Bioidentical Hormones - U.S. Senate Special Committee on Aging

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ever, as Dr. Wartofsky points out, many women went straight to what they thought
were natural alternative treatments. Many women are not fully aware of the differences,
and more importantly, the similarities between bioidentical hormones,
compounded hormones, and those hormones used in the Women's Health Initiative.
It concerns me that women who think they are choosing a natural alternative may
not have all of the facts.
That is why this hearing is so important. Hopefully it will shed more light on
compounded bioidentical hormones so that not just Congress, but consumers, are
more educated about the products that are out there. With that said, I want to welcome
our witnesses and I look forward to hearing from them.
Senator SMITH. Thank you, Senator Craig.
Our first panel consists of Dr. Jacques Rossouw, who is the chief
of the Women's Health Initiative branch of the National Heart,
Lung and Blood Institute at NIH. Dr. Rossouw will discuss findings
from the Women's Health Initiative and its implications for the
current approach to hormone therapy.
He will be followed by Dr. Steve Galson. He is the deputy director
for the Center for Drug Evaluation and Research at FDA. We
look forward to hearing about FDA's suggestions for legislative and
regulatory initiatives.
Eileen Harrington is the deputy director of the Bureau of Consumer
Protection at the FTC. Ms. Harrington will discuss the
FTC's enforcement efforts regarding online sales of hormone products.
We look forward to hearing FDA's future plans for oversight
in the area.
So with that, Dr. Rossouw, take it away.
STATEMENT OF JACQUES ROSSOUW, CHIEF OF THE WOMEN'S
HEALTH INITIATIVE BRANCH, NATIONAL HEART, LUNG AND
BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH,
BETHESDA, MD
Dr. Rossouw. I am pleased to appear before this-
Senator SMITH. Hit your button there on the microphone.
Dr. Rossouw. Yes.
I am pleased to appear before this committee. I am here to tell
you about the Women's Health Initiative, which used conjugated
equine estrogens. I will also briefly comment on other forms of estrogen
therapy.
Recall that, prior to 1990, the main use of hormone therapy in
post-menopausal women was to treat the symptoms of menopause
and prevent osteoporosis. During the 1990's, there was increasing
use for prevention of coronary heart disease. In fact, that was the
standard recommendation at that time.
This recommendation was based on preceding observational studies
indicating benefit for cardiovascular disease in particular in
hormone users compared to nonusers.
NIH felt that this recommendation was an example where the
policy was exceeding the science basis and mounted the Women's
Health Initiative to test the very hormones-conjugated equine estrogens
and medroxyprogesterone-which were suggested to be associated
with benefit in preceding observational studies.
The expectation was that we would show benefit for hormone
therapy-either estrogen alone or in combination with a progestin.
What we found was that the estrogen alone and the estrogen with
progestin did not protect against coronary heart disease.