Federally funded medical researchers often flout law; Drugs' effects on women overlooked, reports find


WASHINGTON -- Medical researchers who receive federal money often flout a federal law that requires them to analyze the effects of new drugs and treatments on women, three new studies have found.

Experts say health care for women may suffer as a result because researchers overlook important differences between the sexes in clinical trials evaluating new methods of treating or preventing disease.

The conclusions of the three reports are somewhat surprising because the Clinton administration has repeatedly emphasized the importance of women's health and Congress has been prodding the National Institutes of Health to pay more attention to the issue.

One study is about to be issued by the General Accounting Office, an investigative arm of Congress. The others, by an academic physician and several scientists, will be published this summer in the Journal of Women's Health, a peer-reviewed publication focusing on diseases that pose particular risks to women.

Researchers in the emerging field of "gender-based biology" have found that men and women sometimes report different symptoms of the same disease, and that certain drugs are more effective in one sex than in the other or produce more severe side effects in one sex. Diseases such as multiple sclerosis and rheumatoid arthritis afflict far more women than men.

Scientists receiving federal money generally include women as subjects in their clinical research, as the government requires. But they often ignore the requirement that they analyze their data to see whether women and men respond differently to a given treatment, the reports said.

The purpose of including women, officials said, is not to satisfy quotas for proportional representation, but to acquire scientific knowledge that can be generalized to the entire population of the United States. That knowledge, they said, can lead to major improvements in care.

In its report to be issued next month, the General Accounting Office found that though the National Institutes of Health "has made substantial progress in ensuring inclusion of women in studies," it has not enforced the requirement for researchers to examine whether women and men fare differently in such clinical studies.

Moreover, it said, the NIH, the government's main sponsor of biomedical research, has done a haphazard job of tracking data on research that involves or affects women.

In its latest investigation, the Phyllis E. Greenberger, executive director of the Society for Women's Health Research, an advocacy group that worked with Congress on the 1993 law, said the findings confirmed what she had come to suspect. "The GAO report substantiates our concern that sex analysis is not routinely being done in research supported by the NIH," she said.

Don Ralbovsky, a spokesman for the NIH, said agency officials had no immediate comment on the report.

A separate study, in the Journal of Women's Health, found that very few researchers analyzed their data to determine whether prescription drugs, surgical procedures and preventive measures, such as changes in diet or behavior, had different effects on women and men.

"Analysis of outcomes by sex is sorely lacking," said the article by Dr. Regina M. Vidaver and colleagues at the Society for Women's Health Research and George Washington University.

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