Natural Hormone Group Protests FDA Crackdown

Stung by a crackdown on unproven claims about the safety and effectiveness of medications made by compounding pharmacies to treat menopause, supporters of the drugs have launched a lobbying campaign aimed at the FDA,

Last week, the HOME (Hands Off My Estrogens!) Coalition, a group based in Edinburg, Va., placed a full-page ad in five newspapers, including USA Today and the Wall Street Journal, accusing the agency of being hostile to "natural" hormonal medicines made according to a doctor's prescription by a compounding pharmacy.

The ads urge women and their physicians to e-mail the White House and members of Congress asking them to protect patient access to meds they claim are "bio-identical" to those found in the body, the Post reports. A key ingredient in these made-to-order drugs is estriol, a form of estrogen that the coalition claims is safe and protects against breast cancer - but that the FDA says is unapproved.

Jonathan Wright, a Seattle doc whose name appears on the ad, says drugs made by compounders are "a heck of a lot safer than approved drugs." As the Post points out, however, Wright has had a long, adversarial relationship with the FDA, which in 1991 seized bottles of a banned supplement from a clinic and pharmacy with which he is affiliated. "A woman should be able to take care of her own health in any way she and her doctor see fit," he insists. Since 1983, Wright adds, he's prescribed estriol-containing products to more than 2,000 women with no ill effects. "This is a safe hormone produced by the human body."

Compounded drugs for menopause have become increasingly popular since 2002, when a landmark federal study linked conventional replacement hormones in women over 50 to an increased risk of cancer, stroke, heart attack and dementia - diseases they were thought to prevent. The paper notes that some manufacturers of compounded hormones, often prescribed by docs who specialize in alternative or anti-aging medicine, have made similar unsubstantiated claims, according to the FDA.

Last month, the FDA sent letters to seven pharmacies warning that marketing claims about the safety and effectiveness of their products were "false and misleading" because they were been proven. The agency also ordered the pharmacies to stop making products containing estriol. Mainstream physicians groups, including the Endocrine Society, applauded the action, as did the National Women's Health Network, an advocacy group.

"Women need to ask the same questions about these drugs as they do about conventional hormones: What is the evidence of safety and efficacy?" said Amy Allina, program director of the women's health network. The ad, Allina said, is "so full of inaccuracies it's hard to know where to begin." The FDA, she notes, did not take action against all compounded hormone products, as the ad implies.

Adriane Fugh-Berman, an associate professor of physiology and biophysics at Georgetown Univeristy and an expert in alternative medicine, says estriol, by itself, has been shown to increase the risk of endometrial cancer. And excessive doses of hormones can cause harm, including cancers. Fugh-Berman tells the Post the ad misrepresents the conclusion of a Department of Defense study: The coalition says the study demonstrates a reduction in breast cancer cases and high estriol levels. "Just because our bodies make the hormones doesn't mean that higher levels are beneficial," she says.