BIDIL AND RACIALIZED MEDICINE

Abstract

On June 23, 2005 the Food and Drug Administration (FDA) approved a drug to treat heart failure in African-Americans, and only African-Americans. This race-specific drug is called BiDil. BiDil is not a new drug. It is merely a combination into a single pill of two existing generic drugs that have been used to treat heart failure regardless of race for over a decade. BiDil was brought to the FDA by NitroMed, a hitherto small Massachusetts biotech company with no other products on the market. NitroMed explicitly requested race-specific FDA approval for its drug based on clinical data produced by its “African-American Heart Failure Trial (A-HeFT) ” on the grounds that the trial population happened to be all African-American. BiDil does indeed appear to significantly help many people suffering from heart failure – a debilitating and ultimately fatal disease afflicting several million Americans. There is no scientific evidence, however, that race has anything to do with how BiDil works. This is for the simple reason that A-HeFT enrolled only “self identified ” African-Americans. With no comparison population, no legitimate claims can be sustained that BiDil works differently or better in African-Americans than in anyone else. The FDA, however, accepted NitroMed’s argument that because the trial population was African-American then the drug should be labeled as indicated only for African-Americans. This sends the troubling and unsubstantiated message that the subject population’s race was somehow a relevant biological variable in assessing the safety and efficacy of BiDil. Ominously, it also gives the federal government’s imprimatur to the use of race as, in effect, a genetic or biological category. By seeking and granting approval of BiDil as a drug solely to treat African Americans, NitroMed and the FDA thus opened a Pandora's box of racial politics without fully appreciating the implications of what they were doing