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Bio-Identical Hormones At Risk
Big Pharma and their FDA Cohorts Seek to Eliminate Custom Compounded
Bio-Identical Hormone Formulations
The Food and Drug Administration (FDA) has announced a major assault on compounding medicine and bio-identical
hormones. The FDA is using a multi-prong approach that started last year with a Congressional Hearing before the
Aging Committee, and continuing with banning estriol, denying the term “bio-identical” to characterize compounded
hormones therapies, and encouraging consumers to use drugs instead.
We acted swiftly last year and were able to stop the introduction of the so-called “Safe Drug Compounding Act of
2007” in Congress by powerful Senators. Now we have a new battle.
In a series of warning letters to compounding pharmacies across the country, the FDA is asserting a policy that would
deny hundreds of thousands of women access to many compounded bio-identical hormones, substituting the FDA’s judgment
for that of doctors. (Remember when Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products,
petitioned the FDA in October 2005 to restrict access to bio-identical hormones? More than 70,000 doctors,
patients, and pharmacists filed comments with the FDA opposing Wyeth's petition.) By targeting estriol and
indicating that they are planning on banning its importation, this will effectively end compounded hormones for
women because 80% of all bio-identical hormone therapy uses estriol.
The FDA seems particularly upset with “marketing” claims that bio-identical hormones are a better choice than
“FDA approved menopausal hormone therapy drug products.”
In a Consumer Health Information flyer Consumer Health Information flyer, the FDA points out that they have
not approved any drug containing estriol so therefore the safety and effectiveness of estriol are unknown.
Of course since estriol is a natural ingredient and is therefore unable to be patented, no company has submitted
it to the billion dollar pipeline at the FDA. The FDA is ignoring the fact that before Premarin the work on hormone
replacement therapy was with "bio-identical" hormones. Additionally, there are several European studies about
estriol that are quite impressive.
The FDA also downplays the lack of adverse event reports in relation to bio-identical hormones. Their flyer
says, “Unlike commercial drug manufactures, pharmacies aren’t required to report adverse events associated with
compounded drugs.” What they are not saying is that consumers can report any AER and furthermore doctors and
hospitals are required to report all adverse events.
What You Can Do
This is an unexpected attack and we need your financial support in order to devote our resources to battle
this important issue. Please join and donate today! For lobbying efforts join and donate to AAHF and for
research and educational efforts, please make a tax-deductible donation to our Health Freedom Foundation.
1) Spread the word. Tell people to visit
www.healthfreedom.net
Download, print, and distribute our flyer.download flyer
2) Be prepared to contact Congress and the FDA in a few weeks to let them know what you think about bio-identical
hormones.
3) Join the organization Patients and Professionals for Customized Care, at
www.www.savemymedicine.org
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