title: Examining the ethics of clinical use of unproven interventions outside of clinical trials during the Ebola epidemic.
abstract: The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease (EVD), debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned with the interests of their providers and drug developers. Second, we focus on the resource constraints facing providers, funders, and patients and conclude that they often counsel against the use of unproven interventions against EVD.
authors: a Clinical Center Department of Bioethics, Division of AIDS, National Institutes of Health , Bethesda , Maryland , USA.
authors: Seema K
authors: SK
authors: Shah
authors: David
authors: D
authors: Wendler
authors: Marion
authors: M
authors: Danis
mesh_terms: D000354:Africa, Western / Q000453:epidemiology; D002986:Clinical Trials as Topic; D057176:Compassionate Use Trials / Q000941:ethics*; D004196:Disease Outbreaks / Q000517:prevention & control; D032984:Ethics, Research; D019142:Hemorrhagic Fever, Ebola / Q000453:epidemiology* / Q000517:prevention & control / Q000628:therapy*; D006801:Humans; D010817:Physician-Patient Relations / Q000941:ethics; D040841:Resource Allocation / Q000941:ethics*; D036302:Therapeutic Human Experimentation / Q000941:ethics*
keywords: compassionate use; experimental therapy; physician-patient relationship; research ethics; resource allocation