‘A Most Equitable Drug’: How the Clinical Studies of Convalescent Plasma as a Treatment for SARS-CoV-2 Might Usefully Inform Post-Pandemic Public Sector Approaches to Drug Development

The Journal of Law, Medicine & Ethics, 2023

71 Pages Posted: 17 Jan 2023 Last revised: 14 Apr 2023

See all articles by Quinn Grundy

Quinn Grundy

University of Toronto - Lawrence S. Bloomberg Faculty of Nursing

Chantal Campbell

University of Toronto - Lawrence S. Bloomberg Faculty of Nursing

Ridwaanah Ali

University of Toronto - Lawrence S. Bloomberg Faculty of Nursing

Matthew Herder

Dalhousie University - Faculties of Medicine and Law; Dalhousie University - Faculty of Medicine

Kelly Holloway

University of Toronto - Institute of Health Policy, Management and Evaluation

Date Written: January 11, 2023

Abstract

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and public funding and infrastructure. Clinical studies also served to build public sector and health system capacity and generate clinical trials and blood services infrastructure. Though convalescent plasma represents a failed COVID-19 treatment, key insights from these studies can be used to enhance the likelihood of success of future models of biopharmaceutical production, designed in the service of ensuring equitable access to biopharmaceuticals, should the political will and financing to support such models someday follow.

Note:
Funding declaration: This work was funded by the Social Science and Humanities Research Council (SSHRC) of Canada through a Partner Engage Grant and the MITACS Accelerate Program in partnership with Canadian Blood Services. MH holds funding from the Canadian Institutes of Health Research (CIHR PJT 156256) and has been awarded a chair in Applied Public Health, which is funded by the CIHR and the Public Health Agency of Canada.

Conflict of Interests: QG, CC, RA, and KH declare no conflicts of interest. MH reports being a member of the Patented Medicine Prices Review Board, Canada’s national drug price regulator, and receiving honoraria from the Board for his service.

Keywords: Convalescent plasma; randomized controlled trials, clinical trials, public sector, innovation, pharmaceutical industry

JEL Classification: I18

Suggested Citation

Grundy, Quinn and Campbell, Chantal and Ali, Ridwaanah and Herder, Matthew and Holloway, Kelly, ‘A Most Equitable Drug’: How the Clinical Studies of Convalescent Plasma as a Treatment for SARS-CoV-2 Might Usefully Inform Post-Pandemic Public Sector Approaches to Drug Development (January 11, 2023). The Journal of Law, Medicine & Ethics, 2023, Available at SSRN: https://ssrn.com/abstract=4322653 or http://dx.doi.org/10.2139/ssrn.4322653

Quinn Grundy (Contact Author)

University of Toronto - Lawrence S. Bloomberg Faculty of Nursing ( email )

Chantal Campbell

University of Toronto - Lawrence S. Bloomberg Faculty of Nursing

Ridwaanah Ali

University of Toronto - Lawrence S. Bloomberg Faculty of Nursing

Matthew Herder

Dalhousie University - Faculties of Medicine and Law ( email )

6225 University Avenue
Halifax, Nova Scotia B3H 4H7
Canada

Dalhousie University - Faculty of Medicine ( email )

Kelly Holloway

University of Toronto - Institute of Health Policy, Management and Evaluation

Do you have negative results from your research you’d like to share?

Paper statistics

Downloads
67
Abstract Views
579
Rank
608,356
PlumX Metrics