Sad but true: Women are still woefully underrepresented in medical research studies, despite 20 years of work to right this wrong. Not only does this practice put women’s health at risk, it dampens scientific discovery.
For a while there was hope that the decades-long bias of using primarily men for biomedical research would change. In the early-to-mid ’90s we learned about the upsides and downsides of hormone replacement therapy, that women have different heart disease symptoms than men and about early detection of cervical cancer by PAP smears. Much of this information came from research done after an innovative piece of legislation was signed into law by President Bill Clinton: the National Institutes of Health (NIH) Revitalization Act of 1993, which mandated that women and minorities be included in clinical studies funded by the NIH.
Today is a different story. By all accounts, complacency has set in and the fight for gender parity in medical research needs to be reinvigorated. “We still have a long way to go,” says Paula A. Johnson, M.D., Ph.D., a professor of medicine at Harvard Medical School and executive director of Connors Health and Gender Biology. “Sex matters down to the cellular and molecular levels when you look at illness in men and women. [Yet] if you look at preclinical studies—in animals—the majority are done with male animals, or the sex is not identified.”
There are also gender gaps in medical care for women, especially in cardiovascular disease. “Since the data on quality of care is not routinely assessed or reported by gender,” says Chloe Bird, Ph.D., senior sociologist at the RAND Corporation and coauthor of Gender and Health: The Effects of Constrained Choices and Social Policies, “the problem remains invisible and consequently intractable.”
For example, “Alzheimer’s and aging are areas in which we haven’t focused enough on the differences in men and women,” says Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “There are many factors at play here, since women are more likely to live longer and need longer-term care than men.”
Johnson points out that women often have a different disease course than men, but research is needed to show why. “The women’s office at NIH has made great strides,” she says, “but suffers from a lack of funding and an inability to direct funds independently.”
So what has to change? “Calling for greater inclusion of women in research on the leading causes of death is the obvious place to start,” says Bird. Adds Johnson. “We need to ask how we insure that an adequate number of women are in clinical studies and female animals in preclinical studies. And we need to insure that the data is being analyzed by sex.”
Ultimately, additional legislation and regulation may be needed. Today, a detailed report [PDF] by Johnson, Salganicoff and three others was released at Charting the Course: A National Policy Summit on the Future of Women’s Health in Boston. Its recommendations include making research on sex and gender differences the norm, not the exception; requiring that all medical product evaluations contain separate safety and efficacy data for women and men; starting all studies of sex differences at the cellular and animal-research level; and integrating sex and gender considerations into all medical education. The authors also encouraged the public to speak out, both to policymakers and their own doctors, to make sure sex differences are researched and that the outcome of those studies are employed in treatment.
“The public is the single most important factor in pushing research money into gender-specific research,” adds Marianne J. Legato, M.D., a pioneer in the study of gender medicine and founder of the Foundation for Gender Specific Medicine. “If [it insists] on research that looks at both sexes, it will happen.”
MARY JANE HORTON is an editor and freelance writer with a special interest in women’s health.