FDA should approve heart drug for blacks

Medical and legal communities must recognize physiological differences exist between races.

Two University researchers are trying to gain Food and Drug Administration approval for a drug combination called BiDil – and are rightfully breaking politically correct boundaries at the same time by posing the suggestion that the drug be marketed specifically for blacks.

Drs. Jay Cohn and Anne Taylor of the University’s Medical School want FDA approval for Cohn’s brainchild: A combination of old drugs, hydralazine and isosorbide dinitrate, to treat patients with heart failure. The drugs were previously used to treat other heart-related conditions.

In a preliminary study, Cohn found the addition of the two drugs to the standard regimen of medications in heart failure patients decreased mortality in blacks by 40 percent, but had no statistically significant impact on white mortality. The FDA did not accept the overall results as significant, so Cohn and Taylor pursued a different route: Testing the product on blacks alone.

Cohn said blacks seem to be more predisposed to heart disease than whites because some unknown factors – genetic, environmental or both – predispose them to having less active nitric oxide systems, which are protective of the heart and arteries. BiDil contains nitric oxide enhancers, which Cohn reasoned would make the drug more likely to be effective in blacks. It turns out he was right.

Cohn and Taylor’s study found significantly decreased mortality in black heart failure patients taking BiDil. Because the study included only black patients, the FDA might only allow the product to be marketed toward blacks. But that would not bar doctors from prescribing the drug to any patient they think might benefit; just because one ethnic group is more predisposed to a condition does not mean that condition doesn’t exist in another group, and doctors can make their own judgments.

Unfortunately, Cohn and Taylor have come under fire for recognizing medicine might at times be race-specific. Cohn was quick to point out the drug’s effectiveness has nothing to do with skin color; its value is purely physiological. The medical and legal communities must recognize legitimate physiologoical differences exist between races, and researchers must be allowed to develop products that save lives regardless of whom those products benefit the most.