HEART for Women Act seeks improvement of clinical trial data reporting

New funding for education and awareness initiatives included in legislation.

Issue: April 2009

New proposed legislation aims to make heart disease and stroke more widely recognized in women while improving some data reporting standards.

The Heart Disease Education, Analysis and Research, and Treatment (HEART) for Women Act will implement several strategies and initiatives to raise awareness of women and heart health, according to a summary of the bill.

“We have a big gender gap with respect to CVD — about 50,000 more women die of CVD than men,” Susan Bennett, MD, national spokesperson for the American Heart Association and director of the Women’s Heart Program at George Washington University Hospital in Washington, D.C., told Cardiology Today. “Although rates have gone down for the past couple years, they have really gone down precipitously in men, and women are lagging behind. This legislation is to help correct a big part of that, which is a lack of clinical trial data.”

The legislation would tighten the existing requirements on manufacturers for the reporting of clinical trial data to the government. The legislation would emphasize requirements for the reporting of clinical trial data stratified by race, sex and ethnicity. The bill also authorizes the release of grants for professional education for physicians and for educational CVD awareness programs aimed at older women as well as improved screening and insurance for the uninsured and low-income women.

“The message that people should take home here is that women are different and we cannot assume that every drug or device works equally well in women,” Bennett said. “It may be that we are so different that we cannot make that assumption and instead have to go out and prove it through clinical trials.”

The bill was proposed by Sen. Debbie Stabenow, D-Mich., Sen. Lisa Murkowski, R-Alaska and Rep. Lois Capps, D-Calif. – by Eric Raible