Contact: Nancy Loving
202 728 7199, ext. 3

Women Heart Patients Decry "FOR MEN ONLY"
Artificial Heart Clinical Trial

Washington, DC (January 31) -- A national association of women heart patients today criticized the recent artificial heart clinical trial that involved six male heart patients. It has also requested an FDA inquiry into the trial.

"We are incredulous," said WomenHeart executive director, Nancy Loving. "How is it possible that not one woman was selected to test this exciting new technology, especially since more women than men die of heart disease each year?" Heart disease continues to be the leading cause of death of American women, killing nearly 500,000 each year.

Loving noted that, while body size is often a concern when testing new medical devices, the artificial heart fits 20% of women and 50% of men. "There are thousands of women heart patients who have the right body size and can meet the other selection criteria. The question is: was anyone looking for them?" she asked.

In a letter to Acting FDA Commissioner Bernard Schwetz, WomenHeart asked for a formal inquiry into the selection process that resulted in the all-male trial. The association's Oct. 2001 letter to the device’s manufacturer, Abiomed, was never answered.

Specifically, WomenHeart asks the FDA to determine:

• Were women candidates ever considered? If yes, why were they eventually excluded?
• Were any women selected but later excused themselves? If yes, why?
• Were the selection criteria unintentionally biased against women or written in such a way that none could qualify?

"We are concerned about fairness," said Dr. Susan K. Bennett, WomenHeart's medical advisor and a cardiologist at Washington Hospital Center. "A central tenet of medical research ethics is that no one group should bear the burden of risk for experimental treatments - not men, not women, not blacks, not whites. All groups need to share this burden. We need to know if new technologies are safe and effective in both men and women and if not, why not."

National Coalition for Women with Heart Disease
Copyright 2000