Below is a letter written by Dr. Abrahams in response to the editorial Compounded Bio-Identical Hormone Therapy: Time for a Reality Check? in the September 2015 issue of Menopause, which is the journal of the North American Menopause Society.
Compounded Bio-Identical Hormone Therapy: Time for a Reality Check?
Menopause, September 2015
My name is Michael Abrahams, MD, FACOG, NCMP, and I am director of the Menopause division at a large hospital and residency training program in Brooklyn, NY. I am a loyal member of NAMS and believe me, I am as traditionally minded as they come. I regularly read the majority of articles and reviews in Menopause, and particularly appreciate your “nuts and bolts” approach to the treatment of menopause. But, I would like to write a comment to your editorial in the September 2015 edition of Menopause, entitled, Compounded Bio-Identical Hormone Therapy: Time for a Reality Check?
I really hoped you were going to go in a different direction.
To take a rather different approach, I would like to express a position that I have taken over the last decade and a half since the initial debut of the epic WHI study. I am not ashamed to say that I do prescribe compounded bio-identical hormone therapy, from a PCAB accredited pharmacy when necessary, yet I also very much support the 2013 DQSA on compounding to insure its quality. Although I always try to utilize the growing number of “approved” products available through the pharmaceutical industry as they become available, there was a time when compounded therapy was mostly all that was available. This is the irony.
If anything, CBHT (Compounded Bio-Identical Hormone Therapy) has been the VERY movement and impetus for us physicians to OPEN our minds from the “one size fits all”, to providing the tailored and individualized therapy that our organization now espouses. Before Oprah and the celebrities introduced me to the “foreign” concept of measuring hormone levels, I did not even consider the fact that one cannot even measure a serum “Premarin” or “Provera” level. I, like you, only measure estradiol levels after initiating treatment, but this is only if the woman is receiving estradiol, an outgrowth of the bio-identical movement. Nor could I distinguish a progestogen from a progestin or progesterone, a distinction missed and ignored by contributors to our journal to this very last issue. Every new study, the KEEPS, ELITE, REPLENISH, MsFLASH, is an ODE to the chemists, pharmacists and “misdirected” women who paid attention to the last arm of the PEPI study, the basic science articles of the late 90’s, and the public pressure to create a micronized progesterone available by prescription. I do not disagree with the statements demanding consistency, regulation and safety in the production of compound hormones, and I do believe that that was the intention of your editorial, but we can’t ignore that currently, transdermal delivery, progesterone, and “bio-identical” therapy, independent of who produces them, is becoming the mainstay, preferred, and indeed, probably safer options. BHRT started as a patient driven movement based on legitimate scientific premises and early overlooked studies.
I am a firm believer that the REALTY CHECK, is for the pharmaceutical companies, physicians, and even NAMS, to embrace the “bio-identical” message, and not continue to “bad mouth” the pathway by which we got here, to our own detriment.
I would also comment, that embracing the science, literature and clinical experience of the International Menopause Society and community, which has been in existence since 1978, should not be shunned or ignored. I also read the Climacteric journal. It seems that they already more comfortable using estriol (E3) and testosterone, which we seem to turn our back on their experience. There is no reason to criticize the “maverick” women and their spokespersons, who seek out the expertise and experience of a tested population. Why is it necessary to re-create the wheel or have the FDA place obstacles for the development of “bio-identical” compounds.
As far as cost to the patient, in the current ACA environment, I have the everyday proof that the cost of the FDA approved bio-identical hormones are often MORE expensive to the consumer than the alleged premium prices being charged by compound pharmacies (Estring for example is over 300 dollars). I am yet to find a day where required pre-authorization for my regulated therapies doesn’t rob me of hours from the day, only to be declined.
Additionally, I may comment that there is only a minimum option of dosing for micronized progesterone available. Years back, before the movement, this also applied to estrogens. Sometimes I need to titrate a dose. My REI colleagues have been ordering compounded progesterone and measuring levels for years without a roar. We are also only about to begin studies on transdermal progesterone, which patients seem to prefer and which NAMS itself has stated “should have a metabolic advantage over higher doses of oral therapy.”
Finally, why are CEE’s still the mainstay of oral therapy? While some of the components of Premarin may have shown desirable estrogen receptor activity by chance, others certainly do not. Just as SERM development is evolving, isn’t it time to make a more ideal estrogen “cocktail”. Do we still produce and use porcine insulin as is, unmodified?
I can’t help but be shocked by a certain continued “bravado” amongst our organization, which is why the public first lost faith in our profession in 70’s, handing them unopposed estrogen; and then again in the wake of the WHI “havoc” for which we are now playing catch up. We must not disappoint another group of women or fool ourselves. I really thought that you were going to suggest, and I would have agreed, that we the physicians, were the ones who are grateful for the reality check.
Michael Abrahams, MD, FACOG, NCMP