This is a response to the response by Robyn Bluhm to my paper, and I am again arguing for a limited role of capacities in psychiatry, given the current scientific uncertainties.

Evidence hierarchies are widely used to assess evidence in systematic reviews of medical studies. I give several arguments against the use of evidence hierarchies. The problems with evidence hierarchies are numerous, and include methodological shortcomings, philosophical problems, and formal constraints. I argue that medical science should not employ evidence hierarchies, including even the latest and most-sophisticated of such hierarchies.

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 issue of how to incorporate the individual's first‐hand experience of illness into broader medical understanding is a major question in medical theory and practice. In a philosophical context, phenomenology, with its emphasis on the subject's perception of phenomena as the basis for knowledge and its questioning of naturalism, seems an obvious candidate for addressing these issues. This is a review of current phenomenological approaches to medicine, looking at what has motivated this philosophical approach, the main problems it faces and (...) suggesting how it might become a useful philosophical tool within medicine, with its own individual, but interrelated, contribution to make to current medical debates. After the general background, there is a brief summary of phenomenological ideas and their current usage in a medical context. Next is a critique of four key claims within current phenomenological medical works, concerning both the role phenomenology plays and the supposedly clear divide between phenomenology and other approaches. There are significant problems within these claims, largely because they overlook the complexity of the questions they consider. Finally, there is some more in‐depth examination of phenomenology itself and the true complexity of phenomenological debate concerning subjectivity. The aim is to show that it will be both more productive and truer to phenomenology itself, if we use phenomenology as a philosophical method for explicating and gaining deeper understanding of complex and fundamental problems, which are central to medicine, rather than as providing simple, but flawed solutions. (shrink)

We claim that if a complete philosophy of evidence-based practice is intended, then attention to the nature of causation in health science is necessary. We identify how health science currently conceptualises causation by the way it prioritises some research methods over others. We then show how the current understanding of what causation is serves to constrain scientific progress. An alternative account of causation is offered. This is one of dispositionalism. We claim that by understanding causation from a dispositionalist stance, many (...) of the processes within an evidence-based practice framework are better accounted for. Further, some of the problems associated with the health research, e.g. external validity of causal findings, dissolve. (shrink)

I describe two traditions of philosophical accounts of evidence: one characterizes the notion in terms of signs of success, the other characterizes the notion in terms of conditions of success. The best examples of the former rely on the probability calculus, and have the virtues of generality and theoretical simplicity. The best examples of the latter describe the features of evidence which scientists appeal to in practice, which include general features of methods, such as quality and relevance, and general features (...) of evidence, such as patterns in data, concordance with other evidence, and believability of the evidence. Two infamous episodes from biomedical research help to illustrate these features. Philosophical characterization of these latter features—conditions of success—has the virtue of potential relevance to, and descriptive accuracy of, practices of experimental scientists. (shrink)

As the quality movement in health care now enters its fourth decade, the language of quality is ubiquitous. Practitioners, organizations, and government agencies alike vociferously testify their commitments to quality and accept numerous forms of governance aimed at improving quality of care. Remarkably, the powerful phrase ‘‘quality of care’’ is rarely defined in the health care literature. Instead it operates as an accepted and assumed goal worth pursuing. The status of evidence-based medicine, for instance, hinges on its ability to improve (...) quality of care, and efforts are made by both proponents and detractors to unpack the contents and outcomes of evidence-based practice while the contents of ‘‘quality of care’’ are presumed to be understood. Because the goals of medicine are far from obvious, this paper investigates the neglected term, ‘‘quality of care,’’ in an effort to understand what it is that health care practices are so uncritically assumed to be striving for. Finding lack of consensus on the terminology in the quality literature, I propose that the term operates rhetorically by way of persuasive appeal (and lack of descriptive meaning). Unsatisfied that ‘‘quality of care’’ operates as a mere buzzword in morally contentious debates over resource allocation and duties of care, I implore health care communities to go beyond mere commitments to quality and, instead, to focus attention on the difficult task of specifying what counts as quality care within an economically constrained health care system. (shrink)

Robin Nunn has argued that we should stop using the terms ‘placebo’ and ‘placebo effect’. I argue in support of Nunn’s position by considering the logic of why we perform placebo comparisons. Like all comparisons, placebo comparison is just a case of comparing one thing with another, but it is a mistake, I argue, to think of placebo comparison as a case where something is compared to ‘a placebo’. Rather, placebo comparison should be understood as a situation which sets-up the (...) treatment and control groups in a particular way; not as a case involving objects or procedures called ‘placebos’ employed in order to control for ‘placebo effects’. (shrink)

An astonishing volume and diversity of evidence is available for many hypotheses in the biomedical and social sciences. Some of this evidence—usually from randomized controlled trials (RCTs)—is amalgamated by meta-analysis. Despite the ongoing debate regarding whether or not RCTs are the ‘gold-standard’ of evidence, it is usually meta-analysis which is considered the best source of evidence: meta-analysis is thought by many to be the platinum standard of evidence. However, I argue that meta-analysis falls far short of that standard. Different meta-analyses (...) of the same evidence can reach contradictory conclusions. Meta-analysis fails to provide objective grounds for intersubjective assessments of hypotheses because numerous decisions must be made when performing a meta-analysis which allow wide latitude for subjective idiosyncrasies to influence its outcome. I end by suggesting that an older tradition of evidence in medicine—the plurality of reasoning strategies appealed to by the epidemiologist Sir Bradford Hill—is a superior strategy for assessing a large volume and diversity of evidence. (shrink)

My dissertation combines philosophy of science and political philosophy. Drawing directly on the work of Alasdair MacIntyre and inspired by John Dewey, I develop two rival conceptions of scientific practice. I show that these rivals are closely linked to the two basic sides in the science and values debate -- the debate over the extent to which ethical and political values may legitimately influence scientific inquiry. Finally, I start to develop an account of justice that is sensitive to these legitimate (...) and illegitimate influences. (shrink)

Robustness is a common platitude: hypotheses are better supported with evidence generated by multiple techniques that rely on different background assumptions. Robustness has been put to numerous epistemic tasks, including the demarcation of artifacts from real entities, countering the “experimenter’s regress,” and resolving evidential discordance. Despite the frequency of appeals to robustness, the notion itself has received scant critique. Arguments based on robustness can give incorrect conclusions. More worrying is that although robustness may be valuable in ideal evidential circumstances (i.e., (...) when evidence is concordant), often when a variety of evidence is available from multiple techniques, the evidence is discordant. †To contact the author, please write to: Jacob Stegenga, Department of Philosophy, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093; e‐mail: [email protected]. (shrink)

Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic review of the critical literature. It (...) finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context. (shrink)

The paper examines definitions of ‘cause’ in the epidemiological literature. Those definitions all describe causes as factors that make a difference to the distribution of disease or to individual health status. In the philosophical jargon, causes in epidemiology are difference-makers. Two claims are defended. First, it is argued that those definitions underpin an epistemology and a methodology that hinge upon the notion of variation, contra the dominant Humean paradigm according to which we infer causality from regularity. Second, despite the fact (...) that causes be defined in terms of ‘difference-making’, this cannot fixes the causal metaphysics. Causality in epidemiology ought to be interpreted according to the epistemic theory. In this approach relations are deemed causal depending on the evidence and on the available methods. Indeed, evidence to establish causal claims requires difference-making considerations; furthermore, those definitions of cause reflect the ‘variational’ epistemology and methodology of epidemiology. (shrink)

In evidence-based medicine (EBM), methodology has become the central means of determining the quality of the evidence base. The “gold standard” method, the randomised, controlled trial (RCT), imbues medical research with an ethos of disinterestedness; yet, as this essay argues, the RCT is itself a rhetorically interested construct essential to medical-professional boundary work. Using the example of debates about methodology in EBM-oriented research on complementary and alternative medicine (CAM), practices not easily tested by RCTs, I frame the problem of method (...) as a fundamentally rhetorical problem, situated within a boundary drama, and deeply rooted in the discursive practices of science and medicine. The genre of the RCT report, for example, idealises the research process and can tilt the course of arguments about CAM, while the notion of efficacy can function as a rhetorically mobile boundary object that can redefine the very terms of debate. I suggest herein that arguments about method in CAM debates can productively be read, metonymically, as expressions of more general anxieties in medicine about knowledge and evidence, community values, and professional boundaries; as such, these debates can illuminate some of the rhetorical dimensions of EBM. (shrink)

Evidence-Based Medicine has little consideration for mechanisms and philosophers of science and medicine have recently made pleas to increase the place of mechanisms in the medical evidence hierarchy. However, in this debate the notions of mechanisms seem to be limited to 'mechanistic processes' and 'complex-systems mechanisms,' understood as 'componential causal systems'. I believe that this will not do full justice to how mechanisms are used in biological, psychological and social sciences and, consequently, in a more biopsychosocial approach to medicine. Here, (...) I propose, following (Kuorikoski, 2009), to pay more attention to 'abstract forms of interaction' mechanisms. The present work scrutinized review articles on depression and medically unexplained pain, which are considered to be of multifactorial pathogenesis, for their use of mechanisms. In review articles on these disorders there seemed to be a range of uses between more 'abstract forms of interaction' and 'componential causal system' mechanisms. I therefore propose to expand the notions of mechanisms considered in medicine to include that of more 'abstract forms of interaction' to better explain and manage biopsychosocial disorders. (shrink)

Evidence based-policy (EBP) is a popular research paradigm in the applied social sciences and within government agencies. Informally, EBP represents an explicit commitment to applying scientific methods to public affairs, in contrast to ideologically-driven or merely intuitive “common-sense” approaches to public policy. More specifically, the EBP paradigm places great weight on the results of experimental research designs, especially randomised controlled trials (RCTs), and systematic literature reviews that place evidential weight on experimental results. One hope is that such research designs and (...) approaches to analysing the scientific literature are sufficiently robust that they can settle what really ‘works’ in public policy. Can EBP succeed in displacing reliance on domain-specific expertise? On our account, this is seldom, if ever, the case. The key reason for this is that underlying this approach is generally an appeal to argument by induction, which always requires further assumptions to underwrite its validity, and if not induction, some other argument form that also requires assumptions that are very often not validated for the case at hand. (shrink)

The philosophy of medicine is an area that has experienced significant growth and change in the last decade or so. While usually thought to be distinct from bioethics, the philosophy of medicine addresses a wide range of questions having to do with epistemology, metaphysics, and values. In this survey, I use the concept of the reference class to draw connections between a number of questions of longstanding and of more recent concern in the philosophy of medicine. By focusing on the (...) way in which the reference class plays a role in questions and approaches that sometimes seem to be at odds with one another, I hope to illustrate the ways in which these oppositions are less complete than they might at first appear, and to show how the connections between different problems are being redrawn. (shrink)

In a well-cited book chapter, ecologist Jared Diamond characterizes three main types of experiment performed in community ecology: laboratory experiment, field experiment, and natural experiment. Diamond argues that each form of experiment has strengths and weaknesses, with respect to, for example, realism or the ability to follow a causal trajectory. But does Diamond’s typology exhaust the available kinds of cause-finding practices? Some social scientists have characterized something they call “causal process tracing.” Is this a fourth type of experiment or something (...) else? I examine Diamond’s typology and causal process tracing in the context of a case study concerning the dynamics of wolf and deer populations on the Kaibab Plateau in the 1920s, a case that has been used as a canonical example of a trophic cascade by ecologists but which has also been subject to controversy. I argue that ecologists have profitably deployed causal process tracing together with other types of experiment to help settle questions of causality in this case. It remains to be seen how widespread the use of causal process tracing outside of the social sciences is (or could be), but there are some potentially promising applications, particularly with respect to questions about specific causal sequences. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

In the human sciences, experimental research is used to establish causal relationships. However, the extrapolation of these results to the target population can be problematic. To facilitate extrapolation, we propose to use the statistical technique Latent Class Regression Analysis in combination with the analogical reasoning theory for extrapolation. This statistical technique can identify latent classes that differ in the effect of X on Y. In order to extrapolate by means of analogical reasoning, one can characterize the latent classes by a (...) combination of features, and then compare these features to features of the target. (shrink)

Medical research makes intensive use of statistics in order to support its claims. In this paper we make explicit an epistemological tension between the conduct of clinical trials and their interpretation: statistical evidence is sometimes discarded on the basis of an underlined Bayesian reasoning. We suggest that acknowledging the potentiality of Bayesian statistics might contribute to clarify and improve comprehension of medical research. Nevertheless, despite Bayesianism may provide a better account for scientific inference with respect to the standard frequentist approach, (...) Bayesian statistics is rarely adopted in clinical research. The main reason lies in the supposed subjective elements characterizing this perspective. Hence, we discuss this objection presenting the so-called Reference analysis, a formal method which has been developed in the context of objective Bayesian statistics in order to define priors which have a minimal or null impact on posterior probabilities. Furthermore, according to this method only available data are relevant sources of information, so that it resists the most common criticisms against Bayesianism. (shrink)

Male circumcision—partial or total removal of the penile prepuce—has been proposed as a public health measure in Sub-Saharan Africa, based on the results of three randomized control trials showing a relative risk reduction of approximately 60 per cent for voluntary, adult male circumcision against female-to-male human immunodeficiency virus transmission in that context. More recently, long-time advocates of infant male circumcision have argued that these findings justify involuntary circumcision of babies and children in dissimilar public health environments, such as the USA, (...) Australasia and Europe. In this article, we take a close look at the necessary ethical and empirical steps that would be needed to bridge the gap between the African RCTs and responsible public health policy in developed countries. In the course of doing so, we discuss some of the main disagreements about the moral permissibility of performing a nontherapeutic surgery on a child to benefit potential future sexual partners of his. In this context, we raise concerns not only about weaknesses in the available evidence concerning such claims of benefit, but also about a child’s moral interest in future autonomy and the preservation of his bodily integrity. We conclude that circumcision of minors in developed countries on public health grounds is much harder to justify than proponents of the surgery suggest. (shrink)

ABSTRACT“Evidence-based” methods, which most prominently include randomized controlled trials, have gained increasing purchase as the “gold standard” for assessing the effect of public policies. But the enthusiasm for evidence-based research overlooks questions about the reliability and applicability of experimental findings to diverse real-world settings. Perhaps surprisingly, a qualitative study of British educators suggests that they are aware of these limitations and therefore take evidence-based findings with a much larger grain of salt than do policy makers. Their experience suggests that the (...) real world is more heterogeneous than the world imagined by evidence-based policy enthusiasts. (shrink)

Philosophical discussions on causal inference in medicine are stuck in dyadic camps, each defending one kind of evidence or method rather than another as best support for causal hypotheses. Whereas Evidence Based Medicine advocates the use of Randomised Controlled Trials and systematic reviews of RCTs as gold standard, philosophers of science emphasise the importance of mechanisms and their distinctive informational contribution to causal inference and assessment. Some have suggested the adoption of a pluralistic approach to causal inference, and an inductive (...) rather than hypothetico-deductive inferential paradigm. However, these proposals deliver no clear guidelines about how such plurality of evidence sources should jointly justify hypotheses of causal associations. We here develop such guidelines by first giving a philosophical analysis of the underpinnings of Hill’s viewpoints on causality. We then put forward an evidence-amalgamation framework adopting a Bayesian net approach to model causal inference in pharmacology for the assessment of harms. Our framework accommodates a number of intuitions already expressed in the literature concerning the EBM vs. pluralist debate on causal inference, evidence hierarchies, causal holism, relevance, and reliability. (shrink)

The disconnect problem arises wherever there is ongoing and severe discordance between the scientific assessment of a politically relevant issue, and the politics and legislation of said issue. Here, we focus on the disconnect problem as it arises in the case of climate change, diagnosing a failure to respect the necessary tradeoff between authority and autonomy within a public institution like science. After assessing the problematic deployment of scientific authority in this arena, we offer suggestions for how to mitigate climate (...) change’s particular disconnect problem, as well as more general proposals for reforming science advising. (shrink)

Over the past seven decades, randomised controlled trials (RCTs) have revolutionised clinical research and achieved a gold standard status. However, extending their use to evaluate complex interventions is problematic. In this paper we will demonstrate that complex intervention RCTs violate the necessary premises that govern the RCTs logic and underpin their rigour. The lack of blinding, heterogeneity of participants, as well as poor treatment standardisation and difficulty of controlling for confounders, which characterise complex intervention RCTs, can potentially be profoundly detrimental (...) to their integrity. Proponents of this approach argue that matching “real world” circumstances, while maintaining the randomised design, enhances external validity. We counter this argument by pointing out that an inverted U relation exists between internal and external validity, and thus relaxing the experimental conditions beyond a certain threshold can potentially paradoxically render the RCT externally invalid, i.e. its results cannot be used anywhere. We shall illustrate the inappropriate use of RCTs to evaluate community treatment orders and propose an alternative epistemic model that is based on mechanistic reasoning and Cartwright's capacity concept. (shrink)

Evidence-based policy has support in many areas of government and in public affairs more generally. In this paper we outline what evidence-based policy is, then we discuss its strengths and weaknesses. In particular, we argue that it faces a serious challenge to provide a plausible, over-arching account of evidence. We contrast evidence-based policy with evidence-based medicine, especially the role of evidence in assessing the effectiveness of medicines. The evidence required for policy decisions does not easily lend itself to randomized controlled (...) trials, nor, for that matter, being listed in a single all-purpose hierarchy. (shrink)

John Worrall and Nancy Cartwright have both argued that randomized controlled trials are “testing the wrong theory.” They claim that RCTs are designed to test inferences about the causal relationships in the study population, but this does not guarantee a justified inference about the causal relationships in the more diverse population in clinical practice. In this article I argue that the epistemology of theory testing in trials is more complicated than either Worrall’s or Cartwright’s accounts suggest. I illustrate this more (...) complex theoretical structure with case studies in medical theory testing from Alzheimer’s research and anticancer drugs in personalized medicine. (shrink)

This paper outlines the methodological and empirical limitations of analysing the potential relationship between complex social phenomena such as democracy and inequality. It shows that the means to assess how they may be related is much more limited than recognised in the existing literature that is laden with contradictory hypotheses and findings. Better understanding our scientific limitations in studying this potential relationship is important for research and policy because many leading economists and other social scientists such as Acemoglu and Robinson (...) mistakenly claim to identify causal linkages between inequality and democracy but at times still inform policy. In contrast to the existing literature, the paper argues that ‘structural’ or ‘causal’ mechanisms that may potentially link the distribution of economic wealth and different political regimes will remain unknown given reasons such as their highly complex and idiosyncratic characteristics, fundamental econometric constraints and analysis at the macro-level. Neither new data sources, different analysed time periods nor new data analysis techniques can resolve this question and provide robust, general conclusions about this potential relationship across countries. Researchers are thus restricted to exploring rough correlations over specific time periods and geographic contexts with imperfect data that are very limited for cross-country comparisons. (shrink)

Two approaches to evidential reasoning compete in the biomedical and social sciences: the experimental and the pragmatist. Whereas experimentalism has received considerable philosophical analysis and support since the times of Bacon and Mill, pragmatism about evidence has been neither articulated nor defended. The overall aim is to fill this gap and develop a theory that articulates the latter. The main ideas of the theory will be illustrated and supported by a case study on the smoking/lung cancer controversy in the 1950s.

Consensus conferences are social techniques which involve bringing together a group of scientific experts, and sometimes also non-experts, in order to increase the public role in science and related policy, to amalgamate diverse and often contradictory evidence for a hypothesis of interest, and to achieve scientific consensus or at least the appearance of consensus among scientists. For consensus conferences that set out to amalgamate evidence, I propose three desiderata: Inclusivity, Constraint, and Evidential Complexity. Two examples suggest that consensus conferences can (...) readily satisfy Inclusivity and Evidential Complexity, but consensus conferences do not as easily satisfy Constraint. I end by discussing the relation between social inclusivity and the three desiderata. (shrink)

Proponents of evidence-based medicine have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches and that the emphasis on evidence (...) hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence. (shrink)

The paper addresses charges of risk and loss aversion as well as of irrationality directed against the precautionary principle (PP), by providing an epistemic analysis of its specific role in the safety law system. In particular, I contend that: 1) risk aversion is not a form of irrational or biased behaviour; 2) both risk and loss aversion regard the form of the utility function, whereas PP rather regards the information on which to base the decision; 3) thus PP has formally (...) nothing to do with risk or loss aversion but rather with risk awareness; 4) PP removes a fictional construct in the legal system, according to which any hazard should be ignored and denied until it is scientifically proven; 5) the quandary originates in the tension between current methods of evidence evaluation, and the logic underlying PP which demands for a probabilistic epistemology. (shrink)

Surgery is an important part of contemporary health care, but currently much of surgery lacks a strong evidence base. Uptake of evidence-based medicine (EBM) methods within surgical research and among practitioners has been slow compared with other areas of medicine. Although this is often viewed as arising from practical and cultural barriers, it also reflects a lack of epistemic fit between EBM research methods and surgical practice. In this paper we discuss some epistemic challenges in surgery relating to this lack (...) of fit, and investigate how resources from feminist epistemology can help to characterize them. We point to ways in which these epistemic challenges may be addressed by gathering and disseminating evidence about what works in surgery using methods that are contextual, pluralistic, and sensitive to hierarchies. (shrink)

Several have argued that the aims of scientific research are not always independent of social and ethical values. Yet this is often assumed only to have implications for decisions about what is studied, or which research projects are funded, and not for methodological decisions or standards of evidence. Using the case of the recently developed HPV vaccines, we argue that the social aims of research can also play important roles in justifying decisions about (1) how research problems are defined in (...) drug development, (2) evidentiary standards used in testing drug “success”, and (3) clinical trial methodology. As a result, attending to the social aims at stake in particular research contexts will produce more rational methodological decisions as well as more socially relevant science. (shrink)

The notion of ‘causal web’ emerged in the epidemiological literature in the early Sixties and had to wait until the Nineties for a thorough critical appraisal. Famously, Nancy Krieger argued that such a notion isn’t helpful unless we specify what kind of spiders create the webs. This means, according to Krieger, (i) that the role of the spiders is to provide an explanation of the yarns of the web and (ii) that the sought spiders have to be biological and social. (...) This paper contributes to the development of the notion of causal web, elaborating on the two following points: (i) to catch the spiders we need multi-fold evidence—specifically, mechanistic and difference-making—and (ii) for the eco-social to be explanatory, the web has to be mechanistic in a sense to be specified. (shrink)

Public policymakers and institutional decision-makers routinely face questions about whether interventions “work”: does universal basic income improve people’s welfare and stimulate entrepreneurial activity? Do gated alleyways reduce burglaries or merely shift the crime burden to neighbouring communities? What is the most cost-effective way to improve students’ reading abilities? These are empirical questions that seem best answered by looking at the world, rather than trusting speculations about what will be effective. Evidence-based policy (EBP) is a movement that concretizes this intuition. It (...) maintains that policy should be based on evidence of “what works.” Not any evidence will do, however. Following on the heels of its intellectual progenitor, evidence-based medicine (EBM), EBP insists on the use of high-quality evidence produced in accordance with rigorous methodological standards. Though intuitively compelling, EBP has attracted significant criticism from methodologists, political scientists, and philosophers. This chapter provides a critical overview of EBP through a philosophical lens, reviewing and discussing some of the most pressing challenges that EBP faces and outlining some proposals for improving it. I first provide a brief overview of EBP and distinguish a broader and narrower understanding of it. I then review existing lines of criticism of EBP, two of which are considered in detail. The first elaborates how EBP struggles with extrapolation, that is, the use of evidence from study populations to make inferences about the effects of policies on novel target populations. The second maintains that EBP’s methodological tenets are deeply entwined with moral and political values, which can threaten EBP’s promise to promote objectivity in policymaking. Finally, I make some proposals for how EBP could be improved going forward. (shrink)

There are two important traditions in the philosophy of induction. According to one tradition, which has dominated for the last couple of centuries, inductive arguments are warranted by rules. Bayesianism is the most popular view within this tradition. Rules of induction provide functional accounts of inductive support, but no rule is universal; hence, no rule is by itself an accurate model of inductive support. According to another tradition, inductive arguments are not warranted by rules but by matters of fact. Norton’s (...) material theory of induction (MTI) is an influential view within this tradition. Norton’s MTI fails to provide an account of inductive support, but it provides a good account of inductive warrant that can help us define the domain of validity of each rule of induction. Despite their limitations, both approaches to induction are illuminating important aspects of how relations of inductive support work. In this article I present a hybrid theory of induction (HTI), in which I acknowledge and articulate the role of both rules and matters of fact in our understanding of inductive support. According to the HTI, rules of induction accurately describe relations of inductive support when they are warranted, and a rule of induction is warranted if the right facts about the matter of the induction obtain. Crucially, the HTI allows us to address the main challenges that each tradition faces while retaining their strengths, thus obtaining a functional and accurate account of inductive support. The HTI also provides a useful general framework to examine and understand induction, to make sense of how different rules of induction can coexist and to tackle some problems in epistemology. Moreover, the HTI allows us to clarify and resolve some current debates on induction, like the apparent divide between Norton and rule-based theorists. (shrink)

Exploratory experiments are widely characterized as experiments that do not test hypotheses. Experiments that do test hypotheses are characterized as confirmatory experiments. Philosophers have pointed out that research programmes can be both confirmatory and exploratory. However, these definitions preclude single experiments being characterized as both exploratory and confirmatory; how can an experiment test and not test a hypothesis? Given the intuition that some experiments are exploratory, some are confirmatory, and some are both, a recharacterization of the relationship between exploratory and (...) confirmatory experimentation is needed. I discuss ‘phase IV’ trials to show what this recharacterization could look like. Phase IV trials can be exploratory and confirmatory insofar as they concurrently test hypotheses and explore for unforeseen phenomena. Even if it is uncontroversial that a single experiment can have multiple aims, the recharacterization of the relationship between exploratory and confirmatory experimentation is still required for these aims to be held together coherently. I offer an alternative characterization of the relationship between exploratory and confirmatory experimentation where the former remains a distinct kind of experimentation but is not characterized as non-hypothesis-testing. (shrink)

Agent-based models (ABMs) are one type of simulation model used in the context of the COVID-19 pandemic. In contrast to equation-based models, ABMs are algorithms that use individual agents and attribute changing characteristics to each one, multiple times during multiple iterations over time. This paper focuses on three philosophical aspects of ABMs as models of causal mechanisms, as generators of emergent phenomena, and as providers of explanation. Based on my discussion, I conclude that while ABMs cannot help much with causal (...) inference, they can be viewed as etio-prognostic explanations of illness occurrence and outcome. (shrink)

Pluralism about scientific method is more-or-less accepted, but the consequences have yet to be drawn out. Scientists adopt different methods in response to different epistemic situations: depending on the system they are interested in, the resources at their disposal, and so forth. If it is right that different methods are appropriate in different situations, then mismatches between methods and situations are possible. This is most likely to occur due to method bias: when we prefer a particular kind of method, despite (...) that method clashing with evidential context or our aims. To explore these ideas, we sketch a kind of method pluralism which turns on two properties of evidence, before using agent-based models to examine the relationship between methods, epistemic situations, and bias. Based on our results, we suggest that although method bias can undermine the efficiency of a scientific community, it can also be productive through preserving a diversity of evidence. We consider circumstances where method bias could be particularly egregious, and those where it is a potential virtue, and argue that consideration of method bias reveals that community standards deserve a central place in the epistemology of science. (shrink)

Clinical equipoise has been proposed as an ethical principle relating uncertainty and moral leeway in clinical research. Although CE has traditionally been indicated as a necessary condition for a morally justified introduction of a new RCT, questions related to the interpretation of this principle remain woefully open. Recent proposals to rehabilitate CE have divided the bioethical community on its ethical merits. This paper presents a new argument that brings out the epistemological difficulties we encounter in justifying CE as a principle (...) to connect uncertainty and moral leeway in clinical ethics. The argument proposes, first, that the methodology of hypothetical retrospection is applicable to the RCT design and that it can accommodate uncertainty. As currently understood, however, HR should give up its reliance on the assumption of uncertainty transduction, because the latter assumes the principle of indifference, which does not accommodate uncertainty in the right way. The same principle is then seen to distort also the received interpretations of CE. (shrink)

The standardised randomised clinical trial (RCT) has been exceedingly popular in medical research, economics, and practical policy making. Recently, RCTs have faced criticism. First, it has been argued by John Worrall that we cannot be certain that our sample is not atypical with regard to possible confounding factors. I will argue that at least in the case of medical research, we know enough about the relevant causal mechanisms to be justified to ignore a number of factors we have good reason (...) not to expect to be disruptive. I will also argue against an argument provided by Nancy Cartwright and Eileen Munro that RCTs should not be taken to deductively infer probabilistic causal claims, but ampliatively. The paper will end on a discussion of evidence hierarchies and a defence of the stance of evidence-based medicine that RCTs are the best available method to assess a treatment’s efficacy. (shrink)

Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 ‘first in human’ trials, but evidence from these trials is rarely published, despite the fact that such trials provide the (...) foundation for assessing the harm profile of medical interventions. If a medical intervention is deemed safe in a phase 1 trial, it is tested in larger phase 2 and 3 clinical trials. One way to think about the problem of underestimating harms is in terms of the statistical ‘power’ of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as power-B and the latter as power-H. I identify several factors that maximize power-B by sacrificing powerH in phase 3 clinical trials. If a medical intervention is approved for general use, it is evaluated by phase 4 post-market surveillance. Phase 4 surveillance of harms further contributes to underestimating the harm profile of medical interventions. At every stage of clinical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions. (shrink)