| A Bombshell to Older Women and Gynecologists |
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By Ulysses Torassa
San Francisco Chronicle
July 15, 2002 Last week's announcement that the estrogen-progestin pills taken by six million American women are doing more harm than good came as a bombshell both to older women and to gynecologists who have long believed in the health benefits of the hormone-replacement therapy. Although negative news about the therapy has been trickling out for the past few years, it wasn't until Tuesday's announcement by the Women's Health Initiative about combination hormones that the evidence became irrefutable. (An additional eight million women who have had hysterectomies take estrogen alone, and the results from that part of the study aren't yet in.) Meanwhile, some have asked why it has taken so long for the medical community to get definitive answers about a therapy that's been widely used since the 1970s. The risks uncovered are small for individual women -- an extra eight cases of breast cancer, seven heart attacks and eight strokes per year in 10,000 women on the therapy. But when spread over a large population, the risks became quite significant, leading researchers to halt the study three years early to protect participants from further harm. But the relatively small risk to individuals is one reason experts say it took time for the pattern to emerge. "Lots of us -- including myself -- thought at the time that it was definitely going to work. We just didn't know how well," said Dr. Deborah Grady of the University of California-San Francisco, a leading authority on hormone-replacement therapy. "It's still pretty surprising that it doesn't reduce the risk for heart disease, and astonishing that it actually increases the risk." Dr. Marcia Stefanick of Stanford University, who helped put together the study, said in retrospect that it seems people embraced the positive findings and discounted the evidence of problems. "It was such a long-standing belief that hormones were beneficial that all data got interpreted as proof of a benefit, and these other things came out only later," she said. Some women's-health advocates, such as the National Women's Health Network, have pointed the finger at drug companies for pushing hormones before all the evidence was in. Hormone-replacement therapy got its initial boost from the best-selling 1966 book "Feminine Forever," in which Dr. Robert Wilson likened estrogen replacement in menopausal women to giving insulin to diabetics -- a restoration of a natural hormone to counteract a harmful shortage. Turns out that Wilson, who died in 1981, got the money to write the book from drug maker Wyeth-Ayerst, his son Ronald Wilson told The New York Times last week. Ronald Wilson also said the company financed his father's research foundation and sent his parents to speaking engagements about the book. Stefanick and Grady said the influence of pharmaceutical makers on medicine has clearly been problematic, but the picture is a bit more complicated. For one thing, Wyeth-Ayerst also paid for or supported with free drugs their two studies, which have essentially eviscerated hormone-replacement therapy's reputation. Furthermore, Grady said, Western cultural ideas about women and aging have also led many to embrace hormone replacement. "Even if Wyeth had never said a word, there is a lot of magical thinking among women and doctors about estrogen," Grady said. "If many people didn't believe that hormones keep women young, we'd probably think differently about it." Oddly, the first large trial of hormone-replacement therapy and heart disease was done on men in 1973. Researchers halted part of the trial early because those on estrogen were already getting more heart attacks. Many chalked up the results to the high dose used in the study and did not believe the results would apply to women. Also by the mid-1970s, doctors realized that women on estrogen therapy were more likely to get endometrial cancer. As a result, progestin was added to counteract those effects in women who still had a uterus. Meanwhile, as more women began HRT for relief from menopausal symptoms like hot flashes and night sweats, researchers began to notice that they also had lower rates of heart disease. "What they didn't focus on was that the estrogen users were healthier in general -- they were thinner, more physically active, less likely to smoke and went to the doctor more often," Stefanick said. Another confusing part of the picture came from scientists studying estrogen. They found that it had beneficial effects on the lining of arteries and on the ability of blood vessels to dilate. With the indirect evidence showing a cardiovascular benefit, doctors began urging women to consider taking it long-term, because heart disease is the leading killer of women. More studies were undertaken, but funding constraints meant they focused on intermediate markers such as cholesterol levels, rather than on heart attacks or strokes. The results were mixed but, again, seemed to provide enough evidence of a benefit to convince many doctors that the therapy remained worthwhile. Finally, in the mid-1990s, two randomized trials comparing hormone-replacement therapy and a placebo and looking at heart disease outcomes got under way. One led by Grady reported on July 3 that hormone-replacement therapy did nothing for women with heart disease. The Women's Health Initiative, which followed more than 16,000 healthy women, provided the final nail in the coffin Tuesday. Although there is now broad agreement that long-term use of hormone replacement therapy is not a good thing, doctors say it still has a place in the short term for relieving menopausal symptoms in women who are extremely uncomfortable. (Distributed by Scripps Howard News Service, www.shns.com.)
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