Race-based studies: The slippery slope of pharmacogenetics?

Race serves an important, yet controversial, role in many pharmacogenetic studies. The 2005 FDA approval of BiDil (isosorbide dinitrate/hydralazine), the first drug with a race-specific indication, fueled the debate regarding the risks and benefits of race-based studies. Proponents of BiDil contended that this drug's race-specific development and approval was appropriate and necessary. By focusing on African Americans, researchers were able to target a subgroup of patients who were more likely to respond to the drug, thereby increasing the likelihood of success and decreasing the time to market. They argued that race is a reasonable substitute for specific genetic information, yielding valuable information regarding relevant biological pathways. Critics, however, stated that race represents more than genetic information, often reflecting social and environmental factors. They argued that race-based studies perpetuate racism and lead to inferior care for populations that are considered inappropriate markets by the pharmaceutical industry. After considering these arguments, we believe there is a role for race-based studies in pharmacogenetics. However, these studies must be designed and interpreted cautiously. Researchers must be aware of the social and ethical implications of their studies, and policy makers should prioritize research funding for studies involving financially disadvantaged populations.