Medical Methodology

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

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

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

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

In this article, we analyse how researchers use the categories of race and ethnicity with reference to genetics and genomics. We show that there is still considerable conceptual “messiness” (despite the wide-ranging and popular debate on the subject) when it comes to the use of ethnoracial categories in genetics and genomics that among other things makes it difficult to properly compare and interpret research using ethnoracial categories, as well as draw conclusions from them. Finally, we briefly reconstruct some of the (...) biases of reductionism to which geneticists (as well as other researchers referring to genetic methods and explanations) are particularly exposed to, and we analyse the problem in the context of the biologization of ethnoracial categories. Our work constitutes a novel, in-depth contribution to the debate about reporting race and ethnicity in biomedical and health research. First, we reconstruct the theoretical background assumptions about racial ontology which researchers implicitly presume in their studies with the aid of a sample of recent papers published in medical journals about COVID-19. Secondly, we use the typology of the biases of reductionism to the problem of biologization of ethnoracial categories with reference to genetics and genomics. (shrink)

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

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

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

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

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

This article develops a constructive criticism of methodological conventionalism. Methodological conventionalism asserts that standards of inductive risk ought to be justified in virtue of their ability to facilitate coordination in a research community. On that view, industry bias occurs when conventional methodological standards are violated to foster industry preferences. The underlying account of scientific conventionality, however, is problematically incomplete. Conventions may be justified in virtue of their coordinative functions, but often qualify for posterior empirical criticism as research advances. Accordingly, industry (...) bias does not only threaten existing conventions but may impede their empirically warranted improvement if they align with industry preferences. My empiricist account of standards of inductive risk avoids such a problem by asserting that conventional justification can be pragmatically warranted but has, in principle, only a provisional status. Methodological conventions, therefore, should not only be defended from preference-based infringements on their coordinative function but ought to be subjected to empirical criticism. (shrink)

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

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

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

Ethically permissible clinical trials must not expose subjects to risks that are unreasonable in relation to anticipated benefits. In the research ethics literature, this moral requirement is typically understood in one of two different ways: as requiring the existence of a state of clinical equipoise, meaning a state of honest, professional disagreement among the community of experts about the preferred treatment; or as requiring an equilibrium between individual and collective ethics. It has been maintained that this second interpretation makes it (...) mandatory to minimize the number of patients receiving the treatment that will eventually be shown to be inferior by the trial. This requirement has led to the development of adaptive trials, i.e., trials in which treatment allocation is determined by data accumulated during interim analysis. Many statisticians argue that in some circumstances—typically with potentially high benefits, as in the much discussed ECMO trial—adaptive design is the only ethically permissible experimental design. Nevertheless, some proponents of clinical equipoise argue that adaptive trials are neither ethically required nor permissible. More specifically, they argue that clinical trials using adaptive designs fail to meet the moral requirement of clinical equipoise, since these trials presuppose an epistemic state that is incompatible with a physician’s duty of care to her subjects. This paper emphasizes that the debate is to a large extent resting on an epistemological confusion. Specifically, I argue that this response conflates two different conceptions of statistical evidence, and that recognizing this distinction elucidates an epistemological framework in which adaptive trials are both consistent with and recommended by the moral requirement of clinical equipoise. (shrink)

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

THE IMMORTAL FLY: ETERNAL WHISPERS. WHO IS SHE? Author: Rituparna Ray Chaudhuri. Hello, Recently my book named, ‘The Immortal Fly: Eternal Whispers : Based On True Events of a Family' been published from Partridge (USA) In Association with Penguin Random House (UK) and achieved a separate Google identity. -/- As being # the author of the book, I thought to define self in the book what is definition of 'Depression'. I wanted to explain self in many ways, but the best (...) quotation appeared to me : “My life will end someday, but it will end at my convenience.’’ -/- ***** I am missing "her". By now, years passed without 'her' . Even though, unlike before, everything is becoming to be more scattered, gloomy and desolate. She is no-where whom I share my feelings. Even now, when I do close my eyes, I can visualize the same that I had left years since on 7th February, 2019 at 8.20 A.M. in the hospital struggling a continuous period of fifty days : on the fifty one day, my father said, ”The End of our Fifty Years relationship has been completed with the Fifty Days”….’Whoever’ she was to others , but she is our legend…To me, she is ‘My Ma’. -/- The story could begin, 'I failed preciously on success of my life.' Simplicity, Innocence, Belief, Faith and Personality met unknowingly with filthy waves skillfully immersed in Betray, Sorcery, Jealousy, Greediness, Revenge, Lie... ‘’ ******* The Daughter writes, “I had asked Ma many times, but her ‘impenetrable personality’ and dynamic words to everyone with a tinge of smile as reflected on her face, she was reluctant to continue her conversation with me. I had thought, hence, I must not be indefinite on my spoken words. Who shall I blame!” Based on true story of a family came from South Calcutta (India) to a suburb, on staying at home of the Daughter’s maternal grandmother’s house, this book reveals in facts and true events how Destiny had unknowingly ‘further’ played an abominable role to Fate of The Daughter, when eventually one day on 7th February, 2019 everything was finished within 8.20A.M. The Daughter is, therefore, left alone on terrestrial with immortal words as written in her Diary, ‘Eternal Whispers’: “My words to self that I am to fulfill my Ma’s - wish. ’’ ‘’ -/- • Keywords: 1. Diary and True Events 2. The Chaotic Society 3. Fatality 4. Of A-Family 5. Science , Philosophy and Literature 6. Severe Depression 7. Medical Journey. -/- The Alternative Title of the Book: The Greatest Mistake or Fortune:: The book is mainly carrying with intense words of a journey of the relationship between a Mother with her Daughter has left readers in an abrupt situation where ,perhaps, I can define "Man is the innocent creature with 'his' personality under circumstances..." -/- . (shrink)

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

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

Gegenstand dieses Beitrags ist eine Auseinandersetzung mit der Wissenschaftlichkeit der Medizin. Den Leitfaden der Analyse bildet dabei ein jüngerer Ansatz in der analytischen Wissenschaftstheorie, wonach Systematizität als zentrales Kriterium von Wissenschaft anzusehen ist (Hoyningen-Huene 2013). Ich werde im Detail zeigen, dass die Medizin dieses mehrdimensionale Kriterium insgesamt erfüllt, dass aus der Wissenschaftlichkeit der Medizin aber gleichwohl normative Konsequenzen folgen, die beispielsweise zur Abgrenzung von der Homöopathie und einer kritischen Bewertung des biopsychosozialen Modells führen. Zudem resultieren der Anwendungscharakter der Medizin und (...) die zentrale Bedeutung des Arzt-Patienten-Verhältnisses nicht in einer Schwächung des Anspruchs der Medizin als Wissenschaft. (shrink)

Part of a symposium devoted to ‘Prediction, Understanding, and Medicine’, in which Alex Broadbent argues that the nature of medicine is determined by its competences, i.e., which things it can do well. He argues that, although medicine cannot cure well, it can do a good job of enabling people not only to understand states of the human organism and of what has caused them, but also to predict future states of it. From this Broadbent concludes that medicine is (at least (...) in part) essentially a practice of understanding and predicting, not curing. In reply to this bold position, I mount two major criticisms. First, I maintain that the reasons Broadbent gives for doubting that medicine can cure provide comparable reason for doubting that medicine can provide an understanding; roughly, the best explanation of why medicine cannot reliably cure is that we still lack much understanding of health and disease. Second, I object to the claim that a practice is medical only if it facilitates understanding and prediction. Although Broadbent has brought to light certain desirable purposes of medicine that are under-appreciated, my conclusion is that he has not yet provided enough reason to think that understanding and prediction are essential to it. Instead of supposing that medicine has an essence, in fact, I suggest that its nature is best understood in terms of a property cluster. (shrink)

The first part of a symposium devoted to Alex Broadbent's essay titled ‘Prediction, Understanding and Medicine’, this article notes the under-development of a variety of issues in the philosophy of medicine that transcend bioethics and the long-standing debates about the nature of health/illness and of evidence-based medicine. It also indicates the importance of drawing on non-Western, and particularly African, traditions in addressing these largely metaphysical and epistemological matters.

Modern medicine is often said to have originated with nineteenth century germ theory, which attributed diseases to bacterial contagions. The success of this theory is often associated with an underlying principle referred to as the “doctrine of specific etiology”. This doctrine refers to specificity at the level of disease causation or etiology. While the importance of this doctrine is frequently emphasized in the philosophical, historical, and medical literature, these sources lack a clear account of the types of specificity that it (...) involves and why exactly they matter. This paper argues that nineteenth century germ theory involves two types of specificity at the level of etiology. One type receives significant attention in the literature, but its influence on modern medicine has been misunderstood. A second type is present in this model, but it has been completely overlooked in the extant literature. My analysis clarifies how these types of specificity led to a novel conception of etiology that continues to figure in medicine today. (shrink)

The paper will compare two methods used in the design of diagnostic strategies. The first one is a method that precises predictive value of diagnostic tests. The second one is based on the use of Bayes’ theorem. The main aim of this article is to identify the epistemological assumptions underlying both of these methods. For the purpose of this objective, example projects of one and multi-stage diagnostic strategy developed using both methods will be considered.

Patient centred diagnosis is best practised through shared decision making; an iterative dialogue between doctor and patient, whichrespects a patient’s needs, values, preferences, and circumstances. -/- Shared decision making for diagnostic situations differs fundamentally from that for treatment decisions. This has important implications when considering its practical application. -/- The nature of dialogue should be tailored to the specific diagnostic decision; scenarios with higher stakes or uncertainty usually require more detailed conversations.

Over the past 25 years, several new “medicines” have come screeching onto health care’s various platforms, including narrative medicine, personalized medicine, precision medicine and person-centred medicine. Philosopher Miriam Solomon calls the first three of these movements different “ways of knowing” or “methods,” and argues that they are each a response to shortcomings of methods that came before them. They should also be understood as reactions to the current dominant model of medicine. In this article, I will describe our dominant model, (...) which I call “the new medical model.” I will argue that several towering problems in modern medicine can be traced to its philosophical foundations, which calls for philosophical analysis. (shrink)

Debates about the ethics and effects of placebos and whether ‘placebos’ in clinical trials of complex treatments such as acupuncture are adequate rage. Yet there is currently no widely accepted definition of the ‘placebo’. A definition of the placebo is likely to inform these controversies. Grünbaum’s characterization of placebos and placebo effects has been touted by some authors as the best attempt thus far, but has not won widespread acceptance largely because Grünbaum failed to specify what he means by a (...) therapeutic theory and because he does not stipulate a special role for expectation effects. Grünbaum claims that placebos are treatments whose ‘characteristic features’ do not have therapeutic effects on the target disorder. I show that with four modifications, Grünbaum’s definition provides a defensible account of placebos for the purpose of constructing placebo controls within clinical trials. The modifications I introduce are: adding a special role for expectations, insisting that placebo controls control for all and only the effects of the incidental treatment features, relativizing the definition of placebos to patients, and introducing harmful interventions and nocebos to the definitional scheme. I also provide guidance for classifying treatment features as characteristic or incidental. (shrink)

This article investigates the changing justifications of one of the hallmarks of orthodox psychoanalytic practice, the neutral and abstinent stance of the psychoanalyst, during the middle decades of the 20th century. To call attention to the shifting rationales behind a supposedly cold, detached style of treatment still today associated with psychoanalysis, explanations of the clinical utility of neutrality and abstinence by ‘classical’ psychoanalysts in the United States are contrasted with how intellectuals and cultural critics understood the significance of psychoanalytic abstinence. (...) As early as the 1930s, members of the Frankfurt School discussed the cultural and social implications of psychoanalytic practices. Only in the 1960s and 1970s, however, did psychoanalytic abstinence become a topic within broader intellectual debates about American social character and the burgeoning ‘therapy culture’ in the USA. The shift from professional and epistemological concerns to cultural and political ones is indicative of the changing appreciation of psychoanalysis as a clinical discipline: for psychoanalysts as well as cultural critics, I argue, changing social mores and the professional decline of psychoanalysis infused the image of the abstinent psychoanalyst with nostalgic longing, making it a symbol of resistance against a culture seen to be in decline. (shrink)

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

Despite its vagueness Personalized, Precision, P4, P5, individualized, stratified medicine—or p-medicine in short—has become an increasingly popular term in biomedical literature. Philosophers have attempted to analyze what these various terms involve and have discussed consequences for medical practices. In this article, I argue that an important question remains unaddressed: what has made this project of p-medicine convincing to so many? My argument is that without real achievements, it would never have been. I also make the case that these achievements stem (...) from the domain of monoclonal antibodies, a new type of drug that justifies talks of personalized, precise, stratified, etc., medicine. In conclusion, while it may be possible to label any projection in the future of medicine as ‘p-medicine’, it is impossible to overlook mab-medicine as the spearhead. (shrink)

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

En este artículo expondré un análisis de la valoración negativa de las consecuencias que suelen atribuirse al fenómeno de la medicalización y, partiendo de aquí, mi objetivo básico será mostrar que la medicalización no es en sí mismo un fenómeno negativo. Sólo lo será cuando se obtenga un valor negativo del cálculo entre, por un lado, la efectividad de la propuesta médica para solucionar el problema y, por otro lado, el balance entre los beneficios de dicha propuesta médica y sus (...) posibles efectos secundarios; o bien, cuando se dé un contexto en el que el individuo, ya sea por desinformación o por una restricción externa (paternalismo médico), no tiene la libertad suficiente de escoger entre una propuesta médica y una propuesta no-médica. (shrink)

Neurodevelopmental disorders such as autism affect one-eighth of all U.S. newborns. Yet scientists, accessing the same data and using Bradford-Hill guidelines, draw different conclusions about the causes of these disorders. They disagree about the pesticide-harm hypothesis, that typical United States prenatal pesticide exposure can cause neurodevelopmental damage. This article aims to discover whether apparent scientific disagreement about this hypothesis might be partly attributable to questionable interpretations of the Bradford-Hill causal guidelines. Key scientists, who claim to employ Bradford-Hill causal guidelines, yet (...) fail to accept the pesticide-harm hypothesis, fall into errors of trimming the guidelines, requiring statistically-significant data, and ignoring semi-experimental evidence. However, the main scientists who accept the hypothesis appear to commit none of these errors. Although settling disagreement over the pesticide-harm hypothesis requires extensive analysis, this article suggests that at least some conflicts may arise because of questionable interpretations of the guidelines. (shrink)

Review of Bloomsbury Companion to Contemporary Philosophy of Medicine, ed James A Marcum.

Evidence in medicine can come from more or less trustworthy sources and be produced by more or less reliable methods, and its interpretation can be disputed. As such, it can be unclear when disagreements in medicine result from different, but reasonable, interpretations of the available evidence and when they result from unreasonable refusals to consider legitimate evidence. In this article, we seek to show how assessments of the relevance and implications of evidence are typically affected by factors beyond that evidence (...) itself, such as our beliefs about the credibility of the speaker or source of the evidence. In evaluating evidence, there is thus a need for reflective awareness about why we accept or dismiss particular claims. (shrink)

This chapter discusses several kinds of reduction that are often found in the biomedical sciences, in contrast to reduction in fields such as physics. This includes reduction as a methodological assumption for how to investigate phenomena like complex diseases, and reduction as a conceptual tool for relating distinct models of the same phenomenon. The case of Parkinson’s disease illustrates a wide variety of ways in which reductionism is an important tool in medicine.

Evidence based medicine (EBM) is under critical debate, and person centered healthcare (PCH) has been proposed as an improvement. But is PCH offered as a supplement or as a replacement of EBM? Prima facie PCH only concerns the practice of medicine, while the contended features of EBM also include methods and medical model. I here argue that there are good philosophical reasons to see PCH as a radical alternative to the existing medical paradigm of EBM, since the two seem committed (...) to conflicting ontologies. This paper aims to make explicit some of the most fundamental assumptions that motivate EBM and PCH, respectively, in order to show that the choice between them ultimately comes down to ontological preference. While EBM has a solid foundation in positivism, or what I here call Humeanism, PCH is more consistent with causal dispositionalism. I conclude that if there is a paradigmatic revolution on the way in medicine, it is first of all one of ontology. (shrink)

The modern history of experimentation with human beings is notable for its ethical lacunae. In 1865, in his great work, An Introduction to the Study of Experimental Medicine, Dr. Claude Bernard, the French physician who first established the use of the scientific method in medicine, echoed the earlier injunctions of physician-moralist Moses Maimonides in counseling his fellow physicians not to treat their patients solely as a means of advancing knowledge. Yet such cautions had no apparent effect on the physicians who, (...) at the end of the 19th century, studied the transmission of venereal diseases by intentionally infecting poor and institutionalized people without their knowledge, much less their consent. In response... (shrink)

. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. Therefore, the (...) standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)

Dr. Henry Beecher, a renowned Harvard Medical School anesthesiologist, sent shock waves through the medical research community and the lay press when he described 22 examples of “unethical or questionably ethical studies” by reputable researchers at major institutions in his now well-known 1966 New England Journal of Medicine article. Beecher concluded this exposé by noting: “The ethical approach to experimentation in man has several components: two are more important than the others, the first being informed consent.... Secondly, there is the (...) more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator”. Beecher’s... (shrink)

Current research in molecular epidemiology uses biomarkers to model the different disease phases from environmental exposure, to early clinical changes, to development of disease. The hope is to get a better understanding of the causal impact of a number of pollutants and chemicals on several diseases, including cancer and allergies. In a recent paper Russo and Williamson address the question of what evidential elements enter the conceptualisation and modelling stages of this type of biomarkers research. Recent research in causality has (...) examined Ned Hall’s distinction between two concepts of causality: production and dependence. In another recent paper, Illari examined the relatively under-explored production approach to causality, arguing that at least one job of an account of causal production is to illuminate our inferential practices concerning causal linking. Illari argued that an informational account solves existing problems with traditional accounts. This paper follows up this previous work by investigating the nature of the causal links established in biomarkers research. We argue that traditional accounts of productive causality are unable to provide a sensible account of the nature of the causal link in biomarkers research, while an informational account is very promising. (shrink)

The routine practice of clinical research involving patient-subjects without informed consent prior to 1966 unquestionably was unethical. Does it follow that all clinical research involving competent adult patient-subjects is unethical without informed consent?In his landmark 1966 paper, Henry Beecher noted that of the 50 example studies he had originally compiled in preparation for that paper, only two even mentioned consent, and he observed further that mention of consent is “meaningless unless one knows how fully the patient was informed”. Some of (...) the studies in Beecher’s paper, such as one comparing sulfadiazine with no treatment to assess the complications of streptococcal pharyngitis (when the... (shrink)

Fifty years ago, Henry Knowles Beecher published his essay on clinical research ethics in the New England Journal of Medicine. The culmination of more than a decade and a half’s rumination and reflection on the use of patients and “captive populations” in research, Beecher’s 1966 article understandably casts a large shadow in American bioethics. In 1976, the Institute of Society, Ethics and the Life Sciences established the Henry Knowles Beecher Award for Contributions to Ethics and the Life Sciences and named (...) the Harvard professor as the first recipient of the Award. “It is unusual for a researcher,” Daniel Callahan explained, on behalf of the Board of Directors of the... (shrink)

“You are interested in ethics,” the clinician said, “there are problems with medical ethics in Taiwan.” It was 2005, shortly after I had moved to Taiwan. A little later, a professor told me of a university hospital that served as a site for a transnational clinical trial run by a pharmaceutical company. He said that since no informed consent procedure was in place at that time, the hospital had simply obtained employer consent. “That’s why companies want to come to Taiwan (...) to do clinical testing, because you can do anything here—things that can’t be done in the US. That’s why everyone wants to come to Taiwan.” These statements may seem, at first, to indicate a lack of concern in Taiwan for medical and scientific... (shrink)

Henry Beecher was a distinguished professor of anesthesia and clinical investigator at Harvard Medical School. He became an iconic figure in bioethics, best known for his 1966 article describing 22 examples of unethical clinical research. This is one of the most frequently cited articles on ethics in the medical literature. Indeed, it may be seen as marking a watershed in the moral climate of medical research. In his history of bioethics, Albert Jonsen characterized Beecher as one of the “stars in (...) the bioethical firmament”. Daniel Callahan, founder of the Hastings Center, explained Beecher’s impact in a 1991 interview:“I think the role of Henry Beecher was very important in the mid 60s when he blew the... (shrink)