In May, U.S. Reps. Jim Cooper, D-TN, and Cynthia Lummis, R-WY, introduced bipartisan legislation to expand gender equality to all essential aspects of medical research and to guarantee that clinical drug trials include enough women to demonstrate their safety and effectiveness for both men and women. Since 1993, when the NIH mandated that researchers include women and minorities publicly funded health research, some progress has been made, but most medical research focuses exclusively on men or fails to break out drug response rates by sex.
“‘Mad Men’ may be ending soon, but medical research is still stuck in the ‘60s,” Cooper said. “Women deserve good medicine just as men do.”
In 2013, the Food and Drug Administration recommended halving the dosage of the sleeping medication zolpidem prescribed to women to reflect the difference in the way men and women metabolize the drug. Women obtain maximum blood levels 45% higher than men and those levels can remain high into the morning, causing impaired driving and other issues.
Increasingly, evidence suggests that differences between men and women affect how they experience disease and respond to medications. Low-dose aspirin reduces the risk of heart attack in healthy men, but not in women. Myocardial infarction in young women more often presents as nausea and shortness of breath rather than the “elephant on the chest” sensation or radiating arm pain men more typically experience.
Despite these known differences and heart disease’s status as the leading killer of women, just 33% of cardiovascular clinical trial subjects are female and less than a third of these clinical trials report outcomes by sex, according to a study by researchers at Brigham and Women’s Hospital.
Underrepresentation of female biology begins in basic research. While women experience depression at twice the rate of men, less than half of the animal studies on depression include female lab animals. The Research for All Act introduced by Cooper and Loomis would mandate inclusion and separate analysis of male and female animals, tissues and cells in research funded by the National Institutes of Health (NIH).
The Brigham and Women’s Hospital study authors noted that “once clinical trials begin, researchers frequently do not enroll adequate numbers of women or, when they do, fail to analyze or report data separately by sex. This hampers our ability to identify important differences that could benefit the health of all.”
For more information on how your female and male patients could benefit from participation in a clinical trial, please contact gotoprotocol.com.
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