Institute of the History, Philosophy and Ethics of Medicine, Ulm University, 89073 Ulm, Germany.
Int J Environ Res Public Health. 2021 May 26;18(11):5685. doi: 10.3390/ijerph18115685.
This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions.
本文旨在以德国为例,分析 COVID-19 大流行早期实验性药物使用所面临的伦理挑战。德国在全国范围内很早就制定了统一的伦理准则,这被其他州认为是可取的,有助于减少不确定性并传递团结一致的信息。这项伦理分析旨在为未来制定公共卫生紧急情况下使用药物的指南提供帮助。本研究从有利、不伤害、公正和自主这四项伦理原则的角度,分析了羟氯喹、瑞德西韦和 COVID-19 恢复期血浆在临床环境中的应用。我们发现,大流行期间的药物安全性和药物分配影响到所有四项伦理原则。因此,我们建议制定以下伦理准则:(i)与所有有迫切需求的人群的患者讨论实验性治疗方案;(ii)方便记录药物在超适应证使用中的患者反应;(iii)扩大临床试验的纳入标准,以避免排除组出现潜在的负面效应;(iv)为有既往疾病的患者保持足够的再利用药物的可及性。