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

138
makes these hormones uniquely standardized. In other words, a
woman in New Mexico can pick up the same Wiley Protocol as a
woman in New York City if, in fact, she goes to a pharmacy that
has agreed and committed to make them in this certain way.
I went for standardization because, obviously, it removes variables
for the doctors in discerning what is going on with their patients.
More importantly, I was aware that'no large pharmaceutical
company is going to sponsor clinical trials for the Wiley Protocol,
and that clinical trials would be useless without a standardized
compound.
So by engaging enough pharmacies and asking them to donate
a percent of their volume that they do in the Wiley Protocol, ultimately,
to a national trial, I would have a standardized product
that could be looked at.
Senator SMITH. Do you have any relationship to the FDA? Do
they monitor what you do?
Ms. WILEY. No. Other than they monitor the bulk substances
that the Wiley Protocol, you know, derives from.
Senator SMITH. But they have investigated your products, I assume,
and
Ms. WILEY. I believe they only investigate the bulk material that
pharmacists use, and then that is, as Dr. Allen said, a pharmacyto-pharmacy
case, whether or not FDA inspects
Senator SMITH. Those women who sign up for the Wiley Protocol,
you have found overwhelmingly good results?
Ms. WILEY. Surprisingly good results.
I don't know what I anticipated. I was just interested. The
oncologist I have worked with for over 7, 8 years, and a very large
group of doctors both in Santa Barbara and around the country, we
are all surprised at how remarkably well the women seem to do.
Senator SMITH. Dr. Allen, how does the Wiley Protocol fit within
your academy's view of things?
Dr. ALLEN. Well, I can address it from the, formulation standpoint.
Physicians in prescribing a compounded preparation may want a
certain effect, and so the pharmacist has some leeway in the different
excipients, or non-active ingredients, that can be included.
So for the Wiley Protocol, it is, as was explained, a set formulation
so that it can be compared-
Senator SMITH. Which would be different from your members
who might be coming up with their own formulations and having
pharmacies produce them?
Dr. ALLEN. Yes. The individual physician, based upon what they
want in their specific prescription for their specific patients, they
have some flexibility in the different excipients that can be used,
yes.
Senator SMITH. Dr. Manson and Dr. Wartofsky, if compounded
products could be standardized, as Ms. Wiley has done with her
products, would that alleviate your concerns?
Dr. WARTOFSKY. I would have
Senator SMITH. Push your button there.
Dr. WARTOFSKY. Sorry. I would have residual concern. The concern
with compounded products is that they may not be of suffi-