From time to time, we here at Prescription Access Litigation invite members of our coalition of advocacy organizations and labor unions to write guest posts for the PAL blog. We present to you a great post by Marian Sadler, from PAL member National Women’s Health Network. The National Women’s Health Network improves the health of all women by developing and promoting a critical analysis of health issues in order to affect policy and support consumer decision-making. The Network aspires to a health care system that is guided by social justice and reflects the needs of diverse women.

The post below is about a recent ad taken out by a group called “Hands Off My Estrogens.” The ad criticizes the Food and Drug Administration for recently taking action against misleading marketing claims about natural hormones that are sold by compounding pharmacies.

Here’s a partial screen shot of the ad:

Without further ado, here is the terrific analysis of this ad and this issue by Marian Sadler of NWHN:

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Many of you may have opened up your newspapers last week to find a full page ad warning you about the Food and Drug Administration’s (FDA) new position on bio-identical hormones, also known as natural hormones. The ad presents the issue as an attack on “natural health” and women’s rights, claiming that the FDA is defending the “sales and profits of its clients, the big drug companies.” If you’re a regular reader of this blog, that probably sounds pretty believable to you. And it’s true that big drug companies wanted the FDA to crack down on the widespread marketing of natural hormones. Unfortunately, that’s about all that’s true in the ad. The rest of the text seriously misrepresents what the FDA did, and even worse, repeats the same unsubstantiated promotional claims about natural hormones that the FDA rightly took a stand against.

The ad was run by the HOME (Hands Off My Estrogens!) Coalition, a group based in Edinburg, Virginia. The Coalition is referring to an all-too-rare enforcement action that the FDA took in January 2008 against misleading marketing claims about natural hormones that are sold by compounding pharmacies. The FDA told the pharmacies that the safety and effectiveness claims they were making about bio-identical hormone products “are unsupported by medical evidence and are considered false and misleading by the agency.”

The FDA identified several specific claims as misleading including statements that natural hormones are better or safer than conventional hormone therapy; that natural hormones can treat or prevent Alzheimer’s disease, stroke and cancer; and the use of the term bio-identical which implies “a benefit for the drug, for which there is no medical or scientific basis.” The agency also warned that selling products containing estriol is a violation of federal law because it has never been approved by the FDA.

The HOME Coalition ad reaches out to readers on an emotional level, with its photo of a concerned young woman and a wise female doctor. It prompts you to feel indignant about the FDA’s action and supportive of women who rely on alternative medicine options, like natural hormones. It’s designed 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 the reality is not so simple.

In fact, the ad is a poorly disguised sales pitch for natural hormones. To justify its inaccurate claim that estriol (a form of estrogen that’s chemically identical to the estrogen that women’s own bodies produce) has been proven safe, it cites a study that found that women who produced the most estriol during their first pregnancy had 58 percent less breast cancer over the next forty years. But that doesn’t prove taking estriol that’s not produced by your body is safe or beneficial. And the HOME Coalition fails to cite studies showing that estriol increases the risk of endometrial cancer. These defenders of natural hormones don’t think it’s necessary to tell women there’s no reasonable scientific evidence that estriol has anticancer effects or that it’s safer than other estrogens. 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.

The National Women’s Health Network has been urging the FDA for years to exercise better oversight over natural hormones. When the agency finally took action last month, we applauded its actions although we remain concerned that the steps taken are not enough to protect women’s health. These were good first steps, but we’ve also called on the agency to publish regulations to govern appropriate labeling and advertising of pharmacy-compounded hormone products. All labeling and advertisements for natural hormones provided to patients and health care professionals should include the facts that the product is not approved by the FDA, the product was compounded in a pharmacy and is not subject to FDA standards for good manufacturing practices, and that the product has not been demonstrated as safe or effective in clinical trials.

For more information on natural hormones and about the FDA decision, read the National Women’s Health Network’s newly updated fact sheet on Natural Hormones at Menopause. And if you see ads or other promotions for natural hormone therapy that make unproven claims – please send them to us at nwhn@nwhn.org.

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This entry was posted on Friday, February 15th, 2008 at 11:01 AM and is filed under bioidentical hormones, estriol, FDA, marketing, menopause, National Women's Health Network, PAL coalition. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.