Is Translational Science and Medicine new? Its dramatic expansion has spelled a dizzying array of new disciplines, departments, buildings, and terminology. Yet, without novel theories or concepts, Translational Science and Medicine may appear to be nothing more than an old concept with a new brand. Yet, is this view true? As is illustrated herein, histories of TSM which treat it as merely an old product under a new name misunderstand its essential architecture. As an expressly economic (...) transformation, modern translational approaches are differentiated precisely by a set of semi-permanent architectures which render it an altogether different kind of object when compared to previous attempts by institutions to turn science into medicine. Powered by new software, embedded within campuses that now house companies, and with legal agreements that outline agreed-upon scientific activity, TSM is now powered by a set of robust and durable structures that differentiate it from previous approaches. Based on ethnographic research about translational neuroscience in North America, this paper suggests that the sense of TSM as not being new is a consequence of analytic modes that tend to see scientific enterprises in epistemic terms alone. Analyzing TSM as primarily a scientific object misses the fact that it is a principally a financial one. (shrink)

The above-mentioned article has been published online on 7 November 2019 as part of topical collection ‘_Before Translational Medicine: Laboratory Clinic Relations_’.

The reigning paradigm of rational drug discovery in translational medicine attempts to exploit biological theories and pathophysiological explanations to identify novel drug targets and therapeutic strategies. Given that there are limited human and material resources available for testing experimental therapeutics, this theory- and explanation-driven strategy of drug development seems to make good sense: it narrows the number of plausible drug candidates to be put through rigorous and expensive testing; it potentially improves the success rate of clinical translation; and (...) it provides some epistemological basis to extrapolate evidence from one domain to another and potentially minimize risks to patient-subjects.Yet... (shrink)

Cortisone, initially known as ‘compound E’ was the medical sensation of the late 1940s and early 1950s. As early as April 1949, only a week after Philip Hench and colleagues first described the potential of ‘compound E’ at a Mayo Clinic seminar, the New York Times reported the drug’s promise as a ‘modern miracle’ in the treatment of rheumatoid arthritis. Given its high profile, it is unsurprising that historians of medicine have been attracted to study the innovation of cortisone. (...) It arrived at the end of a decade of ‘therapeutic revolutions’, kicked off by penicillin transforming the treatment of bacterial infections and ending with hopes of a revolution in the treatment of non-infectious, chronic inflammatory diseases. Despite these studies of cortisone’s introduction, few historians have taken the story forward and considered how cortisone was adopted and adapted into clinical practice. This article tells the longer of how the drug and its derivatives were taken from research laboratories and integrated into clinical practice; what has in recent decades become known as translational medicine. In exploring cortisone’s first decade in Britain, we focus specifically on its role in the treatment of RA. Our approach is always to consider cortisone’s use in the context of other treatments available to clinicians, and at local and national institutional settings. We do not discuss the many other therapeutic uses of cortisone, which ranged for topical applications for skin diseases to the management of cancers, especially childhood leukaemia, nor do we discuss its close analogue ACTH—AdenoCorticoTropic Hormone. We think there are lessons in our study for TM policies today. (shrink)

This article explores the development of a novel biomedical research organism, and its potential to remake the species and spaces of translational medicine. The humanized mouse is a complex experimental object in which mice, rendered immunodeficient through genetic alteration, are engrafted with human stem cells in the hope of reconstituting a human immune system for biomedical research and drug testing. These chimeric organisms have yet to garner the same commentary from social scientists as other human–animal hybrid forms. Yet, (...) they are rapidly being positioned as central to translational medicine in immunological research and pharmaceutical development. This article explores the complex relations between species and spaces they seek to enact. Humanizing mice simultaneously moves these animal forms towards the intimate geographies of corporeal equivalence with humans and the expansive geographies of translational research. These multiple trajectories are achieved by the way humanized mice function as both uncertain ‘epistemic things’ and as expansive ‘collaborative things’, articulating mouse genetics with other research, notably stem cell science. In the context of post-genomics, their indeterminacy is critical to their collaborative value; their expansive potential follows as much from their biological openness as from specific expectations. Yet, these new research organisms have both accumulative and disruptive capacities, for there are patterns of interference between these trajectories, remaking boundaries between experimental practices and clinical contexts. (shrink)

This article discusses some aspects of the practice of complementary and traditional medicine in urban Mexico through a transcultural paradigm, hence it focuses on how medical knowledge(s) are commodified as well as how a `travelling' medical knowledge acquires agency in a transculturation process. This study, while analysing different practices of Chinese and Japanese medicine, argues that oriental medicine is translated in at least two ways - a popular and a cosmopolitan form - that shape particular expressions of (...) citizenship. The popular form is carried out in low-income neighbourhoods and it focuses around a `Mexicanization' of oriental medicine and the reaffirmation of the popular as part of the national. Cosmopolitan medicine, on the other hand, is particularly practised in exclusive health spas and seeks to purge the popular out of the national and to incorporate `traditional' medicine as one of the multiple components of cosmopolitan consumption. The article argues that both popular and cosmopolitan expressions are important to understanding how complementary and oriental medicine have become not only part of a global market, but also part of a particular history of national and popular medical systems. (shrink)

The concept of “translational bioethics” has received considerable attention in recent years. Most publications draw an analogy to translational medicine and describe bioethical research that aims at implementing and evaluating ethical interventions. However, current accounts of translational bioethics are often rather vague and seem to differ with regard to conceptual and methodological assumptions. It is not clear and scarcely analyzed what exactly “translation” in the field of bioethics means, in particular regarding goals and processes so that (...) it is justified to appeal to translational medicine. In this article, we thus explore possible analogies and disanalogies between translational medicine and translational bioethics to establish whether the often occurring reference to concepts of translational medicine in the field of bioethics can be justified by substantial analogies. We will first provide an account of different models of translational medicine. In a second step, we will propose an analytic definition that explicitly articulates the essential characteristics of “translational research” irrespective of the research field (i.e., biomedicine, bioethics). Subsequently, we will explore whether and in how far general characteristics and phases of translational research in medicine can be applied to translational research in bioethics. Based on our analyses, we will come to the skeptical conclusion that at present there are considerable conceptual disanalogies and unsolved conceptual problems that disallow using “translational bioethics” in a meaningful analogy to respective accounts in biomedicine. Nevertheless, we will demonstrate that some insights gained by the conceptual accounts of translational medicine can contribute to advance current research activities in bioethics. (shrink)

Herophilus, a contemporary of Euclid, practiced medicine in Alexandria in the third century B.C., and seems to have been the first Western scientist to dissect the human body. He made especially impressive contributions to many branches of anatomy and also developed influential views on many other aspects of medicine. Von Staden assembles the fragmentary evidence concerning one of the more important scientists of ancient Greece. Part 1 of the book presents the Greek and Latin texts accompanied by English (...) translation and interpretative commentary. Significant background information is given in the introductory essay preceding each chapter. Part 2 briefly sketches the major developments within the Herophilean school after Herophilus, and discusses the individual members within it. Anyone interested in the history of science, the history of medicine, or intellectual history will find this book a rich source of information about an unusual and important aspect of Greek culture. (shrink)

Next SectionIn a series of previous articles, we have considered how we might reconceptualise central themes in medicine and medical education through ‘thinking with Homer’. This has involved using textual approaches, scenes and characters from the Iliad and Odyssey for rethinking what is a ‘communication skill’, and what do we mean by ‘empathy’ in medical practice; in what sense is medical practice formulaic, like a Homeric ‘song’; and what is lyrical about medical practice. Our approach is not to historicise (...) medicine and medical education, but to use thinking with Homer as a medium and metaphor for questioning the habitual and the taken-for-granted in contemporary practice. In this article, we tackle the complex theme of ‘translation’. We use the lens of translation studies to examine the process of turning the patient's story into medical language. We address the questions: what makes a ‘good’ translation? What are the consequences of mistranslation and poor translation? And, while things are inevitably lost in translation, does this matter? (shrink)

Despite considerable scientific progress and the evolution of regulatory pathways to ensure safety and efficacy, US healthcare continues to see increasing health disparities. This suggests that clinical translation in of itself cannot be the only measure of its own success, especially when the most marginalized patients, are neglected in the development and implementation of medical innovations. This raises the question of whether a system that is narrowly focused on technical achievement can meet the moral obligations of medicine and public (...) health. We argue that traditional technocratic standards are failing to integrate normative considerations into biomedical translation. What is needed is a translational domain that moves beyond safety and efficacy toward anticipating how proposed technologies will be effective in society as it exists. We propose an additional metric of success: translational justice. (shrink)

Genomic medicine has the potential to contribute to the development of an array of novel technologies within the clinical armoury, making possible early detection and management of high-risk conditions such as cancer. While significant impact has already been felt in the context of rare inherited single gene disorders, much of the advancement in patient care through genomic medicine more broadly is going to be made possible by research involving large data sets that enable analyses of multiple genetic variants (...) that contribute to risk of common diseases. 1 As well as informing diagnosis and treatment of these diseases, these advances will support prediction and prevention. Considering risk prediction, combining data from multiple variants can produce a polygenic (or integrated) score (PGS/IGS). This will provide more accurate prediction than simply relying on environmental risk factors. While still in their early stages of development and implementation, it is clear that translation... (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)

Translational research in medicine requires researchers to identify the steps to transfer basic scientific discoveries from laboratory benches to bedside decision-making, and eventually into clinical practice. On a parallel track, philosophical work in ethics has not been obliged to identify the steps to translate theoretical conclusions into adequate practice. The medical ethicist A. Cribb suggested some years ago that it is now time to debate ‘the business of translational’ in medical ethics. Despite the very interesting and useful (...) perspective on the field of medical ethics launched by Cribb, the debate is still missing. In this paper, I take up Cribb’s invitation and discuss further analytic distinctions needed to base an ethics aiming to translate between theory and practice. (shrink)

RésuméTechnê iatrikêde Galien a été traduit en hébreu trois fois. Deux fois dans le midi, autour de l'an 1199: d'abord, à partir de la version latine de Constantine l'Africain, par un médecin anonyme qui utilisait le pseudonyme “Doeg l’Édomite”; et une seconde fois de l'arabe, par Samuel Ibn Tibbon à Béziers, laVorlageétant maintenant la version arabe de Ḥunayn Ibn Isḥāq (al-Ṣināʿa al-ṣaġīra), accompagnée par le commentaire de ʿAlī Ibn Riḍwān. (La paternité de Samuel Ibn Tibbon de cette traduction a été (...) contestée, mais elle est établie dans l'article de Gad Freudenthal dans ce numéro d’ASP.) Une troisième traduction, encore une fois du latin et comprenant le commentaire d'Ibn Riḍwān, a été réalisée par Hillel ben Samuel à Rome à la fin du XIIIesiècle, mais elle n'entre pas dans notre sujet.Nous présentons leTegniet décrivons son histoire. Puis nous posons la question pourquoi cet ouvrage a été traduit en hébreu deux fois exactement au même moment et dans la même région. Nous montrons que les deux traducteurs ont répondu à un besoin des médecins juifs lisant seulement l'hébreu. Doeg réalise sa traduction dans le cadre de son vaste projet de mise à disposition en traduction hébraïque de la plus grande partie du corpus de l’école de Salerne. Samuel Ibn Tibbon, pour sa part, a traduit leTegniavec le commentaire d'Ibn Riḍwān parce que, après avoir été médecin, il évoluait graduellement vers la vocation d'un traducteur de l'arabe en hébreu d’œuvres philosophiques et ce texte médico-philosophique était en adéquation avec cette évolution d'un médecin avec des intérêts philosophiques vers un scientifique-philosophe. (shrink)

While many "benchtop-to-bedside" research pathways have been developed in "Type I" translational medicine, vehicles to facilitate "Type II" and "Type III" translation that convert scientific data into clinical and community interventions designed to improve the health of human populations remain elusive. Further, while a high percentage of physicians endorse the principle of citizen leadership, many have difficulty practicing it. This discrepancy has been attributed, in part, to lack of training and preparation for public advocacy, time limitation, and institutional (...) resistance. As translational medicine and physician-citizenship implicate social, political, economic and cultural factors, both enterprises require "integrative" research strategies that blend insights from multiple fields of study, as well as rhetorical acumen in adapting messages to reach multiple audiences. This article considers how argumentation theory's epistemological flexibility, audience attentiveness, and heuristic qualities, combined with concepts from classical rhetoric, such as rhetorical invention, the synecdoche, and ethos, yield tools to facilitate translational medicine and enable physician-citizenship. (shrink)

Evaluation of a volume of English renderings of Akkadian-language texts con- cerning treatment of illness in ancient Assyria and Babylonia.

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 article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is historical. The (...) development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements. (shrink)

In 2018-2019, at the Keck School of Medicine of the University of Southern California, we developed and piloted a narrative-based health systems science intervention for patients living with HIV and medical students in which medical students co-wrote patients’ life narratives for inclusion in the electronic health record. The pilot study aimed to assess the acceptability of the “life narrative protocol” from multiple stakeholder positions and characterize participants’ experiences of the clinical and pedagogical implications of the LNP. Students were recruited (...) from KSOM. Patients and staff were recruited from the Maternal, Child, and Adolescent/Adult Center for Infectious Disease and Virology at Los Angeles County+USC Medical Center. Ten patients, seventeen students, and ten MCA staff participated in the pilot study. Qualitative methods were used to gather data from students’, patients’, and staff’s perspectives. Three themes emerged from the thematic analysis: patients’ life narratives conveyed their unique life experiences and voices; the protocol could result in wide-ranging effects on HIV care; the LNP enabled students to contribute value to patients’ healthcare. Across groups, participants considered the LNP an acceptable intervention. The LNP, its limitations, and implications for HIV care, narrative medicine, and health information technology are presented. (shrink)

Translational research is now a critically important current in academic medicine. Researchers in all health-related fields are being encouraged not only to demonstrate the potential benefits of their research but also to help identify the steps through which their research might be ‘made practical’. This paper considers the prospects of a corresponding movement of ‘translational ethics’. Some of the advantages and disadvantages of focusing upon the translation of ethical scholarship are reviewed. While emphasising the difficulties of crossing (...) the gap between scholarship and practice, the paper concludes that a debate about the business of translation would be useful for medical ethics. (shrink)

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a (...) wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. (shrink)

We suggest that in the particular context of medical education, ethics can be considered in a similar way to other kinds of knowledge that are categorised and shaped by academics in the context of wider society. Moreover, the study of medical ethics education is translational in a manner loosely analogous to the study of medical education as adjunct to translational medicine. Some have suggested there is merit in the idea that much as translational research attempts to (...) connect the laboratory scientist's work to its implications for patient care, translational ethics focuses on bringing ethics scholarship into the sphere of personal and public action. We distinguish the term ‘translational ethics’ (the study of ethics being translated between academy, classroom and clinic) from other prominent definitions in the bioethics literature. To do this, we build off a notion of knowledge translation that focuses on the nonlinear movement of information that comes to professionals through multiple competing sources. We suggest that this knowledge, and particularly knowledge about ethics, becomes embodied by the individual. It is through a reflective practice that internally embedded ethics knowledge might be modified, and this work might be best carried out with a moral community that maintains a sense of practical wisdom. Applying this translational approach to the study of medical ethics education can be both academically relevant and practically useful. This view of translation can help bridge the evident, multidirectional relationships between research, education and performance. It might also create further opportunities to develop medical ethics education theory. (shrink)

Translational research is a main focus of current health policy (Albani and Prakken 2009; PLoS Medicine 2008). Translation of biomedical research knowledge to effective clinical treatment is essential to the public good (Lavis et al. 2003). Only 5% of basic science studies showing significant therapeutic promise are successfully translated into clinical application (Contopoulos-Ioannidis, Ntzani, and Ionannidis 2003; FDA 2004). As Hall (2001) observes, this is a problem: "When too many important discoveries lie dormant, the public good suffers" (p. (...) G1127). Recent health policy initiatives intended to foster the translation of basic science into clinical advances must consider the unique bioethical issues raised by .. (shrink)

The label ‘Translational Research’ (TR) has become ever more popular in the biomedical domain in recent years. It is usually presented as an attempt to bridge a supposed gap between knowledge produced at the lab bench and its use at the clinical bedside. This is claimed to help society harvest the benefits of its investments in scientific research. The rhetorical as well as moral force of the label TR obscure, however, that it is actually used in very different ways. (...) In this paper, we analyse the scientific discourse on TR, with the aim to disentangle and critically evaluate the different meanings of the label. We start with a brief reconstruction of the history of the concept. Subsequently, we unravel how the label is actually used in a sample of scientific publications on TR and examine the presuppositions implied by different views of TR. We argue that it is useful to distinguish different views of TR on the basis of three dimensions, related to (1) the construction of the ‘translational gap’; (2) the model of the translational process; and (3) the cause of the perceived translational gap. We conclude that the motive to make society benefit from its investments in biomedical science may be laudable, but that it is doubtful whether the dominant views of TR will contribute to this end. (shrink)

A Literary History of Medicine: The ʿUyūn al-anbāʾ fī ṭabaqāt al-aṭibbāʾ of Ibn Abī Uṣaybiʿah. Edited and translated by Emilie Savage-Smith, Simon Swain, and Geert Jan van Gelder. Handbuch für Orientalistik, 1: The Near and Middle East, vol. 134. 5 vols. Leiden: Brill, 2020. $865. Open access: https://scholarlyeditions.brill.com/lhom/.

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

Disproportional morbidity and mortality experienced by ethnic minorities in the UK have been highlighted by the COVID-19 pandemic. The ‘Black Lives Matter’ movement has exposed structural racism’s contribution to these health inequities. ‘Cultural Safety’, an antiracist, decolonising and educational innovation originating in New Zealand, has been adopted in Australia. Cultural Safety aims to dismantle barriers faced by colonised Indigenous peoples in mainstream healthcare by addressing systemic racism.This paper explores what it means to be ‘culturally safe’. The ways in which New (...) Zealand and Australia are incorporating Cultural Safety into educating healthcare professionals and in day-to-day practice in medicine are highlighted. We consider the ‘nuts and bolts’ of translating Cultural Safety into the UK to reduce racism within healthcare. Listening to the voices of black, Asian and minority ethnic National Health Service (NHS) consumers, education in reflexivity, both personal and organisational within the NHS are key. By listening to Indigenous colonised peoples, the ex-Empire may find solutions to health inequity. A decolonising feedback loop is required; however, we should take care not to culturally appropriate this valuable reverse innovation. (shrink)

It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, analyze, and manage a range of ethical issues. While there is a small but growing literature that addresses the ethics of translational research, there is a dearth of scholarship regarding how this might apply to engineers. In this paper we examine engineers as key translators and argue that they are well positioned to ask transformative ethical questions. Asking (...) engineers to both broaden and deepen their consideration of ethics in their work, however, requires a shift in the way ethics is often portrayed and perceived in science and engineering communities. Rather than interpreting ethics as a roadblock to the success of translational research, we suggest that engineers should be encouraged to ask questions about the socio-ethical dimensions of their work. This requires expanding the conceptual framework of engineering beyond its traditional focus on “how” and “what” questions to also include “why” and “who” questions to facilitate the gathering of normative, socially-situated information. Empowering engineers to ask “why” and “who” questions should spur the development of technologies and practices that contribute to improving health outcomes. (shrink)

In this paper, we describe the spiritual and kinship alliances between heads of an urban Santo Daime church from Rio de Janeiro and some leaders of the Yawanawá people from the Amazonian region. We suggest that these alliances involve exchanges and dialogical relationships that hold different meanings for the diverse social actors that take part in them. Further, we argue that equivocation and functional misunderstandings have an important role in these multidirectional dialogues. Based on this case study, we approach the (...) Yawanawá strategies for capturing otherness, and the insertion of the daimistas in the indigenous sociality networks. We focus especially on the Yawanawá mode of producing kin by capturing non-indigenous people and their participation in exchange networks that encompass multiple regimes of value. From the daimista point of view, we describe these relationships using the native category of “eclecticism.” We suggest that the daimistas attempt to translate the Yawanawá shamanic knowledge and the consumption of the “forest medicines,” experiencing the performance of “becoming indigenous.”. (shrink)

Since the arrival of Translational Medicine, as both a term and movement in the late 1990s, it has been associated almost exclusively with attempts to accelerate the “translation” of research-laboratory findings to improve efficacy and outcomes in clinical practice. This framing privileges one source of change in medicine, that from bench-to-bedside. In this article we dig into the history of translation research to identify and discuss three other types of translational work in medicine that can (...) also reshape ideas, practices, institutions, behaviours, or all of these, to produce transformations in clinical effectiveness. These are: making accessible state-of-the-art knowledge and best practice across the medical profession; remodelling and creating institutions to better develop and make available specialist knowledge and practice; and improving public and patient understandings of disease prevention, symptoms and treatments. We do so by examining the work of William S. C. Copeman, a dominant figure in British rheumatology from the 1930 through the late 1960s. Throughout his long career, Copeman blended approaches to “translation” in order to produce transformative change in clinical medicine, making his work an exemplar of our expanded notion of TM. (shrink)

In this paper, we describe the spiritual and kinship alliances between heads of an urban Santo Daime church from Rio de Janeiro and some leaders of the Yawanawá people from the Amazonian region. We suggest that these alliances involve exchanges and dialogical relationships that hold different meanings for the diverse social actors that take part in them. Further, we argue that equivocation and functional misunderstandings have an important role in these multidirectional dialogues. Based on this case study, we approach the (...) Yawanawá strategies for capturing otherness, and the insertion of the daimistas in the indigenous sociality networks. We focus especially on the Yawanawá mode of producing kin by capturing non‐indigenous people and their participation in exchange networks that encompass multiple regimes of value. From the daimista point of view, we describe these relationships using the native category of “eclecticism.” We suggest that the daimistas attempt to translate the Yawanawá shamanic knowledge and the consumption of the “forest medicines,” experiencing the performance of “becoming indigenous.”. (shrink)

Chaplains often describe their work in health care as “translation” between the world of the patient and the world of hospital medicine. Translators usually work with texts, interpreters with words. However, when chaplains use this metaphor, it describes something other than a discrete task associated with the meaning of words. While medical professionals focus on patients' medical conditions, chaplains seek to read the whole person, asking questions about what people's lives are like outside of the hospital, what they care (...) about most, and where they find joy and support in the world. Chaplains offer a supportive presence that serves to remind patients and caregivers that people are more than just their medical conditions or their current collection of concerns. Some chaplains are skilled at translating patients' experiences and sources of meaning in real time, allowing medical teams to better understand the person they are treating. “Translation” is also defined as metamorphosis. Chaplains provide this sort of translation when they are alone with patients, listening to their deepest concerns, helping them redefine their lives. (shrink)

Trust relations in the health services have changed from asymmetrical paternalism to symmetrical autonomy-based participation, according to a common account. The promises of personalized medicine emphasizing empowerment of the individual through active participation in managing her health, disease and well-being, is characteristic of symmetrical trust. In the influential Kantian account of autonomy, active participation in management of own health is not only an opportunity, but an obligation. Personalized medicine is made possible by the digitalization of medicine with (...) an ensuing increased tailoring of diagnostics, treatment and prevention to the individual. The ideal is to increase wellness by minimizing the layer of interpretation and translation between relevant health information and the patient or user. Arguably, this opens for a new level of autonomy through increased participation in treatment and prevention, and by that, increased empowerment of the individual. However, the empirical realities reveal a more complicated landscape disturbed by information ‘noise’ and involving a number of complementary areas of expertise and technologies, hiding the source and logic of data interpretation. This has lead to calls for a return to a mild form of paternalism, allowing expertise coaching of patients and even withholding information, with patients escaping responsibility through blind or lazy trust. This is morally unacceptable, according to Kant’s ideal of enlightenment, as we have a duty to take responsibility by trusting others reflexively, even as patients. Realizing the promises of personalized medicine requires a system of institutional controls of information and diagnostics, accessible for non-specialists, supported by medical expertise that can function as the accountable gate-keeper taking moral responsibility required for an active, reflexive trust. (shrink)

Evidence-based medicine has been rapidly and widely adopted because it claims to provide a method for determining the safety and efficacy of medical therapies and public health interventions more generally. However, as others have noted, EBM may be riven through with cultural bias, both in the generation of evidence and in its translation. We suggest that technological and scientific advances in medicine accentuate and entrench these cultural biases, to the extent that they may invalidate the evidence we have (...) about disease and its treatment. This creates a significant ethical, epistemological and ontological challenge for medicine. (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. 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