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

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claim." Therefore, since the term "bioidentical" has become commonplace
in the industry, shouldn't the FDA develop guidance with
respect to the term that could be used both on over-the-counter and
prescription products? Is there any effort to do that, to define this?
Dr. GALSON. The term, you are correct, does not mean anything
to us.
I was just talking to Dr. Rossouw before the hearing got started
about the fact that in my remarks I was very careful to say "socalled
bioidentical" hormones. Dr. Rossouw didn't mention the term
at all.
We hate this term. We don't think it means anything. We are not
sure that it should mean anything.
It implies, by the very words "identical" and "bio," that it is
something that patients should like and should use. We just don't
think-we think these are drugs, and they deserve warning labels
like the drugs that we approve.
Senator SMITH. So you have a problem with all the Web sites out
there using this term that holds out medical promise and hope?
Dr. GALSON. I certainly do.
Senator SMITH. I certainly hope that the FDA will define the
term "bioidentical" or at least repudiate it; and that then the FTC
will do its part in getting these Web sites down. It just shouldn't
be happening in this day and age.
Do you have any comment about the term "bioidentical," Dr.
Rossouw?
Dr. Rossouw. Except to agree with my colleague. It is not a medical
term. It is a marketing term.
Senator SMITH. Yes. That is the same kind of marketing they
used to do in the 19th century.
Let me thank you all. This is, I am sure, not pleasant for you,
but it is important to the American people that we highlight what
is out there and that they not just be told, "Buyer beware," because
we are dealing with people's health here.
So, please regard this hearing as done in the spirit of trying to
get information out there so that people aren't just told to beware,
that they actually have the opportunity to buy products that have
health benefits to them and are not scammed by things that may
actually be harmful to their health.
So, with that, I thank you for your attendance.
We will call up our next panel.
On our second panel, we are pleased to welcome medical experts
and industry representatives to further outline these issues.
Our first witness will be Dr. JoAnn Manson, who is the Chief of
preventive medicine at Brigham and Women's Hospital in Boston.
She is also the Elizabeth F. Brigham professor of Women's Health
and professor of Medicine at Harvard Medical School. Dr. Manson
is a recognized medical expert in hormone therapy and has published
a substantial body of work on the topic; and has recently
served as a medical consultant for the "Today" show.
That is why I recognize you.
She will be followed by Dr. Leonard Wartofsky, who is the chairman
of the Washington Hospital Center's Department of Medicine
and is the president of the Endocrine Society, an internationally
recognized association of 11,000 members from over 80 countries.