In 1997, a new heart failure treatment called BiDil appeared dead on arrival. The Food and Drug Administration rejected the drug, saying that studies supporting it were inconclusive.Then, proponents of BiDil refocused their strategy. This Thursday, eight years after the drug was rejected for use in the general public, an F.D.A. panel will consider whether BiDil should become the first drug intended for one racial group, in this case, African-Americans. A study of 1,050 African-American heart failure patients showed that BiDil significantly reduced death and hospitalization, prompting the American Heart Association to call BiDil one of the top developments of 2004. BiDil increases levels of nitric oxide, which widens blood vessels. The drug’s maker, NitroMed Inc., says its decision to test and market BiDil as a drug for African-Americans is based on solid science. But BiDil’s application has engendered controversy, with many scientists convinced that race is too broad and ill-defined a category to be relevant in determining a drug’s approval, especially since geneticists have failed to identify a biological divide separating one race from another. The drug has also raised questions about how marketing, regulatory and political considerations play a role in new drug development, with critics of NitroMed saying the company has artfully managed the regulatory system and patent law, as well as historical inequities in medical treatment for African-Americans, to drive its product to market.The idea of seeking approval of BiDil for African-Americans grew out of a study at veterans hospitals in the 1980’s. The research indicated that the drug, a combination of two generic drugs, worked better in African-Americans than in whites.
