Kerry et al. criticize our discussion of causal knowledge in evidence-based medicine (EBM) and our assessment of the relevance of their dispositionalist ontology for EBM. Three issues need to be addressed in response: (1) problems concerning transfer of causal knowledge across heterogeneous contexts; (2) how predictions about the effects of individual treatments based on population-level evidence from RCTs are fallible; and (3) the relevance of ontological theories like dispositionalism for EBM.

Despite its phenomenal success since its inception in the early nineteen-nineties, the evidence-based medicine movement has not succeeded in shaking off an epistemological critique derived from the experiential or tacit dimensions of clinical reasoning about particular individuals. This critique claims that the evidence-based medicine model does not take account of tacit knowing as developed by the philosopher Michael Polanyi. However, the epistemology of evidence-based medicine is premised on the elimination of the tacit dimension from clinical judgment. This (...) is demonstrated through analyzing the dichotomy between clinical and statistical intuition in evidence-based medicine’s epistemology of clinical reasoning. I argue that clinical epidemiology presents a more nuanced epistemological model for the application of statistical epidemiology to the clinical context. Polanyi’s theory of tacit knowing is compatible with the model of clinical reasoning associated with clinical epidemiology, but not evidence-based medicine. (shrink)

Because few would object to evidence-based medicine’s (EBM) principal task of basing medical decisionmaking on the most judicious and up-to-date evidence, the debate over this prolific movement may seem puzzling. Who, one may ask, could be against evidence (Carr-Hill, 2006)? Yet this question belies the sophistication of the evidence-based movement. This chapter presents the evidence-based approach as a socio-medical phenomenon and seeks to explain and negotiate the points of disagreement between supporters and detractors. This is done by casting EBM (...) as more than the simple application of research findings to clinical care and improved health outcomes, but rather an umbrella term that harnesses a specific set of pedagogical objectives (some rather radical) under a name that makes it difficult to argue against. (shrink)

The philosophy of evidence-based medicine -- What is EBM? -- What is good evidence for a clinical decision? -- Ruling out plausible rival hypotheses and confounding factors : a method -- Resolving the paradox of effectiveness : when do observational studies offer the same degree of evidential support as randomized trials? -- Questioning double blinding as a universal methodological virtue of clinical trials : resolving the Philip's paradox -- Placebo controls : problematic and misleading baseline measures of effectiveness -- (...) Questioning the methodological superiority of "placebo" over "active" controlled trials -- Examining the paradox that traditional roles for mechanistic reasoning and expert -- Judgment have been up-ended by EBM -- A qualified defence of the EBM stance on mechanistic reasoning -- Knowledge that versus knowledge how : situating the EBM position on expert clinical judgment -- Moving EBM forward. (shrink)

It is important and urgent to question therelationship between evidence-based medicineand power shifts in health care systems.Although definitions of EBM are phrased as ascientific approach to medicine, EBM is anormative concept: it aims to improve medicineand health care. Both proponents and opponentsuse a normative concept. More particularly,they provide particular views on positions,responsibilities, possibilities, norms andrelationships between professionals, patientgroups, governments and other parties in healthcare and society. From this perspective, wewant to analyse the role of EBM in modernwestern societies. By (...) using citizenshiptheory, we will argue that the role of EBM isnot fixed but depends on the relation betweenstate and society. We will first analyse thefundamental change in western societies duringthe past decades, from modern to post-modernsocieties. Then, we will elaborate a fourfoldmodel of possible relationships between stateand society, and discuss the issue of how EBM mayfit in, by giving some examples of the practiceof EBM in different European countries. On thisbasis, we conclude to consider EBM as a publicforum where proponents and opponents of EBMdiscuss diverse and possibly conflicting waysof changing medicine, health care, and healthpolicy. This requires the incorporation of theperspective of citizens and their socialnetworks, professionals with practical andtacit knowledge, and diverse public views onwhat is regarded as `a good life'. Inasmuch asEBM is expected to be practically relevant, itought to be tied to rather than separated fromthe normative world of emancipated patients anddiverse health care practices. Proponents andopponents of EBM should be prepared to defendthe normative claims and power effects that areinherently tied to any presentation ofevidence. (shrink)

The paper outlines the role that tacit knowledge plays in what might seem to be an area of knowledge that can be made fully explicit or codified and which forms a central element of Evidence Based Medicine. Appeal to the role the role of tacit knowledge in science provides a way to unify the tripartite definition of Evidence Based Medicine given by Sackett et al: the integration of best research evidence with clinical expertise and patient values. Each of (...) these three elements, crucially including research evidence, rests on an ineliminable and irreducible notion of uncodified good judgement. (shrink)

Evidence-based psychiatry (EBP) has arisen through the application of evidence-based medicine (EBM) to psychiatry. However, there may be aspects of psychiatric disorders and treatments that do not conform well to the assumptions of EBM. This paper reviews the ongoing debate about evidence-based psychiatry and investigates the applicability, to psychiatry, of two basic methodological features of EBM: prognostic homogeneity of clinical trial groups and quantification of trial outcomes. This paper argues that EBM may not be the best way to pursue (...) psychiatric knowledge given the particular features of psychiatric disorders and their treatments. As a result, psychiatry may have to develop its own standards for rigour and validity. This paper concludes that EBM has had a powerful influence on how psychiatry investigates and understands mental disorders. Psychiatry could influence EBM in return, reshaping it in ways that are more clinically useful and congruent with patients’ needs. (shrink)

The increased demand for evidence-based medicine has proven much more challenging for psychiatry to accept than for medicine in general. Among the concerns is a perception that EBM does not respond appropriately to the character and complexity of psychiatric disorders and treatments, that the concept of ‘evidence’ is too narrowly construed, and that it may encourage a false sense of competence. It has also been claimed that EBM may encourage a kind of ‘cookbook medicine,’ leaving out tacit (...) knowledge and the empathic and caring aspects of the psychiatrist– patient relationship. (shrink)

Debates about how knowledge is made and valued in evidence-based medicine (EBM) have yet to understand what discursive, social, and historical conditions allowed the EBM approach to stabilize and proliferate across western medical education. This paper uses a genealogical approach to examine the epistemological tensions that emerged as a result of various problematizations of uncertainty in medical practice. I explain how the problematization of uncertainty in the literature and the contingency of specific social, political, economic, and historical relations allowed (...) the EBM approach to become a programmatic and pedagogical focus of the Faculty of Medicine at McMaster University and beyond. (shrink)

In this paper, we outline a framework for understanding the different kinds of knowledge required for medical practice and use this framework to show how scientism undermines aspects of this knowledge. The framework is based on Michael Polanyi’s claim that knowledge is primarily the product of the contemplations and convictions of persons and yet at the same time carries a sense of universality because it grasps at reality. Building on Polanyi’s ideas, we propose that knowledge can be described along two (...) intersecting “dimensions”: the tacit–explicit and the particular–general. These dimensions supersede the familiar “objective−subjective” dichotomy, as they more accurately describe the relationship between medical science and medical practice. Scientism, we argue, excludes tacit and particular knowledge and thereby distorts “clinical reality” and impairs medical practice and medical ethics. (shrink)

This paper critically evaluates central themes of values-based medicine (VBM). First, I discuss the 'non-descriptivist' conception of value judgments at the heart of VBM. According to it, no inferences can rationally be drawn from factual criteria to value judgments and the inferences that are naturally formed are a matter of human psychology. I argue, however, that it is an essential feature of value judgments that they are themselves subject to normative assessment. This implies an important role for an evaluatively (...) rich notion of psychology. Second, I discuss the role of 'dissensus' in VBM and argue that, although value judgments need not converge, the processes for exploring conflicting values must, themselves, be normatively assessable. Third, I examine how these aspects interact in complex real cases such as the case study of Diane Abbot. (shrink)

Decisions in healthcare are made against the background of cultural and philosophical definitions of disease, sickness and illness. These concepts or definitions affect both health policy and research , as well as individual encounters between patients and physicians . It is therefore necessary for evidence-based medicine to consider whether any of the definitions underlying research prior to the hierarchisation of knowledge are indeed compatible with its own epistemological principles.

Several countries maintain universal health coverage, which implies responsibility to organize delivery formats of healthcare services and products for citizens. In Brazil, the health system has a principle of universal access for more than 30 years, but many deficiencies remain and the country observes a day practice for those seeking judicial decisions to determine provision of healthcare.

The Salivaomics Knowledge Base (SKB) is designed to serve as a computational infrastructure that can permit global exploration and utilization of data and information relevant to salivaomics. SKB is created by aligning (1) the saliva biomarker discovery and validation resources at UCLA with (2) the ontology resources developed by the OBO (Open Biomedical Ontologies) Foundry, including a new Saliva Ontology (SALO). We define the Saliva Ontology (SALO; http://www.skb.ucla.edu/SALO/) as a consensus-based controlled vocabulary of terms and relations dedicated to the salivaomics (...) domain and to saliva-related diagnostics following the principles of the OBO (Open Biomedical Ontologies) Foundry. The Saliva Ontology is an ongoing exploratory initiative. The ontology will be used to facilitate salivaomics data retrieval and integration across multiple fields of research together with data analysis and data mining. The ontology will be tested through its ability to serve the annotation ('tagging') of a representative corpus of salivaomics research literature that is to be incorporated into the SKB. Background Saliva (oral fluid) is an emerging biofluid for non-invasive diagnostics used in the detection of human diseases. The need to advance saliva research is strongly emphasized by the National Institute of Dental and Craniofacial Research (NIDCR), and is included in the NIDCR's 2004- 2009 expert panel long-term research agenda [1]. The ability to monitor health status, disease onset, progression, recurrence and treatment outcome through noninvasive means is highly important to advancing health care management. Saliva is a perfect medium to be explored for personalized individual medicine including diagnostics, offering a non-invasive, easy to obtain means for detecting and monitoring diseases. Saliva testing potentially allows the patient to collect their own saliva samples at home, yielding convenience for the patient and savings in health costs, and facilitating multiple sampling. Specimen collection is less objectionable to patients and easier in children and elderly individuals. Due to these advantages. (shrink)

While evidence-based medicine (EBM) is often accused on relying on a paradigm of 'absolute truth', it is in fact highly consistent with Karl Popper's criterion of demarcation through falsification. Even more relevant, the first three steps of the EBM process are closely patterned on Popper's evolutionary approach of objective knowledge: (1) recognition of a problem; (2) generation of solutions; and (3) selection of the best solution. This places the step 1 of the EBM process (building an answerable question) in (...) a pivotal position for the understanding of the whole process, and underscores a few aspects which are often overlooked in EBM courses. First in this step internal evidence (including personal expertise) must be appraised and integrated in the problem. Second, issues of applicability of the possible solution should be anticipated. Third, and possibly more important, the goal of the intervention should be set at this stage (typically by choosing the outcome in a PICO question). Depending whether or not goals depend on the goals of others, and whether they concern others' voluntary behaviour, goals may be classified as self-serving, moral, altruistic or moralistic. Thus, delicate ethical questions must be addressed at this stage, which means that patient preferences and values must be carefully sought, so that empathy, counselling and narrative medicine must be mastered to be able to formulate correctly an answerable question. The need to modify the current description of the EBM process to increase the recognition of implicit assumptions and increase the consistency of this model is discussed. (shrink)

In this paper I argue that evidence based medicine (EBM) offers a more transparent system of knowledge and medical care than complementary medicine (CM). While an individual’s choice to use CM should be respected, users of this form of medicine, nevertheless, risk loss of autonomy. This loss of autonomy is an outcome of CM’s offering fewer transparent possibilities for informed patient consent In both EBM and CM patients risk physical harm(s) but science gives EBM patients the benefit (...) of being able to factor known side effects into their health care decisions. (shrink)

There are, broadly speaking, two kinds of knowledge—analytic and intuitive, explicit and tacit. Analytic knowledge is arrived at by logical deductive thinking, and is a sequential thought process in which each step can be explained and defended. Intuitive knowledge, in contrast, is frequently alogical or nonrational, and often involves nonconscious mental processes. Though intuitive ways of knowing are essential to both scientific research and scientific medicine, the culture of medicine celebrates only the analytic, evidentiary kind of knowledge, while (...) eschewing intuition as being “nonscientific.” The popularity and prevalence of what is known as evidence-based medicine reflects this bias in favor of the analytic and the explicit. Though the evidence-based approach has contributed greatly to standardizing medical care, favoring treatments for which there is evidence of effectiveness, it has limitations. An overreliance on evidence-based medicine is problematic, because this approach leaves out important factors in the actual practice of clinical medicine such as diagnosis, nonverbal cures provided by patients, and the way the doctor–patient relationship bears on patient management and compliance, and because it is not appropriate for dealing with medical conditions that do not lend themselves to study by controlled clinical trials. (shrink)

Evidence based medicine has been a topic of considerable controversy in medical and health care circles over its short lifetime, because of the claims made by its exponents about the criteria used to assess the evidence for or against the effectiveness of medical interventions. The central epistemological debates underpinning the debates about evidence based medicine are reviewed by this paper, and some areas are suggested where further work remains to be done. In particular, further work is needed on (...) the theory of evidence and inference; causation and correlation; clinical judgment and collective knowledge; the structure of medical theory; and the nature of clinical effectiveness. (shrink)

Evidence-Based Medicine (EBM) and Personalized Medicine (PM) share a common goal: reducing the gap between the results of biomedical research and their clinical application. PM is, however, often presented as a “new paradigm” for medicine, just as EBM was in the 1990s. It covers a wide variety of projects but the core idea that generally unites them is the ambition of better taking account of individual specificities than did EBM with its statistical and population-centred approach. In this (...) article, I concentrate on PM in cancerology, the essence of which is to target treatments based on the molecular profile of the patient. This targeting is made possible by gaining better knowledge about the molecular mechanisms of cancers. The classification of patients as a function of their molecular profile entails the creation of patient sub-groups. This creates a problem for the traditional evaluation of therapeutic treatment promoted by EBM, in particular the use of randomized trials using sizeable cohorts. But a better understanding of the mechanisms and the greater precision of treatments could reduce the need for these trials. Does PM thus represent the revenge of a physio-pathological and mechanistic culture in clinical research against the statistical and empirical one of EBM? My objective is to show how current practices of PM leads to epistemological changes in our estimation of what count as relevant types of information and proof in medicine, in particular in the field of therapeutic evaluation. I defend the idea that PM, far from obviating the need for statistical approaches and the search for correlations, ultimately poses new challenges for EBM. PM drives EBM to strengthen the articulation and the integration of statistical and mechanistic data with a view to providing a better service for each patient. (shrink)

Despite the entrenched acceptance of normal science in health care, it appears that authoritative, positivist, linear, risk averse, certainty-based thinking can only get us so far along the route of optimum health. This paper examines labor and childbirth as a paradigm case of a complex adaptive system (CAS) and offers the example of techniques used in a master-level course on normal childbirth to illustrate how maternity care clinicians can be introduced to complexity-based thinking through reflexive analysis of real life clinical (...) narratives. It suggests that these techniques might be used as a basis for answering the question, what is likely to work for this person, in this situation, given the range of evidence, and given their values and beliefs, my values and beliefs, and my clinical skills and knowledge? Topics discussed in this paper include complexity, pregnancy, and childbirth; mainstreaming complexity-focused decision making in maternity care; and using story in practice. In conclusion, complexity theory appears to offer a good explanatory model for pregnancy and childbirth, both in general, and for specific individuals. Future work in this area should examine the efficacy and limits to formal story telling in maternity care, with the aim of increasing optimal maternity care for mothers and babies, and for the staff and organizations that deliver the care. (PsycINFO Database Record (c) 2010 APA, all rights reserved). (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)

A certain kind of externalism—"the view from nowhere"—lies at the heart of evidence-based medicine (EBM). As a consequence, the individual case glides out of focus. However, to judge to what extent external knowledge is applicable to an individual case, the clinician has to rely on some sort of knowledge of the case at hand. The article focuses on the tension between the externalism of EBM and the "internal evidence" one has to presuppose when making clinical judgments.

Ethical problems are related to computer data bases, containing data on individuals and groups of persons, as well as to computer knowledge bases, containing general rules and elements of expert systems.In the present essay the following conclusions are made regarding computer data bases: privacy, security, and confidentiality of medical computer data bases should be ensured. This duty should rest with physicians in hospitals. The principle of informed consent should be applied to gathering information which is to be stored and processed (...) by computers. Information stored in computer data bases should not be used for purposes for which the subjects (patients as well as personnel) have not given their consent. In order to decrease the possibility of misuses of medical data bases containing information on individuals, these registers should not be linked to other central data bases. (shrink)

The debate on the validity of the evidence-based medicine (EBM) paradigm in psychiatry and psychotherapy has tended to be rather polarized. Critics of the paradigm maintain that there is a basic conflict between the general knowledge of treatment of groups of patients ('techne') and the contextual understanding of individual patients ('phronesis'). This paper argues that the existence of firm general knowledge is crucial to the legitimacy of the psychiatric as well as the medical profession as a whole, and defends (...) the controlled clinical trial as a central instrument to establish such knowledge. At the same time, however, the paradigm does not solve the old Aristotelian techne–phronesis dilemma, which seems to be more or less inescapable. Focusing on psychotherapy, the paper discusses problems connected with the 'techne-oriented' use of diagnostic principles and of therapy manuals, the criteria for therapeutic progress, and the apparent conflict between experimental efficacy and practical effectiveness. (shrink)

A long-debated question in the philosophy of health, and contingent disciplines, is the extent to which wise clinical practice (“clinical wisdom”) is, or could be, compatible with empirically validated medicine (“evidence-based medicine”—EBM). Here we respond to Baum-Baicker and Sisti, who not only suggest that these two types of knowledge are divided due to their differing sources, but also that EBM can sometimes even hurt wise clinical practice. We argue that the distinction between EBM and clinical wisdom is poorly (...) defined, unsupported by the methodology employed, and ultimately incorrect; crucial differences exist, we argue, not in the source of a particular piece of clinical knowledge, but in its dependability. In light of this subtle but fundamental revision, we explain how clinical wisdom and EBM are—by necessity—complementary, rather than in conflict. We elaborate on how recognizing this relationship can have far-reaching implications for the domains of clinical practice, medical education, and health policy. (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)

In lieu of an abstract, here is a brief excerpt of the content:Medicine-Based Values?Åge Wifstad (bio)KeywordsEthics committees, judgment, common moralityToulmin's DiagnosisIn his classical article with the unforgettable title "How medicine saved the life of ethics" (Toulmin 1982), Stephen Toulmin claims that medicine saved ethics by giving the philosophers a positive reality check through medical challenges: (1) Ethics in medicine is a serious topic, not just something to discuss at seminars. If, for example, both A and B (...) need treatment and there are only enough resources for one, the fundamental interests of these two people compete against each other. (2) In clinical medicine, the individual case might demand a different approach than that suggested by theory. Similarly, an ethicist who is confronted by a diversity of medical cases becomes aware of the fact that solutions drawn from ethical theory can be irrelevant in practice. (3) The moral philosopher has often focused on the individual and his or her universal commitments. The fact that ethical dilemmas can have deep roots in practical challenges and must be understood within a certain context has been "forgotten." (4) In clinically relevant ethics, it is important to find solutions that all involved parties find reasonable. This revitalizes central Aristotelian schools of thought on, for example, ethical judgment and situational understanding.Today, there is a common understanding that in both the education of doctors and in the implementation of medical knowledge and technology there needs to be ethical guidelines and control. Toulmin wants us to see that the background for this agreement is multifaceted. It was not just the ethicists who saved the doctors. The doctors helped the ethicists to escape their academic isolation.Ethics CommitteesThe establishment of ethics committees is perhaps the most interesting example of this. Here it is especially clear how ethical judgment establishes a basis for decision making: Each case presented to an ethics committee is special because one cannot reference decisions made in similar cases. At the same time, we are expected to handle similar cases equally. Consideration of the concrete, individual case must be balanced with the principle of similar treatment. Second, as a committee member, one must interpret and respect ethical principles that cannot be easily defined. Every principle must be interpreted and implemented within a specific and concrete context. Third, one must consider the law, but seen isolated, the implications of relevant rules can be difficult to determine. Fourth, the status of principles and rules are open for interpretation. The most important example of this is the Declaration of Helsinki, which was established through cooperation between the worlds' doctors unions. The strength and end result of such a document can be discussed. Fifth, multiple but partly conflicting juridical and ethical considerations can be [End Page 179] relevant at the same time. An example: Decisions about confidentiality can prevent data gathering that is crucial in ensuring that a research project is scientifically acceptable. Two important ethical considerations are then put up against one another. As a sixth and final point, it can be mentioned that the ethics committee is expected to make a qualitative, scientific judgment. But what kind of quality judgment and how detailed it should be is up for discussion.Two Definitions of Ethical JudgmentThe fact that the committee must base their holistic decision on ethical judgment means that the committee, in an important sense of the word, stands freely: It can be difficult to refer to specific ethical rules or laws when making an external review of the committee's decision. Unless the committee has clearly not followed known principles and rules, then the committee is able to confront criticism by replying that the decision is based on holistic considerations, where many views have been taken into account. In this way, the usage of ethical judgment makes sure that the committee has freedom to act. The catch here is that the committee's responsibility becomes even more obvious. One cannot simply say that the decision is made based on rules and principles formulated by others, such as the state. The committee must, as a unit, be able to defend their decision.The complexity of the work of the committee can, however, make it more tempting to think about ethics in... (shrink)

Analysis of the debate concerning the appropriate way of researching the effects of complementary and alternative medicine (CAM) treatments highlights the controversial issue of the mind–body bond in medical research. The article examines a range of approaches, extending from outright opposition to CAM research, through the demand to employ only rigorous trials, to suggestions to use a hierarchy of evidence, up to practice‐based research proposals. These diverse approaches are analysed using theoretical concepts from the field of sociology of science (...) and knowledge. The article uses the concept of “hybrid knowledge” to denote the knowledge being constructed in late modern CAM discourse—knowledge that hybridises differentiated and even contradictory modern categories of knowledge. The article suggests that the different approaches taken by sociologists of science and knowledge, such as strong anti‐dualism and the assertion that there are differences in our understanding of the natural and the cultural–social terrain, are all useful and are not necessarily mutually exclusive. The article seeks to clarify the debate concerning the appropriate way of researching CAM and to contribute to the ongoing development and application of sociology of knowledge. (shrink)

Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a key (...) player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)

Philosophical investigation in synthetic biology has focused on the knowledge-seeking questions pursued, the kind of engineering techniques used, and on the ethical impact of the products produced. However, little work has been done to investigate the processes by which these epistemological, metaphysical, and ethical forms of inquiry arise in the course of synthetic biology research. An attempt at this work relying on a particular area of synthetic biology will be the aim of this chapter. I focus on the reengineering of (...) metabolic pathways through the manipulation and construction of small DNA-based devices and systems synthetic biology. Rather than focusing on the engineered products or ethical principles that result, I will investigate the processes by which these arise. As such, the attention will be directed to the activities of practitioners, their manipulation of tools, and the use they make of techniques to construct new metabolic devices. Using a science-in-practice approach, I investigate problems at the intersection of science, philosophy of science, and sociology of science. I consider how practitioners within this area of synthetic biology reconfigure biological understanding and ethical categories through active modelling and manipulation of known functional parts, biological pathways for use in the design of microbial machines to solve problems in medicine, technology, and the environment. We might describe this kind of problem-solving as relying on what Helen Longino referred to as “social cognition” or the type of scientific work done within what Hasok Chang calls “systems of practice”. My aim in this chapter will be to investigate the relationship that holds between systems of practice within metabolic engineering research and social cognition. I will attempt to show how knowledge and normative valuation are generated from this particular network of practitioners. In doing so, I suggest that the social nature of scientific inquiry is ineliminable to both knowledge acquisition and ethical evaluations. (shrink)

The use of case-based reasoning in teaching professional ethics has come of age. The fields of medicine, engineering, and business all have incorporated ethics case studies into leading textbooks and journal articles, as well as undergraduate and graduate professional ethics courses. The most recent guidelines from the National Institutes of Health recognize case studies and face-to-face discussion as best practices to be included in training programs for the Responsible Conduct of Research. While there is a general consensus that case (...) studies play a central role in the teaching of professional ethics, there is still much to be learned regarding how professionals learn ethics using case-based reasoning. Cases take many forms, and there are a variety of ways to write them and use them in teaching. This paper reports the results of a study designed to investigate one of the issues in teaching case-based ethics: the role of one’s professional knowledge in learning methods of moral reasoning. Using a novel assessment instrument, we compared case studies written and analyzed by three groups of students whom we classified as: Experts in a research domain in bioengineering. Novices in a research domain in bioengineering. The non-research group—students using an engineering domain in which they were interested but had no in-depth knowledge. This study demonstrates that a student’s level of understanding of a professional knowledge domain plays a significant role in learning moral reasoning skills. (shrink)

This article investigates five kinds of vagueness in medicine: disciplinary, ontological, conceptual, epistemic, and vagueness with respect to descriptive-prescriptive connections. First, medicine is a discipline with unclear borders, as it builds on a wide range of other disciplines and subjects. Second, medicine deals with many indistinct phenomena resulting in borderline cases. Third, medicine uses a variety of vague concepts, making it unclear which situations, conditions, and processes that fall under them. Fourth, medicine is based on (...) and produces uncertain knowledge and evidence. Fifth, vagueness emerges in medicine as a result of a wide range of fact-value-interactions. The various kinds of vagueness in medicine can explain many of the basic challenges of modern medicine, such as overdiagnosis, underdiagnosis, and medicalization. Even more, it illustrates how complex and challenging the field of medicine is, but also how important contributions from the philosophy can be for the practice of medicine. By clarifying and, where possible, reducing or limiting vagueness, philosophy can help improving care. Reducing the various types of vagueness can improve clinical decision-making, informing individuals, and health policy making. (shrink)

According to the PubMed resource from the U.S. National Library of Medicine, over 750,000 scientific articles have been published in the ~5000 biomedical journals worldwide in the year 2007 alone. The vast majority of these publications include results from hypothesis-driven experimentation in overlapping biomedical research domains. Unfortunately, the sheer volume of information being generated by the biomedical research enterprise has made it virtually impossible for investigators to stay aware of the latest findings in their domain of interest, let alone (...) to be able to assimilate and mine data from related investigations for purposes of meta-analysis. While computers have the potential for assisting investigators in the extraction, management and analysis of these data, information contained in the traditional journal publication is still largely unstructured, free-text descriptions of study design, experimental application and results interpretation, making it difficult for computers to gain access to the content of what is being conveyed without significant manual intervention. In order to circumvent these roadblocks and make the most of the output from the biomedical research enterprise, a variety of related standards in knowledge representation are being developed, proposed and adopted in the biomedical community. In this chapter, we will explore the current status of efforts to develop minimum information standards for the representation of a biomedical experiment, ontologies composed of shared vocabularies assembled into subsumption hierarchical structures, and extensible relational data models that link the information components together in a machine-readable and human-useable framework for data mining purposes. (shrink)