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Why is our medicine one size fits all?

Carol Morrissey was on a New Year’s Day walk when the symptoms started. She felt a cold rush of air in her chest, then a wave of perspiration and wooziness.

Morrissey, then 53, had no doubt it was a heart attack. But she wasn’t confident others would recognize her symptoms. So when her husband helped her through the emergency room doors, Morrissey began calling out “Chest pain, chest pain” -- a classic heart attack symptom -- even though she felt none.

“I wanted a clot-busting drug, and I wasn’t sure they’d give it to me,” said Morrissey, aware she did not fit the profile of the typical heart attack patient. “I’m a woman, I’m tiny, I exercise. I thought they wouldn’t believe anything was wrong with me.”

Things have changed since 1995, when Morrissey, now 66 and living in Chapel Hill, had her attack. Physicians today know well that heart disease is not just a man’s disease. They know that more women than men die from it each year. They know that women tend to experience symptoms later than men -- in their 50s instead of their 40s -- and that their symptoms are more apt to be cold sweats, fatigue and dizziness than the sudden, crushing pain often seen in men.

Heart disease is just one example of the medical community’s growing awareness that men and women often experience illness differently. Women are far more likely than men, for example, to develop debilitating autoimmune diseases such as multiple sclerosis and lupus. Studies suggest that women who smoke are more likely to develop lung cancer.

But science has done little to find out why or to answer what seems like an obvious question: If the sexes are so different when it comes to health, why is so much of our medicine still one size fits all?

“It’s a very new issue,” said Phyllis Greenberger, president of the Society for Women’s Health Research.

The notion that sex-based differences matter has only been on the radar since about 1990, when the society was established. But the idea didn’t gain credibility until the Institute of Medicine of the National Academies, which advises the federal government on science and medicine, issued a call in 2001 for more research and confirmed that understanding sex differences would improve human health. Even so, researchers still aren’t routinely doing the types of studies needed -- even though federal law in effect since 1993 requires such research.

Under that law, women are to be included in all federally funded biomedical research unless there is compelling reason not to do so -- for example, the condition is male-only, such as prostate disease. Studies also are supposed to report results by sex, detailing the clinical benefits and side effects for men and for women, not just what they are in patients overall.

But a paper published in December in the Journal of Women’s Health reported that women made up just 37 percent of participants in all federally funded studies published in major medical journals in 2004. And only a quarter of participants in drug trials that got federal support were women.

“If women are not included, how do we know the research pertains to them?” Greenberger said. “We cannot use the excuse that it isn’t safe. Women are taking these drugs.”

Despite calls for more research, the number of NIH-funded studies on sex differences dropped 16 percent between 2000 and 2003, according to the society. During the same period, the total number of grants awarded by NIH increased 20 percent.

The society also found that the three NIH institutes with the largest budgets, and therefore the most ability to affect the direction of scientific research, allocated the smallest portion of their budgets -- 1 percent or less -- to sex-based research.

Failing to include women isn’t even the biggest problem, the Journal of Women’s Health paper found. Nearly 90 percent of the federally funded studies it reviewed failed to report results by sex.

And what women don’t know about the treatments they use can hurt them. A recent glimpse into prescription drug recalls underscores the danger.

Eight out of 10 medicines pulled from the U.S. market between 1997 and 2000 posed greater health risks to women, according to a government audit of U.S. Food and Drug Administration data. In at least four of those cases, the drugs were prescribed equally to men and women, so the audit concluded that women likely were biologically more susceptible to problems.

Journals slowly tuning in

Signs suggest that the research community is coming around -- but progress is slow.

The prestigious Journal of the American Medical Association now requires studies to include a sex-based analysis of results, unless the study is done only in men or only in women. Other prominent journals also are becoming more attuned to the issue. The journal Cancer, for example, requests a sex-based analysis whenever the editors consider it necessary.

“We are very sensitive to this issue,” Dr. Raphael Pollock, a Houston cancer surgeon and Cancer’s editor in chief, wrote in an e-mail response to a question about the journal’s publication criteria.

Last fall, researchers doing work in sex-based biology came together to establish a new scientific organization in hopes of stimulating dialogue and new knowledge in the field. The Organization for the Study of Sex Differences holds its first annual meeting this spring in Washington, D.C.

Sherry Marts, who directs science programs for the women’s health society, said studying sex differences from the cellular level on up will ultimately benefit both sexes.

“The more we understand about basic differences, the more we can look at how we screen for, diagnose and prevent illness and start to get to that elusive goal we’ve had of individualized medicine,” she said.

Although progress remains slow, recent years have brought breakthroughs in sex-based research.

A groundbreaking example is the Women’s Health Initiative, a 15-year study of 160,000 women that, in part, was done to test the widely held view that hormone-replacement therapy offered protection against heart disease. In 2002, however, researchers abruptly halted a portion of the study early after results showed that a widely used combination of male and female hormones -- estrogen and progesterone -- actually appeared to raise women’s risks of breast cancer, heart disease and stroke.

The aspirin surprise

More recently, a continuing national study on the effects of aspirin in women turned up more surprising news. Previous research, done mostly on men, found that a daily aspirin can prevent heart attack. But this new study of nearly 40,000 women found that aspirin didn’t reduce the rate of heart attack in women unless they are 65 or older. The study, which continues to study the effects of Vitamin E and other dietary supplements in women, did find that younger women who take daily aspirin had fewer strokes -- a benefit not seen in men.

Such studies underscore the importance of exploring sex-based differences. But doctors still don’t have enough data to offer treatments that are truly tailored to female patients.

Take the recent aspirin findings, for example. The American Heart Association this year changed its heart disease prevention guidelines to recommend that doctors discuss daily aspirin with their female patients as a preventive treatment for stroke. But the jury is still out as to whether the drug does or doesn’t protect women from heart attack.

Another study on aspirin and women released just last week, for example, contradicted the earlier research, reporting that daily aspirin did prevent heart attack in women.

“There really isn’t very much sex-based medicine, because we still don’t know how to apply the research,” said Greenberger, the Society for Women’s Health Research president. “We have many more questions than we have answers.”

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