Safety of Bioidentical Hormones

Are Women's Bio-identical hormones Safe? by Jeffrey Dach MD Bio-identical hormones exist naturally in the human body, so it is axiomatic that these are safe. However, we are interested in a slightly different question. What is the safety of bio-identical hormones as routinely used in medical practice? Let's try to answer this question. Left Image: Water with Droplets Courtesy of Wikimedia

The Safety of Water compared to Bio-Identical Hormones

Water is safe, beneficial and healthy. Yet, even so, drinking excess amounts of water causes death from Fatal Water Intoxication.(1) Similarly, just like water, bio-identical hormones are safe and beneficial when used at proper dosages. Like excessive water, excessive hormone dosage may result in their own adverse side effects. Excess estrogen, for example, causes fluid retention, breast sensitivity and enlargement, and disturbed mood.

Humans Have Bio-Identical Hormones - Ask Darwin

Another answer to the safety question is that bio-identical hormones are found in the human body naturally. Any harmful substance in the human body would impair survival, and over millions of years of evolution would be eliminated by natural selection. This is the basic concept of Darwinian evolution which is accepted by mainstream medical science.

A 50 Million Year Medical Experiment

Consider the following medical experiment, performed over the last 50 million years with the help of our friend, Darwinian evolution.(2) Bio-Identical Hormones have been present in the human body for 50 million years, and we humans are still here on the planet. I would consider that a successful medical experiment, wouldn't you?

Either Excess or Deficiency of Anything Can be Harmful

One of our routine labs tests called the Chem Panel measures electrolytes and glucose levels in the blood. The body automatically maintains these within narrow ranges to maintain health. If levels deviate above or below these normal ranges, this causes a serious health disturbance. For example elevated potassium levels causes cardiac arrest. Magnesium deficiency causes muscle spasm and arrhythmia. Excessive amounts of Vitamins A and D are toxic. Hormones levels enjoy a considerably wide range of acceptable limits. Even so, a deficiency or an excess of women's bio-identical hormones can produce adverse symptoms. This is called estrogen deficiency/excess, and progesterone deficiency/excess, and they each have typical signs and symptoms easily recognized.(3)

Common Signs of Estrogen Deficiency (4)

Mental fogginess Forgetfulness Depression Minor anxiety Mood change Difficulty falling asleep Hot flashes Night sweats Temperature swings Day-long fatigue Reduced stamina Decreased sense of sexuality Lessened self-image and attention to appearance Dry eyes, skin, and vagina Loss of skin radiance Feel balanced 2nd part of cycle Sagging breasts and loss of fullness Pain with sexual activity Weight gain Increased back and joint pain Episodes of rapid heartbeat Headaches and migraines Gastrointestinal discomfort Constipation

Common Signs of Excess Estrogen (takes longer to notice)

Breast tenderness or pain Increased breast size Water retention, fingers, legs Impatient, snappy behavior, but with clear mind Pelvic cramps Nausea

Common Signs of Progesterone Deficiency

No period at all (no ovulation) The period comes infrequently (every few months) Heavy and frequent periods (large clots, due to buildup in the uterus) Spotting a few days before the period. (Progesterone level is dropping) PMS Cystic breasts Painful breasts Breasts with lumps Most cases of endometriosis, adenomyosis, and fibroids. Anxiety, irritability, nervousness and water retention Above list courtesy of Uzzi Reiss MD (4)

No Reported Adverse Events from Bio-Identical Hormones

Over-the-counter pain pills (NSAIDs) such as aspirin, naproxen and ibuprofen are considered fairly safe. After all, you don't need a prescription to buy them, yet they cause an estimated 16,500 deaths in the US annually, mostly from gastric bleeding.(5) Compare this to no reported adverse events from bio-identical hormones last year, according to an FDA Press Conference on Bioidentical Hormones Jan 2008. (6)

Do Bio-Identical Hormones Cause Breast Cancer?(7) The answer is NO.

Left Image: Eiffel Tower Paris France Courtesy of Wikimedia Commons

According to the French Cohort study, there is no increase in breast cancer in women using bio-identical hormones.(8) However, having said that, avoiding excess environmental estrogens as well as excessive estrogen levels from any source, is the key to preventing breast cancer.(9) My previous article covers our program for breast cancer prevention which includes iodine supplementation, Indole-3-carbinol and fiber. To read about this, see: Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD.(10)

What Causes Cancer ?  Environmental Chemicals

If bioidentical hormones do not cause cancer , What Does? The answer is known for many years. Carcinogenic chemicals in the environment , water and food supply cause cancer. Here is a partial list of carcinogens in our food supply- Bisphenol A (BPA) Phthalates, Pesticides, Styrene , Vinyl Chloride, etc. The list of environmental carcinogens is almost endless.

Do Bio-Identical Hormones Cause Heart Disease ?

Again, the answer is NO. A study of CAT calcium scores by JoAnn E. Manson in the June 2007 JAMA actually showed less heart disease in the women taking unopposed estrogen (they had hysterectomies and were not given the synthetic progestins).(11) These same results had already been published 2 years previously in a calcium score study by Budoff in J Womens Health 2005. (12)

A Closer Look at the Women's Health Initiative WHI Study

Understanding the Women's Health Inititative (WHI) study is not difficult, and is very important to answer the question of hormone safety. The WHI study was the large NIH sponsored medical study which compared synthetic hormones to placebo in two large groups of women. The WHI study consisted of two arms. The first arm used the synthetic hormones Premarin and Provera, and the second arm used Premarin alone.(13)(14)

What is Premarin and Provera?

Premarin and Provera are not bio-identical hormones. Premarin is a hormone obtained from pregnant horses, which contains Equilin, a horse hormone not found in humans.(15) Provera is a synthetic hormone which is not found anywhere in the natural world (see provera diagram below).(16) The Premarin and Provera combination is called PremPro, a synthetic hormone pill commonly prescribed by mainstream medicine. Prempro was the hormone preparation used in the first arm of the WHI study.(13)

WHI study First Arm:

The WHI study (first arm published in JAMA 2002) was terminated early because the combination of premarin and provera (Prempro) caused increased breast cancer and heart disease.(13) Immediately after this study was published, there was a massive switch by women to bio-identical hormones which resulted in a 4 billion dollar loss for Wyeth, the maker of Prempro. Wyeth is still trying to recoup that money by manipulating the FDA. They want the FDA to ban their competition, the bio-identical hormones or their components.(36-38)

WHI Study (Second Arm):

All the women in the second arm of the WHI study had prior hysterectomies (uterus absent), so they did not need the synthetic progestin, provera commonly given to prevent endometrial cancer. Rather, they were only given Premarin (the horse hormone, also called CEE, for Conjugated Equine Estrogen). Unlike the first arm of the study, these women had no increase in breast cancer risk.(18) (see chart below)

Left Chart: This chart shows data from the second arm of the WHI in JAMA 2004.(14)

The blue bars represents adverse events in the placebo group. The red bars represents adverse events in women (ages 50-59) on premarin only, with no Provera (progestin). Note that the Red bars are all Lower than the Blue bars. The Red bar (Premarin-only) group shows LESS heart disease, LESS breast cancer and LESS Mortality when compared to placebo (blue bar). Chart Courtesy of Susan Ott MD Bone Physiology.(19)

Premarin causes endometrial cancer, so the mainstream medical system always gives Provera (progestins) to prevent endometrial cancer, unless of course, the uterus is absent from prior hysterectomy.(20)

The WHI Culprit was the Synthetic Progestin (an altered form of Progesterone)

Back to the first arm of the WHI which used Prempro, it is clear from the data that the culprit which caused breast cancer and heart disease was Provera, a synthetic monster hormone. This is nothing new. For years, Provera has been known to cause heart disease and breast cancer.(21)(22)(39)

Provera Proven to Cause Breast Cancer

In fact, medical studies prove that Provera causes breast cancer. In these studies, Primates were treated with either Progesterone or Provera showing that the Provera causes breast cancer, while the Progesterone provides protection from breast cancer.(22)

Monster Hormones are Chemically Altered

Chemically altered hormones were used in the WHI study, and are routinely handed out by the medical system. These altered hormones are monsters that should never have been approved for marketing to the American people. They should be banned. Image Left: Another Monster: Boris Karloff from Frankenstein 1931.Courtesy of Wikimedia.

The Media Says Hormones Cause Cancer and Heart Disease

If bio-identical hormones are so safe, then why do the newspapers say that women's hormones cause breast cancer and heart disease?(23) The answer is that the media and the medical profession routinely confuse synthetic chemically altered monster hormones with the bio-identical hormones. The drug companies intentionally create this confusion because they want to hide the fact that synthetic hormones are monsters that should be banned. Chemically altered hormones were made because of a quirk in our legal system which grants patent protection for chemically altered versions of a natural substance. The natural hormones were chemically altered so that they could be patented to protect profits from competition. Naturally occurring bio-identical hormones by law cannot be patented. Examples of monster synthetic hormones are provera, all progestins, and birth control pills which are never found in nature. These are the monster hormones.

A Listing of a Few Monster Hormones:

Chemically Altered forms of progesterone: Dienogest, Desogestrel, Drospirenone, Dydrogesterone, Ethisterone, Etonogestrel, Ethynodiol diacetate, Gestodene, Gestonorone, Levonorgestrel, Lynestrenol, Medroxyprogesterone, Megestrol, Norelgestromin, Norethisterone, Norethynodrel, Norgestimate, Norgestrel, Norgestrienone, Tibolone Chemically altered forms of estrogen: Dienestrol, Diethylstilbestrol, Ethinylestradiol, Fosfestrol, Mestranol Chemically alered hormones in BCP's Birth Control Pills: levonorgestrel and ethinyl estradiol [oral contraceptive] (ALESSE 28, AVIANE, NORDETTE, SEASONALE, TRIPHASIL, TRIVORA-28); norethindrone and ethinyl estradiol (COMBI PATCH, LOESTRIN FE 1/20, NEOCON 1/35, ORTHO-NOVUM 7/7/7, OVCON 35); norgestimate and ethinyl estradiol (ORTHO-CYCLEN, ORTHOTRI-CYCLEN, TRINESSA); norgestrel and ethinyl estradiol (LO/OVRAL 28, LOW-OGESTREL), desogestrel and ethinyl estradiol (DESOGEN, MIRCETTE, ORTHO-CEPT), drospirenone and ethinyl estradiol (YASMIN) Chemically altered forms of testosterone: Androstanolone, Fluoxymesterone, Mesterolone, Methyltestosterone




Take a good look at human bio-identical Progesterone ( upper left image), and the chemically altered version (below left image) Provera also called medroxyprogesterone. The added side-chain is labeled in RED on the right side of the Provera molecule.

How to make a Monster Hormone, Add a Side-Chain (in Red below) Below Images: Courtesy of wikimedia commons.

 Human Progesterone Provera - the Monster Hormone

This side-chain (in red) has been added in order to make a totally new structure that can be patented, and is the only difference with progesterone (upper left). In the process of adding this side-chain, a Monster was created. In the opinion of John R Lee MD, "to prescribe a chemically altered version of progesterone called Provera is medical malpractice", and yet this practice is common in mainstream medicine.

 

An Illustration which Explains the Problem with Synthetic Chemically Altered Drugs

Supposing a biochemist working for a drug company has an idea to alter the chemical structure of vitamin C so a patent can be obtained. The biochemist adds a chlorine molecule to the vitamin C carbon ring, and gives is a new name "super-Vitamin C", which is really a chlorinated version of vitamin C. Next they do a one year medical study with 5,000 people taking the chlorinated vitamin C tablet every day, and another 5000 people taking a placebo. After the year is up, they count a .5 per cent incidence of heart disease events in the Super Vitamin C group and a 1.0 percent in the placebo group. FDA approval is easily obtained based on reduction in heart disease events by 50 per cent (.5 per cent is 50% of 1.0 %). The drug company is at liberty to spend million dollars on television advertising designed to rake in millions more for the new heart prevention miracle drug. This absurd scenario is now the norm for our medical system. Why would anyone want to spend money for a monster version of vitamin C when the real thing is available for pennies? Why use a monster hormone when human hormones are available? Compared to their monster counterparts, Bio-Identical Hormones are more effective, have fewer adverse side effects, and are less costly.

High Hormone Levels of Early Pregnancy Confer Protection from Breast Cancer.

During the 16th century in Italy, breast cancer was quite rare. An Italian doctor, Bernardino Ramazzini, noted in 1713 the relatively high incidence of breast cancer in nuns and wondered whether this was related to celibate lifestyle.(24) Recent studies confirm that early pregnancy and multiple pregnancies confer protection from breast cancer, while no pregnancies (as in the nuns) leads to increased risk of breast cancer.(25) This protection is thought to be confered by high levels of progesterone. This was confirmed in a 2007 study by Rajkumar who showed that hormone treatment protected genetically engineered mice from developing breast cancer. (26) Left image Pregnancy, courtesy of wikimedia commons.

Progesterone, the Great Protector

Progesterone is so safe, it is available over the counter without a prescription. In addition, a deficiency of progesterone is associated with an increase in breast cancer risk.(27) Progesterone is known to be protective and prevents breast cancer.(28)

Why Don't Birth Control Pills use Natural Progesterone?

Birth Control Pills, BCP's, are very effective at preventing pregnancy by suppressing ovulation. However, BCP's contain synthetic hormones which have adverse side effects.(29)(30)(31) To avoid these monster hormones, the non-hormonal Copper T- IUD (intra-uterine device) is available.  See my article on this topic HERE..

More on Breast Cancer and Hormone Levels

If high estrogen levels were the primary cause of breast cancer, we would expect to find more breast cancer mortality in women with higher hormone levels at age 30, and less breast cancer in women with low hormone levels at age 60 (post-menopausal). However, what we find is the exact opposite. According to the CDC, mortality from breast cancer is 7 times higher in the older women aged 60 (0.7 per cent), compared to younger women aged 30 (0.1 per cent). Mortality from breast cancer is 700 % higher in post-menopausal women with low hormone levels.(link) Conclusion In conclusion, bio-identical hormones used at appropriate dosages are safe, effective, and beneficial for health. On the other hand, any chemical alteration of a human hormone creates a monster hormone, which is not bioidentical. These monster hormones should never have been approved for marketing and sale to the American people. These monster hormones are unsafe, causing cancer and heart disease, and should be banned immediately.

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

Resources for the Safety of BioIdentical Hormones

(1) The Case for Bioidentical Hormones Steven F Hotze MD. 2008.(33)
(2) The Safety of Bioidentical Hormones — the Data vs. the Hype by Jacob Teitelbaum, MD From the Townsend Letter June 2007.(34)
3) The Truth About Hormone Therapy Wall Street Journal  By ERIKA SCHWARTZ , KENT HOLTORF , and DAVID BROWNSTEIN March 16, 2009
4) The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD-3
5) Hormones__in_wellness_and_disease_prevention_common_practices_current_state_evidence_Erika_Schwartz_Kent_Holtorf
6) Hermite_Could_Transdermal_estradiol_Progesterone_be_Safer_HRT
Recommended Books by John R Lee MD (35)
What Your Doctor May Not Tell You About Menopause (TM): The Breakthrough Book on Natural Hormone Balance WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT MENOPAUSE: The Breakthrough Book on Natural Progesterone (Warner Books, 1996)(35)

What Your Doctor May Not Tell You About Premenopause: Balance Your Hormones and Your Life From Thirty to Fifty

WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT PREMENOPAUSE: Balance Your Hormones and Your Life from Thirty to Fifty (Warner Books, 1999)(35)

What Your Doctor May Not Tell You About(TM): Breast Cancer: How Hormone Balance Can Help Save Your Life

WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCER: How Hormone Balance Can Help Save Your Life, by John Lee, David Zava and Virginia Hopkins (Warner Books, 2005)(35)
References
(1) http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1770067 Fatal water intoxication. D J Farrell1 and L Bower. J Clin Pathol. 2003 October; 56(10): 803–804.
(2) http://en.wikipedia.org/wiki/Charles_Darwin Charles Darwin, theory of natural selection.
(3) http://www.johnleemd.com/store/premenstrual_syndrome.html Excerpted From: WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCER: Balance Your Hormones and Your Life from Thirty to Fifty. PHYSIOLOGICAL EFFECTS OF ESTROGEN AND PROGESTERONE. How Hormone Balance Can Help Save Your Life. by John R. Lee, M.D., David Zava, Ph.D. and Virginia Hopkins. Warner Books 2002
(4) http://www.uzzireissmd.com/book_naturalhormone.html Natural Hormone Balance for Women: Look Younger, Feel Stronger, and Live Life with Exuberance. by Uzzi Reiss MD
(5) http://www.drtheo.com/news/NSAIDs.pdf Medical Progress. p 1888. June 17, 1999 The New England Journal of Medicine GASTROINTESTINAL TOXICITY OF NONSTEROIDAL ANTIINFLAMMATORY DRUGS M. MICHAEL WOLFE , M.D., DAVID R. LICHTENSTEIN, M.D.,AND GURKIRPAL SINGH, M.D.
(6) FDA Press COnference on Bioidentical Hormones Jan 2008 Transcript of FDA Press Conference on FDA Actions on Bio-Identical Hormones FTS HHS FDA Susan Cruzan January 9, 2008
(7) http://www.womentowomen.com/breasthealth/estrogenbreastcancer.aspx Causes of Brea6t Cancer- the Estrogen Controversy, Dixie Mills MD
(8) 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 et al. French Cohort Study.
(9) http://www.johnleemd.com/store/cancer_progest.html Breast Cancer Book Intro. WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCER. How Hormone Balance Can Help Save Your Life By John R. Lee, M.D., David Zava Ph.D., and Virginia Hopkins INTRODUCTION
(10) http://jeffreydach.com/2007/05/05/jeffreydachdrdachiodine.aspx Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD
(11) http://content.nejm.org/cgi/content/short/356/25/2591 Estrogen Therapy and Coronary-Artery Calcification. NEJM Volume 356:2591-2602 June 21, 2007 Number 25. JoAnn E. Manson, M.D., et al.
(12) http://www.ncbi.nlm.nih.gov/pubmed/15989413 J Womens Health (Larchmt). 2005 Jun;14(5):410-7. Effects of hormone replacement on progression of coronary calcium as measured by electron beam tomography.Budoff MJ, et al.
(13) 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. First Arm.
(14) http://jama.ama-assn.org/cgi/content/full/291/14/1701 Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women's Health Initiative Randomized Controlled Trial. JAMA. 2004;291:1701-1712. Second Arm. This is the Second Arm of the Study. Premarin Only.
(15) http://en.wikipedia.org/wiki/Premarin Premarin From Wikipedia, the free encyclopedia (16) http://en.wikipedia.org/wiki/Medroxyprogesterone Provera, Medroxyprogesterone, From Wikipedia, the free encyclopedia
(17) http://homecoalition.org/TakeAction Take Action. Write a letter to your elected officials using our online advocacy tool. Act now to defend your right to bio-identical hormones! Please contact your congressional representative, senators, and the White House immediately. HOMECoalition.org.
(18) http://jama.ama-assn.org/cgi/content/full/295/14/1647 Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. Marcia L. Stefanick, PhD et al. for the WHI Investigators. JAMA. 2006;295:1647-1657. Conclusions Treatment with CEE alone for 7.1 years does not increase breast cancer incidence in postmenopausal women with prior hysterectomy. (19)
http://courses.washington.edu/bonephys/opestrogen.html#WHI Osteoporosis and Bone Physiology, Susan Ott, MD, Associate Professor, Department of Medicine, University of Washington. A Review of the results from the Women's Health Initiative.
(20) http://www.ncbi.nlm.nih.gov/pubmed/3358913 The dose-effect relationship between 'unopposed' oestrogens and endometrial mitotic rate: its central role in explaining and predicting endometrial cancer risk.Key TJ, Pike MC. Br J Cancer. 1988 Feb;57(2):205-12.
(21) http://atvb.ahajournals.org/cgi/content/full/24/7/1171 Should Progestins Be Blamed for the Failure of Hormone Replacement Therapy to Reduce Cardiovascular Events in Randomized Controlled Trials? Kwang Kon Koh; Ichiro Sakuma. Arteriosclerosis, Thrombosis, and Vascular Biology. 2004;24:1171.
(22) http://www.ncbi.nlm.nih.gov/pubmed/16841178 Effects of estradiol with micronized progesterone or medroxyprogesterone acetate on risk markers for breast cancer in postmenopausal monkeys.Wood CE et al. Breast Cancer Res Treat. 2007 Jan;101(2):125-34.
(23) http://www.time.com/time/magazine/article/0,9171,1002897,00.html The Truth About Hormones Monday, Jul. 22, 2002 Time Magazine. By CHRISTINE GORMAN AND ALICE PARK
(24) http://www.ama-assn.org/amednews/2006/04/17/hlsa0417.htm AMA Medical NEws. Collecting clues: Cancer registries might have an answer. By Kathleen Phalen Tomaselli, AMNews correspondent. April 17, 2006.
(25) http://breast-cancer-research.com/content/7/3/131 The protective role of pregnancy in breast cancer. Jose Russo et al.Breast Cancer Research 2005, 7:131-142doi:10.1186/bcr1029
(26) http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=17257424 Hormone-induced protection of mammary tumorigenesis in genetically engineered mouse models Lakshmanaswamy Rajkumar et al.Breast Cancer Res. 2007; 9(1): R12.
(27) http://aje.oxfordjournals.org/cgi/content/abstract/114/2/209 BREAST CANCER INCIDENCE IN WOMEN WITH A HISTORY OF PROGESTERONE DEFICIENCY LINDA D. COWAN et al. American Journal of Epidemiology Vol. 114, No. 2: 209-217
(28) http://www.annclinlabsci.org/cgi/content/abstract/28/6/360 Progesterone inhibits growth and induces apoptosis in breast cancer cells: inverse effects on Bcl-2 and p53. B Formby and TS Wiley. Annals of Clinical and Laboratory Science, Vol 28, Issue 6, 360-369
(29) http://en.wikipedia.org/wiki/Birth_control_pill Combined oral contraceptive pill. From Wikipedia, the free encyclopedia. (Redirected from Birth control pill)
(30) http://www.worstpills.org/results.cfm?disease_id=26 Oral Contraceptives on Worst Pills.org. The pill can cause many adverse effects. Some of them are merely a nuisance, while others can be life-threatening. The pill can cause headaches, bloating, nausea, irregular bleeding and spotting, breast tenderness, weight gain, or vision changes. Other more serious adverse effects that can occur from a few months to a few years after starting oral contraceptives include high blood pressure, gallbladder disease, liver tumors, depression, and metabolic disorders, such as diabetes. Temporary infertility has been associated with the period of time right after pill use is stopped. But the two most dangerous risks associated with taking birth control pills are blood clots and cancer.
(31) http://www.jeffreywarber.com/hc%20pages/pillsideeffects.html Birth COntrol Pill Adverse Side Effects by Jeffrey Warber MD
(32) http://www.quickoverview.com/reproductive/birth-control-pill.html History and Development of an effective combined oral contraceptive. People Involved.
(33) http://www.jpands.org/vol13no2/hotze.pdf Point/Counterpoint: The Case for Bioidentical Hormones Steven F. Hotze, M.D.Donald P. Ellsworth, M.D.Journal of American Physicians and Surgeons Volume 13 Number 2 Summer 2008
(34) http://www.townsendletter.com/June2007/painfree0607.htm The Safety of Bioidentical Hormones — the Data vs. the Hype by Jacob Teitelbaum, MD
(35) http://www.johnleemd.com/store/main_books.html Books by John R Lee MD Wyeth and the FDA (36) http//:naturalnews.com/022595.html FDA's Assault of Bioidentical Hormones Demonstrates Pro-Pharma Loyalties, Disregard for Consumer Choice Tuesday, February 05, 2008 by: Mike Adams
(37) February 16, 2008. Women, Doctors Wage Crucial Battle With FDA To Save Bioidentical Hormones From Wyeth's Wrath. A major coalition of informed women and their doctors have launched an all out war on the Federal Drug Administration's (FDA) cynical and corrupt decision to ban compounded hormones containing Estriol.
(38) FDA Declares War on BioIdentical Hormones by Jeffrey Dach MD Provera and Heart Disease
(39) http://atvb.ahajournals.org/cgi/content/full/17/1/217 Medroxyprogesterone Acetate Antagonizes Inhibitory Effects of Conjugated Equine Estrogens on Coronary Artery Atherosclerosis. Michael R. Adams; Thomas C. Register; Deborah L. Golden; Janice D. Wagner; J. Koudy Williams .Arteriosclerosis, Thrombosis, and Vascular Biology. 1997;17:217-221. Bio-Identical Hormone Inititiative
(40)  Bioidentical vs. Synthetic HRT, A review of the literature
(41) Bio-Identical Hormone Inititiative, Erika Schwartz MD, David Brownstein MD, Kent Holtorf MD Additional References
http://www.endfatigue.com/health_articles_f-n/Menapause-safety_effectiveness_bioidentical_hormones.html
The Safety and Effectiveness of Bio-Identical Hormones: Natural (Bio-Identical) vs. Synthetic HRT Kent Holtorf, M.D. Dr. Holtorf is the Medical Director of the Holtorf Medical Group, Inc, Center for Hormone Imbalance and Fatiguing Conditions in Los Angeles, specializing in CFS, FM, hypothyroidism, chronic illness and the treatment of complex endocrine dysfunction. He is board certified and is a Board Examiner for the American Academy of Anti-Aging Medicine. He is also chief of the Medical Advisory Board for the Fibromyalgia and Fatigue Centers, Inc.
http://www.thorne.com/media/hormones11-3.pdf
A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks Deborah Moskowitz, ND. Altern Med Rev 2006;11(3):208-223)
http://www.drcranton.com/hrt/hrt_references.htm
Hormone Replacement References. Most references below are linked to the National Library of Medicine (MEDLINE)
http://www.medscape.com/viewarticle/408096_print
Special Article: Addressing Postmenopausal Estrogen Deficiency: A Position Paper of the American Council on Science and Health January 26, 2001 Sander Shapiro, MD Medscape General Medicine 3(1), 2001.

http://www.womeninbalance.org/research/ research available women in balance. Fatal Water Intoxication http://www.msnbc.msn.com/id/16614865/ Woman dies after water-drinking contest Natural and Synthetic Substances in Medicine
http://www.fimdefelice.org/archives/arc.promise.htmlThe Promise and Problems of Natural Substances in Medicine Stephen L. DeFelice, M.D.
http://www.iupac.org/publications/pac/2002/pdf/7410x1957.pdf Natural and synthetic substances related to human health. The dubious honor of being the most powerful toxic substance goes to a protein produced by the bacterium, Clostridium botulinum. This protein is responsible for fatal food poisoning—botulism—being produced when the bacterium grows in the absence of oxygen in canned or preserved food. 2002 IUPAC, Pure and Applied Chemistry 74, 1957–1985 Synthetic Hormones and Breast Cancer
http://www.nwhn.org/healthinfo/detail.cfm?info_id=9&topic=Fact%20Sheets Menopause Hormone Therapy and Breast Cancer. National Women's Health Network
http://www.bmj.com/cgi/content/full/310/6979/598/b BMJ 1995;310:598 (4 March) Letters Risk factors for breast cancer Hormone Levels, Age and Breast Cancer
http://www.cdc.gov/cancer/breast/statistics/age.htm Risk of Breast Cancer by Age, CDC .Percent of U.S. Women Who Die from Breast Cancer Over 10-, 20-, and 30-Year Intervals. According to Their Current Age, 2002–2004. Age 30 is 0.1% age 60 is 0.7% .
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New Study Shows Women Prefer Bioidentical Hormones

A new study  from the  Department of Bioethics at Case Western Reserve examined women's attitudes about bioidentical hormones for menopausal symptoms.(1)  

Above left image: Case Western Reserve Campus Courtesy of WIkimedia.

How Was the Study Done ?

The study was done by conducting in-depth interviews with 25 women on bioidentical hormone replacement therapy (BHRT) for menopausal symptoms.

Motivations of the Women to Use Bioidentical Hormones

The 25 women interviewed said they were motivated to use bioidentical hormones to relieve menopausal symptoms of hot flashes and night sweats, to feel "energized" and to avoid and prevent chronic degenerative diseases of aging. The 25 post-menopausal women "expressed a desire to return to an "optimal" state and believed that bioidentical hormones would do this."(1)  The women were concerned that synthetic chemically altered hormones offered by the conventional medical system such as Prempro and Provera, cause cancer and heart disease, while bioidentical hormones were free of these adverse effects.

Reasons to Use Bioidentical Hormones:

The 25 post menopausal women cited three main reasons for seeking medical attention from a medical professional who prescribes bioidentical hormones:(1)
1) Patients received more time and attention from the clinician during the office visit.
2) Bioidentical Hormones are seen as "natural" and thought to return one to an "optimal state of being".
3) Bioidentical Hormone Replacement (BHRT) was perceived as safer than conventional hormone replacement therapy.

Jeffrey Dach MD

Articles with related interest:
Safety of Bioidentical Hormones
Importance of Bioidentical Hormones
Safety of Bioidentical Hormones

Links and references:

(1) http://www.eurekalert.org/pub_releases/2014-08/cwru-sfw081214.php
Contact: Susan Griffith
Case Western Reserve University
Study finds women seek anti-aging clinicians to treat menopausal symptoms
Also involved in the study was Richard Settersten Jr., professor of public health at Oregon State University, Michael Flatt  at Case Western Reserve University and Jennifer Fishman, assistant professor at McGill University.
(2) http://www.sciencedaily.com/releases/2014/08/140818012322.htm
Women seek anti-aging clinicians to treat menopausal symptoms, study finds
Date: August 18, 2014
Source: Case Western Reserve University
Summary: Feeling that conventional doctors did not take their suffering seriously, women instead sought out hormonal treatments for menopausal symptoms from anti-aging clinicians, according to a study that investigated the appeal of anti-aging medicine.
Jeffrey Dach MD
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Synthetic Hormones Lose in Court

Posted on March 11, 2015

Synthetic Hormones Lose in Court

Pfizer-Wyeth Loses Big Case
Prempro Causes Breast Cancer
112 Million in Punitive Damages
by Jeffrey Dach MD

A 112 million dollar punitive award is a very loud statement.  It states that the jury was outraged by the “wanton and reckless” conduct by Wyeth.   

112 Million Dollars in punitive damages was awarded to two breast cancer victims who took Wyeth’s synthetic hormone, Prempro, all the while thinking it safe. The jury was outraged that Wyeth ignored and suppressed evidence that Prempro causes breast cancer.  Wyeth paid consultants and ghostwriters of medical journal articles to play down concerns about breast cancer, and declined to study known risks. Once again, company profit was placed ahead of patient safety. This is the tip of the iceberg, as another ten thousand cases are waiting for their day in court.

Women’s Health Initiative Bombshell

Years ago, a bombshell appeared in the medical literature, and massive numbers of women switched from Prempro to safer bio-identical hormones. This was the 2002 WHI study which showed that PremPro causes breast cancer. This massive shift away from synthetic Prempro reduced breast cancer rates by 10,000 fewer cases per year. (NEJM Volume 356:1670-1674 April 19, 2007 Number 16)

The American Public Hoodwinked
Left image : Natural Progesterone   
This Prempro court case teaches us an important lesson. When a “Bad Drug” like Prempro gets FDA approval and placed on the market, what happens?  The public is hoodwinked, and the drug company profits handsomely. The wheels of justice turn slowly.  After 65 years and thousands of victims, our court system has finally ended a bad drug, in this case, a synthetic hormone called Prempro.

Altered PremPro


Left image show how to chemically alter a natural bioidentical hormone by adding  chemical groups. This is done in order to obtain a patent on the new chemical structure which protects profits for the drug company. This is a bad idea because any alteration of a hormone creates a MONSTER.  Left image medroxyprogesterone.

Another Important Lesson – Don’t Use Synthetic Hormones

Another important lesson from this case is that synthetic hormones like Prempro, which are chemically altered versions of human hormones, are all “Monster Hormones” which should never have been approved by the FDA in the first place. Any alteration in a chemical structure of a hormone creates a Monster, and in the case of Prempro, the result is increased cancer and heart disease.

Changed Chemical Structure Results in Monster Hormones
The drug companies changed the chemical structure of human hormones to obtain patent protection and maximize profits. Human bioidentical hormones cannot be patented because they are found naturally in the human body, therefore they are not profitable for the drug companies.  Left Image : Bright spot represents  breast cancer on PET mammogram combined imaging.

Just Another Round in the Medical Information War
Drug companies routinely use their influence to control information in the mainstream media and the medical journals. They downplay adverse side effects of their products in order to maximize profits. This is merely part of the Medical Information War played out in the media every day.

Bioidentical Hormones Are Safe and Effective
This case highlights another important lesson. While the chemically altered synthetic hormones like Prempro are dangerous, the original version from nature, called Bioidentical hormones are safe, effective and beneficial for health.

Addendum June 19 2012 from Bloomberg News:

June 19 (Bloomberg) by Jef Feeley — Pfizer Inc. has paid $896 million to resolve about 60 percent of the cases alleging its menopause drugs caused cancer in women.  Pfizer has now settled about 6,000 lawsuits that claim Prempro and other hormone-replacement drugs caused breast cancer, and it has set aside an additional $330 million to resolve the remaining 4,000 suits, according to a filing with the U.S. Securities and Exchange Commission.

The reserve means New York-based Pfizer has committed more than $1.2 billion to resolving claims that its Wyeth and Pharmacia & Upjohn units failed to properly warn women about the menopause drugs’ health risk. Based on the May 10 filing, the company is paying an average of about $150,000 a case.

Articles with related Interest:

The Importance of BioIdentical Hormones
The Safety Of Bio-Identical Hormones
Importance of Bioidentical Hormones

Here is an important article on HRT by Jonathan Wright MD, the originator of bioidentical hormones. Read it here:
FDA approved HRT- Prempro is Risky by Jonathan Wright MD written in 2003.
Links to Related Content:
Iodine Treats Breast Cancer, Overwhelming Evidence by Jeffrey Dach MD

Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD

Links and References

http://blog.legalbroadcastnetwork.com/
the-lbn-blog/2009/11/24/zoe-littlepage-discusses-112-million-wyeth-hrt-verdicts.html
Zoe Littlepage Discusses $112 Million Wyeth HRT Verdicts. Tuesday, November 24, BEST with video of Zoe Littlepage
http://menstruationresearch.org/2009/11/23/prempros-losing-streak-continues/
Blog of the Society for Menstrual Cycle Research.  PremPro’s Losing Streak Continues November 23rd, 2009 by Elizabeth Kissling
There are more than 10,000 lawsuits against Wyeth/Pfizer regarding the link between PremPro and breast cancer. There have been 12 verdicts so far, and juries have awarded money to the plaintiffs in ten of those cases. The latest was announced today, in Donna Kendall v. Wyeth (Phila. CCP, June Term, 2004, No. 0965). The jury awarded Ms. Kendall $6.3 million in compensatory damages, and $28 million in punitive damages. So far, thirteen women have settled their claims with Wyeth/Pfizer, but if awards like these continue, can we expect Pfizer soon to be offering to settle the rest?video here.
http://www.nytimes.com/2009/11/24/business/24wyeth.html
Another Loss for Pfizer in Drug Suits By DUFF WILSON November 23, 2009 NY Times.  Pfizer has been ordered to pay a total of $103 million in punitive damages to two women who were found to have breast cancer after they used hormonal drugs, state court officials in Philadelphia said Monday. Punitive damages in Pennsylvania require a finding of “wanton and reckless” conduct. The jurors heard testimony that Wyeth paid consultants and ghostwriters of medical journal articles to play down concerns about breast cancer, as well as testimony that Pharmacia did not study known risks. The punitive award was split $16 million for Wyeth and $12 million for Pharmacia.
http://www.philly.com/philly/business/homepage/
20091125_Prempro_plaintiffs__lawyers_sold_their_story_to_the_jury.html
Posted on Wed, Nov. 25, 2009 Prempro plaintiffs’ lawyers sold their story to the jury.  By Chris Mondics and Miriam Hill Inquirer Staff Writers The lawyers who won $103 million in two jury verdicts announced Monday against Pfizer Inc. relied as much on their storytelling ability as their knowledge of the law.
http://www.dailymail.com/ap/ApTopStories/200911230561
AP Featured News Monday November 23, 2009 $75M verdict unsealed in Prempro-cancer case PATRICK WALTERS Associated Press Writer
http://www.abajournal.com/news/
article/juries_award_103m_in_punitives_in_two_prempro_cases/
Verdicts & Settlements Juries Award $103M in Punitives in Two Prempro CasesPosted Nov 24, 2009 By Debra Cassens Weiss Philadelphia juries have awarded two breast-cancer victims $103 million in punitive damages in two separate cases against Pfizer Inc. involving the marketing of the hormone replacement drug Prempro.
Jurors had heard testimony that Wyeth, the maker of Premarin and Prempro, paid consultants to write medical journal articles to play down the risks of breast cancer, and evidence that another drug maker, Pharmacia, didn’t study known risks of its replacement drug, Provera, the New York Times reports. Both companies have been acquired by Pfizer. Yesterday jurors awarded $28 million in punitives to Donna Kendall of Decatur, Ill., in addition to $6 million in compensatory damages already awarded, the Legal Intelligencer reports.
After the verdict, the court unsealed an award of $75 million in punitives in a case filed by Connie Barton of Peoria, Ill. She had already been awarded $3.5 million in compensatory damages. Fordham University law professor Howard Erichson told the Philadelphia Inquirer that the $75 million punitive award will likely be reduced because it is so much larger than compensatory damages.
At least 1,500 cases over the hormone drugs have been filed in Philadelphia, the location of Wyeth, the Times says. Across the country, more than 10,000 cases have been filed. Esther Berezofsky, a lawyer for one of the plaintiffs, told the Times that women with breast cancer have won awards in 10 of 12 hormone drug cases. Pfizer counters that out of 34 hormone replacement cases that have been tried, all but four of the plaintiffs’ verdicts were set aside, according to the Intelligencer.
Jeffrey Dach MD

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The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician — patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.
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The Origin of Bioidentical Hormones by Jeffrey Dach MD

Russell Marker and the Origins of Bioidentical Hormones 

by Jeffrey Dach MD

Where do Bioidentical Hormones Come From ?

 A couple of times a week, I get the question, “Where do hormones comes from ?”  Russell E Marker was the Penn State chemist who originated Progesterone and other Bioidentical Hormones from a plant steroid called Diosgenin.  (upper left image Russell Marker courtesy of American Chemical_Society)

Who was Russell Marker ?

Russell Marker was a Penn State chemist in 1938 who invented a practical way to mass produce Progesterone, the pregnancy hormone. using a technique known as the Marker degradation process.

Chemistry Professor at Penn State

In 1938, Marker was a chemistry professor at Pennsylvania State College working on plant steroid chemistry.   During this time, Marker found a plant steroid from the Dioscorea family called Diosgenin which could be easily converted into the human bioidentical hormone, Progesterone.
Next, Marker needed an economical source of the plant material to isolate the plant steroid called Diosgenin.  (upper left image Russell Markerwith plants courtesy of   American Chemical_Society )





Finding the Plant Material in Mexico

In November 1941,  Marker found what he had been searching for in a botany textbook describing a Dioscorea plant  indigenous to Veracruz in Mexico, called Cabeza de Negro.

Left image: Diosgenin from Diascorea plant Mexican Yam courtesy of wikimedia commons.
In 1942, Marker then traveled to Mexico where he purchased some of the Dioscorea plant material and started the mass production of the bioidentical hormone, Progesterone.
In 1943,  Marker resigned from Penn State University and moved to Mexico to begin mass production of Progesterone and other bioidentical hormones.    Marker refused to assign patent rights to anyone, including himself, thus granting free use of his invention to anyone interested.

In early 1944, Syntex was formed in Mexico to manufacture Progesterone from the Diascorea Diosgenin.  In May 1945, over a dispute, Marker left Syntex and started a new company, Botanica-mex, near Mexico City which then made  several kilos of Progesterone.   Botanica-mex folded in March 1946,   and was restarted as a new company called Hormonosynth.   During this time, the cabeza de negro plant source was replaced by another yam called barbasco, containing 500% more diosgenin.   After Marker’s retirement, the company was again reorganized as Diosynth.

(upper image Chemcial Diagram of Marker Degradation  courtesy of   American Chemical_Society_CNBP_027297 )

Syntex After Marker Leaves  – Syntex Prospers

After Marker left Syntex , the company recruited another chemist George Rosenkranz, who began October 1945, and Syntex was again selling progesterone.    Rosenkranz extended the process to the production of testosterone and other bioidentical hormones .   Rosenkranz built a research program at Syntex, and recruited other  Ph.D. chemists including Carl Djerassi and Alejandro Zaffaroni.

Cortisone and the “Pill”   

Further research at Syntex led to discovery that this same plant steroid precursor Diosgenin could be converted to cortisone, a powerful anti-inflammatory steroid.  The company also worked on the synthetic birth control pill.   By the 1950s, Syntex and its competitors were the major supplier of  bioidentical hormones to the United States.

Health Benefits of Diosgenin

While using Diosgenin as a precursor to progesterone, Russel Marker had no way of knowing that Diosgenin has its own health benefits.   One of which is as a natural anti-cancer drug.  Diosgenin also reduces inflammation, serving as an anti-inflammatory drug.  Diosgenein also serves as a lipid control drug, with beneficial effects of lipid profiles.


Articles with Related Interest:

The Safety of Bioidentical Hormones
The Importance of Bioidentical Hormones
Bioidentical Hormones Prevent Heart Disease
Bioidentical Hormones Prevent Arthritis

Author: Jeffrey Dach MD

 Links and References: 

1)http://portal.acs.org/portal/PublicWebSite/education/whatischemistry/landmarks/progesteronesynthesis/index.htm
2) http://portal.acs.org/preview/fileFetch/C/CNBP_027297/pdf/CNBP_027297.pdf

3) http://portal.acs.org/portal/acs/corg/content?_nfpb=true&_pageLabel=PP_ARTICLEMAIN&node_id=926&content_id=CTP_004452&use_sec=true&sec_url_var=region1&__uuid=5aab01fd-b815-4dc5-b156-86688fc64df6
The following pages commemorate the designation of the “Marker Degradation” and creation of the Mexican steroid hormone industry as an International Historic Chemical Landmark. The designation was conferred by the American Chemical Society and the Sociedad Química de México in ceremonies at The Pennsylvania State University, University Park, Pennsylvania, on October 1, 1999, in Monterrey, Mexico, on October 25, 1999, and in Mexico City, Mexico, on December 2, 1999.
4) http://en.wikipedia.org/wiki/Marker_degradation
The Marker degradation is a three-step synthetic route in steroid chemistry developed by American chemist Russell Earl Marker in 1938–40.
5) http://pubs.acs.org/doi/abs/10.1021/ja01869a023
The Marker semi-synthesis of progesterone from diosgenin. Marker RE, Krueger J (1940). “Sterols. CXII. Sapogenins. XLI. The Preparation of Trillin and its Conversion to Progesterone”. J. Am. Chem. Soc. 62 (12): 3349–3350.
6) http://pabook.libraries.psu.edu/palitmap/Prog.html
Road to Hope for Female Infertility: Progesterone
By Stephen T. Spagnol, Spring 2010
7) pdf file:Russell_Marker_Syntex_Progesterone_Chemical_Society_CNBP_027297
THE “MARKER DEGRADATION” AND CREATION OF THE MEXICAN STEROID HORMONE INDUSTRY 1938–1945 AN INTERNATIONAL HISTORIC CHEMICAL LANDMARK UNIVERSITY PARK, PENNSYLVANIA, OCTOBER 1, 1999  , MEXICO CITY, DECEMBER 2, 1999
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The reader is advised to discuss the comments on these pages with his/her personal physicians and to only act upon the advice of his/her personal physician. Also note that concerning an answer which appears as an electronically posted question, I am NOT creating a physician — patient relationship. Although identities will remain confidential as much as possible, as I can not control the media, I can not take responsibility for any breaches of confidentiality that may occur.

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Copyright (c) 2013 Jeffrey Dach MD All Rights Reserved. This article may be reproduced on the internet without permission, provided there is a link to this page and proper credit is given.
FAIR USE NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of issues of significance. We believe this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.