Journal of Law, Medicine and Ethics 36 (3):449-457 (2008)

Paul Martin
University of Florida
The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1111/j.1748-720X.2008.290.x
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 55,968
Through your library

References found in this work BETA

[Jonas Cohn].[author unknown] - 1947 - Zeitschrift für Philosophische Forschung 1 (2):408-408.

Add more references

Citations of this work BETA

Add more citations

Similar books and articles

Speaking Off Label.Stephen R. Latham - 2010 - Hastings Center Report 40 (6):9-10.


Added to PP index

Total views
17 ( #585,173 of 2,403,328 )

Recent downloads (6 months)
3 ( #256,954 of 2,403,328 )

How can I increase my downloads?


My notes