Defining the Future
The story behind the landmark women's health study that is creating exciting breakthroughs
The new research is sure to get another close look during this week's conference examining the future and legacy of the WHI. The findings are more complex than headlines would have you believe, say WHI investigators, and the nuances have yet to be explored. For example, women who took at least 80 percent of their calcium supplements had 29 percent fewer hip fractures than those on placebos. And perhaps down the road, future follow-up may reveal greater benefits to that low-fat diet. Still, some critics blame the WHI for creating confusion about women's most important health concerns. "When you have a study that is this big, the tendency is to think it's going to answer all of our questions--like a Santa Claus bag we should be able to keep reaching into," says Jennifer Hays, a WHI principal investigator at the Baylor College of Medicine.

Uncertainties. Given the paucity of medical research on women, experts say it's only natural that there are still so many uncertainties. In the past, researchers sometimes excluded women of childbearing age to avoid harming fetuses if the women became pregnant. And scientists also claimed men were easier to recruit and retain, that women were unwilling to participate, and that female hormonal cycles would skew results.
But in the early '80s, there was a growing consensus that those perceptions had to change. A few major studies galvanized the cause: the Multiple Risk Factor Intervention Trial, or "MRFIT," which set out to test cholesterol-lowering drugs in 15,000 men, and the Physicians' Health Study, which tracked 22,071 male doctors to examine aspirin's effects on heart disease. In both cases, researchers excluded women because heart disease was considered a men's disease--even though it was and still is the leading killer of women.
Such bias can translate into poor diagnosis and treatment of real women (story, Page 74). Julia Carvalho, for example, lost her mother to a heart attack at the age of 53. "I can remember doctors trying food fads to get her blood pressure down. Once she ate nothing but white rice," recalls Carvalho, now 85, of Carmichael, Calif. The mother of seven was worried about her own heart. But when she tried to learn more about diet or lifestyle changes that prevent heart disease, "every study I read about was a study made on men, not women."
In 1986, the National Institutes of Health began urging research applicants to include women in studies. But when the Congressional Caucus for Women's Issues asked for an evaluation three years later, little had changed. The report served as "a watershed moment that galvanized public opinion and spurred Congress to action," says Republican Sen. Olympia Snowe of Maine, then cochair of the caucus.
Around the same time, physician and former chairman of the research institute of the Cleveland Clinic Foundation Bernadine Healy (now health editor at U.S.News) was appointed the first female director of the NIH. She was in the eye of a perfect storm: Key policymakers and scientists were well aware of the research disparity, and a powerful bipartisan contingent in Congress was eager to support a feel-good women's health cause that had nothing to do with abortion or reproductive rights. Healy decided the time was ripe for a large-scale study of the diseases that beset older women.
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