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
"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
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.
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 www.clinicaltrials.gov.
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.
Project officer Dr. Jacques Rossouw of NHLBI called the archive
of refrigerated samples "an enormously valuable resource.it 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."