Bias may have influenced the conclusions and recommendations of the NASEM committee

The participation of one former FDA official with oversight of compounding and stated conflict of interest is particularly troubling


The NASEM committee had an obligation to ensure that their report was unbiased and objective. Even the FDA, in its acquisition plan selecting NASEM to conduct the study, stated that:

Due to the nature of the requirement, it is in the public interest to receive the independent advice of unparalleled objectivity of the highest quality that provides an inherent degree of acceptability.

Given what is at stake — the health of millions of patients — it is critical that any potential bias in the process be examined carefully.

But the process was not independent at all. Indeed, bias may have been the point.

The committee and its review team may have had members who were biased against compounded hormones.

For at least the past two decades, the FDA and drug manufacturers have worked to discredit compounded hormones and to limit access to them. Indeed, members of the committee had close ties to large pharmaceutical companies that were opposed compounded hormones. (The same pharmaceutical companies that stand to profit from less competition from compounded hormones.)

The FDA made recommendations to NASEM about who should be on the “independent” committee.

Given its stated goal of independence and objectivity, it's telling that the FDA recommended so many members of the committee and reviewers with close ties to large pharmaceutical companies that have a history of opposition to compounded hormones. That none of the members of the committee had any experience at all in prescribing or compounding hormones is equally telling.

One former FDA official stands out.

Based on a review of documents obtained by the law firm Reed Smith, through a FOIA request, it is clear that the FDA sought to guarantee that the committee reached the conclusion the FDA wanted, in part by ensuring its proxy was deeply involved in the report.

That proxy is the FDA's former lead on compounding pharmacy. Since retiring from the FDA, she has been an outspoken critic of compounding. Originally invited by the FDA to serve on the committee, she turned down the position because of a stated conflict of interest: "I don’t think I can do it as I have a client interested in bioidentical hormones."

And yet, this former FDA official was invited and did serve as both a presenter to the committee and as a reviewer for the final report.

Unsurprisingly, one of the report’s final recommendations mirrors the position for which the former official advocated both as the FDA lead on compounding and in her capacity as an “independent expert” for the NASEM committee.

Her involvement is one reason it can't be said that the NASEM report is free from bias in favor of the FDA, or that the report was developed “independently.”


Source Material

The foundation of this website is an independent analysis of the original NASEM report, The Panel Put Policy-Making  Before Patient Need, written and published by The Berkeley Research Group. You can download the analysis here. 



Hear their stories, in their own words. Protect their access to compounded hormones.

On this page, we can only touch on the data that demonstrates the importance of compounded hormones to the lives of millions of women in this country. While the decision to take this vital therapy from patients and physicians might be profitable for the big pharmaceutical companies, it will be disastrous for the millions of patients that those same pharmaceutical companies cannot serve!

We encourage the appropriate committees in both the House and Senate to hold hearings on this critical issue.

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