BiDil for heart failure in black patients: implications of the U.S. Food and Drug Administration approval.
In 2005, the combination of hydralazine hydrochloride and isosorbide dinitrate was approved by the U.S. Food and Drug Administration (FDA) for treating heart failure in black patients. In departing from its long history of approving drugs for general clinical indications without regard to demographic classification, the FDA cited the need to address racial disparities in health as an important contributor to their decision. The authors argue that this decision, although perhaps well-intentioned, was based on flawed scientific interpretation of trial results that claimed differential drug response by race and ignored the considerable literature on the cause of racial disparities in health and health care. Because of its potential impact on future drug approvals, the FDA's decision is a setback in the scientific and policy discourse on medical therapeutics and race and specifically hinders the efforts aimed at eliminating health and health care disparities.
Bibbins-Domingo
Kirsten
K
Division of General Internal Medicine, San Francisco General Hospital, University of California, San Francisco, San Francisco, California 94143-1364, USA. bibbinsk@medicine.ucsf.edu
Fernandez
Alicia
A
D044383:Black People; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D017277:Drug Approval; D004338:Drug Combinations; D006333:Heart Failure / Q000188:drug therapy* / Q000208:ethnology*; D006801:Humans; D006830:Hydralazine / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000627:therapeutic use*; D011640:Public Policy; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D001741:Black or African American
D002317:Cardiovascular Agents; D004338:Drug Combinations; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate