Following the widespread occurrence of birth defects from the use of thalidomide to treat nausea during pregnancy in the 1960s and 1970s, the Food and Drug Administration became particularly vigilant about the use of therapeutic agents during pregnancy and in women of childbearing potential. The FDA developed a list that categorizes an agent according to the known risks to a fetus. The drug thalidomide falls into Category X: agents that have demonstrated clear risk of fetal abnormalities and whose risks outweigh (...) the benefits of use during pregnancy.Another Category X drug is isotretinoin, commonly known by its trade name Accutane. Isotretinoin is an oral medication prescribed for severe recalcitrant, nodular acne in patients who are unresponsive to conventional therapy. Isotretinoin has been available since 1982, and it remains the only effective treatment for this condition. (shrink)

The United States Food and Drug Administration , in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin , a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential (...) corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential as it compares to the risk-benefit relationship of using isotretinoin. (shrink)

The American Journal of Bioethics, Volume 11, Issue 11, Page 31-38, November 2011.

The American Journal of Bioethics, Volume 12, Issue 1, Page W1-W2, January 2012.

In their article in the September-October 2010 issue of IRB: Ethics & Human Research, Chris Kaposy and Françoise Baylis argue that the contraception policy of the University of Nebraska Medical Center’s institutional review board fails to meet an ethically ideal standard in establishing the criteria investigators should follow when including women of childbearing potential in clinical research. In this response, we argue that the UNMC IRB’s policy is evidence-based and pragmatically oriented and that it therefore better safeguards women’s autonomy than (...) an ideal policy could. We also offer some of our experiences with the policy since it was implemented six years ago. (shrink)

Four experiments examined the strategies that individuals develop in sentential reasoning. They led to the discovery of five different strategies. According to the theory proposed in the paper, each of the strategies depends on component tactics, which all normal adults possess, and which are based on mental models. Reasoners vary their use of tactics in ways that have no deterministic account. This variation leads different individuals to assemble different strategies, which include the construction of incremental diagrams corresponding to mental models, (...) and the pursuit of the consequences of a single model step by step. Moreover, the difficulty of a problem (i.e., the number of mental models required by the premises) predisposes reasoners towards certain strategies. Likewise, the sentential connectives in the premises also bias reasoners towards certain strategies, e.g., conditional premises tend to elicit reasoning step by step whereas disjunctive premises tend to elicit incremental diagrams. (shrink)

In many experimental sciences, like particle physics or molecular biology, the proper place for establishing facts is the laboratory. In the sciences of population biology, however, the laboratory is often seen as a poor approximation of what occurs in nature. Results obtained in the field are usually more convincing. This raises special problems: it is much more difficult to obtain stable, repeatable results in the field, where environmental conditions vary out of the experimenter’s control, than in the laboratory. We examine (...) here how this problem affected an influential experimental research tradition in community ecology, the study of the ecology of the rocky seashores. In the 1960s, a handful of North-American ecologists, most notably Joseph Connell, Robert Paine and Paul Dayton, made the rocky seashores a model study system for experimenting in the field. Their experiments were deceptively simple: they removed species living on the seashore and described the resulting effects on the local ecology. These experiments exerted a deep influence on community ecology. They provided evidence for speculative developments concerning the theory of interspecific competition, the factors responsible for species richness and the ecology of food webs. They also stimulated novel conceptual developments. In particular, Paine developed the predation hypothesis, which states that the presence of predators can favour species richness, before introducing the keystone species concept, according to which some species exert disproportionate effects on ecological systems. More broadly, these experiments gave support to a methodological trend in favour of field experimentation. Only controlled perturbations in the field, it seemed, provided a reliable method to get insights into the structure of ecological communities. However, as experiments were continued in time and repeated in different sites, divergent results appeared. We analyse here how intertidal researchers coped with the variability of environmental conditions and tried to stabilize their results. In the process, they reconsidered not only their early conclusions, but also the exclusive status given to field experiments. Expanding on this case study, we discuss some significant differences between laboratory and field experiments. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Narrative Symposium:Conflicting Interests in MedicineLaura Jean Bierut, Sal Cruz-Flores, Laura E. Hodges, Anthony A. Mikulec, Govind K. Nagaldinne, Erine L. Bakanas, John F. Peppin, Joel S. Perlmutter, William H. Seitz Jr., Edward Diao, Andre N. Sofair, and David M. Zientek• To Recruit or Not to Recruit for a Clinical Trial• An Unexpected Lesson• Am I on call for the entire Midwest?• Why is Medicare Wasting Away?• The Downside (...) of the Informed Consent Juggernaut• Expert Testimony at the Food and Drug Administration: Who Wants the Truth?• Crossroads: The Intersection of Personal, Professional Society, and Industry Relationships• A Change of Heart• The Evolution of Conflicts of Interest in a New Subspecialty: A Case Study of the Development of Interventional CardiologyCopyright © 2011 The Johns Hopkins University Press... (shrink)

Four experiments examined the strategies that individuals develop in sentential reasoning. They led to the discovery of five different strategies. According to the theory proposed in the paper, each of the strategies depends on component tactics, which all normal adults possess, and which are based on mental models. Reasoners vary their use of tactics in ways that are not deterministic. This variation leads different individuals to assemble different strategies, which include the construction of incremental diagram corresponding to mental models, and (...) the pursuit of the consequences of a single model step by step. Moreover, the difficulty of a problem (i.e. the number of mental models required by the premises) predisposes reasoners towards certain strategies. Likewise, the sentential connectives in the premises also bias reasoners towards certain strategies, e.g., conditional premises tend to elicit reasoning step by step whereas disjunctive premises tend to elicit incremental diagrams. (shrink)

Four experiments examined the strategies that individuals develop in sentential reasoning. They led to the discovery of five different strategies. According to the theory proposed in the paper, each of the strategies depends on component tactics, which all normal adults possess, and which are based on mental models. Reasoners vary their use of tactics in ways that have no deterministic account. This variation leads different individuals to assemble different strategies, which include the construction of incremental diagrams corresponding to mental models, (...) and the pursuit of the consequences of a single model step by step. Moreover, the difficulty of a problem (i.e., the number of mental models required by the premises) predisposes reasoners towards certain strategies. Likewise, the sentential connectives in the premises also bias reasoners towards certain strategies, e.g., conditional premises tend to elicit reasoning step by step whereas disjunctive premises tend to elicit incremental diagrams. (shrink)

Web-based platforms play an increasingly important role in managing and sharing research data of all types and sizes. This article presents a case study of the data storage, sharing, and management platform Figshare. We argue that such platforms are displacing and reconfiguring the infrastructure of norms, technologies, and institutions that underlies traditional scholarly communication. Using a theoretical framework that combines infrastructure studies with platform studies, we show that Figshare leverages the platform logic of core and complementary components to re-integrate a (...) presently splintered scholarly infrastructure. By means of this logic, platforms may provide the path to bring data inside a scholarly communication system still optimized mainly for text publications. Yet the platform strategy also risks turning over critical scientific functions to private firms whose longevity, openness, and corporate goals remain uncertain. It may amplify the existing trend of splintering infrastructures, with attendant effects on equity of service. (shrink)

INTRODUCTION JEAN-MICHEL GANTEAU AND SUSANA ONEGA The rise of trauma theory in the critical field is a recent phenomenon associated with the revival of ...

Bullying often results in negative coping in victims, including an increased consumption of alcohol. Recently, however, an increase in alcohol use has also been reported among perpetrators of bullying. The factors triggering this pattern are still unclear. We investigated the role of empathy in the interaction between bullying and alcohol use in an adolescent sample (IMAGEN) at age 13.97 (±0.53) years (baseline (BL), N = 2165, 50.9% female) and age 16.51 (±0.61) years (follow-up 1 (FU1), N = 1185, 54.9% female). (...) General empathic distress served as a significant moderator of alcohol use in perpetrators (F9, 493 = 17.978, p < 0.01), which was specific for males and FU1. Male perpetrators, who are generally less sensitive to distress, might thus be more vulnerable to alcohol abuse. (shrink)

Dans les sociétés démocratiques contemporaines, les individus revendiquent le droit d'aimer librement. Ils sont attachés à la réussite de leur vie sentimentale et à l'épanouissement de leur sexualité. Mais le corps épris nous permet-il d'accéder à l'existence heureuse que nous désirons? Dans ce livre, Jean-Marie Frey met au jour les ressorts de l'inquiétude suscitée par l'amour charnel. Il montre comment la pudibonderie et le libertinage expriment, chacun à leur manière, une tentative pour se rassurer. Les prudes désireux de voiler (...) les femmes et les libertins exhibant un corps morcelé dans l'imagerie pornographique, n'éprouvent-ils pas les uns et les autres une crainte devant la chair désirable? L'auteur oppose les figures du pudibond et du libertin à celle d'un amant disposé à jouer le jeu d'une passion amoureuse à la fois inquiétante et joyeuse. (shrink)

Argumentation is a very fertile area of research in Artificial Intelligence, and various semantics have been developed to predict when an argument can be accepted, depending on the abstract structure of its defeaters and defenders. When these semantics make conflicting predictions, theoretical arbitration typically relies on ad hoc examples and normative intuition about what prediction ought to be the correct one. We advocate a complementary, descriptive-experimental method, based on the collection of behavioral data about the way human reasoners handle these (...) critical cases. We report two studies applying this method to the case of reinstatement (both in its simple and floating forms). Results speak for the cognitive plausibility of reinstatement and yet show that it does not yield the full expected recovery of the attacked argument. Furthermore, results show that floating reinstatement yields comparable effects to that of simple reinstatement, thus arguing in favor of preferred argumentation semantics, rather than grounded argumentation semantics. Besides their theoretical value for validating and inspiring argumentation semantics, these results have applied value for developing artificial agents meant to argue with human users. (shrink)

L'Islam, dont la société se caractérise par un attachement massif à la règle et au précepte, n'en a pas moins connu au long des siècles les effets de courants divers. Mais cette société intègre des interprétations intérioristes ou mystiques, parfois en conflit avec la loi, et elle fait une place aux héritages des sagesses étrangères, iranienne et hellénique notamment.

BackgroundRadiotherapy is an essential component of cancer treatment, yet many countries do not have adequate capacity to serve all patients who would benefit from it. Allocation systems are needed to guide patient prioritization for radiotherapy in resource-limited contexts. These systems should be informed by allocation principles deemed relevant to stakeholders. This study explores the ethical dilemmas and views of decision-makers engaged in real-world prioritization of scarce radiotherapy resources at a cancer center in Rwanda in order to identify relevant principles.MethodsSemi-structured interviews (...) were conducted with a purposive sample of 22 oncology clinicians, program leaders, and clinical advisors. Interviews explored the factors considered by decision-makers when prioritizing patients for radiotherapy. The framework method of thematic analysis was used to characterize these factors. Bioethical analysis was then applied to determine their underlying normative principles.ResultsParticipants considered both clinical and non-clinical factors relevant to patient prioritization for radiotherapy. They widely agreed that disease curability should be the primary overarching driver of prioritization, with the goal of saving the most lives. However, they described tension between curability and competing factors including age, palliative benefit, and waiting time. They were divided about the role that non-clinical factors such as social value should play, and agreed that poverty should not be a barrier.ConclusionsMultiple competing principles create tension with the agreed upon overarching goal of maximizing lives saved, including another utilitarian approach of maximizing life-years saved as well as non-utilitarian principles, such as egalitarianism, prioritarianism, and deontology. Clinical guidelines for patient prioritization for radiotherapy can combine multiple principles into a single allocation system to a significant extent. However, conflicting views about the role that social factors should play, and the dynamic nature of resource availability, highlight the need for ongoing work to evaluate and refine priority setting systems based on stakeholder views. (shrink)

Un mot d'usage quotidien, "danger", est devenu concept chez Heidegger. L'usage heideggerien de "danger" n'est pourtant pas celui de ce livre, qui refuse de s'engager de front dans la "question de l'être" au profit des manières ou modes d'être, dont il explore un échantillon sans prétention exhaustive mais utilisé comme trame heuristique. Mode d'être de l'oeuvre d'art, mode d'être de la "chose" ou du sacrement, mode d'être comme "existence" et comme "vie", un danger est toujours présent : l'existence, telle que (...) décrite chez Heidegger, est déconstituée par des phénomènes auxquels elle ne peut rendre justice ; la vie abrite l'existence mais court le risque perpétuel de n'être que dans les frontières de l'existence, etc. Et si l'étant nous est toujours donné dans un comment - comment de son apparaître, donc comment de son être -, rien ne garantit la pérennité de cette donation : presque tout étant, et d'abord l'étant que nous sommes, est en danger d'apparaître autre qu'il ne nous apparaît maintenant. Aussi convenait-il, après avoir ajointé le concept de vie à celui d'esprit, après avoir dit que la vie est "spirituelle", de justifier le titre du livre en liant "être" et "danger" ; et il restait au final le temps de proposer, dans l'élément du possible, l'hypothèse d'une eschatologie de l'être, avant tout de notre être, sur laquelle le danger n'aurait plus de prise. (shrink)

Le terme de République est un mot dont l’évidence et la présence dans notre culture politique contemporaine n’ont d’égales que ses indéterminations de longue durée. La première de ces indéterminations tient d’ailleurs à l’origine de « république » dans le syntagme latin res publica avec le sens immédiatement complexe et polysémique d’une notion que l’on retrouve abondamment utilisée sous la République romaine proprement dite mais aussi sous l’Empire. Questionner la res publica, c’est donc évidemment questionner un pan crucial de l’histoire (...) politique romaine mais c’est aussi intervenir dans l’histoire politique tout court et dans la réflexion méthodologique sur la langue de cette politique. Pas de modélisation stabilisée donc et pas plus de recherche de « l’essence de la chose », pas non plus de prétention à une définition de l’objet d’étude puisqu’une suite d’effacements et de réapparitions des noyaux de sens est le propre de la res publica. L’enquête dynamique porte sur une question qui devient, selon un syntagme présent, de façon significative, dans la dernière page de l’ouvrage de Claudia Moatti, « référence mobilisatrice », politique donc. En effet, dans ce parcours, l’acceptation de l’incertitude et de l’indétermination devient en quelque sorte le prix à payer pour retrouver la vie des mots et leur charge historique, en tant qu’ils se lient à l’action des hommes, à leur engagement dans le monde, sans s’appuyer sur les certitudes sémantiques ni sur un programme à mettre en œuvre mais en partant de questions ouvertes justement parce qu’aucune des réponses proposées ne s’est avérée satisfaisante. La comparaison avec un autre moment de crise politique et sémantique, le moment machiavélien, permettra en conclusion d’illustrer la fécondité de la perspective adoptée. (shrink)

De la pierre de Jacob, décrite dans la Bible à la pierre philosophale ; des mégalithes de Stonehenge à la pierre cubique des francs-maçons, combien de fois la pierre a-telle été représentée en tant que symbole! L'auteur invite le lecteur à faire ce voyage dans l'espace et dans le temps, où, systématiquement, la pierre va se trouver associée à un événement qui a marqué l'humanité : les mégalithes, alignés dans la direction du lever du soleil aux solstices, les "pierres tombées (...) du ciel", dont on s'est demandé si elles n'étaient pas messagères des dieux ; les pierres qui guérissent, celles utilisées pour prédire l'avenir... La pierre résiste à l'usure du temps. Elle va donc servir de mémoire, de support pour transcrire les grands faits marquants qui ont ponctué notre histoire. Mais elle est aussi le matériau noble de la construction, celle avec laquelle on construit des temples pour rendre hommage aux divinités. La Franc-maçonnerie, ensuite, reprendra à son compte l'héritage et le corpus symbolique des métiers de la construction : la pierre brute, la pierre cubique, la pierre de fondation, la pierre d'angle, la clef de voûte, pour en tirer un enseignement philosophique. (shrink)

Extensive research has demonstrated that rs1360780, a common single nucleotide polymorphism within the FKBP5 gene, interacts with early-life stress in predicting psychopathology. Previous results suggest that carriers of the TT genotype of rs1360780 who were exposed to child abuse show differences in structure and functional activation of emotion-processing brain areas belonging to the salience network. Extending these findings on intermediate phenotypes of psychopathology, we examined if the interaction between rs1360780 and child abuse predicts resting-state functional connectivity (rsFC) between the amygdala (...) and other areas of the salience network. We analyzed data of young European adults from the general population (N = 774; mean age = 18.76 years) who took part in the IMAGEN study. In the absence of main effects of genotype and abuse, a significant interaction effect was observed for rsFC between the right centromedial amygdala and right posterior insula (p <.025, FWE-corrected), which was driven by stronger rsFC in TT allele carriers with a history of abuse. Our results suggest that the TT genotype of rs1360780 may render individuals with a history of abuse more vulnerable to functional changes in communication between brain areas processing emotions and bodily sensations, which could underlie or increase the risk for psychopathology. (shrink)

Virtue and the Moral Life brings together distinguished philosophers and theologians with younger scholars of consummate promise to produce ten essays that engage both academics and students of ethics. This collection explores the role virtues play in identifying the good life and the good society.

Virtue and the Moral Life brings together distinguished philosophers and theologians with younger scholars of consummate promise to produce ten essays that engage both academics and students of ethics. This collection explores the role virtues play in identifying the good life and the good society.

We estimate that 208,000 deep brain stimulation (DBS) devices have been implanted to address neurological and neuropsychiatric disorders worldwide. DBS Think Tank presenters pooled data and determined that DBS expanded in its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. The DBS Think Tank was founded in 2012 providing a space where clinicians, engineers, researchers from industry and academia discuss current and emerging DBS technologies and logistical and ethical issues facing the field. (...) The emphasis is on cutting edge research and collaboration aimed to advance the DBS field. The Eighth Annual DBS Think Tank was held virtually on September 1 and 2, 2020 (Zoom Video Communications) due to restrictions related to the COVID-19 pandemic. The meeting focused on advances in: (1) optogenetics as a tool for comprehending neurobiology of diseases and on optogenetically-inspired DBS, (2) cutting edge of emerging DBS technologies, (3) ethical issues affecting DBS research and access to care, (4) neuromodulatory approaches for depression, (5) advancing novel hardware, software and imaging methodologies, (6) use of neurophysiological signals in adaptive neurostimulation, and (7) use of more advanced technologies to improve DBS clinical outcomes. There were 178 attendees who participated in a DBS Think Tank survey, which revealed the expansion of DBS into several indications such as obesity, post-traumatic stress disorder, addiction and Alzheimer’s disease. This proceedings summarizes the advances discussed at the Eighth Annual DBS Think Tank. (shrink)