BiDil was the drug approved by the FDA not too long ago that was supposedly designed for African-Americans with congestive heart failure. I was very suspicious of this from day one (I talked about my opposition to this drug back in 2005 – here and here). The following was found in next month’s edition of Scientific American:
Known as pharmacogenomics, this approach to drug development promises to reduce the cost and increase the safety and efficacy of new therapies. BiDil was also hailed as a means to improve the health of African-Americans, a community woefully underserved by the U.S. medical establishment. Organizations such as the Association of Black Cardiologists and the Congressional Black Caucus strongly supported the drug’s approval.
A close inspection of BiDil’s history, however, shows that the drug is ethnic in name only. First, BiDil is not a new medicine—it 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. (the article goes into the whole history of this drug. Definitely worth the read)
Now all of this leads me to my next question:”What was the Association of Black Cardiologists and the Congressional Black Caucus given in exchange for their immediate seal of approval on this product?” Inquiring minds want to know.
