Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of ‘compassionate therapies’ in times of catastrophic pandemics

Author:

Zuckerman ShlomitORCID,Barlavie Yaron,Niv Yaron,Arad Dana,Lev Shaul

Abstract

Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients, either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, we suggest using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan–Do–Study–Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research—even during a pandemic.

Publisher

BMJ

Subject

Health Policy,Arts and Humanities (miscellaneous),Issues, ethics and legal aspects,Health (social science)

Reference66 articles.

1. First Case of 2019 Novel Coronavirus in the United States

2. Chloroquine for the 2019 novel coronavirus SARS-CoV-2

3. Chloroquine for COVID-19: rationale, facts, hopes;Cortegiani;Crit Care,2020

4. FDA News Release April 24th Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems. Available: https://www.fda.gov/news-events/press-announcements/coronavirus-COVID-19-update-fda-reiterates-importance-close-patient-supervision-label-use [Accessed 27 Jun 2020].

5. Paediatric prescribing: using unlicensed drugs and medicines outside their licensed indications

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