I have just returned from Washington D.C., where I spoke on a panel in front of a Committee of The National Academy of Science, Engineering and Medicine (NASEM) on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy (cBHRT). What an important event for bioidentical hormones and compounding pharmacies! No less than the future of what we do is at stake!
The day was split into two segments with a stark and palpable difference between the morning’s presenters and the afternoon’s. The first half of the day was dedicated to presenters speaking and then being asked questions concerning the prescribing of hormones while the second half was devoted to compounding pharmacists represented by four leaders from the Professional Compounding Centers of America (PCCA). The contrasts of the two segments brought into focus just how important our collective actions as prescribers of hormones are to how we are perceived in government and, thus, how we will or will not be regulated in the future.
I was the last to speak. On the table in front of me was a two inch stack of the 28 citations and supporting materials I’d built my opening remarks around as well as another two-inch stack of testimonials gathered from women whose lives were changed by cBHRT (thanks to the generous efforts of physicians, nurse practitioners, and especially Dr. Jonathan Wright and Suzanne Somers). My goal was to build as solid an argument as possible, using defensible standards-of-care practices.
Because I knew that I would be given limited time, I provided a printout of my opening remarks as well as full articles plus the testimonials to each committee member on a thumb drive. Five minutes and a few questions answered was not a lot of time!
In stark contrast to most of the morning presentations, the afternoon team from the PCCA was given plenty of time and did a phenomenal job, reflecting and embodying over 35 years of impeccable practices. The Committee also asked pertinent questions, drilling down into the details of the procedures, processes, testing, regulations, etc that are of great importance to the FDA and to the public.
What a contrast! A morning with almost four hours of a predominantly negative, often irrelevant, often opinions-without-backup-evidence with no unified voice contrasting with a clear unified, organized, and well-presented team representing our sisters and brothers in the world of compounding pharmacists!
I left this day thinking that if we prescribers do not quickly create standards of care, and a unified voice, our future will be decided for us! Either we self-regulate, using reasonable and uniform: 1) standards and practices of education 2) standardized prescribing methods and 3) scientifically defensible testing and monitoring procedures with identified target ranges of optimal dosing defined by best scientific evidence, OR THESE WILL BE DETERMINED FOR US!
A major gift of the meeting in Washington D.C. was the strengthening of my relationship with the leaders of the PCCA. We are proceeding forward to see if we can go back to the Committee for me to give a more extensive presentation to them. We are formulating together the details of the formation of a Specialty Board with Board Certification. We are laying plans to attempt to meet with the leaders of the traditional menopause treatment world, the North American Menopause Society (NAMS). We intend to put together two Summit meetings, one with the leaders in the bioidentical physician’s world and a second with NAMS.
So, the upshot of NASEM is a launch into the next phase of the evolution of this great work. If you have an interest in lending a hand, let us know.