Greenwall Scholar to Examine Use of 'Race' in Medicine
June 16 , 2009
Durham, NC -- People cannot be classified into distinct races based on their biology, but that hasn’t stopped the use of racial categories in clinical research and practice.
“There is need for a balance between social justice and scientific validity in addressing disparate health outcomes,” said Charmaine Royal of the Duke Institute for Genome Sciences & Policy. “A pressing question is: How do you eliminate or reduce health disparities” -- an effort that by necessity involves the identification and partitioning of people into groups – “and stay true to the science?” she asked. “How do you do both?”
Royal will seek answers to that and related questions over the next three years as a Greenwall Faculty Scholar, a prestigious bioethics award granted by The Greenwall Foundation. She will approach the problem through careful examination of the case of BiDil, a controversial heart failure drug that the FDA approved in 2005 only for use in self-identified African Americans.
“For me, it’s less about BiDil and more about the lessons BiDil has for us, which haven’t been adequately unveiled and appreciated,” said Royal, who has become increasingly interested in the complexities of the BiDil case ever since she testified against the drug’s approval in the June 2005 FDA hearing.
Although much has been written about BiDil since that time, Royal thinks a more nuanced approach to the issues raised by the case has been lacking. After all, decisions about whether or how to use race or ancestry in biomedical research and clinical practice are not made in isolation, she notes. Rather, they are made within a “complex web comprising academic, scientific, commercial, political, social, economic, regulatory, clinical and other forces.” Even when all parties try to do “good,” as Royal believes they typically do, conflicts among the interests and ethics within each of those realms make for a complicated balancing act.
To better understand that interplay, Royal will conduct a detailed case study of BiDil’s history. She also intends to interview many of the major players in the case, including representatives of NitroMed, the company that made the drug; the FDA, which advised the company to conduct the drug trial involving only African Americans and later approved the drug based on those study results; and the National Association for the Advancement of Colored People (NAACP), which pushed for the drug’s approval. She will also talk with heart failure patients and cardiologists.
“I’m looking forward to unraveling the case,” she said. “Many people probably think that BiDil came and went, but there are a lot of nooks and crannies that need to be probed.”
Lessons learned from the case “will move us well beyond BiDil to anticipate and better respond to all kinds of discoveries and diagnosis- and treatment-related applications that might be based on race or ancestry information,” she said.
The Greenwall Foundation’s program in bioethics has provided funding to scholars representing many disciplines since 1991, with the goal to provide “guidance for those engaged in decision making at the bedside as well as those responsible for shaping institutional and public policy.” Royal is the second Greenwall Scholar at Duke in recent years. Anne Lyerly, an assistant professor of obstetrics and gynecology, was named a Greenwall Scholar in 2004 to study women’s attitudes about their own frozen embryos.