According to the LA Times
by Jeffrey Dach MD
An article on Bioidentical Hormones appeared in the Los Angeles Times written by “The Healthy Skeptic”.(1) The author was a medical journalist with a master’s degree in biology. Sadly, this article contained a number of omissions, errors and falsehoods that require correction:
The author says:
“Over the decades, millions of women have taken some form of hormone therapy to relieve symptoms of menopause… The treatment typically included Premarin, estrogen isolated from the urine of pregnant mares, combined with Provera, a synthetic version of the hormone progesterone.”
The article correctly states that millions of women have taken hormone preparations to relieve symptoms of menopause. However, the author then presents a biased and narrow viewpoint: all took “synthetic” chemically altered hormones in the form of Provera and Premarin. These are the chemically altered hormones sold by the major drug companies. The truth is that millions of women have taken and continue to take human Bioidentical Hormones, rather than Premarin and Provera for relief of menopausal symptoms.
The author of the LA Times article then discusses the 2002 Women’s Health Initiative Study, halted early because the study showed that synthetic, chemically altered hormones (Premarin and Provera) cause cancer and heart disease. In this, they are quite correct.(23) The author says:
“But when a six-year study of more than 16,600 postmenopausal women that was part of the Women’s Health Initiative found that the combination of Premarin and Provera seemed to increase the risk of breast cancer, stroke and heart disease, doctors and patients suddenly had to consider other options.“
Although this is correct, I would remove the word, “seemed” from the text. The synthetic hormones, Premarin and Provera didn’t “seem” to cause cancer and heart disease. They DID cause cancer and heart disease in the WHI study. That’s why the study was terminated early, a small fact conveniently left out of the story.
The author then goes on the state:
“Soon after the WHI made headlines, some pharmacies, alternative health clinics and a few outspoken doctors started heavily promoting so-called “bioidentical hormones” for the treatment of menopausal symptoms. Unlike Premarin or Provera, bioidentical hormones — which are produced in laboratories using yam and soy phytoestrogens as a starting point — exactly match the hormone made by human ovaries.“
After the revelations of the WHI study were made public in 2002, millions of smart women abandoned synthetic hormones and switched to Bioidentical Hormones. This switch was not caused by a massive drug advertising campaign of the type seen with statin drugs or SSRI antidepressants. As a matter of fact, there was no TV advertising for Bioidentical Hormones, so I would disagree that Bioidentical Hormones were “heavily promoted”. They weren’t. The massive switch was caused by rank and file physicians who simply stopped writing prescriptions for Medroxyprogesterone (MPA, Provera™), the synthetic hormone used in the WHI study.
Nine Per Cent Decline in Breast Cancer Rates
A small piece of information conveniently left out of the story is that this sudden decline in synthetic hormone prescriptions in 2003 was accompanied by a nine per cent decline in breast cancer rates as reported by Dr. Ravdin in the New England Journal of Medicine. (22) A similar decline in breast cancer rates was seen in Canadian women after halting Prempro synthetic hormone use.(24) Left Image breast cancer (white spot) courtesy of wikimedia commons on PET scan.
Exactly the Same as Hormones Made by the Ovary
The author is quite correct in the statement that Bioidentical Hormones are exactly the same as the hormones made by the female ovary.
FDA Approved Bioidentical Hormones
The author then states,
“The Food and Drug Administration has approved several prescription-only drugs that contain bioidentical hormones, including Estrace pills, Estrasorb topical cream and the Alora patch. But many health clinics and pharmacies also sell non-approved creams that contain bioidentical estrogen and/or progesterone. These creams are often custom-made — or “compounded” — for each patient, sometimes based on the results of a saliva test that measures a woman’s hormone levels.”
Many FDA approved Bioidentical Hormone preparations are available at the corner drugstore. However, the author omits the fact that compounding pharmacies are regulated at the state level, not by the federal government, so FDA approval is not required or even desired for compounded hormone preparations. Insisting on FDA approval for compounded hormone preparations is similar to insisting that your state driver’s license is invalidated because it was not issued by the federal government.
FDA approval is sometimes waved about like a majestic frond, as if it grants magical qualities to a drug. In reality, FDA approval does not automatically mean the drug is effective or desirable. Ten percent of all FDA approved drugs are later recalled or banned and designated as “Bad Drugs“.(25) Another ten per cent of FDA approved drugs later receive black box warnings.(25) FDA approval means a major drug company has paid a lot of money for studies showing efficacy over placebo. Sometimes, these studies are fudged.
Catch 22 for Natural Substances
Another important omitted fact is that the FDA approval process is so expensive that it makes financial sense only for patented drugs with prospects for large returns. It is unlikely that any drug company will invest the millions for FDA approval studies when the drug in question is a natural substance such as a Bioidentical Hormone that cannot be protected by a patent. The publicly financed Women’s Health Initiative study sponsored by the NIH was done with patented hormones, Premarin and Provera, not the natural non-patentable bioidentical hormones. This no doubt reflects drug company control over NIH research dollars. The NIH should be studying natural substances like bioidentical hormones, but they rarely do.
The LA article goes on: “Dr. Kent Holtorf, a physician and proponent of bioidentical hormones …The website for Holtorf’s clinic says that women using bioidentical hormones “feel great” without suffering any of the side effects of “synthetic hormones,” said to include fatigue, depression and weight gain, along with the increased risk of breast cancer and heart disease. In a phone interview, Holtorf said that Bioidentical Hormones are more effective and safer than traditional treatments. “Over and over, women have told me that they feel much better” after taking the Bioidentical Hormones, he says.”
In the Other Corner, We have Dr. Nanette Santoro Representing Mainstream Medicine and Synthetic Hormones. The LA Times author states:
“Bioidentical hormones have an obvious appeal to women seeking relief for menopausal symptoms, says Dr. Nanette Santoro, chair of the department of obstetrics and gynecology at the University of Colorado Health Sciences Center in Denver and vice president of clinical science for the Endocrine Society. After all, it just seems to make sense that anything that exactly mimics a woman’s own hormones must be better than mare’s urine or a man-made compound that doesn’t exist in nature.“
“But Santoro says there is no proof that bioidentical hormones are any safer or more effective than traditional treatments. “All of the evidence that we have suggests that all of these hormones should be painted with the same brush,” she says.“
Dr Santoro represents mainstream medicine and synthetic hormones sold by the major drug companies, and as such uses coded language which requires translation. “Traditional Treatments” means synthetic chemically altered hormones sold by the drug companies. “Painted with the same brush” is the usual attempt to confuse the difference between chemically altered hormones and Bioidentical Hormones, claiming they are all the same thing. They are not the same thing. Chemically altered hormones are “Monster Hormones” that cause cancer and heart disease. Bioidentical hormones have the same chemical structure as the hormones in the human body and are safe and effective.
Bioidentical Hormones Are Safer and More Effective than Synthetics
Dr Kent Holtorf’s review article, “The_Bioidentical_Hormone_Debate” , cites 196 medical studies showing bioidentical hormones are safer and more effective than synthetic altered hormones.(2) The French Cohort study is another good reference showing safety and efficacy of bioidentical hormones. (27)
Synthetic Hormones Are Monsters
In my opinion, chemically altered hormones are MONSTERS that should never have been approved for human use. Lehninger’s textbook of biochemistry uses the word hormone which means a “bioidentical” hormone. Synthetic chemically altered hormones do not exist in the human body. The sole purpose of chemically altering a hormone chemical structure is to obtain a patent to protect profits of the drug industry. These chemically altered monster hormones are a recent invention in the history of medicine and are MONSTERS that should never have been approved for human use. Alternatively, bioidentical hormones and other natural substances by definition cannot be patented and therefore not profitable for the drug industry.
Dr. Nanette Santoro Has Concerns
The LA TImes author goes on to state:
“She has many concerns about bioidentical hormones that don’t have FDA approval. For one thing, she says, it’s impossible to know if unapproved creams have the promised amounts of hormones. “I’ve seen patients on these compounds actually losing bone mass because they were getting an insufficient dosage,” she says. “Why take that chance?”
We have discussed the FDA approval issue above. Compounding pharmacies are regulated by the states, not the federal government, so FDA approval is neither required nor desired for compounded preparations. The issue of quality control and proper dosage is a real consideration that applies to ALL TYPES of medications whether FDA approved or not. To get the best quality, I recommend working with a knowledgeable physician familiar with the best compounding pharmacies with the highest reputation for quality and service. Perhaps Dr Santoro’s statement is referring here to over-the-counter progesterone creams which are regulated by the cosmetics act. I agree with her point. These are not recommended because the amount of active hormone is not listed on the label, nor is there any assurance of the amount of active hormone inside the product.
Drug Company Fear Mongering
“Why take a chance?” says Dr Nanette Santoro. This is typical drug company propaganda and fear mongering that is usually seen with drug company television advertising. This plants doubt about compounded preparations. The problem with this logic is that the same doubt can be raised about hospital pharmacies which are all compounding pharmacies. For example, the intravenous medications prepared in the hospital pharmacy are, in fact, compounded medications. The reality is that synthetic hormones are the monsters, and the Bioidentical Hormones are safe and more effective than synthetic hormones, as demonstrated in the French Cohort study published in 2002 Climacteric.(27)
Dr. Cynthia Stuenkel, Clinical Professor of Medicine at UC San Diego
The LA TImes author then goes on to state:
“Dr. Cynthia Stuenkel, clinical professor of medicine at UC San Diego and president of the North American Menopause Society, shares this concern. “Some progesterone creams may contain little or no progesterone, while others contain so much that they definitely should be available only with a prescription,” she says. “Taking hormones without the careful guidance of a doctor is risky business,” Stuenkel says, ” Among other things, too many hormones can potentially cause blood clots and endometrial hyperplasia, a precursor to uterine cancer.”
Dr Stuenkel is correct in that progesterone creams are relatively safe, and available OTC (over the counter) without a prescription. These are regulated by the cosmetics act. She is also correct in that the OTC progesterone creams may vary in potency. The highest quality and most reliable progesterone creams are made by prescription at a compounding pharmacy. These are freshly prepared according to the prescribed dosage written by the physician. This is all OK.
Blood Clots, Endometrial Hyperplasia, Uterine Cancer – Omitting History
Dr. Stuenkel is right that certain types of hormones cause blood clots and uterine cancer. However, blood clots are caused by oral estrogen, not progesterone. Uterine cancer is caused by oral estrogen, specifically Premarin. Progesterone is not on this list and does not cause blood clotting problems. Jumping from progesterone to blood clots and endometrial hyperplasia is somewhat misleading and reveals a lack of understanding of the history of medicine. Progesterone does not cause blood clots, endometrial hyperplasia, or uterine cancer. Progesterone is protective. This is taught to first year medical students. Blood clots, endometrial hyperplasia and uterine cancer are all caused by oral estrogen tablets, called Premarin, given without progesterone, which historically was the usual practice from 1950 to 1975. This medical practice was halted with the publication of a NEJM report revealing that Premarin causes uterine cancer.(21) To prevent uterine cancer, a synthetic progesterone called Provera was added to the regimen, hence Prempro (a combo drug of Premarin plus Provera), the same drug used in the WHI (women’s health initiative) study. This is a little history omitted by the author of the LA Times article.
Also omitted was that oral estrogen tablets cause increased coagulability and increased risk of blood clots. For example, oral estrogen in birth control pills is the cause of blood clots, deep venous thrombosis, pulmonary emboli and stroke in young women. On the other hand, Bioidentical Estrogen in topical cream form is safe, and not associated with increased risk of blood clots. See my article on this: The Safety of Transdermal Estrogen.
On the Payroll of Wyeth
Also omitted from the LA Times article was that the two hormone experts, Stuenkel and Santoro both disclosed financial ties to Wyeth and other drug companies that make synthetic chemically altered “Monster'” hormones. These financial ties were publicly disclosed elsewhere as required by medical ethics rules. In addition, The North American Menopause society has financial ties to Wyeth and other synthetic hormone makers. This is publicly disclosed on the NAMS position statement in which many members of the NAMS advisory panel have financial ties to the drug industry.(15-17)
The Los Angeles Times also conveniently omits important historical information about the first synthetic hormone invented in 1938, DES, Diethylstilbestrol. This monster hormone drug was used from the 1940s until the late 1980s, as an FDA-approved estrogen-replacement therapy. In 1972, the first reports of cervical cancer in the daughters of DES treated women was published in the New England Journal, and the drug was banned in 1975 after millions of women had been exposed.(5-7)
Another early synthetic hormone was Bisphenol A, originally invented in 1936, and now, six billion pounds per year is used for baby bottles, water bottles, and children’s toys.(8-9) These early “monster” hormones gave us a preview of coming attractions with the pharmaceutical industry continuing to sell chemically altered hormones to the public. It’s all about money, not health. The take home message is that smart women are avoiding the “monster hormones”. Upper Left Image: Boris Karloff from The Bride of Frankenstein,1931, courtesy of Universal Studios and Wikimedia Commons.
Post-menopausal women refuse to be fooled by drug company marketing tactics attempting to persuade them to use synthetic monster hormones. Smart women have rejected synthetic hormones for the monsters they really, and have switched in massive numbers to safer and more effective bioidentical hormones.
Articles with Related Interest:
Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Fl 33314
Links and References:
LA Times, Bioidentical hormones for menopausal symptoms. Proponents boast improvement over older treatments; others say there isn’t enough evidence yet. The Healthy Skeptic June 07, 2010,|By Chris Woolston, Special to the Los Angeles Times, Chris Woolston, M.S
(2) http://www.postgradmed.com/index.php?article=1949 Postgraduate Medicine: Volume 121: No.1 by Kent Holtorf , The Bioidentical Hormone Debate: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?
(3) BioIdentical Hormone Disinformation From AP Medical Writer, Marilynn Marchione
(4) http://www.usatoday.com/news/health/2009-10-29-menopause-herbal_N.htm Bioidenticals: Estrogen without FDA approval for menopause? By Marilynn Marchione, The Associated Press
(5) http://www.nejm.org/doi/full/10.1056/NEJM197108122850707 Vaginal Cancer after Maternal Treatment with Synthetic Estrogens, Peter Greenwald, M.D., Joseph J. Barlow, M.D., Philip C. Nasca, M.S., and William S. Burnett, M.D. N Engl J Med 1971; 285:390-392August 12, 1971
DES Exposure: Questions and Answers- What is DES? Amer Cancer Society
(7) http://www.medscape.com/viewarticle/450670_2 Diethylstilbestrol (DES) Update: History of DES
Bisphenol A from Our Stolen Future: Are We Threatening Our Fertility, Intelligence, and Survival?–A Scientific Detective Story, Theo Colborn, Dianne Dumanoski, John Peter Meyers, Plume, 1997.
(9) http://www.environmentcalifornia.org/environmental-health/stop-toxic-toys/bisphenol-a-overview Bisphenol A Overview
(10) http://www.kentonbruicemd.com/blog/Tag/synthetic-hormones Kenton Bruice MD, Why Synthetic Hormones Can Be Dangerous to the Body
(11) http://www.wsu.edu/~delahoyd/frank.comment3.html Frankenstein: The Man and the Monster- Suzanna Storment October 2002 – The future of science, if uncontrolled, could be disastrous.
(12) http://www.medpagetoday.com/pdf/IndiciaME03/ Cynthia A. Stuenkel, MD, NCMP Dr. Stuenkel is a consultant for Eli Lilly, Upsher-Smith, and Wyeth.
(13) http://www.clinicianschannel.com/pik/1833/index.cfm Cynthia A. Stuenkel, MD, has received honorarium from Wyeth Pharmaceuticals, Upsher-Smith Laboratories, Inc, and Ally Pharma Options Pvt. Ltd.
(14) http://cme.medscape.com/viewarticle/709447 Cynthia A. Stuenkel, MD, financial relationships
(15) http://www.drugs.com/news/american-association-clinical-endocrinologists-north-american-menopause-society-fail-disclose-7750.html American Association of Clinical Endocrinologists and North American Menopause Society Fail to Disclose Financial Ties to Wyeth Pharmaceuticals – Half of NAMS’s Board of Trustees for 2007-2008 receives consulting fees or research support from Wyeth, including Dr. Utian.
(16) Wyeth funds research, awards, annual meetings, lectureship funds, educational programs and other activities of NAMS.
(17) http://www.menopause.org/donorlist.pdf Corporate Supporters of NAMS
Nanette Santoro, M.D., Grants/Research Support: Ferring Pharmaceuticals Inc., Serono SA. Consultant/Advisory Board: Ferring Pharmaceuticals Inc., Serono SA, Wyeth, Pfizer Inc. Speakers’ Bureau: Wyeth, Pfizer Inc., Berlex Inc.
(19) Nanette F. Santoro, M.D.Professor and Chair, Reproductive Endocrinology and Infertility Department of Obstetrics and Gynecology University of Colorado
(20) http://www.clinicianschannel.com/pik/1833/index.cfm Nanette F. Santoro, MD, has received grants, support , consulting fees honorarium from Wyeth.
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.
(22) http://www.nejm.org/doi/full/10.1056/NEJMsr070105 The Decrease in Breast-Cancer Incidence in 2003 in the United States, Peter M. Ravdin, Ph.D., M.D et al. N Engl J Med 2007; 356:1670-1674April 19, 2007
23) Writing Group for the Women’s Health Initiative Investigators. “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial.” JAMA 288.3 (2002): 321-333.
(24) Breast Cancer Incidence and Hormone Replacement Therapy in Canada. Prithwish De, C. Ineke Neutel, Ivo Olivotto and Howard Morrison. J Natl Cancer InstVolume102, Issue19Pp. 1489-1495
25) JAMA. 2002;287(17):2215-2220. Timing of New Black Box Warnings and Withdrawals for Prescription Medications . Karen E. Lasser, MD, MPH; et al.
27) 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.
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Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Fl 33314
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