The Pill for Black people

In June 2005 the FDA approved BiDil, a pharmaceutical drug specifically approved for African Americans. An antihypertensive for patients with congestive heart failue, it was the first race-based prescription drug in American history. BiDil’s release generated controversy. Some, including the NAACP and the Congressional Black Caucus, praised it as a step towards better addressing the often under-served and overlooked healthcare needs of Black patients. Others called it pseudoscientific medical racism.

BiDil was not originally intended to be race-specific. It’s development began in the early 1980s when the University of Minnesota collaborated with the Veterans Administration to develop a new treatment for heart failure. The found promising early results with a combination of hydralazine and isosorbide dinitrate and received a patent in 1989. A company called Medco licensed the patent and spent several years preparing an application to seek FDA approval. But the FDA rejected the application, saying that clinical trial data did not sufficiently prove the treatment was actually effective.

Dr. Jay Cohn, the cardiologist who organized the trials, reanalyzed the data and found that the drug seemed to work better in patients who had self-identified themselves as African Americans. He saw this as spectacular news, because it was widely known that the conventional drugs for treating hypertension in patients with Congestive Heart Failure were substantially less effective for Black patients.

With this new hypothesis, the parent was licensed to a different company, NitroMed, who then ran the African-American Heart Failure Trial. The new drug seemed like a miracle! In Black Congestive Heart Failure patients, it reduced hospitalizations by 39 percent, and mortality by 43 percent. The drug was so successful that the trial was ended early to avoid additional deaths among the patients in the study who were receiving a placebo. The FDA approved the drug, and BiDil was quickly added to the standard treatment guidelines for treating Congestive Heart Failure.

 

So pharmaceuticals are a social construct.