The Safety of Bioidentical Hormones

Drop_impact3The Safety of Bioidentical Hormones 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 Commons. Author: Roger McLassus, CC 3.0.

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, Charles Darwin and 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
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

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

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)
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  Natural Hormone Balance for Women.  (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  according to Micheal Wolfe in the  New England Journal  (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.

Eiffel_towerLeft Image: Eiffel Tower Paris France Courtesy of Wikimedia Commons

According to the 2008 French Cohort study by Dr. Agnes Fournier, there is no increased risk of breast cancer in women using bio-identical hormones, estradiol combined with progesterone. However, breast cancer risk is increased with the estradiol/ synthetic progestin  combination. Synthetic progestins are carcinogenic via two mechanisms. Firstly, as suggested by Dr. Sebastián Giulianelli in 2012, progestins activate ER-alpha which together with the PR (progesterone receptor) activates Cyclin D1 and MYC oncogenes. Secondly as Dr. Steven Birrell suggests in 2007, synthetic progestins have androgenic properties which interfere with androgenic activation of ER-Beta, the tumor suppressor receptor. Note: ER-alpha is the proliferative, procarcinogenic receptor, while ER-beta is the tumor suppressor receptor.(40-54)

French Cohort Study

In 2008, Dr Agnes Fournier from Paris, France studied 80,377 postmenopausal women using various hormone replacement regimens for a mean duration of 8.1 years in the E3N/EPIC study using self administered questionnaires. Pathology reports for 2,354 cases of invasive breast cancer were reviewed in 96 percent of cases. Almost all (98 percent) of the women used estradiol, and only 2 percent used CEE (Premarin). Estradiol-alone users had a 29 percent increase in breast cancer due to proliferative effects of estradiol. However, the estradiol/progesterone combination group had no increase in risk for breast cancer compared to the general population, thus suggesting an anti-proliferative effect of natural progesterone. However, when a synthetic progestin is added to the estradiol, these women had a 69 percent increased risk for breast cancer. These results are similar to those of Dr. Charles Wood using a primate model of post menopausal hormone replacement. For more on primate hormone studies, see: Don’t Monkey with my Hormones.  Dr. Agnès Fournier writes:

Recently, Wood et al. [22] compared the effects of estradiol given with either medroxyprogesterone acetate or micronized progesterone on risk biomarkers for breast cancer in a postmenopausal primate model. In this randomized crossover trial, they found that, compared to placebo, estradiol + medroxyprogesterone acetate resulted in significantly greater proliferation (as measured by Ki67 expression) in lobular and ductal breast epithelium, while estradiol + micronized progesterone did not. This result supports our findings suggesting that, when combined with an estrogen, progesterone may have a safer risk profile in the breast compared with some other progestagens. (8A-C)

Avoid Endocrine Disrupting Chemicals

We should mention here breast cancer prevention involves avoiding endocrine disrupting chemcials in the environment as well as excessive estrogen levels from any source.  A good resource for learning about EDC’s (endocrine disrupting chemicals ) is Hormone Deception by Dr. Lindsey Berkson, and Our stolen future: Are we threatening our fertility, intelligence, and survival? by Theo Colburn. (9-10) (55-56)

What Causes Breast Cancer ?

If estrogen/progesterone bioidentical hormone replacement does not cause cancer, then the next obvious question is what does cause breast cancer?  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. When researchers wish to study breast cancer in mice, they induce breast cancer with the carcinogenic chemical DMBA, or the synthetic progestin medroxyprogesterone. (57-59)

Etiology of Breast Cancer in Humans

In humans, breast cancer is thought related to carcinogenic effects of certain estrogen metabolites called 4-hydroxy-quinones which act as DNA adducts, causing oxidative damage to DNA. Normally estrogen is preferentially metabolized towards the favorable pathways leading to 2-MEO (2 methoxy-estradiol) which is cancer preventive. However, in some cases of nutritional deficiency, or genetic disorders involving methylation pathways, unfavorable 4-hydroxy quinones may accumulate in a bottleneck, thus increasing risk for breast cancer as suggested in 2021 by Dr. Ercole Cavalieri. That is where a knowledgeable doctor is helpful for laboratory tests and providing supplements such as iodine, DIM, methylfolate, selenium, resveratrol, N-acetylcysteine and vitamin D3 to reduce the risk for breast cancer. (60-62)

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.(15Provera 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.   Use this easy tool to email your Congressman and voice your opposition to Wyeth’s attempts to ban estriol and other bio-identical hormones.(17)  While you are at it, tell your Congressman that synthetic hormones are chemically altered monsters that should be banned.

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)

WHI_2_CCAbove 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)

Frankenstein_3Monster 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

How to make a Monster Hormone, Add a Side-Chain (in Red below)







Human  Progesterone                          Medroxyprogesterone (Provera) – the Monster Hormone

Take a good look at human bio-identical Progesterone (Upper left), and the chemically altered version (upper right) Provera (medroxyprogesterone).  The added side-chain is labeled in RED on the right side of the Provera molecule.  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. Above Images: Left Natural Progesterone, Right Synthetic medroxyprogesterone, Courtesy of wikimedia Rhododendronbusch

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)

In 2005, Dr. Jose Russo studied the protective role  of pregnancy in breast cancer, finding early pregnancy and multiple pregnancies confer protection from breast cancer, while no pregnancies (as in the nun in a convent) leads to increased risk of breast cancer. Dr. Russo writes:

Women who gave birth to a child when they were younger than 24 years of age exhibit a decrease in their lifetime risk of developing breast cancer, and additional pregnancies increase the protection. The protective effect of full-term pregnancy is a well-established concept not only in humans, but also in experimental rodent models. (25)

What is the Molecular Mechanism of Pregnacy Induced Protection from Breast Cancer?

Since pregnancy confers protection from breast cancer, perhaps this holds the key to understanding how to prevent and treat breast cancer.In 2019 and 2020, Dr Mary Feigman studied this question in a transgenic mouse model called CAGMYC. These are mice inbred to have overexpression of the cMYC oncogene. Dr. Mary Feigman found that in this CAGMYC mouse model, pregnancy conferred protection by increasing the P53 protein content in the MECs (mammary epithelial cells) that blocked the development of malignancy. Pregnancy made the MEC’s less responsive to cMYC oncogene overexpression, thus blocking the devopment of premalignant lesions, writing:

But how can pregnancy decrease mammary oncogenesis?…To characterize the influence of a pregnancy-induced epigenome on the response to oncogene expression, we used a transgenic mouse strain (CAGMYC), in which overexpression of the oncogene cMYC, an inducer of mammary tumor development23, is driven in a doxycycline (DOX)-dependent manner…Using this transgenic mouse strain, we found that the post-­pregnancy epigenome was incompatible with cMYC overexpression, blocking the activation of MYC-­downstream signals and their progression to oncogenesis… Our study revealed a substantial increase of p53 protein in post-pregnancy CAGMYC [transgenic mice with cMYC overexpression] organoids, possibly promoting a senescent state that could block the development of malignant phenotypes…Using inducible cMYC overexpression, we demonstrate that post-pregnancy MECs are resistant to the downstream molecular programs induced by cMYC, a response that blunts carcinoma initiation, but does not perturb the normal pregnancy-induced epigenomic landscape…Using this system, we confirmed post-pregnancy MECs are less responsive to cMYC overexpression. (63-64)

Bioidentical Hormones Prevent Breast Cancer in Mouse Models

This protection from breast cancer is thought to be conferred by high hormones levels of estrogen and progesterone of pregnancy. This was confirmed in 2007 by Dr. Rajkumar who studied 2 different models of genetically engineered mice who spontaneously develop breast cancer.  When Dr. Rajkumar treated these mice with estrogen, progesterone and testosterone, the incidence of breast cancer was drastically reduced, demonstrating that hormone treatment protected genetically engineered mice from developing breast cancer. (26)

In 1985,  Dr Akira Inoh from Japan showed progesterone prevented breast cancer in inbred W/Fu strain mice. These mice were prone to develop spontaneous cancers of various types, including breast cancer. When the mice were ovariectomized and given prolonged treatment with diethylstilbestrol [synthetic estrogen] or 17 beta-estradiol [natural estrogen], the mice developed multiple breast . However, when when the mice were simultaneously given progesterone along with the estrogen, the “multiplicity and size of estrogen-induced MTs [multiple tumors] were reduced by the simultaneous administration of either progesterone or tamoxifen”.

Inoh, Akira, et al. “Protective effects of progesterone and tamoxifen in estrogen-induced mammary carcinogenesis in ovariectomized W/Fu rats.” Japanese Journal of Cancer Research GANN 76.8 (1985): 699-704.

In 1973, Dr. Albert Segeloff from New Orleans studied a mouse model of radiation induced breast cancer. When the mice were treated with progesterone, none of them developed breast cancer, writing:

In this preliminary experiment none of the animals that bore just progesterone pellets and were radiated developed mammary carcinomata.

Segaloff, Albert. “Inhibition by progesterone of radiation-estrogen-induced mammary cancer in the rat.” Cancer Research 33.5 (1973): 1136-1137.

Above left image: M-Mode Ultrasound Image of early pregnancy, Author: Nevit Dilmen, 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 IUD (intra-uterine device) is available.

Here is a listing of people involved in the early  development of birth control pills: Russell Marker, Percy Lavon Julian, Carl Djerassi, Luis E. Miramontes, George Rosenkranz, Gregory Pincus, Min Chueh Chang, John Rock.(32)

In the future of medicine, I predict that progesterone will replace progestins as oral contraception .  The bio-identical hormone, Progesterone, will be used in the birth control pills of the future.  Early research on contraception was done with progestereone, and research was switched to synthetic progestins to obtain a patent and make a profit. Another consideration was ease of use of the oral tablet, at the time available only as a progestin.  Bio-Identical progesterone suppresses ovulation and was the original agent investigated in early research for a contraceptive agent.  However, timing and dosages were never officially worked out, so we currently are left with the synthetic birth control  pills by default.  Again, the IUD can be used instead to avoid the monster hormones.   I predict that new research outside the US in the next decade will establish progesterone as the hormone of choice for birth control.  Most likely, funding for this research will come from a foreign government agency, in a country with universal health care which has economic incentives to make a healthier pill.

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)


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

Inept FDA Declares War on Bioidentical Hormones

 Articles on 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 By Erika Schwartz , Kent Holtorf , and David Brownstein March 16, 2009 WSJ

4) Hormones-in-Wellness and Disease Prevention Holtorf Schwartz By Erika Schwartz and Kent Holtorf

5) Natural_vs_Synthetic_HRT_Literature_Review Kent Holtorf

6) Bioidentical-hormone-debateThe bioidentical hormone debate Holtorf_Kent_Postgraduate medicine_2009

Recommended Reading: books by John R Lee MD (35)

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 (Warner Books, 1999)(35)

WHAT YOUR DOCTOR MAY NOT TELL YOU ABOUT BREAST CANCER: How Hormone Balance Can Help Save Your Life, (Warner Books, 2002)(35)

Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie Fl 33314


Fatal water intoxication. D J Farrell1 and L Bower. J Clin Pathol. 2003 October; 56(10): 803–804.

Charles Darwin, theory of natural selection.

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) Natural Hormone Balance for Women: Look Younger, Feel Stronger, and Live Life with Exuberance. by Uzzi Reiss MD

(5) Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs NSAIDS Micheal Wolfe NEJM 1999  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

Causes of Brea6t Cancer- the Estrogen Controversy, Dixie Mills MD

8A) Fournier A, Berrino F, Clavel-Chapelon F. Unequal risks for breast cancer associated
with different hormone replacement therapies: results from the E3N cohort study. Breast Cancer Res Treat 2008;107:103–11

8B) Fournier A, Berrino F, Riboli E, et al. Breast cancer risk in relation to different types
of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer 2005; 114:448–54.

8C) De Lignieres, B., et al. “Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.Climacteric 5.4 (2002): 332-340.


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) Breast Cancer Prevention and Iodine Supplementation by Jeffrey Dach MD

Estrogen Therapy and Coronary-Artery Calcification. NEJM Volume 356:2591-2602  June 21, 2007  Number 25. JoAnn E. Manson, M.D., et al.

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.

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.

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.

Premarin From Wikipedia, the free encyclopedia

Provera, Medroxyprogesterone, From Wikipedia, the free encyclopedia

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.

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.

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.

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.

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.

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.

The Truth About Hormones Monday, Jul. 22, 2002 Time Magazine. By CHRISTINE GORMAN AND ALICE PARK

AMA Medical NEws. Collecting clues: Cancer registries might have an answer. By Kathleen Phalen Tomaselli, AMNews correspondent. April 17, 2006.

25) Russo, Jose, et al. “The protective role of pregnancy in breast cancer.” Breast cancer research 7 (2005): 1-12.

Women who gave birth to a child when they were younger than 24 years of age exhibit a decrease in their lifetime risk of developing breast cancer, and additional pregnancies increase the protection [3]. The protective effect of full-term pregnancy is a well-established concept not only in humans, but also in experimental rodent models [4-12].

26) Rajkumar, Lakshmanaswamy, et al. “Hormone-induced protection of mammary tumorigenesis in genetically engineered mouse models.” Breast Cancer Research 9 (2007): 1-11.


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

Combined oral contraceptive pill. From Wikipedia, the free encyclopedia. (Redirected from Birth control pill)

Oral Contraceptives on Worst 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.

Birth Control Pill Adverse Side Effects by Jeffrey Warber MD

History and Development of an effective combined oral contraceptive. People Involved.

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

The Safety of Bioidentical Hormones — the Data vs. the Hype by Jacob Teitelbaum, MD

Books by John R Lee MD

Wyeth and the FDA

(36)   http//

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

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.

40) Birrell, Stephen N., et al. “Disruption of androgen receptor signaling by synthetic progestins may increase risk of developing breast cancer.” The FASEB Journal 21.10 (2007): 2285-2293.

41) Giulianelli, Sebastián, et al. “Estrogen receptor alpha mediates progestin-induced mammary tumor growth by interacting with progesterone receptors at the cyclin D1/MYC promoters.” Cancer research 72.9 (2012): 2416-2427.

42) Dhanasekaran, Renumathy, et al. “The MYC oncogene—the grand orchestrator of cancer growth and immune evasion.” Nature reviews Clinical oncology 19.1 (2022): 23-36.

43) Kim, Jong Kyong, and J. Alan Diehl. “Nuclear cyclin D1: an oncogenic driver in human cancer.” Journal of cellular physiology 220.2 (2009): 292-296.

44) Perkins, Meghan S., et al. “Upregulation of an estrogen receptor-regulated gene by first generation progestins requires both the progesterone receptor and estrogen receptor alpha.” Frontiers in Endocrinology 13 (2022): 959396.

45) de Lignières B. Effects of progestogens on the postmenopausal breast. Climacteric

46) Campagnoli C, Clavel-Chapelon F, Kaaks R, et al. Progestins and progesterone in
hormone replacement therapy and the risk of breast cancer. J Steroid Biochem Mol
Biol 2005;96:95–108.

47) Ory K, Lebeau J, Levalois C, et al. Apoptosis inhibition mediated by medroxyprogesterone acetate treatment of breast cancer cell lines. Breast Cancer Res Treat 2001;68:187–98. 554

48) Hofseth LJ, Raafat AM, Osuch JR, et al. Hormone replacement therapy with estrogen or estrogen plus medroxyprogesterone acetate is associated with increased epithelial proliferation in the normal postmenopausal breast. J Clin Endocrinol Metab 1999;84:4559–65.

49) Jeng MH, Parker CJ, Jordan VC. Estrogenic potential of progestins in oral contraceptives stimulate human breast cancer cell proliferation. Cancer Res 1992;52:6539–46.

50) Kalkhoven E, Kwakkenbos-Isbrücker L, de Laat SW, et al. Synthetic progestins induce proliferation of breast tumor cell lines via the progesterone or estrogen receptor. Mol Cell Endocrinol 1994;102:45–52.

51) Papa V, Reese CC, Brunetti, et al. Progestins increase insulin receptor content and insulin stimulation of growth in human breast carcinoma cells. Cancer Res 1990;50:7858–62.

52) Hissom JR, Moore MR. Progestin effects on growth in the human breast cancer cell
line T-47D—possible therapeutic implications. Biochem Biophys Res Commun 1987;145:706–11.

53) Catherino H,Jeng MH, Jordan VC. Norgestrel and gestodene stimulate breast cancer
cell growth through an oestrogen receptor mediated mechanism. Br J Cancer 1993;67:

54) Cline JM, Soderqvist G, von Schoultz E, et al. Effects of conjugated estrogens,
medroxyprogesterone acetate, and tamoxifen on the mammary glands of macaques. Breast Cancer Res Treat 1998;48:221–9

55) Berkson, D. Lindsey. Hormone Deception. Contemporary Books., 2000.

56) Colborn, Theo, Dianne Dumanoski, and John Peterson Myers. Our stolen future: Are we threatening our fertility, intelligence, and survival?–a scientific detective story. Penguin, 1997.

57) Escrich, Edward. “Validity of the DMBA-induced mammary cancer model for the study of human breast cancer.” The International journal of biological markers 2.3 (1987): 197-206.

58) Buqué, Aitziber, et al. “MPA/DMBA-driven mammary carcinomas.” Methods in cell biology. Vol. 163. Academic Press, 2021. 1-19.

59) Lanari, Claudia Lee Malvina, et al. “The MPA mouse breast cancer model: evidence for a role of progesterone receptors in breast cancer.” (2009).

60) Cavalieri, Ercole, and Eleanor Rogan. “The 3, 4-quinones of estrone and estradiol are the initiators of cancer whereas resveratrol and N-acetylcysteine are the preventers.” International journal of molecular sciences 22.15 (2021): 8238.

61) Cavalieri, Ercole L., and Eleanor G. Rogan. “Inhibition of depurinating estrogen-DNA adduct formation in the prevention of breast and other cancers.” Trends in breast cancer prevention (2016): 113-145.

62) Cavalieri, Ercole L., and Eleanor G. Rogan. “The etiology and prevention of breast cancer.” Drug Discovery Today: Disease Mechanisms 9.1-2 (2012): e55-e69.

63) Feigman, Mary J., et al. “Pregnancy reprograms the epigenome of mammary epithelial cells and blocks the development of premalignant lesions.” Nature communications 11.1 (2020): 2649.

But how can pregnancy decrease mammary oncogenesis?…To characterize the influence of a pregnancy-induced epigenome on the response to oncogene expression, we used a transgenic mouse strain (CAGMYC), in which overexpression of the oncogene cMYC, an inducer of mammary tumor development23, is driven in a doxycycline (DOX)-dependent manner… Our study revealed a substantial increase of p53 protein in post-pregnancy CAGMYC [transgenic mice] organoids, possibly promoting a senescent state that could block the development of malignant phenotypes.

Using inducible cMYC overexpression, we demonstrate that post-pregnancy MECs are resistant to the downstream molecular programs induced by cMYC, a response that blunts carcinoma initiation, but does not perturb the normal pregnancy-induced epigenomic landscape. cMYC overexpression drives post-pregnancy MECs into a senescence-like state, and perturbations of this state increase malignant phenotypic changes.

Importantly, our mammary organoid experiments confirmed the cell-autonomous characteristics of pregnancy-induced changes, and their ability to block responses to cMYC overexpression. Using this system, we confirmed post-pregnancy MECs are less responsive to cMYC overexpression.

64) Feigman, Mary J., et al. “Pregnancy reprograms the enhancer landscape of mammary epithelial cells and alters the response to cMYC-driven oncogenesis.” bioRxiv (2019): 642330.

transgenic mouse strain (CAGMYC), in which overexpression of the oncogene cMYC, a known inducer of mammary tumor development [7, 23, 24], is driven in a doxycycline-­dependent manner. Using this transgenic mouse strain, we found that the post-­pregnancy epigenome was incompatible with cMYC overexpression, blocking the activation of MYC-­downstream signals and their progression to oncogenesis.

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Additional References

Natural_vs_Synthetic_HRT_Literature_Review Holtorf
Bioidentical vs. Synthetic HRT, A review of the literature

The bioidentical hormone debate Holtorf_Kent_Postgraduate medicine_2009: Natural (Bio-Identical) vs. Synthetic HRT by  Kent Holtorf, M.D. Dr. Holtorf is the Medical Director of the Holtorf Medical Group, Inc,
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)
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.
research available women in balance.

Fatal Water Intoxication
Woman dies after water-drinking contest

Natural and Synthetic Substances in Medicine

The Promise and Problems of Natural Substances in Medicine Stephen L. DeFelice, M.D.×1957.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
Menopause Hormone Therapy and Breast Cancer. National Women’s Health Network
BMJ 1995;310:598 (4 March) Letters Risk factors for breast cancer

Hormone Levels, Age and Breast Cancer
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% .

Jeffrey Dach MD
7450 Griffin Road
Davie, Fl 33314

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The Safety of Bioidentical Hormones
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The Safety of Bioidentical Hormones
The Safety of Bioidentical Hormones
Jeffrey Dach MD
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About Jeffrey Dach MD

Medical Director of TrueMedMD, a Clinic in Davie Florida specializing in Bioidentical Hormones and Natural thyroid. Office address 7450 Griffin Road Suite 190, Davie, Florida 33314 telephone 954-792-4663

14 thoughts on “The Safety of Bioidentical Hormones

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  12. Thank you Dr. Dach for all your work! and sharing of such important information. I’ve been taking bioidentical hormones since a total hysterectomy at age 37 in 1997. After a year of messing with synthetic hormones with no relief and terrible side effects, I persued finding a better option and did in compounded bioidentical hormones. Thank you for continuing to educate about the importance them.

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