BiDil: assessing a race-based pharmaceutical.
Isosorbide and hydralazine in a fixed-dose combination (BiDil) has provoked controversy as the first drug approved by the Food and Drug Administration marketed for a single racial-ethnic group, African Americans, in the treatment of congestive heart failure. Family physicians will be better prepared to counsel their patients about this new drug if they understand a number of background issues. The scientific research leading to BiDil's approval tested the drug only in African American populations, apparently for commercial reasons, so the drug's efficacy in other populations is unknown. Race as a biological-medical construct is increasingly controversial; BiDil offers a good example of how sociocultural factors in disease causation may be overlooked as a result of an overly simplistic assumption of a racial and hence presumed genetic difference. Past discrimination and present disparities in health care involving African American patients are serious concerns, and we must welcome a treatment that promises to benefit a previously underserved group; yet the negative aspects of BiDil and the process that led to its discovery and marketing set an unfortunate precedent. Primary care physicians should be aware of possible generic equivalents that will affect the availability of this drug for low-income or uninsured patients.
Brody
Howard
H
Department of Family Practice and the Center for Ethics and Humanities in the Life Sciences, Michigan State University, East Lansing, MI, USA. habrody@utmb.edu
Hunt
Linda M
LM
D001741:Black or African American; D004338:Drug Combinations; D004345:Drug Industry; D006333:Heart Failure / Q000188:drug therapy* / Q000191:economics / Q000208:ethnology*; D006801:Humans; D006830:Hydralazine / Q000191:economics / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000191:economics / Q000627:therapeutic use*; D008389:Marketing of Health Services; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic
D004338:Drug Combinations; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate