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The
following message is provided by International Academy of
Compounding Pharmacists.
January 30, 2009 Oprah
Winfrey Continues BHRT Discussion Robin McGraw,
Dr. Phil's wife and a BHRT patient, and Dr.
Christiane Northrup, renowned author and
speaker, started the conversation a couple weeks ago
when they joined Oprah to talk about BHRT. Women
across the country wrote in to "The Oprah Show"
wanting more information on how to take control of
their menopause symptoms. Somers shared her experience being
treated by her physician with BHRT to alleviate her
menopause symptoms. She also demonstrated her daily
regimen of compounded medications and dietary
supplements. "By replacing my hormones with
bioidentical hormones, I got my life back. I got my
health back, I got my figure back, I got my
happiness back," Somers said. Oprah stressed that women "have
the right to demand a better quality of life" and
they should all do their research. However, positive praise of BHRT
was also met with harsh criticism when Dr.
Lauren Streicher, an assistant professor of
obstetrics and gynecology at Northwestern University
and a practicing ob-gyn at Chicago's Northwestern
Memorial Hospital, expressed her dislike for
compounding pharmacies. To be certain, Dr. Streicher's
commentary was the most grievous offense contained
in the episode on compounding pharmacies. She
misstated facts and presented a distorted picture of
pharmacy compounding and how the profession is
regulated. Today IACP sent a formal letter to the
producers of "The Oprah Show" to dispel the untruths
presented by Dr. Streicher. (See below for full
commentary.) At the end of the show, a taped
segment featured a woman who shared her struggles
with menopause on part one of the BHRT debate that
aired Jan. 15. Robin McGraw escorted the woman to
have her hormone levels checked. It was determine
that she needed BHRT, and only nine days later she
was noticing the difference. "The side effect from
the bioidentical hormones is a big dose of joy. It's
fantastic," she told Oprah via webcam. To view segments and read about
what was discussed on the show, click
here. IACP
Responds to Oprah She drew a false distinction
between "FDA-approved pharmacies and non-FDA
approved pharmacies," and insinuated that
compounding pharmacies are not approved by the
FDA. In fact, there is no such thing as an
FDA-approved pharmacy. All pharmacies are
registered, inspected, and regulated by state
boards of pharmacy ;including compounding
pharmacies. "They (compounding
pharmacists) have no obligation to support their
claims. The can say what they want... The truth
is, you can get the exact same product in an
FDA-approved pharmacy from true experts."
Actually, the truth is pharmacies cannot say
whatever they want. They cannot give false or
misleading information without facing potential
enforcement action by FDA, FTC, and the state
board of pharmacy. Further, it is true that some
bioidentical hormones are now manufactured by
FDA-registered manufacturers and dispensed by
state board registered pharmacies. These meet
the needs of some patients. For other patients,
they are prescribed compounded doses and dosage
forms that must be compounded by a specialty
pharmacy. She misstated that all
synthetic hormones were plant-derivatives. This
is not the case. For example, some of the most
widely prescribed synthetic hormones are
conjugated estrogens derived from horse urine.
These are not biological equivalents as are
estradiol or estriol. She suggested bioidentical
hormones are generally obtained directly from
compounding pharmacies. Bioidentical estrogens,
whether compounded or manufactured, may only be
dispensed to a patient pursuant to a valid
prescription from a licensed prescriber
(physician, nurse practitioner, etc). Dispensing
these medications without a valid prescription
is a violation of both federal and state law.
Click
here to read IACP's letter to Oprah Winfrey and
her show producers.
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