Sunday, January 13, 2008

The Drama Surrounding “the Juice of Youth”: The FDA Weighs in on “Natural Hormones”

The popularity and perceived value of medications prepared by compounding pharmacies—particularly of hormone medications—is nothing new, and over the last several years has generated a tremendous surge in both interest and controversy fueled by endorsement of bioidentical hormones by celebrities such as actress Suzanne Somers, followed by subsequent complaints ranging from doctors to the Food and Drug Administration (FDA), in which both camps are critical of claims touting the “benefits” of the drugs and manner in which they’re prepared, as unsubstantiated marketing that could endanger the health of women not properly informed.

Somers states she’s only attempted to raise awareness and empower women to analyze and explore alternative HRT therapies available, rather than simply settling for synthetic preparations marketed by big pharma; on the one side, Somers’s supporters praise her courage and conviction, while her detractors are scathingly critical of her endorsement of drugs that they say have not been proven safe—as well as attribution to those they portray as dubious professionals with questionable credentials.

Last week the FDA publicly announced that there was no difference between hormone medications marketed as bioidentical, and prepared by compounding pharmacies, than those marketed as synthetic preparations manufactured by drug companies. The fallout from this stance of course is that compounders are not restricted from claims that their products are better. Many of those who support bioidenticals are convinced that the FDA’s public stance was based more in the drop in sales of commercial prescription HRT medications. Pharma giant Wyeth, no stranger to HRT controversy, has asked the FDA to step in against compounders, who are currently under state regulation, not federal. Again, women are caught in the middle in determining the best course of action.

Details in this blog article from the NY Times

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