I recently received the flowing press release from the medical/health newswire service to which I subscribe:
Results from one of the largest national surveys of doctors involved in menopause care conducted since the release of initial findings from the Women's Health Initiative (WHI) leave no doubt - even five years later, a cloud of confusion lingers for both physicians and patients regarding the results of the WHI study. The study, which was one of five major studies that comprised the large clinical trial called the Women’s Health Initiative (WHI), was discontinued because the synthetic hormones were found to increase a woman’s risk of breast cancer as well as heart disease, blood clots and stroke. Later findings also linked synthetic hormone replacement to an increased risk for Alzheimer’s disease. The findings were published in JAMA, the Journal of the American Medical Association.
The online survey of over 400 physicians concludes that patients remain confused about the risks of hormone therapy (HT); in fact, only 15% of doctors believe their patients accurately perceive the risks of HT. The survey was conducted by Richard Day Research on behalf of The Hormone Foundation, with the support of Novogyne Pharmaceuticals. Amongst the key findings of the survey is that only 18 percent of physicians have "no confusion at all" about the WHI findings. However, physicians feel the confusion that exists among the general public is much greater:
- 93% feel the level of misinformation patients bring to their office about the WHI findings has "somewhat" or "very much" affected their practice
- More than two-thirds feel their patients and the media have "a great deal of confusion" now about the WHI findings
- 83% of doctors report their patients are as or more confused now than when the findings were first released in 2002
- 81% of doctors believe the media are as or more confused now than when the findings were first released.
I firmly believe that you, the patient, must take responsibility for educating your physicians about the safety and efficacy of bio-identical hormone therapies. Why you? Because they certainly aren’t learning about bio-identical hormone replacement in pharmaceutical sponsored medical education programs or even in medical school. It is essential that you participate in a continuous open dialogue with your physician to arrive at treatment decisions best for your individual needs. Let me try and cut through the confusion and help you inform yourself so that you might have an intelligent and productive conversation when you next speak to your doctor.
Over the last several years, hormone replacement has frequently been in the news. In magazine articles and television shows, celebrities have bandied around terms like “natural”, “bio-identical”, “synthetic”, or “pharmaceutical” as if they were interchangeable. They are not.
“Natural” human hormones are those hormones produced within the body by the ovaries, the testes, the adrenal glands or the hypothalamus. These hormones travel through the blood stream to fit into specific hormone receptor sites located throughout the body and brain. Each hormone receptor site will recognize the specific molecular structure of a single type of hormone. This means that a receptor site for progesterone will not recognize estrogen or testosterone; it will only recognize the molecular structure of progesterone.
Natural human hormones attach to their receptor sites like keys fitting into locks. The chemical term for this key and lock phenomenon is called relative binding affinity (RBA). Natural human hormones have a 100 percent RBA for their respective receptor sites.
Why Bio-Identical Hormones Are Safe and Synthetic Hormones Are Dangerous
Bio-identical hormones are derived from plants (soybeans or wild yams) using biochemistry processes. The biochemical process assures that the molecular structure of bio-identical hormones is identical to that of the natural human hormones produced in the body. When introduced into the body, bio-identical hormones fit perfectly into the hormone receptor “lock” and trigger exactly the same response as the one previously fostered by the hormones produced in the ovaries, adrenal gland or hypothalamus.
Bio-identical hormones also have a 100 percent RBA for the hormone receptor sites within the body. Because the body recognizes and accepts bio-identical hormones just as it would naturally occurring human hormones, bio-identical hormone replacement is both safe and effective.
It is important to realize that the molecular structure of natural human hormones cannot be patented. Consequently, neither can the identical molecular structure of bio-identical hormones be patented. Without a patent, how could a pharmaceutical company protect its formulation and, most importantly, its profits?
The answer is: they can’t. Consequently, for almost three quarters of a century, pharmaceutical companies have been developing, patenting and marketing hormones that have a slightly different molecular structure from natural human hormones and bio-identical hormones. The pharmaceutically produced and patented hormones should be referred to as synthetic hormones. The list of synthetic hormones on the market today includes such brand names as Premarin, Prempro, Menest, Orthoest, Activella and Femhrt, among many others.
Synthetic hormones have shapes not seen in nature. Synthetic hormones’ poor fit with the body’s hormone receptors produces unnatural chemical reactions and striking alterations in biologic activity. As a result, their RBA is less than 100 percent resulting in side effects and health risks. Premarin, for instance, is metabolized horse estrogen with a low affinity for binding with any human hormone receptor. Premarin is also composed of 49.3% of estrone (E1), the cancer-promoting estrogen. This is almost ten times the ratio that occurs naturally within the body.
Many medical studies have substantiated the dangers of synthetic hormone replacement. In July of 2002, the National Institutes of Health (NIH) halted WHI because of the previously identified dangers. WHI studied the effects of a widely used type of synthetic hormone replacement therapy medication, Prempro, which combines the altered molecular structures for both estrogen and progesterone. (Note: Synthetic progesterone is referred to as progestin.)
Unfortunately, the bio-identical “progesterone” is often confused with synthetic “progestin.” It is critical to understand that the WHI used synthetic progestin, NOT bio-identical progesterone. There is no documented evidence in scientific literature of any cases of cancer as a result of treatment with bio-identical progesterone.
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In contrast, studies reported in both the International Society for Preventive Oncology’s 1999 Cancer Detection and Prevention Journal and the International Union Against Cancer’s 2005 International Cancer Journal found that women using synthetic progestins plus estrogen had a significantly higher risk of breast cancer, whereas women using bio-identical progesterone plus estrogen had a lower risk of breast cancer than women using estrogen alone.
If bio-identical hormone replacement is so safe, you may be wondering why more physicians continue to prescribe synthetic hormones. The answer is a mix of ignorance, confusion and marketing. Pharmaceutical companies make billions of dollars on the sales of synthetic hormone products. In a discussion of the safety of synthetic vs. bio-identical hormone replacement, pharmaceutical companies have a lot to lose. Consequently, these companies spend millions of dollars marketing these synthetic hormones to physicians via sponsored continuing medical education (CME) programs, office lunch presentations and off-site forums at resort locations.
In her book The Truth About Drug Companies, Marcia Angell, M.D., former Editor in Chief of The New England Journal of Medicine states: “Drug companies have become vast marketing machines wielding nearly limitless influence over medical research, education and how doctors do their jobs.”
There are volumes of solid, credible clinical trials and medical studies validating the safety and efficacy of bio-identical hormone therapies. Unfortunately, the medical research institutions and universities that have published these studies have not had the budget to hire a sales force to go out into the field to educate physicians. Consequently, most doctors continue to remain unenlightened regarding the currently available science behind the use of bio-identical hormones as a safe treatment option. That is where you come in.
Educate your doctor about bio-identical hormone therapies. Give him/her a copy of my book, FROM HORMONE HELL TO HORMONE WELL. Let him/her know that I will be happy to speak to them in person to address any questions they might have as well as suggest where they might attend continuing medical education programs on bio-identical hormone replacement.
If you will, we can work together to make a difference in women’s health one doctor and one patient at a time. I believe that is what true healing is all about.
I wish you WELL!
Dr. Randolph
* Please Note: Because legally we are unable to provide prescriptions for telephone consultation patients unless they have been previously seen in my office, should you require a prescription for a more comprehensive panel of bio-identical hormone replacement, my nurse practitioner will advise you how to locate a physician and compounding pharmacy in your area.