Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization

Abstract

Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research. In conditions of scarcity, prioritization approaches should minimize harm, maximize benefit, and promote fairness. To promote continued data collection, patients seeking access to unproven COVID-19 drugs should receive lower priority for allocation when they decline to participate in clinical trials, either of the requested drug or other investigational products, offering a comparable balance of risks and benefits; special attention should be paid to concerns of voluntariness and distrust. In addition, institutional treatment protocols that can contribute more robust real world data should be preferred to single patient requests for access, with priority for inclusion based on traditional clinical allocation criteria relying on available evidence. Fairness demands distribution of these protocols across a diverse range of sites, particularly those serving marginalized populations, among other protections.     

The Significance of Political and Economic Change in Two Generations of Slovaks and Hungarians

Two generations of Slovaks and of Hungarians responded to a short questionnaire sampling their opinions about recent political and economic changes in their respective countries. The younger generation were aged 18–23 and the older generation 40–45. In general, Slovaks expressed a higher degree of freedom of choice compared to Hungarians in various areas of their lives. Hungarians reported themselves to be more interested in politics at all levels (national, European and international) than their Slovak counterparts. These and other significant effects (relating to generational differences and differences in levels of education) are discussed in relation to recent changes in the political economies of the two countries. (© 1997 by John Wiley & Sons, Ltd.)     

FRAMES OF COMPARISON Anthropology and Inheriting Traditional Practices

This essay seeks to develop and illustrate an approach to comparison based on ad hoc frames. A frame is defined by a question, to which different thinkers can be seen as offering complementary and/or competing responses. Pursuing a middle ground between universalist conceptions of comparison and particularist rejections of comparison, this approach brings various positions into dialogue in a manner that is not inherently totalizing. The article draws extensively on Hegel's philosophy of religion to articulate this approach to comparison and its presuppositions. The second section of the essay seeks to illustrate the value of this approach by using the question of how traditional practices are inherited to frame a comparison of Hegel on habit and the Confucian thinker Xunzi on ritual. This comparison functions principally to indicate the process of comparison and suggest the value of pursuing this comparison in greater depth.     

Moral dilemmas and moral rules

Recent work shows an important asymmetry in lay intuitions about moral dilemmas. Most people think it is permissible to divert a train so that it will kill one innocent person instead of five, but most people think that it is not permissible to push a stranger in front of a train to save five innocents. We argue that recent emotion-based explanations of this asymmetry have neglected the contribution that rules make to reasoning about moral dilemmas. In two experiments, we find that participants show a parallel asymmetry about versions of the dilemmas that have minimized emotional force. In a third experiment, we find that people distinguish between whether an action violates a moral rule and whether it is, all things considered, wrong. We propose that judgments of whether an action is wrong, all things considered, implicate a complex set of psychological processes, including representations of rules, emotional responses, and assessments of costs and benefits.     

Relationships,not boundaries

The authors find it more useful to payattention to relationships than to boundaries.By focusing attention on bounded, individualpsychological issues, the metaphor ofboundaries can distract helping professionalsfrom thinking about inequities of power. Itoversimplifies a complex issue, inviting us toignore discourses around gender, race, class,culture, and the like that support injustice,abuse, and exploitation. Making boundaries acentral metaphor for ethical practice can keepus from critically examining the effects ofdistance, withdrawal, and non-participation.The authors describe how it is possible toexamine the practical, moral, and ethicaleffects of our participation in relationshipsby focusing on just relationships rather thanon boundaries. They give illustrations andclinical examples of relationally-focusedethical practices that derive from a narrativeapproach to therapy.     

Medical Decision-Making: An Argument for Narrative and Metaphor

This study examines the processes ofdecision-making used by intensive care(critical care) specialists. Ninety-ninespecialists completed a questionnaire involvingthree clinical cases, using a novel methodologyinvestigating the role of uncertainty andtemporal-related factors, and exploring a rangeof ethical issues. Validation and triangulationof the results was done via a comparison studywith a medically lay, but highly informed groupof 37 law students. For both study groups,constructing reasons for a decision was largelyan interpretative and imaginative exercise thatwent beyond the data (as presented), commonlyresulting in different reasons supporting thesame conclusions and similar reasons supportingopposite conclusions. The skills of ethicalimagination and interpretation were related toan individual's prior lived experience,construed in the broadest sense. Application ofthese skills of ethical imagination andinterpretation always occurred, to some degree,in a state of uncertainty and almost alwaysinvolved temporal relationships.Using these results, a theory of ethicaldecision-making is proffered. Three levels ortypes of reasoning processes may be present.Type I decision-making involves the applicationof rules, usually in a deductive fashion. TypeII decision-making is characterised by aprocess where a plurality of reasons arebalanced, weighed and sifted with each other.Type III decision-making is intimately linkedwith respondents lived experiences and `crafts'the content of type I and II reasoningprocesses, via the application of ethicalimagination and interpretation. Relationshipsbetween these three types of reasoningprocesses, and with narrative ethics, are alsodiscussed.     

Traversing boundaries: clinical ethics,moral experience,and the withdrawal of life supports

While many have suggested that to withdraw medical interventions is ethically equivalent to withholding them, the moral complexity of actually withdrawing life supportive interventions from a patient cannot be ignored. Utilizing interplay between expository and narrative styles, and drawing upon our experiences with patients, families, nurses, and physicians when life supports have been withdrawn, we explore the changeable character of boundaries in end-of-life situations. We consider ways in which boundaries imply differences – for example, between cognition and performance – and how the encounter with boundaries can generate altered meanings important for understanding decisions and actions in these contexts. We conclude that the reliance on mere roles to support the moral weight of withdrawing medical interventions is inadequate. Roles that lead us to such moments are exceeded by the responsibility encountered in such moments. And here, we suggest, is the momentous character of withdrawal: it presents the grave astonishment, the trembling awe, in the not-being-there of the other in death.     

Boundaries in the doctor-patient relationship

Boundaries in the doctor–patient relationshipis an important concept to help healthprofessionals navigate the complex andsometimes difficult experience between patientand doctor where intimacy and power must bebalanced in the direction of benefitingpatients. This paper reviews the concept ofboundary violations and boundary crossings inthe doctor–patient relationship, cautions aboutcertain kinds of boundary dilemmas involvingdual relationships, gift giving practices,physical contact with patients, andself-disclosure. The paper closes with somerecommendations for preventing boundaryviolations.     

Conflicts of interest in science and medicine: the physician's perspective

The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association’s Code of Medical Ethics (2000–2001 Edition) that address the various forms of conflict of interest that can arise in the practice of medicine are outlined. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. The World Medical Association (WMA) is a global federation of National Medical Associations representing the millions of physicians worldwide. Acting on behalf of patients and physicians, the WMA endeavours to achieve the highest possible standards of medical care, ethics, education and health-related human rights for all people.