Tighter rules on trendy hormones urged Claims touting anti-aging 'bioidenticals' are wrong, doctors' group says

Fred Prouser / Reuters file The nation's largest doctors' group wants the FDA to impose stricter regulation of so-called natural hormones touted in a book by celebrity Suzanne Somers.

CHICAGO - The American Medical Association has stepped into the controversy over alternative hormone treatments for aging that Suzanne Somers advocates in a hot new book.

The nation's largest doctors' group voted this week to seek stricter Food and Drug Administration oversight and regulation of these so-called "bioidentical" hormone compounds.

Some of the treatments are promoted as alternatives to estrogen and progestin supplements once widely used for hot flashes and other menopause symptoms. Somers' new book, "Ageless: The Naked Truth About Bioidentical Hormones" on national best-seller lists, maintains that these treatments also can reverse the aging process and keep people mentally sharp, physically fit and sexually active.

Some doctors who were quoted in "Ageless" say the book overpromises anti-aging benefits from these products and wrote a letter of complaint last month to the book's publisher.

The actress-fitness guru could not immediately be reached for comment, but she has defended the book and appeared Wednesday night on CNN's "Larry King Live" to address her critics.

"If we all figure out that we just put back the hormones we've lost in the aging process to the exact amount that we need, we won't need all the other drugs that we're being offered," she told CNN.

Landmark government research linking conventional hormone pills with health risks led many women to quit taking them.

But there's no evidence that bioidenticals are any safer and they may even have other risks, Dr. Robert Vigersky, a member of the Endocrine Society delegation to the AMA, said Wednesday. The society represents doctors who specialize in hormone-related disorders.

"This is a safety issue, there's no question about it," said Dr. Ardis Hoven, an AMA board member.

Worries about safety
The products, sometimes called "natural" hormones, are compounds that have the same chemical and molecular structure as hormones that are produced in the human body. They are custom-mixed by special pharmacies according to a doctor's prescription.

Promoters say they are plant-based, but Vigersky said some contain synthetic products and their exact ingredients aren't always known because they are not FDA-approved.

"We think that people are being misled into thinking that they are safer and we're worried that they may be inappropriately prescribed," said Vigersky, an endocrinologist at Walter Reed Army Medical Center. He said he has no financial ties to pharmaceutical companies that produce hormone pills.

The AMA adopted the new policy at its interim meeting Monday in Las Vegas. Wyeth Pharmaceuticals, which makes conventional hormone pills, requested similar scrutiny in an FDA petition earlier.

The AMA will urge the FDA to assess the purity of ingredients in the alternative compounds, evaluate any side effects and require manufacturers and compounding pharmacies to report any adverse events.

The doctors group also endorses creation of a registry of adverse events linked to bioidenticals, along with standard patient safety information on the product packaging.

While the custom compounds are not FDA-approved, the agency has regulatory authority over them because they are considered drugs. An FDA spokesman said the agency shares the AMA's concerns about potentially misleading claims and is paying close attention to the issue.

Dr. Erika Schwartz, a New York physician who objects to the wide-ranging claims in Somers' book, nevertheless criticized the AMA for taking the side of the pharmaceutical industry.

Schwartz said that while she shares the AMA's general concerns about safety, there's no evidence that the hormone compounds are not safe.

"I don't believe in overpromising," Schwartz said. "I believe hormones are only part of the anti-aging process. If you want to stay young and healthy, you need to eat right, to exercise, to deal with stress, to sleep," she said. "The hormones are one other option."