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Jeffrey Dach
Bioidentical Hormone Fallacies by Jeffrey Dach
Thu Dec 16, 2010 19:43

10 Ten Bioidentical Hormone Fallacies of Staness Jonekos

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A recent article on hormones for menopause caught my attention. I was puzzled by the fact that the author, Staness Jonekos, has no medical credentials, 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, Staness joined up with Wendy Klein MD , 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.

Above left image: Bioidentical Hormones represented by Natural Redhead courtesy of wikimedia commons.

10 Ten Hormone Facts should be renamed 10 Ten Hormone Fallacies

Firstly, the Jonekos article maligns bioidentical hormones as unregulated, non-FDA approved and not supported by science. These claims against bioidentical hormones are false, and are a smokescreen to hide the really scary 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.

Left Image: Synthetic Hormones are Monster Creations. Boris Karlof in The Bride of Frankenstein 1935, Courtesy of Wikimedia Commons

Thirdly the article contradicts itself in number 7, stating that blood testing is not needed, while the author earlier reported that blood testing revealed a high estrogen level. Obviously, blood testing 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 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 Staness 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 Jonekos 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: This bioidentical hormone program of estrogen gel 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: Apparently Jonekos visited a bioidentical hormone doctor in Beverly Hills. Uzzi Reiss MD is well known in Beverly Hills and prominently mentioned in Suzanne Somer’s book. Jonekos obviously did not read Reiss’s books on bio-identical hormones which explain the symptoms of estrogen excess. These are fluid retention, bloating, breast enlargement and tenderness. Once these estrogen excess symptoms are identified, the estrogen dosage is held until symptoms are gone. Educating the patient about estrogen excess symptoms, and when to hold hormone dosage is the key to successful treatment program.

An omission Jonekos revealed in a blog posting elsewhere is the story of birth control pills for many years. Birth control pills are synthetic hormones, and when these are abruptly stopped, this causes onset of menopausal symptoms. This complicates the story considerably. Birth control pills are a form of chemical castration, halting ovulation. Birth control pills cause artificial cycles without ovulation. Once the pills are stopped, there is usually a delay of months before normal ovarian function and normal cycling resumes. Until ovarian function returns, there is no hormone production and patients experience typical menopausal symptoms with low hormone levels.

Let's assume such as a scenario took place. When such a patient begins a bioidentical hormone program, hormone levels will go up with relief of menopausal symptoms. The patient feels better. However, a few months later, there is resumption of ovarian function which pumps new hormones into the patient's body, added to the levels produced by her hormone creams. This causes hormonal excess with all the usual symptoms of bloating, breast enlargement and mood disorder. This is not a failure of the bioidentical hormone medication. Hormonal excess means the hormones are working too well, raising estrogen levels too much. This is not a failure of the medication, rather it is a failure of patient monitoring and failure to alert the patient to these symptoms. Blood testing is useful here to show elevated estrogen levels.

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: Jonekos clearly has 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 (link ) and 90,000 articles will come up. Dr Holtorf’s review article The Bioidentical Hormone Debate in PostGraduate, cites 196 articles showing that bioidentical hormones are safer and more effective than synthetic chemically altered hormones.

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.

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 aproved indications

Drugs are FDA approved for certain medical indications. About 20% of the time, doctors prescribe drugs for non-FDA approved indications. For example, Dr Wendy Klein advocates the use of SSRI antidepressants as a non-hormonal treatment for hot flashes. This is a non-FDA approved use of the drug. At the same time, Dr Klein criticizes doctors who prescribe compounded bioidentical hormones as non-FDA approved. This is hypocrisy.

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 structure is identical to the human hormone.

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 receive 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.

Finanical Disclosures for the authors: 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.

On a follow up comment to her Huff Po article, Jonekos states,
"Neither Dr. Wendy Klein nor I are associated with “Big Pharma.” We do not make money from the pharmaceutical industry nor from promoting any menopause products, drugs or tests. Our work is meant to provide women with accurate information supported by sound scientific research and by reputable professional organizations, such as The North American Menopause Society and the Endocrine Society."

In other words, the authors have no financial conflicts to disclose, implying their views are neutral and nonbiased, based on the "scientific research", and positions of the "neutral and non-biased" North American Menopause Society (NAMS) and the Endocrine Society.
As mentioned above, both NAMS and the Endocrine Society have financial ties to the synthetic hormone industry, so one could hardly claim these organizations are neutral or non-biased. In fact, they advocate a very pro-synthetic drug industry view.

Dr Wendy Klein's Boss Discloses Ties to Drug Industry

Although Dr Wendy Klein may not receive direct financial consideration from the drug industry, her Boss certainly does. Wendy Klein serves as Deputy Editor of the Journal of Women's Health, and also served as senior deputy director of VCU's Institute for Women's Health (she is now emeritus, replaced by Dace Svikis). In both positions, Dr Klein's boss, was Susan Kornstein MD, executive director of VCU-IWH, and editor-in-chief of the Journal of Women's Health. Wendy's boss, Susan Kornstein, has made the following Disclosures: Consultant: Wyeth, Pfizer, Inc., Bristol-Myers Squibb, Eli Lilly and Company, Forest Laboratories; Grants/Research Support: Wyeth, Eli Lilly, Bristol-Myers Squibb, Forest Laboratories, Berlex Laboratories, Boehringer-Ingelheim, Sepracor.

A major activity of The VCU Institute of Women's Health is "Big Pharma" funded clinical research. As such, Dr. Klein's VCU paycheck was indirectly generated by funds from Big Pharma. Kornstein, having dual professorship in OB/Gyne and Psychiatry is strategically positioned to conduct clinical research overlapping the two disciplines. Kornstein was the "first to evaluate the use of low-dose antidepressants for PMS," Don't get me wrong, clinical research funded by "Big Pharma" is a legitimate, honorable activity, with the added bonus of being lucrative. However, the halls of academia ring with the voices of "Big Pharma", and academic physicians "tow the party line", having a distinctly pro-synthetic drug industry bias, against bioidenticals, and against compounding. When Dr. Klein recommends non-FDA approved use of antidepresants for PMS or menopausal symptoms, it's because of Kornstein's influence.

Compounding Pharmacy Quality Control

2006 Limited FDA Survey of Compounded Hormones Drug Products

Variation in potency.

FDA collected both active pharmaceutical ingredient (API) and finished compounded drug product samples during unannounced visits to compounding pharmacies located throughout the country. The samples were sent to FDA field laboratories for chemical analysis to measure identity of active ingredients, potency, and uniformity of dosage.
Thirty-three percent of compounded finished product samples did not conform to product labeling in terms of potency and/or content uniformity. The majority of the finished compounded product samples analyzed in this survey were hormone therapy products. These products appear to be popular, commonly compounded, and available at many pharmacies.

As the above FDA study shows, compounded medications are subject to human error, and quality control is an issue. This is actually old news, and hospitals deal with this on a daily basis. Every Intravenous drug made up by the hospital pharmacy is a compounded medication, a new unapproved drug. Regarding popular compounded hormones, it is best to use the large national pharmacies that specialize in this, and PCAB accreditation, and better Quality assurance practices. Better yet, the pharmacy should routinely analyze finished product for potency. Patients rely on the doctor to select the highest quality compounding pharmacy that will give the best results.

The FDA study above did not list the actual pharmacy names in the study. I suspect these were smaller local or hospital pharmacies not skilled in making hormone preparations. Had they used the larger national pharmacies, I suspect the results would have been quite different.

The compounding vs. manufactured drug debate is similar ro the generic vs. trade name debate. It is up to the discretion of the physician to decide what is best.
If one wishes to avoid compounding, FDA approved bioidenticals are available, and these are certainly a better choice compared to the synthetics.

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. However, the above statement is nonsensical. The important fact to remember is that Bioidentical hormone therapy is safe and effective while synthetic “monster” hormones cause cancer and heart disease.

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 higher standard dosage. 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 . Another 10% receive a black box warning.

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 (Newsweek ) (Jama Jan 5, 2010 ) Regarding efficacy for hot flashes, drug company funded studies done by academic physician like Dr Klein showed efficacy over placebo was marginal. Synthetic altered hormones are bad enough, they cause cancer and heart disease. Effexor and Pristiq are even worse, they are chemically addictive with horrendous withdrawal effects. The use of SSRI antidepressants for menopausal symptoms is not about health, its about money, and is a grotesque caricature of what real medical care should be.

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: Many mainstream doctors will ask patients to “live with it” if they deem the menopausal symptoms 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 was due to her body's resumption of hormonal production after stopping birth control pills. A resumption of hormone production in addition to using the estrogen cream results in hormone excess.

To avoid hormonal excess, we monitor patients closely, and alert them to watch for signs of hormonal excess. At the earliest sign of hormonal excess, the patient stops using the estrogen cream. This type of program very safe. In my experience prescribing compounded hormone preparations and monitoring patients, the formulas have been very consistent and standardized, and patients have been happy with the results.

In the end, the author confesses she returned to bioidentical hormones, namely Estradiol. 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 authors 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 Dr Wendy Klein, 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.

A Plea to Staness Jonekos

Rather than rely on biased advice from Wendy Klein, who advocates synthetic hormones and SSRI antidepressants for menopause, I suggest you find a more balanced viewpoint by interviewing 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, web sites and call them.

A plea to Dr Wendy Klein and all other supplicants to the drug companies: Join with Marcia Angell in her crusade to free medical academia from the drug company money which has corrupted medical education and research. Read Marcia Angell's talk given at Harvard University on December 10, 2009, outlining the way forward. I call on you to renounce synthetic hormones and antidepressants for menopause as a disservice to women. Join with thousands of your colleagues who prescribe bioidentical hormones.

A plea to all others: 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. To find a bioidentical hormone doctor in your area, click here for the doctor's directory, AHMA , ACAM , A4M .

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Links and References:

10 Hormone Therapy Facts Every Woman Should Know by Staness Jonekos

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
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.
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.
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.
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
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.
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*
MAY/JUNE 2010 Big Pharma, Bad Medicine-
How corporate dollars corrupt research and education by Marcia Angell

Jeffrey Dach MD
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Hollywood Fl 33021

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