…Back to Menopause
Corfman tells an anecdote about Premarin. "It's an old drug that goes back to the '40s," he says. Apparently chemists had to formulate a heavy varnish coating to keep the pills from dissolving too soon in the stomach. Otherwise, "when a woman burped, she might detect what the drug was made of," Corfman says.
With promises of relief from menopausal symptoms (see sidebar) and a fountain of youth to boot, menopausal women began taking pills and suffering fewer hot flashes, crying jags, and other symptoms.
Then a glitch occurred. Two major studies, published in 1975 in the New England Journal of Medicine (NEJM), confirmed that estrogen supplements could increase by 14 times a woman's risk of cancer of the lining of the uterus–the same cancer that had killed Seaman's aunt 16 years earlier. Drug sales fell. In response, Seaman explains, physicians and pharmaceutical companies crafted another strategy–combining estrogen with another hormone, progesterone, thus producing what is now known as "hormone replacement therapy" (HRT). Progesterone generates a menstrual period and thereby counters the increased cancer risk of estrogen supplementation used alone.
By the 1980s, Seaman says, doctors were singing the praises of hormones for postmenopausal women. Based on a dozen studies that showed the benefits of HRT, physicians, backed by drug companies, advocated that it would also lower the risk of heart disease, osteoporosis, and potentially Alzheimer's disease. The companies did receive approval from the FDA to promote HRT for the prevention of osteoporosis, as well as menopausal symptoms, Seaman says, but never for the prevention of heart disease, stroke, or Alzheimer's.
One NEJM study, conducted on 122,000 nurses and published in 1985, showed that estrogen could halve the risk of heart disease. Yet, in that same issue, a second equally powerful study predicted that hormones would increase, and, in fact, double a postmenopausal woman's risk of heart disease, particularly among women who smoked.
The latter, however, was "the road not taken," says medical oncologist Rowan Chlebowski of the Harbor UCLA Research and Education Institute in Torrance, California.
Seaman says it was no mystery; drug companies and the medical community suppressed the negative in favor of the positive results. Em-ploying what Seaman views as "science by press release," Wyeth-Ayerst, backed by other HRT providers, asked the FDA in 1990 to approve Premarin as a preventer of heart disease. The NWHN objected to the request, pointing to the negative studies, including those demonstrating that estrogen-related drugs could aggravate the risk of breast cancer.
Not long afterward, the NIH started the Women's Health Initiative (WHI), a large clinical trial on women's health that involved approximately 16,600 postmenopausal women randomly assigned to take either sugar pills or the most widely prescribed estrogen and progesterone combination, Prempro. This was by far the largest drug study of this type ever undertaken. Presumably confident of a positive outcome, Wyeth provided pills for the trial for free.
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