What a long, strange trip it's been
An insider's take on the Women's Health Initiative
By SUSAN IPAKTCHIAN
It’s been a 15-year roller coaster ride, but Marcia Stefanick
isn’t ready to hop off just yet.
The largest-ever study of postmenopausal women’s health — the
paradigm-smashing, controversy-generating Women’s Health Initiative — wraps
up in February 2006. Stefanick, PhD, professor of medicine at the Stanford
Prevention Research Center, served as chair of the WHI steering committee
through most of the project — a post to which she has been continually
re-elected by the 39 other principal investigators.
Although the WHI had components that examined the health effects of
a low-fat diet and of calcium supplements, most people associate it with
one thing: hormone therapy. WHI studies published in 2002 and 2004 essentially
blew up the conventional wisdom about hormone therapy and raised concerns
among a few medical organizations that remain critical of the findings.
“It’s hard to keep going and have people attack you,” says
Stefanick. “But I’m proud that the practice of prescribing
hormones to postmenopausal women and to women with heart disease has
been stopped because WHI gave us evidence it won’t benefit them.”
Hormones relieve hot flashes and other symptoms of menopause. But observational
studies over the years had also suggested that hormones protected women
against heart disease, weak bones and dementia. “Hormones were
being prescribed to women who had very mild or even no menopausal symptoms
as a way to prevent the diseases of aging, but this was being done without
having the data to prove that it worked,” Stefanick says.
In 2000, four years of data from the WHI trial showed that the combination
of estrogen and progestin increased the participants’ risk for
heart attacks and strokes as well as blood clots. By the spring of 2002,
increased risks for breast cancer were also noted. At that point, officials
decided to halt the estrogen-progestin portion of the trial.
“We knew that once the women were informed, there were going to
be all kinds of ‘What’s going on?’ questions and the
scientific community had to have the data,” Stefanick says. And
so she spent the next five weeks in a flurry of activity — collaborating
on writing the scientific paper and drafting a letter to all WHI participants
in addition to assisting in plans for informing the media.
The July 2002 announcement generated shock waves as anxious women inundated
their doctors with questions as to whether they should continue taking
their hormones — regardless of whether they were past menopause,
as were the WHI participants. Stefanick acknowledges that “we didn’t
do a good enough job of separating treatment of menopausal symptoms from
the effects of menopausal hormones on diseases of aging.”
With hormone therapy being viewed in a harsher light, the decision in
2004 to halt the estrogen-only arm of the trial for similar reasons caused
less of a stir. But many menopausal women remain confused about whether
to take hormones. “Our understanding of menopause is much too primitive
and largely wrong,” Stefanick says. Other questions remain for
postmenopausal women as well, and that’s why Stefanick will continue
as chair of the five-year extension study. “Some women have said, ‘Well,
if I’ve been taking hormones and I already have a higher risk of
heart attack, why don’t I just keep taking them,’ ” she
says. “They want to know, and I think we owe it to them to learn
more.”
Let the next ride begin.
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