BiDil for Heart Failure in Black Patients

IN RESPONSE:

Critics of the FDA's approval of BiDil for treating heart failure in self-identified black persons have taken 2 positions: 1) Approval for blacks was premature because further testing should have been performed before approval to discover what characteristics in black and white patients might predict responses (1, 2), and 2) the FDA should have approved BiDil, but for the broader population (3). We note that Dr. Kahn, in his letter, states the latter is what he meant—not that there should have been no approval.

Our paper focused on why delaying approval would have been intolerable, given the dramatic effect shown in the black population and the extreme difficulty of assessing effects further in white patients or discovering clinical predictors of response. But approval for the black population alone was not based, as Bibbins-Domingo and Fernandez assert (2), on the argument that BiDil's approval was urgently needed to address racial disparities in health. Approval for all …