Outrage Over FDA Crackdown on Biodentical Hormones? Not So Fast, says National Women's Health Network

February 20, 2008

The Washington Post last week reported on an ad campaign protesting the FDA’s crackdown on pharmacies that manufacture and market biodentical hormones to treat symptoms of menopause. Sandra J. Boodman writes:

Last week the HOME (Hands Off My Estrogens!) Coalition, a group based in tiny Edinburg, Va., placed a full-page ad in five newspapers, including USA Today and the Wall Street Journal, accusing regulators 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 patients’ access to medications they claim are “bio-identical” to those found in the body.

Hold the outrage. There is no scientific evidence that bioidentical hormones are safer than conventional hormone therapy drugs — and marketing claims that such drugs can restore youth and prevent or treat serious conditions such as cancer have long irked many in the medical community. As the Post story notes, “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.”

Last month, the FDA sent letters to seven pharmacy operations that compound biodentical hormones, warning them that their claims about the safety and effectiveness of bioidentical hormone replacement therapy “are unsupported by medical evidence, and are considered false and misleading.”

While this upset the HOME Coalition, the National Women’s Health Network, along with physician groups such as the Endocrine Society, applauded the enforcement. The NWHN has long been concerned about the oversight of natural hormones — here’s a handy fact sheet on the subject — and two years ago the NWHN petitioned the FDA to stop companies from marketing estrogen-and-testosterone combination pills.

Marian Sadler of the NWHN critiques the Home ad over at Prescription Access Legislation. Sadler writes that the ad attempts to “make you feel that the HOME Coalition is looking out for women’s health and women’s rights, defending natural care from hostile attacks by drug companies and the FDA, and ‘speaking the truth,'” but it’s basically just a sales pitch for natural hormones. She continues:

Like hormones that are synthesized in a lab and sold by drug companies, natural hormones are powerful chemicals that affect many parts of the body. It is very important to understand that products are not necessarily safe just because they’re natural. The same questions we ask about drugs need to be answered for alternative therapies too.

Just as pharmaceutical companies promote drugs, there is a large industry that produces and sells alternative health care products. Whether they are recommended by a doctor, a nurse practitioner, a naturopath or the cashier at the health food store, women should be skeptical of products that claim they will extend life, reverse aging, restore youth or prevent disease without causing any adverse effects.


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