Die Arzneimittelzulassung und der Aufnahmeprozess zur Kostenerstattung sollen die Entwicklung und Vermarktung von pharmazeutischen Innovationen mit Patientennutzen nicht behindern, zugleich aber die Wirtschaftlichkeit der Arzneimittelversorgung für die Kostenträger nicht gefährden. Eine Anpassung der Verfahren an die Merkmale personalisierter Arzneimittel erscheint notwendig. Dabei ist allerdings zu fragen, ob eine ungerechtfertigte Privilegierung erfolgt. In den USA und in der EU werden die jeweiligen Zulassungsverfahren für Arzneimittel und Tests schrittweise angepasst und integriert. Zulassung und Erstattungsentscheidungen sollen koordiniert werden. Eine Privilegierung, wie bei Arzneimitteln (...) für seltene Indikationen (Orphan Drugs), findet jedoch für personalisierte Medizin nicht statt. Es bestehen keine unzumutbaren Hürden für die Hersteller. Zurückhaltung bei der Entwicklung innovativer Produkte wäre deshalb nicht gerechtfertigt. (shrink)

This entirely new translation of Kant's Critique of the Power of Judgment follows the principles and high standards of all other volumes in The Cambridge Edition of the Works of Immanuel Kant. This volume includes for the first time the first draft of Kant's introduction to the work; the only English edition notes to the many differences between the first (1790) and second (1793) editions of the work; and relevant passages in Kant's anthropology lectures where he elaborated on his aesthetic (...) views. (shrink)

Abstract This paper explores gender and mental health with particular reference to the emerging philosophical field of critical realism. This philosophy suggests a shared ontology and epistemology for the natural and social sciences. Until recently, most of the debate surrounding gender and mental health has been guided either implicitly or explicitly within a positivist or constructivist philosophy. With this in mind, key areas of critical realism are explored in relation to gender and mental health, and contrasted with the positions of (...) positivism and constructivism. It is argued that critical realism offers an alternative philosophical framework for the exploration of gender issues within mental health care. (shrink)

This book is an interdisciplinary guide to the religion clauses of the First Amendment with a focus on its philosophical foundations, historical developments, and legal and political implications. The volume begins with fundamental questions about God, the nature of belief and worship, conscience, freedom, and their intersections with law. It then traces the history of religious liberty and church-state relations in America through a diverse set of religious and non-religious voices from the seventeenth century to the most recent Supreme Court (...) decisions. The Companion will conclude by addressing legal and political questions concerning the First Amendment and the court cases and controversies surrounding religious liberty today, including the separation of church and state, corporate religious liberty, and constitutional interpretation. This scholarly yet accessible book will introduce students and scholars alike to the main issues concerning the First Amendment and religious liberty, along with offering incisive new insights into one of the most important topics in American culture. (shrink)

Levinas never engaged closely with Fichte’s work, but there are two places in the chapter “Substitution,” in Otherwise than Being (1974), where he mentions Fichte by name. The point that Levinas underscores in both of these passages is that the other’s encounter with the subject is not the outcome of the subject’s freedom; it is not posited by the subject, as Fichte has it, but is prior to any free activity. The aim of this paper is to deepen the comparison (...) between Levinas and Fichte, giving special attention to Fichte's own novel theory of intersubjectivity and the summons. One result that emerges from this treatment is that both Levinas and Fichte view the second person in a way that has no equivalent in the current philosophical landscape. On this reading, each thinker views responsibility to the other, not only as an immediate and particular obligation, but also as an asymmetrical relation that gives the other moral priority. (shrink)

The similarity of documents in a large database of published Fractals articles was examined for redundancy. Three different text matching techniques were used on publisheds to identify redundancy candidates, and predictions were verified by reading full text versions of the redundancy candidate articles. A small fraction of the total articles in the database was judged to be redundant. This was viewed as a lower limit, because it excluded cases where the concepts remained the same, but the text was altered substantially.Far (...) more pervasive than redundant publications were publications that did not violate the letter of redundancy but rather violated the spirit of redundancy. There appeared to be widespread publication maximization strategies. Studies that resulted in one comprehensive paper decades ago now result in multiple papers that focus on one major problem, but are differentiated by parameter ranges, or other stratifying variables. This ‘paper inflation’ is due in large part to the increasing use of metrics (publications, patents, citations, etc) to evaluate research performance, and the researchers’ motivation to maximize the metrics. (shrink)

The concept of community is increasingly the focus of political argument in Britain, the United States and elsewhere around the world. The sense people have of belonging to coummunities provides a powerful motivation which continues to affecct the political and social face of the world. Recently, debate about the relationship between individuals and their communities has become central to the making of both, American and European social policy. In the United Kingdom this is especially apparent in the area of health (...) care, where ideas of community have informed recent legislation concerning community care, community health trusts and the Children Act among others. This volume explores the focus of interest in community and the emerging theoretical oppostion between communitarianism and liberalism, as well as the practical, theoretical and ethical issues relating to community in the health care professions, including a discussion of the health service as Civil Association, an analysis of liberal and communitarian views on the allocaiton of health care resources, an exploration of the use of genetic information and an examination of health care decision making for incapacitated elderly patients. (shrink)

Die „künstliche Ernährung“ steht in enger Beziehung zu den grundsätzlichen Fragen nach medizinisch sinnvollen und angemessenen Maßnahmen, nach Therapiebegrenzung, Lebensqualität und Sterbehilfe. Im Diskurs müssen die dabei verwendeten Begriffe hinsichtlich der ihnen innewohnenden, oft unbewussten Wertungen zur Diskussion gestellt werden. Einer ethischen Entscheidungsberatung muss eine sorgfältige Abklärung der naturwissenschaftlichen Aspekte, einschließlich einer umfassenden Erhebung der Vorsituation und der gegenwärtigen Befindlichkeit des einzelnen Kranken sowie eine aufrichtige Einschätzung der Zielorientierung vorausgehen. Unter Zugrundelegung der—unter Umständen auch nur ersatzweise wahrgenommenen—Selbstbestimmung des Patienten werden (...) in der ethischen Diskussion mögliche stereotype Vorgehensweisen, latente Entscheidungskonflikte oder eine vermeintliche Vorrangigkeit naturwissenschaftlicher Lösungsansätze zur Sprache kommen. Ziel ist eine gemeinsam erarbeitete individuell angemessene Lösung, die sich—unabhängig vom Ergebnis—heilsam in den Lebenshorizont des Patienten einbetten lässt. (shrink)

This book brings together scholars from a variety of epistemological perspectives to explore the multiple ways in which sexuality does indeed matter in the arena of public education.

Der Selbstbestimmungdes Patienten kommt in der modernen Debatte über das Gesundheitswesen eine zentrale Bedeutung zu. Selbstbestimmung ist aber ein voraussetzungsvoller Begriff, der für Patientengruppen wie Demenzbetroffene, deren Entscheidungs- und Einwilligungsfähigkeit nachlässt oder nicht mehr gegeben ist, eine Reihe von Fragen aufwirft. Auf der Grundlage der jeweiligen Symptomentwicklung der Demenzerkrankung und eigener Erfahrungen im Umgang mit Demenzbetroffenen wirdde rEntwicklungdes Willens in den verschiedenen Stadien der Demenz nachgegangen. Dabei wird den Dimensionen der Differenziertheit der Denkinhalte, der Beurteilungsbasis und der Entscheidungskonstanz eine besondere (...) Bedeutung zugemessen und für eine Graduierung der Selbstbestimmungsmöglichkeiten im Umgang mit Demenzbetroffenen plädiert. Wegen der Schwererkennbarkeit der oft verschlüsselten Willensbekundungen Demenzbetroffener wird der Willenswahrnehmung und dem Training der genauen Beobachtung, Einfühlung und Sensibilität im Umgang mit den Betroffenen großes Gewicht beigemessen. Als Ziel wird die jeweils weitestgehende Selbstbestimmung, im Verlaufe der Erkrankung auch Teilselbstbestimmung und schließlich Mitwirkung bei der individuellen Wohlbestimmung im Sinne eines Grundrechtsschutzes vertreten. (shrink)

A team of renowned philosophers and a new generation of thinkers come together to offer the first book-length examination of the relationship between philosophical anthropology and animal studies.

ABSTRACTEthical scandals involving journalists in English-speaking West African countries have been documented to include conflict of interest, freebies, intellectual theft, deception, carelessness, kowtowing to advertisers and politicians, use of dubious evidence, and outright bias. This study explores how pronounced and clear the rules relating to these breaches are in the codes of these countries and whether the similarities and dissimilarities in wording indicate the influence of individual actors involved in writing them. Relying on thematic and qualitative document analysis methods, the (...) study found that rules in the codes addressing the ethical breaches are pronounced and clear. Although largely similar in content, the codes also feature important differences that are strongly related to the composition of the groups that wrote them. This study discusses why ethical challenges in these countries persist in the midst well-written code of ethics. (shrink)

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest (...) treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical—they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles. (shrink)

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM – whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part 1 of this article took up the first two questions. Part 2 took up the second two questions. Part 3 now deals with Questions 5 & 6. Question 5 confronts the issue of utility, whether the manual design of DSM-III and IV favors clinicians or researchers, and what that means for DSM-5. Our final question, Question 6, takes up a concluding issue, whether the acknowledged problems with the earlier DSMs warrants a significant overhaul of DSM-5 and future manuals. As in Parts 1 & 2 of this article, the general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

Response to "Embodied artificial intelligence", a commentary by Ron Chrisley.

In the conclusion to this multi-part article I first review the discussions carried out around the six essential questions in psychiatric diagnosis – the position taken by Allen Frances on each question, the commentaries on the respective question along with Frances’ responses to the commentaries, and my own view of the multiple discussions. In this review I emphasize that the core question is the first – what is the nature of psychiatric illness – and that in some manner all further (...) questions follow from the first. Following this review I attempt to move the discussion forward, addressing the first question from the perspectives of natural kind analysis and complexity analysis. This reflection leads toward a view of psychiatric disorders – and future nosologies – as far more complex and uncertain than we have imagined. (shrink)

Calcium ions act as modulators of many fundamental processes in eukaryotic cells. Although these processes apparently involve initial interactions between calcium ions and cell membranes, the identity of the putative membrane Ca2+‐binding proteins has until recently been obscure. This article describes a recently discovered family of mammalian membrane proteins, of perhaps ancient origin, that may fulfil this function.

Individual athletes, coaches and sports teams seek continuously for ways to improve performance and accomplishment in elite competition. New techniques of performance analysis are a crucial part of the drive for athletic perfection. This paper discusses the ethical importance of one aspect of the future potential of performance analysis in sport, combining the field of biomedicine, sports engineering and nanotechnology in the form of ‘Nanobiosensors’. This innovative technology has the potential to revolutionise sport, enabling real time biological data to be (...) collected from athletes that can be electronically distributed. Enabling precise real time performance analysis is not without ethical problems. Arguments concerning data ownership and privacy; data confidentiality; and athlete welfare are presented alongside a discussion of the use of the Precautionary Principle in making ethical evaluations. We conclude, that although the future potential use of Nanobiosensors in sports analysis offers many potential benefits, there is also a fear that it could be abused at a sporting system level. Hence, it is essential for sporting bodies to consider the development of a robust ethically informed governance framework in advance of their proliferated use. (shrink)

ABSTRACT Human-technology interactions are omnipresent in daily life, a reality that must be faced to enact positive change without uprooting the technological systems that have come to define us. The present study develops a collective intelligence model for human-technology interaction design that aims to promote peace, prosperity, and happiness through design intentionality informed by utopian targets of radical improvement in society. Participants generated ideas, clarified and consolidated them, and then developed an interpretive structure model of the most important affordances identified (...) during the idea generation phase. Coupled with a two-pass thematic analysis of the original idea set, what emerged is a model that is informed by stakeholder users of the technologies of tomorrow. Affordance themes centered on the importance of promoting world peace through technological means, identifying and rectifying material and financial inequalities, addressing negative well-being effects in current technologies, and increasing global collaboration and eventual expansion into the cosmos. (shrink)

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM - whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part I of this article will take up the first two questions. With the first question, invited commentators express a range of opinion regarding the nature of psychiatric disorders, loosely divided into a realist position that the diagnostic categories represent real diseases that we can accurately name and know with our perceptual abilities, a middle, nominalist position that psychiatric disorders do exist in the real world but that our diagnostic categories are constructs that may or may not accurately represent the disorders out there, and finally a purely constructivist position that the diagnostic categories are simply constructs with no evidence of psychiatric disorders in the real world. The second question again offers a range of opinion as to how we should define a mental or psychiatric disorder, including the possibility that we should not try to formulate a definition. The general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

This paper examines the concept of ‘openness with patients’ from the stand-point of the limitations of biomedical ethics. Initially we review contemporary critiques of bioethics and, in particular, of principlism; we relate how other; somewhat neglected, forms of medical ethics can yield useful information and provide moral guidance.The main section of the paper then shows how a bioethical approach to openness misses the social context in our example, the viewpoints of patients; we present some of the increasing wealth of research (...) evidence which points towards patients wanting more information and a greater degree of openness.Finally we put forward that a principlist’s objection to active encouragement of openness might be based on the risk of infringing upon the ‘right not to know’. We reject this by arguing how rights can be trumped. (shrink)

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM - whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part I of this article took up the first two questions. Part II will take up the second two questions. Question 3 deals with the question as to whether DSM-V should assume a conservative or assertive posture in making changes from DSM-IV. That question in turn breaks down into discussion of diagnoses that depend on, and aim toward, empirical, scientific validation, and diagnoses that are more value-laden and less amenable to scientific validation. Question 4 takes up the role of pragmatic consideration in a psychiatric nosology, whether the purely empirical considerations need to be tempered by considerations of practical consequence. As in Part 1 of this article, the general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

The article is based on the author’s experience as an administrator of three primarily social science institutional review boards (IRBs) to which researchers presented research protocols that purported to be minimal risk studies of teacher practice where the “teacher–researcher” was the “research subject.” Recently, educational, social, and behavioral science researchers encounter many problems with regard to their methodologies and the oversight mandate of the IRBs. There is a divergence between the IRB’s role and assumed bio-clinical predisposition and the ability of (...) behavioral and social science researchers to have their research methodologies and research understood and appreciated by IRB members. The article explores some of the dilemmas confronting IRB members and administrators in the review and administration of the action research protocols, particularly those that involve vulnerable populations and which, from the practitioner–researcher’s perspective, focus on the practitioner–researcher as the object of the research. (shrink)

This article examines the historical representation of the Jinshin Rebellion as a foundational event in the Nihon shoki and other eighth-century Japanese texts. Focusing on the differences between two alternative stories of Tenmu’s departure from the Ōmi capital to Yoshino, I argue that the Nihon shoki contains traces of several competing historical narratives that are the expression of a historical process: the political struggles over the historical record and the representation of Tenmu’s legitimacy in the early eighth century when the (...) Nihon shoki was being compiled. (shrink)

Recovering Reason: Essays in Honor of Thomas L. Pangle is a collection of essays composed by students and friends of Thomas L. Pangle to honor his seminal work and outstanding guidance in the study of political philosophy. These essays examine both Socrates' and modern political philosophers' attempts to answer the question of the right life for human beings, as those attempts are introduced and elaborated in the work of thinkers from Homer and Thucydides to Nietzsche and Charles Taylor.

This volume is a collection of essays by various contributors in honor of the late Laurence Berns, Richard Hammond Elliot Tutor Emeritus at St. John's College, Annapolis. The essays address the literary, political, theological, and philosophical themes of his life's work as a scholar, teacher, and constant companion of the "great books.".

Drawing out literal and metaphorical meanings of 'foreignness' this wide-ranging volume offers much to scholars of postcolonial, gender, and cultural studies seeking new approaches to the study of alterity.