Medical Epistemology

There is a lot of conceptual engineering going on in medical research. I substantiate this claim with two examples, the medical debate about cancer classification and about obesity as a disease I also argue that the proper target of conceptual engineering in medical research are experts’ conceptions. These are explicitly written down in documents and guidelines, and they bear on research and policies. In the second part of the chapter, I propose an externalist framework in which conceptions have both the (...) explanatory power of psychological concepts and that of semantic concepts. It is likely, however, that human activities and practices distinct from medical research, and regulated by different practices and epistemic rules, call for different targets for conceptual engineering. I conclude with indicating an open agenda of problems for philosophers of medicine interested in conceptual engineering. (shrink)

Medical scientists employ ‘quality assessment tools’ (QATs) to measure the quality of evidence from clinical studies, especially randomized controlled trials (RCTs). These tools are designed to take into account various methodological details of clinical studies, including randomization, blinding, and other features of studies deemed relevant to minimizing bias and error. There are now dozens available. The various QATs on offer differ widely from each other, and second-order empirical studies show that QATs have low inter-rater reliability and low inter-tool reliability. This (...) is an instance of a more general problem I call the underdetermination of evidential significance. Disagreements about the strength of a particular piece of evidence can be due to different—but in principle equally good—weightings of the fine-grained methodological features which constitute QATs. (shrink)

The purpose of this chapter is to describe what we see as several important new directions for philosophy of medicine. This recent work (i) takes existing discussions in important and promising new directions, (ii) identifies areas that have not received sufficient and deserved attention to date, and/or (iii) brings together philosophy of medicine with other areas of philosophy (including bioethics, philosophy of psychiatry, and social epistemology). To this end, the next part focuses on what we call the “epistemological turn” in (...) recent work in the philosophy of medicine; the third part addresses new developments in medical research that raise interesting questions for philosophy of medicine; the fourth part is a discussion of philosophical issues within the practice of diagnosis; the fifth part focuses on the recent developments in psychiatric classification and scientific and ethical issues therein, and the final part focuses on the objectivity of medical research. (shrink)

Most of the epidemiological models of the Covid-19 pandemic contain the reproduction number as a parameter. In this article we focus on some shortcomings regarding its role in driving health policies and political decisions. First, we summarize what R is and what it is used for. Second, we introduce a three-question matrix for the evaluation of any construct or parameter within a model. We then review the main literature about R to highlight some of its shortcomings and apply to them (...) our three-question matrix. Finally, we argue that these shortcomings are important for an epistemic and political evaluation of R. (shrink)

In the last decades it has become clear that medicine must find some way to combine its scientific and humanistic sides. In other words, an adequate notion of medicine requires an integrative position that mediates between the analytic-reductionist and the normative-holistic tendencies we find therein. This is especially important as these different styles of reasoning separate “illness” (something perceived and managed by the whole individual in concert with their environment) and “disease” (a “mechanical failure” of a biological element within the (...) body). While the demand for an integrative view has typically been motivated by ethical concerns, we claim that it is also motivated, perhaps even more fundamentally, by epistemological and methodological reasons. Evidence-based bio-medicine employs experimental and statistical techniques which eliminate important differences in the ways that conscious humans evaluate, live with, and react to disease and illness. However, it is precisely these experiences that underpin the concepts and norms of bio-medicine. Humanistic disciplines, on the other hand, have the resources to investigate these experiences in an intersubjectively testable way. Medicine, therefore, cannot afford to ignore its nature as a human science; it must be concerned not only with disease and illness, but also with the ways in which patients as persons respond to malady. Insofar as attitudes and expectations influence the criteria of illness and disease, they must be studied as part of the genuine subject matter of medicine as a human science. In general, we urge that this is a necessary step to overcome today's trend to split evidence-based and clinical medicine. (shrink)

In this paper, we analyse the relation between the use of environmental data in contemporary health sciences and related conceptualisations and operationalisations of the notion of environment. We consider three case studies that exemplify a different selection of environmental data and mode of data integration in data-intensive epidemiology. We argue that the diversification of data sources, their increase in scale and scope, and the application of novel analytic tools have brought about three significant conceptual shifts. First, we discuss the EXPOsOMICS (...) project, an attempt to integrate genomic and environmental data which suggests a reframing of the boundaries between external and internal environments. Second, we explore the MEDMI platform, whose efforts to combine health, environmental and climate data instantiate a reframing and expansion of environmental exposure. Third, we illustrate how extracting epidemiological insights from extensive social data collected by the CIDACS institute yields innovative attributions of causal power to environmental factors. Identifying these shifts highlights the benefits and opportunities of new environmental data, as well as the challenges that such tools bring to understanding and fostering health. It also emphasises the constraints that data selection and accessibility pose to scientific imagination, including how researchers frame key concepts in health-related research. (shrink)

To clarify the proper role of values in science, focusing on controversial expert responses to Covid-19, this article examines the status of (in)convenient hypotheses. Polarizing cases like health experts downplaying mask efficacy to save resources for healthcare workers, or scientists dismissing “accidental lab leak” hypotheses in view of potential xenophobia, plausibly involve modifying evidential standards for (in)convenient claims. Societies could accept that scientists handle (in)convenient claims just like nonscientists, and give experts less political power. Or societies could hold scientists to (...) a higher bar, by expecting them not to modify evidential standards to avoid costs only incidentally tied to error. (shrink)

50 years after its introduction, brain death remains controversial among scholars. The debates focus on one question: is brain death a good criterion for determining death? This question has been answered from various perspectives: medical, metaphysical, ethical, and legal or political. Most authors either defend the criterion as it is, propose some minor or major revisions, or advocate abandoning it and finding better solutions to the problems that brain death was intended to solve when it was introduced. Here I plead (...) for a different approach that has been overlooked in the literature: the philosophy of science approach. Some scholars claim that human death is a matter of fact, a biological phenomenon whose occurrence can be determined empirically, based on science. We should take this claim seriously, whether we agree with it or not. The question is: how do we know that human death is a scientific matter of fact? Taking the philosophy of science approach means, among other things, examining how the determination of human death became an object of scientific inquiry, exploring the nature of the brain death criterion itself, and analysing the meaning of its core concepts such as “irreversibility” and “functions”. (shrink)

The ethical question is whether university mask mandates should be relaxed. I argue that the use of face masks by healthy individuals has uncertain benefits, which potential harms may outweigh, and should therefore be voluntary. Systematic reviews by the World Health Organization (WHO) and Cochrane Acute Respiratory Infections concluded that the use of face masks by healthy individuals in the community lacks effectiveness in reducing viral transmission based on moderate-quality evidence. The only two randomized controlled trials of face masks published (...) during the pandemic found little to no benefit. Without high-quality evidence, it is difficult to justify a requirement rather than a recommendation. Notwithstanding, one might argue that the precautionary principle justifies mask mandates. If the precautionary principle can justify implementing mask mandates due to the risk of forgoing possible benefit, then it might also be able to justify not implementing mask mandates due to the risk of potential harm caused by the intervention. It is commonly thought that there is little to lose from the use of face masks, but this is not necessarily true. It is possible that masks have done more harm than good. (shrink)

Lockdowns, or modern quarantines, involve the use of novel restrictive non-pharmaceutical interventions (NPIs) to suppress the transmission of COVID-19. In this paper, I aim to critically analyze the emerging history and philosophy of lockdowns, with an emphasis on the communication of health evidence and risk for informing policy decisions. I draw a distinction between evidence-based and modeling-based decision-making. I argue that using the normative framework of evidence-based medicine would have recommended against the use of lockdowns. I first review the World (...) Health Organization’s evidence-based pandemic preparedness plans for respiratory viruses. I then provide a very brief history of COVID-19 modeling, which was cited as justification for the use of lockdowns in the U.K., the U.S., and much of the world. I focus on the so-called Imperial College model designed by Neil Ferguson et al. as well as the so-called Oxford model designed by José Lourenço et al. I analyze the evidence-based pandemic response known as ‘mitigation’, and I compare it with Ferguson et al.’s experimental strategy known as ‘suppression’. I summarize the strengths and weaknesses of these strategies based on their diametric aims and each model’s parametric assumptions. Based on my critical analysis of the suppression strategy, I attempt to expose what has been called the ‘logic of lockdowns’, which Sunetra Gupta of the Oxford model group has suggested is flawed. Finally, I consider Trisha Greenhalgh’s objection to evidence-based policy based on the precautionary principle, and I attempt to offer a response. I conclude with a brief narrative review of the emerging randomized evidence on restrictive NPIs, which seems to support my claim that mitigation was the strategy that would have been recommended by evidence-based medicine. If this is true, then COVID-19 modeling may serve as an important reminder of the enduring lesson of evidence-based medicine: that one should always ‘Trust the Evidence!’ for better health policy. (shrink)

Evidence-based medicine is a clinical decision making framework which makes claims about what physicians ought to do. Though heralded as the cutting edge of medical science evidence-based medicine is a value laden normative theory which implicitly depends on substantive views regarding what is morally good or right. In this paper, I provide an ethical analysis of evidence-based medicine. I consider its normative underpinnings in three ethical theories: utilitarianism, Kantian deontology, and virtue ethics. In the face of uncertainty, evidence-based medicine endorses (...) expected utility theory using the best available evidence in order to avoid doing more harm than good. In accordance with the Kantian respect for individuals as ends in themselves, evidence-based medicine calls for integrating the values and preferences of the patient. De-emphasizing intuition, clinical expertise, and pathophysiologic rationale emphasizes the need for the intellectual virtues of curiosity, critical thinking, and courage. Evidence-based medicine is a successful clinical practice that can be morally justified by all three major ethical theories. Although its focus on maximizing good health outcomes and integrating respect for individual patients has been emphasized, the role of the intellectual virtues in evidence- based medicine remains highly under-explored. (shrink)

For children, the collateral damage of the COVID-19 pandemic response has been considerable. In this paper, we use the framework of evidence-based medicine to argue that child abuse is another negative side effect of COVID-19 lockdowns. While it was certain that school closures would have profound social and economic costs, it remains uncertain whether they have any effect on COVID-19 transmission. There is emerging evidence that lockdowns significantly worsened child abuse on a global scale. Low-income and middle-income countries are particularly (...) vulnerable to increases in child abuse. The best available external evidence from systematic research during the pandemic demonstrates an increase in the risk of child maltreatment, an increase in child maltreatment hospitalisations and a concerning decrease in official child maltreatment referrals. The paradoxical phenomenon of increased hospitalisations and decreased reports is unlikely to be explained by a genuine decrease in child abuse. We conclude that lockdowns have an unacceptably high risk of negative side effects for children, as evidenced by child abuse, the true extent of which appears to be masked by lockdown-related disruptions to schools and other surveillance systems. The desire for a sense of security may be a tempting bias towards emphasising the resilience of children, but it is ethically problematic to push children towards abuse in the name of public health. It is our view that the collateral damage of prolonged school closures for society’s most vulnerable members is a powerful ethical consideration against any pandemic response which involves their use. (shrink)

"Correlation is not causation" is one of the mantras of the sciences—a cautionary warning especially to fields like epidemiology and pharmacology where the seduction of compelling correlations naturally leads to causal hypotheses. The standard view from the epistemology of causation is that to tell whether one correlated variable is causing the other, one needs to intervene on the system—the best sort of intervention being a trial that is both randomized and controlled. In this paper, we argue that some purely correlational (...) data contains information that allows us to draw causal inferences: statistical noise. Methods for extracting causal knowledge from noise provide us with an alternative to randomized controlled trials that allows us to reach causal conclusions from purely correlational data. (shrink)

Epidemiological explanation often has a “black box” character, meaning the intermediate steps between cause and effect are unknown. Filling in black boxes is thought to improve causal inferences by making them intelligible. I argue that adding information about intermediate causes to a black box explanation is an unreliable guide to pragmatic intelligibility because it may mislead us about the stability of a cause. I diagnose a problem that I call wishful intelligibility, which occurs when scientists misjudge the limitations of certain (...) features of an explanation. Wishful intelligibility gives us a new reason to prefer black box explanations in some contexts. (shrink)

This is the first book to explore the epistemology and ethics of advanced imaging tests, in order to improve the critical understanding of the nature of knowledge they provide and the practical consequences of their utilization in healthcare. Advanced medical imaging tests, such as PET and MRI, have gained center stage in medical research and in patients’ care. They also increasingly raise questions that pertain to philosophy: What is required to be an expert in reading images? How are standards for (...) interpretation to be fixed? Is there a problem of overutilization of such tests? How should uncertainty be communicated to patients? How to cope with incidental findings? This book is of interest and importance to scholars of philosophy of medicine at all levels, from undergraduates to researchers, to medical researchers and practitioners (radiologists and nuclear physicians) interested in a critical appraisal of the methodology of their discipline and in the ethical principles and consequences of their work. -/- . (shrink)

Advanced medical imaging, such as CT, fMRI and PET, has undergone enormous progress in recent years, both in accuracy and utilization. Such techniques often bring with them an illusion of immediacy, the idea that the body and its diseases can be directly inspected. In this paper we target this illusion and address the issue of the reliability of advanced imaging tests as knowledge procedures, taking positron emission tomography in oncology as paradigmatic case study. After individuating a suitable notion of reliability, (...) we argue that PET is a highly theory-laden and non-immediate knowledge procedure, in spite of the photographic-like quality of the images it delivers; the diagnostic conclusions based on the interpretation of PET images are population-dependent; PET images require interpretation, which is inherently observer-dependent and therefore variable. We conclude with a three-step methodological proposal for enhancing the reliability of advanced medical imaging. (shrink)

In the domain of medical science, factual evidence is usually considered as the criterion on which to base decisions and construct hypotheses. Evidence-based medicine is the translation of this approach into the field of patient care, and it means providing only the type of care that is based on evidence that proves its effectiveness and appropriateness. However, while the literature has focused on the types and force of evidence used to establish the recommendation and treatment guidelines, the problem of how (...) evidence is used in doctor–patient interactions to motivate, or refuse, treatment or habit change has been almost completely neglected. In this specific context, characterized by the epistemic unbalance between the interlocutors and a specific conversational goal, the scientific categories of evidence are often irrelevant. The goal of this paper is to address this challenge by analyzing the role evidence plays in doctor–patient interactions in diabetes care. After introducing an analytical distinction between the epistemic and the pragmatic aspect of evidence, we will propose a classification of the types and functions of evidence in chronic care communication, and illustrate its possible uses through its application to our corpus of diabetes-care consultations. From our qualitative analyses, it is possible to observe how in this communicative context a crucial role is played by the conflicts of evidence, in which providers correct patients’ uses of evidence leading them to using less defeasible levels of evidence. (shrink)

In The Biopsychosocial Model of Health and Disease, Derek Bolton and Grant Gillett argue that a defensible updated version of the biopsychosocial model requires a metaphysically adequate account of disease causation that can accommodate biological, psychological, and social factors. This present paper offers a philosophical critique of their account of biopsychosocial causation. I argue that their account relies on claims about the normativity and the semantic content of biological information that are metaphysically contentious. Moreover, I suggest that these claims are (...) unnecessary for a defence of biopsychosocial causation, as the roles of multiple and diverse factors in disease causation can be readily accommodated by a more widely accepted and less metaphysically contentious account of causation. I then raise the more general concern that they are misdiagnosing the problem with the traditional version of the biopsychosocial model. The challenge when developing an explanatorily valuable version of the biopsychosocial model, I argue, is not so much providing an adequate account of biopsychosocial causation, but providing an adequate account of causal selection. Finally, I consider how this problem may be solved to arrive at a more explanatorily valuable and clinically useful version of the biopsychosocial model. (shrink)

The following pages sketch the outlines of “a Canaanite reading” of the health system. Beginning with the Black person—African, Afro-diasporic, Aboriginal, and Torres Strait Islander—who is seen by a health professional, the functions and effects of the racializing gaze are examined. I wrestle with Al Saji’s understanding of “colonial disregard,” Whittaker’s insights into the extractive disposition of settler institutions vis-à-vis Indigenous peoples, and Saidiya Hartman and Fred Moten’s struggle with the spectacular. This leads me to conclude that the situation of (...) the Black within the health system is a tragic one. The prescription for the path out of this tragedy that I settle on, responding to Okiji’s opening call, is found in Vernon Ah Kee’s “Unwritten” series. (shrink)

The paper investigates the epistemological and communicative competences the experts need to use and communicate evidence in the reasoning process leading to diagnosis. The diagnosis and diagnosis communication are presented as intertwined processes that should be jointly addressed in medical consultations, to empower patients’ compliance in illness management. The paper presents defeasible reasoning as specific to the diagnostic praxis, showing how this type of reasoning threatens effective diagnosis communication and entails that we should understand diagnostic evidence as defeasible as well. (...) It argues that metaphors might be effective communicative devices to let the patients understand the relevant defeasors in the diagnostic reasoning process, helping to improve effective diagnosis communication, and also encouraging a change in patients’ beliefs and attitudes on their own experience of illness and illness’ management. (shrink)

Precision medicine and molecular systems medicine (MSM) are highly utilized and successful approaches to improve understanding, diagnosis, and treatment of many diseases from bench-to-bedside. Especially in the COVID-19 pandemic, molecular techniques and biotechnological innovation have proven to be of utmost importance for rapid developments in disease diagnostics and treatment, including DNA and RNA sequencing technology, treatment with drugs and natural products and vaccine development. The COVID-19 crisis, however, has also demonstrated the need for systemic thinking and transdisciplinarity and the limits (...) of MSM: the neglect of the bio-psycho-social systemic nature of humans and their context as the object of individual therapeutic and population-oriented interventions. COVID-19 illustrates how a medical problem requires a transdisciplinary approach in epidemiology, pathology, internal medicine, public health, environmental medicine, and socio-economic modeling. Regarding the need for conceptual integration of these different kinds of knowledge we suggest the application of general system theory (GST). This approach endorses an organism-centered view on health and disease, which according to Ludwig von Bertalanffy who was the founder of GST, we call Organismal Systems Medicine (OSM). We argue that systems science offers wider applications in the field of pathology and can contribute to an integrative systems medicine by (i) integration of evidence across functional and structural differentially scaled subsystems, (ii) conceptualization of complex multilevel systems, and (iii) suggesting mechanisms and non-linear relationships underlying the observed phenomena. We underline these points with a proposal on multi-level systems pathology including neurophysiology, endocrinology, immune system, genetics, and general metabolism. An integration of these areas is necessary to understand excess mortality rates and polypharmacological treatments. In the pandemic era this multi-level systems pathology is most important to assess potential vaccines, their effectiveness, short-, and long-time adverse effects. We further argue that these conceptual frameworks are not only valid in the COVID-19 era but also important to be integrated in a medicinal curriculum. (shrink)

We were slightly concerned, upon having read Eric Winsberg, Jason Brennan and Chris Surprenant’s reply to our paper “Were Lockdowns Justified? A Return to the Facts and Evidence”, that they may have fundamentally misunderstood the nature of our argument, so we issue the following clarification, along with a comment on our motivations for writing such a piece, for the interested reader.

Were governments justified in imposing lockdowns to contain the spread of the COVID-19 pandemic? We argue that a convincing answer to this question is to date wanting, by critically analyzing the factual basis of a recent paper, “How Government Leaders Violated Their Epistemic Duties During the SARS-CoV-2 Crisis” (Winsberg et al. 2020). In their paper, Winsberg et al. argue that government leaders did not, at the beginning of the pandemic, meet the epistemic requirements necessitated to impose lockdowns. We focus on (...) Winsberg et al.’s contentions that knowledge about COVID-19 resultant projections were inadequate; that epidemiologists were biased in their estimates of relevant figures; that there was insufficient evidence supporting the efficacy of lockdowns; and that lockdowns cause more harm than good. We argue that none of these claims are sufficiently supported by evidence, thus impairing their case against lockdowns, and leaving open the question of whether lockdowns were justified. (shrink)

This contribution explores how Forrester’s work on cases has opened up an arena that might be called ‘the medical case as a travelling genre’. Although usually focused on the course of disease in an individual patient and authored mostly by one medical author, medical case histories have a social dimension: Once published, they often circulate in networks of scholars. Moreover, scholars of the history of literature have shown that numerous medical cases seem to travel easily beyond the context of medical (...) science into the realm of popular literature and journalism. After tracing the idea of cases travelling in Forrester’s Thinking in Cases, I discuss several contributions by authors who, in the wake of interdisciplinary research on cases in the past two decades, have dealt in different ways with this idea. In the third section, I present my own research on a case of self-crucifixion that was widely discussed in 19th-century Europe. I suggest that understanding the case as a ‘traveling genre’ – an expression borrowed from literary genre theory – highlights the role of readers and publication formats as constitutive for cases, and enables us to see more clearly what cases do for scientists and writers who work with them. (shrink)

How is scientific data used to represent phenomena and as evidence for claims about phenomena? In this paper, I propose that a specific type of claims – evidential claims – is involved in data practices to define and restrict the representational and evidential content of a dataset. I present an account of data practices in the epidemiology of the exposome based on the notion of evidential claims, which helps unpack the approaches, assumptions and warrants that connect different stages of research. (...) I identify three different strategies to generate different types of evidential claims in this case. The macro strategy, which individuates the dataset that serves as the initial evidential space for research. The micro strategy, which is used to generate evidential claims about the microscopic and individual component of target phenomena. The association strategy, that uses evidence from the other strategies to identify a dataset as representation of the different levels and relations of exposure and disease. Differentiating between these strategies sheds light on the multi-faceted landscape of biomedical research on environment and health; and the roles of data and evidence in the process of inquiry. (shrink)

This book offers a philosophically-based, yet clinically-oriented perspective on current medical reasoning aiming at 1) identifying important forms of uncertainty permeating current clinical reasoning and practice 2) promoting the application of an abductive methodology in the health context in order to deal with those clinical uncertainties 3) bridging the gap between biomedical knowledge, clinical practice, and research and values in both clinical and philosophical literature. With a clear philosophical emphasis, the book investigates themes lying at the border between several disciplines, (...) such as medicine, nursing, logic, epistemology, and philosophy of science; but also ethics, epidemiology, and statistics. At the same time, it critically discusses and compares several professional approaches to clinical practice such as the one of medical doctors, nurses and other clinical practitioners, showing the need for developing a unified framework of reasoning, which merges methods and resources from many different clinical but also non-clinical disciplines. In particular, this book shows how to leverage nursing knowledge and practice, which has been considerably neglected so far, to further shape the interdisciplinary nature of clinical reasoning. Furthermore, a thorough philosophical investigation on the values involved in health care is provided, based on both the clinical and philosophical literature. The book concludes by proposing an integrative approach to health and disease going beyond the so-called “classical biomedical model of care”. (shrink)

Bradford Hill (1965) highlighted nine aspects of the complex evidential situation a medical researcher faces when determining whether a causal relation exists between a disease and various conditions associated with it. These aspects are widely cited in the literature on epidemiological inference as justifying an inference to a causal claim, but the epistemological basis of the Hill aspects is not understood. We offer an explanatory coherentist interpretation, explicated by Thagard's ECHO model of explanatory coherence. The ECHO model captures the complexity (...) of epidemiological inference and provides a tractable model for inferring disease causation. We apply this model to three cases: the inference of a causal connection between the Zika virus and birth defects, the classic inference that smoking causes cancer, and John Snow’s inference about the cause of cholera. (shrink)

Forrester’s proposed seventh style of reasoning – thinking in cases – functions as an analogous, dyadic relationship that, whilst indebted philosophically to the logical reasoning and semiotics of Charles Peirce, is prone to creating feedback loops between induction and deduction, precluding novel abductive hypotheses from advancing medical knowledge. Reasoning with a Peircean triadic model opens up the contexts and methods of meaning-making and reasoning through medical cases, and the potent influence of their genre conventions, to intellectual critical scrutiny. Vitally, it (...) offers a third mode – abduction – that this article argues needs to be reintroduced into Forrester’s model of reasoning with cases. This article demonstrates this by applying a Peircean triadic model of reasoning to Forrester’s own model, tracing a shared genealogy but one in which the abductive element was lost. The article goes on to illustrate the explanatory and predictive potential of Peircean abductive reasoning and the necessary re-theorising of the case this entails. This argument is supported through an analysis of early case reports of what would become HIV/Aids, drawn from the Case Records of Massachusetts General Hospital series in the New England Journal of Medicine. (shrink)

Requiring family authorization for apnea testing subtracts health professionals control over death determination, a procedure that has traditionally been considered a matter of clinical expertise alone. In this commentary, we first provide evidence showing that health professionals’ (HPs) disposition to act on death determination without family’s prior consent could be much lower than that referred to by Berkowitz and Garrett (2020). We hypothesize that HPs may have reservations about their own expertise as regards death, and may thus hesitate to impose (...) their views on patients’ families. We then address the theoretical question of clinical expertise in death determination by distinguishing judgments about facts (e.g., the presence or absence of spontaneous breathing) from interpretations given of these facts (i.e., their meaning for the vital status of an individual). We argue that, while clinicians may claim some expert authority on the former, they hold no particular authority on the latter. (shrink)

The COVID-19 pandemic has demonstrated how different (even conflicting) interventions on nature can be scientifically justified: interventions can be deemed "effective" only in relation to specific target variables - in relation to variables the values of which we seek to control. Choosing the "right" target variables, in turn, depends on our values and pragmatic aims. This essay is based on a presentation given at the symposium "Multidisciplinary Perspectives on the COVID-19 Pandemic", organised at the Helsinki Collegium for Advanced Studies on (...) 16 June 2020. (shrink)

Within the evidence-based medicine construct, clinical expertise is acknowledged to be both derived from primary experience and necessary for optimal medical practice. Primary experience in medical practice, however, remains undervalued. Clinicians’ primary experience tends to be dismissed by EBM as unsystematic or anecdotal, a source of bias rather than knowledge, never serving as the “best” evidence to support a clinical decision. The position that clinical expertise is necessary but that primary experience is untrustworthy in clinical decision-making is epistemically incoherent. Here (...) we argue for the value and utility of knowledge gained from primary experience for the practice of medicine. Primary experience provides knowledge necessary to diagnose, treat, and assess response in individual patients. Hierarchies of evidence, when advanced as guides for clinical decisions, mistake the relationship between propositional and experiential knowledge. We argue that primary experience represents a kind of medical knowledge distinct from the propositional knowledge produced by clinical research, both of which are crucial to determining the best diagnosis and course of action for particular patients. (shrink)

Cancer research is experiencing ‘paradigm instability’, since there are two rival theories of carcinogenesis which confront themselves, namely the somatic mutation theory and the tissue organization field theory. Despite this theoretical uncertainty, a huge quantity of data is available thanks to the improvement of genome sequencing techniques. Some authors think that the development of new statistical tools will be able to overcome the lack of a shared theoretical perspective on cancer by amalgamating as many data as possible. We think instead (...) that a deeper understanding of cancer can be achieved by means of more theoretical work, rather than by merely accumulating more data. To support our thesis, we introduce the analytic view of theory development, which rests on the concept of plausibility, and make clear in what sense plausibility and probability are distinct concepts. Then, the concept of plausibility is used to point out the ineliminable role played by the epistemic subject in the development of statistical tools and in the process of theory assessment. We then move to address a central issue in cancer research, namely the relevance of computational tools developed by bioinformaticists to detect driver mutations in the debate between the two main rival theories of carcinogenesis. Finally, we briefly extend our considerations on the role that plausibility plays in evidence amalgamation from cancer research to the more general issue of the divergences between frequentists and Bayesians in the philosophy of medicine and statistics. We argue that taking into account plausibility-based considerations can lead to clarify some epistemological shortcomings that afflict both these perspectives. (shrink)

Philosophers of science and medicine now aspire to provide useful, socially relevant accounts of mechanism. Existing accounts have forged the path by attending to mechanisms in historical context, scientific practice, the special sciences, and policy. Yet, their primary focus has been on more proximate issues related to therapeutic effectiveness. To take the next step toward social relevance, we must investigate the challenges facing researchers, clinicians, and policy makers involving values and social context. Accordingly, we learn valuable lessons about the connections (...) between mechanistic processes and more fundamental reasons for medical interventions, particularly moral, ethical, religious, and political concerns about health, agency, and power. This paper uses debates over the controversial morning-after pill to gain insight into the deeper reasons for the production and use of mechanistic knowledge throughout biomedical research, clinical practice, and governmental regulation. To practice socially relevant philosophy of science, I argue that we need to account for mechanistic knowledge beyond immediate effectiveness, such as how it can also provide moral guidance, aid ethical categorization in the clinic, and function as a political instrument. Such insights have implications for medical epistemology, including the value-laden dimensions of mechanistic reasoning and the “epistemic friction” of values. Furthermore, there are broader impacts for teaching research ethics and understanding the role of science advisors as political advocates. (shrink)

The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. I focus on (...) three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

Brummett and Salter propose a useful and timely taxonomy of clinical ethics expertise (2019). As the field becomes further “professionalized” this taxonomy is important, and the core of it is right. It needs some refinement around the edges, however. In their conclusion, Brummett and Salter rightly point out that there is a significant difference between the ethicist whose recommendations are procedure- and process-heavy, consensus-driven, and dialogical and the authoritarian ethicist whose recommendations flow from “private moral views” (Brummett and Salter, 2019). (...) This admission doesn’t go far enough. Brummett and Salter’s taxonomy fails to capture the notion that offering recommendations whose normative force is moral is different in kind from recommendations whose normative force is non-moral, such as those recommendations that are free of moral content or justified by convention. The difference is in kind, not scale. I argue further that clinical ethics expertise, if possible, consists at least in offering recommendations whose normative force is moral. These two claims imply that the taxonomy fails to cut clinical ethics expertise at the joints: the ethicist who offers justified non-moral normative recommendations is a different kind of ethicist from the one who offers justified moral normative recommendations, yet both are categorized as clinical ethics experts. I finish by offering a refinement of the taxonomy that more precisely categorizes clinical ethicists. (shrink)

Recently, there has been increasing interest in methodological aspects of advanced imaging, including the role of guidelines, recommendations, and experts’ consensus, the practice of self-referral, and the risk of diagnostic procedure overuse. In a recent Delphi study of the European Association for Nuclear Medicine (EANM), panelists were asked to give their opinion on 47 scientific questions about imaging in prostate cancer. Nine additional questions exploring the experts’ attitudes and opinions relating to the procedure of consensus building itself were also included. (...) The purpose was to provide insights into the mechanism of recommendation choice and consensus building as seen from the experts’ point of view. Results: Regarding the factors likely to influence the willingness to refer a patient for imaging, the most voted were incorporation into guidelines and data from scientific literature, while personal experience and personal relationship were chosen by a small minority. Regarding the recommendations more relevant to prescribe an imaging procedure, it resulted the incorporation into guidelines promoted by scientific societies (59% of votes); these guidelines also resulted the more trusted. With respect to patients’ preferences considered when prescribing an imaging procedure, the most voted was accuracy, resulted more important than easy access and time to access to the procedure. The majority of the experts expressed the opinion that there is a scarce use of imaging procedures in prostate cancer. With respect to the most relevant factor to build consensus, it resulted the transparency of the process (52% of votes), followed by multidisciplinarity of contributors. The main obstacle to incorporation of modern imaging procedures into guidelines resulted the lack of primary literature on clinical impact. Conclusions: Firstly, the panelists portray themselves as having Evidence-Based Medicine oriented and scientifically inclined attitudes and preferences. Secondly, guidelines and recommendations from scientific societies, especially clinical ones, are positively taken into account as factors influencing decisions, but panelists tend to consider their own appraisal of the scientific literature as more relevant. Thirdly, in respect of overuse, panelists do not think that advanced diagnostic procedures are overutilized in the specific case of Prostate Cancer, but rather they are underutilized. (shrink)

We raise a problem of applicability of RCTs to validate nuclear diagnostic imaging tests. In spite of the wide application of PET and other similar techniques that use radiopharmaceuticals for diagnostic purposes, RCT-based evidence on their validity is sparse. We claim that this is due to a general conceptual problem that we call Prevalence of Treatment, which arises in connection with designing RCTs for testing any diagnostic procedure in the present context of medical research, and is particularly apparent in this (...) case. We also identify three practical reasons why RCTs do not qualify as the best option for PET validation, which have to do with specific characteristics of nuclear diagnostic imaging, and of radiopharmaceuticals. The paper is meant to contribute both to the philosophical discussion on the EBM hierarchy of evidence, and on the specific debate on radiopharmaceuticals in nuclear medicine. (shrink)

The modern concept of ideology was established by the liberal politician and philosopher Destutt de Tracy, with the objective of creating an all-embracing and general science of ideas, which followed the sensualist and empiricist trend initiated by Locke that culminated in the positivism of Comte. Natural selection and immunity are two key concepts in the history of biology that were strongly based on the Malthusian concept of struggle for existence. This concept wrongly assumed that population grew faster than the means (...) of existence. This “natural” law contained implicitly the idea that the poor and least gifted would not survive. This idea led to the progressive development of the concept of natural selection, whose definitive version was given by Darwin. Mechnikov took the concepts of struggle for existence and natural selection and conceived infectious diseases as a struggle between a host and its invader, the so-called phagocytosis theory. This theory created the necessity to possess mechanisms to discriminate between the own and the foreign, and led to the conception of the immune self. These concepts were not developed from ideas coming from perceptions or sensations, but from ideas coming from their values: individual interest, inevitable inequality, property, utility and profit. Values are ideals that constitute an ideological matrix which exerts a numinous activity and influence the development of our future actions. In consequence, science and its practice cannot avoid and ignore the values that drive them and impulse them towards certain directions. (shrink)

In this chapter I explicate and evaluate the concept of medical error. Unlike standard philosophical approaches to analyzing medical phenom- ena in the abstract, I instead address medical error specifi cally within the context of an embodied social world. I illustrate how, as a deeply contex- tual concept, medical error is inextricably tied to the social conditions— and concrete, powerful interests—of the particulars in which it is found. -/- I begin with an analysis that demonstrates the relational quality of medi- (...) cal error, as a functional, outcome-oriented concept, evaluating the origin and context of the term’s emergence, and connecting it to a similarly contextual concept, “standard of care.” I move on to note the concern- ing implications of medical error identifi cation and measurement when viewed through an intersectional standpoint. To do so, I discuss what intersectional approaches can help reveal about our contemporary social world of medicine and public health. Intersectional approaches, as I will explain, focus on how intersections of social identity can unmask social structures that negatively impact groups and individuals. It appears, as -/- I will suggest, that disparities in social goods (e.g., social standing, edu- cation, wealth) complicate our identification of medical error, itself, and compound concerns of equity and access to medical goods for those who have diminished expectations for health. (shrink)

My purpose in this paper is to show how a re-examination of Snow’s famous South London water study, widely taken to have established that cholera is water-borne, highlights some problems with current, scientific realist accounts of theory-change. When examining scientific controversies, such accounts focus disproportionately on the ‘winning’ theories and their properties, or on those of the reasoning of the scientists who proposed them. I argue that this focus is misguided and leads us to neglect much of what is epistemically (...) valuable in episodes of theory-change, thereby leading to inaccurate views about both the dynamics of theory-change and the notion of scientific progress that accompanies it. I end by sketching some implications for the philosophy of epidemiology. (shrink)

Personalised medicine has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified medicine and (...) computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies—a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system. (shrink)

This book covers the overlap between informatics, computer science, philosophy of causation, and causal inference in epidemiology and population health research. Key concepts covered include how data are generated and interpreted, and how and why concepts in health informatics and the philosophy of science should be integrated in a systems-thinking approach. Furthermore, a formal epistemology for the health sciences and public health is suggested. -/- Causation in Population Health Informatics and Data Science provides a detailed guide of the latest thinking (...) on causal inference in population health informatics. It is therefore a critical resource for all informaticians and epidemiologists interested in the potential benefits of utilising a systems-based approach to causal inference in health informatics. (shrink)

Medical explanations have often been thought on the model of biological ones and are frequently defined as mechanistic explanations of a biological dysfunction. In this paper, I argue that topological explanations, which have been described in ecology or in cognitive sciences, can also be found in medicine and I discuss the relationships between mechanistic and topological explanations in medicine, through the example of network medicine and medical genetics. Network medicine is a recent discipline that relies on the analysis of various (...) disease networks in order to find organizing principles in disease explanation. My aim is to show how topological explanations in network medicine can help solving the conceptual issues that pure mechanistic explanations of the genetics of disease are currently facing, namely the crisis of the concept of genetic disease, the progressive geneticization of diseases and the dissolution of the distinction between monogenic and polygenic diseases. However, I will also argue that topological explanations should not be considered as independent and radically different from mechanistic explanations for at least two reasons. First, in network medicine, topological explanations depend on and use mechanistic information. Second, they leave out some missing gaps in disease explanation that require, in turn, the development of new mechanistic explanations. Finally, I will insist on the specific contribution of topological explanations in medicine: they push us to develop an explanation of disease in general, instead of focusing on single explanations of individual diseases. This last point may have major consequences for biomedical research. (shrink)

The new field of meta-research investigates industry bias, publication bias, contradictions between studies, and other trends in medical research. I argue that its findings should be used as meta-evidence for evaluating therapies. ‘Meta-evidence’ is evidence about the support that direct ‘first-order evidence’ provides the hypothesis. I consider three objections to my proposal: the irrelevance objection, the screening-off objection, and the underdetermination objection. I argue that meta-research evidence works by rationally revising our confidence in first-order evidence and, consequently, in the hypothesis—typically, (...) downward. (shrink)

In the 20th century, the boundaries of psychosis emerged as an area in which psychiatric judgement faced numerous and profound uncertainties. Between obvious neuroses and personality and reactive disorders on the one hand, and unquestionable psychoses on the other, psychiatrists faced a world of suspected cases of schizophrenia, doubtful personality disorder diagnoses or probable cases of psychosis constituting a garden of equivocal clinical presentations in which both individual psychiatrists and the discipline as a whole were confronted with the limits of (...) their knowledge. This article examines how psychiatrists from two German university clinics managed the multiple uncertainties involved in diagnosing cases of early psychosis between 1950 and 1980. Based on the analysis of a sample of records, we propose a pragmatic interpretation of the ways in which these uncertainties were recorded by psychiatrists. How were uncertainties and doubts expressed in the records and managed by clinicians? What means were used to dispel doubt? What were the consequences for patients of these diagnostic uncertainties? The article defines an uncertainty diagnosis as a diagnosis expressed with reservations by its author and recorded as such in a medical file. Depending on the nature of the uncertainty, the types of evidence used by the professionals and how this evidence was dealt with, we have identified three types of uncertainty diagnoses: suspicion, plausibility and probability diagnoses. The article then reflects on the role of the patients themselves in shaping these uncertain situations. (shrink)

This paper summarizes the seminar AI in Medicine in Context: Hopes? Nightmares? that was held at the Centre for Ethics at the University of Toronto on October 17, 2017, with special guest assistant professor and neurosurgeon Dr. Sunit Das. The paper discusses the key points from Dr. Das' talk. Specifically, it discusses about Dr. Das' perspective on the ethical and moral issues that was experienced from applying artificial intelligence (AI) in law and how such issues can also arise when applying (...) AI to medicine, and concludes with a brief discussion on how such issues can be prevented. (shrink)

Contemporary reasoning about health is infused with the work products of experts, and expert reasoning about health itself is an active site for invention and design. Building on Toulmin’s largely undeveloped ideas on field-dependence, we argue that expert fields can develop new inference rules that, together with the backing they require, become accepted ways of drawing and defending conclusions. The new inference rules themselves function as warrants, and we introduce the term “warranting device” to refer to an assembly of the (...) rule plus whatever material, procedural, and institutional resources are required to assure its dependability. We present a case study on the Cochrane Review, a new method for synthesizing evidence across large numbers of scientific studies. After reviewing the evolution and current structure of the device, we discuss the distinctive kinds of critical questions that may be raised around Cochrane Reviews, both within the expert field and beyond. Although Toulmin’s theory of field-dependence is often criticized for its relativism, we find that, as a matter of practical fact, field-specific warrants do not enjoy immunity from external critique. On the contrary, they can be opened to evaluation and critique from any interested perspective. (shrink)