Date: Mon, 7 Aug 2000 17:33:02 -0700 (PDT)

The Washington Post

SECOND OPINION -

Closing the Gender Gap in Medical Research

By Abigail Trafford

Tuesday , August 1, 2000 ; Z09

Left out. The girls feel left out. And so they scream:

Not fair! Against the law! Women are being left out--again.

Or are they?

We're not talking about who gets to be dean of the medical school or even who gets elected to Congress. We're talking about who gets to be a guinea pig for biomedical research.

Last week, the Department of Health and Human Services sponsored a seminar on "Sex/Gender Analysis" to see how well women are doing as objects of scientific interest.

To women health activists, the verdict is: not well enough. While many more women are now included in human studies, two recent reports in the Journal of Women's Health and Gender-Based Medicine found that only a minority of studies in leading medical journals looked at the differences in how men and women responded to an experimental treatment.

A report from Congress's General Accounting Office has also called for closer attention to sex differences. While hailing the increase in female participants, the GAO pointed out that the National Institutes of Health (NIH) "has made less progress in implementing the requirement that certain clinical trials be designed and carried out to permit valid analysis by sex, which could reveal whether interventions affect women and men differently."

The law is on the activists' side. Legislation in 1993 not only stipulated that research funded by NIH had to include women and minorities. It also required that the studies be designed to analyze sex differences.

And so the advocates of women's health are crying foul.

To many in the scientific community, the criticism is too harsh. Look at the numbers, they say. Latest NIH figures show that more than 65 percent of participants in studies in 1998 were women. Of 6,947 studies supported by NIH that year, nearly 6,000 included both men and women. Fewer than 250 studies were designed for men only; about 740 studies were limited to women. Indeed, women's health problems such as breast cancer have received so much research attention in recent years that activists for men's health are starting to cry "me too! "But numbers aren't the whole story. In testing a new drug, it's important to know if men and women respond differently.

Metabolically speaking, what's good for the gander is not always good for the goose--and vice versa. A new Glaxo-Wellcome drug for irritable bowel syndrome, for example, has been proven very effective for women, but not for men. Drugs also trigger different side effects. The popular antihistamine Seldane was pulled off the market because it caused a certain kind of arrhythmia--mostly in women. From the laboratory to the bedside, the sex winds in medicine are changing. Sexual equality at the cellular level has given way to Vive la difference!

That's why sex-based research is making headlines. "This is a topic people care about--and they should," said Raymond Woosley, Georgetown University Hospital's head of pharmacology, at the HHS seminar.

The women's health movement has already accomplished much. Gone are the bad old days when women were simply left out of clinical research, and men were used as the generic model of a human being. (Remember the recommendation to take a baby aspirin a day to ward off a heart attack? That study was done using men only. It took another study to show a benefit in women.)

The no-women-need-apply policy in research began as paternalistic protection after the drug disasters of thalidomide and DES, in which catastrophic effects appeared in the children of women who took these drugs. By the mid-1980s, however, a task force on women's health pointed out the flaws in male-only research and urged that women be included in studies. NIH responded with new guidelines.

But not much happened to close the gender gap. In 1990 a GAO report lambasted NIH for failing to include women in research, and legislation followed in 1993.

So the research community has had plenty of time to get used to the idea of diversity in clinical research. Excuses for not analyzing by sex--it's not always relevant, it would cost too much, it could delay important findings--sound defensive. The reality is that change comes slowly in medicine. It takes more than a piece of legislation to alter the collective mind-set of how science is done.

The advocates of women's health know this. That's why they are making a fuss. They are sending a message to the scientific community that they're watching and they won't let up. That's the real news behind the debate over sex-based research.

This isn't just good for women. It's good for men, too. As physician Katherine Sherif, of the Center for Women's Health at Hahnemann School of Medicine in Philadelphia, put it: "What I hope

from the women's health movement is that we end up taking better care of everyone."

We should all be glad these women are so vigilant.

Abigail Trafford can be reached by e-mail at trafforda@washpost.com.

Join her Tuesday at 2 p.m. on washingtonpost.com

for a discussion on women and medical research. Her guest will be Phyllis Greenberger, executive director of the Society for Women's Health Research.

© 2000 The Washington Post Company

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