New Report Calls for More Research on Gender Differences – American Heart Association Urges FDA to Adopt Recommendations

March 03, 2014 Categories: Advocacy News

Washington, D.C., March 3, 2014 American Heart Association President Mariell Jessup M.D., issued the following statement in support of the new report "Sex Specific Medical Research: Why Women's Health Can't Wait," released today by the Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital

“While many Americans may think heart disease is a man’s disease, it is in fact the No. 1 killer of women, and sometimes affects them in different ways. Yet, as this helpful new report points out – only one-third of participants in cardiovascular clinical trials are women, and fewer than 31 percent of trials with women report outcomes by gender.

Even though this report chronicles progress in the fight against heart disease, it correctly underscores that more research about how gender impacts the health of women is desperately needed, especially when it comes to this life-threatening illness.

That’s why this report is such an important contribution to the conversation about putting an end to disparities in research. Without such efforts, we not only do women a disservice, we also put the health of all Americans at risk because we miss out on opportunities to better understand disease.

It is because of this goal to “do more” that the American Heart Association worked with Congress and other leading patient and women’s groups to get Section 907 of the Food and Drug Administration (FDA) Safety and Innovation Act enacted into law in 2012. As a result, the FDA is now working to develop an Action Plan that addresses gaps in the participation of women, minorities and the elderly in clinical trials, the analysis of gender and other subgroup differences, and the availability of subgroup-specific data to clinicians, researchers and patients.

The association strongly encourages the FDA to adopt the recommendations of today’s outstanding report, as well as the comments we previously submitted in partnership with the Society for Women’s Health Research, WomenHeart: The National Coalition for Women with Heart Disease and the National Women’s Health Network, as it drafts the Action Plan.


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