My Bioidentical Hormone Creams Are Killing Me !!!
by Jeffrey Dach MD
With the publication of the NASEM report July, 2020, I was astonished to learn that for the past 20 years, compounded bioidentical hormones have been killing every one.(1) If only we had used FDA approved hormone pills and patches manufactured by the Pharmaceutical Industry, everything could have been so much better.
This is All Nonsense
Of course, this is all nonsense, because over the past 20 years of prescribing compounded bio-identical hormones to thousands of patients, I can attest to good outcomes in patients on compounded bioidentical hormones, with relief of menopausal symptoms and good quality of life (QOL). Of course, adverse side effects can occur, most commonly related to excess hormone dosage. These are easily managed by adjusting dosage under the supervision of a knowledgeable physician. .
Evidence Does Not Support Clinical Utility of Compounded Bioidentical Hormones
Here is the conclusion of the NASEM Report:
“Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA),” (1)
Endocrine Nonsense Society ?
This NASEM report reminds me of the last time this came up in 2016 when the Endocrine Society advised doctors against using compounded bioidentical hormones. Four years ago, I wrote an article suggesting the organization should change their name to the “Endocrine Nonsense Society”. Similarly, NASEM which stands for National Academy of Science Engineering and Medicine should change its name to the ” National Academy of Nonsense, Engineering and Medicine“.(2)
Compounded Bioidentical Hormones Are on the Chopping Block
The Drug Industry has a long history using unethical and illegal activities including “dirty tricks” to advance its financial interests. Indeed, the Drug industry has paid out 35 Billion Dollars in penalties for Criminal and Civil Violations. One of the “dirty tricks’ over the years is the seeding of medical literature with “Ghost Written” articles disparaging bioidentical hormones and promoting their own patented synthetic hormones.(5-7)
Pharmaceutical Industry as Organized Crime Syndicate
Books by two eminent physicians Drs. Peter Gotsche, and Marcia Angell have documented the enormous corruption of the Pharmaceutical industry. Dr. Peter Gotsche has gone so far as to compare the Pharmaceutical Industry with an organized crime cartel which has captured our legislative bodies, regulatory agencies, medical societies, medical meetings, medical research, and the mainstream media, thus wielding enormous power over our society. (5-7)
Insidious New Campaign to Eliminate Compounded Hormones
With the publication of the NASEM Report, the Pharmaceutical Industry has launched an insidious new campaign to eliminate compounded bioidentical hormones. This campaign is based on the NASEM report claim that only randomized placebo controlled trials represent “medical evidence”. The FDA, an agency captured by the drug industry, funded a report by the NASEM (National Academy of Science Engineering and Medicine) to come up with the predestined conclusion: Since there is no evidence for efficacy or safety for bioidentical hormones, therefore bioidentical hormones should be placed on the FDA “Difficult to Compound List”, a regulatory move which essentially bans compounded bioidentical hormones, eliminating a major economic competitor. It’s just business. Two consequences will be:
1) Post Menopausal women will have no access to the compounded hormone creams they are currently using.
2) Compounding pharmacies across the nation will go out of business.
The Old Gimmick Used by the Pharmaceutical Industry
The basis for the FDA funded NASEM report is an old gimmick used over and over again by the drug industry to eliminate competing natural substances, and thereby gain market share. According to patent law, natural substances such a bioidentical hormones can not be patented, so there is no money for expensive clinical trials.
The Only Acceptable Evidence
The old gimmick is to “declare” that the only acceptable “evidence” is the randomized double blind placebo controlled drug trial of the the type required for FDA new drug approval. Although the Randomized Double Blind Placebo Controlled Trial is considered the gold standard for FDA drug approval, this type of drug trial is not practical for natural substances which can not be patented, nor for Off-Label drug use. The reason patent protection is required is the cost involved in a randomized trial is prohibitively expensive in the range of 100 to 250 million dollars. No drug company in their right mind would incur this expense without patent protection to guarantee profits on the back end. The same is true for most Off-Label drug use, usually involving Off-Patent drugs, meaning these are old drugs with expired patents.
Using a False Claim to Defeat the Competition
To make the claim that the only acceptable “evidence” is a randomized placebo controlled drug trial is not only false, it is standard gimmick or ploy used by the pharmaceutical industry for decades. Off-Label prescribing is in the same boat, since there are no randomized placebo controlled trials to support Off Label use of an old drug. So, such an attack on compounded hormone preparations is also an attack on Off-Label prescribing, comprising 20% of all presciptions
The Privilege of Off-Label Prescribing
New drugs are FDA approved for a specific “indication”, a medical condition placed on the drug label. However, about twenty percent (one fifth) of all drug prescriptions are prescribed Off Label.(1) This means the drug is prescribed for a different indication unrelated to the original FDA approval.
Prescribing an Antibiotic for Cancer Off-Label
An example of “Off-Label” use is the prescribing of Clarithromycin for Multiple Myeloma by Dr. Tomer Mark of Cornell as a repurposed anti-cancer drug for Multiple Myeloma. Clarithromycin’s original FDA approved indication is an antibiotic to treat bacterial infection, not as a repurposed anti-cancer drug. (3-4)
This common medical practice of “Off-Label Use” of a drug has always been accepted by all medical societies and regulatory agencies as a prerogative and privilege of the prescribing physician. Since twenty percent of prescriptions are not based on a randomized double blind placebo controlled trial (typically used for FDA new drug approval), the next obvious question is: What other types evidence are used to justify Off-Label prescribing of drugs?
Other Types of Evidence for Prescribing Drugs Off Label
Doctors rely on many other types of evidence such as in-vitro and in-vivo animal studies, human observational trials, and registry trials. Another powerful and highly accepted type of medical evidence called challenge, rechallenge, which proves drug causality. Challenge-Rechallenge is accepted by medical science as well as our legal system (a court of law), and is used in medical research to show causality of a drug or treatment.
Of course, the doctor must understand the physiology, the basic science showing the mechanism of action of the drug. The importance of this cannot be over-emphasized, as it provides confidence that the drug is effective and can be used, or ineffective and should not be used.
NASEM Committee Rejects All Other Types of Medical Evidence
All of these other perfectly valid types of medical evidence have been rejected by the esteemed doctors of the NASEM committee who came to their ridiculous conclusion, that there is no evidence of clinical utility of compounded bioidentical hormones. Needless to say this amounts to a form of scientific deception and fraud which, in a free society, should not be tolerated. This erosion of scientific integrity is real, and if unchecked by a grass roots movement of enraged post-menopausal women, this insidious campaign against compounded hormone replacement is likely to prevail, resulting in catastrophic consequences for millions of post menopausal women, and their compounding pharmacies..
FDA Approved Bioidentical Hormones Preparations:
All the hormones used in compounded preparations have been FDA approved and are used OFF-Label in compounded preparations. Here is a partial list of FDA approved hormone preparations for Estradiol, Progesterone and Testosterone:
Hormone Product Year of FDA Approval Manufacturer
Alora (estradiol): FDA approved 1996 Watson Labs
Climara (estradiol): FDA approved 1994 Bayer
FemPatch : (estradiol) FDA approved 1997 Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 Novartis
Estraderm: (estradiol) FDA approved 1986 Novartis
Esclim: (estradiol) FDA approved 1998 Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 Bristol Myers Squibb
Estring: (estradiol) FDA approved 1996 Pharmacia UpJohn
Prometrium (progesterone): FDA approved 1998 Solvay Pharmaceuticals
Crinone: (progesterone) FDA approved 1997 Columbia Labs
AndroGel (testosterone): FDA approved 1999 Unimed / Abbott
Testim (testosterone): FDA approved 2002 Auxilium
Compounded Bioidentical Hormones Are a Form of OFF-Label Use
As you can see with the above chart, the bioidentical hormones, Estradiol, Progesterone and Testosterone have all been FDA approved for specific indications on the basis of randomized placebo controlled trials. Off-Label use of these drugs and other drugs is a common physician practice. Compounded formulations of combinations of these three hormones is a form of Off-Label use and as such, the NASEM report requirement of placebo controlled randomized trial for each compounded formulation is a ridiculous proposal, and in fact is has never been required in the history of medicine for OFF-Label prescribing by a physician.
Medical Evidence Supporting Off Label Use of Bioidentical Hormones
The next obvious question is where is all this medical evidence excluded by the NASEM Report supporting the clinical utility, safety and efficacy of bioidentical hormones for Off Label prescribing ? This evidence is abundant in the medical literature. For starters, I refer the reader to two excellent review articles by Drs. Kent Holtorf, Erika Schwartz and David Brownstein. (8-9) There are many others.(10-18) A Google Scholar search for the key words, “bioidentical hormones” yields 5,200 articles in the scientific literature. Go take a look.
Here are two of my articles on the safety and efficacy of bioidentical hormones:
The Safety of Bioidentical Hormones
The Importance of Bioidentical Hormones
Hormone Replacement is Not a Stand Alone Program
The one pill, one clinical trial, one FDA indication mentality of the drug industry is inadequate for the complexities of actual clinical practice prescribing bioidentical hormones for the typical post menopausal patient. A Bioidentical Hormone Program should not be considered a stand alone medical intervention. A more holistic, integrative approach is required to achieve the best results. A complete patient evaluation which addresses micro-nutrient deficiencies, thyroid function, and gluten sensitivity is included in the program. I would recommend adding a cancer prevention program, as well, with testing for and supplementation with Iodine, vitamin D3, Selenium and DIM (Di-Indole Methane).
Subservience to the Pharmaceutical Industry
In most of the NASEM Reports, subservience to the pharmaceutical industry agenda is not so obvious. This one is very blatant. This NASEM “Decree” reminds me of a scene in a Woody Allen movie, “Bananas”. The little island of San Marcos has a new Dictator, and his first proclamation is: “All subjects are to wear their underwear on the outside”. Oh well, Just another day for George Orwell’s “Ministry of Health and Truth”. America, it’s a Great Country..(3) See video below:
In the 1940’s an obscure Penn State chemist by the name of Russell Marker devised the Marker Degradation Process which opened the door for manufacturing bioidentical hormones inexpensively in large volumes. Russell Marker gave this “Process” as a gift to the world, declining to obtain a patent for his chemical formulation. Since the 1940’s, bioidentical hormones have been prescribed by physicians for the betterment of human life, specifically to relieve post-menopausal symptoms. The FDA is seeking to change that by using a fraudulent NASEM report to ban the use of compounded bioidentical hormones. This is the most evil, despicable thing I have seen in a long time. Where is the outrage?
Jeffrey Dach MD
7450 Griffin Road Suite 180/190
Davie, Florida 33314
Articles with Related Interest:
Click Here for Bioidentical Hormone Articles by Jeffrey Dach MD
Links and references
1) National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. https://doi.org/10.17226/25791.
2) Santoro, Nanette, et al. “Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement.” The Journal of Clinical Endocrinology & Metabolism 101.4 (2016): 1318-1343. Nanette Santoro, Glenn D. Braunstein, Cherie L. Butts, Kathryn A. Martin, Michael McDermott, and JoAnn V. Pinkerton
3) Mark, Tomer M., and Morton Coleman. “It’s time to take clarithromycin seriously in multiple myeloma.” Acta haematologica 135.2 (2016): 101-102.
4) Mark, Tomer M., et al. “Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma.” Blood advances 3.4 (2019): 603-611.
5) Fugh-Berman, Adriane J. “The haunting of medical journals: how ghostwriting sold “HRT”.” PLoS Med 7.9 (2010): e1000335. The haunting of medical journals how ghostwriting sold HRT Fugh-Berman Adriane J PLoS Med 2010
6) Angell, Marcia. The truth about the drug companies: How they deceive us and what to do about it. Random House Incorporated, 2005.
“The combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion) [in 2002]. Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself.”
7) Gøtzsche, Peter. “Deadly medicines and organised crime.” How Big Pharma has corrupted healthcare. London: Radcliffe (2013).
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm.
The research literature is distorted by scientific misconduct through trials with flawed designs and analysis, selective publication of trials and data, and ghostwritten papers.
The author states on page 39, “Almost every type of person who can affect the interests of the industry has been bribed: doctors, hospital administrators, cabinet ministers, health inspectors, customs officers, tax assessors, drug registration officials, factory inspectors, pricing officials, and political parties.”
8) Schwartz, Erika T., and Kent Holtorf. “Hormones in wellness and disease prevention: common practices, current state of the evidence, and questions for the future.” Primary Care: Clinics in Office Practice 35.4 (2008): 669-705.
9) Holtorf, Kent. “The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy?.” Postgraduate medicine 121.1 (2009): 73-85.
10) Ruiz, Andres D., et al. “Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study.” BMC women’s health 11.1 (2011): 27.
This study demonstrates that compounded BHRT improves mood symptoms. Larger studies are needed to examine the impact on vasomotor symptoms, myocardial infarction and breast cancer.
11) Martins, Vera, et al. “Compounded bioidentical HRT improves quality of life and reduces menopausal symptoms.” Journal of Prescribing Practice 2.7 (2020): 384-390.
12) De Lignieres, B., et al. “Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.” Climacteric 5.4 (2002): 332-340.
13) De Lignieres, B. “Effects of progestogens on the postmenopausal breast.” Climacteric 5.3 (2002): 229-235.
14) Fournier, Agnes, et al. “Breast cancer risk in relation to different types of hormone replacement therapy in the E3N‐EPIC cohort.” International journal of cancer 114.3 (2005): 448-454.
15) Wood, Charles E., et al. “Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys.” Breast cancer research and treatment 101.2 (2007): 125-134.
These findings suggest that oral micronized progesterone has a more favorable effect on risk biomarkers for postmenopausal breast cancer than medroxyprogesterone acetate.
16) Hargrove, Joel T., et al. “Menopausal hormone replacement therapy with continuous daily oral micronized estradiol and progesterone.” Obstetrics and gynecology 73.4 (1989): 606-612.
17) L’Hermite, M. “Custom-compounded bioidentical hormone therapy: why so popular despite potential harm? The case against routine use.” Climacteric 20.3 (2017): 205-211.
HT can be optimized by continuously combining transdermal estradiol with progesterone (when required).
18) Thompson, Jennifer Jo, Cheryl Ritenbaugh, and Mark Nichter. “Why women choose compounded bioidentical hormone therapy: lessons from a qualitative study of menopausal decision-making.” BMC Women’s Health 17.1 (2017): 97.
This study finds that women draw upon a range of “push” and “pull” motivations in their decision to use CBHT. Importantly, we find that women are not only seeking alternatives to conventional pharmaceuticals, but alternatives to conventional care where their menopausal experience is solicited, their treatment goals are heard, and they are engaged as agents in managing their own menopause. The significance of this finding goes beyond understanding why women choose CBHT. Women making menopause treatment decisions of all kinds would benefit from greater shared decision-making in the clinical context in which they are explicitly invited to share their experiences, priorities, and preferences. This would also provide an opportunity for clinicians to discuss the pros and cons of conventional HT, CBHT, and other approaches to managing menopause.
FDA: Bioidenticals are “Public Health Concern;” Ban Likely July 9, 2020
FDA Turns Its Back on Women July 23, 2020 Category: War On Natural Medicine
FDA Rigs Process Against Estriol, Other Bioidenticals
November 7, 2019
APC is still reviewing the report, but a few preliminary points are worth noting:
The NASEM study committee was populated by esteemed healthcare professionals, but there was not a pharmacist with patient-facing experience, much less a pharmacy compounder, in their number. Neither was there a physician with substantive experience in bioidentical hormone therapy. Likewise, the peer reviewers for the study included few compounders — but did include one former FDA employee (and current FDA contractor) who is a long-time, well-known opponent of pharmacy compounding.
Although compounded drugs are exempt from the new drug approval process because they are prepared to meet individual patient needs, the foundation of NASEM’s analysis seems to focus on the absence of new-drug-caliber studies of compounded meds. The report makes an illogical leap by effectively deeming cBHT unsafe unless it can mirror drug manufacturing in terms of safety and effectiveness data, labeling, AE reporting, pharmacokinetic data, and scale of clinical trials.
NASEM said it based its recommendations in large part on a review of literature, but identifies only 13 studies as having, in the judgment of the committee, suitable “rigor and relevance” — these, out of literally hundreds of studies out there, not to mention abundant patient outcomes data that could and should have been considered and weighed.
The report calls for restricting use of cBHT to patients with allergies to FDA-approved drugs, despite the fact that many FDA-approved therapies may not meet the dosing needs of patients — a point not addressed by the report’s recommendations.
The recommendations seem to suggest that a prescriber’s medical judgment and a patient’s preferences should play no role in determining a proper course of treatment — a stunning assertion that is applied to no other aspect of medicine or pharmacy care. Women’s needs are much more complex than the cookie-cutter approach offered by current FDA-approved drugs. Individualized therapy is the result of a balanced approach between prescriber, patient and pharmacist assessing each patient’s unique needs.
The NASEM study seems to suggest that states that do not adopt USP <795> and <797> chapters in whole, without question or amendment, are somehow under-regulating compounders, yet it provides no evidence of patient harm that has resulted in states that adhere to different standards.
The report cites concerns over bioavailability. However, many compounders or prescribers perform saliva or serum testing to confirm cBHT is appropriate therapy. Yet how many prescribers routinely check levels of FDA-approved products?
The report sends mixed messages. Individualized therapy is a part of FDA’s newly established goal of creating personalized therapies to target each patient. Factors such as age, weight, genetics, past medical history all contribute to appropriate treatment and dosage selection. Yet these NASEM recommendations seem to assert that FDA-approved drugs are always superior to compounded therapies.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act: