Issue: March 2008
March 25, 2008
2 min read
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Was the action by the FDA warranted — and is it enough?

Issue: March 2008
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The FDA took action against compounded hormone therapy in January by sending letters to seven compounding pharmacies and warning them that their claims about the safety and efficacy of bioidentical hormones are unsupported by medical evidence and considered false and misleading by the FDA.

POINT

FDA action has been a long time coming

Since the late 1980s, the FDA has tried to get at this issue and has been rebuffed on several fronts: on issues of terminology, safety and efficacy, patient and physician education, and more recently large basis compounding vs. manufacturing, and perhaps most importantly on the issue of whether some current compounding practices are simply a way of avoiding oversight and regulation. The compounding pharmacies have largely dismissed the above issues wanting to avoid regulation. I think the current approach that the FDA has taken is not nearly enough, but may be a small step that they can enforce. Its an obvious place to start. If you can focus on a detail to slow down the entire train then maybe you can win the battle.

James A. Simon, MD, PC, CCD, FACOG
James A. Simon

On the other hand, I would hate to see compounding go down the tubes. Clearly, there is an important place for quality compounding pharmacies. This is not really a problem of estriol (the detail being used to slow down the train); this is an approach to the issues that they have not been able to get at in general. It is simply using estriol as a tool. Some compounders have taken the lack of oversight and regulation as an open frontier to branch into what is really manufacturing, large-scale compounding and selling.

There are a lot of legal issues involved, the proverbial “elephant in the room” that no one is talking about, which range from issues of fairness in the marketplace to truth in advertising. They are all part and parcel of this discussion but no one is pointing a finger at those issues because they are much bigger and harder to prove. The practical issues with so called bioidentical hormone therapy are that they come to the patient with no black box warning like other hormones, no patient package insert, they have little or no safety or efficacy data, there are no uniform manufacturing standards, and there has been little check on advertising claims often made by notable celebrities.

James A. Simon, MD, PC, CCD, FACOG, is a Clinical Professor at George Washington University and President and Medical Director of Women’s Health & Research Consultants in Washington, D.C.

COUNTER

Action goes beyond just bioidentical hormones

Everything that has been covered by legislation that allows unregulated products on the market that have the potential to affect health and disease is a mistake. Anything that claims to affect health or disease should be subject to appropriate scientific study with the same rules and regulations that trade products have.

Leon Speroff, MD
Leon Speroff

In retrospect, it is unfortunate that Wyeth appealed to the FDA with their petition [asking the FDA in 2005 to take action against compounding pharmacies making similar products to their Prempro and Premarin] because now it looks like this FDA call for action is linked to the pharmaceutical industry. It is important to emphasize that respected organizations, such as The Endocrine Society and the North American Menopause Society, have issued statements on this particular issue.

My recommendation to clinicians is that if a patient truly wants ‘bioidentical’ or ‘natural’ hormones, use a regulated approved trade product. If you want estradiol there are products on the market that are estradiol. If you want progesterone there are products on the market that are progesterone. Do not use combinations that have been promoted by compounding pharmacies that have no data behind them to substantiate whether they are better or in fact worse.

We have an obligation to bring the public this new message.

Leon Speroff, MD, is a Professor of Obstetrics and Gynecology at Oregon Health & Science University.