BiDil Controversy

BiDil, a drug used to treat congestive heart failure, made history on June 23, 2005, when it became the first drug approved by the U.S. Food and Drug Administration (FDA) for use by one [Page 339]specific racial group. BiDil was approved specifically for use by self-identified black patients after it was shown to substantially reduce deaths in comparison with a placebo in a trial involving only blacks. Some hailed BiDil's race-specific approval as beginning of a new era of personalized medicine in which pharmaceuticals would be prescribed based on an individual's genetic makeup; others found the claims for BiDil to be suspect and also questioned the wisdom of treating self-declared race as a classification based in genetics rather than as a social construct.

The history of BiDil dates back to the 1980s, when a cardiologist, Dr. Jay Cohn, studied the effectiveness of the vasodilators hydralazine and isosorbide dinitrate to treat patients with heart failure. At the time, Cohn was not considering the effects of these drugs on any specific racial group, and the trial subjects consisted of both black and white men. Two trials were organized in conjunction with the U.S. Veterans Administration; the first (Vasodilator Heart Failure Trial I, or V-HeFT I) ran from 1980 to 1985, while the second (V-HeFT II) ran from 1986 to 1991. These trials found that vasodilators could help patients with heart failure, but that another type of drug, the angiotensin-converting enzyme (ACE) inhibitor, was even more effective for most patients. As a result, ACE inhibitors became the treatment of first choice for patients with heart failure, while hydralazine and isosorbide dinitrate, both of which were already available as generic drugs, became an alternative treatment for patients who did not do well with ACE inhibitors.

Cohn continued to study the effectiveness of hydralazine and isosorbide dinitrate (H/I) in combination, and in 1996 presented BiDil, the first H/I drug, for FDA approval. When approval was denied, Cohn reanalyzed the data from the 1980s trials and found that African Americans in those trials had done particularly well when treated with H/I. A new trial testing the effectiveness of BiDil on African Americans proved successful—deaths were reduced by 43 percent in a trial of 1,050 African American patients with heart failure. In fact, the drug was found so superior in comparison to a placebo that the trial was halted early so BiDil could also be offered to the placebo group. Note that in this trial, both groups took their prescribed medications during the trial, so BiDil or the placebo was tested for effectiveness in combination with the patients’ usual drugs. This trial led to BiDil becoming the first drug to receive FDA approval for use with a specific racial group.

A legitimate question has been raised as to why, during Cohn's second attempt to receive FDA approval for BiDil, he did not arrange for trials with a racially mixed group. One possible answer may be economic rather than scientific: the original patent for BiDil (as a treatment for individuals of all races) would have expired in 2007; the new application, based on using BiDil as a treatment for African Americans only, would not expire until 2020. What is certain is that no statement can be made about the effectiveness of BiDil for blacks versus individuals from other races because the study that led to FDA approval included only blacks, and the original studies from the 1980s were not designed to answer the questions necessary to receive FDA approval.

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