U.S. Rep. Jim Cooper (TN-5) and U.S. Rep. Cynthia Lummis (WY-1) today introduced a bipartisan bill that would require the inclusion and separate analysis of both male and female animals, tissues and cells in basic research conducted and funded by the National Institutes of Health (NIH).
Current law does not require researchers to study female animals when conducting basic medical research.
As researchers at Brigham and Women's Hospital recently said, "Medical research that is either sex- or gender-neutral or skewed to male physiology puts women at risk for missed opportunities for prevention, incorrect diagnoses, misinformed treatments, sickness and even death."
Cooper's Research for All Act requires NIH to study female subjects and analyze sex differences in basic research. It also directs the Food and Drug Administration (FDA) to guarantee that clinical drug trials for expedited drug products are sufficient to determine safety and effectiveness for both men and women.
"Men and women are not treated equally in health research," Rep. Cooper said. "Science should not discriminate against women."
"Medical research continues to progress, but as it does so, we need to ensure that we do not cut corners that could cost those being treated," Rep. Lummis said. "Data tell us men and women react differently to varying medical treatments."
Women currently make up more than half the U.S. population, but most medical research focuses on men. 60 Minutes recently featured the issue and explored the consequences.
For example, the unique way women metabolize drugs was ignored when researchers determined the dosage for Ambien sleeping pills; as a result, the initial recommended dosage was double what it should have been for women.
Additionally, cardiovascular disease is the leading killer of all Americans, but only one-third of subjects in cardiac clinical trials are women. Just 30 percent of cardiac studies that include women report outcomes by sex.
Cooper's bill helps alleviate such disparities, and it promotes men's health, too. A recent diabetes drug study suggested that the drug may lower women's risk of heart failure but increase men's risk. Meanwhile, evidence suggests common blood pressure and antibiotic medication are less effective for men.
"We should study both women and men throughout the scientific process, starting with the earliest levels of research," Rep. Cooper said. "Better research leads to better outcomes."
"The Research for All Act requires thorough research to ensure viable and effective medicines for both men and women," Rep. Lummis said. "One sex should not be excluded from testing when it could mean the difference between effective treatment and harm to health."
The Research for All Act is supported by numerous organizations, including the American Heart Association, Association of American Medical Colleges, National Center for Health Research, National Women's Health Network, NOW and the Society for Women's Health Research.
American Heart Association
"Without diversity in research, questions about how cardiovascular disease affects women and other populations differently will remain unanswered," said American Heart Association President Mariell Jessup, M.D. "This legislation will be a critical help in closing that gap."
National Organization for Women
"The National Organization for Women is particularly supportive of the act's widespread implications to improve the health and lives of women across the country," NOW said in a statement. "Under the Research for All Act, more women will be enrolled in clinical trials, addressing the issues of drug effectiveness and appropriate dosage that best relate to women. With larger, well-designed trials in place to track how women and men react to different life-changing drugs, NOW is confident that women will be now able to access more effective treatments for health issues with disparate gender impacts."
Society for Women's Health Research
"This legislation represents a significant step forward towards addressing inequities in research that impact the healthcare of men and women," said Phyllis Greenberger, President and CEO of the Society for Women's Health Research. "We are pleased to support the Research for All Act and thank Representatives Cooper and Lummis for their commitment to improving the health of all Americans through research."