MEDICINE : Research Office for Women’s Health Answers Complaint of Bias in Research

Operating for less than two months out of a borrowed office, with a part-time director, a temporary staff and one purloined secretary, the new Office for Research on Women’s Health at the National Institutes of Health is nonetheless “off and running,” altering the way medical research is conducted for at least half of the population.

The creation of the office, announced Sept. 9, came in response to mounting criticism that NIH, the country’s largest federally financed research agency, had failed to include women in most of its medical research.

“NIH had enumerated a policy some years earlier that women subjects were to be included in all research unless there were sound scientific or medical reasons for not doing so,” said Mark V. Nadel, an associate director of the U.S. General Accounting Office.

“Although they had a policy,” Nadel said, “we found that they, in fact, often were not following it or were following it in inconsistent ways.”

At the behest of the Congressional Caucus for Women’s Issues and the subcommittee on health and the environment, the accounting office last spring undertook an investigation of charges that NIH was, in effect, discriminating against women in medical research. One highly publicized example was an NIH-financed study showing that an aspirin every other day could prevent some heart attacks. The study involved 22,000 subjects--all of them male.

As a result, whether those findings or the findings of hundreds of other studies apply to women, whose physiology and body chemistry differ from those of men, remains unknown, said Dr. Ruth L. Kirschstein, director of the National Institute of General Medical Sciences and acting director of the new office.

Some scientists have argued that it is necessary to exclude women from drug trials and research studies because they could become pregnant and because their hormonal cycles might have an unpredictable impact on the results of studies.

Yet, as many critics have recently pointed out, the results of medical studies are routinely applied to women patients, with little, if any, consideration for those biological differences.

“What we’re talking about here,” one congressional aide said, “is medicine’s ‘double standard’: What’s good for men is good for men, but what’s good for men may or may not be good for women.”

In setting up a separate office on women’s research, NIH will begin to look “more carefully and systematically” at health problems that are unique to women and at women’s unique reactions to drugs and other therapies, said Iris Schneider, assistant director of the National Cancer Institute. Schneider is temporarily overseeing the daily operations of the new office.

One criticism lodged against NIH, for example, is that it has no gynecological or obstetrical research branch, which means that breast cancer, menopause and other health issues peculiar to women get short shrift.

“In the few weeks that we have been in operation, the phone has been ringing off the hook, Schneider said. “We’ve gotten zillions of letters from people asking for jobs and trying to bring specific health concerns to our attention . . . . We’re off and running.”

The first step for the new office will be to get NIH to enforce regulations issued in August, which demand, rather than encourage, that grant applicants include female subjects unless there are “compelling” scientific reasons not to do so. Scientists who ignore the policy will lose their grants, and the office is setting up a computer system to monitor compliance.

The office is planning a workshop in 1991 to spell out what the research agenda for women’s health should be in the 1990s.

A search for a permanent staff also is under way, although selection of a director may take at least a year, given the bureaucratic red tape involved in high-level federal appointments.

But by the end of the month, the staff will have a permanent, newly remodeled office in NIH’s main administrative building in Bethesda, Md. The location, next to the office of the director of NIH, has been interpreted by many at the agency to be a sign of how much clout the staff may have.

But the “real proof of the pudding,” one observer said, will come next year when Congress decides whether to give the office its own budget. With money of its own to allocate to each of NIH’s 14 institutes, the Office for Research on Women’s Health could bring about changes in the nation’s health priorities, even when they are costly.