[Congressional Record (Bound Edition), Volume 152 (2006), Part 18]
[Senate]
[Pages 23468-23470]
[From the U.S. Government Publishing Office, www.gpo.gov]




         GYNECOLOGIC CANCER EDUCATION AND AWARENESS ACT OF 2005

  Mr. ENZI. I ask unanimous consent the Senate proceed to the immediate 
consideration of H.R. 1245, Johanna's Law, which was received from the 
House.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant legislative clerk read as follows:

       A bill (H.R. 1245) to provide for programs to increase the 
     awareness and knowledge of women and health care providers 
     with respect to gynecologic cancers.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. COBURN. Mr. President, as a physician and a two-time cancer 
survivor, I believe that eliminating cancer should be among our 
Nation's highest priorities.
  During my two decades practicing medicine, I have treated countless 
patients of all ages and backgrounds who were diagnosed with various 
forms of cancers. Many were successfully treated and are alive and 
healthy today. Others were not as fortunate. Sadly, most of these cases 
could have been treated if detected earlier. Nearly all could have been 
prevented.
  As a physician, I know firsthand that both patients and health care 
providers are not properly informed about many symptoms and causes of 
cancer. I have long been disappointed that the U.S. Surgeon General and 
the Centers for Disease Control and Prevention, CDC, have failed to 
take an effective leadership role to educate the American people with 
lifesaving information about the various forms of cancer and how to 
protect themselves. As a result, the American Cancer Society estimates 
that 1,399,790 men and women--720,280 men and 679,510 women--will be 
diagnosed with and 564,830 men and women will die of cancer of all 
sites in 2006. Countless others will require invasive treatment that 
will forever affect their lives.
  Each of these individual lives represents a failure to protect the 
health of one of our sisters, daughters, brothers, sons, parents, 
neighbors, and friends.
  One recent patient of mine, an 18-year-old girl, is an example. She 
was diagnosed with human papillomavirus, HPV, infection. HPV is the 
cause of over 99 percent of all cervical cancers and is a sexually 
transmitted disease.
  To prevent the onset of invasive cervical cancer, a large portion of 
this young girl's cervix had to be removed. As a result she is less 
likely to be able to become pregnant in the future and more likely to 
have a premature infant if she does become pregnant. And despite 
already undergoing invasive treatment, she remains at risk for future 
complications and additional surgeries.
  This girl and the others that I am caring for in my medical practice 
are the real faces of those affected by HPV and cervical cancer. What 
we are confronting is not an isolated epidemic.
  About 24 million Americans are currently infected with HPV according 
to the National Cancer Institute and an estimated 5.5 million Americans 
become infected with HPV every year. With 4.6 million of these HPV 
infections acquired by those aged 15 to 24, HPV accounts for over half 
of all new sexually transmitted diseases among young Americans. On 
March 8, 2004, researchers from the Colorado Health Sciences Center 
reported that more than 30 percent of women in a recent study were 
found to be infected with a strain of HPV linked to cervical and anal 
cancer. In comparison, 18.7 percent of men carried HPV-16, one of 10 
high-risk strains of the virus.
  Over 1,350,000 women will have invasive procedures each year just to 
assess the status of their abnormal pap smears secondary to HPV. 
According to the American Cancer Society, every year over 12,000 new 
cases of invasive cervical cancer are diagnosed and more than 4,000 
women die of the disease. And noninvasive cervical cancer is estimated 
to be four times as widespread as the invasive type. HPV is also 
associated with other forms of cancer and more than 1 million 
precancerous lesions that affect both women and men.
  Few of my patients with HPV had ever heard of the virus and were 
unaware of its health risks including its link to cancer. Many of my 
fellow physicians were not even aware of HPV and its symptoms.
  In 2000, I authored legislation directing the CDC and the Food and 
Drug Administration--FDA--to take actions to educate the public with 
``medically accurate information'' about HPV and cervical cancer. I was 
disappointed when groups that claimed to advocate for women's health, 
such as the American College of Obstetricians and Gynecologists--ACOG--
opposed my proposal

[[Page 23469]]

and fought to keep the public in the dark about HPV.
  The HPV law was approved by Congress as a component of the 
Consolidated Appropriations Act of 2001 and became Public Law 106-554 
with the signature of President Bill Clinton on December 21, 2000. In a 
Statement of Administration policy, President Clinton stated:

       The Administration supports the goal of better informing 
     the public about HPV and the fact that the use of condoms may 
     not fully prevent HPV transmission.

  The law directed CDC to develop a report outlining the ``best 
strategies to prevent future infections, based on the available 
science.'' After the repeated urging of Congress, CDC finally issued a 
report in 2004 that concluded:

       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 
     infection. 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 available scientific evidence is not sufficient to 
     recommend condoms as a primary prevention strategy for the 
     prevention of genital HPV infection. . . .
       Regarding other possible prevention approaches, no data 
     indicate that treatment of clinical lesions or use of 
     microbicides will prevent transmission of infection, although 
     HPV vaccines are likely to become available in the next few 
     years and may become an effective prevention tool.

  The CDC's conclusions reflected what has become the scientific 
consensus.
  In a February 1999 letter to the U.S. House Commerce Committee, Dr. 
Richard D. Klausner, then-Director of the National Cancer Institute, 
stated:

       Condoms are ineffective against HPV because the virus is 
     prevalent not only in the mucosal tissue (genitalia) but also 
     on dry skin of the surrounding abdomen and groin, and it can 
     migrate from those areas into the vagina and the cervix. 
     Additional research efforts by NCI on the effectiveness of 
     condoms in preventing HPV transmission are not warranted.

  In 2001, the National Institute of Allergy and Infectious Diseases 
along with FDA, CDC and the U.S. Agency for International Development 
issued a consensus report regarding condom effectiveness that concluded 
``there was no epidemiologic evidence that condom use reduced the risk 
of HPV infection.''
  In November 2002, a meta-analysis of ``the best available data 
describing the relationship between condoms and HPV-related 
conditions'' from the previous two decades was published in the journal 
Sexually Transmitted Diseases. The meta-analysis concluded: ``There was 
no consistent evidence of a protective effect of condom use on HPV DNA 
detection, and in some studies, condom use was associated with a 
slightly increased risk for these lesions.''
  Based upon these findings, the law directs CDC to ``prepare and 
distribute educational materials for health care providers and the 
public that include information on HPV. Such materials shall address 
modes of transmission, consequences of infection, including the link 
between HPV and cervical cancer, the available scientific evidence on 
the effectiveness or lack of effectiveness of condoms in preventing 
infection with HPV, and the importance of regular Pap smears, and other 
diagnostics for early intervention and prevention of cervical cancer.'' 
The CDC has not complied with this requirement.
  The law further requires that ``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.'' Again, Federal agencies 
have not complied with this provision of law.
  The law directed the FDA ``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.'' Six years after this law was signed, the FDA is still 
in the beginning stages of crafting a new medically accurate 
informational label for condom packages. By way of comparison, it took 
410 days to build the Empire State Building and 2 years, 2 months and 5 
days to construct the Eiffle Tower.
  Congress approved the HPV law precisely because Federal health 
agencies had failed to educate the American public about the health 
risks of HPV and how it can be prevented and these same agencies are 
continuing their cover-up of the HPV epidemic, now in violation of 
federal law.
  In 1999, when this law was first offered in Congress, a study 
published by the American Journal of Preventive Medicine in June 1999, 
found that ``only 37 percent of respondents had ever heard of HPV,'' 
meaning knowledge of HPV has not increased in almost a decade. The 1999 
study concluded ``implementing HPV education programs and measuring 
their effectiveness should be a priority.''
  According to a 2005 Health Information National Trends Survey, only 
40 percent of women have ever heard about HPV. Of those that have heard 
of HPV, less than 20 percent knew that HPV could sometimes lead to 
cervical cancer, meaning that only about 8 percent of American women 
are aware that HPV can cause cervical cancer. The only factors 
associated with having accurate knowledge--knowing that it could lead 
to cervical cancer--was an abnormal Pap test or testing positive on an 
HPV test. This suggests that most women are finding out about HPV only 
after experiencing a negative consequence.
  As these numbers show, the failure of CDC and FDA to enact the HPV/
cervical cancer education and prevention law has had real 
consequences--a hidden epidemic that claims thousands of lives every 
year and affects tens of millions of others.
  It is unacceptable that federal health agencies have abdicated their 
responsibility and missions and intentionally ignored the law and, in 
so doing, placed the health and lives of millions in jeopardy.
  Today the Senate has passed another bill, the Gynecologic Cancer 
Education and Awareness Act, or ``Johanna's Law,'' which will again 
direct CDC and FDA to educate the public about cervical cancer as well 
as other forms of gynecological cancer.
  I would like to recognize Senator Arlen Specter, Congressman Darrell 
Issa, cancer survivor Fran Drescher, and the countless other activists 
who are cancer survivors themselves or have a loved one who has been 
diagnosed with gynecological cancer who have championed this bill 
through Congress.
  It is an unfortunate statement that this bill is even necessary. It 
is a recognition that federal health agencies have failed to 
effectively carry out their missions.
  It was my concern that the same agencies entrusted with enacting this 
bill would ignore it in the same manner that the law Congress passed in 
2000 has been ignored. That would mean that the dedication and hard 
work of the activists and survivors who supported this bill was for 
nothing.
  When I voiced these concerns, Senator Specter agreed to amend the 
bill language to include a date certain that the cancer education 
activities that both this bill and the current law require. This 
assures that the law and the epidemic of gynecological and cervical 
cancer can no longer be ignored by federal agencies.
  If the CDC and the FDA do not enact the provisions of this bill and 
the existing law--317P of the Public Health Service Act--by March 1, 
2008, the Department of Health and Human Services is required to submit 
to Congress a ``a detailed description of all actions taken'' to bring 
the Department into compliance every three months until the law has 
been fully enacted.

[[Page 23470]]

  I fully expect that these requirements will compel CDC and FDA to 
enact these important laws and the Department will not deliver ``the 
dog ate my homework'' excuses. Laws, after all, are not optional for 
citizens, for members of Congress or even for government agencies and 
bureaucrats.
  Again, I am pleased that the Senate is directing federal health 
agencies to do their part to help educate and prevent gynecological and 
cervical cancer and that this time we will hold them accountable to 
ensure that not another one of our sisters, daughters, mothers, or 
friends falls victim to this silent epidemic.
  Mr. ENZI. I ask unanimous consent that the amendment at the desk be 
agreed to, the bill as amended be read a third time and passed, the 
motion to reconsider be laid upon the table, and any statements be 
printed.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 5235) was agreed to, as follows:

              (Purpose: To provide a complete substitute)

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Gynecologic Cancer Education 
     and Awareness Act of 2005'' or ``Johanna's Law''.

     SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

       Section 317P of the Public Health Service Act (42 U.S.C. 
     247b-17) is amended--
       (1) in the section heading by adding ``(johanna's law)'' at 
     the end; and
       (2) by adding at the end the following:
       ``(d) Johanna's Law.--
       ``(1) National public awareness campaign.--
       ``(A) In general.--The Secretary shall carry out a national 
     campaign to increase the awareness and knowledge of health 
     care providers and women with respect to gynecologic cancers.
       ``(B) Written materials.--Activities under the national 
     campaign under subparagraph (A) shall include--
       ``(i) maintaining a supply of written materials that 
     provide information to the public on gynecologic cancers; and
       ``(ii) distributing the materials to members of the public 
     upon request.
       ``(C) Public service announcements.--Activities under the 
     national campaign under subparagraph (A) shall, in accordance 
     with applicable law and regulations, include developing and 
     placing, in telecommunications media, public service 
     announcements intended to encourage women to discuss with 
     their physicians their risks of gynecologic cancers. Such 
     announcements shall inform the public on the manner in which 
     the written materials referred to in subparagraph (B) can be 
     obtained upon request, and shall call attention to early 
     warning signs and risk factors based on the best available 
     medical information.
       ``(2) Report and strategy.--
       ``(A) Report.--Not later than 6 months after the date of 
     the enactment of this subsection, the Secretary shall submit 
     to the Congress a report including the following:
       ``(i) A description of the past and present activities of 
     the Department of Health and Human Services to increase 
     awareness and knowledge of the public with respect to 
     different types of cancer, including gynecologic cancers.
       ``(ii) A description of the past and present activities of 
     the Department of Health and Human Services to increase 
     awareness and knowledge of health care providers with respect 
     to different types of cancer, including gynecologic cancers.
       ``(iii) For each activity described pursuant to clauses (i) 
     or (ii), a description of the following:

       ``(I) The funding for such activity for fiscal year 2006 
     and the cumulative funding for such activity for previous 
     fiscal years.
       ``(II) The background and history of such activity, 
     including--

       ``(aa) the goals of such activity;
       ``(bb) the communications objectives of such activity;
       ``(cc) the identity of each agency within the Department of 
     Health and Human Services responsible for any aspect of the 
     activity; and
       ``(dd) how such activity is or was expected to result in 
     change.

       ``(III) How long the activity lasted or is expected to 
     last.
       ``(IV) The outcomes observed and the evaluation methods, if 
     any, that have been, are being, or will be used with respect 
     to such activity.
       ``(V) For each such outcome or evaluation method, a 
     description of the associated results, analyses, and 
     conclusions.

       ``(B) Strategy.--
       ``(i) Development; submission to congress.--Not later than 
     3 months after submitting the report required by subparagraph 
     (A), the Secretary shall develop and submit to the Congress a 
     strategy for improving efforts to increase awareness and 
     knowledge of the public and health care providers with 
     respect to different types of cancer, including gynecological 
     cancers.
       ``(ii) Consultation.--In developing the strategy under 
     clause (i), the Secretary should consult with qualified 
     private sector groups, including nonprofit organizations.
       ``(3) Full compliance.--
       ``(A) in general.--Not later than March 1, 2008, the 
     Secretary shall ensure that all provisions of this section, 
     including activities directed to be carried out by the 
     Centers for Disease Control and Prevention and the Food and 
     Drug Administration, are fully implemented and being complied 
     with. Not later than April 30, 2008, the Secretary shall 
     submit to Congress a report that certifies compliance with 
     the preceding sentence and that contains a description of all 
     activities undertaken to achieve such compliance.
       ``(B) If the Secretary fails to submit the certification as 
     provided for under subparagraph (A), the Secretary shall, not 
     later than 3 months after the date on which the report is to 
     be submitted under subparagraph (A), and every 3 months 
     thereafter, submit to Congress an explanation as to why the 
     Secretary has not yet complied with the first sentence of 
     subparagraph (A), a detailed description of all actions 
     undertaken within the month for which the report is being 
     submitted to bring the Secretary into compliance with such 
     sentence, and the anticipated date the Secretary expects to 
     be in full compliance with such sentence.
       ``(4) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there is authorized to be 
     appropriated $16,500,000 for the period of fiscal years 2007 
     through 2009.''.

  The amendment was ordered to be engrossed and the bill to be read a 
third time.
  The bill (H.R. 1245), as amended, was read the third time, and 
passed.

                          ____________________