NASEM study leads: Andrew Pope, PhD, Director, Board on Health Sciences Policy, Health and Medicine Division; Leigh Miles Jackson, PhD, Senior Program Officer, Board on Health Sciences Policy
NASEM provided FDA with its analysis of compounded bioidentical hormone therapy (cBHT), such as estradiol, estrone, dehydroepiandrosterone and testosterone, on July 1, 2020. They are often advertised as having certain advantages over FDA-approved products, such as being derived from natural sources, being effective and safer than FDA-approved drugs that are synthetic or chemically modified, or not having the risks or side-effects associated with FDA-approved hormone therapies.
Based on its research and analysis, NASEM determined there was a lack of rigorous evidence of safety and effectiveness from well-designed or properly controlled clinical studies. NASEM found information about the safety and effectiveness of cBHT came mostly from low quality data, such as anecdotal claims, patient reports, and prescriber testimonies. Further, there is limited federal and state-level oversight of the quality and use of cBHT preparations. Given the lack of high-quality clinical evidence and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern.
The agency has been concerned that health care professionals and patients may not be aware of the uncertainties of the benefits and potential safety risks with these compounded products. In September 2018, FDA asked NASEM the to organize an ad hoc committee to provide an independent assessment and evaluate scientific evidence relating to the safety and effectiveness of these products and discuss whether the available evidence supports use of cBHT products to treat patients.
Please visit NASEM website for more information.