Heartless: Women kept out of heart device tests

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A disquieting new study published online in Circulation: Cardiovascular Quality and Outcomes shows that research into heart devices isn’t properly considering the effects of these devices on women or employing comparable numbers of female test subjects.

A research team led by Dr. Rita Redberg of the University of California, San Francisco, examined 123 studies undertaken on behalf of 78 high-risk heart devices which received FDA approval between 2000 and 2007. The team noted that since 1994 federal regulations have required applicants to include women subjects in proportion to the patient population likely to receive the device. Also, a statement on possible gender bias must be included in a summary of their results. Yet Dr. Redberg’s team found that only 41 percent of the studies even had a gender bias statement, and only 11 percent of the other studies made any mention of possible gender bias. Moreover, more than 67 percent of the patients in the tests of the devices were male.

Dr. Redberg points out, however, that women often respond differently to these devices. On average they are more prone to bleeding following implantation of some devices, and women show higher mortality rates with certain instruments.

ACSH's Dr. Gilbert Ross says, “There has to be gender balance in the testing. Ignoring a sub-population likely to become recipients of new technology is not acceptable. As per the FDA regulation, which has not been enforced, we need to have a rational gender distribution among the patients.”