The success of precision medicine depends on obtaining large amounts of information about at-risk populations. However, getting consent is often difficult. Why? In this commentary I point to the differentials in social status involved. These differentials are inevitable once personal information is surrendered, but are particularly intense when the studied populations are socioeconomically or socioculturally disadvantaged and/or ethnically stigmatized groups. I suggest how the deep distrust of the latter groups can be partially justified as a lack of confidence (...) that their core values or interests will sufficiently be taken into account. Hence, the ethical challenge here lies not in avoiding status differentials, but in dealing with them appropriately. Scientists should not assume trust from others but adopt a norm of “demonstrating trustworthiness”. (shrink)

As opposed to a ‘one size fits all’ approach, precision medicine uses relevant biological, medical, behavioural and environmental information about a person to further personalize their healthcare. This could mean better prediction of someone’s disease risk and more effective diagnosis and treatment if they have a condition. Big data allows for far more precision and tailoring than was ever before possible by linking together diverse datasets to reveal hitherto-unknown correlations and causal pathways. But it also raises ethical (...) issues relating to the balancing of interests, viability of anonymization, familial and group implications, as well as genetic discrimination. This article analyses these issues in light of the values of public benefit, justice, harm minimization, transparency, engagement and reflexivity and applies the deliberative balancing approach found in theEthical Framework for Big Data in Health and Research to a case study on clinical genomic data sharing. Please refer to that article for an explanation of how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. Our discussion is meant to be of use to those involved in the practice as well as governance and oversight of precision medicine to address ethical concerns that arise in a coherent and systematic manner. (shrink)

Precision medicine functions by grouping patients along genetic, molecular, and related ‘-omics’ factors. This stratification relies on large, growing databases of patient-volunteered information. Both private companies and government bodies incentivize patients to volunteer this genetic information appealing to the creation of collaborative patient partnerships and the concept of empowerment. This paper aims to address two related questions: (1) what is the actual nature of patient participation in precision medicine research? And (2) is this participation in (...) class='Hi'>precision medicine research really that empowering for the average patient? I contend that firstly, the nature of this participation is best conceived of as merely contributory. Contributory participation, as it will be shown, falls short of collaboration. The partnership created by participation in precision medicine research is not one of sharing values, equal say in decisions, or shared benefit. Secondly, I contend that there are important caveats to claims that patient participation in precision medicine is empowering. Empowerment is hindered by the type of participation, the practical use or actionability of genetic data, genetic literacy, the cost of precision drugs for patients that qualify for them, and bioethical considerations of informed consent. (shrink)

Policies that require male-female sex comparisons in all areas of biomedical research conflict with the goal of improving health outcomes through context-sensitive individualization of medical care. Sex, like race, requires a rigorous, contextual approach in precision medicine. A “sex contextualist” approach to gender-inclusive medicine better aligns with this aim.

Given the sordid history of injustices linking genetics to race and ethnicity, considerations of justice are central to ensuring the responsible development of precision medicine programmes around the world. While considerations of justice may be in tension with other areas of concern, such as scientific value or privacy, there are also tensions between different aspects of justice. This paper focuses on three particular aspects of justice relevant to this precision medicine: social justice, distributive justice and human (...) rights. We describe the implications of each for the use of race and ethnicity in precision medicine, and also how they intersect and potentially conflict with each another. By attending to these intersections, we aim to enrich and add nuance to debates over how best to proceed with precision medicine initiatives. (shrink)

Cancer has garnered increasing interest among philosophers. This chapter focuses on cancer medicine and precision oncology, an influential approach to cancer which seeks to individualize treatment on the basis of genetic or molecular features of disease. It reviews a range of ontological, epistemic, and ethical questions raised by precision oncology, relating developments in cancer medicine to broader issues in the philosophy of science and medicine.

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

This paper focuses on Precision Public Health (PPH), described in the scientific literature as an effort to broaden the scope of precision medicine by extrap- olating it towards public health. By means of the “All of Us” (AoU) research pro- gram, launched by the National Institutes of Health in the U.S., PPH is being devel- oped based on health data shared through a broad range of digital tools. PPH is an emerging idea to harness the data collected (...) for precision medicine to be able to tai- lor preventive interventions for at-risk groups. The character of these data concern genetic identity, lifestyle and overall health and therefore affect the ‘intimacy’ of personhood. Through the concept of biological citizenship, we elucidate how AoU and its recruitment tactics, by resonating ‘diversity’, at the same time appeal to and constitute identity, defining individuals as ‘data sharing subjects’. Although PPH is called for; the type of bio-citizenship that is enacted here, has a particular definition, where participant recruitment focuses on ‘citizenship’ in terms of empowerment (front), it is the ‘bio’ prefix that has become the main focus in terms of research. i.e. biosubjectivities vs biocapital. This raises the question whether the societal chal- lenges that often underlie public health issues can be sufficiently dealt with based on the way ‘diversity’ is accounted for in the program. We suggest that the AoU still risks of harming underrepresented groups based on the preconditions and the design of the program. (shrink)

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

The idea of personalised medicine (PM) has gathered momentum recently, attracting funding and generating hopes as well as scepticism. As PM gives rise to differing interpretations, there have been several attempts to clarify the concept. In an influential paper published in this journal, Schleidgen and colleagues have proposed a precise and narrow definition of PM on the basis of a systematic literature review. Given that their conclusion is at odds with those of other recent attempts to understand PM, we (...) consider whether their systematic review gives them an edge over competing interpretations. We have found some methodological weaknesses and questionable assumptions in Schleidgen and colleagues’ attempt to provide a more specific definition of PM. Our perplexities concern the lack of criteria for assessing the epistemic strength of the definitions that they consider, as well as the logical principles used to extract a more precise definition, the narrowness of the pool from which they have drawn their empirical data, and finally their overlooking the fact that definitions depend on the context of use. We are also worried that their ethical assumption that only patients’ interests are legitimate is too simplistic and drives all other stakeholders’ interests—including those that are justifiable—underground, thus compromising any hope of a transparent and fair negotiation among a plurality of actors and interests. As an alternative to the shortcomings of attempting a semantic disciplining of the concept we propose a pragmatic approach. Rather than considering PM to be a scientific concept in need of precise demarcation, we look at it as an open and negotiable concept used in a variety of contexts including at the level of orienting research goals and policy objectives. We believe that since PM is still more an ideal than an achieved reality, a plurality of visions is to be expected and we need to pay attention to the people, reasons and interests behind these alternative conceptions. In other words, the logic and politics of PM cannot be disentangled and disagreements need to be tackled addressing the normative and strategic conflicts behind them. (shrink)

Because we tend to study fight books in isolation, we often forget how difficult it is to understand the precise place they occupy in the sociocultural and historical fabric of their time, and spill the many clues they inevitably contain on their owner, their local society, their precise purpose. In order to unlock that information, we need to study them in their broader sociocultural and historical context. This requires a background and research skills that are not always easily accessible to (...) everyone. To illustrate the point, in this paper I show in some detail what is required to make sense of the claim that Aristotelian philosophy and science influenced the medieval fight books in relevant ways, and that understanding this influence helps us to better understand the fight books per se. I give an outline of the general historical framework, and apply it to a testcase: Talhoffer’s Thott 290 2° Ms., with some interesting results. My hope is that this framework may be of some use to other researchers in HEMA Studies who want to dig deeper in sources of interest to them. (shrink)

In this chapter, we describe three areas within the broad field of ecogenomics or postgenomics: epigenetics, proteomics, and microbiomics. We argue that these fields challenge traditional bioethics in different ways. Since epigenetic, proteomic, and microbiomic data may contain phenotypical information, they may intensify discussions about consent, privacy, and return of results. But these fields also firmly position organisms, including human beings, as deeply entangled with their environments, as constituted by context, history, and experiences as much as genes. This yields new (...) insights into concepts of health and development. We discuss precision medicine as an example of a systemic approach to health. We argue that acknowledging the entanglement of organism and environment also means recognizing the importance of interdisciplinarity for bioethics and thinking together biomedical ethics and environmental ethics. (shrink)

There is disagreement among physicians and medical ethicists on the precise goals of Hospice and Palliative Medicine (HPM). Some think that HPM's goals should differ from those of other branches of medicine and aim primarily at lessening pain, discomfort, and confusion; while others think that HPM's practices should, like all other branches of medicine, aim at promoting health. I take the latter position: using the ars moriendi to set a standard for what it means to die well, (...) I argue that if HPM's practices were to aim at mitigating suffering with little regard to promoting health, some patients would die worse deaths than if HPM's practices were to aim at health. According to the ars moriendi, flourishing at the end of one's life requires that one exercise her agency and pursue the goods most important to her. On this view, HPM's practices should promote patients’ health to enable them to pursue these goods. (shrink)

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares (...) the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality. The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. (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)

Precision Medicine is driven by the idea that the rapidly increasing range of relatively cheap and efficient self-tracking devices make it feasible to collect multiple kinds of phenotypic data. Advocates of N = 1 research emphasize the countless opportunities personal data provide for optimizing individual health. At the same time, using biomarker data for lifestyle interventions has shown to entail complex challenges. In this paper, we argue that researchers in the field of precision medicine need to (...) address the performative dimension of collecting data. We propose the fun-house mirror as a metaphor for the use of personal health data; each health data source yields a particular type of image that can be regarded as a ‘data mirror’ that is by definition specific and skewed. This requires competence on the part of individuals to adequately interpret the images thus provided. (shrink)

A precise overview of pediatric emergencies would require taxological considerations around the differences between strictly neurological factors, as modulated both via neuroanatomical differentiation in the context of normal vs. abnormal biological development, and underlying neurofunctional mechanisms, and the connection with such processes with the neuromodulated activation of digestive processes. Furthermore, an important distinction between nephrological considerations and urological considerations is necessary, more specifically, by focusing on the treatment of diseases affecting the kidneys and their ability to function in the first (...) case, and on the treatment of diseases affecting the urinary tract in the latter. In this paper, we will present a general overview of the most important aspects of each category, starting with the brief description of neurological emergencies as indicating a general (system-based vs. localized) deterioration of mental capacity, with added possible partial or full loss of cognitive capacities and/or impaired perceptual modalities and consciousness, with or without response to stimuli. (shrink)

Research in pharmacogenomics and precision medicine has recently introduced the concept of Polygenic Scores (PGSs), namely, indexes that aggregate the effects that many genetic variants are predicted to have on individual disease risk. The popularity of PGSs is increasing rapidly, but surprisingly little attention has been paid to the idealisations they make about phenotypic development. Indeed, PGSs rely on quantitative genetics models and methods, which involve considerable theoretical assumptions that have been questioned on various grounds. This comes with (...) epistemological and ethical concerns about the use of PGSs in clinical decision-making. In this paper, I investigate to what extent idealisations in genetics models can impact the data gathering and clinical interpretation of genomics findings, particularly the calculation and predictive accuracy of PGSs. Although idealisations are considered ineliminable components of scientific models, they may be legitimate or not depending on the epistemic aims of a model. I thus analyse how various idealisations have been introduced in classical models and progressively readapted throughout the history of genetic theorising. Notably, this process involved important changes in the epistemic purpose of such idealisations, which raises the question of whether they are legitimate in the context of contemporary genomics. (shrink)

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

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and (...) Policy-relevant Ethics in Singapore Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. (shrink)

Based on the Ontology for General Medical Science, we propose definitions for biomarkers of various types of. These definitions provide not only a complete formal representation of what biomarkers are according to the Institute of Medicine (IOM), but also remove the ambiguities and inconsistencies encountered in the documentation provided by the IOM.

Background: The concept of digital twins has great potential for transforming the existing health care system by making it more personalized. As a convergence of health care, artificial intelligence, and information and communication technologies, personalized health care services that are developed under the concept of digital twins raise a myriad of ethical issues. Although some of the ethical issues are known to researchers working on digital health and personalized medicine, currently, there is no comprehensive review that maps the major (...) ethical risks of digital twins for personalized health care services. Objective: This study aims to fill the research gap by identifying the major ethical risks of digital twins for personalized health care services. We first propose a working definition for digital twins for personalized health care services to facilitate future discussions on the ethical issues related to these emerging digital health services. We then develop a process-oriented ethical map to identify the major ethical risks in each of the different data processing phases. Methods: We resorted to the literature on eHealth, personalized medicine, precision medicine, and information engineering to identify potential issues and developed a process-oriented ethical map to structure the inquiry in a more systematic way. The ethical map allows us to see how each of the major ethical concerns emerges during the process of transforming raw data into valuable information. Developers of a digital twin for personalized health care service may use this map to identify ethical risks during the development stage in a more systematic way and can proactively address them. Results: This paper provides a working definition of digital twins for personalized health care services by identifying 3 features that distinguish the new application from other eHealth services. On the basis of the working definition, this paper further layouts 10 major operational problems and the corresponding ethical risks. Conclusions: It is challenging to address all the major ethical risks that a digital twin for a personalized health care service might encounter proactively without a conceptual map at hand. The process-oriented ethical map we propose here can assist the developers of digital twins for personalized health care services in analyzing ethical risks in a more systematic manner. (shrink)

In the debates regarding the ethics of human organoid biobanking, the locus of donor autonomy has been identified in processes of consent. The problem is that, by focusing on consent, biobanking processes preclude adequate engagement with donor autonomy because they are unable to adequately recognise or respond to factors that determine authentic choice. This is particularly problematic in biobanking contexts associated with organoid research or the clinical application of organoids because, given the probability of unforeseen and varying purposes for which (...) a donor’s organoids could be employed and given the different ways in which a donor can relate to her biospecimens, a donor can value her organoids differently in different contexts and her reasons for autonomously permitting use of her cells and tissues in one case may not support an autonomous decision in another. In response, this paper has three aims: firstly, to make the case for why organoid biobanks ought to respect donor autonomy conceived as authentic choice; secondly, to explore the autonomy-respecting limits of established and widely prevalent models of biobank consent; and thirdly, to propose certain conditions that organoid biobanks ought to support or facilitate in order to respect donor autonomy. (shrink)

Concerns over medical paternalism are especially salient when there exists a conflict of values between patient and clinician. This is particularly relevant for psychiatry, the field of medicine for which the phenomenon of conflicting values is most present and for which the specter of medical paternalism looms large. Few cases are as glaring as that of anorexia nervosa (AN), a disorder that is considered to be egosyntonic (meaning its symptoms are reflectively endorsed by the patient) and maintained by the (...) presence of pathological values. One might think, given this, that an approach to medicine that foregrounds the role of values in clinical encounters would be particularly well suited to address the problem of medical paternalism in treating AN. As it happens, this is precisely the goal of values-based medicine, an approach to medicine that prioritizes the integration of patients’ unique values into the aims of treatment and that has been touted as being particularly applicable to psychiatric conditions such as AN. Although this strategy may initially appear promising, in this paper I will argue that the directive to incorporate patient values (as dictated by values-based medicine) cannot do the work of mitigating medical paternalism in the treatment of egosyntonic disorders such as AN. Rather than chalking this up as a failure due to AN being a particularly challenging case, I will instead conclude that the failure of values-based medicine in this context cuts to the heart of the limitations of rectifying medical paternalism within psychiatry as it currently exists. (shrink)

The application of machine-learning technologies to medical practice promises to enhance the capabilities of healthcare professionals in the assessment, diagnosis, and treatment, of medical conditions. However, there is growing concern that algorithmic bias may perpetuate or exacerbate existing health inequalities. Hence, it matters that we make precise the different respects in which algorithmic bias can arise in medicine, and also make clear the normative relevance of these different kinds of algorithmic bias for broader questions about justice and fairness in (...) healthcare. In this paper, we provide the building blocks for an account of algorithmic bias and its normative relevance in medicine. (shrink)

Heterogeneous treatment effects represent a major issue for medicine as they undermine reliable inference and clinical decision-making. To overcome the issue, the current vision of precision and personalized medicine acknowledges the need to control individual variability in response to treatment. In this paper, we argue that gene-treatment-environment interactions (G × T × E) undermine inferences about individual treatment effects from the results of both genomics-based methodologies—such as genome-wide association studies (GWAS) and genome-wide interaction studies (GWIS)—and randomized controlled (...) trials (RCTs). Then, we argue that N-of-1 trials can be a solution to overcome difficulties in handling individual variability in treatment response. Although this type of trial has been suggested as a promising strategy to assess individual treatment effects, it nonetheless has limitations that limit its use in everyday clinical practice. We analyze the existing variability within the designs of N-of-1 trials in terms of a continuum where each design prioritizes epistemic and pragmatic considerations. We then support wider use of the designs located at the pragmatic end of the explanatory-pragmatic continuum. (shrink)

It is unknown to what extent medical researchers generalize study findings beyond their samples when their sample size, sample diversity, or knowledge of conditions that support external validity do not warrant it. It is also unknown to what extent medical researchers describe their results with precise quantifications or unquantified generalizations, i.e., generics, that can obscure variations between individuals. We therefore systematically reviewed all prospective studies (n = 533) published in the top four highest ranking medical journals, Lancet, New England Journal (...) of Medicine (NEJM), Journal of the American Medical Association (JAMA), and the British Medical Journal (BMJ), from January 2022 to May 2023. We additionally reviewed all NEJM Journal Watch clinical research summaries (n = 143) published during the same time. Of all research articles reporting prospective studies, 52.5% included generalizations beyond specific national study populations, with the numbers of articles with generics varying significantly between journals (JAMA = 12%; Lancet = 77%) (p < 0.001, V = 0.48). There was no evidence that articles containing broader generalizations or generics were correlated with larger or more nationally diverse samples. Moreover, only 10.2% of articles with generalizations beyond specific national populations reported external validity strengthening factors that could potentially support such extrapolations. There was no evidence that original research articles and NEJM Journal Watch summaries intended for practitioners differed in their use of broad generalizations, including generics. Finally, from the journal with the highest citation impact, articles containing broader conclusions were correlated with more citations. Since there was no evidence that studies with generalizations beyond specific national study populations or with generics were associated with larger, more nationally diverse samples, or with reports of population similarity that may permit extensions of conclusions, our findings suggest that the generalizations in many articles were insufficiently supported. Caution against overly broad generalizations in medical research is warranted. (shrink)

Ontology is a burgeoning field, involving researchers from the computer science, philosophy, data and software engineering, logic, linguistics, and terminology domains. Many ontology-related terms with precise meanings in one of these domains have different meanings in others. Our purpose here is to initiate a path towards disambiguation of such terms. We draw primarily on the literature of biomedical informatics, not least because the problems caused by unclear or ambiguous use of terms have been there most thoroughly addressed. We advance a (...) proposal resting on a distinction of three levels too often run together in biomedical ontology research: 1. the level of reality; 2. the level of cognitive representations of this reality; 3. the level of textual and graphical artifacts. We propose a reference terminology for ontology research and development that is designed to serve as common hub into which the several competing disciplinary terminologies can be mapped. We then justify our terminological choices through a critical treatment of the ‘concept orientation’ in biomedical terminology research. (shrink)

What makes some acts morally right and others morally wrong? Traditionally, philosophers have thought that in order to answer this question we must find and formulate exceptionless moral principles—principles that capture all and only morally right actions. Utilitarianism and Kantianism are paradigmatic examples of such attempts. In recent years, however, there has been a growing interest in a novel approach—Particularism—although its precise content is still a matter of controversy. In this paper I develop and motivate a new formulation of particularism (...) as a research program and I show that my formulation is not vulnerable to the most common objections to particularism. Moreover, I argue that the particularist research program shows enough promise to warrant further exploration. (shrink)

Modern bioethics is clearly dominated by deontologists who believe that we have some way of identifying morally correct and incorrect acts or rules besides taking account of their consequences. Robert M. Veatch is one of the most outspoken of those numerous modern medical ethicists who agree in rejecting all forms of teleological, utilitarian, or consequentialist ethical theories. This paper examines his critique of utilitarianism and shows that the utilitarianism of John Stuart Mill is either not touched at all by his (...) critique or can be defended against it. This article argues that the dominant deontological majority is mistaken and that a utilitarian theory of moral action very much like Mill’s is precisely what is needed by modern medical ethics and by those medical practitioners who are resolved to practice medicine in a reasonable and morally acceptable manner. (shrink)

Abstract: This essay consists of some clarifying remarks on the doctrine of double effect (DDE). After providing a contemporary formulation of the doctrine we put special emphasis on the distinction between those aspects of an action plan that are intended and those that are merely foreseen (the I/F distinction). Making use of this distinction is often made difficult in practice because salient aspects of the action plan exhibit a felt “closeness” to one another that is difficult if not impossible to (...) articulate with the precision we might like. The essay goes on to examine an especially adroit criticism of DDE best articulated by J.J. Thomson. We conclude with a brand new double effect case (new to the philosophical literature anyway) taken from medicine and Roman Catholic pastoral ministry. (shrink)

It is undeniable that human beings seek happiness and have difficulty finding it. This is not a new phenomenon: ever since ancient times man has wondered about what happiness is, where it lies and how to achieve it. For the Greeks, a people of deep pessimism, the search for happiness (eudaimonia) was a traditional theme of philosophy and it was precisely in Greece where Epicurus ́ (341-270 BC) doctrine of happiness emerged. A cursed and manipulated author (just like his admirer (...) Nietzsche), Epicurus has probably been the thinker who has most lucidly approached the question of eudaimonia. Its doctrine seeks and promises its followers happiness through pleasure (hedoné), self-sufficiency (autarky), friendship (philía) and mental calm (ataraxia), offering itself as medicine against the pain of flesh and the sufferings of the mind. But Epicurean hedonism, which harmonizes well with the ancient Apollonian maxim that wisdom consists of moderation and the knowledge of limits, is totally removed from both the tyranny of the happycracy and from the noxious culture of unrestrained and vacuous desire of contemporary postmodernity. This is precisely why Epicurus's timeless proposal for authentic happiness deserves to be known for everyone: for constituting an effective therapy against the ills that afflict the nihilistic human being of the neoliberal era. (shrink)

This book provides a critical reflection on automated science and addresses the question whether the computational tools we developed in last decades are changing the way we humans do science. More concretely: Can machines replace scientists in crucial aspects of scientific practice? The contributors to this book rethink and refine some of the main concepts by which science is understood, drawing a fascinating picture of the developments we expect over the next decades of human-machine co-evolution. The volume covers examples from (...) various fields and areas, such as molecular biology, climate modeling, clinical medicine, and artificial intelligence. The explosion of technological tools and drivers for scientific research calls for a renewed understanding of the human character of science. This book aims precisely to contribute to such a renewed understanding of science. (shrink)

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery (...) can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS. (shrink)

PT. A noção de “pessoa”, pensada a partir do legado antropológico e filosófico do ocidente, afirma-se como uma unidade corporal e espiritual que determina a sua singularidade no seio da comunidade. A “pessoa” assim perspectivada assume uma importância destacada na reflexão ética das aplicações científicas de artificialização da vida humana. Muito concretamente, a noção de “pessoa” deve contribuir para a fundamentação ética das terapêuticas de transplantação. A transplantação representa um dos mais notáveis avanços da medicina do século XX e com (...) um impacto incontornável na prestação de cuidados de saúde. Os transplantes são considerados o tratamento mais eficaz para patologias crónicas que afectam a funcionalidade de determinados órgãos vitais, restituindo ao doente uma melhoria na sua saúde e/ou qualidade de vida. O sucesso desta terapêutica é, no entanto, condicionado pela disponibilização de pessoas que queiram fazer dádiva de si, do seu próprio corpo, para o bem-estar de outrem. Deste modo, a doação, realizada após a morte da pessoa ou ainda em vida, enfrenta vários desafios técnicos, mas também, e principalmente, desafios éticos. A nossa dissertação centra-se na reflexão ética da doação de órgãos e tecidos para transplante e no impacto que a dádiva de uma parte específica do corpo pode comportar na noção de “pessoa”. Deste modo, ao mesmo tempo em que se procura promover a doação de órgãos para aumentar o número de transplantes, também se vão delineando estratégias para salvaguardar a integridade corporal do dador e a eminente dignidade que o constitui como pessoa. As estratégias consistem fundamentalmente num diálogo entre o princípio de autonomia, que determina a singularidade da pessoa, e o princípio de solidariedade, que é desencadeado pela relação com o outro. Estes princípios éticos, articulados e uma vez cumpridos, são os alicerces da doação voluntária e altruísta, e impedem a instrumentalização e exploração da pessoa dadora. -/- EN. The western anthropological and philosophical notion of ‘person’ emerges as a corporal and spiritual entity, which determines his singularity at the level of community. From this perspective, the notion of ‘person’ holds an important place in ethical considerations concerning the scientific applications of artificial manipulation of human life. More precisely, the notion of ‘person’ must contribute towards the ethical basis of transplant therapeutics. The transplantation of human organs and tissues is one of the most notable advances in twentieth century medicine, and, as such, has had an unquestionable impact on health care practice. Transplants are now seen as the best treatment for chronic diseases that impair the function of some vital organs, improving the patient health and/or quality of life. The success of organs transplantation depends entirely upon the altruism of people giving their bodies for the well-being of others. Organ donation, performed during life or after death, raises not only technical, but also mainly ethical challenges. This work focuses on the ethical considerations associated with human organs and tissue donation for transplantation and on the impact that a donation of an organ has on the notion of ‘person’. At the same time that one recognizes the need to increase the number of organs for transplanting, there is also the need to preserve the donor’s corporal integrity and his eminent dignity. Strategies to preserve the donor’s corporal integrity and dignity must take into consideration the dialogue between the principle of autonomy, which is characterized by the singular entity, and the principle of solidarity, born out of one’s relationship with those around you. These ethical principles, once engaged and fulfilled, are the bases of a voluntary and altruistic donation, and prevent the donor from becoming a mere instrument and being exploited as such. (shrink)

In a "parenthesis of fascinated horror" before "the complete discovery and subjection of the body to science", Renaissance anatomists and poets shared peculiar emotions of dread and desire towards the bodies they dissected and described. Jonathan Sawday's ambitious project is to evoke the common taboos, resistances, and fears which the human body provoked in its various early modern investigators, while telling "stories of terrible cruelty, which are tinged by a form of dark eroticism". He is justifiably proud of the historical (...) range of his study, across medicine, cartography, literature, the law, myth, art, theology, social history, and philosophy. But he seeks more than a synthesis of these disparate domains, hoping also both to sketch a new grand narrative about conceptual, practical, and phenomenological changes regarding the body, and further "if not to dispel, then at least to explain" our own multiple, ambiguous feelings about our innards. Thus he marvellously maintains simultaneous attention to culture and psychology, combining high theory with historical precision in rare and risky fashion. (shrink)

Many people report that reading first-person narratives of the experience of illness can be morally instructive or educative. But although they are ubiquitous and typically sincere, the precise nature of such educative experiences is puzzling—for those narratives typically lack the features that modern philosophers regard as constitutive of moral reason. I argue that such puzzlement should disappear, and the morally educative power of illness narratives explained, if one distinguishes two different styles of moral reason: an inferentialist style that generates the (...) puzzlement and an alternative exemplarist style that offers a compelling explanation of the morally educative power of pathographic literature. (shrink)

In addressing the question of what mental health is we might proceed as if there is a single phenomenon – mental health – denoted by a single overarching concept. The task, then, is to provide an informative analysis of this concept which applies to all and only instances of mental health, and which illuminates what it is to be mentally healthy. In contrast, mental health pluralism is the idea that there are multiple mental health phenomena denoted by multiple concepts of (...) mental health. Analysis and illumination of mental health may still be possible, but there isn’t a single phenomenon or concept to be analysed in addressing the question of what mental health is. The question of pluralism has been overlooked in the philosophy of mental health. The discussion to follow is an attempt to get us to take mental health pluralism seriously. To that end, in this essay I have three primary goals: (1) to give a precise account of what mental health pluralism is, (2) to show that the question of pluralism should not be neglected in debate about what mental health is, and (3) to argue for mental health pluralism. I also draw out some implications of this discussion for philosophy, science, and psychotherapy. (shrink)

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem (...) from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)

The primary aim of this paper is to critically evaluate the deductive model of ethical applications, which is based on normative ethical theories like deontology and consequentialism, and to show why a number of models have failed to furnish appropriate resolutions to practical moral problems. Here, for the deductive model, I want to call it a “Linear Mechanical Model” because the basic assumption of this model is that if a normative theory is sacrosanct, then the case is as it is. (...) The conclusion derived from the case will also be correct, true and acceptable. However, traditional ethicists used to apply their ethical theories, but they did not know which moral theory was effective on the ground level of reality. The study will show readers how ethical theories are in conflict with each other in the case of euthanasia. In more precise words, “which ethical theories are said to be applied, meta-ethical or normative, or both for the resolution of ethical problems? If normative theories are said to be applied, how the application can take place when it is contrary to our experience, that (then) in a situation of moral crises, no one really applies a theory?” For that, my argument is the linear model has failed because it is rigid, often ignores the agents’ intrinsic values, and has no space to amend it, no matter how bizarre the consequence is. Its alternative is the Inductive model. For that, the paper will take three moral principles (autonomy, beneficence including maleficence, and justice) of Beauchamp & Childress. This suggests us for resolving value-laden moral problems, we should consider some steps such as a) recognising moral issues to start with; b) developing the moral imagination; c) sharpening analytical/critical skills; d) testing out disagreements; e) effecting decisions and behavior; and f) implementation, closure, and process are of vital importance, in other words, it starts with the free and informed consensus of all interested parties, but this model also has been failed because the model could not give a systematic organization to their way of resolution. Here, my argument is that the inductive model provides resolution of the practical problem but ignores what is ethically obligatory, permissible, or wrong in that situation, and there are no appropriate suggestions in the case of a moral crisis. (shrink)

Even in the increasingly individualized American medical system, advocates of 'personalized medicine' claim that healthcare isn't individualized enough. With the additional glamour of new biotechnologies such as genetic testing and pharmacogenetics behind it, 'Me Medicine'-- personalized or stratified medicine-- appears to its advocates as the inevitable and desirable way of the future. Drawing on an extensive evidence base, this book examines whether these claims are justified. It goes on to examine an alternative tradition rooted in communitarian ideals, (...) that of the common good as a goal in medicine. (shrink)

Although continued investments in nanotechnology are made, atomically precise manufacturing (APM) to date is still regarded as speculative technology. APM, also known as molecular manufacturing, is a token example of a converging technology, has great potential to impact and be affected by other emerging technologies, such as artificial intelligence, biotechnology, and ICT. The development of APM thus can have drastic global impacts depending on how it is designed and used. This paper argues that the ethical issues that arise from APM (...) - as both a standalone technology or as a converging one - affects the roles of stakeholders in such a way as to warrant an alternate means furthering responsible innovation in APM research. This paper introduces a value-based design methodology called Value Sensitive Design (VSD) that may serve as a suitable framework to adequately cater to the values of stakeholders. Ultimately, it is concluded that VSD is a strong candidate framework for addressing the moral concerns of stakeholders during the preliminary stages of technological development. (shrink)

In this paper, I argue that the concept of normality in medical research and clinical practice is inextricable from the concept of ambiguity. I make this argument in the context of Edmund Pellegrino's call for a renewed reflection on medicine’s basic concepts and by drawing on work in critical disability studies concerning Deafness and body integrity identity disorder. If medical practitioners and philosophers of medicine wish to improve their understanding of the meaning of medicine as well as (...) its concrete practice, I contend that they should take seriously the import and centrality of ambiguity for biomedicine. (shrink)

The issue of how to incorporate the individual's first‐hand experience of illness into broader medical understanding is a major question in medical theory and practice. In a philosophical context, phenomenology, with its emphasis on the subject's perception of phenomena as the basis for knowledge and its questioning of naturalism, seems an obvious candidate for addressing these issues. This is a review of current phenomenological approaches to medicine, looking at what has motivated this philosophical approach, the main problems it faces (...) and suggesting how it might become a useful philosophical tool within medicine, with its own individual, but interrelated, contribution to make to current medical debates. After the general background, there is a brief summary of phenomenological ideas and their current usage in a medical context. Next is a critique of four key claims within current phenomenological medical works, concerning both the role phenomenology plays and the supposedly clear divide between phenomenology and other approaches. There are significant problems within these claims, largely because they overlook the complexity of the questions they consider. Finally, there is some more in‐depth examination of phenomenology itself and the true complexity of phenomenological debate concerning subjectivity. The aim is to show that it will be both more productive and truer to phenomenology itself, if we use phenomenology as a philosophical method for explicating and gaining deeper understanding of complex and fundamental problems, which are central to medicine, rather than as providing simple, but flawed solutions. (shrink)

ABSTRACT: Abstract Most modern knowledge is not science. The physical sciences have successfully validated theories to infer they can be used universally to predict in previously unexperienced circumstances. According to the conventional conception of science such inferences are falsified by a single irregular outcome. And verification is by the scientific method which requires strict regularity of outcome and establishes cause and effect. -/- Medicine, medical research and many “soft” sciences are concerned with individual people in complex heterogeneous populations. These (...) populations cannot be tested to demonstrate strict regularity of outcome in every individual. Neither randomised controlled trials nor observational studies in medicine are science in the conventional conception. Establishing and using medical and other “soft science” theories cannot be scientific. It requires conceptually different means: requiring expert judgement applying all available evidence in the relevant available factual matrix. -/- The practice of medicine is observational. Prediction of outcomes for the individual requires professional expertise applying available medical knowledge and evidence. Expertise in any profession can only be acquired through experience. Prior cases are the fundament of knowledge and expertise in medicine. Case histories, studies and series can provide knowledge of extremely high reliability applicable to establishing reliable general theories and falsifying others. Their collation, study and analysis should be a priority in medicine. Their devaluation as evidence, the failure to apply their lessons, the devaluation of expert professional judgement and the attempt to emulate the scientific method are all historic errors in the theory and practice of modern medicine. (shrink)

If one had to identify the biggest change within the philosophical tradition in the twenty-first century, it would certainly be the rapid rise of experimental philosophy to address differences in intuitions about concepts. It is, therefore, surprising that the philosophy of medicine has so far not drawn on the tools of experimental philosophy in the context of a particular conceptual debate that has overshadowed all others in the field: the long-standing dispute between so-called naturalists and normativists about the concepts (...) of health and disease. In this paper, I defend and advocate the use of empirical methods to inform and advance this and other debates within the philosophy of medicine. (shrink)

This is a volume of twelve essays concerning the fundamental tension in personalised medicine between individual choice and the common good.

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

Medicine is increasingly subject to various forms of criticism. This paper focuses on dominant forms of criticism and offers a better account of their normative character. It is argued that together, these forms of criticism are comprehensive, raising questions about both medical science and medical practice. Furthermore, it is shown that these forms of criticism mainly rely on standards of evaluation that are assumed to be internal to medicine and converge on a broader question about the aim of (...) medicine. Further work making medicine’s internal norms explicit and determining the aim of medicine would not only help to clarify to what extent the criticism is justified, but also assist an informed deliberation about the future of medicine. To illustrate some of the general difficulties associated with such a task, the paper concludes by critically engaging Edmund Pellegrino’s account of the aim of medicine as well as the Hastings Center’s consensus report. (shrink)