There are two competing views regarding the role of mechanistic knowledge in inferences about the effectiveness of interventions. One view holds that inferences about the effectiveness of interventions should be based only on data from population-level studies (often statistical evidence from randomised trials). The other view holds that such inferences must be based in part on mechanistic evidence. The competing views are local principles of inference, the plausibility of which can be assessed by a more general normative principle of inference. (...) Bayesianism tells us to base inferences on both the ‘likelihood’ and the ‘prior’. The likelihood represents statistical evidence. One influence on the prior probability of a hypothesis like ‘d causes x’ is mechanistic knowledge of how d causes x. Thus, reasoning about such inferences by appealing to both statistical and mechanistic evidence is vindicated by our best general theory of inference. The primary contribution of this paper is to assess the merits and weaknesses of the arguments on both sides of the debate, using the Bayesian framework. This analysis lends support to those who argue that we should base our causal inferences about interventions in part on mechanistic evidence. (shrink)

This chapter addresses the problem of ranking available drugs in guideline development to support clinicians in their work. Based on a pragmatic approach to the notion of evidence and a hierarchical view on different kinds of evidence this chapter introduces a decision aid, HiDAD, which draws on the multi criteria decision making literature. This decision aid implements the wide-spread intuition that there are different kinds of evidence with varying degrees of importance by relying on a strict ordinal ordering of kinds (...) of evidence. In order to construct a ranking every pair of drugs is first compared separately on all kinds of evidence. Next, these quantitative comparisons are then aggregated into an overall comparison between drugs based on all the available evidence in a way which avoids that evidence of less importance is trumped by evidence of the higher levels. Finally, these overall comparisons are used to determine the final ranking of drugs which then informs the process of guideline writing. Properties, modifications and applicability of the decision aid HiDAD are discussed and assessed. (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)

This article presents and defends an integrated view of the placebo effect, termed “affective-meaning-making” model, which draws from theoretical reflection, clinical outcomes, and neurophysiological findings. We consider the theoretical limitations of those proposals associated with the “meaning view” on the placebo effect which leave the general aspects of meaning unspecified, fail to analyze fully the role of emotions and affect, and establish no clear connection between the theoretical, physiological, and psychological aspects of the effect. We point out that a promising (...) way to overcome these limitations is given by grounding the placebo effect on Peirce’s theory of meaning, in which the role of the meaning constitution and change is placed in logical and objective structures. We also show the connection between our theoretical proposal and the appraisal theory and integrate it with emotion regulation. (shrink)

The beliefs involved in the placebo effect are often assumed to be self-fulfilling, that is, the truth of these beliefs would merely require the patient to hold them. Such a view is commonly shared in epistemology. Many epistemologists focused, in fact, on the self-fulfilling nature of these beliefs, which have been investigated because they raise some important counterexamples to Nozick’s “tracking theory of knowledge.” We challenge the self-fulfilling nature of placebo-based beliefs in multi-agent contexts, analyzing their deep epistemological nature and (...) the role of higher-order beliefs involved in the placebo effect. (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)

Cooperation and conversation in the public sphere may overcome historical and other barriers to rational argumentation. As an alternative to evidence-based medicine (EBM) and patient-centered care (PCC), the recent development of a modern version of person-centered medicine (PCM) signals an opportunity for a conversational pluralogue to replace parallel monologues between EBM and its critics, and the calls to EBM to debate its critics. This article draws upon elements of Habermas’s theory of communicative action in order to suggest the kind of (...) pluralogue that is required for stakeholders in modern medicine to benefit more from publicly conversing with each other than speaking alone or using debate to argue against each other. This reasoned perspective has lessons for all discourse when deep value-based and epistemological differences cannot be easily adjudicated. (shrink)

What is medicine? One obvious answer in the context of the contemporary clinical tradition is that medicine is the process of curing sick people. However, this “curative thesis” is not satisfactory, even when “cure” is defined generously and even when exceptions such as cosmetic surgery are set aside. Historian of medicine Roy Porter argues that the position of medicine in society has had, and still has, little to do with its ability to make people better. Moreover, the efficacy of medicine (...) for improving population health has been famously doubted by historians and epidemiologists. The curative thesis demands that we have mostly been stupid, duped, or staggeringly hopeful, given that medicine has not until recently offered more than a handful of effective cures. I suggest, in this article, that the core medical competence is neither to cure, nor to prevent, disease, but to understand and to predict it. I argue that this approach does a better job than the curative thesis at explaining why not all medicine is concerned with curative efforts and that it enjoys historical support from the ancient entanglement of prophecy and medicine and from the fact that medicine thrived for centuries with almost no effective cures and continues to thrive today in various forms that are mostly without curative efficacy. I suggest that this approach grounds a fairer approach to alternative, traditional, and other medical practices, as well as some fresh lessons for the development of mainstream medicine. (shrink)

Some contemporary paternalists argue in favor of government interventions based on how experimental psychologists and behavioral economists have found that our behavior often diverges from what would be predicted by rational-choice models. In this article it is argued that these findings can, more specifically, be used to identify decisional trouble spots where paternalist interventions may be legitimate. It is further argued that since the epistemic legitimacy of government paternalism ultimately rests on centralized decision-making having a comparative advantage, it also depends (...) on the possibility of such interventions being governed by an ideal of evidence-based policy-making. The article asks how stringently this requirement should be understood, and to what extent government can legitimately engage in what might be called experimental policy-making of a paternalistic character. (shrink)

Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite (...) its success in treating severe depression there is continued debate as to the effectiveness of ECT: in some studies, it is argued that ECT is marginally more effective than sham ECT. In addition, there is still no clear explanation of how ECT works; among the range of hypotheses proposed it is claimed that ECT may work by harnessing placebo effects. In light of the uncertainties over the mechanism of action of ECT and given the risk of serious side effects that ECT may produce, I contend that the process of informed consent must include comprehensive accounts of these uncertainties. I examine the possible consequences of providing adequate information to potential ECT patients, including the consideration that ECT may still prove to be effective even if physicians are open about the possibility of it working as a placebo. I conclude that if we value patient autonomy as well as the professional reputation of medical practitioners, a fuller description of ECT must be provided to patients and their carers. (shrink)

This paper shows that the history of clinical medicine in the eighteenth century supports Paul Hoyningen-Huene’s thesis that there is a correlation between science and systematicity. For example, James Jurin’s assessment of the safety of variolation as a protection against smallpox adopted a systematic approach to the assessment of interventions in order to eliminate sources of cognitive bias that would compromise inquiry. Clinical medicine thereby became a science. I use this confirming instance to motivate a broader hypothesis, that systematicity is (...) a distinctive feature of science because systematicity is required by processes of knowledge generation that go beyond our everyday cognitive capacities, and these processes are required to produce knowledge of the kinds that science aims at. (shrink)

Despite the consensus promoted by the evidence-based medicine framework, many authors continue to express doubts about the superiority of randomized controlled trials. This paper evaluates four objections targeting the legitimacy, feasibility, and extrapolation problems linked to the experimental practice of random allocation. I argue that random allocation is a methodologically sound and feasible practice contributing to the internal validity of controlled experiments dealing with heterogeneous populations. I emphasize, however, that random allocation is solely designed to ensure the validity of causal (...) inferences at the level of groups. By itself, random allocation cannot enhance test precision, doesn’t contribute to external validity, and limits the applicability of causal claims to individuals. (shrink)

Multidisciplinary models aggregating ‘lower-level’ biological and ‘higher-level’ psychological and social determinants of a phenomenon raise a puzzle. How is the interaction between the physical, the psychological and the social conceptualized and explained? Using biopsychosocial models of pain as an illustration, I argue that these models are in fact level-neutral compilations of empirical findings about correlated and causally relevant factors, and as such they neither assume, nor entail a conceptual or ontological stratification into levels of description, explanation or reality. If inter-level (...) causation is deemed problematic or if debates about the superiority of a particular level of description or explanation arise, these issues are fueled by considerations other than empirical findings. (shrink)

Multidisciplinary models aggregating ‘lower-level’ biological and ‘higher-level’ psychological and social determinants of a phenomenon raise a puzzle. How is the interaction between the physical, the psychological and the social conceptualized and explained? Using biopsychosocial models of pain as an illustration, I argue that these models are in fact level-neutral compilations of empirical findings about correlated and causally relevant factors, and as such they neither assume, nor entail a conceptual or ontological stratification into levels of description, explanation or reality. If inter-level (...) causation is deemed problematic or if debates about the superiority of a particular level of description or explanation arise, these issues are fueled by considerations other than empirical findings. (shrink)

According to the hypothesis-generator account, valid extrapolations from a source to a target system are circular, since they rely on knowledge of relevant similarities and differences that can onl...

Causal pluralism can be defended not only in respect to causal concepts and methodological guidelines, but also at the finer-grained level of causal inference from a particular source of evidence for causation. An argument for this last variety of pluralism is made based on an analysis of causal inference from randomized experiments (RCTs). Here, the causal interpretation of a statistically significant association can be established via multiple paths of reasoning, each relying on different assumptions and providing distinct elements of information (...) in favour of a causal interpretation. (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)

Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...) clinical trials are means to ends, and thus their moral status depends both on how well they perform as means to reach desired ends and on which ends they are meant to achieve. Building upon this normative framework in the next two sections we analyze the specific ethical issues raised by non-inferiority trials. By making it clear that clinical trials are just epistemic tools – i.e. means to certain ends – it is possible not only to clarify the conceptual debate over a fundamental issue in clinical research, but also to identify which ethically relevant considerations ought to be addressed in setting up a non-inferiority trial. (shrink)

Even though the evidence‐based medicine movement (EBM) labels mechanisms a low quality form of evidence, consideration of the mechanisms on which medicine relies, and the distinct roles that mechanisms might play in clinical practice, offers a number of insights into EBM itself. In this paper, I examine the connections between EBM and mechanisms from several angles. I diagnose what went wrong in two examples where mechanistic reasoning failed to generate accurate predictions for how a dysfunctional mechanism would respond to intervention. (...) I then use these examples to explain why we should expect this kind of mechanistic reasoning to fail in systematic ways, by situating these failures in terms of evolved complexity of the causal system(s) in question. I argue that there is still a different role in which mechanisms continue to figure as evidence in EBM: namely, in guiding the application of population‐level recommendations to individual patients. Thus, even though the evidence‐based movement rejects one role in which mechanistic reasoning serves as evidence, there are other evidentiary roles for mechanistic reasoning. This renders plausible the claims of some critics of evidencebased medicine who point to the ineliminable role of clinical experience. Clearly specifying the ways in which mechanisms and mechanistic reasoning can be involved in clinical practice frames the discussion about EBM and clinical experience in more fruitful terms. (shrink)

In this paper we focus on some new normativist positions and compare them with traditional ones. In so doing, we claim that if normative judgments are involved in determining whether a condition is a disease only in the sense identified by new normativisms, then disease is normative only in a weak sense, which must be distinguished from the strong sense advocated by traditional normativisms. Specifically, we argue that weak and strong normativity are different to the point that one ‘normativist’ label (...) ceases to be appropriate for the whole range of positions. If values and norms are not explicit components of the concept of disease, but only intervene in other explanatory roles, then the concept of disease is no more value-laden than many other scientific concepts, or even any other scientific concept. We call the newly identified position “value-conscious naturalism” about disease, and point to some of its theoretical and practical advantages. (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)

This paper scrutinizes the tension between individuals’ rights and paternalism. I will argue that no normative account that includes rights of individuals can justify hard paternalism since the infringement of a right can only be justified with the right or interest of another person, which is never the case in hard paternalism. Justifications of hard paternalistic actions generally include a deviation from the very idea of having rights. The paper first introduces Tom Beauchamp as the most famous contemporary hard paternalist (...) by outlining his moral theory (principlism) and showing why it, as it stands, has to allow for hard paternalism. Secondly, the paper focuses on the notion of rights within principlism. I will employ traditional theories of rights to make sense of rights in principlism. Unfortunately, this attempt fails. In the third part, then, I claim that rights can only be limited with reference to the rights or interests of others. This structure is the very point of rights, it is their bite. I will argue for this claim and show its implications. The most important implication is that not only principlism, but every normative theory that includes rights of individuals, has to abolish hard paternalism. (shrink)

After describing the disorder of psychopathy, I examine the theories and the evidence concerning the psychopaths’ deficient moral capacities. I first examine whether or not psychopaths can pass tests of moral knowledge. Most of the evidence suggests that they can. If there is a lack of moral understanding, then it has to be due to an incapacity that affects not their declarative knowledge of moral norms, but their deeper understanding of them. I then examine two suggestions: it is their deficient (...) practical reason or their stunted emotions that are at fault. The evidence supports both explanations. I conclude with an overview of the debate concerning whether they are morally or legally responsible for their actions. (shrink)

Population health has recently grown from a series of loosely connected critiques of twentieth-century public health and medicine into a theoretical framework with a corresponding field of research—population health science. Its approach is to promote the public’s health through improving everyday human life: affordable nutritious food, clean air, safe places where children can play, living wages, etc. It recognizes that addressing contemporary health challenges such as the prevalence of type 2 diabetes will take much more than good hospitals and public (...) health departments. -/- Blending philosophy of science/medicine, public health ethics and history, this book offers a framework that explains, analyses and largely endorses the features that define this relatively new field. Presenting a philosophical perspective, Valles helps to clarify what these features are and why they matter, including: searching for health’s “upstream” causes in social life, embracing a professional commitment to studying and ameliorating the staggering health inequities in and between populations; and reforming scientific practices to foster humility and respect among the many scientists and non- scientists who must work collaboratively to promote health. -/- Featuring illustrative case studies from around the globe at the end of all main chapters, this radical monograph is written to be accessible to all scholars and advanced students who have an interest in health—from public health students to professional philosophers. (shrink)

Evidence-based medicine has been studied as a rich and diverse set of epistemic and infrastructural practices that relate imperfect medical knowledges to complex clinical practices. We examine instances of medical decision-making where medical professionals relate recommendations from clinical practice guidelines to individual patient characteristics when deciding to prescribe implantable cardioverter defibrillators to treat heart failure. When connecting evidence-based recommendations to decisions about individual patients, we find that clinical deliberations invoke different times, such as linear, chronological time, and biological aging, as (...) well as different futures, such as individual future risks and the future sustainability of health systems. Such different “temporalities of evidence” are integral parts of clinicians’ considerations concerning economy, suffering, risks, and hopes in making decisions on individual patients. In line with calls to anchor science and technology studies scholarship studying EBM in the concerns that matter most to patients and health care providers, we argue that the social study of EBM needs to attend to such temporalities to understand how evidence is weighed, which outcomes are considered important, and hence which clinical action is proposed. However, since different ways of “doing time” lead to different appreciations of the clinical outcomes, the notion of clinical “anchoring” becomes rather elusive. (shrink)

In a recent paper, Levy, Gadd, Kerridge, and Komesaroff attempt to defend the ethicality of homeopathy by attacking the utilitarian ethical framework as a basis for medical ethics and by introducing a distinction between evidence-based medicine and modern science. This paper demonstrates that their argumentation is not only insufficient to achieve that goal but also incorrect. Utilitarianism is not required to show that homeopathic practice is unethical; indeed, any normative basis of medical ethics will make it unethical, as a defence (...) of homeopathic practice requires the rejection of modern natural sciences, which are an integral part of medical ethics systems. This paper also points out that evidence-based medicine lies at the very core of modern science. Particular arguments made by Levy et al. within the principlist medical ethics normative system are also shown to be wrong. (shrink)

Ascriptions of objectivity carry significant weight. But they can also cause confusion because wildly different ideas of what it means to be objective are common. Faced with this, some philosophers have argued that objectivity should be eliminated. I will argue, against one such position, that objectivity can be useful even though it is plural. I will then propose a contextualist approach for dealing with objectivity as a way of rescuing what is useful about objectivity while acknowledging its plurality.

At least historically, it was common for medical practitioners to believe causal hypotheses on the basis of standalone mechanistic reasoning. However, it is now widely acknowledged that standalone mechanistic reasoning is insufficient for appropriately believing a causal hypothesis in medicine, thanks in part to the so-called problem of masking. But standalone mechanistic reasoning is not the only type of mechanistic reasoning. When exactly then is it appropriate to believe a causal hypothesis on the basis of mechanistic reasoning? In this paper, (...) I argue that it has proved difficult to provide a satisfying answer to this question. I also argue that this difficulty is predicted by recent work in knowledge-first epistemology. I think this shows that recent work in epistemology has important implications for practice in the philosophy of science. It is therefore worth paying closer attention in the philosophy of science to this recent work in knowledge-first epistemology. (shrink)

Russo and Williamson put forward the following thesis: in order to establish a causal claim in medicine, one normally needs to establish both that the putative cause and putative effect are appropriately correlated and that there is some underlying mechanism that can account for this correlation. I argue that, although the Russo-Williamson thesis conflicts with the tenets of present-day evidence-based medicine, it offers a better causal epistemology than that provided by present-day EBM because it better explains two key aspects of (...) causal discovery. First, the thesis better explains the role of clinical studies in establishing causal claims. Second, it yields a better account of extrapolation. (shrink)

A particular tradition in medicine claims that a variety of evidence is helpful in determining whether an observed correlation is causal. In line with this tradition, it has been claimed that establishing a causal claim in medicine requires both probabilistic and mechanistic evidence. This claim has been put forward by Federica Russo and Jon Williamson. As a result, it is sometimes called the Russo–Williamson thesis. In support of this thesis, Russo and Williamson appeal to the practice of the International Agency (...) for Research on Cancer. However, this practice presents some problematic cases for the Russo–Williamson thesis. One response to such cases is to argue in favour of reforming these practices. In this paper, we propose an alternative response according to which such cases are in fact consistent with the Russo–Williamson thesis. This response requires maintaining that there is a role for mechanism-based extrapolation in the practice of the IARC. However, the response works only if this mechanism-based extrapolation is reliable, and some have argued against the reliability of mechanism-based extrapolation. Against this, we provide some reasons for believing that reliable mechanism-based extrapolation is going on in the practice of the IARC. The reasons are provided by appealing to the role of robustness analysis. (shrink)

The success of medicine in the treatment of patients brings with it new challenges. More people live on to suffer from functional, chronic or multifactorial diseases, and this has led to calls for more complex analyses of the causal determinants of health and illness. Philosophical analysis of background assumptions of the current paradigmatic model. While these factors do not require a radical paradigm shift, they do give us cause to develop a new narrative, to add to existing narratives that frame (...) our thinking about medical care. In this paper we argue that the increased focus on lifestyle and shared decision making requires a new narrative of agency, to supplement the narrative of “the patient”. This narrative is conceptually linked to the developing philosophy of person-centred care. If patients are seen also as “agents” this will result in a substantial shift in practical decisions: The development and adoption of this narrative will help practitioners work with patients to their mutual benefit, harnessing the patients’ motivation, shifting the focus from treatment to prevention and preventing unnecessary and harmful treatments that can come out of our preoccupation with the patient narrative. It will also help to shift research efforts, conceptual and empirical, from “treating” and “battling” diseases and their purported “mechanisms” to understanding complex contributing factors and their interplay. (shrink)

BackgroundMedical ethics has recently seen a drive away from multiple prescriptive approaches, where physicians are inundated with guidelines and principles, towards alternative, less deontological perspectives. This represents a clear call for theory building that does not produce more guidelines. Phronesis (practical wisdom) offers an alternative approach for ethical decision-making based on an application of accumulated wisdom gained through previous practice dilemmas and decisions experienced by practitioners. Phronesis, as an ‘executive virtue’, offers a way to navigate the practice virtues for any (...) given case to reach a final decision on the way forward. However, very limited empirical data exist to support the theory of phronesis-based medical decision-making, and what does exist tends to focus on individual practitioners rather than practice-based communities of physicians.MethodsThe primary research question was: What does it mean to medical practitioners to make ethically wise decisions for patients and their communities? A three-year ethnographic study explored the practical wisdom of doctors (n = 131) and used their narratives to develop theoretical understanding of the concepts of ethical decision-making. Data collection included narrative interviews and observations with hospital doctors and General Practitioners at all stages in career progression. The analysis draws on neo-Aristotelian, MacIntyrean concepts of practice- based virtue ethics and was supported by an arts-based film production process.ResultsWe found that individually doctors conveyed many different practice virtues and those were consolidated into fifteen virtue continua that convey the participants’ ‘collective practical wisdom’, including the phronesis virtue. This study advances the existing theory and practice on phronesis as a decision-making approach due to the availability of these continua.ConclusionGiven the arguments that doctors feel professionally and personally vulnerable in the context of ethical decision-making, the continua in the form of a video series and app based moral debating resource can support before, during and after decision-making reflection. The potential implications are that these theoretical findings can be used by educators and practitioners as a non-prescriptive alternative to improve ethical decision-making, thereby addressing the call in the literature, and benefit patients and their communities, as well. (shrink)

In 2009, the UK House of Commons Science and Technology Committee conducted an ‘evidence check’ on homeopathy to evaluate evidence for its effectiveness. In common with the wider literature critical of homeopathy, the STC report seems to endorse many of the strong claims that are made about its implausibility. In contrast with the critical literature, however, the STC report explicitly does not place any weight on implausibility in its evaluation. I use the contrasting positions of the STC and the wider (...) critical literature to examine the ‘implausibility arguments’ against homeopathy and the place of such arguments within evidence-based medicine. I argue that the STC report undervalues its strong claims about the mechanistic plausibility of homeopathy because it relies on a misunderstanding about the role of mechanistic evidence within EBM. This is not a conclusion for a revision of the role mechanistic evidence plays within EBM, however. It is a conclusion about the inconsistency of the STC report’s position towards implausibility arguments, given the evidential claims they endorse and the atypical situation that homeopathy presents. It provides a further example of the general point that mechanistic reasoning should not be seen as providing categorically lower quality evidence. (shrink)

It has been argued that supervenience generates unavoidable confounding problems for interventionist accounts of causation, to the point that we must choose between interventionism and supervenience. According to one solution, the dilemma can be defused by excluding non-causal determinants of an outcome as potential confounders. I argue that this solution undermines the methodological validity of causal tests. Moreover, we don’t have to choose between interventionism and supervenience in the first place. Some confounding problems are effectively circumvented by experimental designs routinely (...) employed in science. The remaining confounding issues concern the physical interpretation of variables and cannot be solved by choosing between interventionism and supervenience. (shrink)

Establishing the effectiveness of medical treatments is one of the most important aspects of medical practice. Bradford Hill's viewpoints play an important role in inferring causality in medicine,...

While the importance of mechanisms in determining causality in medicine is currently the subject of active debate, the role of mechanistic reasoning in clinical practice has received far less attention. In this paper we look at this question in the context of the treatment of a particular individual, and argue that evidence of mechanisms is indeed key to various aspects of clinical practice, including assessing population-level research reports, diagnostic as well as therapeutic decision making, and the assessment of treatment effects. (...) We use the pulmonary condition bronchiectasis as a source of examples of the importance of mechanistic reasoning to clinical practice. (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)

This paper discusses the so-called non-interference assumption (NIA) grounding causal inference in trials in both medicine and the social sciences. It states that for each participant in the experiment, the value of the potential outcome depends only upon whether she or he gets the treatment. Drawing on methodological discussion in clinical trials and laboratory experiments in economics, I defend the necessity of partial forms of blinding as a warrant of the NIA, to control the participants’ expectations and their strategic interactions (...) with the experimenter. (shrink)

Courts are increasingly obliged to adjudicate upon challenges to allocative decisions in healthcare, but their involvement continues to be regarded with unease, imperilling the legitimacy of the judicial role in this context. A central reason for this is that judges are perceived to lack sufficient expertise to determine allocative questions. This article critically appraises the claim of lack of judicial expertise through an examination of the various components of a limit-setting decision. It is argued that the inexpertise argument is weak (...) when compared with other rationales for judicial restraint, such as the procedural unsuitability and lack of constitutional competence of courts. (shrink)

This article examines the relationship between the precautionary principle and the well-known Hill criteria of causation. Some have charged that the Hill criteria are anti-precautionary because the...

Measuring the effectiveness of medical interventions faces three epistemological challenges: the choice of good measuring instruments, the use of appropriate analytic measures, and the use of a reliable method of extrapolating measures from an experimental context to a more general context. In practice each of these challenges contributes to overestimating the effectiveness of medical interventions. These challenges suggest the need for corrective normative principles. The instruments employed in clinical research should measure patient-relevant and disease-specific parameters, and should not be sensitive (...) to parameters that are only indirectly relevant. Effectiveness always should be measured and reported in absolute terms (using measures such as 'absolute risk reduction'), and only sometimes should effectiveness also be measured and reported in relative terms (using measures such as 'relative risk reduction')-employment of relative measures promotes an informal fallacy akin to the base-rate fallacy, which can be exploited to exaggerate claims of effectiveness. Finally, extrapolating from research settings to clinical settings should more rigorously take into account possible ways in which the intervention in question can fail to be effective in a target population. (shrink)