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Bioidentical Hoax?

Utah companies skirt FDA regulations to promote "natural" hormone treatment



Tired of being normal? Are you a middle-age woman suffering from “sagging, dragging and nagging”? Have you heard any of these pitches either from websites or billboards featuring happy, smooth-faced grandmothers? Then you’ve likely heard a pitch generally targeted at menopausal women for “Bioidentical Hormone Replacement Therapy” or BHRT—a process that advertises an “all-natural” substitute to current manufactured hormone pharmaceuticals. If you’ve also read that this treatment is safer and more effective than hormone drugs manufactured and regulated by the Food & Drug Administration, you’ve heard a pitch that may be violating federal law.

Currently, the FDA does not recognize BHRT as valid marketing and has, in the past, had to crack down on companies that advertised the treatment as being safer and more effective than FDA-approved hormone drugs, as well as suggesting such drugs could help with ailments likes Alzheimer’s disease and heart problems.

“Sellers of compounded ‘bioidentical’ hormones often claim that their products are identical to hormones made by the body and these products are without the risks of drugs approved by FDA for hormone therapy,” writes FDA spokeswoman Stephanie Yao via e-mail. She adds the FDA can’t verify the safety or effectiveness of the drugs, and companies that have made such claims in the past have been in violation of federal law.

Utah companies aren’t sweating it too much, however, because the FDA is limited in how much it can regulate these cure-all compounds. The FDA gives a wide berth to “compound” pharmaceuticals—prescriptions customized by pharmacists, often to remove ingredients known to cause allergic reactions or to lower the ratio of chemical ingredients. Now, BHRT companies have latched onto this protection to make compound hormone products that use structures found in organic materials, like plants, that are biologically identical to hormones found in humans, and market them as natural products that are safer than clinically tested, FDA-approved hormone drugs. Such drugs, whether synthetic and FDA-tested, or BHRT, have found a market in menopausal women experiencing difficult changes in personality and hot flashes, among other symptoms.

For Michele Curtis, a professor of obstetrics and gynecology at the University of Texas and the lead author of the American College of Obstetrics & Gynecology’s 2005 statement against misleading BHRT claims, the therapy does replicate hormones, but doing it through “natural” materials is no guarantee of being safer.

“It’s true there is an estrogenic structure that you can find in a plant, but that doesn’t mean a pharmacist went out back into a field, picked a bunch of soybeans and boiled them down and that’s what they’re using, for god’s sake,” Curtis says. “There’s a [BHRT] made from horse urine, but I’m not sure how much more natural you want to get than that.”

For Utah consumers, however, it’s hard to draw a clear line on what BHRT can and can’t do. The FDA warned seven pharmacies in 2008 to stop making misleading claims about BHRT but has not taken any other actions since then. While the FDA has culled research from organizations like the Women’s Health Initiative and the American College of Obstetrics & Gynecology and formulated educational materials separating myth from fact about BHRT claims, companies still advertise BHRT and claim the superiority of the product.

In a quick search of companies offering the treatment in Utah, City Weekly found multiple companies making misleading claims. The Gateway Laser Center, located in downtown Salt Lake City, claims on its website that: “[Bioidentical hormones] are safer,

with fewer side effects.” The website even goes on to implore consumers to seek only BHRT: “Unfortunately, many of the hormones regularly prescribed are not identical to those found in the human body. Instead, patients should insist on prescriptions for biologically identical hormones only.” Gateway Laser Center did not a return a comment for this story.

Enlighten Laser in Bountiful offers BHRT, which its website says is “essential for muscle tone, skin smoothness, hair texture and sex drive,” adding that “it may also help deter osteoporosis, Alzheimer’s and heart disease”—exactly the claims the FDA has previously warned are illegal. Enlighten has also posted billboards along the freeway asking passersby if they are “tired of being normal.” Enlighten Laser did not return a comment for this story.

One bioidentical-hormone provider who did comment for the story was Marcia Scoville of the All for Women Health Care clinic in Salt Lake City. Scoville’s website claims that BHRT is safer and more effective than FDAapproved hormone drugs. As a former nurse who has been offering the treatment for the past decade and takes it herself, Scoville says she’s seen the results.

“Women need to have the option of using hormone-replacement therapy. It depends on how profound the changes of menopause affect their lives,” Scoville says. “Some people breeze through it—I never meet these people. Other people, they turn into someone they don’t like.”

Scoville says customized BHRT doses are a big part of her practice, and says that other clinics offer doses of bioidentical hormones that are usually 10 to 100 times stronger than the doses she offers clients. She also points out a study by Kent Holtorf, a doctor in California who did a literature survey and found BHRT having less risk of breast cancer in female subjects compared to FDAapproved hormone drugs.

The Holtorf study, however, does not employ randomized trials to corroborate its findings. Curtis at the University of Texas says the academic consensus in the research overwhelmingly weighs against claims that BHRT is safer than FDA-approved hormone therapies, and the reason why is not so technical—it’s simply that FDA-approved manufactured drugs are regulated, so the doses are always consistent.

“Because compounding involves getting basic ingredients and putting them together, it’s like cooking,” Curtis says. “You’re going to have variations from batch to batch—you just can’t help it.” She also says that FDA-approved drugs come with package inserts, which are instructions going over all possible risks and complications from taking the drugs that have been discovered through thousands of hours of research.

She also points out that while competent pharmacists could compound BHRT very successfully, what consumers don’t realize is that there’s no way to guarantee the pharmacist will consistently mix the drugs better than FDA-approved hormone therapies. As for why the FDA has not had success in regulating bioidenticals well, Curtis says they do operate in a gray area of regulations. She also says that in Utah, they probably also enjoy protections from Sen. Orrin Hatch, R-Utah, who has doggedly protected nutritional supplements from federal regulations.

“Senator Hatch is very effective in keeping the FDA out of that arena,” Curtis says. “That’s well recognized.”

Twitter: @EricSPeterson