Getting even Talk about a sore loser. Wyeth, one of the major players in the patent drug industry, found itself in a world of trouble a few years ago when researchers discovered that two of its biggest money makers, the hormone replacement drugs Premarin and Prempro, can increase women's risks of heart attack, stroke, and cancer. Subsequently -- and understandably -- there was a mass exodus away from these synthetic hormones. Wyeth has been sulking ever since. But it looks like the pharmaceutical giant is done getting mad. Now it wants to get even. And your access to the safe, natural alternatives to their risk-laden drugs hangs in the balance. You see, Wyeth has enlisted Big Pharma's best friend -- the FDA -- in its plot for revenge, clamoring for the agency to crack down on compounding pharmacies offering bio-identical hormone replacement therapy (BHRT). Never one to disappoint (the pharmaceutical industry, that is), the FDA made swift work of sending letters to seven compounding pharmacies that offer bio-identical hormones, warning them that the claims being made about bio-identical hormones are "false and misleading." The agency claims that there's no proof that bio-identical hormones offer protective benefits against Alzheimer's disease, stroke, or cancer; that the safety and effectiveness of estriol is unknown; and that any claims that bio-identical HRT is "better than FDA- approved menopausal hormone therapy drugs" are unsupported. Unsupported?! The large-scale Women's Health Initiative study came screeching to a halt because of the dangers associated with those "FDA-approved hormone therapy drugs." And, yet, since then, thousands of women have turned to the bio-identical versions instead without any reports of any serious problems. (And you can bet that if there were problems, the mainstream -- both medicine and media -- would've pounced all over them.) So what more support does the FDA need that natural is better? Clinical studies? Well, despite their claims to the contrary, there are plenty of those, many of which, Dr. Wright reminded me, have been cited in the numerous articles he's written on BHRT over the years. The whole thing is an absurd and maddening ploy to turn the tide against bio-identical hormones. In fact, the FDA is setting the stage to take this much further by also targeting the very term "bio-identical." In its warning letters to the compounding pharmacies, as well as in its information for the general public, the FDA has decided that the use of the term bio-identical implies that these "drugs" (as they're referred to) are identical to the hormones made by the body and that, somehow, this implication makes it a marketing term. You and I both know that bio-identical is a definition, not an implication or a marketing ploy. And the sad part is, the FDA likely knows that too. But taking aim at a product's marketing is how the FDA typically takes down natural therapies, not actually based on reports of dangerous effects -- just on "claims" it feels are unsubstantiated. (They like to think that it's like getting Al Capone on tax evasion. The only difference is Al Capone was actually guilty of a whole lot more.) But if they succeed in labeling "bio-identical" as a marketing claim, a whole lot of other natural therapies besides BHRT will be in jeopardy soon. So far, the FDA has "only" targeted seven compounding pharmacies. But it's critical to stop them in their tracks now, before that list starts growing. After all, there's no saying whether or not your own pharmacy might be next. Which means it's time to break out the heavy artillery once again and lay siege on Congress with letters and phone calls voicing our disapproval of the FDA's latest power grab. The International Academy of Compounding Pharmacists has set up links on its website, www.iacprx.org, that can help you get your message across loud and clear. Just click on any of the options to "Take action" or "Oppose" the FDA's attempts to restrict BHRT (there are two such links on the iacprx.org homepage). The links will take you to a page that offers contact information for members of Congress, as well an option to send an email directly to your congressmen and the FDA (all you have to do is fill in some blanks). Source:
"FDA takes action against compounded menopause hormone therapy drugs," FDA News, press release (www.fda.gov), 1/9/08 | 
