Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)
The distinction between germline and somatic gene editing is fundamental to the ethics of human gene editing. Multiple conferences of scientists, ethicists, and policymakers, and multiple professional bodies, have called for moratoria on germline gene editing, and editing of human germline cells is considered to be an ethical “red line” that either never should be crossed, or should only be crossed with great caution and care. However, as research on germline gene editing has progressed, it has become clear that not (...) all germline interventions are alike, and that these differences make a significant moral difference, when it comes to ethical questions about research, regulation, clinical application, and medical justification. In this paper, I argue that, rather than lumping all germline interventions together, we should distinguish between revising, correcting, and transferring genes, and I assess the consequences of this move for the ethics of gene editing. (shrink)
Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerningintergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of (...) this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued. (shrink)
Global governance of emerging, disruptive biomedical technologies presents a multitude of ethical problems. The recent paper by Shoziet alraises some of these problems in the context of a discussion of what could be themostdisruptive (and most morally fraught) emerging biomedical technology—human germline genome editing. At the heart of their argument is the claim that, for something like gene editing, there is likely to be tension between the interests of specific states in crafting regulation for the technology, and disagreement about what (...) would be necessary to meet the requirements for responsible translation of gene editing into the clinic. This complicates hopes for a tidy, algorithmic process of crafting global governance via frameworks for regulation built around core ‘ethical values and principles’ (as they are called in the WHO Framework), and also forces us to confront deeper philosophical questions about biotechnology and global health. (shrink)
Valéry’s conceptions of mind, literature and even philosophy often stress the importance of an effort against heterogeneity that should be led in the name of what the author himself calls pureté. On the other hand, the theories that Valéry develops about composition - which is intended both as an aesthetic and a theoretical concept - show the importance of complexity in his representation of the esprit and allows to compare Valéry’s descriptions of the self with the way he represents creative (...) process and even draws the structure of his own works. (shrink)
:Since the advent of recombinant DNA technology, expectations about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context—germline intervention in reproductive medicine—issues (...) about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility. (shrink)
When developing computational models to analyze the tradeoffs between climate risk management strategies (i.e., mitigation, adaptation, or geoengineering), scientists make explicit and implicit decisions that are influenced by their beliefs, values and preferences. Model descriptions typically include only the explicit decisions and are silent on value judgments that may explain these decisions. Eliciting scientists’ mental models, a systematic approach to determining how they think about climate risk management, can help to gain a clearer understanding of their modeling decisions. In order (...) to identify and represent the role of values, beliefs and preferences on decisions, we used an augmented mental models research approach, namely values-informed mental models (ViMM). We conducted and qualitatively analyzed interviews with eleven climate risk management scientists. Our results suggest that these scientists use a similar decision framework to each other to think about modeling climate risk management tradeoffs, including eight specific decisions ranging from defining the model objectives to evaluating the model’s results. The influence of values on these decisions varied between our scientists and between the specific decisions. For instance, scientists invoked ethical values (e.g., concerns about human welfare) when defining objectives, but epistemic values (e.g., concerns about model consistency) were more influential when evaluating model results. ViMM can (i) enable insights that can inform the design of new computational models and (ii) make value judgments explicit and more inclusive of relevant values. This transparency can help model users to better discern the relevance of model results to their own decision framing and concerns. (shrink)
In debates about the moral foundations of intellectual property, one very popular strand concerns the role of labor as a moral basis for intellectual property rights. This idea has a great deal of intuitive plausibility; but is there a way to make it philosophically precise? That is, does labor provide strong reasons to grant intellectual property rights to intellectual laborers? In this paper, I argue that the answer to that question is “yes”. I offer a new view, different from existing (...) labor theories of intellectual property, which I call the productive capacities view. This view gives us a way to make sense of the idea of labor as the basis for intellectual property rights, as well as a tool for critically evaluating existing intellectual property institutions. (shrink)
Diagnostic testing can be used for many purposes, including testing to facilitate the clinical care of individual patients, testing as an inclusion criterion for clinical trial participation, and both passive and active surveillance testing of the general population in order to facilitate public health outcomes, such as the containment or mitigation of an infectious disease. As such, diagnostic testing presents us with ethical questions that are, in part, already addressed in the literature on clinical care as well as clinical research (...) (such as the rights of patients to refuse testing or treatment in the clinical setting or the rights of participants in randomized controlled trials to withdraw from the trial at any time). However, diagnostic testing, for the purpose of disease surveillance also raises ethical issues that we do not encounter in these settings, and thus have not been much discussed. In this paper we will be concerned with the similarities and differences between the ethical considerations in these three domains: clinical care, clinical research, and public health, as they relate to diagnostic testing specifically. Via an examination of the COVID-19 case we will show how an appeal to the concept of diagnostic justice helps us to make sense of the (at times competing) ethical considerations in these three domains. (shrink)
"Paul Valery: Illusions of Civilization" opens a vast discussion of the meaning of civilization, in particular, Western civilization. It causes us to face the problems of survival, meaning, and ends. This discussion with Valery is unique - never before has such an encounter taken place. The reader is overwhelmed and challenged. The problems are presented with amazing clarity and depth.".
"Paul Valery: The Continuous Search for Reality" is William Kluback's fourth volume of Valery studies. The three previous volumes are: "Paul Valery: Philosophical Reflections" ; "Paul Valery: The Search for Intelligence" ; and "Paul Valery: Illusions of Civilizations". These volumes reveal a life-long dedication to one of the greatest figures of twentieth-century Western European civilization. Valery's work embraces poetry and mathematics, theatre and physics, politics and sociology.".
Though questions about whether gene editing should be done at all have dominated ethical discussion, a literature about how it can be done ethically has been growing. Work on responsible translational pathways for human germline gene editing has been criticized for focusing on the wrong questions. But questions about responsible translational pathways—questions about how gene editing could be done ethically—are, in an important sense, prior to questions about whether it is desirable and permissible. Asking “whether” questions about gene editing requires (...) a model of what responsible clinical use of gene editing would look like. (shrink)
In the present article, I will address the question of whether Paul Valéry’s thought can somehow contribute to the recent debate concerning the philosophy of literature. Firstly, I will focus on the idea according to which philosophy can be meant not only as a literary genre but also as an art of thinking. This allows Valéry to state that the poet, too, has a philosophy insofar as he or she is able to think abstractly by practicing his or her own (...) mind. Secondly, following some remarks of Derrida and Rorty, I will discuss Valéry’s idea according to which the philosopher is a philosopher to the extent that he or she forgets that philosophy has to be written. This will lead me to distinguish the peculiar aesthetics of the philosopher as writer from that of the poet. (shrink)
In this article, we describe a project in which philosophy, in combination with methods drawn from mental modeling, was used to structure dialogue among stakeholders in a region-scale climate adaptation process. The case study we discuss synthesizes the Toolbox dialogue method, a philosophically grounded approach to enhancing communication and collaboration in complex research and practice, with a mental modeling approach rooted in risk analysis, assessment, and communication to structure conversations among non-academic stakeholders who have a common interest in planning for (...) a sustainable future. We begin by describing the background of this project, including details about climate resiliency efforts in West Michigan and the Toolbox dialogue method, which was extended in this project from academic research into community organization involving the West Michigan Climate Resiliency Framework Initiative. This extension involved application of several methods, which are the focus of the Methods section. We then present and discuss preliminary results that suggest the potential for philosophical dialogue to enhance mutual understanding in complex community initiatives that focus on sustainable responses to climate change. Overall, the article supplies a detailed, instructive example of how philosophy can support policy-relevant decision-making processes at the community level. (shrink)
Social problems such as racism, sexism, and inequality are often cited as structural rather than individual in nature. What does it mean to invoke a social structural explanation, and how do such explanations relate to individualistic ones? This article explores recent philosophical debates concerning the nature and usages of social structural explanation. I distinguish between two central kinds of social structural explanation: those that are autonomous from psychology, and those that are not. This distinction will help clarify the explanatory power (...) that each type of SSE has, points of convergence with methodological traditions such as critical theory and rational choice theory, and the difficulties that each type of SSE faces. (shrink)
who is absorbed by science and medicine. This is William Kluback's seventh volume in a series of studies on Paul Valéry. This book shows how Valéry went beyond philosophy to wisdom. His achievement was so rare that we remain fascinated by his writings. We see in him a man whose constructions build bridges from one human endeavor. He is a poet who is absorbed by science and medicine.
Where the philosopher has feared to tread, in a realm that has been declared not only non-philosophical, but anti-philosophical, this study attempts quietly to illuminate Paul Valery's reflections on literature, painting, sculpture and poetry. Professor Kluback ventures into this world of aesthetic insights which has often seemed reserved only for the artist, and off limits to the philosopher, whose explorations tend increasingly to be confined to the technicalities of logic and dialectic.".
Devoted to the art of creativity, to the analysis of the creative act, Valery was recognized as the greatest intellectual figure of the twentieth century. This is a book of conversations, an intimate reading of texts attempting to absorb their insights, their elegance and their tones. Reading Valery is an aesthetic experience, a feeling linking the reader to the finesse of thinking. This is the second volume of the author's Paul Valery studies. The first volume was published by Peter Lang (...) in 1987.". (shrink)
In the face of the Gulags and the Holocaust, of mass murder and universal deception, Paul Valery maintained his faith in rationality. In this faith of reason, he found the strength to continue his work. This study of the French poet and essayist examines his interpretation of his role as a political thinker, and the effect of Descartes on his view of Self. This is the author's sixth volume on Valery. Annotation copyrighted by Book News, Inc., Portland, OR.
Yule, Valerie The UN Declaration of Human Rights as it stands is short and intelligible enough for educated people, but language and length are still too hard for everyone. A shorter, simpler version could be understood by all, and be a ready reference. It could be part of the humanist curriculum for schools, and agreement with it part of the admission to citizenship.
To what extent should we focus on implicit bias in order to eradicate persistent social injustice? Structural prioritizers argue that we should focus less on individual minds than on unjust social structures, while equal prioritizers think that both are equally important. This article introduces the framework of transactive memory into the debate to defend the equal priority view. The transactive memory framework helps us see how structure can emerge from individual interactions as an irreducibly social product. If this is right, (...) then debiasing interventions are structural interventions. One upshot is that the utility of the individual versus structural distinction is not apparent for the purposes of intervention. (shrink)
As of this writing, twenty‐one states have passed laws barring transgender youth‐athletes from competing on public‐school sports teams in accordance with their gender identity. Proponents of these regulations claim that transgender females in particular have inherent physiological advantages that threaten a “level playing field” for their cisgender competitors. Existing evidence is limited but does not support these restrictions. Gathering more robust data will require allowing transgender youth to compete (rather than preemptively barring them), but even if trans females are shown (...) to retain some advantage, this would not have greater moral significance than the many other “fair” physical and economic advantages found across sports. These regulations deprive transgender youth, an exceptionally vulnerable population, from the vast physical, mental, and social benefits of sports. While we advocate for transgender inclusion under our current, gender‐segregated model of sport, we propose changes to the overarching structure that would promote a more inclusive and fairer athletic environment. (shrink)
Contrary to the prevailing view, there is not one, but at least two poetic theories in Paul Valéry: the intellectual, formalist and technical poetics Valéry is usually associated to conflicts with another poetics, which highlights sensitivity, lyricism and subjectivity. The constitutive duplicity of Valéry’s literary theory has probably something to do with the ambiguity of his relationship with Stéphane Mallarmé.
This is the first philosophy textbook in moral psychology, introducing students to a range of philosophical topics and debates such as: What is moral motivation? Do reasons for action always depend on desires? Is emotion or reason at the heart of moral judgment? Under what conditions are people morally responsible? Are there self-interested reasons for people to be moral? Moral Psychology: A Contemporary Introduction presents research by philosophers and psychologists on these topics, and addresses the overarching question of how empirical (...) research is relevant to philosophical inquiry. (shrink)
This basic guide introduces the relationships between observation, perception, and learning that form the substance of hierarchy theory. This theory aims to answer the question of whether there is a basic structure to nature, comprising discreet levels of organization within an overall pattern.
Valerie Steele, conservatrice du musée du Fashion Institute of Technology de New York et rédactrice en chef d'une revue de grande qualité, Fashion Theory : the journal of Dress, Body and Culture, est une référence très importante dans le domaine de l'histoire de la mode. Ce livre (traduit de l'américain) ne répond que très imparfaitement à son titre ambitieux « se vêtir » , qui est aussi celui d'une collection (deux ouvrages déjà parus, l'un sur le Moyen Âge (...) et l'autre sur le XVIIIe... (shrink)
A Brilliant Introduction To The Essence Of Living Hinduism The Thirteen Principal Upanisads, Sanskrit Texts In The Religious Traditions Of The Vedas, Lie At The Heart Of Hinduism. Devoted To Understanding The Inner Meaning Of The Religion, They Explicate Its Crucial Doctrines Rebirth, The Law Of Karma, The Means Of Conquering Death And Of Achieving Detachment, Equilibrium And Spiritual Bliss. They Emphasize The Perennial Search For True Knowledge Especially That Of The Connection Between The Self And The Transcendental Absolute. In (...) This Translation, Marked By Empathy And Erudition, Valerie Roebuck Approaches The Upanisads As Belonging To The Tradition Of 'Sruti', Literature Which Is Heard, As Distinct From 'Smriti', Which Is Remembered. Seeking To Reveal The Intent Of The Authors, She Attempts To Represent What, In Fact, Constitutes The Original Text. Care Is Taken To Exclude Later Accretions Of Commentaries. The Invocations Included Underline The Traditional Recitation Of These Texts, And The Literary Devices Repetitions, Dialogue And Word Combat, Riddles, Paradoxes And Word Play Used By The Sages To Express Their Teachings. This Accurate And Exceptional Rendering, While Making Accessible To The Modern Reader Something Of The Beauty And Variety Of The Original Language, Reaffirms The Place Of The Upanishads As One Of The Most Profound Works Of World Literature. This Authentic And Nuanced Rendering Makes Accessible To The Modern Reader Something Of The Beauty And Variety Of These Ancient And Rich Texts Of Hinduism. The Upanisads Belong To The Tradition Of Literature That Is Heard Rather Than Remembered , And In Her Translation Roebuck Seeks To Reveal The Intent Of The Authors And Arrive At 'The Original' Text. (shrink)
The number of distributors selling Fair Trade products is constantly increasing. What are their motivations to distribute Fair Trade products? How do they organise this distribution? Do they apply and communicate the Fair Trade values? This research, based on five case studies in Switzerland, aims at understanding and structuring the strategies and the managerial practices related to Fair Trade product distribution, as well as analysing if they denote an engagement with Fair Trade principles. The results show a high heterogeneity of (...) strategies and engagement. In general, strategies implemented by mainstream actors contribute to increase Fair Trade global sales but do not convey the transformative message of Fair Trade through their engagement. The latter is rather communicated through alternative channels. Problems and potential solutions to this issue are discussed. (shrink)
Just war thinking serves a social and psychological role that international law cannot fill. Law is dispassionate and objective, while just war thinking accounts for emotions and the situatedness of individuals. While law works on us externally, making us accountable to certain people and institutions, just war thinking affects us internally, making us accountable to ourselves. Psychologically, an external focus leads to feelings of shame, while an inward focus generates feelings of guilt. Philosophers have long recognized the importance of these (...) two moral emotions. Recently, psychologists have found that feelings of guilt are linked to positive social outcomes, such as the desire for reconciliation and reparation, while shame generates anger and hostility. Just war thinking, as an inward-looking tradition, has a special relationship with guilt. By focusing on moral emotions, just war thinking can move beyond the law in four ways, by developing an ethic of accountability, by providing a foundation for addressing moral injury, by providing a common language for discussing the costs of war, and for identifying ethical problems in radically new contexts. (shrink)
What is well-being? This is one of humanity's oldest and deepest questions; Valerie Tiberius offers a fresh answer. She argues that our lives go well to the extent that we succeed in what matters to us emotionally, reflectively, and over the long term. So when we want to help others achieve well-being, we should pay attention to their values.