Although no one knows exactly how many are sold annually, doctors around the country, as well as the Food and Drug Administration, say the market is booming and they are bombarded with questions from patients. They warn patients that these unregulated bio-identicals aren’t any safer, effective or more natural than other menopause therapies approved by the FDA and may even be more dangerous because they are not subject to regulatory scrutiny and haven’t been scientifically tested for potency and consistency.
But that hasn’t stopped millions of women from trying them. The exploding demand alarms major medical groups and women’s-health advocates, as well as pharmaceutical companies, and all have been pushing for federal restrictions. Last month, the FDA responded with a crackdown on seven pharmacies that were producing and promoting unregulated bio-identicals. All are “compounding” pharmacies, meaning they specialize in creating “individualized” drugs, formulas customized to individual patients, often based on blood or saliva tests. But the FDA action has left many consumers confused. Is the agency targeting only a few pharmacies, or is it trying to get rid of bio-identicals forever? Are all bio-identicals banned? And what should women do if they’re suffering with hot flashes and night sweats?
Before we answer those questions, here’s a little background. Any discussion of “bio-identical” hormones gets confusing fast because the term means very different things to different people. It is not a medical term, just marketing jargon. And it’s being used not only by Internet pharmacies but also by Big Pharma. When doctors refer to bio-identicals, they are often talking about the growing category of FDA-approved, plant-based hormone products, which are available in creams, pills and patches in a wide variety of doses. These FDA-approved bio-identicials can be very effective in reducing menopausal symptoms, but product inserts make it clear that they can also increase user’s risk of heart disease, breast cancer, stroke and blood clots. But in recent years, the term bio-identical has been usurped by marketers who claim that the made-to-order hormone treatments created by compounding pharmacies are safer and more natural. Some advocates even argue that these individually prepared hormones are not even drugs, although they clearly are. The raw material may come from plants, but the active ingredients are synthesized in the lab. “There is no such thing as nonsynthetic hormone therapy,” says Dr. Alan Altman, an assistant professor of obstetrics and gynecology at Harvard Medical School.
The FDA hasn’t banned all unregulated bio-identicals. However, production of some of the most common customized hormone therapies—those that include estriol, a weak synthetic form of estrogen never approved by the FDA (like the so-called bi-est, consisting of estradiol and estriol, and tri-est, which also contains estrone, another form of estrogen)—seems to be at an end. Marketers tried to convince women that they need to supplement all three kinds of estrogen, says Dr. Nanette Santoro, director of the division of reproductive endocrinology at the Albert Einstein College of Medicine. “But,” she adds, “there is no scientific basis in fact for this claim.”
In addition to stopping the production of bio-identical products with estriol, the FDA also says it will eliminate false claims that hormone products made by compound pharmacists for individual clients are any safer, effective or natural than FDA-approved drugs. “Claims like these mislead consumers and health-care providers with inaccurate information,” said Deborah Autor, director of the of the office of compliance in the Center for Drug Evaluation and Research at the FDA, at a recent briefing. In announcing the crackdown, FDA officials went so far as to say that they would consider any commercial use of the term “bio-identical” to be considered “false and misleading.” (At a recent press briefing, FDA officials said they would like to see the term bio-identical disappear altogether from the menopausal lexicon.) Pharmacies that ignore the rules could face enforcement actions from the FDA ranging from seizure of products to injunctions against businesses.
The FDA’s focus on this issue will very likely shrink the market for hormone therapies produced by compounding pharmacies. Regulators and doctors hope the crackdown will encourage women to be more skeptical consumers and seek out reliable information about the ever-increasing number of safer hormone options that have been carefully studied. And the best advice for using these products is to take the lowest effective dose for the shortest possible time.
The FDA’s Web site is offering an expanded consumer information section on bio-identicals for women looking for a better solution. The more women learn about the wide range of hormone therapies now available, the less upset they’ll likely be about the loss of many of these customized bio-identicals. While some women may be frustrated in the short run that the treatments they have come to rely on will be increasingly harder to get, in the long run, they should end up with an answer that works better, is safer and costs a lot less.
