August 19, 2003

Ms. Dara Corrigan

Acting Principal Deputy Inspector General

Office of the Inspector General

Department of Health and Human Services\
330 Independence Avenue, S.W.\
Washington, D.C. 20201

Dear Ms. Corrigan,

Dr. Tom Coburn, a former member of the U.S. House of Representatives,
recently contacted the Subcommittee regarding the failure of the Centers
for Disease Control and Prevention (CDC) and the Food and Drug
Administration (FDA) to comply with the legal requirements of Public Law
106-554. This law is intended to educate the public about the dangers of
human papillomavirus (HPV) and to prevent its spread and its harmful
consequences, which include cervical cancer and death. This policy was
overwhelmingly supported by Congress and signed into law by President
Clinton on December 21, 2000.

I request that the Office of the Inspector General conduct a thorough
investigation to determine whether Public Law 106-554 has been
faithfully executed and, if not, to make recommendations to ensure that
the appropriate agencies immediately comply with the directives and
intent of this law. Please also determine if federal agencies and
organizations receiving federal funds are complying with P.L. 106-554 by
providing medically accurate information about HPV, reflecting the
findings of the July 2001 scientific report entitle "Scientific Evidence
on Condom Effectiveness for STD Prevention" issued by NIH/CDC/FDA/USAID.

A copy of Dr. Coburn's correspondence outlining the allegations against
CDC and FDA is attached.

Thank you for your attention to this serious matter.

> Sincerely,

Mark E. Souder

Chairman,

Subcommittee on Criminal Justice,

Drug Policy and Human Resources

cc: Honorable Claude A. Allen

Honorable Tom A. Coburn, M.D.

Tom A. Coburn, M.D.

# **FAMILY PRACTICE**

## P.O. Box 1760

Muskogee, Oklahoma 74402

\(918\) 687-8950

August 12, 2003

Ms. Dara Corrigan

Acting Principal Deputy Inspector General

Office of the Inspector General

Department of Health and Human Services\
330 Independence Avenue, S.W.\
Washington, D.C. 20201

Dear Ms. Corrigan,

Cervical cancer is a largely preventable disease, yet according to the
American Cancer Society, an estimated 13,000 new cases of invasive
cervical cancer were diagnosed in 2002 and over 4,000 women die of the
disease every year. Tens of thousands of others will be treated for
related pre-cancerous conditions.

Experts agree that infection with certain strains of the human
papillomavirus (HPV) is one of the strongest risk factors for cervical
cancer. HPV infection, in fact, is associated with nearly all cervical
cancer. HPV has also been linked to other forms of cancer and to genital
warts.

HPV is the most common sexually transmitted disease and scientific
studies have repeatedly concluded that condoms do not provide effective
protection against HPV infection. In 2001, the National Institutes of
Health along with the U.S. Agency for International Development, the
Centers for Disease Control and Prevention (CDC) and the Food and Drug
Administration (FDA) released a report entitled "Scientific Evidence on
Condom Effectiveness for STD Prevention." This report provided the
single most comprehensive review of the published scientific data on the
effectiveness of condoms in preventing sexually transmitted diseases
(STDs). The document states "for HPV, the Panel concluded that there was
**no** epidemiological evidence that condom use reduced the risk of HPV
infection."

Because of the widespread prevalence of HPV, a general lack of knowledge
about the disease and how to prevent its transmission, the significant
numbers of Americans harmed or killed as a result of HPV infection every
year, and the failure of the Centers for Disease Control and Prevention
(CDC) and the Food and Drug Administration (FDA) to address the
epidemic, Congress passed and President Clinton signed Public Law
106-554 in 2000.

This law requires CDC to educate the public about HPV and the lack of
effectiveness of condoms in preventing HPV infection. All educational
materials produced by CDC and other federal agencies and federal
grantees are also required to provide similar medically accurate
information about HPV and condoms. The law directs the FDA to "reexamine
existing condoms labels... to determine whether the labels are medically
accurate regarding the overall effectiveness or lack of effectiveness in
preventing sexually transmitted diseases, including HPV." The law also
required CDC to conduct HPV research and provide recommendations
regarding \"the best strategies to prevent future \[HPV\] infections.\"

As the author of this law and a practicing physician who has cared for
countless patients affected by HPV, I am deeply troubled by the federal
bureaucracy's continued failure to address the HPV and to adhere to and
abide by the legal requirements of P.L. 106-554.

I sent a letter to the Department of Health and Human Services July 18,
2001 regarding my concerns and requested that the Department take
"appropriate actions to properly enact the law." I did not receive a
response and it is obvious that actions to properly enact the law have
still not been undertaken.

Expressing similar concerns, Congressmen Billy Tauzin, Chairman of the
House Energy and Commerce Committee, and Joe Pitts sent a letter to the
Department of Health and Human Services in May 2002 requesting an update
on the status of the implementation of the law but 15 months later have
still not received a response.

An independent review by another Congressional Subcommittee has found
that two and a half years after the effective date of the federal HPV
prevention and education law, CDC and FDA have largely ignored the law
and maintain the indifferent attitude towards the HPV epidemic that
prompted the need for this law.

In addition to ignoring much of the law, the areas of the law that CDC
has implemented have been done so in a manner that appears to
deliberately undermine its intent.

The law is clear that the CDC and other government agencies and partners
must provide "medically accurate information regarding the effectiveness
or lack of effectiveness of condoms" in preventing HPV and other
sexually transmitted diseases (STDs). Yet in a July 2001 "Dear
Colleague" letter to its partners, the CDC issued inaccurate information
regarding the effectiveness of condoms. The CDC states "epidemiological
studies have generally not demonstrated an association between condom
use and the risk of HPV infection, but these studies are inconclusive
because of limitations in how they were designed. Again, these
limitations would generally lead to an underestimation of the protective
effect." The inaccurate claim that studies are "inconclusive" is
repeated several times in the CDC letter. The CDC letter also provides
what is labeled "Theoretical Basis for Protection" that claims
"consistent and correct use of latex condoms would be expected to
protect against transmission of genital ulcer diseases and HPV in some,
but not all, instances." This is medically inaccurate and does not
reflect the available clinical science.

The law also states that the "educational material" on HPV required to
be printed by this law "and all other relevant educational and
prevention materials prepared and printed from this date forward for the
public and health care providers by the Secretary (including materials
prepared through the Food and Drug Administration, the Centers for
Disease Control and Prevention, and the Health Resources and Services
Administration), or by contractors, grantees, or subgrantees thereof,
that are specifically designed to address STDs including HPV shall
contain medically accurate information regarding the effectiveness or
lack of effectiveness of condoms in preventing the STD the materials are
designed to address." The law provides a clear mandate for all federal
agencies and private partners. Yet the CDC's July 2001 letter states
that the requirement is limited to only materials "funded by CDC." To
the contrary, the law does not apply to only CDC funded materials. It
is, rather, a requirement that all organizations receiving federal
funding [must]{.underline} abide by as a condition of eligibility for
federal funding.

The CDC was directed to conduct a number of research activities on HPV.
These included investigating the impact of HPV-related diagnosis on
individuals, the development of educational messages and information for
the public, patients and their partners and determine the public and the
medical community's knowledge and awareness about HPV. The CDC has
provided a \$940,000 grant to Planned Parenthood of Southwest and
Central Florida to conduct this study. Planned Parenthood opposed the
enactment of this law and has consistently downplayed the impact of HPV
infection on women's health and distorted the facts about the lack of
effectiveness of condoms in preventing HPV. The selection of such a
biased organization is just another indication that CDC is intentionally
undermining this law.

The actions and lack of actions taken by the CDC and FDA to undermine
this law are both illegal and threaten the health of millions of
Americans.

The following chart outlines the provisions of Public Law 106-554 and
the status of the each:

  ----------------------------------- -----------------------------------
  **Public Law 106-554 Provision**    **Status**

  Conduct HPV prevalence and          CDC has selected Planned
  prevention research                 Parenthood, which opposed the
                                      enactment of the HPV law, to
                                      conduct this research.

  Progress reports on HPV research to Incomplete \-- Over one and a half
  be submitted to Congress before     years overdue.
  January 2001                        

  Develop and disseminate educational Incomplete.
  materials on HPV and its prevention 

  Report providing recommendations of Due December 2003.
  the best strategies to prevent HPV  
  infection                           

  All educational materials on STDs,  CDC has issued inaccurate claims
  HPV and condoms prepared by federal based upon a "theoretical" and
  agencies and their partners must    unproven hypothesis, inconsistent
  provide medically accurate          with both the law and scientific
  information including the lack of   data.
  effectiveness of condoms in         
  preventing infection                

  Condom labels to be rewritten to be Incomplete.
  medically accurate to reflect the   
  effectiveness or lack of            
  effectiveness in preventing HPV and 
  other STDs                          
  ----------------------------------- -----------------------------------

I would request that the Office of the Inspector General conduct a
thorough investigation to determine why Public Law 106-554 has been both
misinterpreted and largely ignored by CDC and FDA and to make
recommendations to ensure that these agencies immediately comply with
the directives and intent of this law. Please also determine if federal
agencies and organizations receiving federal funds are providing
medically accurate information about HPV, reflecting the findings of the
2001 scientific report issued by NIH/CDC/FDA/USAID.

Thank you for your assistance with this request. Please do not hesitate
to contact me if you have any questions or if I can be of any assistance
with this investigation.

> Sincerely,
>
> Tom A. Coburn, M.D.
>
> Member of Congress (retired)

cc: Honorable Judd Gregg, U.S. Senate

Honorable Billy Tauzin, Member of Congress

Honorable Joe Pitts, Member of Congress

> Honorable David Weldon, MD, Member of Congress

Honorable Mark Souder, Member of Congress

Honorable Sue Myrick, Member of Congress