Just days before the ten year anniversary of the Women’s Health Initiative‘s (WHI) groundbreaking findings that hormone replacement therapy can cause serious health problems in otherwise healthy women (including an increased risk of breast cancer), MedPage Today reports that Dr. Wulf Utian, founder of the North American Menopause Society isn’t so sure. Claiming that the WHI’s findings have done more harm than good, Utian argues that the WHI’s conclusions are not supported by the evidence. Utian is calling for an independent panel to review WHI’s publications “to confirm whether there was irresponsibility that needs to be identified and admitted.”
The National Institutes of Health established the Women’s Health Initiative (WHI) in 1991 to address the most common causes of death, disability and impaired quality of life in postmenopausal women–namely heart disease, cancer, and osteoporosis. Budgeted at about $700 million, the unprecedented 15-year study is one of the largest preventive women’s health studies ever done in the United States. It has three major components: (1) a randomized controlled trial (RCT) of promising but unproven approaches to prevention; (2) an observational study to identify predictors of disease; and (3) a study of community approaches to developing healthful behaviors. In all the Initiative enrolled more than 160 thousand generally healthy postmenopausal women. At issue for Utian is the Initiative’s hormone trial.
The hormone trial involved two separate studies and aimed at clarifying the risks and benefits of hormone therapy, particularly its use in the prevention of cardiovascular diseases. The estrogen-plus-progestin study gave progestin in combination with estrogen to more than 16 thousand women between the ages of 50 and 79 who had an intact uterus. The estrogen-alone study gave only estrogen to 11,000 healthy postmenopausal women who did not have a uterus, and who had had a hysterectomy prior to the study. In both studies, participants were randomly assigned to one of two groups, either the group receiving the drug being studied, or the group receiving the placebo.
The estrogen-plus-progestin study was scheduled to run for eight years, but it was stopped early and abruptly (after only 5 years) because the risks outweighed the benefits. Compared to the placebo, the hormone group saw a reduction in hip fractures and colon cancer, but it also saw an increase in heart disease, stroke, pulmonary embolism, and breast cancer. The study’s Data Safety Monitoring Board (which is an independent advisory committee that regularly reviews study data and oversees participant’s safety) recommended that the trial be stopped. The findings confirmed earlier studies that found an increased risk of breast cancer among hormone replacement users with duration of use. This is important since it is the body of research rather than single studies that are necessary for developing protocols and health policy.
Clearly, there is a relationship between the use of synthetic hormone therapies and breast cancer even if the mechanisms are not fully understood. In 2002, when the findings from the Women’s Health Initiative estrogen-plus-progestin study came out, about 38 percent of postmenopausal women in the U.S. were using some type of hormone therapy drug. When the WHI findings hit the news, sales plummeted and breast cancer incidence rates also dropped. An article published in the New England Journal of Medicine attributed the sharp decline (6.7 percent) in breast cancer incidence in 2003 to be “temporally related to the first report of the Women’s Health Initiative and the ensuing drop in the use of hormone-replacement therapy among postmenopausal women in the United States.”
Given the body of research linking synthetic hormone therapy drugs and breast cancer, I’m confused by Dr. Utian’s statement that the WHI’s conclusions are somehow out of proportion or fail to be supported by evidence. He has himself acknowledged both that the “long term use of hormone therapy drugs may increase incidence of breast cancer” and that “HRT is not the only treatment against menopause.” A position statement from the organization he founded, the North American Menopause Society, also acknowledges an increased risk of breast cancer incidence and mortality with increased duration of hormone therapy drugs as well as a lack of safety data supporting the use of estrogen therapy in women who have already been diagnosed with breast cancer.
I hope Dr. Utian will join the National Women’s Health Network for two briefings on the Women’s Health Initiative to be held on Monday, July 9th in Washington, DC to get a deeper understanding of the Initiative’s findings and implications. The two panels will include leaders in clinical research, women’s health, evidence-based health care, and consumer advocacy:
If you’re in Washington DC, you might also want to drop by to hear them “set the record straight on the Women’s Health Initiative.” Click here to RSVP.
For more information on the politicization of menopause, check out Liz Scherer’s analyses on Flashfree: Not Your Mama’s Menopause.