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

By Christine Cupaiuolo — 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.


One response to “Outrage Over FDA Crackdown on Biodentical Hormones? Not So Fast, says National Women’s Health Network”

  1. The FDA crack down on “bio-identical” therapies was specifically requested by Wyeth (makers of Premarin) and therefore should be understood as a turf war. Wyeth pays the FDA to approve its compounds therefore FDA listens.

    There is a lot of confusion about hormones that are biochemically the same as those made by women’s bodies (which I will call “physiologically identical hormones (PIH).” First of all, physiologically identical hormones are widely available by prescription and pharmaceutically manufactured–they don’t directly equate with compounded. Examples of this include oral micronized progesterone (Prometrium) and oral micronized 17 B estradiol (Estrace), and transdermal estradiol as Estragel, Estradot and others.

    All of the physiologically identical hormones have one major advantage over altered but biochemically similar products–we know exactly how they will behave in women’s bodies, how they will sit on receptors, be metabolized, and be excreted. Isn’t that at least a theoretical advantage? In respect to medroxyprogesterone (MPA) versus oral micronized progesterone (OMP), there now is evidence that progesterone is safer for breast cancer (E3N large observational study from France showed estrogen with MPA increased breast cancer 1.79 RR, versus estrogen with progesterone RR 1.0–Fournier A. 2008).

    In Canada all compounded hormones require a prescription from a licensed health care provider/physician. That would be the simple solution to the “problem” of bio-identical hormones in the USA.

    Meanwhile, the focus on bio-identical and the false advertising of some alternate care commercial products is detracting from the important debate that needs to occur–the addiction of women’s health establishment to estrogen when really estrogen and progesterone are partner hormones in their actions, in all tissues and across women’s life cycles. For more information about the “Estrogen Myth” see The Estrogen Errors–Why Progesterone is Better for Women’s Health by Susan Baxter and Jerilynn Prior, Praeger/Greenwood/ABC-CLIO Conn. May 2009.

Comments are closed.