Wyeth ganging up on estriol and compounding pharmacies

[Guest guest]

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 | Permalink

[Guest guest]

I thought that the big pharma companies supply the hormones that the

compounding pharmacies use in their formulations? Each of these pharmacies

is not a manufacturer, they use hormones that are manufactured on a vast

scale. The hormones are all manufactured products, even if they are

chemically identical to the bodies hormones.

That means they must make a profit on the compounded ones as well. So I

don’t know why they would be so against compounding, unless it is because

they want to market their own bio-identical hormone brands.

Karima

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 | Permalink