Jonathan V. Wright M.D.

The “National Academies of Sciences, Engineering and Medicine Health and Medicine Division” has announced1 an investigation titled Clinical Utility of Treating Patients with Compounded “Bioidentical Hormone Replacement Therapy”. The fact that this written title describing the investigation has quotation marks only around “Bioidentical Hormone Replacement Therapy” gives us a very large clue that from the start this investigation will be biased, as it can’t bring itself to fully recognize the name that has been used by physicians and the millions of individuals using this treatment since the 1980s.

Also indicating that this investigation will be biased from the start is the admission that it is not an independent effort by the “Medicine Division” of the National Academy of Sciences1. Instead, it is sponsored by (guess whom) the “public servants” at the Federal Food and Drug Administration! According to the same announcement1, the “Topics” to be considered are “Biomedical and Health Research, Public Health, Quality and Patient Safety”.

Exactly the opposite of “patient safety”—patient endangerment—would have been the outcome the last time FDA attacked bio-identical hormone replacement therapy, had that attack been successful. In 2008, alleging that they had a “citizen complaint”, our “public servants” at FDA sent a message to every compounding pharmacy ordering them to stop compounding estriol (the only anti-carcinogenic “major estrogen”) as part of bio-identical hormone replacement for women. Fortunately, a very vigorous public outcry appeared to cause the “public servants” at FDA to “back off”, and estriol (exactly identical to the estriol made by functioning ovaries) remains in bio-identical hormone therapy as a significant safeguard against estrogen-related cancer.

The real motivation of that 2008 letter—not at all “patient safety”—was made clear when the identity of the “complaining citizen” was revealed. The “complaining citizen” was the Wyeth Company, suppliers of Premarin®, (trade name for horse estrogen), not at all bio-identical to human estrogen. Premarin® sales had been declining because of the adverse outcome of the Women’s Health Initiative research report, and the rapidly growing competition from bio-identical (to human, not horse) estrogen and other bio-identical hormones.

Testosterone (bio-identical, of course) is also a part of bio-identical hormone replacement therapy, of course in smaller quantities for women (that’s how Nature is; “Copy Nature!”) and in larger quantities for men. Most men don’t know that approximately a decade ago, “compounded bio-identical hormone therapy” for men could contain the major research-proven anti-carcinogenic testosterone2 “3β-Adiol”! For a few months, bio-identical “3β-Adiol” (longer name “5α-androstane-3β,17β-diol”) could be prescribed and compounded with “regular” testosterone, a combination particularly useful to men with a family history of prostate or other testosterone related cancer. That’s greater patient safety, no?

After a few months being able to prescribe 3β-Adiol, notifications were received from the compounding pharmacies that “a certain Federal agency” had made it impossible for them to obtain it. That’s still the case as this is written in 2019.

It’s quite obvious that if “patient safety” were a major concern to the “public servants” involved, there would have been no letter to compounding pharmacies in 2008 telling them to stop compounding anti-carcinogenic estriol! If “patient safety” were a real concern, 3β-Adiol would be available on prescription at compounding pharmacies. Very, very likely you’re not fooled by the mention of “public safety” in this FDA-sponsored investigation!

Of course it’s not enough to see through this “public safety” smokescreen and realize that this is “Big Pharma” (which paid our “public servants” at FDA $7.67 billion* between 1992 and 20163; no kidding, check the citation) and FDA trying to stifle as much as possible the competition from bio-identical hormone replacement therapy.

Before suggesting what we can do to stop our “public servants” at FDA from interfering with or taking away our bio-identical hormone replacement, a brief interlude:

What Is Bio-Identical Hormone Replacement? Is It Safe?

For the one or two of us reading this who aren’t familiar with “bio-identical hormone replacement therapy (BHRT), it’s the use of molecules precisely identical to what are found in human bodies, in the same range of quantities found in human bodies, following the same timing as naturally occurs in human bodies. Briefly put, BHRT is strictly Copying Nature by duplicating for “older” bodies what’s naturally present in younger bodies.

It’s like putting duplicates of the original Ford, Chevrolet, or Toyota parts into Fords, Chevrolets, and Toyotas! Using non-bio-identical hormones (or patent medicines also called “pharmaceuticals or “drugs”) for human bodies is like trying to fix a Ford with Chevrolet or Toyota parts. Makes no sense at all!

Two excellent scientific reports detailing the beneficial effects and safety of bio-identical hormone use can be found at:

http://drricki.com/wp-content/uploads/2010/02/BioIdentical-Hormones-Holtorf-Post-Grad-Med-2009.pdf

https://www.ijpc.com/Abstracts/Abstract.cfm?ABS=3604
Several more abstracts on this topic can also be found at this same URL.

A relatively recent (2018) scientific review article4 tells us: “…minor chemical changes to human sex steroids result in physiologically distinct actions that are not optimal for tissue health and functioning.” A scientific way of saying that bio-identical molecules belong in human bodies, and non-bio-identical hormones don’t

Now back to:

Protect Your Bio-Identical Hormones!

We are told that abortion is part of a woman’s right to control her own health and her own body. So why isn’t using bio-identical hormone replacement also part of a woman’s (or a man’s) right to control her or his own health and body? Obviously, it is! Our own nation’s Declaration of Independence states that we all have “… certain unalienable Rights, that among these are Life, Liberty, and the pursuit of Happiness” and that “… to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed… (emphasis added). It’s time for us to tell our “public servants” at FDA that we do not consent to their disguised attempt to tell us what we can do to take care of our own health with safe, effective bio-identical hormones! Our “public servants” should leave health matters to be decided by each adult individual with the help of their own physician or physicians!

In 2008, the Alliance for Natural Health coordinated on-line a large part of a successful effort to stop our “public servants” from endangering our health by removing anti-carcinogenic estriol from bio-identical hormone replacement therapy. Much of this successful campaign was via e-mails sent simply and quickly (done in as little as five minutes) by anyone who cared to send them from the ANH website directly to their own U.S. Representative and U.S. Senators.

The effort by our “public servants” to dictate to us how, when, and why we can or cannot use bio-identical hormones has already started! The first meeting5 of the committee hired by FDA to “advise” them was held on March 5th, 2019! The website5 tells us: “This meeting will provide an opportunity for the committee to discuss their Statement of Task with representatives of the U.S. Food and Drug Administration.” We know who’s in charge here, and what the goal is!

Please go to the ANH website https://anh-usa.org/fda-feeling-the-heat-on-bioidentical-hormones/ today, read the additional information there, then click on “Take Action”, to send an e-mail (either the pre-done message or your personal message) to your U.S. Representative and U.S. Senators. Tell all your family and friends about this not-very-well disguised attack on health care freedom!

The public outcry—over 100,000 e-mails to members of Congress—that were sent in 2008 “got the job done”. Since then, physicians have been able to prescribe, and compounding pharmacists have been able to provide women with bio-identical estrogens including estriol, which significantly reduce estrogen-related cancer risk!

Of course it’s too soon to know which parts—if not all parts—of bio-identical hormone replacement our “public servants” at FDA are trying to eliminate or “regulate”. Let’s not wait to find out! We’ve all heard that “an ounce of prevention is better than a pound of cure”. Protect your bio-identical hormones now so we don’t have the much harder task of rescuing them from the results of this FDA-funded “investigation”!

Please, please go to the ANH website noted above, send that e-mail today, and then keep sending e-mails until this “investigation” goes away, leaving the use (or not) of bio-identical hormones to be decided by each of us and our physician, not dictated and ruled by “public servants” at FDA!


1 http://nationalacademies.org/hmd/activities/quality/bioidenticalhormonereplacementtherapy.aspx

2 For more details and multiple citations to the science, see Green Medicine Newsletter, April 2018 and Feb. 2019.

3 https://www.businessinsider.com/fda-user-fees-from-pharmaceutical-companies-2016-8

4 Atwood CS, Ekstein SF. Human versus non-human sex steroid use in hormone replacement therapies part 1: Preclinical data. Mol Cell Endocrinol. 2019 Jan 15;480:12-35.

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