Since the early 1980s, private, for-profit corporations have become increasingly involved in all aspects of scientific research, especially of biomedical research. In this essay, I argue that there are dangerous epistemic consequences of this trend, which should be more thoroughly examined by social epistemologists. In support of this claim, I discuss a recent episode of pharmaceutical research involving the painkiller Vioxx. I argue that the research on Vioxx was epistemically problematic and that the primary cause of these inadequacies was faulty (...) institutional arrangements. More specifically, the research was organized in such a way as to allow short-term commercial interests to compromise epistemic integrity. Thus, the Vioxx case study, in conjunction with numerous case studies developed elsewhere, provides strong reasons for believing that the privatization of the biomedical sciences is epistemically worrisome, and it suggests that the primary response to this situation should be a social, or organizational, one. What kind of organizational response would be most beneficial? I briefly discuss two prominent social epistemological proposals for how scientific research should be organized - namely those of Philip Kitcher and Helen Longino - and I suggest that they are incapable of dealing with the phenomenon of privatization. I then draw upon the Vioxx episode in order to outline an alternative suggestion for reorganizing certain aspects of pharmaceutical research. (shrink)

Medical nihilism is the view that we should have little confidence in the effectiveness of medical interventions. Jacob Stegenga argues persuasively that this is how we should see modern medicine, and suggests that medical research must be modified, clinical practice should be less aggressive, and regulatory standards should be enhanced.

Evidence-Based Medicine is a relatively new movement that seeks to put clinical med- icine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence-the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs (randomized controlled trials).

Evidence-Based Medicine is a relatively new movement that seeks to put clinical medicine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence—the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs.

The evidence from randomized controlled trials (RCTs) is widely regarded as supplying the ‘gold standard’ in medicine—we may sometimes have to settle for other forms of evidence, but this is always epistemically second-best. But how well justified is the epistemic claim about the superiority of RCTs? This paper adds to my earlier (predominantly negative) analyses of the claims produced in favour of the idea that randomization plays a uniquely privileged epistemic role, by closely inspecting three related arguments from leading contributors (...) to the burgeoning field of probabilistic causality—Papineau, Cartwright and Pearl. It concludes that none of these further arguments supplies any practical reason for thinking of randomization as having unique epistemic power. IntroductionWhy the issue is of great practical importance—the ECMO casePapineau on the ‘virtues of randomization’Cartwright on causality and the ‘ideal’ randomized experimentPearl on randomization, nets and causesConclusion. (shrink)

The scientific investigation of mental disorders is an invigorating area of inquiry for philosophers of mind and science who are interested in exploring the nature of typical and atypical cognition as well as the overarching scientific project of ‘carving nature at its joints’. It is also important for philosophers of medicine and bioethicists who are concerned with concepts of disease and with the development of effective and ethical treatments of mental disorders and the just distribution of mental health services. Philosophical (...) worries surrounding mental health and its care have recently extended beyond the bounds of academia, becoming a vigorous topic of debate in a variety of public domains in the wake of the publication of the most recent revision of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition , the psychiatric classification system used by mental health professionals in the USA, and increasingly, by those around the world.The DSM-5 lists mental disorders according to the observable symptoms presented by patients. It is designed for pragmatic use across a variety of settings to accomplish several tasks: to facilitate clinical treatment, to provide clear criteria of eligibility for various administrative and policy related purposes ), and primarily, to further scientific research into mental disorder aetiology. Although designed to meet the needs and interests of various stakeholders , the recently revised manual has not fully satisfied any of them. This failure challenges the assumption that a single manual …. (shrink)

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.

We argue that the health sciences make causal claims on the basis of evidence both of physical mechanisms, and of probabilistic dependencies. Consequently, an analysis of causality solely in terms of physical mechanisms or solely in terms of probabilistic relationships, does not do justice to the causal claims of these sciences. Yet there seems to be a single relation of cause in these sciences - pluralism about causality will not do either. Instead, we maintain, the health sciences require a theory (...) of causality that unifies its mechanistic and probabilistic aspects. We argue that the epistemic theory of causality provides the required unification. (shrink)

One way to make philosophy of science more socially relevant is to attend to specific scientific practises that affect society to a great extent. One such practise is biomedical research. This paper looks at contemporary U.S. biomedical research in particular and argues that it suffers from important epistemic, moral and socioeconomic failings. It then discusses and criticises existing approaches to improve on the status quo, most prominently by Thomas Pogge (a political philosopher), Joseph Stiglitz (a Nobel-prize winning economist) and James (...) Robert Brown (a philosopher of science). Finally, it sketches an alternative proposal and argues for its superiority. The proposal has four components: changing the intellectual property regime; instituting independent clinical research; aligning innovators' and patients' interests; and enacting additional regulation. (shrink)

Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special attention to the privileged role assigned to randomized controlled trials (RCTs) in evidence based medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended (...) effects, in that the unknowns at stake are heterogonous in the two contexts. However, although “lower level” evidence is increasingly acknowledged to be a valid source of information contributory to assessing the risk profile of medications on theoretical or empirical grounds, current practices have difficulty in assigning a precise epistemic status to this kind of evidence because they are more or less implicitly parasitic on the (statistical) methods developed to test drug efficacy. My thesis is that (1) “lower level” evidence is justified on distinct grounds and at different conditions depending on the different epistemologies which one wishes to endorse, in that each impose different constraints on the methods we adopt to collect and evaluate evidence; (2) such constraints ought to be understood to be different in the case of evidence for risk versus benefit assessment for a series of reasons which I will illustrate on the basis of the recent debate on the causal association between acetaminophen (a.k.a. paracetamol) and asthma. (shrink)

Several feminist philosophers of science have argued that social and political values are compatible with, and may even enhance, scientific objectivity. A variety of normative recommendations have emerged regarding how to identify, manage, and critically evaluate social values in science. In particular, several feminist theorists have argued that scientific communities ought to: 1) include researchers with diverse experiences, interests, and values, with equal opportunity and authority to scrutinize research; 2) investigate or "study up" scientific phenomena from the perspectives, interests, and (...) conditions of marginalized stakeholders potentially affected by the research; and 3) make gender, ethnicity, class, and geographical location "visible," or use them as categories of analysis when appropriate. Yet, more work is needed to determine what exactly these recommendations would require, and the benefits they would yield, in specific research contexts. Using the recent development of the human papillomavirus (HPV) vaccines, we examine how these three feminist recommendations would have applied. We argue that these principles would have yielded several epistemic and social benefits in the HPV case, as well as in biomedical research more generally. That is, biomedical research guided by these principles would not only be epistemically superior, but also more socially responsible. (shrink)

Measurement outcomes are frequently used as evidence in favor of or against medical and surgical interventions, health policies, and system designs. Indeed, in the medical and health services research literature, outcomes are the currency of policy debate and decision making. Yet in the philosophy of science and philosophy of medicine, the measures used in evidence-based medicine (EBM) are rarely discussed. Rather, the focus here is almost exclusively on study design and hierarchies of evidence. This concentration on the methodology of study (...) design has meant that for practical purposes the measures used in randomized controlled trials, observational studies, audits, and so forth, appear as a “black box.” Yet as I argue in the first part of this article, an engagement with measurement can improve our understanding of EBM and the quality of our evidence. In the second part of the article, I develop such an engagement with one aspect of measurement, namely, the validity of patient-reported outcome measures. Here, I illustrate some of the complexity that is required to improve the validity of these measures and hence the validity of our study outcomes, that is, evidence. The concentration in philosophy of science on study design over measurement methodology perhaps reveals the interest that many philosophers of medicine have in causation, but there is more to the production of high-quality scientific evidence than securing the causal inference. (shrink)

"--Richard Grandy, Rice University "This is the first compelling diagnosis of what has gone awry in the raging 'science wars.

In Science as Social Knowledge, Helen Longino offers a contextual analysis of evidential relevance. She claims that this "contextual empiricism" reconciles the objectivity of science with the claim that science is socially constructed. I argue that while her account does offer key insights into the role that values play in science, her claim that science is nonetheless objective is problematic.

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

In this paper I argue that ethics and evidence are intricately intertwined within the clinical practice of differential diagnosis. Too often, when a disease is difficult to diagnose, a physician will dismiss it as being “not real” or “all in the patient’s head.” This is both an ethical and an evidential problem. In the paper my aim is two-fold. First, via the examination of two case studies (late-stage Lyme disease and Addison’s disease), I try to elucidate why this kind of (...) dismissal takes place. Then, I propose a potential solution to the problem. I argue that instead of dismissing a patient’s illness as “not real,” physicians ought to exercise a compassionate suspension of judgment when a diagnosis cannot be immediately made. I argue that suspending judgment has methodological, epistemic, and ethical virtues and therefore should always be preferred to patient dismissal in the clinical setting. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Philosophers of science have insisted that evidence of underlying mechanisms is required to support claims about the effects of medical interventions. Yet evidence about mechanisms does not feature on dominant evidence-based medicine “hierarchies.” After arguing that only inferences from mechanisms (“mechanistic reasoning”)—not mechanisms themselves—count as evidence, I argue for a middle ground. Mechanistic reasoning is not required to establish causation when we have high-quality controlled studies; moreover, mechanistic reasoning is more problematic than has been assumed. Yet where the problems can (...) be overcome, mechanistic reasoning can and should be used as evidence. (shrink)

The terms ``objectivity'''' and ``objective'''' are among the mostused yet ill-defined terms in the philosophy of science and epistemology. Common to all thevarious usages is the rhetorical force of ``I endorse this and you should too'''', orto put it more mildly, that one should trust the outcome of the objectivity-producing process.The persuasive endorsement and call to trust provide some conceptual coherenceto objectivity, but the reference to objectivity is hopefully not merely an attemptat persuasive endorsement. What, in addition to epistemological endorsement,does (...) objectivity carry with it? Drawing on recent historical and philosophical work,I articulate eight operationally accessible and distinct senses of objectivity.While there are links among these senses, providing cohesion to the concept, I argue thatnone of the eight senses is strictly reducible to the others, giving objectivity itsirreducible complexity. (shrink)

Although epistemic values have become widely accepted as part of scientific reasoning, non-epistemic values have been largely relegated to the "external" parts of science (the selection of hypotheses, restrictions on methodologies, and the use of scientific technologies). I argue that because of inductive risk, or the risk of error, non-epistemic values are required in science wherever non-epistemic consequences of error should be considered. I use examples from dioxin studies to illustrate how non-epistemic consequences of error can and should be considered (...) in the internal stages of science: choice of methodology, characterization of data, and interpretation of results. (shrink)

Objectivity has a history, and it is full of surprises. In Objectivity, Lorraine Daston and Peter Galison chart the emergence of objectivity in the mid-nineteenth-century sciences--and show how the concept differs from its alternatives, truth-to-nature and trained judgment. This is a story of lofty epistemic ideals fused with workaday practices in the making of scientific images. From the eighteenth through the early twenty-first centuries, the images that reveal the deepest commitments of the empirical sciences--from anatomy to crystallography--are those featured in (...) scientific atlases, the compendia that teach practitioners what is worth looking at and how to look at it. Galison and Daston use atlas images to uncover a hidden history of scientific objectivity and its rivals. Whether an atlas maker idealizes an image to capture the essentials in the name of truth-to-nature or refuses to erase even the most incidental detail in the name of objectivity or highlights patterns in the name of trained judgment is a decision enforced by an ethos as well as by an epistemology. As Daston and Galison argue, atlases shape the subjects as well as the objects of science. To pursue objectivity--or truth-to-nature or trained judgment--is simultaneously to cultivate a distinctive scientific self wherein knowing and knower converge. Moreover, the very point at which they visibly converge is in the very act of seeing not as a separate individual but as a member of a particular scientific community. Embedded in the atlas image, therefore, are the traces of consequential choices about knowledge, persona, and collective sight. Objectivity is a book addressed to anyone interested in the elusive and crucial notion of objectivity-- and in what it means to peer into the world scientifically. Lorraine Daston is Director at the Max Planck Institute for the History of Science in Berlin, Germany. She is the coauthor of Wonders and the Order of Nature, 1150-1750 and the editor of Things That Talk: Object Lessons from Art and Science. Peter Galison is Pellegrino University Professor of the History of Science and of Physics at Harvard University. He is the author of Einstein's Clocks, Poincaré's Maps: Empires of Time, How Experiments End, and Image and Logic: A Material Culture of Microphysics, and other books, and coeditor of The Architecture of Science. (shrink)

In this groundbreaking book, psychiatrist and ethicist Mona Gupta analyzes the basic assumptions of Evidence-based medicine (EBM), and critically examines their applicability to psychiatry. Highlighting ethical tensions between psychiatry and EBM, she asks the controversial question - should psychiatrists practice evidence-based medicine at all?

The public, mental health consumers, as well as mental health practitioners wonder about what kinds of values mental health professionals hold, and what kinds of values influence psychiatric diagnosis. Are mental disorders socio-political, practical, or scientific concepts? Is psychiatric diagnosis value-neutral? What role does the fundamental philosophical question "How should I live?" play in mental health care? In his carefully nuanced and exhaustively referenced monograph, psychiatrist and philosopher of psychiatry John Z. Sadler describes the manifold kinds of values and value (...) judgements involved in psychiatric diagnosis and classification systems like the DSM. Professor Sadler takes the reader on a fascinating conceptual tour of the inner workings of psychiatric diagnosis, considering the role of science, culture, sexuality, politics, gender, technology, human nature, patienthood, and professions in building his vision of a more humane psychiatric diagnostic process. (shrink)

In Moody Minds Distempered philosopher Jennifer Radden assembles several decades of her research on melancholy and depression. The chapters are ordered into three categories: those about intellectual and medical history of melancholy and depression; those that emphasize aspects of the moral, psychological and medical features of these concepts; and finally, those that explore the sad and apprehensive mood states long associated with melancholy and depressive subjectivity. A newly written introduction maps the conceptual landscape, and draws out the analytic and thematic (...) interconnections between the chapters. Radden emphasizes and develops several new themes: the implications, theoretical phenomenological and moral, of recognizing melancholy and depressive states as mood states; questions of method, as they affect how we understand and characterize claims about melancholy and depression; and the persistence and force of cultural tropes linking such states to brilliance, creativity, and sagacity. Insights from literature and the history of medicine, psychology, and psychiatry are woven together with those from the more recent disciplines of feminist theory and cultural studies. This is interdisciplinary writing at its best-part analytic philosophy, and part history of ideas. (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)

Inferences like these are known as extrapolations.

Advance Praise: "A distillation of the wisdom accumulated over a lifetime by one of our leading thinkers in psychiatry. . . .It should interest. . .anyone who has thought seriously about the brain, the mind and the meaning of illness." --Albert J. Stunkard, M.D., Professor of Psychiatry, University of Pennsylvania.

his article develops a set of recommendations for the psychiatric and medical community in the treatment of mental disorders in response to the recently published fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, that is, DSM-5. We focus primarily on the limitations of the DSM-5 in its individuation of Complicated Grief, which can be diagnosed as Major Depression under its new criteria, and Post-Traumatic Stress Disorder (PTSD). We argue that the hyponarrativity of the descriptions of these disorders (...) in the DSM-5, defined as the abstraction of the illness categories from the particular life contingencies and personal identity of the patient (e.g., age, race, gender, socio-economic status), constrains the DSM-5's usefulness in the development of psychotherapeutic approaches in the treatment of mental disorders. While the DSM-5 is useful in some scientific and administrative contexts, the DSM's hyponarrativity is problematic, we argue, given that the DSMs are designed to be useful guides for not only scientific research, but also for the education of medical practitioners and for treatment development. our goal therefore is to offer suggestions for mental health practitioners in using the DSM-5, so that they can avoid or eliminate the problems that may stem from the limitations of hyponarrativity. When such problems are eliminated, we believe that effective psychotherapeutic strategies can be developed, which would be successful in repairing the very relationships that are strained in mental disorder: the patient's relationship to herself, her physical environment, and her social environment. (shrink)