Bioidentical hormones center of debate

Women are turning to them as a less risky alternative to relieve menopause symptoms.

January 16, 2006

By CHERIE BLACK, The Times-Union

In March 2004, women looking for relief from their menopausal symptoms were dealt a blow when the U.S. Food and Drug Administration halted its second nationwide hormone replacement drug study, citing stroke risks.

Nearly 200 Jacksonville women were involved in one portion of the trial conducted by the Women's Health Initiative. A previous study was suspended two years earlier, also amid fears of heightened risks of strokes, as well as coronary heart disease and blood clots.

Looking for a less risky alternative, many women turned to something called bioidentical hormones, derived from plants and similar to those the body produces. They are creams, customarily made by a pharmacist, that can be applied to the skin, to relieve menopause symptoms without the serious side effects, according to some physicians.

In November, The American College of Obstetricians and Gynecologists raised major concerns about the use of these products. The organization claimed there is no scientific evidence to support their effectiveness and expressed concern about FDA warnings.

The FDA has determined that over-the-counter creams containing bioidentical hormones are not generally recognized as safe and effective, according to a spokesman. But because the bioidentical hormones are not a drug regulated by the FDA, pharmacies are not required to inform consumers of potential health risks.

But some physicians dismiss those concerns and say the reason some groups and physicians oppose the use of bioidentical hormones is because pharmaceutical companies can't make money from products that are manufactured in local pharmacies.

"The average gynecologist learns from pharmaceutical companies who give them free samples of their products," C.W. Randolph told the Times-Union last March after the NIH study was halted. He is a Jacksonville Beach obstetrician/gynecologist who offers natural hormone therapy to his patients.

"There are no samples of natural hormones, and the companies can't patent them and make money. These women are desperate, and we're just giving them back what they're missing," he said.

Gary Bernard, a physician with BodyLogicMD, a hormone replacement therapy center in Orange Park, said bioidentical hormones work because they are specifically tailored for each individual patient's needs.

Bernard determines a patient's hormone imbalance through a blood test -- others use a saliva test -- and then makes a natural estrogen gel or a progesterone cream that is absorbed into the skin to effectively treat hot flashes, pain and nausea caused by hormone imbalances.

Wyatt McNeill, associate professor of obstetrics and gynecology at the University of Florida, said patient response to the topical creams is a placebo effect, and the marketing of herbal products in place of proven medicine doesn't represent good science.

"This has been driven by an unjustifiable fear of hormones and an effort of entrepreneurial physicians to fill the gap," he said.

But patients using bioidentical hormones say the benefits far outweigh the criticisms.

"I'm furious [bioidentical hormones] are still being disputed by the mainstream medical field," said Linda Cornelio, 58, one of Randolph's patients. She has been using a progesterone cream since 2002 after her former gynecologist said she couldn't take synthetic hormones after recovering from breast cancer. She said the treatment straightened out her sleep patterns and eliminated hot flashes.

"They're still trying to force women to take drugs that have disclaimers for awful side effects like stroke," she said. "Women have to do their research and be their own advocate."

cherie.blackjacksonville.com, (904) 359-4504