Is the FDA Looking Out for Women or Wyeth?

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The FDA announced that it will be “cracking down” on pharmacies that sell customized hormone mixtures prescribed by physicians to alleviate menopause symptoms.   This is the latest move in an ongoing debate over the growing use of  “compounded” hormone products.  In 2006, The American Medical Association  passed a resolution concerning compounded hormones and the U.S. Senate circulated a copy of proposed draft legislation called the Safe Drug Compounding Act of 2007 , which opponents – namely the trade association of compounding pharmacists – said would give FDA “unprecedented” authority and greatly restrict access to compounded medications. (To see their response to the FDA’s latest action this week, click here.)  And finally, in 2006, Wyeth filed a petition with the FDA  asking the agency “to address the growing trends of unlawful manufacture and marketing of so-called bio-identical hormone replacement therapies (BHRTs).” Since Wyeth makes Premarin and PremPro, both made from the urine of pregnant mares and used in HRT, one could surmise that the company is asking the government to eliminate competition from plant-based hormones. The FDA denies a connection between their action this week and the Wyeth complaint, but it does raise the question – is the FDA looking out for women or the drug company?

Specifically, the FDA told seven individual pharmacies that they couldn’t sell hormone mixtures containing Estriol, an estrogen produced by the human body, that the agency views as a new drug that hasn’t been approved.  In addition, these pharmacies are to refrain from using the word “bio-identical” to describe the compounded mixtures. 

The interest in and increasing use of “bio identical” hormones has resulted from the fact that there are an estimated 6,000 women reaching menopause every day (according to the North American Menopause Society) and many are seeking natural alternatives to HRT given their potential hazards. 

Elizabeth Lee Vliet, M.D.is a physician who specializes in individualized hormone therapy and the author of several books including Women, Weight & Hormones, and  The Saavy Women’s Guide to Hormone Headlines.  She weighed in on this debate in an email that was sent today to subscribers of her newsletter. She offered, I believe, a balanced perspective on the issue.  Though she is a proponent of “proper use of compounded medications” she “applauds the FDA’s action” and stated her concern about unregulated “natural” hormone mixtures. “Many of these formulas advertised on pharmacy websites on the internet contain hormones that can have adverse effects, or doses that are potentially dangerous, she explained.”   

As someone who has considered using bio-identical hormones, I’m more confused than ever about their efficacy and safety. Whom should we trust to give us straight answers?  Dr. Vliet states that she is not paid by nor is she is any way affiliated with pharmaceutical companies or other advocacy groups, so I’ll be tuning in to her Blog Talk Radio program on Monday, Jan. 14^th  (9pm est), when she will talk about  “bio-identical hormones – sorting out myths and facts.” You can find details about this program on her website and at Blog Talk Radio. 

I’m interested in hearing from anyone who has used bio identical hormones. Have they worked for you?