Georgetown Expert Helps Reverse Male Sex Bias in Research
June 26, 2014 – A Georgetown University Medical Center (GUMC) expert is helping reverse gender bias in animal research that can lead to skewed clinical outcomes.
“Sex differences are evident in physiology and even down to the level of cell biochemistry and genes,” says Kathryn Sandberg, director of GUMC’s Center for the Study of Sex Differences in Health, Aging and Disease. “Men and women are not the same, but when they are treated that way, medicine suffers.”
She notes that the Food and Drug Administration has withdrawn or changed the dosage of several drugs because of after-market discoveries of serious toxic side effects in women.
Sandberg’s own research has shown that basic mechanisms underlying hypertension are not identical in males and females. That means that new drugs developed using only male animal models could be less effective or toxic for women.
Other diseases affecting men and women differently include multiple sclerosis, Parkinson’s disease, schizophrenia, stroke and metabolic disorders.
The Georgetown researcher played a significant role in the National Institutes of Health (NIH) recent announcement and pending commitment to reforms addressing underrepresentation of female cells and animals in preclinical research.
NIH Policy Changes
Sandberg and Scott Fleming, Georgetown’s associate vice president for federal relations, met with the offices of Representatives Nita M. Lowey (D- N.Y.) and Rosa DeLauro (D-Conn.) over the last year to make the case for gender equality in publicly funded basic research.
After that meeting, Lowey and DeLauro wrote to NIH Director Dr. Francis Collins, who along with Dr. Janine Clayton, NIH director of the Office of Research on Women’s Health, responded positively to their argument for these changes.
In a May 14 commentary in the journal Nature, the NIH leaders vowed to balance male and female cells and animals used in preclinical studies in future applications for NIH funding.
New NIH policies are expected to begin in phases starting October 2014, they wrote.
Scientists have relied disproportionately on male mice, rats and other animals for decades. A recent New York Times article suggests that some researchers have avoided using female research models because their reproduction cycles and hormone changes make them more complicated and thus more costly to study.
A 2011 study in Neuroscience Biobehavioral Review estimated that male-only animal models continue to dominate basic research — with a ratio of four to one across multiple disciplines.
Sandberg says she wants to make sure that the new NIH policies go far enough.
I propose that the proportion of male and female models used to investigate specific diseases should reflect the disease prevalence in the general population."
—Kathryn Sandberg, Center for the Study of Sex Differences in Health, Aging and Disease Director
Rather than attempting to achieve a male/female balance in every preclinical study, she says, NIH could tie the ratio to diseases that disproportionately affect one gender over the other.
“I call this a Title IX position,” says Sandberg, who outlined the proposal in the June issue of American Journal of Physiology. “I propose that the proportion of male and female models used to investigate specific diseases should reflect the disease prevalence in the general population.”
Just as researchers have worked hard to include more minorities and females in clinical research, a similar transition in preclinical research “should have been done nationwide years ago,” says Robert Clarke, GUMC’s dean for research and a breast cancer investigator with Georgetown Lombardi Comprehensive Cancer Center.
“We have had a very good start at Georgetown on changing our strategy based on Dr. Sandberg’s work,” Clarke says, “and we are committed to going all the way to provide the best study possible of both male and female disease.”