Chapter 8. Abandoning the Synthetic Hormone Ship

Chapter 8:

Abandoning the

Synthetic Hormone Ship

Shirley is 52, and suffering from menopausal symptoms of hot flashes, night sweats, insomnia and mood disturbance. The first chance she had, Shirley asked her doctor for bioidentical hormones.  Instead, her doctor offered a prescription for Lexapro™, an SSRI antidepressant.  Shirley declined the prescription and ran out the door crying all the way home. A few days later, Shirley was sitting in my office asking, "Why won't my doctor give me what I want, bioidentical hormones?"

Ghost Writing – A Shocking Medical Scandal

I explained to Shirley that her doctor’s opinion is shaped by misleading information in medical journals corrupted by a technique called medical ghostwriting, a shocking scandal uncovered by  Senator Grassley’s Committee.(1)  In this sinister practice, the prestigious name of an academic MD “opinion leader” appears as author.  However, unknown to the reader, the article is actually written by the drug company’s paid-for-hire writers.  Grassley discovered that sixty articles on women’s hormones were ghostwritten, downplaying the adverse effects of synthetic hormones, and casting doubts about bioidentical hormones.  Medical ghostwriting is scientific misconduct and fraud which harms society and corrupts the medical literature.

A Brief History of Synthetic Hormones – Re-Living the Nightmare

The following is a short history of synthetic hormone replacement as brought to you by the Drug Industry. (2)  Many people have forgotten about the disaster of DES, Diethylstilbestrol, the first synthetic hormone invented in 1938.  This carcinogenic, monster hormone was approved by the FDA and given to millions of women from 1940 until it was banned in 1975 when it was shown carcinogenic, causing cervical cancer.  The first reports of cervical cancer in the daughters of DES treated women were published in April 1971 in the New England Journal of Medicine.(3-4) 

Next, the Drug Industry invented Premarin, a horse estrogen isolated from the urine of pregnant horses.   Available since FDA approval in 1942, Premarin has caused an estimated 15,000 cases of endometrial cancer, representing the largest epidemic of serious iatrogenic disease ever reported.(5-8)    One might think this would be the end of any drug.   However Premarin was promptly rehabilitated with the addition of another synthetic hormone, a progestin, to prevent endometrial cancer.  Thus, in 1995, Prempro was born, a synthetic hormone pill containing both Premarin (the horse estrogen) and Provera (the progestin).  Again, this was FDA approved, thought safe and handed out freely to millions of women.

However, storm clouds soon appeared on the horizon when four large scale studies showed increased breast cancer and heart disease from this estrogen-progestin combination pill.  The  Breast Cancer Detection Demonstration Project, published in 2000, showed an eight fold increase in breast cancer for estrogen-progestin users.(9)  The Swedish Record Review, published in 1996, had a fourfold increase in breast cancer with progestin use.(10)  The Million Woman study, published in Lancet in 2003, had a fourfold increase in breast cancer for estrogen-progestin combination users compared to estrogen alone users.(11)  The brakes came on to this synthetic hormone experiment in 2002 with the JAMA publication of the Women’s Health Initiative (WHI), an NIH funded study terminated early because of increased breast cancer and heart disease in the estrogen-progestin users.(12)

Abandoning the Synthetic Hormone Ship

Two important things happened after this 2002 WHI study was published.  Smart women abandoned synthetic hormones and switched in large number to bioidentical hormones, producing an immediate decline in breast cancer rates of about nine per cent.(13,14)  A second important thing happened.  Apparently, women have decided to turn to lawyers to protect them, since the FDA has been unable to do so.  Thirteen thousand women have filed cases in court claiming synthetic hormones caused their breast cancer.  These cases are slowly working their way through the court system, and the jury is still out, so stay tuned.(15)

Dispelling the Myths and Misconceptions

Over the years, I have compiled a list of myths and misinformation commonly encountered about bioidentical hormones in newspapers and magazines.  Here are a few of them, followed by the corrections.  The misinformation is in italics, with the correct information to follow.

Myth Number One: "The term bioidentical hormone is undefined and has no meaning." 

This is incorrect.  Bioidentical is a term which is defined as having the exact same chemical structure as hormones found naturally in the human body.   Bioidentical Hormones are the ones circulating in your blood stream right now.

Myth Number Two: "There is no proof that Bioidentical Hormones are safer and more effective than synthetic hormones...All of the evidence that we have suggests that all of these hormones should be painted with the same brush,”

This is incorrect and misleading.  As we have seen in the above short history of synthetic hormones, there exists a large body of science showing that synthetic chemically altered hormones cause cancer and heart disease.(9-14)  On the other hand, medical studies have found bioidentical hormones are safe with no increase in breast cancer or heart disease compared to non-hormone users. (33-41)  An excellent review of this medical science can be found in a 2009 article by Kent Holtorf MD in Postgraduate Medicine. (16)

Myth Number Three: "Bioidentical Hormones are not FDA approved." 

This is blatantly incorrect.  There are twenty or so FDA approved bioidentical hormone preparations widely available at corner drug stores. Here are a few examples: Vivelle-Dot™, Estrace™,  Climara™, Prometrium™, Androgel™ , etc.

Myth Number Four: "Bioidentical Hormones made by compounding pharmacies are Non-FDA approved."

This is not only incorrect, it is misleading and deceptive.  Compounding pharmacies are regulated at the state level, and do not fall under FDA jurisdiction.   So, of course compounding is not FDA approved.  No FDA approval is required or even desired.  Your local hospital pharmacy is a compounding pharmacy that makes up life saving medication such as IV antibiotics with no FDA oversight or “approval”.  The FDA approval process is designed for manufactured capsules and tablets, and is impractical and unnecessary for compounded medications prepared to order by hand.   Are we going to reject IV antibiotics from the hospital pharmacy because these are non-FDA approved compounded medication?  Of course not.  Compounding is here to stay.

Myth Number Five: "Unless a woman has symptoms of hot flashes and night sweats, she doesn’t need hormones."

This is incorrect.  In addition to night sweats and hot flashes, there are many other valid symptoms of hormone deficiency such as insomnia, cognitive dysfunction, menopausal arthritis, evaporative dry eye, anxiety, panic, mood disorder, vaginal dryness, and decreased libido and post hysterectomy.  These are all good indications for prescribing bioidentical hormones. (17-25)

Myth Number Six:  "The idea that Menopause is a Hormone Deficiency Disease was disproven, and the idea that hormone replacement rejuvenates youth, or prevents degenerative diseases is also disproven….Hormones decline with age, and is normal and does not require treatment."

This is incorrect. There is no question that hormonal decline is a health risk. Three separate studies have shown low testosterone in males carries a 40% increase in mortality.(26-28)  Studies in females show the same findings, with low hormone levels in women after hysterectomy associated with increased mortality. (29-30)  Hormonal decline is a direct cause of degenerative diseases of aging, all of which may be prevented or partially reversed by replenishing hormone levels, a vastly more effective treatment which competes directly with the Drug Industry.(42-46)

Myth Number Seven: "Hot flashes and sweats in menopausal women can be treated with SSRI antidepressants.  They don’t need to use hormones." 

This is not only wrong, it is criminal. The use of SSRI antidepressants for menopausal symptoms is NOT FDA approved, and is a cruel mistreatment and medical victimization of women.  This practice should be halted immediately.  Studies of SSRI drugs show they are no better than placebo for most cases of depression(31), and they are not much better than placebo for menopausal hot flashes. (32)  Synthetic hormones are bad enough, they cause cancer and heart disease.  SSRI drugs like Lexepro™,  Effexor™ and Pristiq™ are even worse; they are chemically addictive with horrendous withdrawal effects.  Avoid becoming a medical victim.  Stay away.

In Conclusion:

It is time to awaken from the nightmare of synthetic hormones, known for decades to cause cancer and heart disease.  You can put lipstick on a pig, and it is still a pig.  The drug industry can spin, deceive, and misleading the medical journals and media.  Yet, after all the lies and propaganda, synthetic hormones remain monsters that should be avoided.   Smart women have made the switch to safer and more effective bioidentical hormones.  The future of medicine is your choice to make.  It is recommended you work closely with a knowledgeable physician before making any decisions regarding hormone treatment.  Please feel free to share this chapter with your doctor. 

Articles with Related Interest:

The Safety of Bio-Identical Hormones

The Importance of BioIdentical Hormones

Bioidentical Hormones Prevent Arthritis

Bioidentical Hormone Estrogen Prevents Heart Disease

Morning Rounds With Steven Economou MD

Don’t Monkey With My Hormones

Waking Up from the Synthetic Hormone Nightmare

HRT Does Not Cause Breast Cancer

(10) http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0215(19960729)67:3%3C327::AID-IJC4%3E3.0.CO;2-T/pdf  
see also http://www.ncbi.nlm.nih.gov/pubmed/8707404  
Cancer incidence and mortality in women receiving estrogen and estrogen-progestin replacement therapy—long-term follow-up of a Swedish cohort.  Ingemar Persson et al. International Journal of Cancer Volume 67, Issue 3, pages 327–332, 29 July 1996

(11) http://www.ncbi.nlm.nih.gov/pubmed/12927427    Lancet. 2003 Aug 9;362(9382):419-27. Breast cancer and hormone-replacement therapy in the Million Women Study. Beral V; Million Women Study Collaborators.

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

(13) 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; 356:1670-1674 April 19, 2007.  A comparison of incidence rates in 2001 with those in 2004 (omitting the years in which the incidence was changing) showed that the decrease in annual age-adjusted incidence was 8.6% .

(14) http://jnci.oxfordjournals.org/content/early/2010/09/23/jnci.djq345.abstract Breast Cancer Incidence and Hormone Replacement Therapy in Canada by Prithwish De, C. Ineke Neutel, Ivo Olivotto and Howard Morrison. JNCI J Natl Cancer Inst (2010) . This drop occurred concurrently with a 9.6% decline in the incidence rate of breast cancer

(15) http://www.bloomberg.com/news/2010-08-27/pfizer-settles-arkansas-prempro-case-before-retrial-over-punitive-damages.html Pfizer Said to Pay $330 Million to Settle Prempro Lawsuits Claiming Cancer By Jef Feeley - Feb 9, 2011 4:42 PM ET

(16)http://jeffreydach.com/files/80618-70584/The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD.pdf
Postgraduate Medicine: Volume 121: No.1 January 2009. The Bioidentical Hormone Debate:Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy? Kent Holtorf, MD

(17) http://www.ncbi.nlm.nih.gov/pubmed/11386980 Arch Gen Psychiatry. 2001 Jun;58(6):529-34.  Efficacy of estradiol for the treatment of depressive disorders in perimenopausal women: a double-blind, randomized, placebo-controlled trial. by Soares CN et al.

(18)  http://www.neurology.org/cgi/content/abstract/57/4/605 Neurology 2001;57:605-612, 2001 American Academy of Neurology  High-dose estradiol improves cognition for women with AD Results of a randomized study by S. Asthana, MD et al.

(19)  http://www.ncbi.nlm.nih.gov/pubmed/19804793 Estradiol reduces anxiety- and depression-like behavior of aged female mice by Alicia A. Walf and Cheryl A. Frye  Neuroscience

(20)  http://www.ncbi.nlm.nih.gov/pubmed/16142740   Arthritis Rheum. 2005 Sep;52(9):2594-8. Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Felson DT, Cummings SR.

(21) http://www.ncbi.nlm.nih.gov/pubmed/9609575  Am J Obstet Gynecol. 1998 May;178(5):1002-9.When does estrogen replacement therapy improve sleep quality? Polo-Kantola P et al.

(22)  http://cme.medscape.com/viewarticle/512093 "Menopausal Arthritis" May Develop in Women Receiving Estrogen-Depleting Treatments News Author: Laurie Barclay, MD CME Author: Désirée Lie, MD, MSEd

(23)  http://www.emaxhealth.com/70/3606.html Women treated with aromatase inhibitors often experience joint pain and musculoskeletal aching: severe enough, in some cases, to make them stop the treatment.

(24) http://www.ncbi.nlm.nih.gov/pubmed/11173183 Maturitas. 2001 Jan 31;37(3):209-12. Treatment of keratoconjunctivitis sicca with topical androgen. by Worda C et al.

(25) http://abstracts.iovs.org/cgi/content/abstract/44/5/2450 Invest Ophthalmol Vis Sci 2003;44: E-Abstract 2450. Treatment of Dry Eye with a Transdermal 3% Testosterone Cream by C.G. Connor.

(26) http://eurheartj.oxfordjournals.org/content/31/12/1494.abstract  Eur Heart J (2010) 31 (12): 1494-1501. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20–79, Robin Haring et al.

(27) http://circ.ahajournals.org/cgi/content/abstract/116/23/2694  Endogenous Testosterone and Mortality Due to All Causes, Cardiovascular Disease, and Cancer in Men European Prospective Investigation Into Cancer in Norfolk (EPIC-Norfolk) Prospective Population Study (Circulation. 2007;116:2694-2701.)

(28) http://archinte.ama-assn.org/cgi/content/abstract/166/15/1660  Vol. 166 No. 15, Aug 14/28, 2006 Low Serum Testosterone and Mortality in Male Veterans Molly M. Shores, MD et al.  Arch Intern Med. 2006;166:1660-1665.

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(30) http://www.ncbi.nlm.nih.gov/pubmed/19384117 Obstet Gynecol. 2009 May;113(5):1027-37.Ovarian conservation at the time of hysterectomy and long-term health outcomes in the nurses' health study. Parker WH et al.

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AUthor: Jeffrey Dach MD