The Ethical Justifiability of the Off-Label Use of Hydroxychloroquine During the COVID-19 Pandemic

Abstract

Hydroxychloroquine (HCQ) was granted emergency use authorization (EUA) for use in COVID-19 treatment from various health regulatory authorities in the early stages of the pandemic. This EUA led to the widespread use of HCQ during this period, attracting significant media attention and prompting ethical debates as the drug lacked evidence of effectiveness in treating COVID-19 disease. The EUA was later revoked due to emerging scientific evidence showing that HCQ did not provide the anticipated benefit for COVID-19 treatment and raised safety concerns due to its harmful side effects. The justifiability of the off-label use and temporary authorization of HCQ is normatively analyzed using the moral theory of utilitarianism. It is argued that the risks associated with its widespread use and EUA, including the harm caused to patients, to the medical profession and to society, outweigh any potential benefits. Further analysis using principlism illustrates that patient autonomy was undermined, and the principles of non-maleficence, beneficence, and justice were compromised by the off-label use and EUA of HCQ. Lastly, a virtue ethics analysis demonstrates that the decision by health regulatory authorities to grant the EUA reflects a misapplication of the virtue of compassion and undermined the virtues of prudence, trustworthiness, integrity and justice expected from the healthcare profession and health regulatory bodies.