Women heart patients decry "for men only" artificial heart clinical trial.(Brief Article)

2002 MAR 7 - (NewsRx.com & NewsRx.net) -- A national association of women heart patients in the U.S. criticized the recent artificial heart clinical trial that involved six male heart patients.

It has also requested a U.S. Food and Drug Administration (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 October ...