Medicine in black and white: BiDil®: race and the limits of evidence‐based medicine

  title={Medicine in black and white: BiDil{\textregistered}: race and the limits of evidence‐based medicine},
  author={George T. H. Ellison},
  • G. Ellison
  • Published 1 September 2006
  • Medicine
  • Significance
When the US Food and Drug Administration licensed the drug BiDil® in June 2005 it was hailed as a significant step towards “personalised prescribing”. This is because BiDil® had been patented, tested and approved for use by just one group of patients: those “of African descent”. George Ellison examines the statistical evidence that underpinned the development of BiDil® as a “racial drug” and finds it less than satisfactory. 
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There is likely to be widespread agreement with much of the FDA’s rationale for approving BiDil as a treatment for heart failure, and most would concede that using race as a “descriptive” variable can help identify differences in health and access/response to treatment that might warrant further investigation or intervention.
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How a drug becomes "ethnic": law, commerce, and the production of racial categories in medicine.
  • J. Kahn
  • Medicine
    Yale journal of health policy, law, and ethics
  • 2004
This article is a retrospective analysis of how law, commerce, science, and medicine interacted to produce a distinctive understanding of BiDil as an ethnic drug, shaping which questions got asked at critical junctures in its development and orienting how they were pursued.
From Disparity to Difference: How Race-Specific Medicines May Undermine Policies to Address Inequalities in Health Care
  • J. Kahn
  • Political Science, Medicine
    Southern California interdisciplinary law journal
  • 2005
This analysis begins with a consideration of the race-specific clinical trials that preceded the FDA approval and then moves on to elaborate upon some of the broader implications of BiDil in the context of genomic medicine and the politics of heath care.
‘Population profiling’ and public health risk: When and how should we use race/ethnicity?
The limited reliability of race/ethnicity and the sensitivity surrounding its use to stereotype, discriminate and rationalize difference suggest it should not be used in population profiling for
Statistics and the medicine of the future
Chris Harbron points to a future where drugs will be better targeted, no longer off‐the‐shelf but tailored exactly to suit the authors' own individual genome.
Combination of isosorbide dinitrate and hydralazine in blacks with heart failure.
The addition of a fixed dose of isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among black patients with advanced heart failure.
Effect of vasodilator therapy on mortality in chronic congestive heart failure. Results of a Veterans Administration Cooperative Study.
The data suggest that the addition of hydralazine and isosorbide dinitrate to the therapeutic regimen of digoxin and diuretics in patients with chronic congestive heart failure can have a favorable effect on left ventricular function and mortality.
Veterans Administration Cooperative Study on Vasodilator Therapy of Heart Failure: influence of prerandomization variables on the reduction of mortality by treatment with hydralazine and isosorbide dinitrate.
A reduction in mortality with hydralazine-isosorbide dinitrate was observed in all of the above pairs of subgroups as well as in those above and below 60 years of age and those with and without a history of hypertension or excess alcohol ingestion.
A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure.
The different effects of the two regimens (enalapril and hydralazine-isosorbide dinitrate) on mortality and physiologic end points suggest that the profile of effects might be enhanced if the regimens were used in combination.
Influence of Prerandomization (Baseline) Variables on Mortalit and on the Reduction of Mortalit by Enalapril Veterans Affairs Cooperative Study on Vasodilator Therapy of Heart Failure (V‐HeFT II)
Of the prerandomization characteristics that were predictive of mortality in patients with CHF, only neurohormone measurements, cardiothoracic ratios, arrhythmia severity, and NYHA class identified subgroups of patients who benefited most from treatment with enalapril.