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Director's Message
Susan F. Wood, Ph.D.
On Tuesday, May 26th, 2003, FDA Commissioner Dr. Mark B. McClellan
spent the morning discussing his priorities and key issues in
women's health with a wide variety of women's and health organization
leaders. This "Coffee and Conversation with the Commissioner"
was hosted by the Washington Business Group on Health and the
FDA Office of Women's Health. Dr. McClellan expressed his interest
in working with these groups on a broad range of women's health
topics. Dr. McClellan spent time explaining his top 5 priorities
and then each of the participants highlighted individual and
organization concerns, including older women's health, new product
development, analysis of data by gender, race and ethnicity,
and reproductive health.
The last part of the meeting focused on the Women's Health
Initiative Memory Study, which was released later that same
day. This important adjunct study to the Women's Health Initiative
demonstrated the lack of improvement on cognitive functioning
and an increase in dementia for women over the age of 65 who
were using the combination estrogen + progestin therapy. The
Commissioner conveyed the message from FDA that, although these
results are important and may lead to some changes in the labeling
of menopausal hormone products, hormone therapy is still indicated
for treatment of menopausal symtoms. When used, hormone therapy
should be used at the lowest dose that relieves symtons for
the shortest time needed.
The focus on hormone therapy for menopause and providing good
information to consumers will continue, as FDA Office of Women's
Health, in partnership with other HHS agencies and non-governmental
organizations, will be launching an effort in the fall to inform
women about the appropriate uses of hormone therapy. Stay tuned
to the OWH Update and our web site www.fda.gov/womens for more
information on this effort and to get information about how
organizations can be involved.
Guidance for Race and Ethnicity Data
The FDA is finalizing its Guidance for Industry on the Collection
of Race and Ethnicity Data in Clinical Trials. This final document
is intended to assist sponsors in the collection of race and
ethnicity information in clinical trials conducted in the United
States and abroad for certain FDA regulated products using a
standardized approach. The recommended standardized approach
was developed by the Office of Management and Budget (OMB).
FDA believes that the use of the OMB race and ethnicity categories
will facilitate comparisons across clinical studies analyzed
by the FDA and with data collected by other Federal agencies.
Although FDA has long requested race and ethnicity data on subjects
in certain clinical trials, the Agency is now making recommendations
on the categories to use when collecting and reporting data.
The final guidance is expected to be available by September
2003.
OWH Intramural Research Program Focuses on Preventing Heart
Disease
Although heart disease is the number one killer of women, for
many years, women were not included in clinical trials designed
to prove therapies are safe and effective. In FY 2002, DHHS
made the prevention of heart disease a Women's Health priority.
This year FDA's Office of Women's Health funded four intramural
research projects on preventing heart disease and toxicity.
Two projects will attempt to learn more about the development
of the potentially fatal heart arrhythmia known as Torsade de
Pointes. Many different drugs cause this cardiac toxicity and
women experience the drug-induced arrhythmia at appromatly twice
as often men. The first project by Dr. Jogarao Goburru will
address Are woman at higher risk from proarrhythmic drugs? In
the second project, Electrophysiological characterization of
several torsadogenic drugs in isolated rabbit hearts, Dr. John
Koerner will use a rabbit heart model to characterize torsadogenic
drugs from different pharmacological classes. In the third project
entitled, Dr. Mel Stratmeyer will examine the Cardiovascular
effects of ultrasound contrast agents in intact and ovariectomized
female animals. Finally, Dr. Eugene Herman will conduct a project
titled Discovery and Evaluation of Interspecies Biomarkers to
Monitor the Early Onset and the Progression of Cardiovascular
Toxicity Associated with Tiazolidinedione Compounds Used in
the Treatment of Type 2 Diabetes minimizes the cardiac toxicity
associated with these drugs.
Dioxin in Tampons
Periodically, concerns are raised about dioxin in feminine
hygiene products especially tampons. To address this concern,
FDA/OWH funded Jeffrey C. Archer to examine dioxin content in
seven brands of tampons thatwere purchased either via Internet
or from retail stores. Two lots of "Regular Absorbency" and
two lots of the highest absorbency of each brand were purchased.
All samples were analyzed via GC/HRMS using a Micromass AutoSpec
Ultima high resolution mass spectrometer at 10,000 mass resolution.
Most detected quantities were at or near detection limit values.
Only one brand of Super-Plus had levels of 2,3,7,8-Tetrachlorodibenzofuran
(TCDF) that were considered statistically significant - greater
than the average blank at a 99% level. Several brands had levels
of Heptachlorodibenzo-p-dioxin (HpCDD) and OCDD significantly
greater than the blank average. The Joint Expert Committee on
Food Additives (JECFA) has set a provisional tolerable monthly
intake of 70 pg/kg body weight per month of total dioxin equivalence.
Basing a risk assessment assuming total absorption of dioxin
from the tampon, the dioxin content of the highest brand (roughly
0.225 pg/tampon), use of 24 tampons in a month and hypothesizing
a 50 kg female; the theoretical exposure equals 5.4 pg/month
or 0.108 pg/kg body weight in a month. This results in less
than 0.2% of the tolerable monthly intake set by JECFA.
Women and Diabetes Town Hall Meeting
Diabetes is a serious health concern for approximately 17 million
Americans, with over 9 million women in the US effected by this
disease. On May 20th, 2003, the Department of Health and Human
Services (DHHS) Coordinating Committee on Women's Health and
the American Diabetes Association (ADA), in collaboration with
the Congressional Caucus for Women's Issues and the Congressional
Diabetes Caucus sponsored the "Women and Diabetes Town Hall
Meeting" in Washington, DC. The meeting was also provided as
satellite broadcast to over 70 sites across the country and
via live web cast.
As part of President Bush's "Healthier U.S." initiative, the
Town Hall meeting brought together both government and private
sector leaders from the diabetes community to raise public awareness
about the higher risk of diabetes to women. Speakers included
Deputy Secretary Claude A. Allen and principal Deputy Assistant
Secretary Dr. Cristina Beato, Department of Health and Human
Services (DHHS), Dr. Francine Kaufman, President, Congressional
members, as well as subject matter experts from research, policy
and academia. The key objectives were to discuss the impact
and consequence of diabetes and to spread the message of diabetes
prevention and management. And, those guest speakers living
with the disease, including ADA Spokeswoman, Nicole Johnson,
Miss America, 1999, encouraged participants by putting a "face"
to diabetes. All highlighted the importance of overall good
health practices and shared their commitmentto work toward a
future without diabetes.
The Town Hall meeting also highlighted the FDA "Take Time to
Care...about Diabetes" Campaign, which, through partnership
with ADA and the National Association of Chain Drug Stores (NACSDS),
as well as many other supporting organizations, reaches out
to women and their families with information on preventing and
managing diabetes.
You can view the Women and Diabetes Town Hall meeting at the
following URL:
http://www.mchcom.com/diabetes_frame.htm
Recent Approvals
FemCap (3/03): FemCap is prescribed for women of childbearing
age who wish to prevent or postpone pregnancy. It is made of
medical grade silicone rubber and comes in three sizes to fit
most women, and is to be used with nonoxynol-9 spermicide. Based
on a clinical effectiveness study for women using FemCap for
one year 30 women out of 100 can expect to become pregnant.
http://www.fda.gov/cdrh/mda/docs/P020041.html
CosmoDerm and CosmoPlast Human Based Collagen Implants (3/03):
Manufactured by Inamed Corp. these implants are sterile injectable
liquids made of highly purified human collagen, a natural protein
that supports the skin. They are injected into the skin to correct
soft tissue defects such as wrinkles and acne scars. CosmoDerm
is used for minor skin defects. CosmoPlast is used for more
serious defects.
http://www.fda.gov/cdrh/mda/docs/p800022s050.html
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