As an expert panel described Monday at the George Washington University Hospital, the Women’s Health Initiative — a study created by the Department of Health and Human Services in 1991 to research major health problems in older women — created a firestorm 10 years ago and has been questioned ever since.

But among 10 facts for 10 years discussed by the panel, one stood out: “The WHI has saved thousands of lives by debunking conventional wisdom and allowing millions of women and their doctors to make key health decisions based on scientific evidence.

“In virtually every institution, important findings … have made people uncomfortable,” said Carolyn Clancy, director of HHS’s Agency for Healthcare Research and Quality. “You can’t do it alone as researchers; you need clinicians, advocates and policymakers behind you. The WHI showed us this is possible. What we need to do now is make sure this isn’t a one-hit wonder.”

“We were asked, ‘Didn’t this study just confuse women?’ I don’t know if you want to call a study confusing if it reveals new scientific data, just because it doesn’t show what you want.”

  • Vivian Pinn, formerly of NIH

Clancy and Vivian Pinn, former director of the National Institutes of Health’s Office of Research on Women’s Health, described WHI history and how its results have informed and improved the health of women over the last decade. On July 9, 2002, the institute found through case studies that estrogen-plus-progestin hormone replacement therapy to manage menopause increases a woman’s risk of breast cancer and heart disease. Since then, roughly 160,000 American women have avoided breast cancer with the aid of decreasing exposure to unnecessary menopause hormone therapies.

“We were asked, ‘Didn’t this study just confuse women?’” Pinn said. “I don’t know if you want to call a study confusing if it reveals new scientific data, just because it doesn’t show what you want.”

Among the WHI-centered conclusions championed by the panel:

  • A woman’s risk of heart disease and stroke increases during the first year of menopause hormone therapy use, and risks remain elevated up to five years after use.
  • The findings of WHI trials led the U.S. Food and Drug Administration to declare that hormone therapy drugs should not be prescribed for preventative cardiovascular health.
  • After being on combination hormone therapy for several years, women in the WHI study experienced a 29 percent increase in heart attacks, a 41 percent increase in strokes and nearly twice the risk of serious blood clots compared to women who did not take hormones.
  • Women aged 65 and over who had received hormone therapy experienced higher rates of dementia than those who did not.

The initiative continues to research for a better understanding of hormones and midlife women’s health, according to Clancy, an APHA member, who described the future of WHI as “an ecosystem of developing better research.”

“We collect all this data from patients and don’t use it,” she said. “We have the capacity to get to a point where we can collect real evidence… Gaps in knowledge are the key basis in transforming the entire U.S. health system.”

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