Washington, D.C., June 26, 2012 – The American Heart Association, Society for Women’s Health Research (SWHR), and WomenHeart: The National Coalition for Women with Heart Disease, today applauded passage of important legislation that would make crucial data available about how new drugs and medical devices affect women, minorities and ethnic groups.
The groundbreaking language took the form of an amendment sponsored by Senator Debbie Stabenow (D-Mich.) to the Food and Drug Administration user fee bill. It strengthens an earlier provision set forth in the HEART for Women Act – bipartisan legislation passed in the House by a voice vote in 2010. Final passage of the overall FDA bill came today and it is expected that President Obama is expected to sign the FDA bill into law.
“We want to thank Senator Stabenow, Representative Lois Capps and other supporters of this important amendment to the FDA bill,” said American Heart Association President Gordon Tomaselli, M.D. “They matched vision to action and determination to results. We view this as an enormous step forward in providing crucial information that can be used not only to advance the fight against CVD and stroke, but also help end the disparities and inequality in health care for women and minorities.”
Progress on women’s healthcare research has been painfully slow – and with tragic consequences. For example, it comes as an unwelcome surprise to many that heart disease, stroke, and other forms of cardiovascular disease (CVD) are the leading cause of death in American women, claiming about 432,000 lives each year – or nearly one death each minute. CVD kills more women than the next four causes of death combined, including all forms of cancer. Minority women and those belonging to low-income groups are disproportionately affected by heart disease; the death rate was 28 percent higher for black women than their white counterparts in 2006.
Over the past few decades, researchers have learned that gender differences play an important role in the prevention, diagnosis and treatment of CVD. Heart attack symptoms may manifest themselves differently in women than in men, and women may also respond differently to cardiac medications. For example, digoxin is used to treat heart failure, yet is associated with an increased risk of death among women but not men. And a next-generation device used in heart failure patients is associated with a higher risk of stroke in women.
Women represent just 38 percent of subjects in National Institutes of Health-funded cardiovascular studies. In addition, three-fourths of cardiovascular clinical trials do not report gender-specific results, making it difficult for researchers and clinicians to draw conclusions about their effects on women.
“This provision has been one of SWHR’s key advocacy priorities for over two decades,” said Phyllis Greenberger, president and CEO of SWHR. “We are pleased to have worked with AHA and WomenHeart to achieve this advancement for women and minorities. It is important that this data is submitted to the FDA for analysis if we hope to achieve personalized medicine in the United States.”
This legislation will help provide for more informed decisions by patients and healthcare providers. It would require the FDA to publicly report within one year on the extent to which clinical trial participation and safety and efficacy data by gender, age, race and ethnicity is included in applications for FDA approval of new drugs and medical devices. Moreover, the agency is required to create an action plan to improve the availability of helpful information to patients, healthcare providers and researchers.
“The inclusion of this provision is a game changer for women’s health,” said Lisa M. Tate, Chief Executive of WomenHeart: The National Coalition for Women with Heart Disease. “Knowing how women will be affected by the drugs and devices used in their treatment will lead to better and more informed choices by patients and providers.”