FDA approves

4 July 2005

The US Food and Drug Administration (FDA) has approved the first ever drug marketed for use solely in a specific ethnic group. BiDil, produced by US company NitroMed, has been approved for the treatment of heart failure in self-identified black patients, having been through clinical trials for the treatment of African Americans (see November 2004 newsletter item). This decision has been made amid considerable controversy; critics say that using race or ethnicity as a marker for genetic differences is crude and inaccurate, and fear that approval of BiDil lends weight to notions of race as a distinct biological marker. Others, such as the Association of Black Cardiologists, who sponsored the Nitromed trials, welcomed the decision.

FDA Associate Director of Medical Policy Dr Robert Temple said the drug was "a striking example of how a treatment can benefit some patients even if it does not help all patients

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