I am writing in response to the recent National Academies for Science, Engineering, and Mathematics (NASEM) report on compounded bioidentical hormones, as well as David Zava’s recent report “Topical Therapy with Estradiol, Progesterone and Testosterone and Their Distribution in Saliva, Capillary Blood Serum, and Urine” (Townsend Letter, January 2021). While both had impressive graphs and charts, justifying scholarly work, I disagree with the conclusions of each.

Just because something is published, be it a NASEM report or an article in Townsend, does not mean it is true but may be grounds for further inquiry with valid observers. Both articles attempt to justify the authors’ narrow interpretation in order to convince readers of the outcome, with little willingness to include a broader discourse. With Zava’s work, perhaps the salivary information may be useful for general use in women without the significant mood issues we work with, but we have found it often inaccurate in our work.

Early in our studies we found women, desperately in need of primary estrogen (E2=estradiol), were told from saliva tests that they were estrogen dominant, which was often not the full story. A woman could be very low in estrogen and still be called ‘estrogen dominant’ if she had even less progesterone available to mitigate. We used blood tests and saw repeated evidence of low serum estradiol in the demographic of depressed women. These women were helped enormously in terms of depression when they got enough transdermal estrogen. We repeated measurements of estradiol and found increased levels over time as women improved.

We also measured blood levels of progesterone and found that once we had a progesterone baseline, we rarely need to retest as progesterone increases slowly and symptoms of anxiety and irritability tell the story. We believe that if a laboratory test does not mirror symptoms, then it is not a useful tool.

The only point in the entire SASEM report that made sense to me was that symptoms were acknowledged as being useful in treating menopausal women, backed up by blood tests when necessary.

Transdermal hormones are the safest way to use hormones, as there are receptors everywhere. Most women absorb these hormones readily through the skin. While Zava’s goal may be to support use of bioidentical hormones, he makes the same type of error, failing to identify that women with mood issues improve when using compounded creams, and how easy these are to work with and adjust.

The NASEM report states that estradiol patches are better than compounded cream because the E2 cream had lower levels of E1, yet a lower level of E1 is actually a good thing, given that E1 is the most toxic estrogen! This kind of error is pervasive throughout the entire report.

I agree with the rebuttal that Rachael Pontikes, a partner in the Life Sciences Health Industry Group at the international law firm Reed Smith LLP, sent to the FDA on behalf of a coalition of traditional compounding pharmacies and outsourcing facilities, in which she states:

We…request that FDA reject the conclusions and recommendations published by The National Academies of Sciences, Engineering, and Medicine (“NASEM”) in its report titled The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (the “Report”). FDA cannot adopt the Report or rely on it in any way, because the Report patently fails to represent an independent perspective and is rooted in striking biases.

Phyllis J. Bronson, PhD