[Congressional Record Volume 152, Number 135 (Friday, December 8, 2006)]
[House]
[Pages H9256-H9258]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
GYNECOLOGIC CANCER EDUCATION AND AWARENESS ACT OF 2005
Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent to take
from the Speaker's table the 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, with a Senate amendment
thereto, and concur in the Senate amendment.
The Clerk read the title of the bill.
The Clerk read the Senate amendment, as follows:
Senate amendment:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Gynecologic Cancer Education
and Awareness Act of 2005'' or ``Johanna's Law''.
[[Page H9257]]
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.''.
Mr. BARTON of Texas (during the reading). Mr. Speaker, I ask
unanimous consent that the Senate amendment be considered as read and
printed in the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Ms. DeLAURO. Mr. Speaker, let me thank again everyone who has made
this legislation such a priority in the Congress--Congressmen Issa and
Levin for their leadership, as well as everyone outside this
institution, particularly Sheryl Silver--she is an inspiration. I have
always said that when it comes to life and death issues like cancer,
Congress speaks with one voice. And today, it does.
For me, passage of Johanna's Law is one big battle in a fight I,
myself, have waged for 20 years. Indeed, 20 years ago, I was diagnosed
with ovarian cancer during an unrelated doctor's visit. I was fortunate
to have excellent doctors who detected the cancer by accident in Stage
1, and I underwent radiation treatment for the next two and a half
months. Like many survivors, the experience still haunts me today--
hardly a day goes by that I do not think about those weeks, the most
difficult of my life. But I am proud to say that I have now been
cancer-free for a full two decades.
And so you can understand when I say I take great pride in this
victory against cancer today. Great pride--because making sure no woman
has to depend on luck when it comes to cancer is personal. Moments like
these are why I came to Congress.
And this step is so critical. Almost 21,000 women are diagnosed every
year with ovarian cancer; nearly 16,000 will die. With a 45-percent 5-
year survival rate, it claims the lives of nearly three-quarters of
women diagnosed simply because the disease is not detected until it is
too late.
The tragedy is that ovarian cancer, like other gynecologic cancers,
can be cured if it is detected soon enough. When ovarian cancer is
detected in the early stages, 94 percent of women survive longer than 5
years, and most are cured completely. Unfortunately, women have never
had a reliable and accurate method of screening for ovarian cancer in
the early stages. On top of that, many doctors misdiagnose this
disease, with 85 percent of women reporting they do not know which
symptoms to look for.
For all our progress--through research at the NIH, at the Department
of Defense, and with the recent approval of the HPV vaccine--Johanna's
Law recognizes that one of the most effective weapons we have to beat
gynecologic cancers like ovarian, cervical, and uterine cancer is
public education. In creating a federal campaign to educate women and
health care providers alike, as this legislation does, we can take a
bold step toward ensuring women know which symptoms to look for and how
to seek help before it is too late.
This legislation represents only a first step. But this is a fight
every woman has a stake in--a fight the Silver family has dedicated
itself to making sure we win. And so I urge my colleagues to help us
pass this bill and take such an important step forward. It is, indeed,
an idea whose time has come.
Mr. SOUDER. Mr. Speaker, today the House passed H.R. 1245, the
Gynecologic Cancer Education and Awareness Act of which I am a co-
sponsor.
This bill directs the Department of Health and Human Services (HHS)
to carry out a national campaign to increase the awareness and
knowledge of gynecologic cancers. It mirrors a similar law passed by
Congress in 2000 that directed HHS to educate women and health care
providers about cervical cancer. Unfortunately, the 2000 law has never
been fully implemented which is, in part, why this new law is needed.
I am pleased that the Senate revised the bill to set a deadline of
March 2008 for HHS to enact this bill and the 2000 law.
The Subcommittee on Criminal Justice, Drug Policy and Human
Resources, which I chair, has been very active in cervical cancer
issues over the past 5 years. I have been very disappointed with the
lack of progress enacting the 2000 cervical cancer awareness law. I
introduced a bipartisan resolution in 2003 urging federal agencies to
comply with this law, held a hearing on the topic in 2004, and have
sent numerous letters to the agencies responsible for carrying out this
law. Yet 6 years after being signed, the law has still not been fully
enacted and that is why setting a deadline has become necessary.
This is important because thousands of women die of and many more are
diagnosed with cervical cancer every year in the U.S. Yet many women
and few Americans are even aware of the facts about cervical cancer,
including what causes it and how it can be prevented.
Medical experts agree that infection with certain strains of human
papillomavirus (HPV) is the primary cause of nearly all cervical
cancer. The Centers for Disease Control and Prevention (CDC) estimates
20 million Americans are currently infected with HPV and 5.5 million
Americans become infected with HPV every year. According to the
American Cancer Society, nearly 13,000 women develop invasive cervical
cancer annually in the United States and over 4,000 women die of the
disease every year. HPV infection is also associated with other cancers
and more than 1 million pre-cancerous lesions. By way of comparison,
[[Page H9258]]
nearly the same number of women die annually as a result of cervical
cancer as do of HIV/AIDS in the United States.
HPV is a sexually transmitted disease and despite claims by condom
manufacturers and advocates, studies have repeatedly found that condoms
do not provide effective protection against HPV infection.
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.''
CDC 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.
Based on these findings, the law required 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 largely ignored this provision of the law and as a result
few women are aware of HPV or its link to cervical cancer. 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. This is the real life consequence of the CDC's
failure to enact this law and to make women aware of the facts
regarding HPV and cervical cancer.
The law also directs the Food and Drug Administration (FDA) to ensure
that such condom labels are medically accurate regarding the lack of
effectiveness of condoms in preventing HPV infection.
The Subcommittee first wrote to the FDA requesting a status update on
the enactment of this law on August 23, 2001. ``FDA is currently
developing an implementation plan for carrying out Public Law 106-
554,'' was the response from Melinda K. Plaisier, FDA Associate
Commissioner for Legislation, dated November 20, 2001.
On February 12, 2004, the Subcommittee wrote to Dr. Mark B.
McClellan, FDA Commissioner, requesting ``the agency's timetable for
relabeling condoms in compliance with Public Law 106-554.'' In a
response to the Subcommittee dated March 10, 2004, Amit K. Sachdev, FDA
Associate Commissioner for Legislation, stated, ``the Agency is working
on developing a proposed rule to be accompanied by draft labeling
guidance for public comment later this year.''
In a hearing before the Subcommittee on March 11, 2004, Dr. Daniel G.
Schultz, FDA Director of Device Evaluation, stated ``FDA is working to
present a balanced view of the risks and benefits in condom labeling .
. . FDA is preparing new guidance on condom labeling to address these
issues, with the target of publishing that guidance as a draft for
public comment later this year.''
On November 19, 2004, the Subcommittee sent a letter to Acting FDA
Commissioner Lester Crawford requesting an update on whether or not the
oft repeated deadline previously provided would be met.
And earlier this year, I sent a letter to HHS Secretary Michael
Leavitt again asking for a date certain when the FDA will finally be in
compliance with Public Law 106-554 by requiring condom labeling to be
medically accurate and an explanation for the continued delay by the
FDA in complying with this 4-year-old law.
Just this week, mere days before the 6-year anniversary of the
signing of the law, FDA staff has admitted that the agency 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 Eiffel Tower.
Over the 6 years since this law was signed, CDC and FDA have
repeatedly delayed and found excuses to avoid complying with the simple
requirements of the law that would empower women with lifesaving
information. This continued delay undermines the scientific integrity
of both agencies and further jeopardizes the confidence of the public
and many in Congress in these agencies' ability to fulfill their very
important missions.
It is my hope that a year from now Congress will not have to pass yet
another new law to direct HHS, CDC and FDA to enact the existing law.
The lives of our sisters, daughters, mothers, or friends are too
important to allow yet another one to fall victim to this silent
epidemic.
Mr. LEVIN. Mr. Speaker, I rise in strong support of H.R. 1245,
``Johanna's Law,'' which earlier today passed the Senate by unanimous
consent.
It was more than 4 years ago that Sheryl Silver first told me about
her sister, Johanna, who died of ovarian cancer in 2000 after a fierce,
hard-fought battle.
This legislation, in honor of Johanna Silver and her valiant fight,
is emblematic of the fight undertaken by so many women across the
country battling gynecological cancer and their determination to help
other women be treated sooner.
Like so many women, Johanna had experienced symptoms, which were not
identified initially. By the time she was properly diagnosed, her
cancer had advanced significantly, to a point where treatment is
considerably more complicated. Because gynecological cancers are highly
treatable at early stages, public education for women and their primary
care physicians is all the more important.
Johanna's Law does just this, creating a national public information
campaign to educate women and health care providers about the risk
factors and early warning signs of gynecologic cancers, but goes a step
further, requiring HHS to quickly develop a national strategy to get
this information to women at the highest risk and their health care
providers.
After 3 years since this legislation was first introduced, it is
finally coming to fruition. Its passage is a real victory for everyone
who has been fighting to get the facts out about gynecologic cancers.
I want to thank all the people whose determined efforts have gotten
us to where we are today, including Sheryl Silver, who worked
tirelessly from the conception of this legislation through to the
organization of the advocacy done by many organizations and individuals
to assure its passage, as well as cancer survivors and families across
the country, physicians, my colleagues on both sides of the aisle,
especially Darrell Issa, Rosa DeLauro, and Kay Granger, and our
counterparts in the Senate for getting the bill back to us in such
short order.
I urge all of my colleagues to support Johanna's Law and strike a
blow against gynecologic cancers.
The SPEAKER pro tempore. Is there objection to the original request
of the gentleman from Texas?
There was no objection.
A motion to reconsider was laid on the table.
____________________