by Rebecca Boxhorn, JD, Research Associate at the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota

The second day of the 2012 Advancing Ethical Research (AER) Conference got off to an engaging start thanks to the Keynote Address given by Dr. James R. Gavin III, executive vice president and chief medical officer of Healing Our Village, and clinical professor of medicine at Emory University School of Medicine. Dr. Gavin examined health disparities among minority communities and their relationship to clinical trials. He also demonstrated the inadequate safety and efficacy research of clinical interventions for minority populations and advocated for increased minority recruitment in clinical studies. Dr. Gavin suggested that increased involvement in clinical trials by minorities could lead to more positive medical interventions in communities who bear a disproportionate burden from chronic conditions such as diabetes and heart disease.

Human subjects research has an infamous history in the Black community. From the ethically indefensible acts at Tuskegee to the more nuanced concerns that emerged from Henrietta Lacks’ HeLa cells, the actions of biomedical researchers have fostered mistrust in the Black community. Although Dr. Gavin recognized minority communities’ “justified reluctance” to participate in clinical research, his Healing Our Village organization aims to increase minority engagement in clinical research. In order to achieve diversity in recruitment for clinical trials, Healing Our Village has highlighted the importance of cultural competence, honoring and respecting the beliefs, language, and behaviors of clinical trial participants. Increasing minority populations, Dr. Gavin argued, is required to improve the health status of medically underserved populations.

The inclusion of racial criteria in medicine is not without controversy, however. In 2005, the Food and Drug Administration approved BiDil, the “first treatment specifically for African Americans with heart failure.” The approval of BiDil set off a flurry of debate about the inclusion of self-identified racial categories in medicine. Professor Dorothy E. Roberts has been a leading critic of the basis of BiDil’s race-based usage. In a 2011 piece, Roberts argues that race-specific medicine is scientifically flawed, commercially motivated, and politically dangerous. Roberts also argues that race is a political, rather than biological, grouping. Health disparities, therefore, result “primarily [from] social inequality” rather than genetic or biological differences. The “biological definition of race” in medicine, she argues, is a false cure for health disparities and “threatens to make health and other social inequalities even worse.” Although Dr. Gavin alluded to the genetic heterogeneity of the African American population, the emphasis on recruiting self-identified minority populations in clinical trials would appear to support a biological understanding of race. Biological difference, however, cannot explain away health disparities altogether. As Professor Roberts notes, several studies undercut the correlation between genetics and the comparatively poor health status of minorities in the United States.

Although Dr. Gavin did not address these controversies, they are as present in clinical trials as in race-based pharmaceutical marketing. Both Dr. Gavin and Professor Roberts seek to reduce health disparities in minority populations. Their approaches to this unifying goal, however, may depend on incompatible definitions of race.