<DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:96225.wais]
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
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http://www.house.gov/reform
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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:]
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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:]
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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:]
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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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<all>