Heart pill geared toward blacks
WASHINGTON – Federal health advisers on Thursday endorsed the approval of a drug to treat heart failure in African Americans, which would make the controversial pill the first medicine targeted at a specific racial group.
The Food and Drug Administration advisory panel voted unanimously to recommend the agency approve a request by NitroMed Inc. of Lexington, Mass., to sell the drug BiDil for patients with severe heart failure, and a majority agreed with the company that its label should say that it is specifically intended for blacks. The agency is not bound by the panel’s decision but usually follows the advice.
The closely watched vote marked a crucial step for the drug, which has triggered intense debate, coming amid intensifying efforts to tailor “personalized” treatments to the genetic makeup of individual patients and groups of patients. Supporters say the drug would represent one of the first steps in that direction, offering an urgently needed treatment to a group that suffers more from many health problems and has been long neglected by medical research.
Opponents say marketing the drug this way would be an alarming development that would promote racial stereotyping and the discredited idea that there are fundamental genetic differences between races. They also condemn the plan as a cynical attempt to exploit race for economic reasons. The company has two patents for BiDil, and the one covering its use for blacks extends an extra 13 years.
“This development with BiDil is a foot in the door – the first step of what could be seen as racialized medicine,” said Troy Duster, a New York University sociologist. “Race is too crude a measure. We should be looking at the individual and his and her biochemcial makeup – not whether he or she is black or white.”
More than 700,000 U.S. blacks suffer from heart failure, in which the heart is progressively weakened by heart attacks, high blood pressure, diabetes or some other factor, leaving victims increasingly weak, struggling for breath and eventually dying. Blacks are especially prone to it, are often diagnosed younger, tend to respond more poorly to existing treatments and are more likely to die from it.
Studies have suggested that blacks tend to have lower levels of nitric oxide, and researchers noticed during studies in the 1980s that the drug combination, while appearing to offer no benefit in the general population, may be useful among black patients. A follow-up study of 1,050 black patients was stopped early and released in November when it concluded that the drug significantly improved quality of life, reduced the likelihood of being hospitalized by 39 percent and cut the chance of dying by 43 percent.