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Selling The Promise Of Youth

...At that point, many traditional gynecologists shied away from prescribing hormones.

Through the Cracks More recent studies have downplayed the heart disease risk, but in the meantime, anti-aging doctors have stepped in to fill the void, promoting natural, or "bio-identical," hormones as safe alternatives.

Critics take issue with these products for several reasons.

First, bio-identical hormones are made by so-called compounding pharmacists.

Historically, they have been permitted by law to customize medications for individual patients - for example, people who react adversely to certain ingredients.

But under FDA rules, they should not be manufacturing or selling drugs to a mass market.

To get into that business, they would have to submit to strict supervision of their facilities, the quality of their products, the claims on their labels, and the like.

Critics blast the FDA for letting too much activity slip through the cracks.

The second big complaint involves the very term "bio-identical." The hormones prescribed by anti-aging doctors are generally derived from plants such as soybeans and sweet potatoes, and combined into proprietary recipes, which may never be tested in human trials.

Anti-aging proponents say the substances are natural, safe alternatives to FDA-approved hormones such as Prem...

FANS to FDA: Stick with Science; Leave Science Fiction to ...

... This study was stopped by Wyeth in 2002 because the data demonstrated a link between Wyeth's products and significant adverse effects, including increased risk of breast cancer, heart attacks, strokes and blood clots.

The study contained NO data suggesting that BHRT was dangerous.

In fact, there is no scientific data available that supports this claim.

"It is unconscionable that Wyeth claims to be acting in the best interests of women and their health while continuing to market Premarin, and simultaneously undermining proven safe and effective treatments," said Dr.

Hotze.

As a result of the WHI study, Wyeth suffered a $1.2 billion (68 percent) decline in the sales of its Premarin line between 2002 and 2004, which led to the closing of one of its manufacturing plants.

Yet, Wyeth refuses to pull Premarin from the market.

"Wyeth's actions have nothing to do with a concern for a patient's health; rather it has everything to do with eliminating its competition through overregulation.

At stake is a woman's right to make the healthcare choices that are right for her without the interference or undue burden of the federal government," concluded Dr.

Hotze.http://www.usnewswire.com/ -0- /© 2006 U.S.

Newswire 202-347-2770/ Printer Friendly Format © 2006 U.S.

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USA Today Examines Criticism of Women's Health Initiative Study on ...

... However, WHI researchers said that about 30% of hormone trial participants were between ages 50 and 60 when they enrolled in the trial and noted that Premarin and Although the WHI results led FDA to begin advising women to take HRT only to reduce menopausal symptoms and then only to take the lowest dose for the shortest amount of time, "a coterie of gynecologists and other researchers refuse to give up on estrogen," according to USA Today.

Two ongoing studies - the Kronos Early Estrogen Prevention Study and the Early Versus Late Intervention Trial with Estradiol - will examine the differences in heart attack rates for postmenopausal women ages 42 to 58 who are taking estrogen and assess plaque buildup in arteries with X-rays and/or ultrasound.

Some researchers - including menopause researcher Deborah Grady, a University of California-San Francisco internist who was not part of WHI - said, "If it's true that estrogen is helpful right around menopause, maybe that's scientifically interesting," adding, "What then?

You take it from 50 to 59?

Then at some point it becomes dangerous?

...

How do we figure it out?

" (Rubin, USA Today, 2/23).

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