Wylie Burke, M.D., Ph.D
Professor and Chair, Department of Bioethics and Humanities
University of Washington
The clinical utility of medical care is determined by the value of the outcomes it produces. Like other measures of value, it is often contested. Stakeholders may have different views about benefits and risks and about the importance of social versus health outcomes. They also commonly disagree about the evidence needed to determine whether a test or procedure is effective in achieving a specific outcome. These debates occur routinely in the evaluation of innovative care, and are already an important part of the discourse about genomic translation. Defining the different issues at stake is therefore an important element of policy-making. These issues include evidence standards for test use – in particular, the circumstances under which prospective controlled data should be required and the feasibility, cost and equitable delivery of services. Proposals for genomic profiling also raise questions about the goals of population-based screening programs, including the role of social outcomes in evaluating test value. Addressing each of these issues will require methods for effective deliberation that incorporate diverse stakeholder perspectives.