E-Newsletter No. 65

Taking another step into the arena of replacement hormone therapy, the U.S. Food and Drug Administration (FDA) announced that it has warned seven pharmaceutical operations to stop making false and misleading claims, unsupported by medical hormone replacement therapy (BHRT) products are safer and more effective than traditional hormone therapies. The agency stated that “bioidentical” has no scientific or medical meaning and is purely a marketing term. The FDA also issued a written response to the October 2005 citizen petition submitted by Wyeth Pharmaceuticals requesting that the FDA investigate manufacturing, labeling, and advertising practices of compounding pharmacies. 

BHRT producers have asserted that prevents or treats illnesses such as Alzheimer’s disease, stroke, and certain forms of cancer. The FDA said there are no scientific data to support the claim that compounded BHRT drugs are less risky than FDA-approved hormone therapy drugs. No scientific evidence shows that BHRT is better at relieving menopausal symptoms than FDA-approved treatments, and other alleged benefits of BHRT have either been disproved or lack supporting evidence. Those compounding pharmacies producing BHRT that continue to make these claims for their products are in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and may face enforcement action, the FDA said. In addition to clamping down on false claims, the FDA cited the pharmacies for including in BHRT preparations the hormone estriol, which has not been approved for human use. 

Many women turned to BHRT after a large study of the effects of taking estrogen with progestin on heart disease by the National Institutes of Health Women’s Health Initiative (WHI) was cut short in 2002 when the hormones were shown to have signifi cant health risks. Proponents of BHRT claimed that it was safer than the synthetic hormones used in the WHI study, because BHRT hormones were “natural,” in the dual sense that they were derived from plants and chemically identical to endogenous hormones. 

In October 2006, The Endocrine Society issued a position statement, subsequently adopted as American Medical Association policy, advocating increased scientific and medical scrutiny of bioidentical hormones. The Society rejected assertions that the adverse or beneficial effects found in the WHI study were caused by the molecular structure of the synthesized hormones. Estrogen containing hormone therapies, whether “bioidentical” or traditional, of the same dosage and purity would have the same risks and benefits. The Society said that “customized” hormones would not have changed the study’s outcome, as BHRT proponents have claimed. The Society also raised concerns about the lack of consistency in dosage and purity in BHRT prepared by compounding pharmacies. 

Because of The Endocrine Society’s leadership in this, Society Past-President Leonard Wartofsky, M.D., was called to testify on the use and regulation of bioidentical hormones at a 2007 hearing before the U.S. Senate Special Committee on Aging. He called for greater oversight of BHRT compounding and inclusion of accurate patient information in product packaging. 

In response to one of the citizen petition’s requests, the FDA announced at its news conference that it is launching a public awareness campaign to reach women and health care professionals to provide accurate information about bioidentical hormones. The agency published an article on its Consumer Health Information Web page titled, “Bio-identicals: Sorting Myths from Facts.” (www.fda.gov/consumer) 

The Society supports FDA public education and regulatory efforts to contravene misleading and false claims made by BHRT producers about their products’ safety and effectiveness. It urges the agency to increase oversight of the BHRT industry by surveying products for purity and dosage accuracy, mandating the reporting of adverse events from hormone preparations, establishing a registry of these events, and requiring that all hormone product packaging include uniform patient information with warnings and precautions.

Jenny Lee is a free-lance science writer living in Silver Spring, Md.

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