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

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"natural," because all lead to substantially higher blood levels of estrogen and/or
progesterone than the levels that occur naturally in women after menopause. (also
see response to question #3)
Question. Could you clarify for the record your position on the use of FDA-approved
bioidentical versus custom-compounded hormone therapy products?
Answer. Provided that they are appropriate candidates for hormone therapy,
women who prefer to use FDA-approved bioidentical hormone preparations (such as
estradiol and micronized progesterone) rather than traditional hormone products
(such as conjugated equine estrogens and synthetic progestins), or transdermal over
oral delivery systems, can be encouraged to do so, as these products may offer some
advantages over traditional ones. That said, until we have solid data from randomized
clinical trials that indicate otherwise, the conservative and prudent approach
is to assume that all FDA-approved hormone formulations confer a roughly similar
balance of benefits and risks.
There is no evidence that custom-compounded bioidentical hormone products are
safer than FDA-approved bioidentical products, and healthcare providers should
clearly convey this message to their patients. Indeed, custom-compounded bioidentical
products carry unique risks-insufficient quality control; unreliable information
about benefits and risks; misleading advertising claims; and are often accompanied
by unreliable and expensive saliva and blood tests;-and should not be used by most
women. Few women have a legitimate need to select a custom-compounded hormone
product over other hormone options. The main valid reasons for a woman to choose
a custom-compounded hormone product are allergies to certain ingredients (e.g.,
peanut oil in Prometrium) or intolerance to doses of commercially available products.
With the recent availability of many different dose levels, there should be even
less need than in the past to select a custom-compounded hormone product.
Question. When you spoke of the need for clinical trials on bioidentical hormones,
did you mean head-to-head studies between FDA-approved bioidentical hormone
products and traditional conjugated equine products, or did you mean custom-compounded
bioidentical hormones and traditional products? If you were referring to
custom compounding, how could you have a controlled trial without having a "standardized"
compound preparation?
Answer. There are two types of double-blinded randomized clinical trials that
need to be done. First, we need clinical trials that directly compare FDA-approved
bioidentical hormone products to traditional hormone therapies such as conjugated
equine estrogens or other synthetic products. These studies should compare different
hormone formulations, as well as routes of delivery (such as pill, patch, or cream),
with respect to their effects on blood-based biomarkers (including levels of cholesterol,
C-reactive protein and other markers of inflammation, and markers of thrombosis),
intermediate endpoints (such as noninvasive measures of atherosclerotic
build-up or mammographic density), and, eventually, hard clinical endpoints (such
as heart attack or breast cancer). Second, we need clinical trials that directly compare
FDA-approved bioidentical hormone products with custom-compounded bioidentical
hormones to determine which type of therapy, if either, is more effective
at relieving menopausal symptoms and improving quality of life and sleep. In the
FDA-approved bioidentical hormone arm of such a trial, the dosing should be determined
in the usual way-i.e., start with the lowest possible dose and then adjust
the dose based on the symptoms subsequently reported by the participant. In the
custom-compounded bioidentical hormone arm, the initial and subsequent dosing
would be based on results of ongoing blood and saliva tests until hormone levels are
"stabilized" according to a preset protocol. Both types of clinical trials are affordable
and feasible; they can be conducted with relatively few women and in a short time
span, providing answers to many of the research questions in 6 to 12 months of follow-up.
If initial trials look promising, then serious consideration should be given
to mounting a large-scale clinical trial to compare the effect of these various hormone
products on clinical events.
RESPONSES TO SENATOR SMITH QUESTIONS FROM LEONARD WARTOFSKY
Question. In your testimony you referenced internet pharmacies going beyond
proper professional bounds and doctors on the "fringe" who were prescribing compounded
bioidenticals. Can you give the <strong>Committee</strong> any further information on
these problems you've identified, i.e. where and how frequently this is happening?
Answer. Unfortunately, no hard data exists detailing how frequently physicians
in the broader medical community are prescribing compounded bioidentical hormones.
However, the vast majority of The Endocrine Society members support our
position statement, providing evidence that most endocrinologists do not prescribe