Heart Drug for Blacks Endorsed
By Rob Stein Washington Post Staff Writer Friday, June 17, 2005; A01
(Recommended by Darcy R. Lima & Mario C. Maranhao)
Federal health advisers yesterday 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 that 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 it is specifically intended for African Americans. 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. (more)
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