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A history and update of the FDA's current challenge to cBHRT.

If we lose Compounded Bioidentical Hormone Replacement Therapy

As we look over the tools available to us, are there any more important than compounded bioidentical hormones? Imagine the day you would have to tell your patients that you can no longer prescribe these hormones to them. Imagine the impact on their lives, relationships, on careers, and to the health of our population as a whole. Devastating. And, NASEM1 and the FDA threaten access to compounded bioidentical hormones for women, men, and health care professionals. If we lose Compounded Bioidentical Hormone Replacement Therapy
As so many of you know, back in the early 1980s, an American medical doctor. searched for hormone alternatives to the few widely utilized, FDA-approved, pharmaceutically manufactured hormone treatments of the time.2 This physician pioneered the use of topical and bioidentical Bi-est, comprised of Estriol and Estradiol, a compounded hormone that is widely prescribed by health care practitioners to this day—and, is available, along with many other formulations, only through compounding pharmacies.
Women and men vary enormously individual to individual as to their needs, sensitivities, balances, absorption, preferences and so much more. Without our compounding brethren and sistren, there would simply be no way to personalize treatment programs for each patient. This customization is at the very core of sound hormone replenishment medicine!
As most of you know, hormone treatment of women radically changed when the Women’s Health Initiative3 (WHI) study was published in 2002. The WHI incorrectly4 concluded that women in menopause who were treated with Prempro were subject to an increased risk for breast cancer, heart attack, and stroke. Even though the study, itself, did not back up this assertion of increased risk,4 this report triggered an explosion of fear amongst women patients and prescribing health care professionals.
This fear generated by the WHI resulted in a precipitous decline in the number of women who were being treated with hormone replacement therapy (HRT). Prior to the WHI, 18 million American women — 40% of all those who were in menopause — were receiving HRT, and almost all of that being from Premarin and Prempro. After the WHI women being treated declined to a fraction of this number.5 The subsequent health consequences to women worldwide were monumental and egregious. The loss of profits and market share to pharmaceutical manufacturers was also colossal. Before the WHI study, Premarin and its derivatives had been one of the most popular and profitable manufactured drugs of all time.
As an unintended consequence, however, the WHI study also inspired many women and physicians all across America and the world to seek safer and more effective alternatives… and they turned towards the use of compounded bioidentical hormones.
Of great note, that has gone almost entirely unnoticed: in 2017, the original WHI study group retracted its original assertion about a hormone-cancer link. They published, again in JAMA,6 that “among postmenopausal women, hormone therapy with CEE (conjugated equine estrogens) plus MPA (medroxyprogesterone acetate–Prempro) was not associated with risk of all-cause, cardiovascular, or cancer mortality during a cumulative follow-up of 18 years.” Even though risk information has finally been corrected and thoroughly addressed, (see reference7) the perception persists, both by the public and by healthcare professionals, that there is risk to women who are taking hormones.
Also of note: by 2016, approximately 5 million American menopausal women were using replacement hormones. Big difference: now, over half of these women are being treated with compounded bioidentical hormone replenishment therapies (cBHRT). 8, 9
Backing up in time, in 2008, the FDA launched its first concerted effort to restrict or even remove bioidentical hormones from the market. Overwhelming opposition from a public response – over 77,000 letters sent to the FDA and Congress, primarily by American women, during the public comment period – convinced Congress and the agency to temporarily suspend its ongoing quest to restrict women’s health care choices.
As many of you know, fast forward, the FDA tasked NASEM with determining the safety and efficacy of compounded bioidentical hormones. The results of which are that NASEM has passed its findings in their Report10 onto the FDA and the FDA then issued its report11 including suggesting that cBHRT could be classified on the “too difficult to compound” list.
This would be a catastrophe that would mean the end of hormone medicine as we know it and millions of women and men depend upon.
The Committee’s “recommendations”12 and the follow-up FDA report, could have serious and disastrous consequences. Here are the most challenging issues.

The NASEM Report concluded that the FDA should:

  1. “Restrict the use of compounded bioidentical hormone therapy  preparations. Prescribers should restrict the use of bioidentical hormone  preparations to the following situations:

– documented allergy to an active pharmaceutical ingredient or excipient of an FDA-approved drug product, or a documented requirement for a different dosage form … “

This regulation directly has the FDA determining how a healthcare professional should practice medicine. This overreach goes beyond the mandate and authority of the FDA and like violations have been successfully challenged in the past.

         – “Patient preference alone should not determine the use of bioidentical preparations.”….

This overreaches into the freedom of women and men patients to freely and privately choose their healthcare providers and, according to the modes of therapies and expertise offered.

  1. “Review select bioidentical hormone therapies and dosage forms as candidates for the U.S FDA Difficult to Compound List, [including]: estradiol, estrone, estradiol cypionate, estriol, pregnenolone,  dehydroepiandrosterone (DHEA) progesterone, testosterone, testosterone cypionate, and testosterone propionate…”

This recommendation is potentially devastating to providers and patients.  No drug can be compounded, if it is on the “Too Difficult to Compound List.” 13    If these bioidentical products are put on this list, that would be the immediate end of all bioidentical hormone therapy. 

This regulation would destroy the present ability of physicians and patients even to access bioidentical hormone treatments, at all.  Such undue limitation will impact millions of patients (both women and men) who are living fulfilling, productive lives, thanks to these currently legal bioidentical hormone treatments.

There are other alarming recommendations in the NASEM report: 

“A state-level certification program for providers seeking to start or continue to prescribe bioidentical hormones.” 

Professional societies (which are often supported by money from the pharmaceutical industry) will promote “best practices” guidelines, stating when a provider should consider using a bioidentical hormone in lieu of an FDA-approved drug- essentially telling doctors when, how, and which formulations they could even think about using. 

“Additional federal and state-level oversight.”  This expansive recommendation includes new mandates, inspections, paperwork, reporting requirements, and other onerous restrictions on compounding pharmacies.

The Response:

The robust response of cBHRT professionals and the public to these challenges has been inspiring. Coming forward are millions of American women, and many men, that are being treated with compounded bioidentical hormones. Along with them are thousands of physicians, nurse practitioners, and physician’s assistants that are treating these women, as well as thousands of compounding pharmacies that are dispensing these hormones.

Memorandum to the FDA report. An immediate response to the FDA report came from Rachel Pontikes,  an attorney with Reed-Smith, a prominent international law firm.) Supported by several compounding pharmacies, she issued a profound legal memorandum to the FDA that has been published in the FDA docket.14 It contains many points of contention:

  • The FDA is overstepping its mandate and is interfering with the rights of women to choose which methods of treatment they want for their health care.
  • The FDA is also exceeding its legal authority and is overreaching by dictating to medical professionals how to practice medicine.  Again,the FDA has been successfully challenged on this issue, in the past.
In a recent follow-up Supplemental Report15  to the FDA, Ms. Pontikes also pointed out the lack of credentialed legitimate authority of the members of the NASEM Committee, the interference of the FDA into the proceedings of the Committee, as well as the commercial conflicts of interest present in some of its members.

APC: The Alliance for Pharmacy Compounding has mounted a phenomenal and multifaceted response. We recommend that you visit their website, and, participate in their calls to action (https://www.a4pc.org). Their commitment is prodigious and determined.

We the Women. One of many organizations devoted to protecting the healthcare rights of women, and, deeply committed and involved in this bioidentical hormone challenge.

ANH  The Alliance for Natural Health Always a major player in the protection of our healthcare rights.

We invite all of you to join us  We are a central focus of much-needed synergy, energy, expertise, creativity, and co-ordination! Please send us your email and/or other contact information, so we can inform you about upcoming events, strategies, conference calls, campaigns, etc., and, also crucial, to be deployed at the best-coordinated timing. There are specific actions you can take to protect our personal and professional health care rights and freedoms. Join us.

  1. NASEM = National Academy of Science, Engineering and Medicine’s Committee on the Safety and Efficacy of Compounded Bioidentical Hormones

  2. Premarin: estrogens derived from pregnant mares’ urine (hence the name, “Premarin”), and Prempro, which is Premarin combined with a synthetic and problematic progestin.

  3. https://jamanetwork.com/journals/jama/fullarticle/195120

  4. Premarin had a 0.79 relative risk (less risk if a woman is treated with Premarin than if not being treated. Prempro had a 1.26 RR, which was noted to be “statistically insignificant” in the body of the study.

  5. Hormone therapy prescribing patterns in the United States. 2004 Nov;104(5 Pt 1):1042-50. doi: 10.1097/01.AOG.0000143826.38439Diana S M Buist, et al

  6. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality. Manson, et al, JAMA. 2017 Sep 12; 318(10): 927–938 https://pubmed.ncbi.nlm.nih.gov/28898378/

  7. Estrogen Matters, Why Taking Hormones in Menopause Can Improve Women’s Well-Being and Lengthen Their Lives — Without Raising the Risk of Breast Cancer, Avrum Bluming, MD and Carol Tavris, PhD, published September 4, 2018.    https://www.amazon.com/Estrogen-Matters-audiobook/dp/B07G9JXT1H/ref=sr_1_1?dchild=1&keywords=estrogen+matters&qid=1616341235&sr=8-1

  8. Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. JoAnn V. Pinkerton, MD1 and Nanette Santoro, MD2. Menopause. 2015 Sep; 22(9): 926–936. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547729/

  9. Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey. JoAnn V. Pinkerton, MD1 and Ginger D. Constantine, MD2. Menopause. 2016 Apr; 23(4): 359– 367. https://pubmed.ncbi.nlm.nih.gov/26645819/

  10. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.https://www.nationalacademies.org/our-work/clinical-utility-of-treating-patients-with-compounded-bioidentical-hormone-replacement-therapy.

  11. National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy. https://www.fda.gov/drugs/human-drug-compounding/national-academies-science-engineering-and-medicine-nasem-study-clinical-utility-treating-patients

  12. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use https://www.nationalacademies.org/our-work/clinical-utility-of-treating-patients-with-compounded-bioidentical-hormone-replacement-therapy, Section 9, page 217

  13. See 21 US Code 353a(b)(3) and 353b for verification.  https://www.law.cornell.edu/uscode/text/21/353a

  14. Reed, Smith: Rachel Pontikes https://www.regulations.gov/comment/FDA-2015-N-0030-8335

  15. Supplemental Report from Reed, Smith: Rachel Pontikes. https://a4pc.org/Common/Uploaded%20files/Advocacy/2021-03_cBHT-Supplemental-Comment-and-Exhibits.pdf

In an attempt once again to eliminate cBHRT, the FDA funded and tasked the National Academy of Science, Engineering and Medicine to form a Committee to Examine the Safety and Efficacy of cBHRT and issue a report of their findings. 

What is the NASEM Study About Bioidentical Hormone Replacement Therapy?

Since the 1980’s, thousands of healthcare providers and millions of patients, both women and men, have turned to compounded hormones to treat hormone-related health concerns. These products often are described as “bioidentical” and are commonly referred to as “Compounded Bioidentical Hormone Replenishment [or Replacement] Therapy” (cBHRT). Pharmacy compounding is a long-established tradition that allows a physician to prescribe a unique medication, prepared by a pharmacist, for a patient’s individual needs. Before massive pharmaceutical companies existed, compounded medications were the majority of prescription drugs.
Again, the Food & Drug Administration (FDA) commissioned an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study to determine whether women and men need the option for prescribed cBHRT, or whether existing manufactured drugs made by large pharmaceutical companies can meet this need. In July 2020, NASEM issued the controversial report of its findings. (A NASEM press release provides a summary of the full report.)
FDA asked NASEM to “examine the clinical utility of treating patients with compounded cBHRT products.” Essentially, FDA wants to hide behind the recommendation of a supposedly independent scientific organization, as it seriously considers whether to severely limit or even take away the option that prescribers and patients currently have to use cBHRT.
The NASEM committee was composed of medical professionals with significant professional credentials. However, none of the committee members had any clinical knowledge, experience, or expertise in treating women or men with compounded hormones, and no expert compounding pharmacists were on the committee! The questions that committee members asked at meetings showed an alarming lack of knowledge about the topic they considered. And, while NASEM is a well-respected organization, its Committees are most familiar with the type of scientific and research information provided by drug companies that spend hundreds of millions of dollars for mass-marketed drug approvals. CBHRT is not designed for mass markets but for patient-specific individualized therapy. Also, cBHRT cannot be patented because it has the same molecular structure that exists in the human body. This type of information and so-called double-blind studies on compounded hormones, which are incredibly expensive to undertake, are simply not available and are not required for compounded medications.
In its request for the NASEM study, FDA said that “ cBHRT products are not FDA-approved, which means these products have not undergone an FDA assessment of safety, effectiveness, and quality.” So, from the start, FDA stated its clear preference for “one-size-fits-all” drug company medications. This ignores the fact that compounded medications are made by pharmacies, which are licensed by state boards of pharmacy, not FDA. Entirely different standards are applied to manufactured drugs than to compounded medications.
All of this means that the NASEM committee was naturally biased towards hormones marketed by the large drug companies, with a one-size approach that has failed both men’s and women’s health needs. Also to be noted is that a sizable proportion of the FDA’s funding comes directly from pharmaceutical manufacturers.
From the start of the NASEM study, FDA officials were present at meetings, directing and overseeing the process of a supposedly independent study. This, coupled with the fact that the NASEM committee did not have any members with any experience in compounding or prescribing cBHRT, violates the Federal Advisory Committee Act (FACA). FACA requires that advisory committees like this have a balanced and representative make-up and that they operate independently of pressure or influence from the sponsoring agency.

The NASEM committee essentially determined that women and men don’t need compounded alternatives to drug-company hormones. As a result, this highly prejudiced and likely illegal study could become the basis for FDA moving to outlaw most if not all cBHRT.

That is why it is important to stop FDA’s assault on compounded hormones using the flawed and biased NASEM study as a rationale for this action.

Letters to Congress