I attended the 33rd annual Breast Cancer Symposium at San Antonio, Texas December 8-12, 2010. It was a huge meeting with over 9,000 delegates. One of the most important presentations (based on media response) was by Dr. Joseph Ragaz, medical oncologist and clinical professor at the School of Population and Public Health at the University of British Columbia at Vancouver, Canada.
His study stunned many if not most listeners in that it contradicted previous results reported by the Women-s Health Initiative study on estrogen replacement therapy back in 2002. In the Ragaz study, women who received estrogen replacement alone showed a 30-40 percent reduction in breast cancer. These were women who had had previous hysterectomies. His conclusion was that exogenous (administered) estrogen has a protective effect, while endogenous (self produced) estrogen can be carcinogenic.
A new book entitled The Testosterone Syndrome is now available in all bookstores. The book, written by Eugene Shippen, M.D. and William Fryer, is subtitled “Reversing the Male Menopause.” Dr. Shippen is an internist in Reading, Pennsylvania, who has long championed hormone replacement therapy for both women and men. His book first came out in 1998 but was basically ignored by the medical community. Now, with testosterone cream available commercially and Suzanne Somers’ book Breakthrough selling briskly, interest has ignited in both bio-identical hormone replacement for women and for men.
Of particular interest is that both estradiol and testosterone subcutaneous pellets are now available and FDA approved. They are inserted in the subcutaneous fat of the abdomen or hip each 3 to 4 months using local (skin) anesthesia with xylocaine. Blood levels are monitored periodically.
As part of the professional services I feel should be provided by me to my patients, screening of the voluminous medical literature has become more and more important. The information in this newsletter is derived from periodicals and books which I have read and whose information I have consolidated. Perhaps you have seen an item that I have not included in this list or have not seen myself. If so, feel free to bring it to my attention.
The current status of hormone replacement therapy (HRT) in this country is a state of flux. The Women’s Health Initiative Study showed that Premarin, Provera, and their combination (Prempro) were a bad and overly simplistic idea. This was evident years ago, but they were used for the study anyway. Given the study results, the FDA should have followed through and removed all three from the market. Why they did not is a mystery. Liability lawyers, always eager to cash in on a possible new area of lawsuits, may inadvertently accomplish what the FDA didn’t. The pharmaceutical companies who manufacture these drugs will have to discontinue making them because of the legal fees that will be required to defend themselves in the thousands of lawsuits being filed against them.
Meanwhile almost half of the women who panicked and stopped taking hormones because the media made all HRT sound dangerous, have resumed using hormone replacement in alternative more effective and safer ways, and periodically monitoring blood hormone levels.
Another study being done in Great Britain called the Million Women Study is producing some of the answers we all hoped the Women’s Health Initiative would produce. Because of the huge number of women being studied, results concerning cardiovascular effects, bone fractures due to osteoporosis and colon cancer protection and breast cancer incidence will be very meaningful. If they turn out to verify the results obtained in a preliminary study done on my patients several years ago by an independent investigator, Dr. Gerald Friede, and described elsewhere on my website, doctors and patients will finally be reassured that HRT, when it is done correctly, is what it had been hoped to be.
The good options for hormone therapy are growing, all being non-oral.
Skin patches and vaginal rings containing estradiol are commercially available now, estradiol creams and can be made by compounding pharmacists to any specification, and subcutaneous estradiol pellets and testosterone pellets by certain compounding pharmacies, as well as progesterone creams. Birth control patches will almost certainly replace birth control pills. The doubling or tripling of a blood test result called C Reactive protein and associated with an increased rate of cardiovascular disease ( the correlation is stronger even than with LDL cholesterol and heart disease) will push all types of oral hormones off the market.
In July, 2002, the first results of the Women’s Health Initiative were published in the national media. These apparently negative results hit the concept of hormone replacement (HRT) like a bombshell. As a result, half the women who were taking hormones in one way or another stopped them over the next year. This was an unfortunate outcome, and as more information about the study has emerged, not a well-reasoned one. So let us consider a more rational approach.
Armed with six hundred twenty eight million tax payer dollars, the National Institutes of Health began the recruiting in 1993 in 40 centers around the country of what became 161,809 postmenopausal women between ages 50 and 79 for a randomized, double-blind study which was to be completed in 2005. The object was to find out once and for all whether hormones (estrogen and progesterone) really did protect women from developing heart problems and other chronic diseases (osteoporosis, colon cancer, Alzheimer’s, etc.). The main evidence in support of HRT came from an ongoing study of more than 48,000 nurses, which in 1991 showed a 50% reduction in heart attack rates.
The Women’s Health Initiative contained two huge hurdles that, in retrospect, severely limited its usefulness. If the study had too many young women, it would take years for them to get old enough to generate enough “events” like heart attacks and fractures to provide a statistically meaningful analysis. Another problem was finding enough women willing to risk a placebo. Women with severe menopausal problems such as hot flashes and night sweats were specifically discouraged from participating in the study because they probably would know almost immediately whether they were getting a sugar pill instead of the real thing.
As a result, the study, at it’s inception, was designed to be a study primarily of older, geriatric women well past menopause and would include only a small portion of younger women (ages 50 to 54), most of whom did not suffer from severe menopausal problems. The average age of a woman in the WHI was 63; 67% were over the age of 60, and only 1,700 women were between the ages 50 to 54. How important is the timing of hormone replacement? The major rise of heart disease and osteoporosis seen in women occurs between 45 and 55. Once that damage is done, it cannot be reversed. Studies in monkeys show, for instance, that delayed hormone replacement does not protect against plaque build-up in arteries.
Another major source of concern with the WHI is that hormone substitution (Premarin, Provera, Prempro) was used rather than real hormone replacement with human estradiol and progesterone. Also, the route of administration was oral (tablets) rather than non-oral (transdermal or subdermal), resulting in a first pass effect through the liver, not a good thing. No blood levels of estrogen or progesterone were measured.
In August, just to complete the debacle, earlier heart data from the WHI was revised and showed that the initially reported 24% increase in heart risk was not really statistically significant.
Basing one’s decision as to whether to use hormone replacement should not be determined by one study, particurarly one as poorly conceived and carried out as the Women’s Health Initiative Study. It should be made in conjunction with the woman’s physician, preferably a board certified specialist in Gynocology, and the doctor’s advice should be based upon the results of numerous studies combined, not just one severely flawed analysis innacurately reported in the media.