The FDA caved.
One of the agency’s biggest benefactors – Wyeth Pharmaceuticals – stamped its feet and said, “Gimmie!” and the FDA said, “Oh all right.”
Its master’s voice
Two years ago, Wyeth petitioned the FDA to impose restrictions on compounding pharmacies that dispense bioidentical hormone replacement therapy (BHRT) to treat symptoms of menopause.
Of course, this was nothing more than a brazenly transparent business strategy dressed up as a “safety” concern.
See, Wyeth happens to manufacture synthetic hormone replacement therapy (HRT) drugs, and BHRT has taken on a huge share of the HRT market in the years since a major study revealed the risks linked to synthetic HRT use (heart attack, stroke, breast cancer – to name just a few).
So about two weeks ago, FDA officials threw Wyeth a bone. They didn’t come right out and ban BHRT or straightforwardly restrict its use (not all of it, anyway), but they did send letters to seven compounding pharmacies that formulate BHRT. The chief complaint is that these pharmacies make misleading claims on their web sites, characterizing BHRT as safer than synthetic HRT.
Now, what everybody involved in this hot mess knows (including all of our “safety conscious” friends at Wyeth and the FDA) is that there’s sound logic behind the claim that BHRT is safer than synthetic HRT. The sticking point is that there have been no clinical trials to confirm the logic. And that’s where the FDA sets the bar for evidence – at the so-called “gold standard” of large, placebo-controlled studies.
But don’t bother trying to tell medical mainstream wonks that these golden studies can be easily manipulated (especially by drug companies with billions of dollars at stake). They’ll just put their fingers in their ears and go, “YA YA YA YA I can’t hear you YA YA YA YA.”
Fast & loose
Along with letters to compounding pharmacies, the FDA also released a Consumer Update titled “Bio-Identicals: Sorting Myths from Facts.”
The FDA? Sorting myths from facts? Hilarious! One of the few areas where the FDA has actually excelled is in promoting myths while concealing facts.
Here’s one of their Myth/Fact gems that really deserves a mythbusting:
“MYTH: Bio-identical hormone products that contain estriol, a weak form of estrogen, are safer than FDA-approved estrogen products.
“FACT: FDA has not approved any drug containing estriol. The safety and effectiveness of estriol are unknown.”
True enough, the agency hasn’t approved estriol use. But that’s by no means the end of the story.
In response to the pharmacy letters, the International Academy of Compounding Pharmacists (IACP) sent out a press release with this comment: “Like many commonly prescribed drugsestriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.”
In the e-Alert “Where’s the Shame?” (2/7/06), I told you about the three primary types of estrogen that are present in a woman’s body between the onset of menstruation and the onset of menopause: estrone, estradiol, and estriol.
Here’s Jonathan V. Wright, M.D., on estriol: “It’s been found that estradiol, when prescribed by itself (as sometimes happens in conventional HRT) can raise the risk of cancer after several years. Estriol, on the other hand, is anti-carcinogenic. Healthy women naturally excrete much more estriol than estradiol and estrone. But when hormone production slows down during menopause, it’s important to replace all three estrogens in the same proportions your body would produce on its own if it could.
“With natural hormone replacement therapy, these estrogens are used along with natural progesterone in proportions as close as possible to those produced in the body.”
The FDA and Wyeth would like everyone to believe that bioidential estriol is dangerous. But logic is not on their side.
You can find more information about bioidentical hormone replacement therapy (including important guidelines for safe use) in this free special report, published by HSI.
“FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs” FDA News, 1/9/08, fda.gov
“Bio-Identicals: Sorting Myths from Facts” FDA Consumer Update, 1/9/08, fda.gov
“FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones” The International Academy of Compounding Pharmacists, 1/9/08, iacprx.com