 | | | | . . ........................... | | September 14, 2007
University of Tennessee Department of Philosophy - Fall 2007 Colloquium Series 3:30 PM (UC, SHILOH)
PHILOSOPHY & PUBLIC POLICY FEST
Further Lessons from ECMO:
The ethics and epistemology of clinical research
Dr. Robyn Bluhm
Postdoctoral Fellow–Neuropsychiatry
University of Western Ontario
Evidence-based medicine (EBM) posits a hierarchy of evidence on which the “best” evidence for the efficacy of a therapy comes from randomized controlled trials (RCTs). Moreover, there is an ethical obligation to conduct the best possible research in order both to provide the best care to future patients and to make sure that the efforts of current research participants are put to the best possible ends. On this view, exceptions to a randomized study are justifiable only when stronger ethical reasons exist for not randomizing participants to study groups, generally when the balance of benefits and harms is very different in the two groups. Thus, it is ethically justifiable to sacrifice methodological rigor when stronger ethical concerns demand it.
A rare exception to the general rule that both ethical and methodological concerns support the use of RCTs is described in Robert Truog’s analysis of the controversial RCTs of extracorporeal membrane oxygenation (ECMO) therapy in newborns. Truog offers both epistemological and ethical reasons in support of his claim that ECMO should not have been tested using RCTs, but that a long-term, large-scale observational study should have been conducted. Central to Truog’s argument, however, is the idea that ECMO is an unusual case. Thus, it is an open question whether Truog’s conclusions can be extended to other areas of medical research. In this talk, I look at epistemological and ethical issues arising in the care of patients with chronic diseases, using ECMO as a starting point. Both the similarities and the dissimilarities of these two cases highlight important issues in biomedical research and support a conclusion similar to Truog’s. Research on the treatment of chronic disease should rest primarily, not on RCTs, but on observational studies of the type described by Truog. I conclude by examining the implications of this claim for EBM.
Co-Sponsored by the Howard Baker Center for Public Policy
For more information contact: hdouglas@utk.edu
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