Compounded Bio-Identical Hormones in the News

[Guest guest]

Women everywhere are talking about the " crackdown " on bio-identical

hormones. I've been following this for awhile and have some strong

opinions on the topic. Thought I would open it up for converstation

if anyone wants to discuss it.

 

Yesterdays article is posted below this one from April, 2006:

 

Wyeth Demands FDA Relief

Medicine - Hormones & Meds

TS-Si News Service

Friday, 21 April 2006

Wants Intervention Against Drug Compounders

 

Drug maker Wyeth is demanding that the U.S. Food and Drug

Administration crack down on specialized compounding pharmacies that

make custom-made hormone drugs to treat menopause. The drugs are made

according to a doctor's prescription.

 

In response to Wyeth's request to the FDA, thousands of women who use

the custom-made treatments have deluged the agency with letters

opposing any move against compounding pharmacies, the Associated

Press reported.

 

Many women turned to the products sold by compounding pharmacies

after a 2002 federal study found that replacement hormones -- HRT --

made by drug companies increased the risk of heart attacks, strokes

and breast cancer, the news service said.

 

Wyeth charges that some compounding pharmacies dupe women with

products that may pose serious health risks. It wants the FDA to use

seizures, injunctions, and warning letters to go after these

pharmacies, the AP reported.

 

The custom-made estrogen, progesterone and testosterone products sold

by compounding pharmacies are not FDA-approved. The FDA said it needs

more time to review and respond to Wyeth's petition and the 27,000

comments about it.

 

January, 2008:

 

FDA Cracks Down on Custom-Made Hormones

Jan 9 2008 2:45PM EST

 

Government health officials on Wednesday began cracking down on

Internet sales of custom-mixed hormones for menopausal women, a

market born when doctors deemed prescription estrogen therapy too

risky for many.

 

But the Food and Drug Administration says these alternative hormone

mixes are no safer, and told seven makers to stop selling them.

 

The FDA said it sent warning letters to the companies saying their

claims about the " bio-identical hormone replacement therapy " or BHRT

products are not supported by medical evidence and are considered

false and misleading.

 

" We want to assure that Americans receive accurate information about

the risks and benefits of drug therapies, " Dr. Janet Woodcock, FDA's

chief medical officer, said in a statement.

 

The agency said it is concerned that the claims for safety and

effectiveness mislead patients, as well as doctors and other health

care professionals.

 

Compounded drugs are not reviewed by the FDA for safety and

effectiveness, and FDA encourages patients to use FDA-approved drugs

whenever possible, the agency said.

 

The warning letters say the pharmacy operations violate federal law

by making false and misleading claims about their hormone therapy

drugs.

 

Following a 2002 study that found replacement hormones made by drug

companies raised the risk of heart attacks, breast cancer and

strokes, many women turned to the estrogen, progesterone and

testosterone products sold by compounding pharmacies.

 

Medical researchers concluded in 2003 that hormone replacement pills

should be taken only as a brief treatment to help women weather the

worst symptoms of menopause.

 

The drug company Wyeth later complained to the FDA about the Internet

sales of compounded products.

[Guest guest]

Translation:

Wyeth is crying like a big baby because compounding pharmacies hit them

where it counts - in the wallet.

FDA is listening to the big baby because Wyeth greases a lot of palms.

 

This has to be the funniest thing I've read in a while...

<<Wyeth charges that some compounding pharmacies dupe women with

products that may pose serious health risks.>>

 

As opposed to THEIR duping women with horse urine that has PROVEN to pose

serious health risks??

 

FDA is after our vitamins, our superfoods, our raw milk, our hormones...

while they poison us with the crap they mandate and allow in products.

Disgusting that they have it all backward.

 

 

Shana

Hormone Health... Nature's Way

http://www.women4balance.com/hhnw

http://www.BalancedNowPodcast.com

 

On Jan 10, 2008 12:05 PM, Michelle <michelle wrote:

 

> Women everywhere are talking about the " crackdown " on bio-identical

> hormones. I've been following this for awhile and have some strong

> opinions on the topic. Thought I would open it up for converstation

> if anyone wants to discuss it.

>

> Yesterdays article is posted below this one from April, 2006:

>

> .

>

>

>