TY - JOUR
T1 - Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic
AU - Shah, Seema K.
AU - Wendler, David
AU - Danis, Marion
N1 - Funding Information:
The Intramural Research Program of the National Institutes of Health (NIH) and the Warren G. Magnuson Clinical Center supported this research. The authors are U.S.
Publisher Copyright:
© 2015 This article is not subject to U.S. copyright law.
PY - 2015/4/3
Y1 - 2015/4/3
N2 - 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.
AB - 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.
KW - compassionate use
KW - experimental therapy
KW - physician-patient relationship
KW - research ethics
KW - resource allocation
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U2 - 10.1080/15265161.2015.1010996
DO - 10.1080/15265161.2015.1010996
M3 - Article
C2 - 25856592
AN - SCOPUS:84927641911
SN - 1526-5161
VL - 15
SP - 11
EP - 16
JO - American Journal of Bioethics
JF - American Journal of Bioethics
IS - 4
ER -