Lack of guidance and regulation for authorizing medical cannabis for conditions involving the health and neurodevelopment of children is ethically problematic as it promulgates access inequities, risk-benefit inconsistencies, and inadequate consent mechanisms. In two virtual sessions using participatory action research and consensus-building methods, we obtained perspectives of stakeholders on ethics and medical cannabis for children and youth. The sessions focused on the scientific and regulatory landscape of medical cannabis, surrogate decision-making and assent, and the social and political culture of (...) medical cannabis. We found that evidence-gathering and data dissemination, pressures on clinical relationships, and the lack of integration of culturally diverse perspectives and Indigenous knowledges were key areas of concern. Participants emphasized the importance of utilizing adaptive study designs, highlighted the importance of trust-building between clinicians, patients and caregivers, and discussed barriers including historical and ongoing stigmatization of medical cannabis. We conclude that continued public consultation and strength-based research that integrate diverse perspectives are critical steps forward. (shrink)

Evidence based medicine has much to offer, but a great deal remains to be done to create a better understanding of what it can and cannot do.The term EBM , as we use it nowadays, was introduced in 1992 by the same group of people who, years before, founded the discipline called “Clinical epidemiology” .1 CE stemmed essentially from the idea of adapting and expanding epidemiological methods to medical and health care decision making; CE was in fact (...) defined as “ the discipline dealing with the study of the occurrence of medical decisions in relation to their determinants”.1CE has been very successful in illustrating new ways of teaching medicine and training health professionals, and has positioned itself around the notion that “critical appraisal skills” are yet another set of essential abilities which—in addition to the interpersonal, diagnostic, and prognostic skills—a good doctor should master. An important by product of CE was documentation which showed that much of the available evidence on diagnosis, prognosis, and treatment of diseases was of poor methodological quality and quite often of dubious transferability to everyday clinical practice.This led to a strong call for improving the scientific basis of clinical practice, which was seen as too often dominated by practices of unproven effectiveness. This was the background for the 1992 Journal of the American Medical Association article that first used the term “evidence based medicine”.2In essence, proponents of EBM said that “all medical action of diagnosis, prognosis, and therapy should rely on solid quantitative evidence based on the best of …. (shrink)

Next SectionEvidence based medicine is rightly at the core of current medicine. If patients and society put trust in medical professional competency, and on the basis of that competency delegate all kinds of responsibilities to the medical profession, medical professionals had better make sure their competency is state of the art medical science. What goes for the ethics of clinical trials goes for the ethics of medicine as a whole: anything that is scientifically doubtful is, other (...) things being equal, ethically unacceptable. This particularly applies to so called orphaned fields of medicine, those areas where medical research is weak and diverse, where financial incentives are lacking, and where the evidence regarding the aetiology and treatment of disease is much less clear than in laboratory and hospital based medicine. Examples of such orphaned fields are physiotherapy, psychotherapy, medical psychology, and occupational health, which investigate complex syndromes such as RSI, whiplash, chronic low back pain, and chronic fatigue syndrome. It appears that the primary ethical problem in this context is the lack of attention to the orphaned fields. Although we agree that this issue deserves more attention as a matter of potential injustice, we want to argue that, in order to do justice to the interplay of heterogeneous factors that is so typical of the orphaned fields, other ethical models than justice are required. We propose the coordination model as a window through which to view the important ethical issues which relate to the communication and interaction of scientists, health care workers, and patients. (shrink)

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an (...) class='Hi'>evidence-based decision-support contain implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

The aim of this article is to explore the complex forms of knowledge involved in diagnostic and interventional decision making by comparing the processes in medicine and nursing, including nurse practitioners. Many authors assert that the practice of clinical decision making involves the application of theoretical knowledge (acquired in the classroom and textbooks) as well as research evidence, upon concrete particular cases. This approach draws on various universal principles and algorithms to facilitate the task. On the other (...) hand, others argue that this involves an intuitive form of judgement that is difficult to teach, one that is acquired principally through experience. In an exploration of these issues, this article consists of three sections. A clarification of terms commonly used when discussing decision making is provided in the first section. In the second section, an epistemological analysis of decision making is presented by examining several perspectives and comparing them for their use in the nursing and medical literature. Bunge's epistemological framework for decision making (based on scientific realism) is explored for its fit with the aims of medicine and nursing. The final section presents a discussion of knowledge utilization and decision making as it relates to the implications for the education and ongoing development of nurse practitioners. It is concluded that Donald Schön's conception of reflective practice best characterizes the skilful conduct of clinical decision making. (shrink)

The use of platelet rich plasma as a novel treatment is discussed in the context of a qualitative research study comprising 38 interviews with sports medicine practitioners and other stakeholders working within the English Premier League during the 2013–16 seasons. Analysis of the data produced several overarching themes: conservatism versus experimentalism in medical attitudes; therapy perspectives divergence; conflicting versions of appropriate evidence; subcultures; community beliefs/practices; and negotiation of medical decision-making. The contested evidence base for the efficacy of (...) PRP is presented in the context of a broader professional shift towards evidence based medicine within sports medicine. Many of the participants while accepting this shift are still committed to casuistic practices where clinical judgment is flexible and does not recognize a context-free hierarchy of evidentiary standards to ethically justifiable practice. We also discuss a tendency in the data collected to consider the use of deceptive, placebo-like, practices among the clinician participants that challenge dominant understandings of informed consent in medical ethics. We conclude that the complex relation between evidence and ethics requires greater critical scrutiny for this emerging specialism within the medical community. (shrink)

Explanatory models in psychiatry reflect what clinicians deem valuable in rendering people's behavior intelligible and thus help guide treatment choices for mental illnesses. This article outlines some key scientific and ethical principles of clinical explanation in twenty-first century psychiatry. Recent work in philosophy of science, clinical psychiatry, and psychiatric ethics are critically reviewed in order to elucidate conceptual underpinnings of contemporary explanatory models. Many explanatory models in psychiatry are reductionistic or eclectic. The former restrict options for diagnostic (...) and therapeutic paradigm choice, while the latter lack a well-defined theoretical basis. These two methodological approaches stand in a dialectical relation to one another insofar as clinicians often move from one approach to its antithesis, ultimately seeking a synthesis of the two approaches that satisfies clinical needs. Pragmatic considerations can help to transcend the reductionism/eclecticism dialectic. In the absence of a completed science of mental disorders, psychiatrists must tolerate ambiguity and uncertainty as they strive to integrate diverse explanatory concepts in a rigorous and evidence-based fashion. A pragmatic explanatory model in clinical psychiatry must focus on favorable treatment outcomes for patients by respecting the pluralistic, participatory, and provisional nature of psychiatric explanation. (shrink)

BackgroundThe overwhelming scarcity of organs within renal transplantation forces researchers and transplantation teams to seek new ways to increase efficacy. One of the possibilities is the use of personalized medicine, an approach based on quantifiable and scientific factors that determine the global immunological risk of rejection for each patient. Although this approach can improve the efficacy of transplantations, it also poses a number of ethical questions.MethodsThe qualitative research involved 22 semi-structured interviews with nephrologists involved in renal transplantation, with (...) the goal of determining the professionals' views about calculating the global immunological risk and the attendant ethical issues.ResultsThe results demonstrate a general acceptance of this approach amongst the participants in the study. Knowledge of each patient's immunological risk could improve treatment and the post-graft follow-up. On the other hand, the possibility that patients might be excluded from transplantation poses a significant ethical issue. This approach is not seen as something entirely new, given the fact that medicine is increasingly scientific and evidence-based. Although renal transplantation incorporates scientific data, these physicians believe that there should always be a place for clinical judgment and the physician-patient relationship.ConclusionsThe participants see the benefits of including the calculation of the global immunological risk within transplantation. Such data, being more precise and rigorous, could be of help in their clinical work. However, in spite of the use of such scientific data, a place must be retained for the clinical judgment that allows a physician to make decisions based on medical data, professional expertise and knowledge of the patient. To act in the best interests of the patient is key to whether the calculation of the global immunological risk is employed. (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)

For at least the past several decades, medicine has been embroiled in a crisis concerning the nature of its professionalism. The fundamental questions that drive this ongoing crisis are primarily three. First, what is the nature of medical professionalism? Second, who are medical professionals? Third, what does medicine or these professionals profess or promise? In this paper, the professionalism crisis vis-à-vis these questions is examined and analyzed chiefly in terms of both Francis Peabody’s and Edmund Pellegrino’s writings. Based (...) on their writings, I introduce a conceptual framework for professionalism to address the crisis. In addition, I contend that to address the professionalism crisis adequately, medicine’s position within an evolving health care network must also be considered. To that end, I first discuss the genesis of the crisis in terms of the Flexner Report and especially Peabody’s response to it. Next, I explore how the crisis intensified during the twentieth century, particularly in terms of medicine’s ultimate scientification and eventual commercialization, and how Pellegrino reacted to this. I then propose a health care professionalism cycle and a care-competence cycle to provide a conceptual framework for addressing the crisis. I conclude that medicine’s position is no longer as the center of health care but rather as another node within a wider evolving health care network. And the resolution of medicine’s professionalism crisis depends on medicine’s positioning and defining itself in terms of the professionalism for each of the other professions within the health care network. (shrink)

From the standpoint of the theory of medicine, a formulation is given of three types of reasoning used by physicians. The first is deduction from probability models (as in prognosis or genetic counseling for Mendelian disorders). It is a branch of mathematics that leads to predictive statements about outcomes of individual events in terms of known formal assumptions and parameters. The second type is inference (as in interpreting clinical trials). In it the arguments from replications of the same (...) process (data) lead to conclusions about the parameters of a system, without calling into question either the probabilistic model or the criteria of evidence. The third is illation (as in the elucidation of symptoms in a patient). It is a process whereby, in the light of the total evidence and the conclusions from the other types of reasoning, one may modify, expand, simplify or demolish a conceptual framework proposed for deductions, and modify the nature of the evidence sought, the criteriology, the axioms, and the surmised complexity of the scientific theory. (The process of diagnosis as applied to a patient may in extreme cases lead to the discovery of an entirely new disease with its own, quite new, set of diagnostic criteria. This course cannot be accommodated inside either of the other two types of reasoning.) Illation has something of the character of Kuhn's scientific revolution in physics; but it differs in that it is the nature, not the degree or frequency of change that distinguishes it from Kuhn's normal science. (shrink)

BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe primary (...) objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Impact of Clinicians on the Diagnostic ManualThomas A. Widiger (bio)Keywordsdiagnosis, classification, DSM, taxonomy, clinical judgmentSurveys of clinicians’ opinions can be very informative. There is a long tradition within medicine that new disorders are discovered within clinical practice. The original edition of the American Psychiatric Association’s (APA) diagnostic manual (DSM) was based in large part on clinical experience. The recent editions have been governed more (...) heavily by more systematic research (Widiger and Clark 2000), but many of the new additions are still said to come from clinical practice. As described for the development of DSM-III (APA 1980), “if there is general agreement among clinicians, who would be expected to encounter the condition, that there are a significant number of patients who have it and that its identification is important in their clinical work, it is included in the classification” (Spitzer, Sheehy, and Endicott 1977, 3).Clinicians can also be surveyed with regard to their opinions concerning a proposed revision. The ultimate consumers of a diagnostic manual are practicing clinicians and any effort to develop an official nomenclature should consider the opinions of the persons who must use the classification within their clinical practice (First et al. 2004; Sadler 2005). Clinicians can also be surveyed (or studied) with respect to how the diagnostic manual is being implemented. Much of this research has demonstrated that clinicians might be failing to apply the diagnostic manual in a reliable or valid manner (Garb 2005; Kutchins and Kirk 1997).It is perhaps obvious, however, that a diagnostic manual should not be governed primarily by clinical opinion or current clinical practice. The authors of DSM-III (APA 1980) and DSM-III-R (APA 1987) indicated that they would include a new diagnosis within the official nomenclature if a group of clinicians indicated that it was important to their clinical practice (Spitzer et al. 1977). This liberal threshold led to the decision of the DSM-III-R Task Force to include such diagnoses as paraphiliac rapism, self-defeating personality disorder, and sadistic personality disorder despite the lack of systematic research supporting their validity and the likelihood that these new diagnoses would have harmful social and forensic applications (Widiger 1995). These diagnoses no longer even appear within the appendix of DSM-IV-TR (APA 2000) for proposed diagnoses needing further study.The authors of DSM-III avoided opinion surveys because “no one wanted to repeat the scene of the general membership voting on a presumably ‘scientific’ issue, as was done in 1973 on the [End Page 277] issue of the elimination of homosexuality from the DSM-II classification” (Spitzer, Williams, and Skodol 1980, 152). Matters of construct validity should probably be addressed through systematic research rather than through opinion polls. Decisions should be informed by a fair hearing of the diversity of perspectives, and these viewpoints and perspectives should be systematically and enthusiastically solicited. Nevertheless, the most scientifically valid decision may at times be “politically incorrect.” The authors of the diagnostic manual should have the authority to make innovative decisions that are scientifically justified even when they are contrary to general clinical consensus (Widiger and Clark 2000).Some persons, though, do suggest that the diagnostic manual should be modeled on how disorders are being diagnosed within clinical practice. This is perhaps most readily evident in the proposals of Westen and Shedler (2000) to diagnose mental disorders via prototypal matching. They eschew the provision of specific and explicit criterion sets in favor of simply matching the patient to a global (e.g., paragraph description) of a prototypic case. A purported strength of this approach is that it is said to “conform to the way clinicians think about psychiatric diagnoses” (First and Westen 2007, 473).There are, however, concerns with respect to prototypal matching. First, it is not really clear that clinicians actually provide diagnoses in this manner. There are data to suggest that clinicians instead reach a diagnostic decision on the basis of just one or two individual diagnostic criteria rather than matching to a global prototype (Herkov and Blashfield 1995).More important, it is unclear whether the diagnostic manual should in fact emulate what is occurring within clinical practice. There is a... (shrink)

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

The more popular complementary and alternative medicine (CAM) has become, the more often it is demanded that the integration of CAM should be limited to those approaches that are scientifically proven to be effective. This paper argues that this demand is ethically and philosophically questionable. The clinical legitimacy being gained by CAM and its increasing informal integration should instead caution against upholding the biomedical framework and evidence-based medicine as conditions of acceptance. Patients’ positive experiences with CAM (...) deserve a truly scientific exploration of non-biomedical conceptualizations of health and illness. It is also problematic to request scientific evidence when there is proven resistance against CAM in research institutions, under-funding and a lack of suitable research methodologies. This is even more so, when much conventional medicine is not practiced with the same level of evidence as demanded from CAM. (shrink)

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of (...) Freiburg in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

Evidence, as viewed through the lens of statistical significance, is not always as it appears! In the investigation of clinical research findings arising from statistical analyses, a fundamental initial step for the emerging fraud detective is to retrieve the source data for cross-examination with the study data. Recognizing that source data are not always forthcoming and that, realistically speaking, the investigator may be uninitiated in fraud detection and investigation, this paper will highlight some key methodological procedures for providing (...) a sounder evidence base for withdrawing from a study on grounds of integrity. The promotion of patient safety is paramount. However, there is a broader rationale for disseminating these ideas. This includes empowering researchers to optimize their personal integrity, make informed choices regarding membership of future research collaborations and successfully voice their concerns to journal editors, particularly where a conflict of interests can render such dialogues particularly difficult. Recommendations will be supported by topical case studies and practical steps involving data exploration, testing of baseline data and application of Benford’s Law. While this paper has a clinical focus, the advice provided is transferrable to a wide range of multidisciplinary research settings outside of Medicine. (shrink)

The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted (...) baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act. (shrink)

The University of Michigan conference “Where Religion, Policy, and Bioethics Meet: An Interdisciplinary Conference on Islamic Bioethics and End-of-Life Care” in April 2011 addressed the issue of brain death as the prototype for a discourse that would reflect the emergence of Islamic bioethics as a formal field of study. In considering the issue of brain death, various Muslim legal experts have raised concerns over the lack of certainty in the scientific criteria as applied to the definition and diagnosis of (...) brain death by the medical community. In contrast, the medical community at large has not required absolute certainty in its process, but has sought to eliminate doubt through cumulative diagnostic modalities and supportive scientific evidence. This has recently become a principal model, with increased interest in data analysis and evidence-based medicine with the intent to analyze and ultimately improve outcomes. Islamic law has also long employed a systematic methodology with the goal of eliminating doubt from rulings regarding the question of certainty. While ample criticism of the scientific criteria of brain death (Harvard criteria) by traditional legal sources now exists, an analysis of the legal process in assessing brain death, geared toward informing the clinician’s perspective on the issue, is lacking. In this article, we explore the role of certainty in the diagnostic modalities used to establish diagnoses of brain death in current medical practice. We further examine the Islamic jurisprudential approach vis-à-vis the concept of certainty (yaqīn). Finally, we contrast the two at times divergent philosophies and consider what each perspective may contribute to the global discourse on brain death, understanding that the interdependence that exists between the theological, juridical, ethical, and medical/scientific fields necessitates an open discussion and active collaboration between all parties. We hope that this article serves to continue the discourse that was successfully begun by this initial interdisciplinary endeavor at the University of Michigan. (shrink)

The often-emphasized tension between the singularity of the patient and technical–scientific reproducibility in medicine cannot be resolved without a discussion of the epistemological and methodological status of the human sciences. On the one hand, the rules concerning human action are analogous to the scientific laws of nature. They are de facto sufficiently stable to allow predictions and explanations similar to those of experimental sciences. From this point of view, it is only a trivial truth, but still a (...) methodological irrelevancy, that the patient and the doctor–patient relationship represent an ontologically irreproducible reality. On the other hand, however, one can never exclude that one can fail in the application of "laws" of the human sciences to the individual patient, for such laws are by no means wholly separated from a patient's personal-hermeneutic mediation, and can at any time be revoked by becoming aware of them. This requires a synergistic collaboration of clinical and statistical methods, and shows a methodologically relevant sense in which one cannot disregard the singularity of the patient. The reason for the crucial role of the patient's singularity in medicine is every individual patient's capacity to revoke, in principle, routines and quasi-automatisms, even though the personal mediation by the patient's consciousness de facto changes them in such a small degree that predictions and explanations modeled in experimental science remain possible. (shrink)

SummaryIt has been argued that clinical medicine should be regarded as a relatively autonomous science. While it draws upon other sciences which variously contribute to medical knowledge, it is not just an “application” of any of these, alone or in combination. Its contributions to medical knowledge are made within the context of patient care (the term “clinical medicine” is used here to emphasize this matter). It is distinct from other sciences in its domain of inquiry and (...) its approach to this domain, studying relationships between events and processes of many kinds and levels as they occur in the human organism. To the fullest extent possible (and to an extent not possible elsewhere) these relationships are investigated as they occur within the living organism. Arguments providing logical justification for this approach have been offered. The practical justification of its approach, and of clinical medicine itself, rests in its accomplishments. Various possible objections to the scientific status of clinical medicine have been discussed and found lacking in force. I have no doubt that there might be other objections. However, these would also, I believe, be found on examination to result from too restrictive definitions of “science,” unacceptable in their exclusion also of other recognized sciences, or from lack of familiarity with modern clinical medicine. (shrink)

Medicine, Power, and the Law demonstrates that criminal and civil justice interact with medicine and public health more than is presently understood. The book focuses on the role of healthcare practitioners and an array of other professionals across industries in identifying wrongdoers, reporting behavior, and testifying on behalf of the state or government agencies. It also covers circumstances in which law enforcement relies on medicine for evidence or support in ways that compromise medical ethics. By reporting (...) or testifying as experts, a range of people, from specialist pediatricians to flight attendants, can have a life-changing impact on individuals in the name of public health or medicine. People who work in hospitals, social work settings, and even airlines, often contribute to wrongful and aggressive criminal and civil actions against society's most vulnerable people, including parents, older adults, and people living with poverty. The book explores a number of examples, including police use of medicine as a restraint or the collection of blood as evidence and the risks of opting out of certain scientific discoveries, such as pharmaceuticals. It describes the harms that may come to those who engage in suboptimal but generally heretofore legal child-raising behaviors, and people opting to live independently as older adults. These can lead to civil and criminal charges when noticed by those in a position of power. Medicine, Power, and the Law is an important contribution for researchers and practitioners in medicine, the law, and the expanding field of bioethics. (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)

This article examines the implicit promises of fairness in evidence based medicine , namely to avoid discrimination through objective processes, and to distribute effective treatments fairly. The relationship between EBM and vulnerable groups is examined. Several aspects of EBM are explored: the way evidence is created , and the way evidence is applied in clinical care and health policy. This analysis suggests that EBM turns our attention away from social and cultural factors that influence health (...) and focuses on a narrow biomedical and individualistic model of health. Those with the greatest burden of ill health are left disenfranchised, as there is little research that is relevant to them, there is poor access to treatments, and attention is diverted away from activities that might have a much greater impact on their health. (shrink)

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood (...) left over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT. (shrink)

Several have argued that the aims of scientific research are not always independent of social and ethical values. Yet this is often assumed only to have implications for decisions about what is studied, or which research projects are funded, and not for methodological decisions or standards of evidence. Using the case of the recently developed HPV vaccines, we argue that the social aims of research can also play important roles in justifying decisions about (1) how research problems are (...) defined in drug development, (2) evidentiary standards used in testing drug “success”, and (3) clinical trial methodology. As a result, attending to the social aims at stake in particular research contexts will produce more rational methodological decisions as well as more socially relevant science. (shrink)

Several have argued that the aims of scientific research are not always independent of social and ethical values. Yet this is often assumed only to have implications for decisions about what is studied, or which research projects are funded, and not for methodological decisions or standards of evidence. Using the case of the recently developed HPV vaccines, we argue that the social aims of research can also play important roles in justifying decisions about (1) how research problems are (...) defined in drug development, (2) evidentiary standards used in testing drug “success”, and (3) clinical trial methodology. As a result, attending to the social aims at stake in particular research contexts will produce more rational methodological decisions as well as more socially relevant science. (shrink)

Evidence-based medicine (EBM) has long deemphasized mechanistic reasoning and pathophysiological rationale in assessing the effectiveness of interventions. The EBM+ movement has challenged this stance, arguing that evidence of mechanisms and comparative studies should both be seen as necessary and complementary. Advocates of EBM+ provide a combination of theoretical arguments and examples of mechanistic reasoning in medical research. However, EBM+ proponents have not provided recent examples of how downplaying mechanistic reasoning resulted in worse medical results than would have (...) occurred otherwise. Such examples are necessary to make the case that EBM+ responds to a problem in clinical practice that urgently demands a solution. In light of this, we examine the failed rollout of efavirenz as a first-line HIV treatment in Zimbabwe as evidence of the importance of mechanistic reasoning in improving clinical practice and public health policy decisions. We suggest that this case is analogous to examples commonly given to support EBM. (shrink)

Few empirical studies have explored how different types of knowledge are associated with diverse objectivities and moral economies. Here, we examine these associations through an empirical investigation of the public policy debate in Israel around medical cannabis, which may be termed a contested medicine because its therapeutic effects, while subjectively felt by users, are not generally recognized by the medical profession. Our findings indicate that beneath the MC debate lie deep-seated issues of epistemology, which are entwined with questions of (...) ethics and morality. Whereas some stakeholder groups viewed evidence-based medicine and mechanical objectivity as the only valid knowledge base, others called for recognition of a particular experience-based knowledge, championing regulatory, administrative, or strong objectivity. Stakeholders’ interpretations of what should be considered as ethical courses of action corresponded to their epistemological views, with most criticizing the regulators for relying on regulatory subjectivity instead of objectivity. Our in-depth mapping of this arena allowed us not only to shed light on the emergence of the new entity called “medical cannabis” but also to reexamine the link between epistemology, ethics, and action and to elucidate how heterogeneous groups view the validity and objectivity of knowledge and the interface between medicine, science, and policy. (shrink)

Over several decades, ethics and law have been applied to medical education and practice in a way that reflects the continuation during the twentieth century of the strong distinction between facts and values. We explain the development of applied ethics and applied medical law and report selected results that reflect this applied model from an empirical project examining doctors’ decisions on withdrawing/withholding treatment from patients who lack decision-making capacity. The model is critiqued, and an alternative “constitutive” model is supported on (...) the basis that medicine, medical law, and medical ethics exemplify the inevitable entanglement of facts and values. The model requires that ethics and law be taught across the medical education curriculum and integrated with the basic and clinical sciences and that they be perceived as an integral component of medical evidence and practice. Law, in particular, would rank as equal in normative authority to the relevant clinical scientific “facts” of the case, with graduating doctors having as strong a basic command of each category as the other. The normalization of legal knowledge as part of the clinician’s evidence base to be utilized in practice may provide adequate consolation for clinicians who may initially resent further perceived incursions on their traditional independence and discretion. (shrink)

Medicine is moving away from reliance on the proclamations of authorities to the use of numerical methods to estimate the size of effects of its interventions. But a rumbling note of uneasiness underlines present-day medical progress: the more we know, The more questions we encounter about what to do with the hard-won information. The essays in Where's the Evidence examine the dilemmas that have arisen as the result of medicine's unprecedented increase in technical powers. How do doctors (...) draw the line between "knowing" (the acquisition of new medical information) and doing" (the application of that new knowledge)? What are the long-term consequences of responding to the demand that physicians always do everything that can be done? Is medicine's primary aim to increase the length of life? Or is it to reduce the amount of pain and suffering? And who is empowered to choose when these ends are mutually exclusive? This engaging collection of essays will be of interest to professionals interested in the evidence-based medicine debate, including epidemiologists, neonatologists, those involved in clinical trials and health policy, medical ethicists, medical students, and trainees. (shrink)

This is a response to a short communication on our research presented in Solbrække et al. :89–103, 2017), which raises a series of serious allegations. Our article explored the rise of ‘the breast cancer gene’ as a field of medical, cultural and personal knowledge. We used the concept biological citizenship to elucidate representations of, and experiences with, hereditary breast cancer in a Norwegian context, addressing a research deficit. In our response to Møller and Hovig’s :239–242, 2018a) opinionated piece, we start (...) by questioning on which scientific grounds they base their knowledge claims and situate their criticism in a pre-determined positivist script, which exposes their incompetency when it comes to establishing a useful critique of our research. We tie this to an attitude of scientific supremacy, which reduces the complexity and specificity of different knowledges into a clichéd divide between ‘hard evidence’ and ‘fiction’—presented in a predictable narrative which seeks to establish research protagonists and antagonists. We elaborate on the rationale of our qualitative approach to analyzing and interpreting situated and mediated aspects of BRCA 1/2. We counter claims that our research does harm to patients. We refer to a medical scandal emerging from Norway where 21 women were wrongfully diagnosed and surgically treated for a mis-interpreted cancer gene mutation. In conclusion, we stand by the integrity of our research as reported in the original paper. Scientific supremacy and pre-scripted criticism impose considerable obstacles for the possibility of establishing interdisciplinary dialogue across knowledge paradigms in health care and medicine. We therefore urge readers to reflect on how we can establish and sustain ethically careful and truthful dialogue—without doing violence to epistemological differences—to protect and advance the interdisciplinarity that constitutes the journal’s scope. (shrink)

One of Ludwik Fleck’s ideas about the development of scientific knowledge is that—once a system of interpretation is in place—the process that follows can be characterised as one of inertia: any new evidence comes under a strong pressure to be incorporated into the established frame. This can result in what Fleck called a harmony of illusions when contradictory evidence becomes almost invisible or is incorporated into the established frame only by huge efforts.The paper analyses early explanations of (...) the tuberculin reaction as a case study of Fleck’s argument. For Robert Koch, who had presented tuberculin in 1890, the compound was supposed to be a diagnostic tool and a cure for tuberculosis. His conception of its effect was rather peculiar, but strictly in line with ideas on the pathogenesis of infectious diseases he had developed much earlier. After tuberculin was released in late 1890, whether Koch’s conception was convincing depended on the place that a given observer had in the medical world in late-nineteenth-century Germany. Inside Koch’s group, the status of the tuberculin reaction remained stable and tuberculin retained its value as a diagnostic and curative tool. On the other hand, observers from outside that thought collective, and in particular from clinical medicine, soon pointed to flaws in its conception. These critics developed a rather different picture of tuberculin as a mysterious and dangerous drug. No reconciliation followed and what we find instead in German medicine around the year 1900 is the presence of rather contradictory concepts and practices surrounding Koch’s wonder cure. (shrink)

ObjectiveTo assess the scientific and ethical basis for clinical innovation in psychopharmacology.MethodsWe conducted a literature review, utilizing MEDLINE search and bibliographic cross-referencing, and historical evidence regarding the discovery and development of new medications in psychiatry. Clinical innovation was defined as use of treatments in a clinical setting which have not been well-proven in a research setting.ResultsEmpirical data regarding the impact of clinical innovation in psychopharmacology are lacking. A conceptual and historical assessment of this topic (...) highlights the ethical and scientific importance of clinical innovation. Ethically, it touches a borderline that, in our judgment, is not adequately framed in contemporary mainstream bioethics. Currently, research is viewed as not at all benefiting the patients who participate in it, while clinical care is viewed as being solely for the benefit of patients. Clinical innovation straddles these two worlds, uncomfortably at times. While many argue that clinical innovation should either be avoided or folded into research projects, we argue that clinical innovation is necessary for progress in psychopharmacology research, and that it can prosper best when guided by the following ethical principles: 1.) The treatment should be based on a viable hypothesis. 2.) Whenever possible, one's clinical observations should be reported so they can be evaluated by the scientific community. 3.) One should be willing to report unexpected observations of drug effects. 4.) A high standard of informed consent should be maintained. Again, this proposal goes against the standard view among bioethicists that research and clinical care are categorically opposed activities, as made clear by the either-or dichotomy of the Belmont Report on bioethics. This approach has so polarized our profession into clinicians versus researchers, that many clinicians will not apply new knowledge produced by clinical research until it eventually gets incorporated into formal treatment guidelines, while researchers have little to guide them as to what kind of new knowledge it is most important to provide.SummaryClinical innovation brings out the ambiguities in our current ethical conceptions of research versus clinical care. Yet, historically, clinical innovation has been an important contributor to progress in psychopharmacology. We argue that clinical innovation should not be discouraged, but rather it should occur under certain ethical conditions."Almost everyone can and should do research...because almost everyone has a unique observational opportunity at some time in his life which he has an obligation to record....If one considers the fundamental operations or methods of research, one immediately realizes that most people do research at some time or another, except that they do not call their activity by that name. There are seven operations....In simple language they are counting, sorting, measuring, comparing, nature-study, guess testing, and reappraisal....Guess testing is of course what most people think of when the word research is mentioned; except that it is bad manners to call a guess a guess. It should be called an hypothesis. Let us make one plea. Guessing becomes merely a game unless it is done in the context of a plan for action. It is a waste of time elaborating untestable hypotheses [1]."John Cade. (shrink)

Many physicians assert that new cost-control mechanisms inappropriately interfere with clinical decision-making. They claim that high costs arise from poorly practiced medicine, and argue that effective utilization of resources is best promoted by advancing the scientific and ethical ideals of medicine. However, the claim is not warranted by empirical evidence. In this essay, I show how it rests upon aesthetic considerations associated with diagnostic elegance. I first consider scientific rationality generally. After a review of (...) analytical empiricist and socio-historical approaches in the philosophy of science, a form of Kant's aesthetic is used to explain how scientific discovery and justification are linked, and to show how meta-theoretical considerations associated with the goals and method of science work together with exemplars of practice. This analysis enables us to understand how the ideals of medicine as a science guide the initial patient history and physical exam in such a way that a parsimonious use of tests is indicated. Aesthetic considerations unite the basic scientific and ethical commitments of the modern medical paradigm and are central for rightly understanding clinical judgment. (shrink)

The question what scientific progress means for a particular domain such as medicine seems importantly different from the question what scientific progress is in general. While the latter question received ample treatment in the philosophical literature, the former question is hardly discussed. I argue that it is nonetheless important to think about this question in view of the methodological choices we make. I raise specific questions that should be tackled regarding scientific progress in the medical sciences (...) and demonstrate their importance by means of an analysis of what evidence-based medicine (EBM) has, and has not, to offer in terms of progress. I show how critically thinking about EBM from the point of view of progress can help us in putting EBM and its favoured methodologies in the right perspective. My conclusion will be that blindly favouring certain methods because of their immediately tangible short-term benefits implies that we parry the important question of how best to advance progress in the long run. This leads us to losing sight of our general goals in doing research in the medical sciences. (shrink)

Uncertainty is the name of the game in philosopher Kenneth W Goodman’s attempt to apply ethics to evidence based medicine . Indeed, the book is as much about epistemology, or the study of how we learn and know about the world, as it is about ethics. Goodman’s desire is to understand what constitutes proof, or evidence, that a particular treatment is better than others. One of the ethical connections is that a failure to use such treatments is (...) blameworthy.EBM is a concept that is getting a great deal of attention these days. At least two factors drive this …. (shrink)

Proponents of evidence-based medicine (EBM) provide the “hierarchy of evidence” as a criterion for judging the reliability of therapeutic decisions. EBM's hierarchy places randomized interventional studies (and systematic reviews of such studies) higher in the hierarchy than observational studies, unsystematic clinical experience, and basic science. Recent philosophical work has questioned whether EBM's special emphasis on evidence from randomized interventional studies can be justified. Following the critical literature, and in particular the work of John Worrall, I (...) agree that many of the arguments put forward by advocates of EBM do not justify the ambitious claims that are often made on behalf of randomization. However, in contrast to the recent philosophical work, I argue that a justification for EBM's hierarchy of evidence can be provided. The hierarchy should be viewed as a hierarchy of comparative internal validity. Although this justification is defensible, the claims that EBM's hierarchy substantiates when viewed in this way are considerably more circumscribed than some claims found in the EBM literature. (shrink)

The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. At the conditions of pandemic, the success of health care system depends significantly on the regular implementation of effective research tools and population monitoring. The earlier the risks of (...) disease can be identified, the more effective process of preventive measures or treatments can be. This publication is about the creation of a prototype for such a tool within the project «Development of methods, algorithms and intelligent analytical system for processing and analysis of heterogeneous clinical and biomedical data to improve the diagnosis of complex diseases», implementted by the V.M. Glushkov Institute of Cybernetics, National Academy of Sciences of Ukraine, together with the United Institute of Informatics Problems, National Academy of Sciences of Belarus. The insurers, entering the market, can insure mostly low risks by facilitating more frequent changes of insurers by consumers and mixing the overall health insurance market. Socio-demographic variables can be risk adjusters. Since age and gender have a relatively small explanatory power, other socio-demographic variables were studied – marital status, retirement status, disability status, educational level, income level. Because insurers have an interest in beneficial diagnoses for their policyholders, they are also interested in the ability to interpret relevant information – upcoding: insurers can encourage their policyholders to consult with doctors more often to select as many diagnoses as possible. Many countries and health care systems use diagnostic information to determine the reimbursement to a service provider, revealing the necessary data. For processing and analysis of these data, software implementations of construction for classifiers, allocation of informative features, processing of heterogeneous medical and biological variables for carrying out scientific research in the field of clinical medicine are developed. The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. Particularly, attention is paid to containerization of biomedical applications, this permits to get reproducibility of the conditions in which the calculations took place, technologies of software pipelining of calculations, that allows to organize flow calculations, and technologies for parameterization of software environment, that allows to reproduce, if necessary, an identical computing environment. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. The experience of using the developed linear classifier, gained during its testing on artificial and real data, allows us to conclude about several advantages provided by the containerized form of the created application: it permits to provide access to real data located in cloud environment; it is possible to perform calculations to solve research problems on cloud resources both with the help of developed tools and with the help of cloud services; such a form of research organization makes numerical experiments reproducible, i.e. any other researcher can compare the results of their developments on specific data that have already been studied by others, in order to verify the conclusions and technical feasibility of new results; there exists a universal opportunity to use the developed tools on technical devices of various classes from a personal computer to powerful cluster. (shrink)

The vast majority of contributions to the literature on spirituality in nursing make extravagant claims about transcendence, eternity, the numinous, higher powers, higher levels of existence, invisible forces, cosmic unity, the essence of humanity, or other supernatural concepts. Typically, these assertions are made without the support of argument or evidence; and, as a consequence, alternative ways of theorizing ‘spirituality’ have been closed off, while the lack of consistent scholarship has turned the topic into a metaphysical backwater. In this paper, (...) I adopt a different premise, rejecting unsupported claims, and surveying the ‘spirituality’ terrain from a naturalistic and reductionist perspective. I argue that, if we rid ourselves of non‐naturalistic assumptions, we will discover theoretical and clinical resources in health psychology, social psychology, neuropsychology, and pharmacopsychology – resources which confirm that it is possible to conceptualize the study of existential concerns, and how health professionals might respond to them, in a properly scientific manner. In order to illustrate the potential usefulness of these resources, I will take palliative care as an example. (shrink)

Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic review (...) of the critical literature. It finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context. (shrink)

POHLMAN S, CIBULKA NJ, PALMER JL, LORENZ RA and SMITHBATTLE L. Nursing Inquiry 2013; 20: 71–81 The placebo puzzle: examining the discordant space between biomedical science and illness/healingThe placebo response presents an enigma to biomedical science: how can ‘inert’ or ‘sham’ procedures reduce symptoms and produce physiological changes that are comparable to prescribed treatments? In this study, we examine this puzzle by explicating the discordant space between the prevailing biomedical paradigm, which focuses on a technical understanding of diagnosis and treatment, (...) and a broader understanding of illness and healing as relational and embodied. Although biomedical achievements are impressive, the knowledge resulting from this paradigm is limited by its ontological and epistemological assumptions. When the body and world are objectified, illness meanings, therapeutic relationships, and healing practices are dismissed or distorted. In spite of a robust critique of the tenets of biomedicine for guiding practice, the biomedical paradigm retains a tenacious hold on evidence-based medicine and nursing, downplaying our clinical understanding of the sentient body, patients’ life-worlds, and illness and healing. In reality, skilled nurses rely on multiple forms of knowledge in providing high-quality care to particular patients. Clinically wise nurses integrate their experience and knowledge of patients’ priorities, fears, and illness trajectories along with biomedical findings to make astute judgments and promote health and healing. (shrink)

Neonatal extracorporeal membrane oxygenation (ECMO), a technology for the treatment of respiratory failure in newborns, is used as a case study to examine statistical and ethical aspects of clinical trials and to illustrate a proposed 'ethics of evidence', an approach to medical uncertainty within the context of contemporary biomedical ethics. Discussion includes the twofold aim of the ethics of evidence: to clarify the role of uncertainty and scientific evidence in medical decision-making, and to call attention (...) to the need to confront the irreducible nature of uncertainty. (shrink)

Inference to the Best Explanation is usually employed in the Scientific Realism debates. As far as particular scientific theories are concerned, its most ready usage seems to be that of a theory of confirmation. There are however more uses of IBE, namely as an epistemological theory of testimony and as a means of categorising and justifying the sources of evidence. In this paper, I will present, develop and exemplify IBE as a theory of the quality of (...) class='Hi'>evidence - taking examples from medicine and showing that IBE can thereby provide the epistemological underpinning and justify the criteria of grading quality of mechanistic evidence that have been recently provided in the Clarke et al. paper on how evidence of medical mechanisms is to be construed alongside population studies. (shrink)

The paper explores the relation between reason and action as it emerges from the texts of Āyurveda. Life or Ayus (commonly understood as life-span) is primary subject matter of Ayurveda. Life is a locus of experience, action and disposition. Experiences and actions are differentially determined by dispositions that characterize the organism; otherwise all living organisms will be identical. Ayus of each living being is uniquely individual and remains constant between birth and death. In this journey, upkeep of ayus is the (...) purpose of Āyurveda or science of life. Ayurveda is a science of experienced matter as well as of experienced body. The living body is critically dependent on the influx of matter for its upkeep. Āyurveda offers a conceptual system to reason about balance and imbalances of the system and the causal role of the material flux through the system. This sensate matter is causally open and makes room for definite causal role for the individual and the effective insertion of the felt-purpose of action. Some of the strengths of Ayurveda are brought forth in the paper such as (a) reasoning out the compatibility between the bodily processes and the selection of the natural products for diet and drug, (b) role for heuristics in medical diagnosis, which takes into cognizance the particularity of each living body and the teleology evident in the very act of diagnostic reasoning. The paper shows that Āyurvedic theory is built on experiential datum whereas scientific medical theory is built on experience-independent datum. Āyurveda explores causal efficacy of ‘secondary qualities’ whereas scientific medicine explores causal efficacy of ‘primary qualities’. The actionable experiential reasoning is at the foundations of Āyurveda whereas modern medical science is ab initio saddled with difficult ‘hiatus theoreticus’ between theory and practice. For Ayurveda it is experience of qualities that discloses behavior of matter. The types of qualities that appear in experience have a special significance for theorizing about the actions of matter with the help of qualities. The paper explores the relation between experience of qualities and the method of science. It shows how efficacy of medical practice is based on the foundational stance of experiential realism in theory. To bring the point home, the paper borrows Aristotalian concepts to show how the relation between phantasm and phronesis is honored in the very theory of Āyurveda. (shrink)

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

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)

As support for clinical ethics committees in the UK grows, care must be taken to define their function, membership and method of working and the status of their decisions.The modern practice of medicine raises a plethora of complex issues—medical, ethical and legal. Doctors and other healthcare professionals increasingly must try to resolve these and may sometimes have to do so in the face of contrary opinion expressed by patients and/or their surrogates. While clearly qualified in the medical arena, (...) and although there is now more ethics teaching in the medical curriculum, healthcare professionals are seldom qualified to adjudicate on ethical or legal matters, or even, perhaps, to recognise them when they arise. Yet, as Doyal says, “clinical life must go on and moral and legal indeterminacy within medicine cries out for practical resolution.”1 Meanwhile, the expectations of patients and their families—and, indeed, of wider society—are that decisions about patient care, resources and therapeutic regimes should be soundly based on appropriate ethicolegal, as well as scientific, principle.Recognition of these additional burdens on healthcare professionals has generated some interest in the provision of ethics consultation. In the USA this has been undertaken by a variety of tribunals and individuals. Hospital ethics committees and ethics consultants feature in many US hospitals and perform a variety of roles. In Europe, a number of countries have also established clinical ethics committees and they are becoming more common in the UK—primarily in England and Wales for the moment. Whereas, however, “[i]n North America, CECs have … become an integral part of the organisational infrastructure of hospitals ...”,1 in the United Kingdom they remain essentially ad hoc bodies, generated for a variety of reasons and with different goals, structures, membership, methods of working and functions. The initial impetus for the …. (shrink)

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