But, they say, inclusion isn't just about equal numbers, it is also about what researchers do with that data. "Time and funding spent on analyzing not one sex but two increases the value of our research investments, spurring innovation toward better diagnostics, treatments and cures. Conversely, when we fail to disaggregate, analyze and report data separately by sex, we’re leaving critical knowledge on the table, and losing chances to save more lives."
They noted that in April 2014, sparked by a report from the Connors Center at the Brigham and Women’s Institute and others, 10 members of Congress from both sides of the aisle asked the Government Accountability Office to examine progress on analyzing and reporting sex differences in NIH clinical trials. The report, which was released last October, showed that sex and gender imbalances persist, and that there is still work to do to improve reporting and analysis to ensure women are accurately represented.
"Our nation can’t afford not to make this a priority," they say. "The value proposition is clear. The personal toll of diseases like Alzheimer’s, cancer and cardiovascular disease is incalculable, but the economic cost of missed research opportunities is apparent every day.
"Consider heart disease, the No. 1 killer of women, killing more women than all cancers combined. If we can do more to prevent, treat and cure cardiovascular disease, more women will live longer, more families will stay together, more workers will stay productive, and we’ll save money on treating a condition that costs the U.S. nearly a billion dollars a day.
"Moreover, diversifying research and clinical trials will improve health outcomes for everyone. Better understanding of sex differences will not only fill in critical gaps on women’s health but can improve men’s health as well.
"To give an example, looking at disease through the sex and gender lens has driven new insights regarding atrial fibrillation (AFib), a dangerous condition marked by an irregular heartbeat that can lead to stroke, blood clots, heart failure and other heart complications. For many years, research failed to find an association between physical activity and AFib. Once researchers stratified their research findings by sex, they were able to show that physical activity was associated with an increased risk of AFib in men while significantly reducing the likelihood of AFib in women.
Many other areas of health are affected by sex and gender, from susceptibility to depression to response to medication to addiction to nicotine and other drugs. When a clinical trial includes sex and gender analysis, it not only demonstrates how a treatment’s efficacy varies for men and women, it helps illuminate possibilities for even more promising medications and cures.
"Last month, the U.S. Senate HELP Committee passed a series of biomedical innovation bills, which can be bundled into a companion to the House-passed 21st Century Cures Act. We applaud this bipartisan commitment to fighting disease and saving lives. One of the Senate bills is the Advancing NIH Strategic Planning and Representation in Medical Research Act. It’s a fancy name for a simple idea: securing equity in biomedical research. Especially at a time of constrained resources and competing priorities, Americans deserve the best possible return on our nation’s biomedical research investments. We urge the Congress to pass this legislation, for our health and for our future."
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