Women have historically been overlooked in medical research, but intentionally excluding them was cemented into policy in the 1970s. In 1977, the Food and Drug Administration created a guideline that recommended excluding women of childbearing age from phase I and early phase II drug trials in response to a widespread tragedy linked to the anti-morning sickness drug thalidomide, according to the National Institutes of Health Office of Research on Women's Health.
The impact of overlooking women in clinical trials Bias against female subjects starts to "creep in at the development stage, years before drugs reach patients," said the Financial Times. Scientists say that preclinical testing has, at times, focused disproportionately on male animals and male cells. When medicine reaches the human trials stage, women are still underrepresented.
Research reinforces the idea that women suffer from this male-centric approach to developing medicine. Since 2000, women in the U.S. have reported "total adverse events," defined as "any untoward medical occurrence," 52% more frequently than men and severe or fatal events 36% more frequently, according to Food and Drug Administration data gathered by the McKinsey Health Institute.
"Historically, the white male body has been seen as the scientific norm, so there's a sense that 'whatever we find in men will apply to women,'" Jill Fisher, a professor of social medicine at the University of North Carolina Center for Bioethics, said to the Financial Times. This assumption, which is also evident in the lack of racial diversity, has been "very difficult to change in the culture of science."
Trying to reverse the trend The White House has taken notice of the lack of attention to women's health in medical research. In November 2023, the president and first lady launched the White House initiative on women's health research, with first lady Jill Biden taking the lead. Research on women's health has been "underfunded for decades, and many conditions that mostly or only affect women or affect women differently have received little to no attention," the first lady said when she announced the initiative.
Progress has been slow, but in the meantime, underrepresented communities should continue to ask questions and put pressure on the whole drug development pipeline. "Drug companies, and all of us, need to see that the group most at risk for adverse outcomes is going to be the sex that's often left out," Teresa Woodruff, a Michigan State University Research Foundation professor, said to the Financial Times. "And that, right now, is women." |