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Unformatted text preview: Essay Focus www.thelancet.com Vol 369 February 24, 2007 703 In 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. 2 Because the study was not designed to compare e cacy of BiDil in people of diff erent 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. 4 In June, 2005, after a hearing in which an FDA committee reviewed reports that BiDil was signifi cantly more eff ective than a placebo, the drugs patent was approved for another 15 years as a race-specifi c drug. 5 Indeed, the race-specifi c claim was what made the drug patentable. 6 The use of black participants only in this BiDil trial is indicative of three problematic assumptions about race and medicine. The fi rst 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. 7 Kahns work shows that claims made by NitroMed, the company that developed BiDil, about the extent of diff er ences in e cacy between black and white people are untrue. Kahn traced the citation sources used people are untrue....
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell University (Engineering School).
- Spring '10