The First Ethnic Drug?

Not so fast, says Scientific American:

A close inspection of BiDil’s history, however, shows that the drug is ethnic in name only. First, BiDil is not a new medicineit is merely a combination into a single pill of two generic drugs, hydralazine and isosorbide dinitrate, both of which have been used for more than a decade to treat heart failure in people of all races. Second, BiDil is not a pharmacogenomic drug. Although studies have shown that the hydralazine/isosorbide dinitrate (H/I) combination can delay hospitalization and death for patients suffering from heart failure, the underlying mechanism for the drug’s efficacy is not fully understood and has not been directly connected to any specific genes. Third, and most important, no firm evidence exists that BiDil actually works better or differently in African-Americans than in anyone else. The FDA’s approval of BiDil was based primarily on a clinical trial that enrolled only self-identified African-Americans and did not compare their health outcomes with those of other ethnic or racial groups.

(Hat tip: 3QD.)