Advocates For Custom-Made Hormones Launch Lobbying Effort Against FDA

Main Category: Women's Health / Gynecology
Also Included In: Seniors / Aging;  Endocrinology;  Regulatory Affairs / Drug Approvals
Article Date: 13 Feb 2008 - 6:00 PDT

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The Edinburg, Va.-based Hands Off My Estrogens Coalition last week placed advertisements in five newspapers that accused FDA of being hostile toward custom-made hormone products aimed at treating symptoms associated with menopause, the Washington Post reports. The ads -- which appeared in USA Today, the Wall Street Journal, the New York Times, Roll Call and the Seattle Times -- called on women and physicians to contact their congressional representatives and the White House and ask them for protected access to custom-made hormones (Boodman, Washington Post, 2/12).

FDA sent letters to seven pharmacies in January ordering them to stop claiming that custom-made hormones are better than approved menopause therapies and that they can prevent and treat other conditions -- including Alzheimer's, stroke and cancer. The agency also objected to the companies using the term "bioidentical" to describe the hormones, saying it incorrectly implies the hormones are natural or identical to the ones made by the body.

In addition, FDA said there is no evidence the custom-made hormones are safer than approved versions of the hormones estrogen and progesterone. The agency also ordered the pharmacies to stop selling hormone mixtures containing the ingredient estriol, which has not received agency approval (Daily Women's Health Policy Report, 1/30). Estriol has been linked to an increased risk of endometrial cancer, according to Adriane Fugh-Berman, an associate professor of physiology and biophysics at Georgetown University (Washington Post, 2/12).

Steven Silverman, assistant director of FDA's Center for Drug Evaluation and Research, criticized the HOME Coalition's assertion that the hormones are safe and identical to those produced naturally. "This kind of unreliable information may mislead women and their health care providers," he said. Jonathan Wright, a Seattle-based physician whose name appeared in the ads, said the hormones are "a lot safer" than FDA-approved drugs. He added that he has prescribed the products to more than 2,000 women since 1983 and has seen no negative side effects. "A woman should be able to take care of her own health in any way she and her doctor see fit," Wright said.

The coalition is affiliated with the Reproduction Research Institute, according to Stephanie Bosserman, director of the institute. Bosserman did not know the cost of the ads, the Post reports (Washington Post, 2/12).

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