APC releases statement on NASEM’s cBHT review

STATEMENT ON RELEASE BY THE NATIONAL ACADEMIES OF SCIENCE, ENGINEERING, AND MEDICINE OF ITS REPORT, “The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use”

July 2, 2020

For pharmacy compounders, the release of NASEM’s FDA-funded Compounded Bioidentical Hormone Therapy study feels a lot like the movie Groundhog Day, only without Bill Murray for laughs. Which is to say: We’ve seen this sort of thing before.

Just a few weeks ago, NASEM released the first of two FDA-funded studies, that one focused on compounded pain creams, in which it managed to come up with recommendations that — surprise! — almost perfectly reflected FDA’s stated concerns about compounded pain creams.

Fast forward to today: NASEM’s recommendations on cBHT hew conveniently close to FDA’s stated concerns about cBHT.

It appears FDA has gotten the best validation taxpayer dollars can buy. But that doesn’t mean all of the recommendations about cBHT as a therapy are reasonable or based on a thorough exploration of evidence and outcomes.

APC is still reviewing the report, but a few preliminary points are worth noting:

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