What kind of knowledge is medical knowledge? Can medicine be explained scientifically? Is disease a scientific concept, or do explanations of disease depend on values? What is ‘evidence-based’ medicine? Are advances in neuroscience bringing us closer to a scientific understanding of the mind? The nature of medicine raises fundamental questions about explanation, causation, knowledge and ontology – questions that are central to philosophy as well as medicine. In this book Paul R. Thompson and Ross E. G. Upshur introduce the (...) fundamental issues in philosophy of medicine for those coming to the subject for the first time. They introduce and explain the following key topics: Understanding the physician-patient relationship: the phenomenology of the medical encounter. Models and theories in biology and medicine: what role do theories play in medicine? Are they similar to scientific theories? Randomised controlled trials: can scientific experiments be replicated in clinical medicine? What are the philosophical criticisms levelled at RCTs? The concept of evidence in medical research: what do we mean by ‘Evidence-based medicine?’ Should all medicine be based on evidence? Causation in medicine What do advances in neuroscience reveal about the relationship between mind and body? Defining health and disease: are explanations of disease objective or do they depend on values? Evolutionary medicine: what is the role of evolutionary biology in understanding medicine? Is it relevant? Extensive use of empirical examples and case studies is made throughout the book. These include debates about smoking and cancer, the use of placebos in randomised controlled trials and controversies about research into the causes of HIV and autism. This is an indispendable introduction to those teaching philosophy of medicine and philosophy of science. (shrink)

This essay explores the role of informal logicand its application in the context of currentdebates regarding evidence-based medicine. This aim is achieved through a discussion ofthe goals and objectives of evidence-basedmedicine and a review of the criticisms raisedagainst evidence-based medicine. Thecontributions to informal logic by StephenToulmin and Douglas Walton are explicated andtheir relevance for evidence-based medicine isdiscussed in relation to a common clinicalscenario: hypertension management. This essayconcludes with a discussion on the relationshipbetween clinical reasoning, rationality, andevidence. It is argued that (...) informal logic hasthe virtue of bringing explicitness to the roleof evidence in clinical reasoning, and bringssensitivity to understanding the role ofdialogical context in the need for evidence inclinical decision making. (shrink)

This paper explores the relationship between concepts of probability and hermeneutics. It seeks to examine the relationship between subjective (Bayesian) views of probability and hermeneutic descriptions of understanding. It is argued that Gadamer'saccount of the prejudicial nature of understanding, derived from Heidegger'sanalysis of foreunderstanding, offers a provocative model of clinical reasoning. The implications of this model for evidence-based medicine are discussed in conclusion.

Evidence-based medicine has beendefined as the conscientious and judicious useof current best evidence in making clinicaldecisions. This paper will attempt to explicatethe terms ``conscientious'''' and ``judicious''''within the evidence-based medicine definition.It will be argued that ``conscientious'''' and``judicious'''' represent virtue terms derived fromvirtue ethics and virtue epistemology. Theidentification of explicit virtue components inthe definition and therefore conception ofevidence-based medicine presents an importantstarting point in the connection between virtuetheories and medicine itself. In addition, aunification of virtue theories andevidence-based medicine will illustrate theneed for (...) future research in order to combinethe fields of virtue-based approaches andclinical practice. (shrink)

As health care embraces the tenets of evidence-based medicine it is important to ask questions about how evidence is produced and interpreted. This essay explores normative dimensions of evidence production, particularly around issues of setting the tolerable level of uncertainty of results. Four specific aspects are explored: what health care providers know about statistics, why alpha levels have been set at 0.05, the role of randomization in the generation of sufficient grounds of belief, and the role of observational studies. The (...) essay concludes with recommendations to acknowledge the value permeation of outcome measures and suggests that attention to reasoning and argument analysis can augment traditional evidence-based approaches in providing a robust critical approach to medical knowledge. (shrink)

Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention (...) trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings. (shrink)

Decisions about targeting medical assistance in humanitarian contexts are fraught with dilemmas ranging from non-availability of basic services, to massive demographic and epidemiological shifts, and to the threat of insecurity and evacuations. Aid agencies are obliged, due to capacity constraints and competing priorities, to clearly define the objectives and the beneficiaries of their actions. That aid agencies have to set limits to their actions is not controversial, but the process of defining the limits raises ethical questions. In MSF, frameworks for (...) resource allocation are subject to constant reflection and reiteration, and perspectives are sought at all levels, from implementers at the programme level to the operational directors at headquarters. The perspectives of the programmes staff hold considerable weight as they have the knowledge and experience with particular communities to assess the degree of vulnerability and need, and are also the people who ultimately have to give explanations to beneficiaries when changes or closures are going to be instituted. Humanitarian agencies have a responsibility to ensuring that their workers are prepared to reflect on these dilemmas, and challenge the status quo when it costs lives. (shrink)

Background Tuberculosis is a major cause of morbidity and mortality globally. Recent scholarly attention to public health ethics provides an opportunity to analyze several ethical issues raised by the global tuberculosis pandemic. Discussion Recently articulated frameworks for public health ethics emphasize the importance of effectiveness in the justification of public health action. This paper critically reviews the relationship between these frameworks and the published evidence of effectiveness of tuberculosis interventions, with a specific focus on the controversies engendered by the endorsement (...) of programs of service delivery that emphasize direct observation of therapy. The role of global economic inequities in perpetuating the tuberculosis pandemic is also discussed. Summary Tuberculosis is a complex but well understood disease that raises important ethical challenges for emerging frameworks in public health ethics. The exact role of effectiveness as a criterion for judging the ethics of interventions needs greater discussion and analysis. Emerging frameworks are silent about the economic conditions contributing to the global burden of illness associated with tuberculosis and this requires remediation. (shrink)

Medical technologies and assistive devices such as ventilators and power wheelchairs are designed to sustain life and/or improve functionality but they can also contribute to stigmatization and social exclusion. In this paper, drawing from a study of ten men with Duchenne muscular dystrophy, we explore the complex social processes that mediate the lives of persons who are dependent on multiple medical and assistive technologies. In doing so we consider the embodied and emplaced nature of disability and how life is lived (...) through bodies coupled with technologies and experienced as 'techno-body-subjects in situ'. Normative implications for theory and research, including bioethics research, are discussed. (shrink)

Medical technologies and assistive devices such as ventilators and power wheelchairs are designed to sustain life and/or improve functionality but they can also contribute to stigmatization and social exclusion. In this paper, drawing from a study of ten men with Duchenne muscular dystrophy, we explore the complex social processes that mediate the lives of persons who are dependent on multiple medical and assistive technologies. In doing so we consider the embodied and emplaced nature of disability and how life is lived (...) through bodies coupled with technologies and experienced as ‘techno-body-subjects in situ’. Normative implications for theory and research, including bioethics research, are discussed. (shrink)

During the early years of the COVID-19 pandemic, preclinical and clinical research were sped up and scaled up in both the public and private sectors and in partnerships between them. This resulted in some extraordinary advances, but it also raised a range of issues regarding the ethics, rigour, and integrity of scientific research, academic publication, and public communication. Many of the failures of scientific rigour and integrity that occurred during the pandemic were exacerbated by the rush to generate, disseminate, and (...) implement research findings, which not only created opportunities for unscrupulous actors but also compromised the methodological, peer review, and advisory processes that would usually identify sub-standard research and prevent compromised clinical or policy-level decisions. While it would be tempting to attribute these failures of science and its translation solely to the “unprecedented” circumstances of the COVID-19 pandemic, the reality is that they preceded the pandemic and will continue to arise once it is over. Existing strategies for promoting scientific rigour and integrity need to be made more rigorous, better integrated into research training and institutional cultures, and made more sophisticated. They might also need to be modified or supplemented with other strategies that are fit for purpose not only in public health emergencies but in any research that is sped-up and scaled up to address urgent unmet medical needs. (shrink)

Making research data readily accessible during a public health emergency can have profound effects on our response capabilities. The moral milieu of this data sharing has not yet been adequately explored. This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies. There are three notable reasons that stand in opposition to a duty to share one’s data, relating to: (i) data property and ownership, (ii) (...) just distribution of benefits and burdens and (iii) the contemporary ethos of science. We argue each reason can be successfully met with corresponding rationale in favour of data sharing. Further support for data sharing has been echoed in policies of health agencies, funding bodies and academic institutions; in documents on the ethical conduct of biomedical research; and in discussions on the nature of public health. From this, we ascertain that sharing data is the morally sound default position. This article then highlights the key roles reciprocity and solidarity play in supporting the practice of data sharing. We conclude with recommendations to regard public health research data as a common-pool resource in order to build a framework for stable data sharing management. (shrink)

Are restrictive measures and duties to care ethically reasonably acceptable to faith-based organizations? This study describes the perceptions of individually interviewed spiritual leaders of the disease control measures used during the recent SARS outbreak in Toronto. Four central themes were identified: the relationship between religious obligation and civic responsibilities; the role of faith-based organizations in supporting public health restrictive measures; the reciprocal obligations of public health and religious communities during restrictions; and justifiable limits to duties to care. We conclude that, (...) within certain constraints, spiritual leaders find restrictive measures ethically reasonable and that spiritual leaders can play an important role during pandemic and epidemic control planning. Public health officials should therefore include them in the early and ongoing deliberations of the criteria and logistics for implementation during public health emergencies. (shrink)

We are pleased to once again present to the readers of Theoretical Medicine and Bioethics papers from the Philosophy of Medicine Roundtable. Previous issues have followed the 3rd and 4th Roundtables, and the current issue presents a selection from the more than 20 papers presented at the 5th Philosophy of Medicine Roundtable, which took place in New York, at Columbia University, in November 2013. Like its predecessors, held in Birmingham, AL, Rotterdam, and San Sebastian, this Roundtable attracted speakers from around (...) the world. It also featured keynote presentations from Rita Charon of Columbia University and Ross Upshur of the University of Toronto.It may seem somewhat odd to feature a special issue on philosophy of medicine in a journal that effectively has philosophy of medicine in its title. However, a review of the contents of this journal and similar ones, such as the Journal of Medicine and Philosophy, will quickly reveal such an issue’s purpose. The dominant content of these j .. (shrink)

This article critically examines current responses to multi-drug resistant tuberculosis and argues that bioethics needs to be willing to engage in a more radical critique of the problem than is currently offered. In particular, we need to focus not simply on market-driven models of innovation and anti-microbial solutions to emergent and re-emergent infections such as TB. The global community also needs to address poverty and the structural factors that entrench inequalities—thus moving beyond the orthodox medical/public health frame of reference.

Health research is increasingly being conducted on a global scale, particularly in the developing world to address leading causes of morbidity and mortality. While research interest has increased, building scientific capacity in the developing world has not kept pace. This often leads to the export of human tissue (defined broadly) from the developing to the developed world for analysis. These practices raise a number of important ethical issues that require attention.

In this paper I analyse the implications of “flattening” the curve for long-term care residents in the Province of Ontario, Canada during the first wave of the SARS-CoV-2/COVID-19 pandemic. I then question what the role of healthcare systems are in the response to public health emergencies and problematize their status as entities in need of protection. The ethical implications of this are discussed in light of potential challenges raised by climate change.

As a result of increased interest in global health, more and more medical students and trainees from the.

The evolving Ebola epidemic in West Africa is unprecedented in its size and scope, requiring the rapid mobilization of resources. It is too early to determine all of the ethical challenges associated with the outbreak, but these should be monitored closely. Two issues that can be discussed are the decision to implement and evaluate unregistered agents to determine therapeutic or prophylactic safety and efficacy and the justification behind this decision. In this paper, I argue that it is not compassionate use (...) that justifies this decision and suggest three lines of reasoning to support the decision. (shrink)

We live in the Age of Big Data. In medicine, artificial intelligence and machine learning algorithms, fueled by big data, promise to change how physicians make diagnoses, determine prognoses, and develop new treatments. An exponential rise in articles on these topics is seen in the medical literature. Recent applications range from the use of deep learning neural networks to diagnose diabetic retinopathy and skin cancer from image databases, to the use of various machine learning algorithms for prognostication in cancer and (...) cardiovascular disease. Many factors are driving the adoption of AI in health care, from... (shrink)

Obesity has been described as pandemic and a public health crisis. It has been argued that concerted research efforts are needed to enhance our understanding and develop effective interventions for the complex and multiple dimensions of the health challenges posed by obesity. This would provide a secure evidence base in order to justify clinical interventions and public policy. This paper critically examines these claims through the examination of models of public health and public health ethics. I argue that the concept (...) of an effective public health intervention is unclear and underdeveloped and, as a consequence, normative frameworks reliant on meeting the effectiveness criterion may miss morally salient dimensions of the problems. I conclude by arguing for the need to consider both an ecological model of public health and inclusion of a critical public health ethics perspective for an adequate account of the public health challenges posed by obesity. (shrink)

Médecins Sans Frontières is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.

The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a “wake-up call”—an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly (...) five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019. It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the “wake-up call” we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn. (shrink)

Paul Ricoeur was one of the foremost interpreters and translators of Edmund Husserl's philosophy. These nine essays present Ricoeur's interpretation of the most important of Husserl's writings, with emphasis on his philosophy of consciousness rather than his work in logic. In Ricoeur's philosophy, phenomenology and existentialism came of age and these essays provide an introduction to the Husserlian elements which most heavily influenced his own philosophical position.

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not (...) being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. (shrink)

"Williams's masterful translation satisfies (at last!) a long-standing need. There are lots of good translations of Augustine's great work, but until now we have been forced to choose between those that strive to replicate in English something of the majesty and beauty of Augustine's Latin style and those that opt instead to convey the careful precision of his philosophical terminology and argumentation. Finally, Williams has succeeded in capturing both sides of Augustine's mind in a richly evocative, impeccably reliable, elegantly readable (...) presentation of one of the most impressive achievements in Western thought--Augustine's Confessions." --Scott MacDonald, Professor of Philosophy and Norma K. Regan Professor in Christian Studies, Cornell University. (shrink)

Naturalistic theories of disease appeal to concepts of biological function, and use the notion of dysfunction as the basis of their definitions. Debates in the philosophy of biology demonstrate how attributing functions in organisms and establishing the function-dysfunction distinction is by no means straightforward. This problematization of functional ascription has undermined naturalistic theories and led some authors to abandon the concept of dysfunction, favoring instead definitions based in normative criteria or phenomenological approaches. Although this work has enhanced our understanding of (...) disease and illness, we need not necessarily abandon naturalistic concepts of function and dysfunction in the disease debate. This article attempts to move towards a new naturalistic theory of disease that overcomes the limitations of previous definitions and offers advantages in the clinical setting. Our approach involves a re-evaluation of concepts of biological function employed by naturalistic theories. Drawing on recent insights from the philosophy of biology, we develop a contextual and evaluative account of function that is better suited to clinical medicine and remains consistent with contemporary naturalism. We also show how an updated naturalistic view shares important affinities with normativist and phenomenological positions, suggesting a possibility for consilience in the disease debate. (shrink)

Four ethical values — maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off — yield six specific recommendations for allocating medical resources in the Covid-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all Covid-19 and non–Covid-19 patients.

Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In this paper, we discuss the (...) difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)