Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

Evidence-based medicine has been the subject of much controversy within and outside the field of medicine, with its detractors characterizing it as reductionist and authoritarian, and its proponents rejecting such characterization as a caricature of the actual practice. At the heart of this controversy is a complex linguistic and social process that cannot be illuminated by appealing to the semantics of the modifier evidence-based. The complexity lies in the nature of evidence as a basic concept that (...) circulates in both expert and non-expert spheres of communication, supports different interpretations in different contexts, and is inherently open to contestation. We outline a new methodology that combines a social epistemological perspective with advanced methods of corpus linguistics and elements of conceptual history to investigate this and other basic concepts that underpin the practice and ethos of modern medicine. The potential of this methodology to offer new insights into controversies such as those surrounding EBM is demonstrated through a case study of the various meanings supported by evidence and based, as attested in a large electronic corpus of online material written by non-experts as well as a variety of experts in different fields, including medicine. (shrink)

The evidence-based medicine (EBM) movement is touted as a new paradigm in medical education and practice, a description that carries with it an enthusiasm for science that has not been seen since logical positivism flourished (circa 1920–1950). At the same time, the term ‘‘evidence-based medicine’’ has a ring of obviousness to it, as few physicians, one suspects, would claim that they do not attempt to base their clinical decision-making on available evidence. However, the apparent obviousness of (...) EBM can and should be challenged on the grounds of how ‘evidence’ has been problematised in the philosophy of science. EBM enthusiasm, it follows, ought to be tempered. The post-positivist, feminist, and phenomenological philosophies of science that are examined in this paper contest the seemingly unproblematic nature of evidence that underlies EBM by emphasizing different features of the social nature of science. The appeal to the authority of evidence that characterizes evidence-based practices does not increase objectivity but rather obscures the subjective elements that inescapably enter all forms of human inquiry. The seeming common sense of EBM only occurs because of its assumed removal from the social context of medical practice. In the current age where the institutional power of medicine is suspect, a model that represents biomedicine as politically disinterested or merely scientific should give pause. (shrink)

BACKGROUND AND RATIONALE: Evidence based medicine is the present backbone of rational and objective, modern medical problem solving and is a meeting ground for quantitative and qualitative researchers alike as it culminates into applying the fruits of clinical research to the individual patient. A systematic enquiry into the evolving paradigms in EBM is a need of the hour. AIMS AND METHODS: A qualitative enquiry examining the impact of different methodologies in EBM and their role in generating meaning interpretable (...) at individual levels. RESULTS: Present day outcome based research deals less with patients as individuals than as populations. Evidence based medicine struggles to apply the fruits of population based research to individuals who are often not as predictable as linear quantitative research would like them to be. The present EBM literature neglects a lot of events it doesn't believe to be statistically significant and perhaps here is an area that needs to be improved on - it assumes that because associations are demonstrated between interventions and outcomes in RCTs/meta-analysis, these associations are linear and causal in the real world. While they may be demonstrated repeatedly in highly controlled environments, in the real 'uncontrolled' world of clinical practice with real people, their validity breaks down. CONCLUSIONS: One needs to make the EBM standard model patient-individual (a projection of collective patient event data) resemble the real human individual patient so that optimal EBM individual data that matches our query can be easily and quickly spotted from the dense jungle of information that has grown over the years. This hints at rethinking our entire research methodology and modifying it to suit the needs of the individual patient. (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)

As a recent special report in the Hastings Center Report demonstrates, many bioethicists are rethinking the way we regulate both biomedical research and clinical practice, as well as the sharp boundary that the field has assumed can and should exist between them. Such a rethinking is long overdue. There is surely a meaningful normative distinction between activities whose expected risk‐benefit profile is and is not “reasonable” for participants (to echo the language in the Common Rule—the core set of human (...) research guidelines found in many federal regulations). But neither the research‐practice distinction nor the criteria underlying it—the intention of the actor, whether the activity is “systematic,” and whether its results are “generalizable”—closely track good and bad outcomes for research participants and patients or justify either the bureaucratic, paternalistic licensing system that governs human subjects research or the comparatively lax governance of medical practice. The specious distinction between research and practice is especially ripe for dismantling in light of the embarrassing fact that evidence‐based medicine remains more aspiration than reality. (shrink)

The relationship between evidence-based medicine (EBM) and clinical judgement is the subject of conceptual and practical dispute. For example, EBM and clinical guidelines are seen to increasingly dominate medical decision-making at the expense of other, human elements, and to threaten the art of medicine. Clinical wisdom always remains open to question. We want to know why particular beliefs are held, and the epistemological status of claims based in wisdom or experience. The paper critically appraises a (...) number of claims and distinctions, and attempts to clarify the connections between EBM, clinical experience and judgement, and the objective and evaluative categories of medicine. I conclude that to demystify clinical wisdom is not to devalue it. EBM ought not be conceived as needing to be limited or balanced by clinical wisdom, since if its language is translatable into terms comprehensible and applicable to individuals, it helps constitute clinical wisdom. Failure to appreciate this constitutive relation will help perpetuate medical paternalism and delay the adoption of properly evidence-based practice, which would be both unethical and unwise. (shrink)

BackgroundExpertise has been a contentious concept in Evidence-Based Medicine. Especially in the early days of the movement, expertise was taken to be exactly what EBM was rebelling against—the authoritarian pronouncements about “best” interventions dutifully learned in medical schools, sometimes with dire consequences. Since then, some proponents of EBM have tried various ways of reincorporating the idea of expertise into EBM, with mixed results. However, questions remain. Is expertise evidence? If not, what is it good for, if anything?MethodsIn this (...) article, I describe and analyze the three historical models of expertise integration in EBM and discuss the difficulties in putting each into practice. I also examine accounts of expertise from disciplines outside of medicine, including philosophy, sociology, psychology, and science and technology studies to see if these accounts can strengthen and clarify what EBM has to say about expertise.ResultsOf the accounts of expertise discussed here, the Collins and Evans account can do most to clarify the concept of expertise in EBM.ConclusionsWith some additional clarification from EBM proper, theoretical resources from other disciplines might augment the current EBM account of expertise. (shrink)

Values-Based Medicine (VBM) is the theory and practice of clinical decision-making for situations in which legitimately different values are in play. VBM is thus to values what Evidence-Based Medicine (EBM) is to facts. The theoretical basis of VBM is a branch of analytic philosophy called philosophical value theory. As a set of practical tools, VBM has been developed to meet the challenges of value diversity as they arise particularly in psychiatry. These challenges are illustrated in this (...) paper by a case study of the differential diagnosis between delusion and religious experience. In a traditional model of scientific medicine, such challenges would be expected to become less pressing with advances in medical science. Philosophical value theory suggests, to the contrary, that scientific progress, through opening up an ever-wider range of choices, will increasingly bring the full range and diversity of human values into play not just in psychiatry but in all areas of medicine. The future, then, for medicine, is an integrated model in which VBM and EBM are equal partners in a genuinelyhuman discipline. (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)

Significant contributions to debates in the philosophy of evidence-based medicine (EBM) have come from a variety of different philosophical quarters, yet mainstream discourse in the field has been largely devoid of contributions from scholars working in the pragmatist tradition. This is a particularly conspicuous omission, given pragmatism’s commitment to the melioristic view that philosophy both can, and should, be about the business of concretely bettering the human estate. Two exceptions to this oversight come from Brian Walsh and (...) Maya Goldenberg. Unfortunately, in both cases, the misapplication of pragmatist thinking leads to the mistaken view that EBM is committed to some form of pernicious objectivism. This article aims to revise these pragmatist critiques in order to bring them more consistently in line with pragmatist values and commitments. Doing so shows that EBM is defensible on pragmatist grounds against objectivist attacks. (shrink)

Individualized care and equality of care remain two imperatives for formulating any scientifically and morally informed public health policy. Yet both continue to be elusive goals, even in the age of genomics, proteomics, and evidence-based medicine. Nonetheless, with the rapid growth and improvement of human biotechnologies, the need to individualize therapies while allocating medical care equally may result partly from our biological constitution. Human beings are all unique, and their biological differences significantly influence variability in disease (...) causation and therapeutic response to treatments. However, because humans have equal moral worth, there is no ethically justifiable reason to establish an a .. (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)

In this article, we discuss epistemological limitations relating to the use of ethnoracial categories in biomedical research as devised by the Office of Management and Budget’s institutional guidelines. We argue that the obligation to use ethnoracial categories in genomics research should be abandoned. First, we outline how conceptual imprecision in the definition of ethnoracial categories can generate epistemic uncertainty in medical research and practice. Second, we focus on the use of ethnoracial categories in medical genetics, particularly genomics-based precision (...) class='Hi'>medicine, where ethnoracial identity is understood as a proxy for medically relevant differences among individuals. Notably, extensive criticisms have been made already against the genetic interpretation of races, but, nonetheless, the concept of race remains a key element of contemporary genomics. This motivates us to explore possible reasons why such criticisms may have been ineffective in redirecting attention to other (non-race-based) ways of controlling for human variability. We contend that popular arguments against the idea that human races have a genetic basis, though convincing in many respects, are not sufficient to exclude the pragmatic use of race and ethnicity as proxies for genetic variability related to complex phenotypes. Finally, we provide two further arguments to support the idea that ethnoracial categories are unlikely to provide meaningful insights into medical genetics, which implies that even the interpretation of race as a useful tool to stratify disease risk is unwarranted. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Do People Defy Generalizations?Examining the Case Against Evidence-Based Medicine in PsychiatryGloria Ayob (bio)KeywordsPhilosophy, psychiatry, action, contentEvidence-based medicine (EBM) in psychiatry presupposes that it is possible to track the causal efficacy of treatments for psychopathological conditions using scientific methods. One central aim of EBM is to ascertain the causally efficacious component of the treatment of a given condition. This is done by collecting data from randomized (...) control trials, where this data are of groups rather than of individuals (Bolton, 2008).EBM is felt by many to have significant limitations when applied in the field of psychiatric medicine, and these limitations are thought to arise owing to a particular fact about psychiatry, namely that the subject of psychiatry is the human person. For brevity, I will refer to this broad claim as the Unsuitability Intuition (UI), which can be stated as follows:The UI is the intuition that EBM is somehow unsuitable for dealing with people.The aims of this paper are twofold. First, I try to pinpoint the source(s) of anxiety about EBM, and therein to clarify the exact sense(s) in which EBM might be said to be unsuitable or problematic. Second, I evaluate the validity of these concerns, focusing on two broad interrelated questions: (1) Is it actually something about human persons that creates trouble for EBM in psychiatry, and if so, what is the nature of this trouble?; and (2) What assumptions about EBM are made such that EBM is problematic in light of the fact that the subject of psychiatry is the human person?As an empirical point, EBM in psychiatry is applied to two methods of treatment: psychotropic drugs, and more recently, cognitive–behavioral therapies. Each of these throws up slightly different issues in light of the two questions just identified. To accommodate relevant differences, I structure this paper as follows. Bearing in mind that the overall aim of the paper is to scrutinize the intuition that EBM is somehow unsuitable for dealing with people, I begin by exploring one common suggestion as to what underpins this intuition: The problem we are confronted with, in applying EBM to people, is the problem of applying generalizations to particular instances (Wifstad 2008). To anticipate, I argue that this worry concerns a problem that, in fact, applies to the scientific method in general. That is, it is not a [End Page 167] problem arising specifically from the fact that the subject of psychiatry is the human person. So if this is the worry about EBM, then as it stands, it does not satisfactorily explain the intuition that EBM is somehow unsuitable for dealing with people.Against this, the UI theorist might defend his intuition by attempting to specify the reasons why persons, unlike physical material, present a special challenge to the scientific method presupposed by EBM. One way of doing this is to point out that the determinants of human behavior cannot be captured by generalizations (and in particular, by causal generalizations). There are two ways of worrying about EBM here: On the first, the problem of EBM in psychiatry is a pragmatic worry that arises in view of the complexity of the determinants of human behavior and the limited capacity for observation. If this is the worry, though, it can be overcome to a greater or lesser extent within psychiatric practice. The second worry consists in the thought that humans pose a constitutive problem for EBM in psychiatry. However, I argue that this worry turns out to rest on assumptions about human behavior that are not unproblematic in themselves. Thus, UI is underpinned either by a pragmatic worry that can be overcome to some extent, or else it is underpinned by certain assumptions that are problematic, if not altogether wrong. This means that UI cannot be founded on a constitutive point about persons—at least, it does not seem to be, if it arises from a concern about applying generalizations to individual human beings.But there is a very different type of worry that might underpin UI, one that does not issue from considerations about the relation between the general and the particular. UI theorists could be worried about specific... (shrink)

Evidence-based medicine’s (EBM) quantitative methodologies reflect medical science’s long-standing mistrust of the imprecision and subjectivity of ordinary descriptive language. However, EBM’s attempts to replace subjectivity with precise empirical methods are problematic when clinicians must negotiate between scientific medicine and patients’ experience. This problem is evident in the case of bibliotherapy (patient reading as treatment modality), a practice widespread despite its reliance on anecdotal evidence. While EBM purports to replace such flawed practice with reliable evidence-based methods, this (...) essay argues that its aversion to subjective language prevents EBM from effectively evaluating bibliotherapy or making it amenable to clinical and research governance. (shrink)

The sequencing of the human genome and decreasing costs of sequencing technology have led to the notion of ‘personalized medicine’. This has been taken by some authors to indicate that personalized medicine will provide individualized treatments solely based on one’s DNA sequence. We argue this is overly optimistic and misconstrues the notion of personalization. Such interpretations fail to account for economic, policy and structural constraints on the delivery of healthcare. Furthermore, notions of individualization based on (...) genomic data potentially take us down the road of genetic reductionism obscuring the role of environmental factors in disease and ill health. We propose that one should see personalized medicine as a way of using personal genomic information to stratify individuals into subpopulations and suggest that personalized medicine be seen within a broader idea of personalized healthcare, reflecting healthcare that integrates personal genomic data into cultural, environmental and personal contexts. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

All the powerful influences exertedby the subjective-interpersonal dimension onthe organic or technical-functional dimensionof sickness and health do not make anintersubjective test concerning medicaltherapeutic results impossible. Theseinfluences are not arbitrary; on the contrary,they obey laws that are de facto sufficientlystable to allow predictions and explanationssimilar to those of experimental sciences.While, in this respect, the rules concerninghuman action are analogous to the scientificlaws of nature, they can at any time be revokedby becoming aware of them. Law-like andreproducible regularities in the sciences ofman (...) are by no means separated from a patient'spersonal-hermeneutic mediation. This makes itpossible for human beings to modify, improve orsometimes even entirely (or better almostentirely) suspend these psychological,sociological, ethnological, medical,regularities. For this reason the sciences ofman including medicine are under the obligationof constantly inspecting the continuingvalidity of the rules on which theirpredictions and explanations are based, namelyby indirect, statistical methods. Thisrequires a synergistic collaboration ofextra-clinical and clinical tests through whichmedicine can obtain a good level ofintersubjective testability. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Laying Medicine Open: Innovative Interaction Between Medicine and the HumanitiesLaurence B. McCullough and Warren Thomas ReichThe past three decades have witnessed the emergence and remarkable success of the fields of bioethics and medical humanities. The intellectual landscape of medicine and that of the humanities have been remarkably altered in the process. Twenty-five to 30 years ago in the United States there existed but a few courses (...) in what came to be called “bioethics” in departments of philosophy, religious studies, and theology in colleges and universities, a handful of programs of teaching in medical schools such as the University of Texas Medical Branch at Galveston and Pennsylvania State University School of Medicine at Hershey, and but one independent research center (the Hastings Center) and one university-based research center (the Kennedy Institute of Ethics at Georgetown University). Articles on bioethics began to appear in the peer-reviewed medical, nursing, and humanities literature and some books were published. There was only one journal in bioethics, The Hastings Center Report (which consolidated two previously separate journals from the Hastings Center). Graduate programs in bioethics and medical humanities in colleges and universities and fellowship training in bioethics and medical humanities in medical schools did not exist. Very little existed in colleges, universities, and medical schools in other countries. Now, of course, everything is different.Teachers, scholars, and students of bioethics and medical humanities should not take these remarkable changes for granted, for they represent a sustained and innovative interaction between medicine and the humanities. We have chosen the metaphor of “laying medicine open” to characterize the history of bioethics and medical humanities of the past three decades. This surgical metaphor was used in eighteenth-century Britain by a number of writers who wanted to make medical science and practice more accessible to the sick and to the lay public more generally (Lawrence 1975). We use the metaphor to characterize the efforts of teachers and [End Page 1] scholars over the past three decades and more to make the value-laden dimensions of biomedical science and practice and of health care policy more accessible to patients and to the lay public more generally. The result of this laying open of medicine has gone a long way toward bringing closer together the two cultures of science and the humanities that had, as C. P. Snow famously described, become significantly isolated from each otherAlbert Jonsen (1998) has recently contributed the first book-length history of what he calls the “birth” of bioethics, adding to the work of other scholars such as Warren Reich (1994; 1995) and Robert Baker (1993) and, before them, Corrado Viafora (1990) and David Rothman (1991). The articles in this issue of the Kennedy Institute of Ethics Journal make additional contributions to the developing understanding of the history of the past thirty years of interaction between medicine and the humanities.Laurence McCullough provides an historical context for the three accounts of the recent laying open of medicine that follow. McCullough examines two times in the history of medicine when it has been laid open to accountability (in addition to its being laid open to and by bioethics and medical humanities). The first laying open occurred in the work of the eighteenth-century Scottish physician and philosopher John Gregory, who set out to create a profession of medicine in a true moral sense of a fiduciary profession by making medicine accountable for its scientific and moral quality. The second occurred in the late twentieth century in which the managed practice of medicine in general, and managed care in particular, have begun to lay medicine open to accountability for its scientific and moral quality, as well as its cost and, at least in the public sector, its accessibility. McCullough argues that, just as Gregory responded to the ethical challenges of medicine laid open more than two centuries ago, bioethics should respond to the ethical challenges in the current laying open of medicine.Warren Reich provides an account of André Hellegers, whose premature death left an enormous gap in the field that will never be filled. Reich claims that Hellegers was engaged substantially in much more than the laying open of medicine: he... (shrink)

In recent years, personalized medicine (PM) has become a highly regarded line of development in medicine. Yet, it is still a relatively new field. As a consequence, the discussion of its future developments, in particular of its ethical implications, in most cases can only be anticipative. Such anticipative discussions, however, pose several challenges. Nevertheless, they play a crucial role for shaping PM’s further developments. Therefore, it is vital to understand how the ethical discourse on PM is conducted, i.e. (...) on what – empirical and normative – assumptions ethical arguments are based regarding PM’s current and future developments. (shrink)

Many prescriptions offered in the literature for enhancing creativity and innovation in organizations raise ethical concerns, yet creativity researchers rarely discuss ethics. We identify four categories of behavior proffered as a means for fostering creativity that raise serious ethical issues: breaking rules and standard operating procedures; challenging authority and avoiding tradition; creating conflict, competition and stress; and taking risks. We discuss each category, briefly identifying research supporting these prescriptions for fostering creativity and then we delve into ethical issues associated with (...) engaging in the prescribed behavior. These four rubrics illustrate ethical issues that need to be incorporated into the creativity and innovation literature. Recommendations for how organizations can respond to the ethical issues are offered based on practices of exemplary organizations and theories of organizational ethics. A research agenda for empirically investigating the ethical impact these four categories of behavior have on organizations concludes the article. (shrink)

This paper examines potential ethical and legal issues arising during the research, develop- ment and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individ- ual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; (...) health; vulnerable populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detri- mental to best personalizing treatment decisions in the clinic. (shrink)

Inclusion of the humanities in undergraduate medicine curricula remains controversial. Skeptics have placed the burden of proof of effectiveness upon the shoulders of advocates, but this may lead to pursuing measurement of the immeasurable, deflecting attention away from the more pressing task of defining what we mean by the humanities in medicine. While humanities input can offer a fundamental critical counterweight to a potentially reductive biomedical science education, a new wave of thinking suggests that the kinds of arts (...) and humanities currently used in medical education are neither radical nor critical enough to have a deep effect on students’ learning and may need to be reformulated. The humanities can certainly educate for tolerance of ambiguity as a basis to learning democratic habits for contemporary team-based clinical work. William Empson’s ‘seven types of ambiguity’ model for analyzing poetry is transposed to medical education to: (a) formulate seven values proffered by the humanities for improving medical education; (b) offer seven ways of measuring impact of medical humanities provision, thereby reducing ambiguity; and (c) --as a counterweight to (b) – celebrate seven types of ambiguity in contemporary medical humanities that critically reconsider issues of proof of impact. (shrink)

Quality of life is an important outcome measure in mental health care. Currently, QoL is mainly measured with paper and pencil questionnaires. To contribute to the evaluation of treatment, and to enhance substantiated policy decisions in the allocation of resources, a web-based, personalized, patient-friendly and easy to administer QoL instrument has been developed: the QoL-ME. While human values play a significant role in shaping future use practices of technologies, it is important to anticipate on them during the design (...) of the QoL-instrument. The value sensitive design approach offers a theory and method for addressing these values in a systematic and principled manner in the design of technologies. While the VSD approach has been applied in the field of somatic care, we extended the VSD approach to the field of mental healthcare with the aim to enable developers of the QoL-instrument to reflect on important human values and anticipate potential value conflicts in its design. We therefore explored how VSD can be used by investigating the human values that are relevant for the design of the QoL-ME. Our exploration reveals that the values autonomy, efficiency, empowerment, universal usability, privacy, redifinition of roles, of responsibilites, reliability, solidarity, surveillance and trust are at stake for the future users of the technology. However, we argue that theoretical reflections on the potential ethical impact of a technology in the design phase can only go so far. To be able to comprehensively evaluate the usability the VSD approach, a supplementary study of the use practices of the technology is needed. (shrink)

Based on Medicine as a human experience / David E. Reiser, David H. Rosen. c1984.

Objective: To examine the role of explainability in machine learning for healthcare (MLHC), and its necessity and significance with respect to effective and ethical MLHC application. Study Design and Setting: This commentary engages with the growing and dynamic corpus of literature on the use of MLHC and artificial intelligence (AI) in medicine, which provide the context for a focused narrative review of arguments presented in favour of and opposition to explainability in MLHC. Results: We find that concerns regarding explainability (...) are not limited to MLHC, but rather extend to numerous well-validated treatment interventions as well as to human clinical judgment itself. We examine the role of evidence-based medicine in evaluating unexplainable treatments and technologies, and highlight the analogy between the concept of explainability in MLHC and the related concept of mechanistic reasoning in evidence-based medicine. Conclusion: Ultimately, we conclude that the value of explainability in MLHC is not intrinsic, but is instead instrumental to achieving greater imperatives such as performance and trust. We caution against the uncompromising pursuit of explainability, and advocate instead for the development of robust empirical methods to successfully evaluate increasingly inexplicable algorithmic systems. (shrink)

James Drane's More Humane Medicine: A Liberal Catholic Bioethics is an outstanding contribution to the study of bioethics in our day. Catholics and others who are interested in the issues discussed here will benefit from this masterful treatment. The author opens with a set of definitions, starting with what he means by a “more humane medicine.” Drane contends that a more humane medicine has become necessary and desired, but not because the traditional medical ethic as “a self-declared (...) and self-imposed ethic, outlining what noble service to others entails” is no longer valid. Rather he defines it as an advance on the traditional ethic; a “new foundation” based on a “lived set of obligations derived from a felt commitment to other persons … an ethics based on the relationship between doctors and patients and essentially an ethics of virtue.” Drane's work is a “liberal Catholic Bioethics” in which he challenges his own faith tradition, the Roman Catholic Church, on such topics as sexuality, birth control, abortion, cloning, stem cell research, aging and dying, and euthanasia and physician-assisted suicide. The present article is a critical essay that analyzes the author's statements and conclusions. (shrink)

The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association’s Code of Medical Ethics (2000–2001 Edition) that address the various forms of conflict of interest that can (...) arise in the practice of medicine are outlined. (shrink)

This paper aims at explicating the role of the connections and interactions between health, well being and beauty. The primary goal of all medical approaches, including the classic biomedical and humanistic or humane approaches, is to restore or create health, whereby medical approaches that include prevention go beyond the mere restoration of health to include the preservation of health. Equating well-being and thus health with a largely self-determined and joyful life, then not only does a healthy life become a beautiful (...) life, a beautiful life also becomes a healthy life! By bringing Beauty into the health discourse, we are entering the field of aesthetics in general and social aesthetics in particular. As the beautiful is not just a decorative element of life but a genuine source of human strength, it gives us the strength and power we need to implement and achieve all that we then experience as “well-being” and that is called a healthy life. Therefore a further development of a human-based medicine is needed, a medicine that focuses not on a disease construct but which places a human being as a whole, with all his potential and limitations at the heart of diagnostic and therapeutic efforts. The noblest therapeutic goal of this kind of medicine can only be the restoration or preservation of a comprehensive state of health in the sense of complete physical, mental and social well-being, in the sense of opening up the possibility for a mostly autonomous and joyful life. (shrink)

IntroductionCardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in (...) which they have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter.ResultsWe point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education.ConclusionWe establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion. (shrink)

This book presents an interpretation of pharmaceutical, surgical and psychotherapeutic interventions based on a univalent metalanguage: biosemiotics. It proposes that a metalanguage for the physical, mental, social, and cultural aspects of health and medicine could bring all parts and aspects of human life together and thus shape a picture of the human being as a whole, made up from the heterogeneous images of the vast variety of sciences and technologies in medicine discourse. The book adopts (...) a biosemiotics clinical model of thinking because, similar to the ancient principle of alchemy, tam ethice quam physice, everything in this model is physical as much as it is mental. Signs in the forms of vibrations, molecules, cells, words, images, reflections and rites conform cultural, mental, physical, and social phenomena. The book decodes healing, dealing with health, illness and therapy by emphasizing the first-person experience as well as objective events. It allows readers to follow the energy-information flows through and between embodied minds and to see how they form physiological functions such as our emotions and narratives. (shrink)

This paper explores the possibility for a means of bringing about novelty which does not rely on kairological philosophies based on an event. In contrast to both common sense and contemporary philosophical understandings of the term where for novelty to arise there must be some break in the repetition of the structure, this paper argues that it is possible for novelty to come about through small-scale experimentation. This is done by relying on the philosophical notion of ‘economy’ in order (...) to understand how we think about the world. In this regard, our thinking about the world depends upon acknowledging certain possibilities at the expense of others. History can then be seen as the distribution of emphasis which allows for these past possibilities and the future potentiality they may hold. Novelty, defined here as a rereading of history, is precisely the disruption of these possibilities and a challenge to the memory of the system. The conclusion to this paper argues that experimentation is an important means by which we can bring novelty into the world. (shrink)

Medicine at the Crossroads is a collection of essays based a column originally published in the Waco-Tribune Herald by renowned cardiologist Dr. Michael Attas of Baylor University. It touches on three perspectives - the physician, the patient, and the healthcare system - and addresses some of the most pressing questions in medicine today.

Autopathographies are an expanding genre of books and articles that are a potential resource for students interested in the medical humanities. New curricula emphasise the need to familiarise medical students with the patient’s point of view. Different specialities compete for the student’s attention and the medical humanities are not an exception. Some form of assessment is necessary to reflect the importance of the patient’s perspective. One way may be to request students analyse their chosen autopathography. The article presents an example (...) based on one of the better know accounts. The identified themes reflect the sudden disruption in the author’s biography. The topics are connected to the medical disorder and illustrated by quotations. The different categories of autopathography can be helpful in understanding the author’s perspective. In this instance the author was a full time editor before his stroke. The style of the book employs professional distance from the narrative. This is more compatible with the description of metapathography rather than the original classification of autopathogrphies as religious, angry or alternative. (shrink)

The purpose of medical humanities is to improve the delivery of effective health care through a better understanding of disease in society, and in the individual. The interfaces between the science of medicine and the arts, philosophy, sociology and law interpret causes and effects of disease. The field of medical ethics is the most prominent offspring of this wider debate, yet the context of disease in the life of the individual and of society is profound and far-reaching. The influences (...) of medicine on the humanities and vice versa are all around, yet only recently have they been recognised in the wider world of health care. How can you encapsulate the essence of medical humanities and teach it to health professionals? Medical Humanities is designed to fill the need for a clear, well illustrated text that both provides the principles for the individual reader, and encourages discussion. The issues are explored in four main sections. Based on a highly successful seminar, and with contributions from leading writers, thinkers, and teachers, this book provides a comprehensive and authoritative reference for what is becoming a professional requirement in medicine. It will be invaluable for clinicians and students alike. (shrink)

Cardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in (...) which they have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter. (shrink)

This book critically assesses the implications of modern medicine's claim to be a natural science. Medicine models its scientific and clinical self-understanding on an obsolete positivist conception of science, reality, and consciousness. In this view, the body is modeled as a biological machine, disease as breakdown of the machine, and therapy as physical measures to fix the machine. The problems besetting medical science and practice are rooted in the inadequacy of the positivist philosophical assumptions regarding the nature of (...) science, reality and consciousness To base the diagnostic practices and therapeutic regimes purely on knowledge of physical processes in the human body is, in view of this analysis, at best grossly inadequate, at worst thoroughly dehumanizing (Anton van Niekerk: Editorial Foreword). This means that medicine's clinical method cannot be transformed without transforming the underlying view of science, of reality, and of the human person. The book proposes a broader model of science which overcomes the outdated dichotomy between human and natural sciences. Science is viewed as an interdisciplinary exercise generating multiple perspectives. The insights of the human sciences are essential for scientific clinical medicine. Utilizing evolutionary biology and complexity theory, the author proposes an alternative understanding of reality and human consciousness as a basis for a transformed clinical method. Reality is a hierarchy of systems of increasing complexity. Different levels can be distinguished, namely material systems, living material systems, conscious living material systems and self-conscious living material systems. Each level represents a new manner of being which requires a different scientific discourse of understanding. Using this model of reality the author argues against understanding human consciousness as a byproduct of physical processes in the brain. The human person is a self-conscious, complex, psycho-somatic system, whose well-being is conditioned by much more than physical processes. (shrink)

Background The increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics. Discussion The recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a solution to the (...) current ambivalence toward the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked. Summary The "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

BackgroundThe increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics.DiscussionThe recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a solution to the current ambivalence toward (...) the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable (or at least non-falsifiable) considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked.SummaryThe "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

Debate over the status of medicine as an Art or Science continues. The aim of this paper is to discuss the meaning of Art and Science in terms of medicine, and to find out to what extent they have their roots in the field of medical practice. What is analysed is whether medicine is an "art based on science"; or, the "art of medicine" has lost its sheen (what with the rapid advancements of science in (...) course of time, which has made present day medicine more sophisticated). What is also analysed is whether the "science of medicine" is a pure one, or merely applied science; or the element of science in it is full of uncertainty, simply because what is accepted as "scientific" today is discarded by medical practitioners tomorrow in the light of newer evidence. The paper also briefly touches upon how, in the field of present medical education, the introduction of medical humanities or humanistic education has the potential to swing the pendulum of medicine more towards the lost "art of medicine". The paper concludes by saying that the art and science of medicine are complementary. For successful practice, a doctor has to be an artist armed with basic scientific knowledge in medicine. (shrink)