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

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How can we determine whether bioidentical hormones are safe
and effective? By conducting well-designed clinical trials which are
scientifically rigorous to gauge the safety and effectiveness of these
medications.
Unfortunately, for many bioidenticals, and for custom-compounded
bioidenticals specifically, such trials have not been done.
Without clinical trials, we simply don't know how safe or effective
these drugs are.
Trials of a relatively small size and short duration could prove
or disprove whether such hormones are effective in treating hot
flashes, night sweats or other symptoms of menopause. These trials
would have to be placebo-controlled.
However, larger-scale trials, even more than 25,000 women-the
scale of the Women's Health Initiative, the both hormone trialswould
be needed to substantiate or refute the claim that bioidentical
or custom-compounded products are safer than conventional
hormone therapy in terms of clinical outcomes such as heart attack,
stroke, or venous blood clots, or breast cancer.
Mid-size studies can be done to look at intermediate end-points
such as blood markers of clotting or inflammation and also noninvasive
imaging of atherosclerosis. Some trials, such as the Kronos
Early Estrogen Prevention Study and the ELITE Trial, are in
progress looking at those issues. But they cannot address whether
there is a difference in clinical outcomes such as cardiovascular
events or breast cancer.
In summary, the prudent Dolicv, in the absence of scientific evidence
to the contrary, is to assume that all post-menopausal hormone
formulations confer similar risks and benefits. However,
many proponents of custom-compounded bioidentical hormones are
making unsubstantiated claims of superiority that run directly
counter to this policy.
Given this pervasive and misleading marketing, I have a deep
concern that women, and even some of their doctors, are not getting
the objective information necessary to make well-informed
choices about hormone therapy.
There is an urgent need for increased regulatory oversight of custom-compounded
bioidentical hormones as is done for traditional
hormone therapy, including assessment of purity and dosage consistency,
the inclusion of uniform patient information about risks
and benefits in the packaging of these products, mandatory reporting
by drug manufacturers and compounding pharmacies of adverse
events related to these hormones, and clinical trials testing
the safety and efficacy of these products.
Thank you very much. I would be happy to answer any questions.
[The prepared statement of Dr. Manson follows:]