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BiDil for Heart Failure in Black Patients
TO THE EDITOR:
At first glance, Temple and Stockbridge (1) present an apparently reasonable rationale for the FDA's approval of the heart failure drug BiDil (NitroMed, Lexington, Massachusetts) with a race-specific label for use only in “self-identified black patients.” Upon closer examination, however, their arguments fail to convince. Bibbins-Domingo and Fernandez (2) clearly show the limits of the post hoc subgroup analysis that the FDA used to justify the race-specific approval.
Beyond this, it is worth noting that since BiDil's approval, NitroMed—BiDil's corporate marketer—has made much of …
