Some menopausal women who are seeking alternatives to traditional, FDA-approved hormone replacement therapy are turning to so-called “bioidentical hormones.” These allegedly customized compounds are marketed as “bioidentical” because they are chemically identical to the hormones produced naturally in a women’s body.

However, the author of a bioethics poster, being presented Saturday, June 2, at The Endocrine Society’s 89th Annual Meeting in Toronto, raised ethical concerns about these hormonalcompounds.

M. Sara Rosenthal, PhD, a University of Kentucky bioethicist with an interest in women’s health and endocrinology notes that there is no ethical oversight on the use of these made-to-order compounds in research involving human subjects. Also, these hormones often are made into compounds, or combinations, of different types of estrogen. The U.S. Food and Drug Administration does not regulate these compounds, just the original ingredients. To date, there have been no credible long-term studies to support the argumentthat compounded bioidentical hormones are any safer or more effective than traditional, FDA-approved hormones.

“The public should know that many bioidentical hormonal therapies promoted as safe, effective and natural are potentially none of those things,” Rosenthal said. “They are still drugs. They could carry the same potential health risks as synthetic hormones.”

Many postmenopausal women stopped taking synthetic hormones in 2002 when the Women’s Health Initiative study found that combination hormone therapy (estrogen and progestin) slightly raised the risk of breast cancer, heart disease, stroke and blood clots. Since then, women looking for alternatives have become vulnerable to false or misleading information, which has created “ethical chaos,” Rosenthal said.

In her poster, Rosenthal focuses on the ethical problems resulting from advocacy of hormone therapiesthat have not been properly developed or studied by people with appropriate scientific or clinical research backgrounds.

Some bioidentical hormone protocols are based on unregulated and unethical research that did not use accepted scientific methods and were not approved by an institutional review board (IRB), normally responsible for the ethical conduct of research to ensure protections for human subjects, according to Rosenthal. Also, laypersons who have no medical background are providing misleading information about such protocols, she warned. In reference to celebrity Suzanne Somers, who promoted the Wiley Protocol and bioidentical hormones in her new book, “Ageless,” Rosenthal called the ethical problems “a mid-Somers nightmare.”

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