GAO Cites Bias in Health Research : Medicine: Women have been largely excluded from federal studies, the agency reports. Officials say skewed testing raises questions about results.

Women are still largely excluded from studies of new drugs and other research funded by the National Institutes of Health, despite an official policy that requires their representation, according to a General Accounting Office report released Monday.

The National Institutes of Health “has made little progress” in having women included as research subjects since the policy was announced in 1986, the report by the congressional watchdog agency said.

“Excluding women raises serious questions about whether the research results can be applied to women” in studies conducted on some diseases and treatments, Mark V. Nadel, the GAO’s associate director for national and public health issues, told members of the House Energy and Commerce subcommittee on health.

He cited, for example, a study of 22,000 male physicians begun in 1981 that found that men who took aspirin every other day reduced their risk of heart attacks.

“Institute officials told us women were not included in this study because to do so would have increased the cost,” he said. “We now have the dilemma of not knowing whether this preventive strategy would help women, harm them or have no effect.”

Subcommittee Chairman Henry A. Waxman (D-Los Angeles) said that the exclusion of women resulted in “a continuous skewing of information” that has created “a blind spot” in research information.

“Drugs are developed with incomplete data on metabolic differences between men and women,” he said. “Diseases are studied without an understanding of the effects of hormones and reproduction. Even preliminary animal studies are usually done only with male rats.”

William F. Raub, acting director of the National Institutes of Health, told the subcommittee that “we share this concern” over the exclusion of women from NIH-sponsored research and agreed that the participation of women “traditionally has not received the emphasis it should.”

The GAO recommended that the entire National Institutes of Health community, including officials who review grants, be better informed of the reasons for the policy. Also, the agency urged that those who review grant proposals always determine “whether the gender of the study population is an issue of scientific merit.”

Raub said he did not believe that the situation was as grim as it had been portrayed but promised that the national institutes would take the corrective action proposed by the GAO.

The National Institutes of Health coordinates the nation’s health research and funds all federal biomedical studies.

“When one looks at the array of ongoing studies (funded by the NIH) . . . in the vast majority, women are indeed well-represented as subjects,” he said. “. . . The system overall is not grossly out of focus. It does need some fine-tuning . . . some sharp-focusing in a particular context. And we intend to do that.”

He said that potential National Institutes of Health grant recipients have been told since January, 1987, that applications “must include a plan for inclusion of women” and that a memo was distributed last July within the institutes outlining how such applications should be reviewed.

Groups that review applications for NIH grants will discuss these requirements “for the first time” when they meet this summer to review grants, he said. Further, he said, NIH advisory councils will be reminded of the policy at meetings this fall.

Reps. Patricia Schroeder (D-Colo.) and Olympia J. Snowe (R-Me.), who are the co-heads of the Congressional Caucus on Women’s Issues and who requested the GAO study, along with Waxman, both criticized the National Institutes of Health for taking so long to implement the policy and for not emphasizing research on women’s health issues.

“The research community and NIH’s attitude has been to consider over half the population as some sort of special case,” Snowe said. “Their attitude has been like that old song from the musical ‘My Fair Lady’: ‘Why Can’t a Woman Be More Like a Man?’ ”

Schroeder agreed. “Gender difference is just not considered to be good science, and since most research is conducted on men to begin with, that too often means women get left in the dark,” she said.