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Vol. LVIII, No. 6
March 24, 2006

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WHI Lauded Despite Its Contrariness

On the front page...

Science is just as valuable to society when it throws convention under the bus as when it confirms received wisdom said a number of health officials at NIH's recent 2-day celebration of the Women's Health Initiative.

The WHI, initiated in the early 1990's by then NIH director Dr. Bernadine Healy, followed 161,808 women over 8 to 12 years in a multicenter effort to learn more about how postmenopausal women age, and is not over yet. But it has overturned established tenets on the usefulness of hormone replacement therapy, the benefits of low-fat diet in preventing cancer and the effect of calcium and vitamin D on avoidance of bone ailments.


  NHLBI director Dr. Elizabeth Nabel

"The Women's Health Initiative has been a landmark event in how to think about long-term studies in medicine," said NIH director Dr. Elias Zerhouni. "It has proven that good science is not beholden to dogma — it brings truth, and it can be disturbing." Acknowledging that the study's conclusions have been controversial, he argued, "If there had been no study at all, it would have been flawless."

As NIH prepares to launch a major initiative this spring that will encourage Americans to participate routinely in clinical trials, Zerhouni called the WHI a harbinger of a new way of doing medicine. "This is the beginning of a long-term process," he said. "The nation needs to come around and understand the concept of large studies that affect millions of lives, and whose real-time collection of data" can result occasionally in sudden and unexpected changes in medical practice.

"I'd like to see a real evolution of our thought processes about how best to use the new methodologies — proteomics and genomics, for example — to move medicine forward. How do you keep that momentum," he asked, "and how do you enlarge it?" He called the WHI an exemplar of "how our country can better learn so that dogma does not dominate — the truth dominates."

NIH director Dr. Elias Zerhouni called the WHI a harbinger of a new way of doing medicine. Former NIH director Dr. Bernadine Healy, now a medical editor at U.S. News & World Report, said the WHI was not so much a study of older women as a frank look at women “in their second prime.” ORWH director Dr. Vivian Pinn lauded the many visiting participants in the WHI, whose involvement defied initial doubts about the study’s ability to draw subjects. The participants were honored with roses.

The WHI still has 5 years to go in an extension phase and is now directed by NHLBI director Dr. Elizabeth Nabel, who declared that

A Snapshot of the WHI

One of the principal designers of the Women's Health Initiative was Dr. William Harlan, former NIH associate director for disease prevention who is now retired and a consultant to the National Library of Medicine's web site Referring to a popular American film, he called the WHI "a Field of Dreams — build it and they will come."

While the WHI extension study is slated to continue until 2010 under the auspices of NHLBI, the main part of it took place between 1993 and 2005. It involved more than 1,000 investigators and staff at 40 clinical centers in the U.S.

There were three controlled clinical trials (diet modification, hormone trial, calcium and vitamin D) that enrolled a total of 68,133 women, and a large observational study that recruited 93,676 women. Participants were ages 50-79.

On campus, 160 NIH scientists and staff were involved in the WHI, from 16 institutes and centers. "I'd like simply to say, 'Well done!' to all those individuals," Harlan said.

her institute "is committed to the future of the WHI. We are very keen to understand the mechanisms underlying our findings." In addition to enormous amounts of yet undigested data, the study collected many thousands of blood, DNA and other specimens that can now be analyzed by techniques more sophisticated than the initial WHI could have envisioned. "We are especially excited about the genetic, genomic and proteomic components of the study. This is the close of chapter one, and we're excited about the start of chapter two," Nabel said.

Project officer Dr. Jacques Rossouw of NHLBI called the archive of refrigerated samples "an enormously valuable may equal or even surpass what we've learned from the WHI."

Former NIH director Healy, now a medical editor at U.S. News & World Report, said the WHI was not so much a study of older women as a frank look at women "in their second prime." Since the study recruited one out of every 200 women in the age range 50-79 in the U.S., she said the WHI represented "really a third women's suffrage movement.It turns out we are different from men — we are not the same."

More than two-thirds of the women who participated in the WHI were overweight or obese at the time of recruitment, noted Dr. T. David Curb, a principal investigator from the University of Hawaii. Weight problems "are among the biggest challenges to the health of American women." More than a third of the women also had high blood pressure, he said.

Reviewing more than half a dozen key facets of the study, including its diverse population, its statistical authority, its provision of answers within its subjects' lifetimes and its integrated view of the whole woman, not just distinct body parts, Healy said the WHI revealed "something important — reality is sometimes complex. Sometimes simplicity is false.

"There are many mysterious findings still to be explored," she said. Quoting poet W.B. Yeats, she called it "a terrible beauty," but also said "it's a gift that women are sharing with their daughters, and that those daughters will share with their daughters."

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