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[Fwd: Wyeth's War on Women and Bioidenticals]

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This doesn't directly affect

our children but it does. When mommy ain't happy, ain't no one happy.

But on a more serious note - compounding pharmacies and a patient's

view on what's best for them has been taken away and once again, Pharma

has it's way. What's next...

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Wyeth's War on Women and Bioidenticals

Date:

Wed, 9 Jan 2008 17:10:15 -0800 (PST)

From:

Dr

To:

jamie@...

Dr.com: Health

   

     

   

Wednesday January 9, 2008

Wyeth's

War on Women and Bioidenticals

The Food and Drug

Administration has declared war on bioidentical hormones and plans to

eliminate the compounding and availability of estriol.

This disgraceful action is the direct result of an intense lobbying

petition by Wyeth, the leading manufacturer of synthetic hormone

products, even though more than 60,000 doctors, patients and

pharmacists filed comments with the FDA opposing Wyeth's petition.

The lesson here: When Wyeth speaks, the FDA listens.

In this case, Wyeth is using the agency to bludgeon compounders out of

business and protect market share of its non-human identical products

which have been shown to cause deadly side effects since 2002.

The FDA sent letters January 9 warning seven pharmacies that the claims

they make about "bioidentical hormone replacement therapy" are

unsupported by medical evidence and said that the agency plans to halt

the compounding of medication containing estriol.

This action has the potential to deny hundreds of thousands of women

access to bioidentical hormones - substituting the FDA's judgment for

that of their own doctors.

Estriol is a human hormone produced by the human body. It is one of the

three estrogen molecules and the most abundant during pregnancy. Women

who cannot tolerate estradiol may use estriol. Like many commonly

prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has

a monograph from the U.S. Pharmacopeia (USP). When Congress passed the

FDA Modernization Act in 1997, it clearly indicated that drugs with a

USP monograph could be compounded.

Estriol is commercially available in many countries. If the FDA has its

way you'll need a passport, not a prescription, to get it.

One more fact that the FDA seems to have overlooked in its rush to

appease Wyeth: The practice of medicine and pharmacy is legislated at

the state level and the relationship is between the doctor and the

patient. This is an area the FDA has no business being involved in.

Women need to know these facts and get together, educate their doctors

and become actively involved to prevent the limitation of treatment

options that may be imposed by financial interest placed ahead of their

wellbeing.

Wednesday January

9, 2008 in Health

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