In lieu of an abstract, here is a brief excerpt of the content:

c h a p t e r e l e v e n Weighing the Benefits and Risks of HRT Estrogen, Heart Disease, and Breast Cancer On a summer morning in 1991, three dozen people gathered in the Parklawn Building on the campus of the Food and Drug Administration in Rockville, Maryland , for a two-day workshop on the current status of combined hormone replacement therapy. This meeting was part of the regular quarterly schedule of the FDA’s standing advisory committee on fertility and maternal health drugs. What was unusual was that this single subject occupied the entire two-day session; ordinarily the agenda addressed several topics of women’s health care. The participants included the thirteen members of the advisory committee (nine outside consultants and four FDA employees) plus about twenty physicians, scientists, and representatives of various professional societies and health care advocacy groups scheduled to testify, some of whom had been invited and others who appeared on their own (or their association’s) initiative. The next day, another fourteen individuals (eight medical researchers and six pharmaceutical company representatives) o√ered testimony to the committee. The mandate to the committee was twofold. One goal was of immediate practical interest, especially to the drug companies: to decide whether to recommend FDA approval of a combination drug product for menopause and postmenopause (containing both an estrogen and a progestin). The second objective—to determine whether enough information existed to support the recommendation of long-term hormone replacement therapy—was ostensibly intended to justify the result of the first. But in a larger sense, it reflected the phoenixlike rise of estrogen in the past decade. No longer limited to the short-term relief of hot flashes during menopause, estrogen and its new partner, progestin, were once again being considered as a lifelong therapy for the prevention of the diseases of aging. The stimulus for this reevaluation of hormone replacement therapy was the growing body of evidence suggesting that estrogen use reduced the risk of car- 206 The Estrogen Elixir diovascular disease in postmenopausal women. In the 1980s, while some researchers were building the case for estrogen as a preventive treatment against the development of osteoporosis, others were investigating the cardio-protective e√ects of estrogen. By 1991, more than twenty case-control and cohort studies reported a relationship between estrogen use and lower levels of heart disease. Because heart disease was the number one cause of death for American women, this correlation had the potential to tip the scales decisively in favor of the widespread prescription of long-term HRT. The pool of potential estrogen users would be greatly expanded, because the number of women at risk for cardiovascular disease was much larger than the number of women at risk for osteoporosis. The ability to reduce the e√ect of both of these ‘‘silent killers’’ raised the profile of estrogen as an important preventive medication, one that women could take to preserve their health, by protecting their bones and their hearts. These long-term benefits of estrogen also changed the way some people thought about menopause. According to one FDA investigator speaking during the workshop, ‘‘menopause has now developed the concept of being a ‘deficiency disease.’ ’’ She went on to pursue the comparison with another endocrinopathy: ‘‘If women can actually have their cardiovasculature [sic] protected and their bones protected by long-term use of estrogens, some would argue, are we not dealing with a deficiency disease of estrogen akin to that of hypothyroidism? Women or men whose thyroids stop working are prescribed thyroid hormone replacement for life. Why should not women, if estrogen deficiency is analogous ?’’∞ Could this really be true? Had some in the medical community returned to the characterization of menopause as a disease, promulgated by men like Robert Wilson and Allan Barnes thirty years earlier? While the image of menopause as estrogen deficiency circulated widely in the 1990s, the simple remedy of estrogen replacement was complicated by the risk of cancer, not only of the endometrium but also, and more ominously, of the breast. Breast cancer came to the attention of the American public in 1974, when Betty Ford, the wife of President Gerald Ford, and Happy Rockefeller, the wife of vicepresident -designate Nelson Rockefeller, were diagnosed within a month of each other. In the 1980s, advocacy groups such as the Susan J. Komen Foundation, with its enormously popular Race for the Cure, held annually in dozens of cities around the...

Share