On July 22, the House Government Reform Subcommittee on Human Rights and Wellness held a hearing entitled, “Balancing Act: The Health Advantages of Naturally Occurring Hormones in Hormone Replacement Therapy.” Chair Dan Burton (R-IN) said, “It is clear that in this day and age of advanced medicine we are constantly looking at new ways to treat individuals in the most effective and beneficial manner. I believe this is going to require us to step outside the box and consider new therapies and treatments like bio-identical hormones.”
Dr. Barbara Alving, acting director of the National Heart, Lung, and Blood Institute at the National Institutes of Health (NIH), detailed the findings from the Women’s Health Initiative (WHI) and commented on alternative therapies. Begun in 1991, the WHI sought to determine whether hormone “replacement” therapy was beneficial in preventing chronic diseases such as heart disease, breast and colorectal cancers, and osteoporosis. In 2002, the estrogen plus progestin trial of the study was halted early. “Compared with women who took a placebo pill, women taking the hormones experienced an excess risk of breast cancer and more episodes of heart attack, stroke, and blood clots. Although the hormone-treated women had lower rates of colorectal cancer and fractures, and overall death rates were equal, it was concluded that the hormone combination should not be recommended as a health-promoting regimen,” stated Dr. Alving. Further, in 2004, the estrogen-alone trial was halted early “upon determination that the hormone therapy had no effect on coronary heart disease risk but increased the risk of stroke. The study also found that estrogen-alone therapy significantly increased the risk of deep vein thrombosis, had no significant effect on the risk of breast or colorectal cancer, and reduced the risk of hip and other fractures.” Additional findings from the WHI Memory Study found that estrogen therapy did not reduce the incidence of dementia and had an adverse effect on cognitive function.
As a result of the WHI findings, Dr. Alving said that the Food and Drug Administration (FDA) made the following recommendations: 1) estrogens and progestins should not be used to prevent memory loss, heart disease, heart attacks, or strokes; 2) postmenopausal women who use or are considering using estrogen or estrogen with progestin treatments should discuss with their physicians whether the benefits outweigh the risks; 3) for hot flashes and significant symptoms of vulvar and vaginal atrophy, these products are the most effective approved therapies; 4) estrogens and progestins should be used at the lowest doses for the shortest duration; 5) there is a higher incidence of abnormal mammograms when using these products; and 6) each woman’s medical situation should be carefully discussed with her health care provider.
“In the aftermath of the WHI findings, increased attention has been focused on the use of complementary and alternative medicine (CAM) to manage symptoms associated with the menopausal transition,” stated Dr. Alving. She added that the National Center for Complementary and Alternative Medicine at the NIH is supporting basic and clinical research on the safety and efficacy of botanicals such as soy, black cohosh, and red clover in alleviating hot flashes, osteoporosis, and cognitive and affective problems. Additionally, the National Institute on Aging is studying the efficacy and safety of phytoestrogen-based approaches for treating perimenopausal and postmenopausal symptoms. Dr. Alving told the subcommittee, “The scientific literature on CAM therapies for menopause is equivocal, due to problems with small trials, short duration or treatment, large placebo effects, and imprecise measures for critical outcomes such as hot flashes.”
Dr. Steven Hotze of the Hotze Health and Wellness Center in Texas urged increased support for research on biologically identical hormone therapy (BIHT): “Biologically identical hormones are hormones that have the same molecular structure as the hormones produced by the human body. They are derived from plant sources and are chemically formulated in the lab to be identical in structure to the hormones that humans produce.” He called on Congress to fund a study on BIHT, saying, “The results could spawn a Wellness Revolution in America that would free millions of women from the health problems that develop in mid-life, as well as decrease women’s risk for the development of breast cancer.”
Dr. Hotze also urged the subcommittee to question an FDA decision to examine whether drug compounding should be considered manufacturing and thereby regulated by the FDA rather than the states. Carol Peterson, managing pharmacist for Women’s International Pharmacy in Wisconsin, explained that compounding “involves weighing hormone powders and incorporating them into creams, gels, lozenges or capsules. A new chemical substance is not created. We dispense our compounded products and those manufactured products that qualify as bio-identical.” She continued, “I would submit that the distinction between compounding and manufacturing is easy and clear. The FDA has clear responsibility for ensuring man-made new chemicals that are introduced into medical practice should be thoroughly screened for potential human damage. Remember compounding produces no new chemicals. Additionally, when a practitioner seeks a compounded product for his or her patient that is specific to that patient and writes a prescription order, this is a practice that no manufacturer can or is willing to do.”
Dr. Adriane Fugh-Berman, associate professor at the Georgetown University School of Medicine and medical advisor to the National Women’s Health Network, disagreed: “Claims that the hormones in compounded hormone prescriptions are safer than commercial pharmaceuticals can only be made by those unfamiliar with or resistant to scientific data. Compounding pharmacies should be regulated to ensure the quality of compounded preparations and to prevent them from making misleading and dangerous claims. To do otherwise risks the health of consumers.” Dr. Fugh-Berman also stated, “Claims that so-called bioidentical, natural, or naturally-occurring hormones are safer than conventional hormones are not backed by science. The three estrogens that humans make are estriol, estradiol, and estrone, and these hormones are the hormones touted by some compounding pharmacies and physicians as harmless alternatives to conventional hormone therapy…But just because humans make a hormone doesn’t mean it’s good for us.”
