TIME: Almanac 1993/TIME Almanac 1993.iso/time/110890/1108991.000

Text File | 1992-08-28 | 7.3 KB | 143 lines

                Ç▒                                                            SELF & SOCIETY, Page 66

MEDICINE

A Perilous Gap


Many drugs are tested on men only, creating grave doubts for
female patients

By ANDREW PURVIS -- With reporting by Julie Johnson/Washington


    One morning two years ago, a 60-year-old woman in Madison,
Wis., asked her doctor what seemed like a simple question. The
patient had just reached menopause and wanted to know whether
she should start taking aspirin daily. She had seen newspaper
and TV reports claiming that the pills lower the risk of heart
attacks, and she knew such risks increase dramatically for women
after they stop menstruating. "My answer was dead silence," says
the woman's physician, Dr. Elizabeth Karlin, who teaches at the
University of Wisconsin medical school. A week later, after
scouring the literature, Karlin came to what she called an
"appalling" conclusion: the finding, trumpeted in some
newspapers as a lifesaver for everyone, was based entirely upon
research on men. "There were simply no data to say this was safe
for women."

    Karlin had discovered an information gap that may be
endangering millions of American women. A number of treatments
now recommended for men and women -- from cholesterol-lowering
drugs and diets to AIDS therapies and antidepressants -- have
been studied almost exclusively in men. Little hard evidence
exists about their efficacy or safety for women. The problem has
begun to concern doctors, patients and now lawmakers. In June
Congress's General Accounting Office released a report
condemning the National Institutes of Health (NIH) for failing
to promote studies that took adequate account of the
differences between the sexes. The Congressional Caucus for
Women's Issues, which commissioned the study, introduced a $237
million legislative package in July aimed at achieving "parity
in medical research." Said caucus co-chair Patricia Schroeder
of Colorado: "Doctors aren't getting the kind of guidance they
need when they try to prescribe for women."

    Medical testing done entirely with male subjects may be
adequate when a disease strikes women and men in the same way,
but a growing body of research shows that this is often not the
case. Some preliminary studies on depression, for example,
suggest that hormonal changes in many women may lead to a
premenstrual deepening of depression. Further research on
appropriate doses of antidepressants throughout the menstrual
cycle is needed, says Dr. Jean Hamilton, a Washington-based
neuropharmacologist, to determine if female patients are
getting adequate medication.

    Women's hearts also differ markedly from men's. Not only
does cardiovascular disease strike women later in life, but
blood cholesterol levels seem to play a somewhat different role
in female patients. Dr. John Crouse, a lipids researcher at
Bowman Gray School of Medicine in North Carolina, notes that
women seem to be less vulnerable than men to high levels of LDL,
the so-called bad cholesterol, and more vulnerable to low levels
of HDL, the "good" cholesterol. Diets that reduce both levels,
such as the one promoted by the American Heart Association, may
actually harm women, Crouse argues. The dearth of data on women
and heart disease may also have contributed to an alarming
problem: women are significantly more likely than men to die
after they undergo heart-bypass surgery. One reason, suggested
a study last spring, is that doctors are slower to spot serious
heart trouble in their female patients and slower to recommend
surgery.

    Many researchers complain that the billion-dollar federal
onslaught on AIDS has also underrepresented women. At a time
when women are the fastest-growing group afflicted by AIDS,
there are troubling uncertainties about whether treatments or
the disease itself are affecting women differently from men.
Some studies, for example, have suggested that women with the
virus die more quickly than men, and from a somewhat different
range of opportunistic infections. "Drugs are developed with
incomplete data on metabolic differences between the sexes,"
charges Congressman Henry Waxman, a major advocate for women's
health. "This is not a question of affirmative action. It is a
question of well-being."

    Why have women been excluded from so many studies? In the
case of heart disease, some researchers argue that it is too
difficult to find enough subjects with the condition, since it
develops later in women. Also, the hormone changes of the
menstrual cycle are thought to complicate research, raising
costs. Perhaps most important, doctors are worried that if women
enrolled in a clinical trial became pregnant, experimental drugs
could endanger the fetus.

    Critics counter these arguments by asserting that it is
worth the trouble and expense of recruiting women research
subjects, given that women make up half the population -- and
half the taxpayers underwriting federal research. Concern for
the fetus is often exaggerated, they say. "There is a tendency
to think of women as walking wombs," says the University of
Wisconsin's Karlin. Most female cardiac patients, she notes, are
not planning to get pregnant.

    Health concerns that primarily affect women get particularly
short shrift in the research community, many doctors say. Breast
cancer, for example, has doubled in incidence since 1960 and is
now killing 44,000 women each year. Yet last year the NIH spent
just $77 million studying the ailment, including only $16
million on basic research. Two years ago, the NIH halted a major
study on breast cancer and low-fat diets because of cost
considerations. "I can't believe that decision," says Dr. Mary
Guinan, assistant director for science at the Centers for
Disease Control. "If we could tell women that their diet lowered
their risk, we could save thousands of lives."

    Research on contraception and menopause has also failed to
garner many federal dollars. Though an estimated one-third of
older women are taking hormone-replacement therapy to combat
osteoporosis and other effects of menopause, many questions
remain about how this treatment might alter the risks of breast
cancer and heart disease. Says Guinan: "As doctors, we think
we're helping women when we may actually be harming them."
Meanwhile, no new contraceptive method has been approved in the
U.S. since the 1960s. Overall, the NIH spends only 13% of its
$7.7 billion budget on women's health issues, according to the
Women's Caucus.

    Officially, the NIH has had a policy since 1986 of requiring
grant applicants to at least "consider" including women in their
research. But that policy has been limply enforced. In September
NIH acting director Dr. William Raub set up a special office to
explore the problem.

    For many experts, though, more study simply means more
delay. Raub's likely successor, Dr. Bernadine Healy of the
Cleveland Clinic -- the first woman recommended to head the NIH
-- has called for "exercising relentless pressure" on
researchers and policymakers to fully represent women in health
studies. Until that is accomplished, it seems, doctors will have
to decide for themselves which presents the greater risk to
their female patients: the disease or a cure proven only for
men.