Flaws in the U.S. Food and Drug Administration's Rationale for Supporting the Development and Approval of BiDil as a Treatment for Heart Failure Only in Black Patients

Abstract

There is likely to be widespread agreement with much of the FDA’s rationale for approving BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) as a treatment for heart failure. In particular, most would agree that the evidence of effectiveness provided by the African American Heart Failure Trial (A-HeFT) is compelling. Likewise, few health scientists would believe that it is either necessary or responsible to withhold therapies such as BiDil from those who might benefit until there is a full understanding of how they work. And although there is substantial concern that biomedical differences between racial groups are routinely misinterpreted as evidence of innate genetic differences (hence Jonathan Kahn’s call for all such claims to be supported by genetic evidence), most would concede that using race as a “descriptive” variable can help identify differences in health and access/response to treatment that might warrant further investigation or intervention.