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

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Senator SMITH. Dr. Allen, as I have listened to your testimony,
it seems to me that you are saying the doctor just recommends a
certain compound and sends that to the pharmacy, and then that
is a kit made just for that particular patient.
What guidance do they have? I mean, is it just based on their
training as a physician, or is there something deeper that they
know that traditional therapies don't have?
Dr. ALLEN. Pharmacists will only fill a prescription from a licensed
physician or a health-care practitioner. It is the responsibility
of the health-care practitioner to care for the patient and to
prescribe appropriate medications.
So, yes, you are correct. When the physician determines that a
specific patient needs a compounded medication, then it is originated
at the physician's office.
Now, in some cases
Senator SMITH. Well, I assume, because they are doctors, they
are very well-trained, but I don't know if their training goes this
deeply into how all these things interact.
I am not a physician. I was trained in law. But I would think,
based on my training in law, they are out there on their own, if
they are doing this, if there is some ill effect from it.
Dr. ALLEN. That is correct. They are trained.
Basically the- physician will prescribe, first of all, the drug, the
dose, the dosage form, the frequency of administration, and the
quantity. That would all go on the prescription. Then they work
with the pharmacist in order to compound the medication specifically
for that patient.
Senator SMITH. Is there any ever very ill effects from this pioneering
method that each physician would take?
Dr. ALLEN. Well, there are obviously ill effects from almost any
medication that may be prescribed across the board. But with clinical
experience, the physicians, you know, continue to prescribe
medications for these specific patients.
Senator SMITH. So it is sort of an ad hoc building block. What
has worked in the past? Let's try this and do that?
Dr. ALLEN. Yes. It is very similar to just the standard practice
of medicine. Not everything works for everybody, and so the physicians
will try a drug product until they find something that that
specific patient will respond to.
Senator SMITH. I appreciate the education you are giving me.
Dr. Wartofsky and Dr. Allen, your two organizations have two
very different positions as to who ought to regulate bioidentical
hormones made by compounding pharmacies. The International
Academy says States are best to regulate it. The Endocrine Society
believes that the FDA, the Federal Government, is best to regulate
it. I wonder if you can each tell the committee how your groups
have reached their very different positions, including what evidence
or information you found to support the conclusion of your academy
or society.
Specifically, did you consider mortality and morbidity rates, consumer
complaints, State statutory and regulatory provisions regarding
compounding? How did you come to such different places
on that?