April 30, 2000

Research Neglects Women, Studies Find

ASHINGTON, April 29 -- 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 that 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 the other, or produce more severe side effects in one sex. Also, some diseases, like 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 if 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 the report to be issued next month, the General Accounting Office found that while 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 N.I.H., the government's main sponsor of biomedical research, has done a haphazard job of tracking data on research involving women.

Federal policy on women's health research has evolved by fits and starts. In 1986, the National Institutes of Health announced a policy encouraging the inclusion of women in clinical research. In 1990, the General Accounting Office found little progress in carrying out the policy, and the N.I.H. established an office to promote such research.

In 1993, Congress passed a law stipulating that women must be included in clinical trials in numbers "sufficient to provide for a valid analysis" of any differences in the way women and men respond to drugs, therapies and treatments.

In the absence of such a requirement, researchers had often reported data from men as if they applied to both men and women.

Now, in its latest investigation, the General Accounting Office has found that many clinical trials financed by the National Institutes of Health "were designed to include women, but not in numbers high enough to allow analysis that would definitively measure different outcomes for men and women."

Don Ralbovsky, a spokesman for the National Institutes of Health, said agency officials had no immediate comment on the report.

Delores L. Parron, a deputy assistant secretary of health and human services who used to work at the N.I.H., said: "Investigators can demonstrate to us that they've included women in their studies, but they don't carefully describe differences in outcomes for males and females. It's frustrating. People are reporting their results in a sloppy way, lumping together the numbers for men and women."

A separate study, being published 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, like changes in diet or behavior, had different effects on women and men.

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

Dr. Vidaver, a molecular biologist, and her colleagues reviewed research published from 1993 to 1998 in four of the nation's leading medical journals, including The New England Journal of Medicine and The Journal of the American Medical Association, to see if researchers had analyzed the data by sex. Some scientists said they had had difficulty recruiting women to participate, in part because women had child care obligations more often than men.

The third study, by Dr. Katherine D. Sherif of the MCP Hahnemann School of Medicine in Philadelphia, found that a small proportion of published research -- less than 15 percent -- did any analysis of the differences in results for men and women.

As a result, Dr. Sherif said, doctors are sometimes slow to recognize dangerous drug combinations. For example, she said, it was mainly women who suffered life-threatening abnormalities in heart rhythm when they took the antihistamine Seldane in combination with erythromycin, a common antibiotic, or ketoconazole, an antifungal agent.

The accounting office said the National Institutes of Health had decided that people conducting certain types of research did not need to report on the inclusion of women. For example, it said, studies that involve only specimens of tissue or body fluids are exempt.

But some scientists said the broad exemption might be inappropriate, because it sometimes makes a difference whether scientists are examining cells from a woman or a man.

Barbara Cohen, the editor of Nature Genetics, a monthly journal, said: "I can understand that exception. But it could lead to the loss of useful information because the cells of men and women, in any part of the body, have different genetic characteristics, and they are exposed and respond to different hormones."

Under the law, the cost of including women in a research project is not a permissible reason to exclude them. The requirement does not apply to the study of diseases that affect only men, like prostate or testicular cancer.

By ROBERT PEAR
Copyright 2000 The New York Times Company
"http://www.nytimes.com/library/national/science/health/043000hth-women-healthcare.html"

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