviously, the best way to prevent transmission of any 
sexually transmitted infection is to abstain from sexual 
intercourse outside a long-term mutually monogamous 
relationship such as marriage. Ad Health, the nationwide 
adolescent health study, found that the best deterrent to 
sexual activity among adolescents involved parental influence, 
moral and religious training, community influences, and 
appropriate peer influences.
    In conclusion, HPV is a preventable disease. You must 
initiate methods to track the incidence and prevalence of 
disease. We must take steps to stop the alarming increase in 
this disease among teens and young adults. We must stop 
promoting methods that are known to have high failure rates in 
preventing HPV transmission, notably the condom, and be honest 
in informing young people about this fact. We must continue to 
emphasize highly effective methods of prevention, namely 
abstinence, whenever possible.
    Thank you, again, for the opportunity to continue to 
promote health.
    Mr. Souder. Thank you. And we will make sure that NIH, FDA, 
and CDC get your number, since they didn't appear to have those 
numbers at a congressional hearing meant to discuss that 
subject, which was a tad frustrating.
    Dr. Bush. Yes, sir.
    Mr. Souder. Dr. Cox.
    Dr. Cox. My name is Tom Cox. I would like to thank you for 
having me here today. I have been a gynecologist for 30 years. 
I am the director of the Women's Clinic at the University of 
California-Santa Barbara. For the last 16 years my primary 
interest has been in studies on the natural history of HPV and 
cervical cancer, and on the best options of prevention of 
cervical cancer, including writing national guidelines for both 
primary screen and management.
    I had the privilege of testifying before the House 
Subcommittee on Health and the Environment on HPV in 1999, and 
at that time I mentioned the tremendous progress this country 
has made in reducing cervical cancer rates as a result of Pap 
screening. In 1949, the year that the Pap screening was 
introduced to this country, the 2004 equivalent of 50,000 cases 
of cervical cancer occurred. This rate is 12,200 this last year 
and is solely, but steadily, declining.
    Since 1999, there has been a real ``sea change'' in 
cervical cancer screening recommendations and in management of 
women with abnormal Pap tests. New recommendations have been 
issued that focus on detection of the cause of cervical cancer, 
and we all know that to be HPV, and not solely on the often 
subjective cervical cellular changes in cytology. Improved 
screening and improved management of abnormal Pap tests, and 
the promise of an effective vaccine against the most important 
of the oncogenic HPV types are moving us toward the eventual 
elimination of cervical cancer. In the near term, better 
targeting of high-risk populations could translate into further 
progress in reducing cervical cancer.
    By high-risk populations, I am referring particularly to 
the majority of women who get cervical cancer who have either 
never had a Pap test or have had one or more Paps, but have not 
had them at recommended intervals. A substantial commitment to 
understanding the reasons for failure to attend screening and 
facilitation of access to health services is necessary in order 
to overcome these barriers. As far as I am concerned, this is 
where our focus today should be, because this is something we 
can truly do something about.
    Cervical cancer not infrequently strikes women of late 
childbearing age, disrupting families and society much more 
than many other cancers that occur with highest frequency in 
the elderly. The fact that cervical cancer can be prevented in 
most circumstances makes these deaths especially tragic. Wise 
investment by Government in a program of cervical cancer 
prevention is, therefore, both morally right and economically 
sound.
    As we have heard repeatedly today, infection with HPV does 
not mean a woman will eventually get cancer. The reality is 
that the vast majority of sexually active Americans will be 
infected with HPV at some point in their lives, but only a 
small proportion of women infected with HPV will see it 
progress to cervical cancer. Most commonly, the immune system 
suppresses or eliminates HPV, usually within 6 to 24 months, 
and although HPV must be present for cervical cancer to 
develop, the converse is not true. The good news is that 
cervical cancer is nearly entirely preventable because the 
progression from pre-cancer to cancer typically takes years or 
even decades, during which time persistent infections leading 
to pre-cancer can be detected by Pap screening or HPV testing, 
and subsequently treated.
    So given the complexities of the HPV-cervical cancer link, 
what are the appropriate public health messages? I would argue 
that policymakers and public health practitioners have an 
obligation to be both realistic and pragmatic. The median age 
for marriage in the United States continues to rise for both 
men and women. By 2000, the median age for first marriage was 
25 years for women and 27 years for men. The median age of 
puberty is 13. Throughout history, virginity, at least for 
women, until marriage has been secured primarily by either very 
early marriage of women, soon after puberty, or by sequestering 
women in strictly controlled separation of sexes until 
marriage. Neither option would be acceptable in this country; 
hence, 90 percent of Americans engage in sex prior to marriage. 
So although abstinence messages for young people make good 
sense, abstinence until marriage as the sole message is 
irresponsible.
    I would urge those individuals influential in making public 
policy to avoid fear-based messages that overstate the risk of 
HPV and understate the protection provided by condoms, 
particularly for other STDs, particularly for HIV. Disparaging 
condoms threatens to undermine the tremendous progress that we 
have made in lowering teen pregnancy rates and in reducing the 
risk of transmission of far deadlier STDs such as HIV. Instead, 
the most helpful public health message for the prevention of 
cervical cancer is to encourage women to get appropriate 
screening and recommended followup care.
    Again, thank you for the opportunity to address these 
issues. I firmly believe that the war against HPV and cervical 
cancer can and will be won in my lifetime, but it will not be 
won by hyperbole, but rather by providing the best protective 
cervical screening available for all women and by providing HPV 
vaccines to all children once these vaccines become available.
    My written testimony contains additional details. I would 
be pleased to answer any questions that you may have.
    [The prepared statement of Dr. Cox follows:]
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    Mr. Souder. Thank you.
    Dr. Meeker.
    Dr. Meeker. Thank you.
    My name is Meg Meeker, and I am a physician of child and 
adolescent medicine. I have been practicing adolescent medicine 
in Michigan for about 20 years. So I represent a population of 
patients very dear to my heart, that is the children in 
America.
    I am grateful to have the opportunity to speak to you on 
behalf of my own patients and the 35 million teenagers across 
the United States. For about 20 years I have taken care of 
thousands of teens, I have authored two books on teen health 
issues, and currently speak across the country on teen health 
issues. I am a fellow of the American Academy of Pediatrics and 
certified by the American Board of Pediatrics.
    Ladies and gentlemen, the epidemic of sexually transmitted 
diseases among our youth in the United States today is sobering 
and poorly recognized by the public at large. This year, in 
2004, 10 million teenagers and young adults under the age of 25 
will contract a new sexually transmitted disease. That 
translates into approximately 8,000 teenagers in the United 
States every day contracting a new sexually transmitted 
disease. Human papillomavirus, as you are hearing, outnumbers 
all other sexually transmitted infections among our youth and 
costs our country billions of dollars yearly because it wreaks 
havoc in the genital tracks of, may I say it again, teen girls 
and very young women.
    We are here to discuss prevention of HPV infections and 
cervical cancer. If I might for a moment, let me permit you 
behind closed doors that physicians like myself see every 
single day. Fifteen years ago I rarely saw abnormal Pap smears 
in young girls; 10 years I personally witnessed a dramatic rise 
in the frequency of abnormal Pap smears among my own patient 
population of young teenage girls, many of those as young as 
13; and 4 years ago I had to break the news to one of my young 
patients, we will call her Amy, just before her 14th birthday 
that, no, she didn't have full-blown cervical cancer, she had 
the milder form of severe dysplasia, but needed cervical 
surgery nonetheless. She had her surgery, 3 months afterwards 
returned to my practice with signs of very serious depression. 
The morbidity, not just the mortality, but the morbidity of 
this disease among young women is tremendous.
    Cervical cancer is a young women's disease and deserves our 
strongest efforts at real and aggressive prevention, not just 
medical management of the cure, that giving an increased number 
of Pap smears to young girls will afford. That is very 
important, but that is medical management of a disease, it is 
not a primary strategy of prevention of the cervical cancer. So 
what can we do to truly prevent human papillomavirus infections 
and cervical cancer in our young women in America?
    We could more aggressively train our children to use 
condoms during sexual intercourse. There are, however, serious 
drawbacks to this approach. The scientific data, and may I say 
from the National Institutes of Health condom effectiveness 
report shows that there is insufficient evidence of any risk 
reduction for sexual transmission of human papillomavirus even 
with 100 percent condom use, which I might add, among youth 
doesn't happen. The primary reason for this, and no one has 
discussed this, is that HPV is not transmitted like HIV, which 
is transmitted through bodily fluids; it is transmitted from 
skin to skin. And even the best condom available out there only 
covers a certain portion of the skin. So unless we make condoms 
a lot larger, it is very difficult, with condoms alone, to 
prevent the transmission of the cervical cancer-causing agent 
human papillomavirus.
    Second, we could increase screening for cervical cancer. 
While increased screening is very important, and I might add 
does not take place in the most at-risk population, and that is 
children, whom I represent, and I am one of the few 
pediatricians who does gynecology in my practice, I might add, 
while that is very important, it is a secondary, not a primary 
strategy for prevention of the disease. At the time of 
screening, many women may have already become infected and show 
signs of dysplasia or even more advanced cancer. Screening 
detects HPV infections, it does not prevent them from 
occurring. The only way to prevent infections and subsequent 
sequela in our young girls is to teach them the only way to 
avoid infection, as Dr. Gerberding's report shows from the CDC, 
is to abstain from sexual activity during the teen years, the 
high-risk years.
    Distinguished Members of Congress, we are indeed living in 
schizophrenic times. Every day our children are bombarded with 
sexual messages from the entertainment industries and 
multimillion dollar corporations aggressively marketing sex to 
them from the age of about 8 years old on. I believe, 
personally, that these messages have a profound effect on their 
sexual behavior. Teens have begun sexual activity at younger 
and younger ages, and have dramatically increased the number of 
sexual partners in recent years. They come to their physician's 
offices and then we, and I speak for the thousands of doctors 
who, across the country, work fervently to deflect the damage 
done to their young bodies, just to their bodies from sexual 
activity. Daily we ``mop up the messes,'' if you will, of too 
much sex too soon.
    We have become overwhelmed and discouraged because the 
bottom line is that sexual activity among our youth is out of 
control. The best medical data on sexually transmitted 
infections in teens teaches us that there is two successful 
ways to drive down the STD epidemic of teens in our country: 
One, delay the onset of sexual debut and two, drive down the 
numbers of sexual partners.
    If we commit to help our young women accomplish these two 
goals, then we offer the best medical care available to prevent 
cervical cancer. We physicians cannot fight the uphill battle 
of rising HPV infections in younger women and out-of-control 
teen sexual activity alone; we need your help in sending clear 
and loud messages to our communities and to our youth that 
sexual activity in teenagers, with or without condoms, is very 
high-risk behavior.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Dr. Meeker follows:]
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    Mr. Souder. Thank you.
    Dr. Zenilman, you will be our cleanup hitter.
    Dr. Zenilman. With a name starting in Z, I am used to being 
at the end.
    Mr. Souder. I can imagine. Except for those rare days when 
they reversed the order, those wonderful days.
    Dr. Zenilman. Good afternoon. Thank you for having me. My 
name is Jonathan Zenilman. I am professor of medicine at the 
Johns Hopkins University School of Medicine and chief of 
infectious diseases at Johns Hopkins Bayview Medical Center. My 
area of research and clinical expertise for the past 18 years 
has been in sexually transmitted infections. I am also the 
president of the American STD Association, representing 450 
academic and public health researchers in this area; and also I 
am a practicing physician and take care of patients with 
reproductive tract infections at the Baltimore City Health 
Department and in my own academic practice at Bayview Medical 
Center.
    More important, I am the proud father of three teenagers, 
one of whom, Aliza Zenilman, with her friend, Mandy Millman, is 
here with us today in the second row sitting behind me. I thank 
the committee for extending your warm welcome to her and her 
friend today.
    I address this committee as a private individual, a 
physician, as a public health practitioner, and as a father who 
gives patients the advice that I give my own children.
    We are hearing and have heard today that HPV infection is 
almost always asymptomatic and is extremely common. I will 
therefore limit my comments to highlight issues which have not 
been already addressed by the previous witnesses.
    Some strains, as you know, of HPV are associated with the 
development of cancer. Recent studies we have performed in a 
Hopkins suburban clinic in Baltimore, supported by the CDC 
Sentinel Surveillance Grant previously mentioned, found that 
the proportion of women infected with high-risk HPV types is 14 
percent higher in persons of color and persons with HIV or 
those at risk for other reproductive tract infections. 
Extrapolating from these and other data, I would estimate that 
approximately 1 in 6 to 7 individuals sitting in this room is 
currently infected with a high-risk HPV type. Let me say, 
however, and emphasize that Pap smears, which have already been 
previously testified to as the major control strategy, are 
actually a screening test for a cancer that is caused by a 
sexually transmitted viral infection.
    In terms of primary prevention of HPV and other STDs, we 
try to give our adolescents and young adults a moral compass 
that will help them in making informed choices regarding their 
sexual health. A British colleague of mine once said, ``The 
most effective contraceptive is ambition,'' which requires us 
as a Nation to provide an environment of educational and 
economic opportunity, as well as positive recreational outlets 
for our young people.
    Effective prevention of risky sexual behavior and their 
consequences, teenage pregnancy and sexually transmitted 
infections, requires two critical components: one, accurate 
based science-based information on reproductive health and 
prevention of infection and pregnancy, and two, a social peer 
and family environment that promotes responsible 
decisionmaking, allowing teens to make an informed choice. 
Unfortunately, many teenagers do not have both of those 
criteria.
    Delaying sexual intercourse is a public health message that 
I and all reproductive health professionals support, in tandem 
with counseling on responsible sexual behavior. An abstinence-
only approach which excludes safer sex messages and includes 
messages that emphasize intercourse only within the context of 
marriage, is therefore clearly out of touch with the realities 
and practices of the vast majority of Americans. We are 
performing a disservice by focusing only an abstinence-only 
approach.
    Condoms are highly effective in preventing sexually 
transmitted infections, including genital herpes and HIV 
infection. In the latter case, condom use is life-saving. In 
communities where condom use has been universally adopted and 
supported, dramatic and striking decreases in overall STD and 
HIV infection rates have been observed.
    As a parent, I want public policies that are reality-based 
and provide the resources necessary for my children, along with 
my patients, to protect themselves. I want them to have access 
to medically accurate sexuality education. I want to see 
support for research efforts to develop and make vaccines and 
other prevention interventions.
    Unfortunately, the debate on human sexuality, sexual 
behavior, and STDs is all too often framed in an absolutist 
stark context in which only simplistic solutions are framed to 
address inherently complex behavioral and social questions. 
This is not a new phenomenon. More than 60 years ago, Dr. 
Thomas Turner was a colonel in the U.S. Army during World War 
II and was in charge of venereal disease control effort for 14 
million servicemen and women. He was later to serve as dean of 
the Johns Hopkins Medical School and died in 2002 at the age of 
100. I had the privilege of getting to know Dr. Turner in the 
late years of his life.
    As a sidebar, if you are a venereologist, you may live to 
be a long age.
    During World War II, Dr. Turner and the Army were faced 
with the same dilemma we now see facing as this Nation develops 
policies and practices. As only he could, he described the 
difficulty in providing expedient and simplistic approaches. 
``If a soldier remained continent, he would not acquire 
venereal disease. Many did remain continent, but no one in his 
right mind would expect this of a high percentage of men in 
their most vigorous and disorganized years. The first paradox, 
therefore, was preaching continence as an official doctrine, 
while simultaneously providing instructions and facilities for 
prevention of disease during and after sexual intercourse. We 
were repeatedly impaled on the horns of this dilemma. Some 
worthy folk urged a firm stand on a high moral plane; otherwise 
accused us of crass hypocrisy.''
    Dr. Turner held steadfast in pursuing a pragmatic solution, 
and I implore you to follow Dr. Turner's lead in approaching 
today's STD problem. Thank you.
    [The prepared statement of Dr. Zenilman follows:]
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    Mr. Souder. One of the things I wanted to clear up at the 
beginning, I understood from our earlier panel, and I thought I 
heard at least alluded to by several of you, that up to 80 
percent of Americans would get HPV sometime during their 
lifetime. Does everybody agree with that?
    [Panel members indicate in the affirmative.]
    Mr. Souder. Then why I was confused, Dr. Cox, is you said 
we shouldn't be alarmists. Eighty percent is a pretty high 
number.
    Dr. Cox. Well, I didn't say that we shouldn't be alarmed. 
What I was saying is that we shouldn't overstate the risk.
    Mr. Souder. But 80 percent? So you are not talking about 
overstating the risk of people getting HPV.
    Dr. Cox. Overstating the risk of what you get from HPV.
    Mr. Souder. The cancer part.
    Dr. Cox. Right. That is correct.
    Mr. Souder. But not invasive procedures?
    Dr. Cox. I think we all have the same goals, and I would 
agree with Dr. Meeker here, that we all want to try to 
encourage young people to delay intercourse as long as they 
possibly can, and give them the health reasons for that. There 
is no question that is a real positive. We all foster that. The 
only difference amongst the four or five of us up at this table 
is the fact that some of us believe that only abstinence should 
be taught in school, and that would protect individuals from 
starting intercourse too early, and others of us feel that you 
have to be more balanced.
    Mr. Souder. I don't believe that. I believe that is an 
inaccurate statement, for the record. You have broader 
disagreements than that, and I am going to explore some of 
those disagreements.
    Dr. Cox. OK.
    Mr. Souder. I agree that is one of the differences of 
opinions.
    First, some have claimed that you can provide medically 
accurate labels on condoms, and that this would discourage 
condom use. Do you believe that condom use would be less if 
things were accurately labeled?
    Dr. Coburn, do you believe if we put a label on that gave 
accurate information, which, by the way, could be argued by 
putting accurate information as a doctor, any of you want to do 
this, we face this problem. Let me ask a general labeling 
question. You were both a doctor and a legislator, and on the 
Energy and Commerce Health Committee. When we said that certain 
things that address diseases or health problems, when they run 
advertising, they have to have warnings on TV, and that they 
have to accurately address what the product does, what was the 
discussion about let us don't accurately label versus they 
might not use that drug? How does this process work, and how do 
we balance that as legislators? And you both being a legislator 
and a doctor, could you talk about how we sort this through? 
Does accurate labeling discourage usage? And what if somebody 
could have used that medication, but we said it might have side 
benefits, so they don't use the medication?
    Dr. Coburn. Well, let me preface it first. Anybody that is 
going to be sexually active in our society today who is going 
to be sexually active, ought to wear a condom. OK? Period. 
Because it will reduce the risk. The difference is saying that 
we don't want to tell people the truth because if we give them 
too much information they might make a bad choice undermines 
the whole basis under which we run our society. And if you 
carry that a little further, the logical conclusion is that if 
you tell everybody to wear a condom and don't tell them 
anything, then why would they ever come get a Pap smear, 
because a condom protects them? So you can't be on both sides 
of the logical argument.
    The fact is we need as a policy, a national policy, that we 
ought to be truthful about the risks of STDs. We shouldn't be 
alarmists, but we should be truthful, and we should trust our 
children to make good choices, and we ought to have leadership. 
And what we don't have in this country today is leadership on 
this issue. You have not heard the surgeon general talk about 
the No. 1 STD in this country and the fact that it relates to 
at least 1.350 million procedures every year, that it costs at 
least $3 billion, and that we could make a difference on. And 
it is not about condoms or non-condoms; it is not about 
abstinence versus non-abstinence. The fact is that we ought to 
teach our kids to give them the best medical advice, and then 
if they choose to not use that best medical advice, if they use 
a device that will help lower their risk, then it ought to be 
labeled accurately.
    And I would take exception. I am head of the President's 
Advisory Commission on HIV/AIDS. We have not lowered HIV 
infection in this country. We have as many or more new HIV 
infections in this country as we had 10 years ago. We have 
failed miserably. We have spent billions of dollars on this 
message. We have a higher rate of STDs today than we have ever 
had; we have a higher rate of HIV infection than we have had; 
we are spending more to treat. So we have sent the message, and 
if we applied the same thing to cigarette smokers, well, our 
society is going to smoke cigarettes and we can't change the 
culture, leadership is about changing the culture, because it 
will pay us big dividends both in health and social and 
emotional aspects of how we interrelate to each other.
    So I think we ought to see a label that is accurate. It 
shouldn't be inflammatory, it should just be scientifically 
accurate, and there shouldn't be anything wrong with it. But it 
ought to be accurate not just about HPV, it ought to be 
accurate about chlamydia, because the studies on chlamydia 
aren't very good, when we are wanting to protect young women 
from chlamydia.
    Mr. Souder. Is there anybody here who opposes more accurate 
labeling on the condoms?
    Dr. Cox. My basic concern about labeling the condom as not 
being an adequate protection from HPV is just you have to cram 
everything on a condom label in such a small area. I am very 
concerned about the mixed messages that individuals might get 
because HPV sounds like HIV, like HSV, like HBV. All these 
other STDs sound similar, so I am concerned that there might be 
decreased use on that basis. I would rather see a label that 
said something like properly used condoms significantly protect 
against some, but not all, STDs. I just get concerned about the 
message when you try to put one single STD on there, and how it 
might be mixed up with others.
    Mr. Souder. Do you believe that other warnings that we have 
on other medicines and medications also can discourage usage, 
and would you favor not labeling them because people might not 
use them?
    Dr. Cox. Personally, I don't quite make the connection 
between those issues, but, yes, I know some people don't take 
medicines because they worry about the warnings we put out on 
medicines.
    Mr. Souder. So would you recommend we label them less 
accurately?
    Dr. Cox. No, I am not recommending that at all. I am just 
saying that I am concerned about the mixed messages individuals 
may get not his.
    Mr. Souder. But, see, the double standard, and this is what 
bothers some of us. We are not arguing about whether we should 
fund Pap smears, we are not arguing about whether we shouldn't 
do more treatment questions, look at at-risk populations. We 
have a specific piece of legislation that says accurate 
labeling, and there are several parts of this that we are going 
to pursue, but, first, most of the Democratic Members who were 
here earlier seem to support accurate labeling. Now, we can 
argue what is accurate, but that in the accurate labeling 
problem here is why we should have warnings. And as Dr. Coburn 
just mentioned the Surgeon General not speaking about this, 
what some of us are wondering, and this is our challenge, is 
are people not speaking up about this problem because they have 
other agendas? Are they blocking warning labels here, where we 
seem to be putting warning labels on all kinds of things, 
because they have other agendas and they are uncomfortable with 
what seems to be the most effective things?
    For example, we have heard multiple times, I know I have 
raised other types of issues, but in smoking we don't give Dr. 
Zenilman used the word ``inherently simplistic messages.'' Our 
messages against smoking are inherently simplistic, and the 
billboards that we see up are very simplistic. Let me just say 
flat out the data under ``Just Say No'' were more effective 
than they were when we gave more inherently complicated 
messages. We can argue whether there were other things going 
on, but the plain fact of the matter is inherently simplistic 
messages move a certain percentage of the population and that, 
in fact other patterns, also to take the quote from Dr. Turner, 
at that time the military was also providing cigarettes to 
people because they believed people couldn't have their 
behavior changed.
    In fact, behavior changed. And if there is something like 
high-risk sexual behavior, that is causing the amount of 
problems that we have in the United States, whether it is HPV, 
HIV and other things, why wouldn't our primary aggressive 
prevention strategy be abstention. And then acknowledge, as Dr. 
Coburn just did, look, if you are going to engage in high-risk 
behavior, make sure it is absolutely clear that it is high-risk 
behavior, it shouldn't be followed. But if you do, here is what 
you have to do, and then if you have done that high-risk 
behavior, we need to treat you and take care of you.
    I don't understand where the resistance is to acknowledge 
that it is aggressively high-risk behavior and needs to be 
reversed. I don't understand the resistance to this. To just 
say, oh, well, it is happening; therefore, we have to not be 
aggressive in our response. We are aggressive on date rape. It 
is happening all the time; it is probably increasing. But we 
don't not speak out against date rape. We have sexual 
harassment as a huge problem in our society, possibly 
increasing, but we don't not speak out against it because it 
seems to be something many people do. I don't understand the 
fatalism that I am hearing.
    Dr. Zenilman. You asked, actually, quite a complex 
question, so I will try to distill it down.
    I don't think we can compare date rape or sexual harassment 
to consensual sexual intercourse between teenagers or young 
adults.
    Mr. Souder. But the consequences of teen pregnancy, out of 
wedlock, not finishing school, teen suicides, lack of stability 
in marriage over long-term, kids having multiple higher rates 
of different problems, sexually transmitted diseases. How can 
you say that there aren't those extreme consequences to out-of-
wedlock pregnancy in our society, and sexual activity, which is 
directly related to that?
    Dr. Zenilman. In reference to the specific, I think that is 
why this is actually an inherently complex issue. First of all, 
in the 1940's, the Army did not recognize that cigarettes were 
a problem. The military and the VA have taken cigarettes out of 
at least onsite consumption or purchase, which was actually a 
direct issue.
    I would argue that this is a much more complex behavioral 
issue than cigarette smoking. And, furthermore, I am in 
agreement with you. I am in agreement with the other members of 
the panel that our major objective should be to delay onset of 
sexual intercourse. I think you have heard unanimity from all 
of the witnesses on this specific issue.
    Mr. Souder. That should be our primary prevention strategy?
    Dr. Zenilman. I think that should be the major focus.
    Mr. Souder. It should be the major focus, the primary 
preventions strategy?
    Dr. Zenilman. It should be the major goal in adolescent 
sexual health. But on the other hand, and you may call it 
fatalistic, I may call it realistic, recognizing that most 
people, the vast majority of Americans are not going to follow 
that advice. So, therefore, in the context of a public health 
reality, our objective is to minimize the risk to individuals 
who are engaging in sexual behavior.
    Now, I would also argue that I don't like the context of 
intercourse in teenagers having consensual intercourse or 
adults having sexual intercourse is not the same as a date rape 
or sexual harassment. The latter has a lot more of the 
consequences that you mentioned previously.
    Mr. Souder. I don't think this data backs that statement 
up. I believe they are awful and I have worked with them, but 
you are not going to argue here that out-of-wedlock pregnancy 
and related things are less damaging overall to a life's career 
than somebody who has been sexually harassed, which, by the 
way, may also occur in the teen pregnancy and the out-of-
wedlock or non-married sexual activity.
    Dr. Zenilman. A consensual adult who is actually having 
sexual relations and is properly informed will be 
contracepting.
    Mr. Souder. This isn't really a debate, and I am sorry I 
got us off into that. We have a substantial disagreement.
    Let me go next to the female physicians on our panel. Some 
have downplayed the threat of HPV infection by suggesting 
routine tests and, if necessary, treatment can prevent the 
development of cervical cancer. Can you describe the treatment 
that a woman would undergo for abnormal cell changes? Dr. Bush, 
maybe you can start with this, because you referred to this 
high number. Is cervical cancer or HPV related dysplasia easily 
treated? And what are some of the side effects of the 
treatment?
    Dr. Bush. Basically, we encourage women, once they have 
initiated sexual activity, to begin getting routine annual Pap 
smears. The reason we are screening is because HPV is the 
leading cause of cervical cancer, and it can be detected with 
the Pap smear. So as someone said, HPV causes cervical cancer 
and it is a preventable disease.
    When the women has an abnormal Pap smear, they can be 
graded into high grade or in low grade or atypia. When a low-
grade atypia is found, we may simply repeat the Pap smear 
because a significant number will spontaneously, because of 
their immune system, get rid of it. But with persistence, and 
that is the problem, 10 to 12 percent of people will have 
persistent infection and it will not go away, and that is 
associated with the high incidence of cervical cancer. If it is 
a high-grade lesion, which goes from moderate to severe 
dysplasia to carcinoma incite two, they are more likely to 
progress to cancer, and often it does not take 10 to 15 years. 
As Dr. Coburn mentioned someone in his practice, I could 
mention someone in my practice who actually initiated sex after 
age 16, and at 19, very recently, I had to do a leap procedure 
because of persistent infection.
    What happens is we do a colposcopy, which takes a 
microscope, looks at the cells, we biopsy and take a chunk of 
the tissue, send it to the lab, let them tell us if the Pap 
smear was accurate or how far it has; sometimes it is less, 
sometimes more. With persistent of the infection confirmed by 
the biopsy results, then you have to remove those cells so that 
they do not progress. Removing means cryosurgery to kill them, 
it means an electrical surgical loop procedure to remove the 
cells, it may mean colonization, which is an outpatient 
surgical procedure surgical procedure, and it does cause pain; 
you have to give anesthesia, analgesia for the removal of that 
tissue, it means that you put the lady at risk whether she 
becomes pregnant, when she becomes pregnant in the future, not 
only the risk of premature delivery, but also perhaps stenotic 
cervix, that she would have to have cesarian section, that her 
cervix hadn't opened.
    To make a long answer short, there is significant morbidity 
that is associated with an abnormal Pap smear. Persistence of 
the infection does progress to cervical cancer, and we are 
talking about 10 to 12 percent of people that have persistence.
    Mr. Souder. Dr. Meeker, the New York Times, you heard us 
refer in the first panel when you were here, to this study that 
we have been kicking around among the members, that a majority 
of high school teens are virgins, according to the latest CDC 
data. This is a reversal from a decade ago. As a pediatrician, 
do you think abstinence is a realistic approach to trying to 
stop STDs among kids?
    Dr. Meeker. Well, I know it is, because I want to remind 
everybody that the epidemic of diseases that we are seeing 
amongst our youth now weren't here 40, 50, 60, 70 years ago, 
even as recently as 30 years ago. And I would ask have we 
fundamentally, as human beings, changed? No. I mean, our 
physiology is the same. What has changed is the direct 
marketing to our younger and younger children sexually 
promiscuous advertisements and so on and so forth.
    What also has changed is the increase in the number of 
sexual partners that teenagers have and the earlier onset of 
sexual activity, and that is what has increased the number of 
STDs. So children, teenagers, the majority of teenagers will 
take their cues from significant adults in their life. The Ad 
Health study shows that. If it is communicated to teenagers, 
expectations about sexual activity from an authority figure in 
their life, teenager or a parent, the majority of teenagers 
will follow that and they will abstain from sexual activity.
    I think there are some very significant and very serious 
misunderstandings about abstinence-only education, if I might. 
There is a sense that those promoting abstinence-only education 
are trying to withhold information. That is absolutely not 
true. What we are trying to do is just teach kids what the very 
real risks are to condom use. No one in this panel would tell a 
kid not to use a condom, and we are all willing to say that 
there is a role in condom use, but our money needs to be and 
our efforts need to be in teaching kids about abstinence. 
Everybody here is saying that we need to communicate messages 
to our kids that will change their behavior, so some say we 
need to encourage them to use condoms more frequently and 
better, or our other alternative is to teach them not to be 
sexually active. Either way, all of us are asking our kids to 
change their behavior.
    We know how well teaching teens about condoms has worked; 
we have the data. And the data shows us that condom use has 
increased; young kids will use condoms the first, second, third 
time, but after that, as their age increases, condom use 
decreases. So we know what the data shows, and that basically 
asking them to change their behavior toward increased condom 
use has not worked. And in the midst of increased condom use, 
the STD rates, HPV too, have risen. So now I will say why not 
try the second approach? Why do we not then say what we need to 
do is put our time and our energy and our money into programs 
that will teach kids to delay the onset of sexual activity, 
which is abstinence?
    Dr. Cox. Chairman Souder, I might add there is a study that 
was just released this week out of England, where they went to 
a full-blown condom message, and what they have is a disaster 
on their hand as they go back and measure, in terms of 
increased teen pregnancies, increased STDs, and increased onset 
of early sexual debut. And what they are doing, the government 
in England now is reassessing whether that program is right, 
because what they did was actually increased sexual activity. 
And I am not saying that all condom messages do that, and I 
would not say that, but the British have decided that maybe 
they went down the road the wrong way, because they actually 
have marked increases in all the bad outcomes associated with 
early sexual activity through a government that was designed to 
do just exactly the opposite of it.
    Mr. Souder. Dr. Zenilman, because one of the things we are 
arguing here are outcomes, and you did a study, you were the 
lead author, in 1995. And if I can quote from this, I would 
like to hear your comments on it. That 15 percent of the men 
who were always condom users had incident sexually transmitted 
diseases, compared with 15.3 percent of those who never used 
condoms, 23.5 percent of the women who were always users in 
incident sexually transmitted diseases, compared to 26.8 
percent of never users. This study did not determine if 
subjects were infected with HPV, it should be pointed out.
    In your study there was no significant statistical 
difference between men and women who always used condoms and 
those who never used condoms. So how do you explain that study? 
I would be interested.
    Dr. Zenilman. Sure. I would be happy to. The title of the 
study was the validity of self-reported condom use, and the 
question that was asked was can we use sexually transmitted 
diseases as a biological marker of condom use. And there is 
subsequent data to support our hypothesis from other areas, 
that if you are actually asking somebody within a clinic 
environment, where the messages are to use condoms all the 
time, and you are seeing them, that we understand that a 
certain proportion of people will over-estimate their condom 
use. In a sense, there is an incentive to say that they use 
when they did not. So the question in that study was actually 
not on the efficacy of condom use, but, rather, do patients 
really tell the truth about their condom use and are there ways 
that we can develop methods from a behavioral standpoint or 
from a biological measure to measure that more accurately. I 
stated actually in the text of the discussion of that article 
that was really the specific objective of the study and what 
our hypothesis was.
    Mr. Souder. So the fact that there were no significant 
difference between usage of condoms and not, you assumed that 
your people were lying.
    Dr. Zenilman. That is correct.
    Mr. Souder. How did you confirm that they were lying?
    Dr. Zenilman. Well, embedded in this study there were a 
large number of partnerships. We never had enough data to 
actually publish this as a formal manuscript, but if we asked 
partners of men who said that they used condoms, the men said 
they used condoms 100 percent of the time. We had a certain 
number of female partners in that study and we actually looked 
at the same question and how they responded to the question, 
and there was no correlation.
    Mr. Souder. How did you know they weren't lying?
    Dr. Zenilman. Somebody is.
    Now, on a subsequent issue, actually, we do have some more 
recent biological markers which we are analyzing from that same 
study.
    Mr. Souder. Because whenever you get into sexual activity 
questions, for example, some believe that the number of people 
who say they are sexually active in certain periods of time in 
American history will be exaggerated; in other times, when 
there is a public message that stresses more abstinence, the 
number of people who say they are abstaining is exaggerated. 
The problem with this is to make claims based on data where you 
don't know whether your subjects are lying seems to be a rather 
tenuous proposition.
    Dr. Zenilman. Well, with all due respect, sir, that actual 
paper had been through several series of peer review by 
journals and had been presented at a number of national 
meetings and has been validated in subsequent studies. I would 
be happy to share that with you.
    Mr. Souder. I wasn't even necessarily referring to your 
paper, because if your assumption is correct that there is a 
certain percentage lying, if you agree that a certain 
percentage lie depending on other variables in the society on 
whether they are abstaining or not abstaining, this whole 
question of scientifically saying effectiveness is in fact 
somewhat challengeable, to say the least, because you can't 
establish who is and who isn't, and, therefore, the scientific 
argument that it is effective is fairly shaky.
    Dr. Zenilman. I think that was a specific objective of the 
NIH committee which was mentioned. And as I am sure you are 
well aware, there was a subsequent research meeting which 
actually established a number of research priorities for the 
NIH and other HHS agencies to investigate this specific issue. 
I mean, that is recognized as a research question.
    Mr. Souder. Dr. Coburn, do you have any comments on this?
    Dr. Coburn. I would just say we are seeing the same thing 
in HIV right now. There are studies out there where people say 
they tell their partners but don't; and then there are those 
that say they always use condoms but don't. So the data is 
skewed based on the lack of truthfulness based on the question 
that is asked. There is a prejudice when you ask the question, 
because right now, today, in today's climate, it is important 
for people who are HIV-infected to always use a condom, it 
works 86 percent of the time. Well, if they are not, but the 
standard in the society is to use it, you are going to get an 
answer that they use it, even though what we know when we have 
people actually inside the groups that are participating and 
actually participating in that behavior, what we see is a very 
different story. And that is why we are seeing, in the gay 
community, a rise in new infections, because they are not using 
condoms anymore, because we have done great research in terms 
of the successful control of the disease for a great many 
people.
    So I think all data is hard to get, and I think this study 
is important in terms of telling us not about whether there is 
a comparison of sexually transmitted diseases with condoms or 
without. It is important in terms of saying it is hard to get 
truthfulness in some of this, and I think it is true.
    I would also say Dr. Cox has been responsible, to a great 
extent, for our change in how we handle cervical cancer, 
especially abnormal Paps. This has changed over 5 to 6 years. 
We are not as aggressive as we used to be because of some of 
the research that has come on that, and I think that needs to 
be said, because that knowledge of HPV in terms of low-risk, we 
aren't as aggressive as we were in the past, and we don't have 
to be because of some of the research that they have put forth.
    Mr. Souder. Well, we have had you here for a long time. Let 
me finish this way. And we will go in reverse order, so you get 
the first chance. Most of you have come as far as the others, 
but we will have you start. And I will let you make any 
comments you want after having heard what each of you said in 
this panel and what you have heard at the hearing today.
    Dr. Zenilman.
    Dr. Zenilman. So it is a general open?
    Mr. Souder. Yes. Open mic time.
    Dr. Zenilman. Right. First of all, I want to thank you and 
the committee for inviting us. I think really, from what I have 
heard, there is less disagreement than actually may be innately 
obvious, because I think the basic messages are there and I 
think we are in agreement on. I think it is specifically how it 
is framed. And I think if we could take a little bit of the 
acrimony out of this, we may be able to be more able to craft a 
message which is consistent with what everybody wants.
    Mr. Souder. Thank you.
    Dr. Meeker.
    Dr. Meeker. Thank you. I totally agree. I think that, 
obviously, when you talk about sexual activity and sexual 
behavior, it is pretty easy for me, because I am talking about 
kids, and everybody is innately protective of kids, so I am 
very glad I am not an internist and talking about sexual 
behavior of 25-year-old women. That is your job. But I think 
that it is a very emotional topic and one of the great 
difficulties for us, and I do agree that we are in much more 
agreement than we believe, is that with the talk and the 
discussion about the very seriousness of HPV infections and 
cervical cancer is completely shifting the way we need to 
approach and rethink condom use.
    Heretofore, I believe the general public has believed, and 
many physicians like me have believed, that condoms are a 
panacea. And the reason we thought that was pretty well 
founded, because condoms do work better, to use non-medical 
language, with HIV than they do with HPV. That is just the way 
it is. And we felt very secure and safe in just teaching people 
just use condoms, use condoms, different colors, different 
flavors, different whatever; anything we needed to do. But this 
is a new day, and now it is time to attend to the needs of our 
young women.
    Cervical cancer is a young woman's disease. I am a 
pediatrician here talking about STDs. Isn't that sad? And so we 
need to dramatically shift our paradigm in how we think and 
approach sexually transmitted diseases. And I don't hate 
condoms, but I know that I took an oath 20-some years ago to 
provide the best medical care that I can to my patients, and as 
far as cervical cancer that I see in my young women, it is 
unabashedly to teach them to delay sexual activity as long as 
possible and to reduce the number of partners; and that is 
where I will go down fighting for that in years to come, 
because that is what the young girls in my practice need to 
hear, and I think the medical community is agreed on that.
    We need some serious Federal money and energy in that. We 
have given it to the HIV/AIDS community, which is wonderful; we 
are making great strides. Now it is time to turn to our young 
women and say we will teach you very aggressively to hold off 
on sexual activity as long as possible. And we really need to 
be willing to step forward into new territory in that way.
    And I thank you for the opportunity to be here.
    Mr. Souder. Thank you.
    Dr. Cox, you have come the farthest.
    Dr. Cox. And have to go back the farthest tonight, yes, and 
be back in the clinic tomorrow morning.
    I think in most ways we are in agreement. I think, as I 
said when I started out this discussion earlier, we all agree 
that delaying intercourse as long as possible is in everybody's 
benefit, and that is the primary message that should be taught 
in our sex education classes. I feel very strongly, though, 
that we need comprehensive sex education that includes all the 
messages, including those of how to best protect one's self 
when you do become sexually active; and that they need to be 
realistic messages. Young people need to be taught that condoms 
are not 100 percent effective and that they don't work as well 
for HPV as they do for HIV. But I think that to eliminate or at 
least diminish the potential of their use would be quite 
detrimental and might increase the risk of HIV.
    I disagree on one statement that was just made, that 
cervical cancer is a young woman's disease. Cervical cancer is 
really non-existent, or almost so, below the age of 21. The 
serious statistics in the last few years have not shown any 
cervical cancers per 100,000 women in women 21 or below, but 21 
to 24 there is 1.7 per 100,000 women that get cervical cancer. 
And of course, the rates go up and start to plateau off in the 
forties. I guess we can still call that young women in the 
forties. But I would agree, though, that the risk of getting 
cervical cancer is an issue that is increased by having 
intercourse and getting exposed to high-risk HPV in very young 
women and teens, and that is where the risk is; it is not that 
there are great risks of cervical cancer then, but certainly 
that exposure then puts them at greater risk than if they had 
gotten exposed to the virus later in life. And we need to make 
sure that our young women know that.
    And if anybody wants to go to the briefing on HPV that I am 
going to do right after this, I am certainly going to stress 
the issues in terms of education of our children, that they 
can't be totally protected by condoms against HPV, and that 
this virus is most risky when they are at that age. We would 
like very much to get motivation to delay intercourse, but we 
also want to make sure that, as we prepare our children to be 
adults, that they have at least the tools, when they become 
adults, to protect themselves.
    Mr. Souder. Can I ask you a technical question? Pardon my 
ignorance. Does the cervical cancer through HPV, does it 
incubate a number of years? In other words, could you be 
exposed to it when you are young and then have it show up?
    Dr. Cox. Most HPV does, if it is going to express itself, 
goes through some cellular expression within a couple of years 
of exposure, but some perhaps may lay in what we call a non-
express or latent phase for a number of years and then immunity 
decreases. And they haven't cleared the virus, which most do, 
but if it goes a number of years and they haven't, it then may 
express itself. But I think probably most get some expression 
early on. And when you get a high-grade lesion in a young 
women, typically those high-grade pre-cancers will be present 
for many, many years before they attain the capability of being 
invasive. So the reason that cervical cytology has diminished 
the risk and the rate of cervical cancer so dramatically is the 
capability of picking up those high-grade changes before they 
become invasive cancer, and treating them.
    Mr. Souder. If you have the pre-cancer lesions and so on, 
does that make it more likely that you could be exposed from 
further sexual activity with different partners later in your 
life? Is there any kind of reoccurrence vulnerability that 
develops?
    Dr. Cox. It is interesting. Most of the studies that have 
looked at women as they age have shown that with increasing 
number of partners, individuals appear to become immune to 
increasing number of types, so that getting exposed to HPV 
again, they may become less likely to be HPV positive. Of 
course, increasing number of partners also increases the risks 
that they may have a viral type that isn't cleared and may 
eventually get cervical cancer.
    But I am not sure I totally answered your question.
    Mr. Souder. I wouldn't totally understand it if you totally 
answered it anyway. I was just trying to get a basic 
understanding. Thank you.
    Dr. Bush.
    Dr. Bush. I was just going to piggy-back on that response. 
The Medical Institute for Sexual Health has published a 
monogram on condoms, and in it it talks about the cumulative 
effect of repeated infections, and that does put you at risk 
for cervical cancer.
    What I was going to originally say was that I have been in 
women's health for 35-plus years, and when I first started, 
principally dealing with childbirth, when we talked about the 
use of condoms, it was always derided as the least effective 
form of contraception. And that is mostly what condoms were 
used for. And, of course, 100 percent effective was your 
hormonal contraceptives, and so condoms were considered 85 
percent effective for prevention of pregnancy, and we 
considered that worthless.
    It is interesting to me now we say condoms are 85 percent 
effective for prevention of HIV and we call it highly 
effective. So that is kind of confusing. I don't know if the 35 
years made the difference or what, but that is interesting.
    I also wanted to add that when a woman gets infected with 
HPV, then the persistence of infection is the thing that gives 
her the increased risk. We don't know which woman is going to 
get rid of the infection with her immune status and which one 
is going to persist. So it is like when I am counseling a woman 
to use the best method to prevent an infection, prevent an 
infection, then not knowing her immune status, I am going to 
give her information that will put her at the greatest health-
promoting method, and that would be to abstain from sex, to 
delay sex, to limit her partners, because I feel like I am 
giving her the best recommendation, to modify her behavior, 
that will promote the best for her long-term. I too am the 
mother of children, and this is what I tell my kids, so I feel 
like it would be unethical for me to tell my patients anything 
less than the best.
    The YRBS study that was put out by the CDC showed that 50 
percent of young people are now reporting that they are 
abstaining from sex, so I feel like the best method to delay 
sexual activity is having an effect. And I am encouraged by the 
fact that in the study, when they broke it out with ethnic 
minorities, the group that showed the greatest progress toward 
abstinence, increasing their rates of abstinence, were African-
American youth. So I feel like the message is being put out 
there, is being heard, and I would like to see us put as much 
effort, as much money, as much resources into promoting the 
method that will give you the best health, that will be primary 
prevention, as opposed to a second tier, which is the condom.
    Mr. Souder. Thank you.
    Dr. Coburn.
    Dr. Coburn. Well, thank you for having this hearing. I 
think it is important. I still am skeptical that the FDA and 
the CDC will come up to the bar that they need to. They have 
made statements; it is my hope that they will do that.
    I was just kind of wondering and thinking out loud what if 
every one of our children aged 12 years and older was taught 
about HPV and what the consequences would be. What would the 
behavior change be if they were actually taught in school here 
is a virus, here is how you get it, here is what is going to 
happen. I will tell you what would happen: the vast majority of 
them would delay the onset of sexual activity. And what we are 
talking about when we talk about abstinence is a realistic look 
at what are the consequences if you have a behavior other than 
that. And we are afraid to tell our children the truth, as far 
as the Government is concerned, and it is time that changed. 
Our children are worth more than that. We ought to invest in 
them. We ought to trust them that the majority of the time they 
are going to make good decisions. They are not going to make 
bad decisions all the time. And then we ought to support them 
at the time when they make a bad decision.
    The other thing is that Congress ought to continue to 
support HPV vaccine research, but it needs to be a broad 
multivalent vaccine. Going after one or two types is halfway, 
and if we put money into that instead of a good solution to it, 
a good secondary treatment option rather than prevention, I 
think we will have failed. So I think oversight in terms of 
what the CDC and the FDA are doing in terms of vaccines are 
very important, because if we just go after HPV-16, what we are 
going to see is the other viruses rise in terms of prevalence, 
if we haven't decreased the age of onset and the number of 
partners.
    So I thank you for holding this hearing. Prevention is the 
best message for our youth, and the best message with that is 
knowledge associated with sexually transmitted disease and an 
attitude of abstinence. We use that method on every other area 
where they are at risk; there is no reason that good leadership 
couldn't use that method on this.
    Mr. Souder. Well, thank you very much. We will put your 
full statements in the record. If you have anything else to 
add, we may have a few written questions for you before we 
close the hearing record.
    With that, the subcommittee stands adjourned.
    [Whereupon, at 2:43 p.m., the subcommittee was adjourned, 
to reconvene at the call of the Chair.]
    [Additional information submitted for the hearing record 
follows:]
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