What's with the new FDA warning on bio-identical hormones?

You're going to be reading a lot of reports about bio-identical hormones in the coming months, and, if you're like most busy people and perhaps not paying too close attention to the details, you might well come away with one troubling sound byte- "The FDA is saying they're not safe!"

Actually, that's not at all what's happening.

After a landmark 2002 Hormone Replacement Therapy study came out showing that conventional hormone replacement therapy was associated with an increased risk of heart attack or stroke, there was a huge drop in sales of drugs like Premarin. Wyeth, the big drug company that makes Premarin and Prempro saw their sales cut in half.

Women began to turn to what they perceived as safer alternatives. Integrative medicine practitioners have been using bio-identicals for years, and bio-identicals were given a huge boost after Suzanne Somers wrote a couple of books touting them. Well-known experts like respected endocrinologist Diana Schwarzbein, MD have also been proponents.

So Wyeth did what any big business would do- they ruthlessly went after the competition.

They put the full might of their company- which took in over 14 billion in gross profit in 2006- into petitioning (and lobbying) the FDA to eliminate competition from the bio-identicals. The period for comments on the petition closed on April 4, 2006. It usually takes the FDA about 18 months to act after a petition is closed for comment, and sure enough, this month (Jan 2008) they did.

The FDA has "issued warnings" to seven major compounding pharmacies.

But what you need to know is this: There has never been a complaint against the bio-identicals. This is not a case like ephedra where there are a hundred or so "suspicious" deaths that "might" be linked to the drug. Nope. Nothing. Nada. Just the Wyeth petition. And if you read the warnings and the FDA press releases, it is very clear to anyone that they are warning these pharmacies against "making claims" that have "not been proven".

The FDA is not saying bio-identicals aren't safe. Nor are they saying they have any reason to believe they're not safe. They're simply saying their safety hasn't been "proven".

Well of course they haven't been "proven". Who's going to put up 100 million dollars for research on a substance they can't patent or profit from?

And remember, there are "claims" that water puts out fire and those haven't been "proven" in double blind randomized control studies either.

The FDA warnings refer to marketing practices only. Wyeth has succeeded in getting the FDA to try to intimidate physicians and pharmacies making these safe and effective alternatives to Premarin- which is made from the urine of pregnant mares.

If you have a hormone-dependent cancer or are at high risk for one, you should of course see a doctor well versed in this stuff before using any kind of hormone replacement, artificial or bio-identical.

Just remember that there's been not a shred of evidence that the bio-identicals have any specific problems associated with them, other than the fact that they seriously cut into Wyeth's profits. As the International Academy of Compounding Pharmacists (IACP) has siad, "Under this policy, patients will suffer while Wyeth profits".