Sorting
Through the Confusion Over Estrogen
By JANE
E. BRODY
 usan
McGee of Bethesda, Md., and Jane Quinn of Brooklyn were not planning
to take hormones at menopause. But after many months of sleep
disrupted nightly by drenching sweats and changes of bedclothes,
they gave in.
Ms. McGee said she became so sleep deprived that she could hardly
do her job and feared falling asleep while driving. Ms. Quinn found
it increasingly difficult to concentrate on her work, became
uncharacteristically irritable and began to think she was losing her
mind. The hormones quickly restored their sleep and their sanity.
|
Advertisement
|
 |
|
These two are among millions of American women near, at or beyond
menopause who are asking why so much remains unknown about a drug
that has been on the market for 60 years, and what they should make
of new findings that are surprising and disappointing proponents of
hormone replacement therapy, or H.R.T.
Estrogen — sold today in myriad forms with and without a
companion hormone progesterone — was originally marketed to counter
the annoying and sometimes disruptive symptoms of menopause.
But in the decades since its initial approval by the Food and
Drug Administration in 1942, estrogen had acquired a reputation as
an antidote to many of the illnesses and afflictions of aging.
Scores of observational and case studies supported this view, and
drug makers and their advertising agencies embraced it with
enthusiasm. By 2000, the therapy had become a $2.75 billion
business.
The benefits of temporary use of estrogen to weather disruptive
menopausal symptoms have not been challenged. Nor is there concern
about vaginal applications of estrogen to counter the atrophy that
can destroy the joy of lovemaking.
Rather, the focus is on how long a woman can safely stay on
hormone replacement that is taken orally or by skin patch and what
effects, good or bad, the long-term therapy may have on her health.
Most of the data on the presumed benefits of hormone replacement
come from observational studies of women who chose to take it or
not. Although in analyzing their findings, researchers tried to
account for differences between these groups of women, there is
always a chance that factors not considered could have influenced
the results, especially since women who choose to use hormones tend
to have healthier habits over all and are likely to be followed more
closely by their physicians.
To establish facts required a large clinical trial in which women
were randomly assigned to take hormones or a look-alike placebo,
with neither the women nor their doctors knowing who was on what
regimen until the study was completed. Major new findings from such
clinical trials have seriously challenged estrogen's image as a
preventive of chronic disease, raising doubts about the benefits of
lifelong hormone replacement.
First, the Heart and Estrogen/Progestin Replacement Study, known
as HERS, found that the hormone combination did not prevent heart
attacks and cardiac deaths in women who already had heart disease.
Initially, in fact, women who took the combination actually had
slightly more heart problems than women given dummy pills.
In July, the Women's Health Initiative, or W.H.I., abruptly ended
a study of the same drug combination, marketed as Prempro, in
younger and initially healthy postmenopausal women. This
well-designed clinical trial found small but statistically
significant increases in health risks — including breast cancer,
heart attacks, strokes and blood clots — that outweighed the
benefits, a lower risk of hip fractures and colon cancer.
"W.H.I. changed the way we think about estrogen; this is not a
drug to be used for prevention," said Dr. Bruce Ettinger, a longtime
researcher on hormone replacement at the Kaiser Permanente Medical
Care Program in Oakland, Calif. "Giving the drug to a lot of healthy
women is not the right thing to do."
He and others suggest that women taking it to relieve severe
menopausal symptoms should use the lowest possible dose and taper
off as soon as possible.
These findings are of grave concern to the more than 40 million
women in the United States at menopause or beyond it and 20 million
others who will reach it in the next decade.
Hormone replacement therapy has soared in popularity in recent
decades after observational studies reported that it might greatly
reduce the risk of heart disease and osteoporosis and might even
protect against Alzheimer's disease and the mental decline
associated with aging.
When added to the widely held belief that estrogen could prevent
wrinkles, preserve sexual vigor and maintain a youthful distribution
of body fat, the claims made the therapy hard to resist for women
willing to take a pill every day or apply a skin patch every week.
Now, as the more precise studies begin producing data, claims for
estrogen are being scaled back to the only two approved indications
for treatment: preservation of bone density and the original reason
for marketing this hormone, to relieve the hot flashes, night sweats
and vaginal dryness and atrophy that disturb about half of American
women to varying degrees when ovarian function slows to a near halt.
These, in fact, are the only benefits manufacturers are permitted
to claim in advertising their estrogen products.
If the findings concerned only the therapy's benefits, the 20
million women already on hormone replacement and the 1.4 million who
reach menopause each year would face a relatively simple choice. But
the recent findings that the therapy may bring risks vastly
complicate things for women who must now decide whether these risks
outweigh benefits already known and those yet to be established.
The pioneering Women's Health Initiative was not begun until
1993, amid rising concern about the relative lack of studies of
women's health problems and pressure from Dr. Bernadine Healy, who
was then the director of the National Institutes of Health. Today
many women wonder why this kind of research did not take place much
earlier.
Forum: Join a Discussion on Women's Health
|
