| Ilena Rose 2006-09-29, 9:28 pm |
| From: Diana Zuckerman
Date: Sep 21, 2006 2:05 PM
Subject: Spread the word!
To: Ilena Rose
I was pleased to be asked to participate in Rep DeLauro's announcement
of her legislation on implants and other women's health issues today.
See details below.
Diana Zuckerman, Ph.D.
President
National Research Center for Women & Families
www.center4research.org
For immediate release
September 21, 2006
www.center4research.org
For more information
Carole Bernard
202-223-4000
cb@center4research.org
Scientist Advocates and Rep. DeLauro
Unveil Legislation for Women's Health
~ The FDA Scientific Fairness for Women Act Sends Clear Message to the
FDA~
Washington, D.C. — A key member of Congress, Rep. Rosa DeLauro (D-CT)
today announced her introduction of the FDA Scientific Fairness for
Women Act. She was joined by Dr. Diana Zuckerman, president of the
National Research Center (NRC) for Women & Families; Dr. Susan Wood,
former Assistant Commissioner for Women's Health of the U.S. Food and
Drug Administration (FDA), and Ed Brent, a widower whose wife was
harmed by FDA's lack of scientific scrutiny.
"Women deserve medical products that have been scientifically proven
to be safe and effective," said Dr. Zuckerman. "Rep. DeLauro's
legislation prioritizes the importance of science and the health needs
of women and helps to ensure that industry pressure and political
ideology do not overrule scientific findings."
"This bill will bring greater assurance that women's health becomes a
priority," Congresswoman DeLauro stated. "I believe that the gold
standard for the FDA has been tarnished, because in fact, FDA
decisions are sometimes based on political, corporate and ideological
pressures. Decisions should be predicated on science."
Dr. Susan Wood explained, "Let good science drive the decision. The
role of Congress is to have oversight over the FDA and to ensure that
it is strong and effective. This bill will try to restore integrity
to the FDA and create an office that can shape women's health and help
to make sure data are reviewed appropriately."
"My wife, P.J., breast-fed two of our daughters after getting
implants. Both are seriously ill," said Ed Brent during the press
briefing. "My daughter Catherine is now in a wheelchair. In addition,
five major studies, including one by National Cancer Institute, found
that women with implants are more likely to commit suicide than other
women. After my wife committed suicide, the autopsy showed that she
had platinum in her brain tissue, which a CDC scientist said could
have influenced her decision to take her own life. That's why the FDA
needs to make sure that the implants being sold now are safe for
long-term use, meaning ten years or more."
Although it is being introduced late in the session, Rep. DeLauro has
considerable power as the highest ranking Democrat on the House panel
that determines the FDA's funding every year. The legislation sends a
clear message to the FDA about this powerful Congresswoman's concerns.
Highlights of the legislation include:
FDA Office of Women's Health
Ø Provide explicit authorization for the Office of Women's
Health within the FDA. The Director for the Office of Women's Health
shall report directly to the FDA Commissioner.
Science on Plan B
Ø Require FDA to convene a workshop within 6 months to review
and evaluate current scientific data on the use of emergency
contraception by females under 18.
Ø This workshop should address the scientific questions
identified in the recent limited approval of Plan B, and should
include the appropriate review divisions and the professional
scientific and clinical staff within these divisions as participants.
Science on Silicone Breast Implants
Ø Require the FDA to define the life of silicone breast
implants, and require their safety to be demonstrated for the life of
the device and prior to approval.
Ø Hold FDA accountable for its actions if silicone breast
implants are approved by requiring the Secretary to report to Congress
within 30 days explaining how the Secretary has complied with the
requirements that the safety be demonstrated for the life of the
device.
Ø Require FDA to list potential members of FDA's breast implant
advisory committees at least 30 days before the meeting and allow NO
exemptions for financial conflicts of interest.
Ø Require FDA to convene and oversee a panel of independent
scientists to design and conduct a study on platinum and platinum
salts in the bodies and breast milk of women with silicone breast
implants.
Controversial products, such as Plan B and breast implants, are often
reviewed by an advisory committee that FDA convenes of outside
experts. A study by NRC for Women & families indicates that the FDA
advisory panels recommend approval for medical devices, such as
implants, 82% of the time.
At the last FDA public meeting on breast implants, in April 2005, the
advisory panel recommended against approving Inamed silicone breast
implants, and voted to recommend approval of Mentor silicone implants
the next day, despite the fact that Mentor had only 2 years of rupture
data in their core studies and Inamed had 3 years of rupture data. "At
the time, this inconsistency seemed to make no sense," points out Dr.
Zuckerman. "However, our analysis found that none of the 89 randomly
selected FDA advisory panels that we studied between 1998 and 2005
ever recommended against approval two times in a row in the same year,
let alone the same week. In other words, once the committee
recommended against approval for Inamed's implants, the chances were
100% that they would recommend approval for the product they reviewed
the next day. Some question whether the science matters in that
situation. That's why this new legislation is so important." Meeting
transcripts indicated that advisory committee members often publicly
apologized to the manufacturers when they did not recommend approval,
and they never rejected two products two days in a row.
NRC for Women & Families is a Washington, DC -based nonprofit,
nonpartisan think tank founded in 1999. The Center focuses on health
information and health policy issues affecting women, children, and
families.
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