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

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Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of ‘compassionate therapies’ in times of catastrophic pandemics
  1. Shlomit Zuckerman1,
  2. Yaron Barlavie2,3,
  3. Yaron Niv4,5,
  4. Dana Arad6,7,
  5. Shaul Lev8
  1. 1 Department of Disaster Medicine & Center for Bioethics and Law, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  2. 2 Division of Intensive Care, Rambam Health Care Campus, Haifa, Israel
  3. 3 Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel
  4. 4 Quality and Safety Program, Ministry of Health, Jerusalem, Israel
  5. 5 Department of Internal Medicine, Ariel University, Ariel, Israel
  6. 6 Division of Patient Safety, Ministry of Health, Jerusalem, Israel
  7. 7 Department of Health System Managment, Bar Ilan University, Ramat Gan, Israel
  8. 8 Unit of General Intensive Care, Hasharon Hospital, Petah Tikva, Israel
  1. Correspondence to Dr Shlomit Zuckerman, School of Public Health, Department of Disaster Medicine, Tel Aviv University Sackler Faculty of Medicine, Tel Aviv 9190501, Israel; shlomit.zuckerman{at}mail.huji.ac.il

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.

  • clinical trials
  • research ethics
  • public health ethics
  • policy guidelines/inst. review boards/review cttes
  • drugs and drug industry

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study. No datasets generated or analysed for this study.

This article is made freely available for personal use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

https://doi.org/10.1136/medethics-2020-106783

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    Data availability statement

    Data sharing not applicable as no datasets generated and/or analysed for this study. No datasets generated or analysed for this study.

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    Footnotes

    • Contributors SZ initiated the manuscript writing, wrote the first draft and was responsible for most revisions content, to finalise and wrap up the group responses to all the reviewers’ comments in all revisions. YB read through and critically commented on the first draft and initiated the section on PDSAYN critically read the first draft, added the history of the clinical trials SOLIDARITY and RECOVERY and assisted in responding to reviewers’ comments. DA added the Israeli experience and regulation regarding pandemic response and added to the history of PDSA and its application to MEURI. SL contributed the ethical perspective regarding compassionate use versus clinical trials in early response to emergency situation in general and the current pandemic in particular and provided explanation of its practical implications. In addition, wrote the part of the statistical limitations.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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