The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency

Loading...
Thumbnail Image

Date

2020

Journal Title

Journal ISSN

Volume Title

Repository Usage Stats

75
views
86
downloads

Citation Stats

Abstract

Abstract The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of physicians to do what they and their patients think is the best course of action. In this essay we ask whether the special conditions existing in a public healthcare crisis, such as the current pandemic, would justify a relaxing of our argument and permit ongoing unregulated off-label use. We outline at least four areas of concern, all of which can be exacerbated by the widespread distress and despair amongst doctors, patients and other stakeholders. We contend that, if anything, these conditions warrant even more caution and scrutiny of this practice.

Department

Description

Provenance

Subjects

Citation

Published Version (Please cite this version)

10.1093/jlb/lsaa031

Publication Info

Coleman, D, and P Rosoff (2020). The Enhanced Danger of Physicians’ Off-Label Prescribing During a Public Health Emergency. Journal of Law and the Biosciences. 10.1093/jlb/lsaa031 Retrieved from https://hdl.handle.net/10161/21293.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Coleman

Doriane Lambelet Coleman

Thomas L. Perkins Distinguished Professor

Doriane Coleman is Professor of Law at Duke Law School, where she specializes in interdisciplinary scholarship focused on women, children, medicine, sports, and law. Her work, single- and co-authored, has been published in numerous U.S. and international journals. She also writes op-eds and is regularly cited in the press.

Her most recent scholarship has centered on sex, its evolving definition, and the implications of this evolution for law and society. The first two articles in this series – Sex in Sport and Re-affirming the Value of the Sports Exception to Title IX's General Non-Discrimination Rule – have been widely read and used in the development of eligibility criteria for the female category. A third article – Sex Neutrality – traces the history of sex in law and addresses the merits of a final move from sex skepticism to sex-blindness. Her forthcoming book On Sex and Gender – A Commonsense Approach (2024) expands on these themes for a broader audience.

At Duke, Coleman is a Faculty Fellow and Member of the Advisory Council of the Kenan Institute for Ethics, and a Faculty Associate of the Trent Center for Bioethics, Humanities & History of Medicine at the School of Medicine, and the University’s Initiative for Science & Society. She is also a member of the University’s Athletic Council and co-director of the Law School’s Center for Sports Law and Policy.

She received her Juris Doctor degree from Georgetown Law and her Bachelor of Arts degree from Cornell University. She was a litigation associate at Wilmer, Cutler & Pickering before beginning her academic career at Howard University School of Law.

Before law school, Coleman ran the 800 meters in collegiate and international competition. She was a multiple All American, All East, and All Ivy athlete, the U.S. National Collegiate Indoor Champion in the 800 meters in 1982, the U.S. National Indoor Champion in the 4 x 400 meters relay in 1982, and the Swiss National Champion in the 800 meters in 1982 and 1983. Over the course of her athletic career she competed for Villanova and Cornell, the Swiss and U.S. National Teams, Athletics West, the Santa Monica and Atoms Track Clubs, and Lausanne Sports.

Rosoff

Philip Martin Rosoff

Professor Emeritus of Pediatrics

My main interests are clinical ethics with a concentration on the equitable allocation of scarce resources (rationing). In this area, I have done work on planning for pandemic influenza and allocation of drugs during shortages. Before retirement I played a major role in the Clinical Ethics Service at Duke Hospital and chair the hospital's Ethics Committee.


Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.