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Viewpoint |

The Ethical Challenges of Compassionate Use

Arthur L. Caplan, PhD1; Amrit Ray, MD, MBA2
[+] Author Affiliations
1Division of Medical Ethics, NYU Langone Medical Center, New York, New York
2Janssen Research & Development LLC, Titusville, New Jersey
JAMA. 2016;315(10):979-980. doi:10.1001/jama.2016.0416.
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This Viewpoint discusses ethical issues related to rapid access to investigational agents (compassionate use) and outlines a patient-focused approach to responding to compassionate use requests.

Granting access to drugs, vaccines, biologics, and devices that have not yet been approved by governmental regulatory authorities is a growing challenge for physicians, public officials, patient advocacy groups, institutional review boards (IRBs), and patients.1 Although the issue of rapid access to investigational agents is not new, tracing back to the early days of the human immunodeficiency virus pandemic, the pace of requests has increased. This is attributable to many factors, including greater awareness of compassionate use on the part of patients and their physicians; more information available through the Internet and websites describing clinical trials; an increase in promising interventions, including genetic markers, immunotherapies, and recombinant vaccines; threats from potential epidemics such as Ebola, cholera, and influenza; and an increased willingness to try novel agents by patients who are chronically ill or dying.

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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