Women's Health Initiative Estrogen
Study as Reported in the Philadelphia Enquirer.
This article outlining the recently halted Women’s
Health Initiative (WHI) estrogen study provides a solid overview of
the preliminary results. Actual data from the halted WHI estrogen
study will likely appear in April.
We would like to bring attention to the fourth paragraph from the
bottom if this article, quoting a critic of the WHI estrogen study. Of
the WHI estrogen study, Harvard University professor of obstetrics and
gynecology Alan M. Altman is quoted as saying, "...to tell us after
spending $650 million that there is an increase in stroke and blood
clots on oral estrogen, we’ve known that for 35 years!"
Ask the typical woman using synthetic estrogen if her doctor made her
clearly aware of the stroke and blood clot dangers of oral estrogen.
Maybe it was worth $650 million to make the information about the
life-threatening dangers of synthetic estrogen clearly available to
women.
The Philadelphia Inquirer, March 3, 2004
Increased stroke risk prompts NIH to halt estrogen trial.
PHILADELPHIA - (KRT) - Eighteen months after a landmark government
study found that long-term treatment with the hormones estrogen and
progestin is clearly harmful to postmenopausal women's health, the
study has found a much cloudier picture for women who take just
estrogen.
So cloudy, in fact, that the National Institutes of Health on Tuesday
released only a partial, preliminary report, without actual data. It
suggests estrogen therapy has no effect on heart disease and breast
cancer risk, reduces hip fracture risk, and raises stroke risk.
The lack of a link between estrogen and breast cancer was a pleasant
surprise, researchers said, given that there were eight added breast
cancer cases a year for every 10,000 women in the estrogen-progestin
trial.
Nonetheless, the small increase in strokes prompted the NIH to halt
the estrogen trial about a year early, after following women taking
the drug or placebo for eight years. The NIH said the stroke increase
"is similar to what was found" in the estrogen-progestin study, or 8
more strokes per year for every 10,000 women taking hormones.
"The NIH believes that an increased risk of stroke is not acceptable
in healthy women in a research study," the institute said in a
statement. "The NIH has determined that the results would not likely
change if the estrogen trial continued to its planned completion in
2005."
Complicating the research was the fact that about half of the 10,700
women who enrolled in the estrogen trial have dropped out. Many quit
in alarm after estrogen-progestin study found that the drug
combination increases the risk of breast cancer, heart attacks,
strokes, dangerous blood clots in the lungs and legs, abnormal
mammograms and dementia, while reducing only two health risks, hip
fractures and colon cancer.
Both the estrogen-progestin and estrogen-only trials are part of the
Women's Health Initiative, a rigorous, 15-year-long, $650 million,
federal study designed to test the prevailing but unproven belief that
taking hormones for decades is healthful, especially for women's
hearts. (Women who have had hysterectomies do not need to take
progestin, which keeps estrogen from overstimulating the uterine
lining.)
The WHI was never intended to evaluate short-term hormone use for
approved purposes - relieving menopausal hot flashes or vaginal
dryness. However, a new conservatism has reshaped all hormone
guidelines, with medical societies and the Food and Drug
Administration urging women seeking menopausal relief to use the
lowest dose for the shortest time possible, and to view estrogen as a
last resort for osteoporosis prevention.
NIH advisers who were monitoring the estrogen study for signs of
unacceptable risks were divided over whether to stop it prematurely.
"In terms of whether I agree with the decision (to halt the study),
I'd like to wait until I have all the data," said Stanford University
professor of medicine Marcia Stefanick, chair of the WHI steering
committee.
A detailed analysis, including data on mental function and dementia,
will be published in a journal, probably in April, WHI director
Barbara Alving said Tuesday during a press briefing. She and WHI
project officer Jacques Rossouw repeatedly deferred questions about
specific findings.
The WHI used the nation's leading estrogen and estrogen-progestin
brands, Premarin and Prempro. The drugs were donated by Wyeth
Pharmaceuticals of Madison, N.J.
Tuesday, the company said the latest findings reinforce the use of
estrogen for its approved purposes. (The company also noted that it
now makes its hormone products in lower dosages.)
But the great hormone debate is far from settled.
Critics of the WHI were quick to argue - as they have for 18 months -
that different hormone formulations, absorbed through the skin, are
beneficial for longterm use, even though rigorous, placebo-controlled
trials have not proven this. They also contend that most women in the
WHI were long past menopause, so the results should not be
extrapolated to perimenopausal women.
"It's a study that gives us information, but not about the patients we
treat," said Alan M. Altman, a Harvard University professor of
obstetrics and gynecology. "And to tell us after spending $650 million
that there is an increase in stroke and blood clots on oral estrogen,
we've known that for 35 years!"
"They can say that, just the way they used to say hormones are good
for protecting women's hearts," said WHI researcher Henry R. Black,
chair of preventive medicine at Rush University Medical Center in
Chicago. "I don't think they're on solid ground."
But even WHI researchers say many questions remain, including whether
the bad cardiovascular effects of hormone therapy are linked to a gene
defect or blood protein.
"We've been looking high and low for that protein and we haven't been
able to find it," said WHI researcher Lewis Kuller, a professor of
public health at the University of Pittsburgh. "The best message at
this time is: We have much better drugs (than hormones) for first-line
prevention of diseases.
© 2004, The Philadelphia Inquirer.
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