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

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cient content, quality, purity, so that women might be either
underdosed or overdosed.
So Dr. Allen's comment that the doctor should pick up these adverse
effects really doesn't apply because some of these effects may
take years, if not decades. For example, if an estrogenic compound
is underdosed and leads to bone mineraf loss and osteoporosis, that
will show up 10, 20 years Iater. The doctor will not pick that up.
Ms. Wiley's standardization of her formulation that is going out
across the country to different pharmacies to me is counterintuitive
to customization. If she is customizing the dosage for the individual
patient, how does this fit a standard protocol?
Her analogy to diabetes and insulin doesn't hold. In the case of
diabetes, we have a very specific marker to follow in terms of the
efficacy of insulin: the blood sugar.
As Dr. Manson mentioned, the test to measure hormones by saliva
or blood tests are notoriously inaccurate and thrown off. So it
is really impossible, as I mentioned in my statement, to truly customize
to an individual woman what her estrogen levels or progesterone
levels should be by some standard formulation analogous
to insulin and blood sugar.
Ms. WILEY. May I respond?
Senator SMITH. Yes. Let me get Dr. Manson. Then we will give
you the last word, like Bill O'Reilly. [Laughter.]
Dr. MANSON. I agree with all of the concerns expressed by Dr.
Wartofsky. But I also want to emphasize that some of the risks of
having an inadequate dose of the progesterone are very serious.
Women who have a uterus who are taking estrogen have increased
growth of the lining of the uterus. It is very important that
they receive an adequate dose of a progestogen, whether it is natural
or synthetic, in order to avoid uterine cancer, endometrial cancer.
So if there is an inadequate dose of the progestogen, then they
are at an increased risk of uterine cancer.
So I think there are some very serious concerns about not having
uniformity of dose or consistency, knowing exactly what doses are
there.
Also, if women are being told about the lack of scientific studies,
the lack of evidence that these custom-compounded hormones are
any safer or more effective then, again, it seems unlikely that they
would be paying as much out-of-pocket for them and having these
tests done that have not been proven to have validity.
Senator SMITH. Ms. Wiley?
MS. WILEY. Well, first of all, I am flattered that anyone could insinuate
low doses with the Wiley Protocol because we use quite a
bit at the Wiley Protocol.
I don't ever involve myself with individual patient response. That
belongs to their doctor.
However, by testing potency four times a year at the registered
pharmacies to make sure what is on the label is in the syringeand
we use syringes-by following these women with what seems
to be a standardized dose-it is one dose not fits all, but starts
all-the customization actually is true.
These women are all on a rhythm. I am very concerned about the
curves in the rhythm. However, their doctors customize this-because
it is a compounded product and not FDA-approved-they cus-