The Food and Drug Administration yesterday approved the controversial drug BiDil to treat heart failure specifically in black patients, marking the first time a medication has been targeted at a racial group.
The agency said the approval marked "a step toward the promise of personalized medicine," and was based on research that found the drug could significantly improve the quality of life for black heart disease patients and markedly reduce their chances of being hospitalized and dying.
"Today's approval of a drug to treat severe heart failure in self-identified black population is a striking example of how a treatment can benefit some patients even if it does not help all patients," said the FDA's Robert Temple. "The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition. In the future, we hope to discover characteristics that identify people of any race who might be helped by BiDil."
The approval was praised by heart experts and black health advocates as a welcome addition for treating a serious health problem.
"I think anything that shows a benefit for heart failure is an advance," said Keith C. Ferdinand, of New Orleans, who is a member of the Association of Black Cardiologists.
But Ferdinand and others expressed reservations about approving a drug specifically for blacks. They cited concern it would provide ammunition for the discredited idea that there are basic biological differences between the races, which historically has been used to justify discrimination.
"It invites people to think there are significant biological distinctions between racial groups when in fact the evidence shows nothing of the sort," said M. Gregg Bloche of Georgetown University. "There's a risk of casual thinking that can shade over into discrimination -- there's a substantial risk."
More than 700,000 blacks suffer from heart failure, a condition in which the heart loses its pumping ability, leaving victims weak, short of breath and eventually dying. Blacks are especially prone and tend to respond more poorly to existing treatments.
BiDil is a combination of two drugs used to treat chest pain and high blood pressure. Although the combination failed to prove effective when tested in the general population, it reduced mortality by 43 percent in a study of 1,050 heart failure patients who identified themselves as African American. That prompted NitroMed Inc. of Lexington, Mass., to seek approval for that purpose.
Critics questioned whether the move was motivated by the fact that the company would gain an extra 13 years of patent protection if the drug were approved specifically for blacks. Others said they were concerned the decision would limit the drug's use to black patients when others might also benefit.
"We all know race is an imperfect proxy for any kind of biological status, and hopefully clinicians will interpret this new approval to suggest that any patient regardless of race or ethnicity that fits the profile of the patients in the trial would benefit from this medication," Ferdinand said.