About Bio-Identical Hormone Therapy – From the FDA

Note:  This Blog is now being published at www.menopausetheblog.com. Please visit and continue reading about Menopause there.

For an explanation of Bio-Identical Hormone Replacement Therapy (BHRT) — a term that the FDA does not recognize — and the issues that led to the FDA’s action this week against certain compounding pharmacies, see the agency’s latest update, “Bio-Identicals: Sorting Myths from Facts.” What is your point-of-view on BHRT. Has it made a difference for you?

Is the FDA Looking Out for Women or Wyeth?

Note: This Blog is now being published at www.menopausetheblog.com  Please visit and continue reading about Menopause at this new URL.

 

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?  

The Consensus on HRT

Every time I have a miserable night’s sleep, and last night was the fifth in a row that I had to take Ambien to knock me out, I reconsider taking hormones for relief of the hot flashes and the associated anxiety that keeps me awake all night and cranky during the day. It would be SOOO easy and I’d feel better in no time. Even my doctor takes them! But then all I have to do is read the latest article in the Harvard Women’s Health Watch newsletter that I now subscribe to. They published an excellent article that revisits hormone therapy’s risks and benefits based on data from the government’s “massive” postmenopausal hormone trials.  The article’s bottom line?   “Hormone therapy should be taken for the shortest time possible and at the lowest effective dose, although we don’t know whether lower doses are actually safer.”  This view is echoed by six different organizations including the FDA, The American College of Obstetricians and Gynecologists, and the U.S. Preventive Services Task Force (USPSTF).  When a woman begins taking hormone replacement  – that is, the gap between the onset of menopause and when she began taking hormones –is proving to be a risk factor for heart attacks, stroke and blood clots, and breast cancer as is whether she took estrogen alone or combined it with progestin. My bottom line?  I don’t want to put my health at risk and I will try complementary and alternative medicine for relief.   The National Center for Complementary and Alternative Medicine (CAM), which is part of the NIH,  (and the Federal Government’s lead agency for scientific research on CAM) concedes that “there’s very little scientific evidence the supports the effectivness of CAM therapies for menopausal symptoms, but they may provide some relief to women during the menopausal transition.” That’s good enough for me!