Chapter 19. Ten Bioidentical Hormone Fallacies

A recent article on Huffington Post on the topic of hormones for menopause caught my attention. (1)  I was puzzled by the fact that the author had no medical credentials, medical training or even a rudimentary knowledge of biological science.  Rather, she is an actress with a theater arts degree from UCLA. She chronicled her menopause experience with a book and blog entitled, “Menopause Makeover”. To make up for her lack of medical knowledge, the author joined up with an academic physician who advocates synthetic, chemically altered hormones (progestins), and SSRI antidepressants for menopausal symptoms.  The latest article by the two women, "10 Hormone Therapy Facts ", is a compilation of nonsense, falsehoods, and half truths, with a hidden agenda  promoting the synthetic hormone industry by maligning natural bioidentical hormones.

10 Ten Hormone Facts Should Be Renamed 10 Ten Hormone Fallacies

Firstly, the article attempts to malign bioidentical hormones, claiming they are unregulated, non-FDA approved and not supported by science. These claims against bioidentical hormones are false, and a smokescreen to hide the really frightening fact that synthetic hormones are monsters that cause cancer and heart disease, as shown in the Women's Health Initiative study.  Secondly, the article tries to confuse the difference between bioidentical hormones and synthetic, chemically altered hormones made by the pharmaceutical industry. Do not be confused, they are very different. Synthetic hormones are chemically altered monsters that cause cancer and heart disease. Bioidentical hormones are identical to hormones found naturally in the human body, the safe and effective choice.  Thirdly, the article contradicts itself, stating that blood testing is not needed, while the author earlier reported that blood testing revealed a high estrogen level. Obviously, blood testing of hormone levels was needed.  Fourth, the article quotes the Menopause and Endocrine Societies as authorities without revealing their financial ties to the synthetic hormone makers such as Wyeth.  Fifth, the author says that bioidentical hormones did not work for her. Quite to the contrary, millions of women use bioidentical hormones every day for relief of menopausal symptoms and quality of life. Bioidentical hormones work quite well.  Sixth, after ranting that bioidentical hormones don't work, the author reports they DO work, and admits she uses estradiol, a bioidentical hormone.  Estrogen alone without progesterone causes increased risk of endometrial cancer. This important information is omitted from the article, possibly harming women readers who accept the author as a medical authority, incorrectly concluding that estrogen without progesterone is acceptable.  It is not acceptable, and is a disservice to women.

Let's go through the article in detail. Note: the article text is in italics:

Bioidentical hormone treatment made my menopausal symptoms worse.

"I splurged for Somers' expensive Beverly Hills doctor recommendation, assuming he must have the answers. He confirmed I was menopausal and gave me tubes of compounded triple estrogen gel and compounded 10 percent micronized progesterone gel, with orders to apply them regularly. After a few months of visiting this overpriced Beverly Hills doctor, my menopause symptoms were exaggerated and my moodiness turned into depression. "

My comment: The above described bioidentical hormone program of topical estrogen and progesterone is the correct one, used by millions of women daily. It is safe and effective. However, close patient monitoring is required, and the patient should be alerted to watch out for signs of hormonal excess.  

Blood Test revealed my estrogen levels were 7 times higher than normal

“A blood test revealed that my estrogen levels were seven times higher than normal, my increased weight now placed me into the overweight BMI category, and my severe crankiness made it impossible to work. There is no need for testing of hormone levels, either in saliva or blood. The science has shown that there is no predictable correlation between hormone levels in saliva or in blood and severity of symptoms. “

My comment:   The author of this article should have studied Uzzi Reiss’s books on bioidentical hormones which explain the symptoms of estrogen excess.(12)  These symptoms are fluid retention, bloating, breast enlargement and tenderness.  Once these estrogen excess symptoms are identified, the patient should hold off using the estrogen until symptoms dissipate and are relieved.  Educating the patient about estrogen excess symptoms, and when to hold hormone dosage is the key to successful treatment program.

Birth Control Pills Can Make Ovarian Function Erratic

Birth control pills complicate the story considerably.  Birth control pills are a form of chemical castration, causing artificial cycles without ovulation.  Once the pills are stopped, there is usually a delay of months before normal ovarian function and normal cycling resumes, and patients typically experience menopausal symptoms.  Upon starting a bioidentical hormone program, the patient will feel better.  However, a few months later with resumption of ovarian function, there may be hormonal excess with symptoms of bloating, breast enlargement and mood disorder. This is not a failure of the medication, rather it is a failure of patient monitoring and failure to alert the patient to estrogen excess symptoms. Blood testing is useful here to show elevated estrogen levels.  However, in most cases testing is not required since the clinical picture is obvious.

Unregulated Hormones Not Supported by Science

"What went wrong? I trusted a resource not supported by science. I was taking unregulated hormones. It was eye-opening to learn that natural compounded bioidentical hormones were unregulated by the FDA. There was no standardization for producing the product, and no tests on the formulations. There are NO real natural hormone products available."

My comment: The author clearly had a bad experience with this first doctor, and then incorrectly concludes there is something wrong with the bioidentical hormones, saying that bioidentical hormones are not supported by science, unregulated, non-standard, and untested. Of course, this is all nonsense. Bioidentical hormones are heavily regulated, tested and supported by science. The statement, “There are NO real natural hormone products available” is more nonsense. Quite to the contrary, millions of women are using them every day.

Science DOES support the use of bioidentical hormones for menopausal symptoms. Go to Medline and do a search for estrogen or progesterone and 90,000 articles will come up. Dr. Holtorf’s review article , “The Bioidentical Hormone Debate”,  published in PostGraduate Medicine, cites 196 medical studies showing that bioidentical hormones are safer and more effective than synthetic chemically altered hormones. (2)

Bioidentical hormones are heavily regulated as both FDA approved products at the corner drug store and as compounded preparations. Compounding does not fall under the jurisdiction of the FDA, so FDA regulation is not needed or even desired. Instead, Compounding pharmacies have a separate system of regulation at the state and local level which is rigorous and recognized by the AMA. Look for a compounding pharmacy with PCAB accreditation. 

1 ) “Natural: The word "natural" is a marketing term. There is no scientific evidence that custom-compounded bioidenticals are safer or more effective or more "natural" than standard pharmaceutical bioidentical prescriptions. The only "natural" hormones are the hormones being made by your body. “

My Comment: The word “natural” is not only a marketing term. Natural means anything found in the natural world that cannot be patented.  This next comment is a tautology as bioidentical is still bioidentical whether found in FDA approved prescriptions or in compounded preparations.  We know from the Women’s Health Initiative study JAMA 2002 , that synthetic hormones are monsters that cause cancer and heart disease. Bioidentical hormones are safe and do not increase risk of cancer or heart disease as shown in the French Cohort study.

2) “Bioidenticals: Laboratories create formulations that are either identical (bioidentical) or not (non-bioidentical) to those in your body. There are FDA approved prescription estradiol products that are bioidentical that are not "compounded." 

My Comment: This is correct.

3) “Compounded hormones: Made in a pharmacy by combining, mixing or altering ingredients to create a customized hormone for an individual patient. Compounding pharmacies must be licensed and regulated by the State Pharmacy boards. However, they do not have to demonstrate the safety, effectiveness and quality control, based on large, scientific studies that the FDA requires of pharmaceutical manufacturers. Compounding pharmacies use chemically synthesized hormones made from plants --the same government-approved ingredients that are used in a manufacturer's laboratory. "Compounded" formulations are neither safer nor more "natural."

My Comment: Compounded Pharmacies are not under FDA jurisdiction, and that is why they are not regulated by the FDA. Instead, they are regulated by the state and local government. To expect and insist on FDA regulation for compounding pharmacies is like saying your state driver's license is invalid because it was not issued by the federal government.  If one rejects compounded medications, then one would also reject intravenous antibiotic treatment at the hospital which is also a compounded medication.  Obviously, there is a problem with the logic used here.

What Does FDA Approval Mean? The author creates confusion about the meaning and significance of FDA Approval.  Food and Drug Administration approval does not confirm that the drug is the most effective or the safest drug for you.  FDA approval means the drug is more effective than placebo for its indicated use and benefits outweigh risks.  Drug Manufacturers spend 500 to 800 million doing clinical studies submitted for FDA approval, because of the future prospects for greater profit.  The chemical structure of a bioidentical hormone, like other natural substances, cannot be patented, so there is very little financial incentive for a drug company to spend all that money on clinical studies when profits cannot be assured. 

Non-FDA Approved Indications

Drugs are FDA approved for certain medical indications.  About 20% of the time, doctors prescribe drugs for non-FDA approved indications. For example, the use of SSRI antidepressants as a non-hormonal treatment for hot flashes is a non-FDA approved use of the drug. Mainstream doctors engage in hypocritical reasoning when they criticize others who prescribe compounded bioidentical hormones as non-FDA approved.   The problem with this argument is that intravenous medications given at the hospital are also non-FDA approved compounded medications.   Get rid of compounding and you must throw out most medications dispensed at the hospital which are, in fact, compounded medications.

Chemically Synthesized Hormones

By using the phrase, “Compounding pharmacies use chemically synthesized hormones”, the author is again confusing the reader with the difference between synthetic hormones and bioidentical hormones. They are quite different.  Synthetic hormones are chemically altered monsters.  On the other hand, bioidentical hormones have the same chemical structure as those found in the human body.  How the hormone was made or manufactured is not important as long as the chemical structures are identical.  A good example is water made by combining an oxygen molecule with two hydrogen molecules.  The manufacturing process is irrelevant, since the final chemical structure is H2O, water, a natural substance that cannot be patented.

4) The North American Menopause Society (NAMS), a non-profit organization of expert scientists and clinicians, "does not recommend custom-compounded products over well-tested, government-approved products for the majority of women." The Endocrine Society has stated that, "Post-market surveys of such (compounded) hormone preparations have uncovered inconsistencies in dose and quality."

My comment: The author omits that both NAMS and Endocrine Society have publicly acknowledged financial ties to the drug industry.   In addition, both organizations advocate the use of synthetic “monster” hormones, and as such, represent the financial interests of the synthetic hormone industry (such as Wyeth and Abbott), rather than the health of the public.  Half of the board of trustees of NAMS receives money from Wyeth in the form of consulting fees or research support.  Wyeth makes Prempro and Pristiq.  These Financial Disclosures are listed page 10 of the NAMS 2007 position statement on Hormones for Menopause.  Medical education and research requires authors to publicly disclose financial ties to the drug industry which alerts the reader to a biased pro-industry viewpoint. 

5) To determine whether hormone therapy is appropriate and safe, one's risk factors must be assessed based on personal and family medical history, as well as personal preference. There is no "one size fits all."

My Comment: Personal and family medical history is always part of any medical evaluation. The above statement refers to risk factors for breast cancer.   All women are at risk for breast cancer from environmental carcinogens, and more so if there is an underlying genetic abnormality such as the BRCA gene for breast cancer.  The important fact to remember is that Bioidentical Hormone therapy is safe and effective, while synthetic “monster” hormones are the ones that cause cancer and heart disease, and should be avoided.

6) “ Low dose hormone therapy, used judiciously, still remains the most effective way to treat the troubling symptoms of menopause for those who need it and who can use it safely.”

My Comment: Since mainstream physicians know that synthetic “monster” hormones are dangerous, causing cancer and heart disease, they shrug their shoulders and accept “low dose” synthetic hormone therapy as more desirable than the higher dosage used routinely. Less of the harmful monster hormone is given to the patient.  Synthetic chemically altered hormones are “Monsters” at any dosage. Stay away.

7) “There is no need for testing of hormone levels, either in saliva or blood. The science has shown that there is no predictable correlation between hormone levels in saliva or in blood and severity of symptoms. Unless there are unusual complications, it is the standard of care to treat symptoms if needed and adjust medications according to response, not saliva levels.”

My Comment: There are no blood tests for synthetic hormones, so proponents of synthetic hormones pretend that lab testing is not needed. The reality is that very useful blood, urine and saliva testing is available for the entire range of bioidentical hormones. If your doctor doesn’t do some sort of testing, you need a new doctor.

8 ) “Standard prescription hormone therapy is the safest form available. It has been tested by the FDA and manufactured in a highly regulated manner. Doses are consistent.”

My Comment:“Standard Prescription hormone therapy” is coded language for chemically altered synthetic “monster” hormones shown to cause cancer and heart disease in the Women’s Health initiative study. That’s not so safe. “Tested by the FDA” is a misnomer and error. The FDA doesn’t do any testing. The drug company pays for testing and then submits the results on paper to the FDA for approval. The testing has to show drug efficacy over placebo. That’s all. Sometimes the testing is fudged. Ten percent of FDA approved drugs are later banned, and another ten per cent are given a “black box” warning. (17)

9) There are also FDA approved non-hormonal therapies available to treat menopause symptoms for those who cannot take hormones.

My Comment: The above statement a reference to the use of SSRI antidepressants for menopausal symptoms. These drugs were recently shown to be no better than placebo for depression.(16)  Regarding efficacy for hot flashes, drug company funded studies showed efficacy over placebo was marginal at best. (14-15)  Synthetic altered hormones are bad enough, they cause cancer and heart disease.  SSRI antidepressant drugs like Effexor™ and Pristiq™ are even worse; they are chemically addictive with horrendous withdrawal effects.(18-19) The use of SSRI antidepressants for menopausal symptoms should be condemned as a misguided adventure.  The practice should be halted.

10 )  “Whether hormone therapy is needed depends on severity of symptoms, including hot flashes, night sweats, vaginal dryness and irritability. Hormone therapy should be individualized, which may mean trying different doses and schedules, as well as different routes of administration.”

My Comment: Mainstream medicine will ask patients to “live with it” if the menopausal symptoms are not severe enough to warrant treatment.  Millions of smart women have rejected synthetic hormones, and SSRI antidepressants, and are finding success with bioidentical hormone programs.

“Unregulated formulas and inconsistent compounded dosing can be dangerous and has jeopardized the health of many women, including myself. I wished I had known the dangers involved with compounded-hormones. After my menopause symptoms were stabilized with a standard prescription of bioidentical estradiol, I found a new way of eating, lost 30 pounds and updated my beauty regime without cosmetic surgery or alterations. I have never been healthier.”

My Comment: The author clearly blames inconsistency in her compounded formula for an episode of hormonal excess. I would disagree, and suggest the hormonal excess may have been due to resumption of hormonal production following cessation of synthetic birth control pills.   To avoid hormonal excess, our office staff monitors patients by phone very closely, reminding them of the warning signs of hormonal excess. At the earliest sign of hormonal excess, the patient stops using the estrogen cream. This type of program is very safe.  In my experience prescribing compounded hormone preparations and monitoring patients, the formulas have been consistent and standardized, and patients have been happy with the results.  For the highest consistency, we use only the large national pharmacies that specialize in bioidentical hormones.

At the end of the article, the author returned to Estradiol, a bioidentical hormone. Yet the author omits the historical information that Estrogen alone (Premarin) causes endometrial hyperplasia and cancer. That is why progesterone must be given with the estrogen to prevent endometrial hyperplasia.  Omitting this information is a disservice to women and potentially harmful for readers.

In Conclusion

This "10 Facts" article is a mixture of nonsense, falsehood and half truth. The quality of information reflects the author’s credentials, which are none, other than briefly visiting a few doctors for symptoms of hormonal imbalance. The medical information appearing in the article comes from regurgitated drug company propaganda advocating synthetic chemically altered “monster” hormones and SSRI antidepressants for menopause,  performing a disservice to women.  A safer, more effective alternative is bioidentical hormone therapy.  Rather than rely on this type of biased advice, a more balanced viewpoint is available from well known medical experts such as David Brownstein, Kent Holtorf,  Bruice Kenton,  Sangeeta Pati, C. W. Randolf, Erika Schwartz, and Jonathan Wright.  Read their books and articles.

The history of modern medicine is replete with the medical victimization of women.  A few discarded examples are: radical mastectomy, excessive hysterectomies, and bone marrow transplant for breast cancer.  Synthetic hormones belong on that list. The latest medical hoax is SSRI antidepressants for hot flashes.  Take back control of your bodies. Do not allow yourselves to be victims of synthetic hormones and antidepressants for menopausal symptoms.  The proper treatment is bioidentical hormone therapy. Bioidentical hormone doctors are available in your area.  You can find them with doctor’s directories from organizations like ACAM and A4M.

Update 2016: Since this chapter was written, the Huffington Post Article has been modified significantly, and the comments have been removed.

For references and links, see my web site: www.bioidenticalhormones101.com

Articles with related Interest:

BioIdentical Hormones Trashed by AP News

Bioidentical Hormones According to the LA Times

Ten Bioidentical Hormone Fallacies

References for Chapter 19. Ten Bioidentical Hormone Fallacies

(1) http://www.huffingtonpost.com/staness-jonekos/10-hormone-therapy-facts_b_615199.html  10 Hormone Therapy Facts Every Woman Should Know by Staness Jonekos

(2) Postgrad Med. 2009 Jan;121(1):73-85. The Bioidentical Hormone Debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Holtorf K. Holtorf Medical Group, Inc., Torrance, CA 90505, USA

(3)  http://www.ncbi.nlm.nih.gov/pubmed/18928825 Prim Care. 2008 Dec;35(4):669-705. 
Hormones in wellness and disease prevention:  common practices, current state of the evidence, and questions for the future. Schwartz ET, Holtorf K.

(4) http://www.ncbi.nlm.nih.gov/pubmed/18775609
Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review.
L'hermite M, Simoncini T, Fuller S, Genazzani AR. Maturitas. 2008 Jul-Aug;60(3-4):185-201. Epub 2008 Sep 5. Department of Gynecology and Obstetrics, Université Libre de Bruxelles, Bruxelles, Belgium.

(5) http://www.jpands.org/vol13no2/hotze.pdf
Point/Counterpoint:The Case for Bioidentical Hormones by Steven F. Hotze, by Steven F. Hotze, M.D. Donald P. Ellsworth, M.D.  Journal of American Physicians and Surgeons Volume 13 Number 2 Summer 2008 p43.

(6) http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf
A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks by Deborah Moskowitz, ND Altern Med Rev 2006;11(3):208-223

(7) http://www.ncbi.nlm.nih.gov/pubmed/17107222 Treat Endocrinol. 2006;5(6):367-374.
Is Bio-Identical Hormone Replacement Therapy Safer than Traditional Hormone Replacement Therapy?: A Critical Appraisal of Cardiovascular Risks in Menopausal Women. Curcio JJ, Wollner DA, Schmidt JW, Kim LS. Women’s Integrative Medicine Department, Southwest College of Naturopathic Medicine, Tempe, Arizona, USA.

(8) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2211383/ Breast Cancer Res Treat. 2008 January; 107(1): 103–111. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study by Agnès Fournier, 1 Franco Berrino,2 and Françoise Clavel-Chapelon1*

(9) http://bostonreview.net/BR35.3/angell.php  Boston Review MAY/JUNE 2010 Big Pharma, Bad Medicine-How corporate dollars corrupt research and education by Marcia Angell

(10) http://jama.ama-assn.org/content/288/3/321.abstract  Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal WomenPrincipal Results From the Women's Health Initiative Randomized Controlled TrialWriting Group for the Women's Health Initiative Investigators JAMA. 2002;288(3):321-333.

(11) http://www.ncbi.nlm.nih.gov/pubmed/171569 N Engl J Med. 1975 Dec 4;293(23):1167-70.
Increased risk of endometrial carcinoma among users of conjugated estrogens.Ziel HK, Finkle WD.

(12) http://www.uzzireissmd.com/refs/04.html The Natural SuperWoman, by Uzzi Reiss MD and Yfat Reiss Gendell, Avery Trade , 2008. web site page containing references for Estrogen chapter.

(13) http://www.ncbi.nlm.nih.gov/pubmed/12626212  Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women. de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F.

(14) http://www.cnsspectrums.com/aspx/article_pf.aspx?articleid=922  Beyond Remission, Rationale, and Design of the Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study, Susan G. Kornstein, MD CNS Spectr. 2006;11:12(Suppl 15):28-34 This supplement is sponsored by Wyeth.

(15) http://www.news.vcu.edu/news/Low_Doses_of_AntiDepressant_May_Spell_Relief_for_Some_Women_Suffering Low Doses of Anti-Depressant May Spell Relief for Some Women Suffering from Moderate-to-Severe PMS.   Sathya Achia Abraham VCU Communications and Public Relations

(16) http://jama.ama-assn.org/content/303/1/47.short?home  Antidepressant Drug Effects and Depression Severity, A Patient-Level Meta-analysis. Jay C. Fournier, MA; Robert J. DeRubeis, PhD; Steven D. Hollon, PhD; Sona Dimidjian, PhD; Jay D. Amsterdam, MD; Richard C. Shelton, MD; Jan Fawcett, MD JAMA. 2010;303(1):47-53

(17) http://www.ncbi.nlm.nih.gov/pubmed/11980521 JAMA. 2002 May 1;287(17):2215-20. Timing of new black box warnings and withdrawals for prescription medications. Lasser KE et al.

(18) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC181155/ Prim Care Companion J Clin Psychiatry. 2001 February; 3(1): 22–27. SSRI Antidepressant Medications: Adverse Effects and Tolerability by James M. Ferguson, M.D.