Stewardship according to context: Justifications for coercive antimicrobial stewardship policies in agriculture and their limitations.

Antimicrobial resistance (AMR) is an urgent, global threat to public health. The development and implementation of effective measures to address AMR is vitally important but presents important ethical questions. This is a policy area requiring further sustained attention to ensure that policies proposed in National Action Plans on AMR are ethically acceptable and preferable to alternatives that might be fairer or more effective, for instance. By ethically analysing case studies of coercive actions to address AMR across countries, we can better inform policy in a context-specific manner. In this article, I consider an example of coercive antimicrobial stewardship policy in Canada, namely restrictions on livestock farmers' access to certain antibiotics for animal use without a vet's prescription. I introduce and analyse two ethical arguments that might plausibly justify coercive action in this case: the harm principle and a duty of collective easy rescue. In addition, I consider the factors that might generally limit the application of those ethical concepts, such as challenges in establishing causation or evidencing the scale of the harm to be averted. I also consider specifics of the Canadian context in contrast to the UK and Botswana as example settings, to demonstrate how context-specific factors might mean a coercive policy that is ethically justified in one country is not so in another.

Ethical issues in Nipah virus control and research: addressing a neglected disease.

Nipah virus is a priority pathogen that is receiving increasing attention among scientists and in work on epidemic preparedness. Despite this trend, there has been almost no bioethical work examining ethical considerations surrounding the epidemiology, prevention, and treatment of Nipah virus or research that has already begun into animal and human vaccines. In this paper, we advance the case for further work on Nipah virus disease in public health ethics due to the distinct issues it raises concerning communication about the modes of transmission, the burdens of public health surveillance, the recent use of stringent public health measures during epidemics, and social or religious norms intersecting with preventive measures. We also advance the case for further work on Nipah virus disease in research ethics, given ethical issues surrounding potential vaccine trials for a high-fatality disease with sporadic spillover events, the different local contexts where trials may occur, and the potential use of unproven therapeutics during outbreaks. Further bioethics work may help to ensure that research and public health interventions for Nipah virus disease are ethically acceptable and more likely to be effective.

Funder priority for vaccines: Implications of a weak Lockean claim.

The development of some COVID-19 vaccines by private companies like Moderna and Sanofi-GSK has been substantially funded by various governments. While the Sanofi CEO has previously suggested that countries that fund this development ought to be given some priority, this suggestion has not been taken seriously in the literature. Considerations of nationalism, sustainability, need, and equitability have been more extensively discussed with respect to whether and how much a country is entitled to advance purchase orders of the vaccine under conditions of absolute scarcity. Yet, little attention has been paid to whether prior investment into developing a vaccine entitles a country to some priority with respect to these orders. Moreover, while not a majority view, some survey results show that a significant minority of the populace does endorse some view like this. This article argues that the minority have a point: recognizing funder countries some priority is justified by the weak Lockean claim (WLC). According to the WLC, the fact that someone has contributed to the development of something gives them some entitlement to the resultant product. This article will defend the WLC, and address objections to the argument, including those pertaining to questions of historical injustice and medical need. This argument does not imply an unconstrained entitlement. Rather, contribution to development is one morally relevant factor that must be tempered by and weighed against potentially more substantial claims to priority based on need, equity, and other considerations.

A trade-off: Antimicrobial resistance and COVID-19.

As we combat the COVID-19 pandemic, both the prescription of antimicrobials and the use of biocidal agents have increased in many countries. Although these measures can be expected to benefit existing people by, to some extent, mitigating the pandemic's effects, they may threaten long-term well-being of existing and future people, where they contribute to the problem of antimicrobial resistance (AMR). A trade-off dilemma thus presents itself: combat COVID-19 using these measures, or stop using them in order to protect against AMR. Currently, I argue, we are choosing to continue with these measures, and thus to prioritize combatting COVID-19, without adequate ethical reflection on the AMR-associated costs of these measures. I discuss the magnitude of the possible costs and benefits involved in making the trade-off in favour of COVID-19, and their distribution. I highlight two salient aspects of distribution that can help determine whether combatting COVID-19 whilst exacerbating AMR produces justly distributed costs and benefits: distribution between current and future populations, and distribution between existing geographical populations. Adopting this account, I argue that based on the magnitude and distribution of costs and benefits of combatting COVID-19, we have good reason to rethink this trade-off, and instead consider prioritizing protecting current and future people against AMR, but jettisoning measures against COVID-19 that also exacerbate AMR.

Enhancing the collectivist critique: accounts of the human enhancement debate.

Individualist ethical analyses in the enhancement debate have often prioritised or only considered the interests and concerns of parents and the future child. The collectivist critique of the human enhancement debate argues that rather than pure individualism, a focus on collectivist, or group-level ethical considerations is needed for balanced ethical analysis of specific enhancement interventions. Here, I defend this argument for the insufficiency of pure individualism. However, existing collectivist analyses tend to take a negative approach that hinders them from adequately contributing to balanced ethical analysis, and often leads to a prohibitive stance. I argue this is due to two common problems with collectivist analyses: inappropriate acceptance of individualist assumptions, and failure to appropriately weigh individual vs collective ethical considerations. To further develop the collectivist critique in the enhancement debate, I suggest we may look to collectivism in public health ethics, which avoids these problems.

Developing an Ethical Evaluation Framework for Coercive Antimicrobial Stewardship Policies.

Antimicrobial resistance (AMR) has been declared one of the top ten global public health threats facing humanity. To address AMR, coercive antimicrobial stewardship policies are being enacted in some settings. These policies, like all in public health, require ethical justification. Here, I introduce a framework for ethically evaluating coercive antimicrobial stewardship policies on the basis of ethical justifications (and their limitations). I consider arguments from effectiveness; duty of easy rescue; tragedy of the commons; responsibility-tracking; the harm principle; paternalism; justice and development; a precautionary approach; and professional duties. I consider how these justifications might form the basis for developing a comprehensive ethical framework, and the need for this to be context-specific and aligned with the priorities, evidence and needs of the particular jurisdictions in which a policy is to be enacted. I demonstrate how the ethical justifications might be used by reference to an example policy of the EU ban on the use of certain human-critical antibiotics for livestock, before concluding with challenges for further development of the framework.

For the Good of the Globe: Moral Reasons for States to Mitigate Global Catastrophic Biological Risks.

Actions to prepare for and prevent pandemics are a common topic for bioethical analysis. However, little attention has been paid to global catastrophic biological risks more broadly, including pandemics with artificial origins, the creation of agents for biological warfare, and harmful outcomes of human genome editing. What's more, international policy discussions often focus on economic arguments for state action, ignoring a key potential set of reasons for states to mitigate global catastrophic biological risks: moral reasons. In this paper, I frame the mitigation of such risks as a global public good, and I explore three possible categories of moral reasons that might motivate states to provide this global public good: nationalism, cosmopolitanism, and interstate obligations. Whilst there are strong objections to moral nationalism as a reason for states to act, moral cosmopolitanism may provide a broad reason which is further supplemented for individual states through the elaboration of interstate moral obligations. The obligations I consider are moral leadership, fairness, and reciprocity. Moral reasons for individual states action may more effectively or more appropriately motivate states to mitigate global catastrophic biological risks.

Interventions to address antimicrobial resistance: an ethical analysis of key tensions and how they apply in low- income and middle-income countries.

Antimicrobial resistance (AMR) is a global health and one health problem. Efforts to mitigate the problem of AMR are challenging to implement due to unresolved ethical tensions. We present an in-depth ethical analysis of tensions that might hinder efforts to address AMR. First, there is a tension between access and excess in the current population: addressing lack of access requires facilitating use of antimicrobials for some populations, while addressing excessive use for other populations. Second, there is a tension between personal interests and a wider, shared interest in curbing AMR. These personal interests can be viewed from the perspective of individuals seeking care and healthcare providers whose livelihoods depend on using or selling antimicrobials and who profit from the sales and use of antimicrobials. Third, there is a tension between the interests of current populations and the interests of future generations. Last, there is a tension between addressing immediate health threats such as pandemics, and AMR as a 'silent', chronic threat. For each of these tensions, we apply 'descriptive ethics' methods that draw from existing evidence and our experiences living and working in low-income and middle-income countries to highlight how these ethical tensions apply in such settings.

Coercive public health policies need context-specific ethical justifications.

Public health policies designed to improve individual and population health may involve coercion. These coercive policies require ethical justification, and yet it is unclear in the public health ethics literature which ethical concepts might justify coercion, and what their limitations are in applying across contexts. In this paper, we analyse a number of concepts from Western bioethics, including the harm principle, paternalism, the public interest, and a duty of easy rescue. We find them plausible justifications for coercion in theory, but when applied to case studies, including HIV testing in Malawi, vaccine mandates in South Africa, and prohibitions of antibiotic use in livestock in the EU, their limitations become clear. We argue that the context-specificity of ethical justifications for coercion has been overlooked, and there is more work needed to identify context-relevant ethical justifications for coercive policies in various settings and for various populations, rather than relying on universalising Western bioethical justifications across all contexts.

Pharmacy Student Education Related to Opioids: A Scoping Review of the Literature.

OBJECTIVES: This scoping review explores and assesses the extent of the literature on the current state of opioid-related training and education of student pharmacists and identifies areas for further research to improve the preparedness of future pharmacists in managing care for patients using opioid medications. This review also examines and maps the literature as it relates to the 4 substance misuse educational content areas (legal/ethical issues; screening, treatment, and stigma; pharmacology and toxicology; and psychosocial aspects) recommended by the 2020 American Association of Colleges of Pharmacy Special Committee on Substance Use and Pharmacy Education. FINDINGS: A systematic literature search was conducted to identify articles reporting opioid-related educational and training initiatives for student pharmacists in the United States through May 2023. A total of 52 articles were included in the review. Nearly 40% of the included studies reported content that addressed all 4 recommended content areas, with only 8 addressing only 1 or 2 content areas. The majority of studies included students in the third year of their pharmacy program, with many reporting interprofessional educational initiatives. Assessments of opioid-related knowledge and attitudes, satisfaction with the activity, and interprofessional attitudes and competencies were reported. SUMMARY: Most of the reported activities addressed at least 3 of the recommended educational content areas. However, relatively few reported sufficient details to support the replication of the activities and there is a need to evaluate the effectiveness of these educational initiatives with more vigorous research methodology to determine their potential effectiveness.

The ethical challenges of diversifying genomic data: A qualitative evidence synthesis.

This article aims to explore the ethical issues arising from attempts to diversify genomic data and include individuals from underserved groups in studies exploring the relationship between genomics and health. We employed a qualitative synthesis design, combining data from three sources: 1) a rapid review of empirical articles published between 2000 and 2022 with a primary or secondary focus on diversifying genomic data, or the inclusion of underserved groups and ethical issues arising from this, 2) an expert workshop and 3) a narrative review. Using these three sources we found that ethical issues are interconnected across structural factors and research practices. Structural issues include failing to engage with the politics of knowledge production, existing inequities, and their effects on how harms and benefits of genomics are distributed. Issues related to research practices include a lack of reflexivity, exploitative dynamics and the failure to prioritise meaningful co-production. Ethical issues arise from both the structure and the practice of research, which can inhibit researcher and participant opportunities to diversify data in an ethical way. Diverse data are not ethical in and of themselves, and without being attentive to the social, historical and political contexts that shape the lives of potential participants, endeavours to diversify genomic data run the risk of worsening existing inequities. Efforts to construct more representative genomic datasets need to develop ethical approaches that are situated within wider attempts to make the enterprise of genomics more equitable.

Justifying the More Restrictive Alternative: Ethical Justifications for One Health AMR Policies Rely on Empirical Evidence.

Global consumption of antibiotics has accelerated the evolution of bacterial antimicrobial resistance. Yet, the risks from increasing bacterial antimicrobial resistance are not restricted to human populations: transmission of antimicrobial resistant bacteria occurs between humans, farms, the environment and other reservoirs. Policies that take a 'One Health' approach deal with this cross-reservoir spread, but are often more restrictive concerning human actions than policies that focus on a single reservoir. As such, the burden of justification lies with these more restrictive policies. We argue that an ethical justification for preferring One Health policies over less restrictive alternatives relies on empirical evidence as well as theory. The ethical justification for these policies is based on two arguments: (i) comparatively greater effectiveness, and (ii) comparatively better tracking of moral responsibility. Yet the empirical assumptions on which these claims rest are limited by existing empirical knowledge. Using livestock farming as an example, we suggest that scientific research into characterising antimicrobial resistance and linking practices to outcomes ought to be guided (at least in part) by the imperative to supply the context-specific data needed to ethically justify preferring a One Health policy over less restrictive alternatives.

The relationship between speculation and translation in Bioethics: methods and methodologies.

There are increasing pressures for bioethics to emphasise 'translation'. Against this backdrop, we defend 'speculative bioethics'. We explore speculation as an important tool and line of bioethical inquiry. Further, we examine the relationship between speculation and translational bioethics and posit that speculation can support translational work. First, speculative research might be conducted as ethical analysis of contemporary issues through a new lens, in which case it supports translational work. Second, speculation might be a first step prior to translational work on a topic. Finally, speculative bioethics might constitute different content altogether, without translational objectives. For each conception of speculative bioethics, important methodological aspects determine whether it constitutes good bioethics research. We conclude that whether speculative bioethics is compatible with translational bioethics-and to what extent-depends on whether it is being employed as tool or content. Applying standards of impact uniformly across bioethics may inappropriately limit speculative bioethics.

Vaccination of individuals lacking decision-making capacity during a public health emergency.

This paper explores the ethical challenges in deciding whether to vaccinate individuals lacking the decision-making capacity needed to provide informed consent during a public health emergency like COVID-19. The best interests standard ordinarily governs such decisions, which under the law in jurisdictions like England, Wales and Singapore takes into account the individual's past wishes and present preferences. However, in a public health emergency, the interests of third parties become more salient: those whom the unvaccinated individual might expose to infection have an interest in the individual's being vaccinated. While current mental capacity law has not been interpreted to take such public health considerations into account, we argue that such considerations are nevertheless ethically relevant, and can legitimately be weighed up alongside other considerations such as the preferences of the individual and impacts on their health. This is most relevant for individuals lacking decision-making capacity who have previously declined or presently resist vaccination. The public health impact of vaccination may in some instances be enough to outweigh preferences of the individual and justify providing vaccination against their past or present wishes.

Most healthcare interventions tested in Cochrane Reviews are not effective according to high quality evidence: a systematic review and meta-analysis.

OBJECTIVE: To estimate the proportion of healthcare interventions tested within Cochrane Reviews that are effective according to high-quality evidence. METHODS: We selected a random sample of 2,428 (35%) of all Cochrane Reviews published between 1 January 2008 and 5 March 2021. We extracted data about interventions within these reviews that were compared with placebo, or no treatment, and whose outcome quality was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We calculated the proportion of interventions whose benefits were based on high-quality evidence (defined as having high quality GRADE rating for at least one primary outcome, statistically significant positive results, and being judged by review authors as effective. We also calculated the proportion of interventions that suggested harm. RESULTS: Of 1,567 eligible interventions, 87 (5.6%) had high-quality evidence supporting their benefits. Harms were measured for 577 (36.8%) interventions. There was statistically significant evidence for harm in 127 (8.1%) of these. Our dependence on the reliability of Cochrane author assessments (including their GRADE assessments) was the main potential limitation of our study. CONCLUSION: More than 9 in 10 healthcare interventions studied within recent Cochrane Reviews are not supported by high-quality evidence, and harms are under-reported.