Compounding R.Ph.s cash in on bioidentical hormones

With a boost from actress Suzanne Somers' new book extolling hormones as the fountain of youth, many compounders are cashing in on bioidentical hormone replacement therapy. But critics contend that such untested products put profits before patients.

Proponents of bioidentical hormone replacement therapy (BHRT) believe that the plant-derived hormones they compound are the same as those produced by the body and that the dosage is calibrated to meet the patient's individual needs. They contend that the products are safe because they are natural compared with synthetic hormones and agents derived from the urine of pregnant mares.

Pharmacies compounding BHRT got a boost last year from Somers' book, The Sexy Years: Discover the Hormone Connection-the Secret to Fabulous Sex, Great Health, and Vitality, for Women and Men. The publisher gushed that the actress "has found the fountain of youth" that can help women lose weight, spice up their sex lives, and fight the symptoms of aging.

"I don't want to share our exact profit margin, but it's good compared with regular prescriptions," Bartel said. "However, you have to be efficient. We've sent our techs to be trained so that the pharmacists do formula work and check at every juncture, but the techs do the compounding. We also do one-time consultations for $60 and hormone-level saliva tests that range from $30 to $150."

Pharmacists who offer BHRT are putting patients at risk because there have been no clinical trials to prove its safety, said Larry Sasich, Pharm.D., M.P.H., Public Citizen Health Research Group. "These people all belong in jail," he said. "This is a totally unregulated shadow industry. The way compounding pharmacists have been promoting their products leaves their patients at substantial risk of harm."

Bartel rejects claims that BHRT is as risky as traditional HRT for patients. "With all the negative publicity about HRT, it would be hard for anybody knowledgeable in medicine to argue the fact that bioidentical hormones that are the same chemical compounds found in our bodies would have the same risk potential as the chemicals in mare's urine or synthetic hormones," he said. "In my opinion, people who think there is the same risk just don't understand it. In fact, there is no reason to even exclude women who have had breast cancer if you give them the right dosage."

The bottom line with BHRT is the bottom line for compounders, said Sarah Sellers, Pharm.D., M.P.H., executive director of the Center for Pharmaceutical Safety and a drug safety consultant to the Food & Drug Administration. Noting that women on BHRT are generally highly educated, have disposable income, and are fearful of menopause and aging, she added, "It's disturbing that this is being marketed as a lucrative cash business for pharmacy. The incentive is the profit, not the patient."