Bioidentical hormones are being sought by an increasing number of women to treat the symptoms of menopause. This alternative therapy is the subject of Suzanne Somers’ new book, Ageless: The Naked Truth About Bioidentical Hormones, which has drawn a lot of attention—and the ire of the medical community. What’s the bottom line?
Bioidentical hormones have the same active ingredients as conventional, FDA-approved hormone drugs.
Most of the FDA-approved hormone drugs contain equine (horse) estrogens and estrodiol, plus one of several progestines. They are designed to replenish female hormone levels that typically drop during menopause. Bioidenticals mostly have estrone, which is a weak type of estrogen. Some are a combination of estrone, estrodiol and estriol, another weak estrogen.
“What the promoters of bioidenticals tend to suggest is that estrone and estriol are much safer than conjugated equine [estrogens] or estrodiol,” says Dr. David Plourd, assistant professor of obstetrics and gynecology at Naval Medical Center in San Diego. “Well, says who? There is zero data on that. What they are is weaker, so you need a lot more of them.”
The risks of bioidenticals are undetermined.
Patient safety is at the heart of the medical community’s beef with bioidenticals. “I call them bio-unknowns,” says Plourd. “The claim is made that they are safer and efficacious despite a paucity of data.”
Dr. Nanette Santoro of the department of obstetrics/gynecology and women’s health at Albert Einstein College of Medicine says this mode of hormone administration “at best can be considered experimental and at worst is medical malpractice. …The absence of data confirming harm is not the same thing as safety.”
The risks associated with conventional hormone therapies are well known and well managed by physicians, who weigh potential benefits against potential risks for qualifying patients.
Bioidenticals are usually prepared in compounding pharmacies.
Pharmacists in compounding pharmacies customize orders for patients by combining approved drugs. Those who want custom-mixed drugs will probably not be able to fill their prescriptions at the local Wal-Mart or CVS; most major chains will not get out the mortar and pestle to personalize an order, and insurance companies may reject coverage. Compounding pharmacies are legal and approved by the FDA, but are not regulated by the FDA. A small-scale FDA study found compounded drugs to be 34 percent more prone to error, with most errors related to incorrect dosage.
According to a November 2005 opinion by the American College of Obstetricians and Gynecologists (ACOG), there is no scientific rationale to support tailored or individualized therapeutic regimens.
The American Medical Association wants bioidentical hormones to be researched and regulated.
Without naming Somers or her Ageless book directly, the AMA adopted a policy on Nov. 13, 2006, to counter “potentially misleading or flawed information about custom-compounded bioidentical hormones.” It has also formally expressed concern about the promotion of bioidenticals as safe and effective by “non-medical professionals.” How’s that for diplomatic?