Thursday, October 10, 2013
If a drug is found that's effective on black patients, but not on whites, (or vice versa) should it be approved? You may be surprised by the answer.
But let us return to Dr. Zuger’s comments, made in the context of reviewing a book about a cardiac drug called BiDil, which was approved in the United States in 2005 specifically for black patients (although it can be prescribed off-label for anyone). Due to the lack of evidence of efficacy in early clinical trials, the drug, which is actually a combination of two proven cardiac medicines (the vasodilators hydralazine and isosorbide dinitrate), had been rejected by the FDA nine years previously for approval for patients of all races. But because analysis of the data in various subgroups revealed a suggestion of benefit to black patients, another trial was performed on 1,050 self-identified black patients with severe heart failure who had already been treated with—but had not responded to—the best available therapy.The results were so striking—43 percent reduction in mortality and 39 percent decrease in hospital visits among patients who received BiDil—
Find out what happened, and what some people thought about it.