The FDA vs. Compounding Pharmacies vs. Wyeth: Act II

Last month, I wrote about the FDA’s action restricting certain compounding pharmacists from dipsensing bio-identical hormones containing estriol - a form of estrogen.  Wyeth, the biggest seller of prescription menopause hormones (Premarin and Prempro), had petitioned the FDA  in April, 2006, to take this action complaining that many compounders make false claims about the drugs’ safety.  The FDA says the two actions aren’t linked, but I say, what a coincidence!

Following Wyeth’s petition, the FDA received 40,000 emails and letters (as reported in a Wall Street Journal “Health Journal” column 5/2/06) from women, doctors and pharmacists protesting Wyeth’s action.  Given the findings of the Women’s Health Initiative, a landmark government study, about the health risks associated with traditional, synethic menopause hormones, the move threatened the availability of an alternative solution for women experiencing severe menopause symptoms. I wondered, was the FDA looking out for women or Wyeth?  Are bio-identical hormones really as unsafe as the FDA suggests? As unsafe as synthetic hormones?

Earlier this week, the International Academy of Compounding Pharmacists struck back. They announced that they are calling upon the American Assoc. of Clinical Endocrinologists and the North American Menopause Society - two independent women’s health organizations that have voiced support for Wyeth’s actions - to “fully disclose their financial ties to Wyeth, when dispensing advice to patients and practitioners, that directly benefits the pharmaceutical giant.”  They claim, for example, that the executive director of NAMS, Dr. Wulf Utian, benefits from Wyeth’s endowment of a lectureship fund named for him. In addition, they state in their press release that Wyeth was named a “partner in menopause education,” which requires a financial contribution, for the NAMS 2007 annual meeting.  Dr. Utian has stated that he is “not funded by Wyeth Pharmaceuticals,” when he appeared on Larry King Live (11/16/06).

It has gotten to the point where it’s hard to trust any advice when it comes to prescription medicine- whether it’s from our doctors or our government. There are competing financial interests, to be sure. But it is not too much to expect that the government agency charged with oversight of the pharmaceutical industry should remain neutral and act with integrity in the best interests of women. Our government’s own study revealed the health consequences posed by synthetic hormones.  In fact, they proved to be so detrimental to our health that a decision was made to end the study prematurely.   Rather than taking them off the market, however, the FDA has recommended instead that “hormones should be used at the lowest dose that helps and for the shortest amount of time.” That certainly isn’t reassuring. And it makes their most recent action against seven pharmacies that dispense “so called bio-identical hormones” most ludicrous.   

For a physician’s point-of-view on this topic, see my Jan 21st interview with Dr. Marsha Nunley. 

If you’re interested in knowing more about the IACP’s lastest action, and the facts as they view them, visit their new website on this topic.  You’ll also be able to sign up for their newsletter, “Custom Care Times,” for continual updates on their efforts to preserve women’s access to custom-compounded, bio-identical hormones.

The organization has also published the FDAs response to letters of protest against their January action against seven compounding pharmacies.