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

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Dr. MANSON. Well, I think that more information is necessary.
I think that some physicians consider that they have adequate information.
But given the paucity of information out there, it is hard to understand
how a rationale can be given for prescribing these hormones
over the retail pharmacy-available hormones, unless there is
a specific reason, such as a patient is allergic to peanuts and there
is peanut oil in the natural micronized progesterone that is available
in retail pharmacies.
Senator SMITH. Maybe a message of this hearing ought to be
"Doctors beware."
Dr. MANSON. Absolutely.
Senator SMITH. Thank you, Dr. Manson.
Dr. Wartofsky, please.
STATEMENT OF LEONARD WARTOFSKY, PRESIDENT, THE
ENDOCRINE SOCIETY, CHEVY CHASE, MD
Dr. WARTOFSKY. Senator Smith, thank you for the opportunity to
testify today. My name is Leonard Wartofsky. I am chairman, Department
of Medicine at the Washington Hospital Center, and Professor
of Medicine at Georgetown University.
But today I am here as President of the Endocrine Society, the
world's largest professional organization of endocrinologists, representing
over 14,000 members.
The Society is deeply concerned about the safety of these socalled
bioidentical hormones and believes the Federal Government
should increase regulatory oversight of these compounds.
As you mentioned in your opening comments, Senator, bioidentical
hormones have been touted inaccurately, by high-profile individuals
with no medical training, as being safer and more effective
than traditional hormone therapies.
You have raised the question of the definition of "bioidentical."
As Dr. Manson said, scientists describe compounds as bioidentical
that are identical to similar compounds produced naturally in the
body.
We do not oppose the use or prescribing of FDA-approved bioidentical
hormones, which have been available to the public for
years. Rather, our concern is with custom-compounded bioidentical
hormones.
The WHI study uncovered risks to women taking hormone replacement,
as we heard this morning. We caution physicians and
patients alike against the unfounded presumption that
bioidenticals would be any safer.
In fact, no study as comprehensive as the WHI has assessed bioidentical
hormones. Until authoritative clinical trials of bioidentical
hormones are conducted, patient safety is best assured by assuming
these hormones carry the same benefits and the same risks as
those studied in the WHI.
Claims about safety and efficacy come from the belief that compounded
hormones are precisely and individually custom-formulated.
While theoretically appealing, such customization is difficult,
if not impossible, to achieve.
Perhaps most alarming, compounded preparations, as you again
mentioned this morning, are not required to have the black-box ad-