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

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He will be followed by Dr. Loyd Allen. He is here representing
the International Academy of Compounding Pharmacists. Dr. Allen
also serves as the editor-in-chief of the International Journal of
Pharmaceutical Compounding, among several other pharmacy-related
posts.
Our final witness will be T.S. Wiley, who is a researcher, published
author, creator of the Wiley Protocol, a bioidentical hormone
regimen that she has developed for women seeking an alternative
to conventional hormone therapy.
Dr. Manson, we will start with you.
STATEMENT OF JOANN MANSON, CHIEF OF PREVENTIVE. MED-
ICINE, BRIGHAM AND WOMEN'S HOSPITAL, PROFESSOR OF
MEDICINE, HARVARD MEDICAL SCHOOL, BOSTON, MA
Dr. MANSON. Thank you.
Ranking Member Senator Smith, thank you for the opportunity
to speak to you today about bioidentical and custom-compounded
hormones.
Because of the risks of conventional hormone therapy that you
have heard about, identified by the Women's Health Initiative, including
stroke, venous blood clots, breast cancer, and other health
problems, there has been a growing interest in bioidentical and
custom-compounded hormones as potentially safer alternatives.
The key question is: Are these products indeed safer or more effective
than conventional hormone therapy, as proponents of these
treatments claim?
Unfort. Lunately, tlie-.e is litle evidence, as you have heard, to support
this assertion. Moreover, women are not getting accurate and
unbiased information to help them make .an informed choice about
the use of these hormones.
In addition, what is the rationale for a different policy about
FDA regulation of bioidentical hormones when they are manufactured
en masse and sold by retail pharmacies, where there is full
FDA regulation, and not for bioidentical products. that are customcompounded
by pharmacists? There is no clear rationale for a difference
in regulation.
Advocates of bioidentical hormones, particularly custom-compounded
ones, assert that these products are more effective at relieving
menopause symptoms, have fewer side effects, and offer a
better balance of long-term health benefits and risks than other
hormone -options.
However, the truth is, we simply don't know that these claims
are valid. Large-scale, scientifically rigorous studies of bioidentical
hormones have not been conducted.
Until we have solid data to indicate otherwise, virtually all medical
authorities and professional societies agree that a conservative
and prudent approach is to assume that all hormone formulations
confer a similar balance of benefits and risks.
The following are specific concerns about custom-compounded
hormones due to their lack of FDA oversight.
As you have heard, quality control is problematic. Preparation
methods can differ from one pharmacy or pharmacist to another,
so patients may not receive consistent amounts of hormones. In addition,
inactive ingredients vary, and contaminants may be present.