A 2020 FDA-funded report published by the National Academies of Sciences, Engineering, and Medicine (NASEM) on the safety and utility of compounded hormones is compromised by potential bias, conflicts of interest and bad science—so says an independent, third-party analysis of the NASEM report released today.
| ALEXANDRIA, Va., April 30, 2021 /PRNewswire/ -- A 2020 FDA-funded report published by the National Academies of Sciences, Engineering, and Medicine (NASEM) on the safety and utility of compounded hormones is compromised by potential bias, conflicts of interest and bad science—so says an independent, third-party analysis of the NASEM report released today. The Food and Drug Administration (FDA) touted the NASEM report, which recommended restrictions on compounded hormone therapy, as “independent” and “comprehensive,” but in fact it was neither. That’s one of the key findings in the white paper by Dr. Alyson Wooten, a director at the nonpartisan Berkeley Research Group (BRG). The paper is titled The Panel Put Policy-Making Before Patient Need: An Independent Analysis of the FDA-Commissioned NASEM Report, “The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.” The Pharmacy Compounding Foundation commissioned Dr. Wooten to conduct the third-party, independent review of the NASEM report. “Given the strong potential bias influencing the Committee’s recommendations and the omission from the final report of key data supporting the safety and efficacy of cBHT, we recommend that FDA not rely on or consider the NASEM Report,” the white paper advises. FDA commissioned NASEM in 2019 to undertake what it said would be an objective review of the safety and effectiveness of compounded hormones. After NASEM released the final report on July 1, 2020—which included a recommendation for across-the-board restrictions on compounded hormones—FDA issued a public statement saying the agency would base its next steps on compounded hormones on the NASEM report. What FDA did not say—but which Wooten’s paper demonstrates—was that the agency exerted inappropriate influence and bias in almost every phase of the commissioned report, even recommending study committee appointees who had no expertise in prescribing or compounding hormones. “This white paper shows how FDA inappropriately meddled in the composition of the NASEM committee, fed the committee selective research for its consideration and even advised the committee on its final recommendations for restricting compounded hormones,” said Pharmacy Compounding Foundation CEO Scott Brunner, CAE. “And all so FDA could have a report that reflected its existing negative view of compounded hormone therapy. The white paper reveals an FDA much more interested in documenting its own biases than in actual objective science. And it was apparently willing to spend $1.3 million in taxpayer dollars to do it.” Dr. Wooten’s review is a repudiation of an FDA staff that manipulated the process and NASEM committee members who lacked expertise in the subject matter they were engaged to study. The white paper documents how:
“These numerous flaws render the NASEM report so thoroughly compromised as to be useless in any discussion of compounded hormone therapy,” said Brunner. About the Pharmacy Compounding Foundation The Pharmacy Compounding Foundation, affiliated with the Alliance for Pharmacy Compounding, promotes pharmacy compounding by:
SOURCE Pharmacy Compounding Foundation |
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