Essay Focuswww.thelancet.comVol 369 February 24, 2007 703In a remarkable turn of fate, however, one of the investigators looked at the data again, and found that a small sub-sample of African Americans in the original clinical trial seemed to have fared better than did white people.2Because the study was not designed to compare eﬃcacy of BiDil in people of different races, a new clinical trial would have had to be approved to investigate such a hypothesis. However, rather than setting up a study design to test this hypothesis, in March, 2001, the FDA approved a full-scale clinical trial, undertaken only in black men and women with heart disease.4In June, 2005, after a hearing in which an FDA committee reviewed reports that BiDil was significantly more effective than a placebo, the drug’s patent was approved for another 15 years as a race-specific drug.5Indeed, the race-specific claim was what made the drug patentable.6The use of black participants only in this BiDil trial is indicative of three problematic assumptions about race and medicine. The first is that African Americans’ risk of developing and dying from heart failure is substan-tially greater than that of white people. An investigation by the Hamline University, St Paul, MN, USA, legal scholar Jonathan Kahn seriously challenges this assertion.7Kahn’s work shows that claims made by NitroMed, the company that developed BiDil, about the extent of differences in eﬃcacy between black and white people are untrue. Kahn traced the citation sources used
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