Myth. Money. Marketing The debate about Bio-identical Hormone Replacement Therapy

by Linda A. Firestone, Ph.D. and Tara Solomon, MD, FACOG

Hormone Replacement Therapy (HRT) is big business! The pharmaceutical industry has invested billions of dollars in promoting and glamorizing HRT for women suffering from menopausal symptoms beginning in the peri-menopause and ending in menopause.

Last year, the debate became heated as women watched Oprah’s take on the hormone replacement therapy issue. Doctors’ phones could be heard ringing off the hooks with questions about the differences between bio-identical hormone replacement therapy (BHRT) and synthetic hormone replacement therapy ( HRT). How does a woman decide what is right for her? Therein lies the rub! Hormone replacement, whether using synthetic or bio-identical hormones is dependent upon, or AT LEAST should be, on a woman’s hormone levels.

What is the difference between bio-identical HRT and synthetic HRT? BHRT uses hormones derived from plant products that when ingested and converted break down to match the body’s own hormone molecular structure. Traditional HRT is made from chemicals produced in a laboratory that do not fit a hormone receptor’s “lock and key' mechanism as well as natural hormones and can therefore cause more side-affects.

The debate grows even more confusing because of competing interests and those interests that are not solely in the interests of better health for women. Dr. Wulf Utian, who specializes in menopause and who is the founder of the North American Menopause Society, appeared on the Oprah Winfrey Show to explain HRT to the audience and help women understand their options. Unfortunately, Utian, neglected to reveal that the pharmaceutical companies are among his major sponsors and are heavily invested in HRT—not BHRT.

The Study that caused great confusion

In 2002, The Women’s Health Initiative, a Wyeth Pharmaceutical funded study, released a report of early findings that left women and doctors scratching their heads. The study was cut short because they found an increase in breast cancer and heart disease among the women being studied. The WHI was indeed a flawed study, but not for the reasons most people believe. The studies’ demographic was women over 60 instead of women in their 40’s and 50’s, which is the average age of menopause in this country. Furthermore, because of a woman’s increased age, she was already more prone to hypertension, strokes, heart attacks, and blood clots in both the legs and lungs. There were problems with the types of hormones being studied as well. What was clear from the study, however, was the need for each woman to be closely monitored and the appropriate hormone replacement prescribed. Dr. Utian came out against the findings of the WHI study because women stopped taking Wyeth’s synthetically formulated hormones, which were derived from the urine of pregnant female horses.

Dr. Sangeeta Pati is a noted hormonal specialist who is a board certified OB/GYN and board certified by the American Board of Anti-Aging and Bioregenerative Medicine argues against HRT and for BHRT. To begin, she explains in her article on the American Academy of Anti-Aging Medicine’s website that during her late 40s a woman develops “an imbalance of the estrogens. Estriol (E3) which is breast and clot protective, decreases from 80% to 10%. Estrone (E1) which is breast and clot stimulating, goes up from 10% to 80%. The increased E1 is undesirable…'

Dr. Pati writes that “Large studies so far have used synthetic hormones (not identical to human hormones) with a ration of estrogen weighted toward (estrone) E1, like the large WHI study…' Rather, she argues, that hormones which are protective to the heart and brain; that non bio-identical progesterone (or synthetic progesterones) have been shown to increase clots and breast cancer in five trials compared with natural progesterone; and that estradiol or E2 delivered through the skin has been shown to decrease clots and the risk of stroke and heart attack as opposed to E1 delivered through the mouth.

Some argue that there have not been long-term studies on bio-identical hormones and that it is just a marketing tool used by pharmacies. Yet, BHRT has been around for several decades. To date, Dr. Pati argues, the FDA has, in fact, approved 20 bio-identical hormone products such as Cimara, Vivelle, Evamist and Prometruim and that the pharmaceutical companies are desperately working on BHRT.

MarketWatch published a synopsis from the Postgraduate Medical Journal, a peer-reviewed publication that reported on the most comprehensive analysis to date of BHRT. Kent Holtorf, MD, a leading expert on hormone therapy whose practice treats over 7,000 women a year, led the study. The research found that BHRT is 'both more effective and has greater health benefits for women suffering with symptoms of menopause…' Dr. Holtorf also stated that, “The medical literature demonstrates that bio-identical hormone replacement therapy is highly effective and carries a reduced …risk of breast cancer and cardiovascular disease.' He is willing to discuss the FDA’s attempt to push synthetic HRT.

The FDA has also started fining certain pharmacies that compound BHRT for making false claims. Credible compounding pharmacies that provide bio-identical hormones should be certified by PCCA or other national organizations that set standards for compounding pharmacies.

In my own practice

As a board-certified OB/GYN and the medical director of the Women’s Wellness Center of South Florida, I have treated over 800 women with bio-identical hormone replacement therapy over the past eight years. Two of my patients have had non-life threatening heart attacks, two had breast cancers and three overweight patients developed uterine hyperplasia, which could have developed into pre-cancer of the uterus.
.
I base my treatment on what is already available on the market for bio-identical hormones. Estradiol is available by prescription, as in the Climara patch and Estrogel. My compounded estradiol and progesterone cream is prescribed on the basis of what I have already used in the past with brand named pharmaceutical hormones. I then do saliva testing in two months to make sure that my patients are balanced. The testosterone cream that I use is based on the Androgel patch. However, Androgel contains methyltestosterone , which can cause untoward male side effects including male patterned baldness, acne and facial hair growth. I have seen much fewer of these side effects with bio-identical testosterone cream. Furthermore, I also balance the thyroid and adrenal hormones that help maintain a stable body weight, libido and sexual drive and healthy sleep patterns.

Should you decide that hormone replacement therapy, whether bio-identical or synthetic, is right for your body, make sure that accurate blood levels are initially taken and that the appropriate hormones and dosages are being prescribed. Regardless, the FDA warns that hormone replacement therapy should be used for no more than 5 years and with the lowest dosage possible.


About the Authors:
Linda A. Firestone is a freelance writer and author of articles, essays, and books. Her writing career spans over 20 years during which time she has written for the Mayor of New York City, the UN Development Program, not for profit organizations, magazines, trade journals, acted as a ghost writer, grant writer and playwright. She is President and founder of The Write Connections where she provides writing services for businesses and publishers.

Dr. Tara A. Solomon, M.D., is a board certified obstetrician/gynecologist. Dr. Solomon, founder and President of the Women's Wellness Center of South Florida, specializes in obstetrics, gynecology and infertility. She completed medical school at the Albert Einstein College of Medicine in New York and her residency at Columbia Presbyterian Medical Center in Manhattan. She is the author of What Your Gynecologist Never Told You. She has also appeared on public television and ra

 

 

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