What’s missing is an in-depth understanding of how women and men respond differently to medications and other therapies, as well as other variables, that profoundly influence human health.
That deficit was explored at Cedars-Sinai’s second annual symposium for the Center for Research in Women's Health and Sex Differences, or CREWHS. The three-hour session, conducted virtually on Oct. 6, also put a spotlight on research being conducted on an array of women’s health issues around Cedars-Sinai.
For generations, scientific researchers didn’t recognize the existence of medical differences between women and men and, as a result, they relied on men as subjects of their studies. At times that practice was carried out at the urging of the federal government. For example, the Food and Drug Administration in 1977 recommended excluding women of reproductive age from drug testing after the emergence of medical disasters such as birth defects linked to the sedative thalidomide.
A push for change came in 1993 when Congress passed legislation that mandated including women in federally funded research trials. There was another move forward in 2016 when the National Institutes of Health started requiring applications for research funds to devote attention to sex-based differences.
Speakers at the CREWHS symposium, however, said the situation has improved only modestly and the body of research into sex-based differences remains thin. That was underscored by the keynote speaker, Doris A. Taylor, PhD, a scientific pioneer and entrepreneur and the founder of RegenMedix Consulting, which is based in Montgomery, Ala.
As an example, Taylor pointed to federal statistics showing that patients currently are being recruited for nearly 100 clinical trials for cell-based therapy for heart disease. Among those trials, she said, only one lists sex differences as a reporting variable.
“So, what do we know about women and cardiovascular regenerative medicine? Very little,” Taylor said in her lecture, which was titled “Sex Differences in Cardiovascular Regenerative Medicine: The 2020 View.”
“Our biology is different,” Taylor elaborated in an interview, referring to men and women. “The solutions for disease need to take that into account.”
When studies don’t break down findings based on sex, Taylor added, “We're not only not developing the right solutions for women, but we're misinterpreting, in my opinion, data that could impact how we treat both men and women.”
Similar points were raised in presentations by Cedars-Sinai researchers from an array of departments. Suzanne Devkota, PhD, an assistant professor of Medicine in the Karsh Division of Gastroenterology and Hepatology, said researchers in her field traditionally paid little attention to sex differences.
The typical pattern, Devkota said, is that researchers would study “the immune system or metabolism and then when they started analyzing the data, they would say, ‘Oh my gosh, there seems to be this difference between males and females.’ And then what people would do is decide, ‘Hey I'm only going to use males or females to eliminate that that confounding aspect’ without actually embracing it and saying, ‘Hey, maybe there's something there.’”