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Healthy Skepticism Library item: 7517

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Brody H, Hunt LM.
BiDil: assessing a race-based pharmaceutical.
Ann Fam Med 2006 Nov-Dec; 4:(6):556-60
http://www.annfammed.org/cgi/content/full/4/6/556


Abstract:

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.

Keywords:
Minority groups • heart failure, congestive • genetic predisposition to disease • delivery of health care • health services research • communication MeSH Terms: African Americans* Drug Combinations Drug Industry Heart Failure, Congestive/drug therapy* Heart Failure, Congestive/economics Heart Failure, Congestive/ethnology* Humans Hydralazine/economics Hydralazine/therapeutic use* Isosorbide Dinitrate/economics Isosorbide Dinitrate/therapeutic use* Marketing of Health Services Patient Selection Randomized Controlled Trials Substances: Drug Combinations isosorbide-hydralazine combination Hydralazine Isosorbide Dinitrate


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