Maturing of women's health: The success of a decade-long clinical test project

The Women's Health Initiative was launched in 1991 in an effort to gain insight into the health issues faced by older women. It has achieved much more.

By Victoria Stagg Elliott, AMNews staff. Dec. 2, 2002.

In 1991, Susan Hendrix, DO, associate professor of obstetrics and gynecology at Wayne State University School of Medicine in Detroit, received the offer: Would she like to be her institution's principal investigator for the Women's Health Initiative?

She jumped at the chance.

At the time, naysayers asked her why she was bothering. Hormone replacement therapy was obviously good for women. And why mess with a randomized clinical trial so large it appeared undoable?

But she had her reasons.

"I was a woman aging, and I wanted answers," said Dr. Hendrix, who turned 50 last month, bringing her within the age range of the study group. "This was different from anything that came before it because it was the kind of study that should change clinical practice."

Since its inception, the National Institutes of Health-sponsored WHI has done exactly that. This multicenter study with more than 160,000 female participants has not only changed how women fit into the medical research enterprise, but also challenged conventional wisdom.

Last summer's announcement regarding the risks of HRT -- one of the initiative's study arms -- is a powerful example. But this is only one aspect of the WHI, and those involved in the continuing research say the emerging body of knowledge will have a place in the exam room for a long time to come.

When Bernadine Healy, MD, the first female director of the National Institutes of Health, launched the WHI in 1991, clinical trial experts said it couldn't be done -- that recruiting such a large number of women to participate in the study was impossible. Women weren't interested in clinical trials. And even if they did sign up, they weren't likely to follow through. [...]