Hormone Replacement Therapy is in trouble once again
Subject: Long term placebo controlled study of hormone replacement therapy
called off because of increased cancer, stroke and heart disease risk.
Here is the article from today's New York Times that many of you have heard
about on the news. The full results of the study will not be published
until July 17th. Expect ongoing news features about this over the next few
weeks. Though these results are not unexpected (early reports while the
study was in progress suggested this would be the outcome), they are a
major about face from the advice many doctors have given their patients
over the years.
Other studies have already disproved the notion that hormone replacement
therapy protected women from heart disease.
If you own stock in Premarin, perhaps it is time to sell.
New York Times July 9, 2002
Citing Risks, U.S. Will Halt Study of Drugs for Hormones
By GINA KOLATA
A large federal study of hormone replacement therapy in postmenopausal
women was abruptly halted, researchers say, because the drugs caused a
slight but significant increase in the risk of invasive breast cancer.
An estimated six million women take the drugs, estrogen and progestin, to
replace the hormones lost at menopause. The hope was that the drugs would
not just relieve the hot flashes, night sweats and vaginal dryness that can
plague women at menopause but that over all they would also improve women's
health. That, the investigators report, did not happen.
The results of the study have been long awaited since it is the first and
only large one to compare the effects of hormone replacement therapy with
placebos in healthy women.
The directors of the study, known as the Women's Health Initiative, sent
letters to the study's 16,000 participants, which they should receive
today, telling them to stop taking their medications.
The data indicate that if 10,000 women take the drugs for a year, 8 more
will develop invasive breast cancer, compared with 10,000 who were not
taking hormone replacement therapy. An additional 7 will have a heart
attack, 8 will have a stroke, and 18 will have blood clots. But there will
be 6 fewer colorectal cancers and 5 fewer hip fractures.
The study was to continue until 2005, said Dr. Jacques E. Rossouw, who is
its acting director. For the first few years that the women took the drugs,
they were at no increased risk of cancer, heart disease or blood clots, and
the study did not address the benefits of using the drugs for a short
period to relieve the symptoms of menopause.
The decision to end the study came on May 31, in a periodic look at its
accumulating data by an expert panel, the data safety and monitoring board.
Suddenly, Dr. Rossouw said, after women had taken the drugs for an average
of 5.2 years, the data had crossed a line. "The breast cancer risk exceeded
the predefined boundary for safety," he said.
While cautioning that the danger to an individual woman is tiny, the study
investigators say that over all the drugs' risks exceed their benefits.
The study did not address the question of estrogen alone. Women who have
had hysterectomies take estrogen by itself - progestin is added only to
prevent estrogen from causing cancer of the uterine lining, and doctors do
not prescribe estrogen alone for women with uteruses.
The risks and benefits of estrogen alone are under study in a second
clinical trial, of 11,000 women, being conducted by the Women's Health
Initiative. That study is continuing because there is no evidence so far
that the drug's risks exceed its benefits. For now, Dr. Rossouw said, with
just estrogen, "the risks and benefits remain unclear," but "we can say
there is no indication of an increased risk of breast cancer."
The findings on the hormone combination will be published in the July 17
issue of The Journal of the American Medical Association. The journal
planned to release them this morning so the data would be available to
doctors and women at the same time as the women in the study received their
letters telling them to stop taking the drugs. But Cox News Service
published the story last night.
Now, with the cessation of this large study, many observers said, the tide
may be turning. Hormone replacement therapy, once thought to be a way for
women to remain forever young, protect them from heart disease and from
osteoporosis, and generally leave them healthier than they would otherwise
be, may be fast losing its allure. Some worry that the news will be seem so
frightening that women will overreact.
"This is a bombshell," said Dr. Wulf Utian, executive director of the North
American Menopause Society, a nonprofit group that has long advocated
hormone replacement therapy for women with a clear reason for taking it,
like hot flashes or bone loss. "I think there is a real danger of panicking
literally hundreds of thousands, if not millions, of women."
Dr. Utian added that he advised women to discuss the findings with their
doctors before deciding to throw away their hormones.
Dr. Suzanne Fletcher, who is professor of ambulatory care and preventive
medicine at Harvard Medical School, also emphasized that there was no
reason to panic.
Dr. Fletcher said she was disappointed by the conclusion but not surprised
by it. The study's directors had told the women in the study twice before,
in 2000 and in 2001, that those taking the drugs seemed to have slightly
more heart attacks, blood clots and strokes than those taking placebos,
although the risks were not enough to stop the study.
"Even though I was upset by these results, that's the reason you do
clinical trials," Dr. Fletcher said.
Now the question is, what should women do?
Dr. Victoria Kusiak, who is vice president of clinical affairs and North
American director at Wyeth, the largest maker of the hormones, emphasized
that there were no other effective treatments for the symptoms of
menopause. While some women are not bothered by those symptoms, others are
miserable, Dr. Kusiak said.
"Eighty-five percent of women do have symptoms," she said. "The hot
flushes, the night sweats, are not just annoying - they can interfere with
Dr. Kusiak said 9 in 10 doctors cited relief of such symptoms as a reason
they prescribed the drugs. "For the longer term, particularly beyond the
four-year point, we would advise that it has to be an individualized
risk-benefit analysis," she said.
Dr. Deborah Grady, who directs the University of California at San
Francisco/Mount Zion Women's Health Clinical Research Center, said she
would urge most women taking the hormone combination to stop.
"This is a dangerous drug," Dr. Grady said.
Many women, she said, can simply stop cold. If there is no return of
menopausal symptoms, then great, she said, but if the symptoms return and
are intolerable, the woman can take the hormones for another year and then
try again to stop.
But, Dr. Grady said, if a woman has taken the hormones for four or more
years, the time when her risk of breast cancer emerges, she should try
harder, tapering her hormone dose until she can do without them.
Dr. Nannette Wenger, a cardiologist at Emory University, said the only
reason she could see for taking the hormone combination was for the
temporary relief of severe symptoms of menopause. But, Dr. Wenger said, "I
would not tell anyone to start taking it."
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