Center for Bioethics and Humanities, University of Colorado Anschutz Medical Campus, Aurora, USA.
Innovation+Design Enabling Access (IDEA) Initiative, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA.
Infect Dis Poverty. 2022 Sep 16;11(1):99. doi: 10.1186/s40249-022-01023-6.
Mass drug administration (MDA) of medications to entire at-risk communities or populations has shown promise in the control and elimination of global infectious diseases. MDA of the broad-spectrum antibiotic azithromycin has demonstrated the potential to reduce childhood mortality in children at risk of premature death in some global settings. However, MDA of antibiotics raises complex ethical challenges, including weighing near-term benefits against longer-term risks-particularly the development of antimicrobial resistance that could diminish antibiotic effectiveness for current or future generations. The aim of this study was to understand how key actors involved in MDA perceive the ethical challenges of MDA.
We conducted 35 semi-structured interviews from December 2020-February 2022 with investigators, funders, bioethicists, research ethics committee members, industry representatives, and others from both high-income countries (HICs) and low- and middle-income countries (LMICs). Interview participants were identified via one of seven MDA studies purposively chosen to represent diversity in terms of use of the antibiotic azithromycin; use of a primary mortality endpoint; and whether the study occurred in a high child mortality country. Data were analyzed using constructivist grounded theory methodology.
The most frequently discussed ethical challenges related to meaningful community engagement, how to weigh risks and benefits, and the need to target MDA We developed a concept map of how participants considered ethical issues in MDA for child mortality; it emphasizes MDA's place alongside other public health interventions, empowerment, and equity. Concerns over an ethical double standard in weighing risks and benefits emerged as a unifying theme, albeit one that participants interpreted in radically different ways. Some thought MDA for reducing child mortality was ethically obligatory; others suggested it was impermissible.
Ethical challenges raised by MDA of antibiotics for childhood mortality-which span socio-cultural issues, the environment, and effects on future generations-require consideration beyond traditional clinical trial review. The appropriate role of MDA also requires attention to concerns over ethical double standards and power dynamics in global health that affect how we view antibiotic use in HICs versus LMICs. Our findings suggest the need to develop additional, comprehensive guidance on managing ethical challenges in MDA.
向整个高危社区或人群大规模投药（MDA）已显示出在控制和消除全球传染病方面的潜力。在一些全球环境中，广谱抗生素阿奇霉素的 MDA 已显示出降低有早逝风险的儿童死亡率的潜力。然而，抗生素 MDA 带来了复杂的伦理挑战，包括权衡近期利益与长期风险——特别是抗生素耐药性的发展，这可能会降低当前或未来几代人的抗生素有效性。本研究旨在了解参与 MDA 的主要利益相关者如何看待 MDA 的伦理挑战。
我们于 2020 年 12 月至 2022 年 2 月期间，对来自高收入国家（HICs）和低收入及中等收入国家（LMICs）的调查人员、资助者、生物伦理学家、研究伦理委员会成员、行业代表等进行了 35 次半结构化访谈。通过有目的选择的七项 MDA 研究中的一项来确定访谈参与者，这些研究在使用抗生素阿奇霉素、使用主要死亡率终点以及研究是否发生在高儿童死亡率国家方面代表了多样性。使用建构主义扎根理论方法分析数据。
最常讨论的伦理挑战与有意义的社区参与、如何权衡风险和收益以及靶向 MDA 的必要性有关。我们绘制了一幅参与者如何考虑 MDA 对儿童死亡率的伦理问题的概念图；它强调了 MDA 在其他公共卫生干预措施、赋权和公平方面的地位。权衡风险和收益方面的伦理双重标准问题作为一个统一的主题出现，但参与者对此有截然不同的解释。一些人认为，减少儿童死亡率的 MDA 是道德义务；另一些人则认为这是不允许的。
抗生素 MDA 对儿童死亡率提出的伦理挑战——涵盖社会文化问题、环境和对后代的影响——需要超越传统临床试验审查进行考虑。MDA 的适当作用也需要关注全球卫生中关于伦理双重标准和权力动态的问题，这些问题影响了我们对高收入国家与中低收入国家抗生素使用的看法。我们的研究结果表明，有必要制定额外的、全面的 MDA 管理伦理挑战指南。
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