108th Congress

“Balancing Act: The Health Advantages of Naturally Occurring Hormones in Hormone Replacement Therapy.” House Government Reform Subcommittee on Human Rights and Wellness Representative Dan Burton [R-IN], Chair

July 22, 2004

Witnesses:

• Dr. Barbara Alving, Acting Director, NHLBI
• Steven Hotze, M.D. - Founder Hotze Health & Wellness Center;
• David Brownstein, M.D. - Director, Center for Holistic Medicine;
• Ms. Carol Petersen - Pharmacist, Women’s International Pharmacy;
• Ms. Vicki Reynolds - Hormone Replacement Therapy Patient;
• Adriane Fugh-Berman, M.D. - Assistant Professor of Physiology and Biophysics.

Representative Burton held the hearing to provide a forum to witnesses who have developed nontraditional or alternative approaches to hormone therapy. These include holistic therapists and compounding pharmacists who use traditional marketplace drugs and compound the doses for individual patients. There was support from Panel Two for "biologically-identical hormones," which were defined as "hormones that have the same molecular structure as the hormones produced from the human body" and are "derived from plant sources and are chemically formulated in the lab to be identical in structure to the hormones humans produce." Dr. Alving, on Panel One, restricted her remarks to the Women's Health Initiative (WHI) and recommendations from the study, leaving the discussion of the biologically identical hormones to Panel Two.

Panel 1

Dr. Alving reviewed the outcome from the WHI and the results of that trial, the medications used in that trial, and other approaches supported by NIH. She mentioned additional possible therapies such as soy and black cohosh. Prior to the WHI, other studies "suggested that women who took estrogen experienced a lower incidence of chronic diseases, particularly heart disease, and enjoyed better health overall." Therefore, the WHI study was initiated to determine whether or not this is demonstrated by research. In 1991, 27,000 healthy post-menopausal women were recruited for the study. In 2002, part of the study was halted after discovering that women who had taken the estrogen and progestin combination actually had an increased "risk of breast cancer and more episodes of heart attacks, stroke and blood clots. Although they also had lower rates of colorectal cancers and fractures, it was felt that overall this did not merit using these drugs as protection against chronic disease." As a result, the FDA made several recommendations regarding the use of estrogen and progestin, including that estrogens and progestins should not be taken to prevent memory loss, heart disease, heart attacks and/or strokes. Although these drugs are helpful in alleviating symptoms of menopause, women are urged to discuss options with their physicians and weigh the risks prior to consumption. Recognizing that for some women drug therapy is the most effective means for controlling hot flashes and symptoms of vulvar and vaginal atrophy, FDA has approved lower doses of the drugs for these purposes. This action was criticized by Representative Burton.

Due to these somewhat negative outcomes from WHI, the National Center for Complementary and Alternative Medicine at NIH is considering botanicals such as soy, black cohosh, and red clover to mitigate symptoms of hot flashes, osteoporosis, and cognitive and affective problems. The FDA, the women's health component of the Department of Health and Human Services, and the National Institute of Aging are all involved in developing alternatives to address these health issues.