(First of a three-part series)
A new government study reveals that medical researchers who receive federal money may not have followed a law requiring them to analyze how new methods for preventing or treating diseases specifically affect women.
The study by an investigative arm of Congress, found “scant” evidence that researchers who received funds from the federally supported medical research institutes had analyzed their results by gender.
Finding out whether women respond differently to various diseases and treatments is crucial for ensuring that women receive optimal health care, experts said. In the past, researchers have often reported results of studies conducted with men as if they applied to women.
Specifically, the congressional investigators for the General Accounting Office faulted the staff of the National Institutes of Health for failing to instruct researchers to design and conduct studies so as to permit a valid analysis of outcomes by gender and for still having an inadequate system to track data.
“The annual reports on the data have generally been limited to NIH-wide summary counts with limited analysis,” the report said.
At the same time, the report credited the institutes for making “significant progress” in ensuring that women are included in studies. In clinical research funded by the institutes, more than half of the participants were women.
Dr. Vivian Pinn, director of the institutes’ Office of Research on Women’s Health, said the agency has made tremendous progress in addressing women’s health despite the shortcomings pointed out by the General Accounting Office report. The data tracking system is still being developed, she said.
“We’ve gone from not having a tracking system to a very complicated system in five years. We’re continually reviewing the data to make sure we have the best data possible,” she added.
However, Phyllis E. Greenberger, executive director of the Society for Women’s Health Research, an advocacy group based in Washington, D.C., said the report should put researchers on notice.
“I think the whole research community needs to take this seriously. The real question is: What progress have we made? The GAO report says NIH is doing a good job of including women in clinical trials, but there’s no consistency in tracking and reporting results,” she said.
“The bottom line to me is: If they’re not tracking and reporting it adequately, how do we know what they’re doing? If it is there someplace and not being reported, why isn’t it being reported? And, if it’s not being done, why isn’t it being done?”
Worse yet, Greenberger said, the implications of the report go far beyond the NIH-funded research.
“NIH is the premier research institution. If NIH isn’t doing it, then the private research institutions probably aren’t doing it either,” she said.
Adding to her colleague’s criticism, Sherry Marts, the society’s scientific director, said the report took a “minimalist” approach in citing the institutes for failing to track data consistently.
“We would have liked more emphasis on the need for better tracking on analysis,” she said. The report is often vaguely worded and couches any criticism in low-key, general terms.
Marts said efforts by the institutes to improve women’s health research also fall short because it does not require researchers who do animal studies or early, small-scale clinical trials to use female subjects. The institutes’ regulations apply only to phase three clinical trials–which are well advanced on the biomedical research spectrum and usually large-scale studies.
Pinn of the national institutes said that criticism is off the mark.
“The legislative language requires that enough women and minorities and their subgroups be included to allow a valid analysis. To do that, you must have very large studies. That’s essentially phase three studies,” she said. By contrast, early studies may have no more than 10 to 25 participants.
“If you have a study that’s women only, then you may not be able to look at gender differences,” she added. “But that doesn’t mean you don’t learn about women’s health and how they react to diseases.”
Marts said animal studies are still routinely conducted with all male subjects. “Even the fact that we don’t look at female animals makes a difference in how research moves forward. Researchers need to look earlier for differences. How do you know what to look for in the phase three trial if you don’t know what to look for in the smaller, earlier trial?” Marts asked.
The General Accounting Office study is the latest to assess the state of medical research for women. And it won’t be the last. Two other studies, which will appear this summer in the peer-reviewed Journal of Women’s Health, are expected to show that few researchers–less than 15 percent in one review–analyzed differences in results for men and women.
Historically, medical researchers have preferred male subjects, in part, to avoid the potentially confounding effects of women’s hormonal changes and to protect potential fetuses. In 1985, a Public Health Service task force concluded that the lack of research on women’s health had compromised women’s care. A year later, the institutes began requiring that women be included in clinical trials. In 1990, a GAO study found women were still being excluded, prompting Congress to create the Office of Research on Women’s Health.
In 1993, Congress mandated the development of guidelines on the inclusion of women and minority men in clinical trials. Those guidelines were not in place until 1995.
Rep. Henry Waxman, D-California, one of four members of Congress who requested the latest General Accounting Office study, said: “Women’s health can’t be adequately protected if researchers fail to analyze health data by sex. NIH needs to ensure that no federally funded research neglects women’s health. My colleagues and I are calling for a further GAO investigation into these issues.”
The other members of Congress who asked for an investigation include Sens.Tom Harkin, D-Iowa, Barbara Mikulski, D-Md., and Olympia Snowe, R-Maine.
Next Week: The role medical journals play in ensuring researchers analyze data by gender.
Melinda Voss was a staff writer at The Des Moines Register for 26 years. In 1999, she earned a master’s degree in public health. She now freelances and teaches journalism.