Defining the Future
The story behind the landmark women's health study that is creating exciting breakthroughs
To get Congress to approve funding of the project, Healy and her staff had to nail down exactly what the initiative would tackle. Diabetes, which wasn't yet the epidemic it is today, was passed over because important trials on the disease were already in progress. Antioxidant research was also already in the works. Lung cancer, a major killer of women, was rejected because research had already found effective prevention--avoid cigarette smoke and certain pollutants. At the time, it was common for doctors to prescribe hormones to prevent cardiovascular disease and a low-fat diet to stave off breast cancer. But there were no clinical trials to back the advice. Another piece of conventional wisdom that begged examination: Do calcium and vitamin D supplements--which women were popping like crazy--prevent hip and bone fractures?
Tasked with the job of running the WHI was Jacques Rossouw, an NIH gastroenterologist from Cape Town, South Africa, whom fellow researchers call the heart, brain, and soul of the WHI. But he fell short in one respect. "I'm gender impaired for a women's research program," says Rossouw. "The public face should be a woman. It's just good politics and good sense." So Rossouw has been working behind the scenes, while the title of director falls to a series of female scientists.
Convincing. Rossouw and other WHI leaders had to choose 40 principal investigators to run clinical trial centers at hospitals and medical centers in places like Miami, Boston, Honolulu, and Tucson, Ariz. Each investigator's task: Recruit 3,500 women and persuade them to stay the course for the duration of the study. Recruiting a racial and ethnic mix was a prime goal. That was a particularly difficult task, as Joan Johnson, 72, of Islip, N.Y., discovered. "I had been one of these people saying that we of African ancestry are not put in trials and tests, so when they said they were looking for women over 50, I put myself on the line," says Johnson. She had a hard time drafting participants from her church, clubs, and her old sorority. A few women cited the Tuskegee Syphilis Study, in which government researchers left the disease untreated in black men for 40 years. A history of exploitation and ethical lapses in minority health trials had also contributed to a culture of distrust within minority communities.
The WHI leaders went all out to enlist participants: Ads and stories were placed in local media, former Murder She Wrote star Angela Lansbury made public service announcements, and representatives were hired for door-to-door solicitation. Their most fruitful tack turned out to be direct mail; the second or third mailing often resulted in enrollment. "Our goal was to make sure every woman had heard about it at least two or three times before she got that letter," says Baylor's Hays.
The result? By 1998, the WHI had enrolled more than 160,000 women. The women were rigorously screened. All had to be past menopause and between the ages of 50 and 79 and had to commit to staying in the area for at least three years. Women who had had breast cancer were not eligible for any of the clinical trials. Those who had suffered a heart attack in the past six months were banned from the hormone trial, and women who were already on a very low-fat diet were not allowed to participate in the dietary modification study.
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