Le culte grandiose de Kali, la Mère, son incomparable symbolisme, ses litanies et ses chants, embrasse l'âme de l'univers qu'il glorifie comme aucune conception religieuse ne le fit jamais. La terrifiante déesse sème la peste et les pires ravages sur ses pas, tout en accordant sa grâce et sa clémence à ses enfants assez hardis pour soulever l'horrible masque derrière lequel elle se cache la figure. Ceux-là retrouveront les traits radieux qui ont enchanté leur enfance. La sublime conception de Kali, (...) la Mère, découle d'une philosophie moniste qui s'écarte pourtant sensiblement de la philosophie Védanta de Shankara. Tous deux partent, il est vrai, de la même idée. Ils admettent l'un et l'autre une substance une, indivisible et éternelle, que les Védantins appellent Brahma et les adorateurs de Kali, la Mère, Siva. Mais il y a divergence quant aux manifestations. Pour Shankara il n'y a qu'illusion. Il tranche le lien qui rattache le phénomène à l'absolu. Il se demande qui a pu susciter l'apparence. Mais, l'absolu étant la vérité même, il n'a pu engendrer l'apparence pas plus que la lumière n'aurait pu engendrer l'obscurité. Qu'y avait-il donc de commun entre les Brahmas et Maya? A première vue il semble qu'il n'y a aucun rapport. Pour Shankara il n'était besoin d'aucune relation, puisque Maya n'existe pas en réalité et que le monde n'est que mirage. Le monde n'existe que pour l'esprit qui est lui-même sujet aux hallucinations. Adorer la Mère, c'est accepter l'univers dans ses aspects les plus terrifiants. Cette philosophie est diamétralement opposée au christianisme dans son culte du Dieu d'amour, du Père plein de miséricorde. Le christianisme enseigne que tout se fait pour notre bien, tandis que pour les adorateurs de Kali, l'univers est féroce et hostile à l'homme, qui avant tout doit se montrer supérieur aux événements. Mais Kali n'est pas seulement la destructrice. Si elle démolit inexorablement toutes les formes vitales qui ont fait leur temps et qui se détériorent, elle en crée au fur et à mesure des nouvelles. C'est dans cette conception de la Mère qu'il faut chercher tout d'abord le mystère de l'esprit indien. Dans son essence la plus intime la mère du monde est l'absolu, est Siva même. Comme telle elle représente la connaissance, l'entité et la joie absolues. Pour les adorateurs de Kali les mots Mantram Saham (je suis elle) renferment la clef de la vie et dissipent crainte et tristesse. (shrink)

Notre époque, traversée de courants mystiques, manifeste un intérêt tout particulier pour les idées du neo-platonicien Plotin. Pour le platonicien l'univers participe à l'idée. Platon considérait les choses comme le reflet de l'idée, ce que Plotin se refusait à admettre. La diversité dont la vie fait preuve atteste son inépuisable richesse, et si les choses dans leur état particulier sont imparfaites et défectueuses, c'est que chaque chose représente sa particularité d'une façon imparfaite. Le dualisme platonicien se retrouve chez Plotin; à (...) côté du monde de l'erreur et de l'apparence il situe celui de la vérité et de la réalité. Mais l'ordre des deux mondes étant différent, nécessairement les catégories qui y règnent diffèrent. Contrairement au monde du temps et de l'espace, où tout est désaccord et combat, l'accord et l'harmonie règnent dans le monde de l'idée. D'après Platon l'idée de l'être implique l'idée du repos. Pour Plotin le mouvement et le repos ne sont pas incompatibles. Il y a encore un point de divergence entre les deux philosophes. Tandis que Platon conçoit le bien comme idée, Plotin le superpose au monde des idées et l'en sépare. A l'oppossé du maître il n'était pas dualiste mais moniste. La conception platonicienne du bien est purement éthique, c.a.d. humaine, la conception de Plotin est plus cosmique. L'univers lui apparaît comme une trinité: le monde sensoriel, le monde idéal et l'unité suprême, et il leur découvre une base commune. Tout en admettant l'imperfection du monde, Plotin nie qu'il soit mauvais et méprisable. Il se tourne contre les Gnostiques chrétiens qui prêchent le mépris du monde, et s'oppose vigoureusement aux doctrines qui font des jouissances sensuelles l'unique but de la vie. L'exercice de la vertu n'est autre chose que le moyen de s'unir à Dieu. Pour Plotin la vertu n'est donc pas une fin en elle-même, mais elle est subordonnée à un but qui la dépasse. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between (...) studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between (...) studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

Patient-reported outcomes are frequently used for medical decision making, at the levels of both individual patient care and healthcare policy. Evidence increasingly shows that PROs may be influenced by patients’ response shifts and dispositions. We identify how response shifts and dispositions may influence medical decisions on both the levels of individual patient care and health policy. We provide examples of these influences and analyse the consequences from the perspectives of ethical principles and theories of just distribution. If influences of response (...) shift and disposition on PROs and consequently medical decision making are not considered, patients may not receive optimal treatment and health insurance packages may include treatments that are not the most effective or cost-effective. We call on healthcare practitioners, researchers, policy makers, health insurers, and other stakeholders to critically reflect on why and how such patient reports are used. (shrink)

This article provides ethical guidance on using race in health research as a variable or in defining the study population. To this end, a plain, non-exhaustive checklist is provided for researchers and research ethics committees, preceded by a brief introduction on the need for justification when using race as a variable or in defining a study population, the problem of exoticism, that distinctions pertain between race, ethnicity and ancestry, the problematic naming of races, and that race does not serve well (...) as a presumed biological construct in genetic research. (shrink)

In this article the authors seek to conceptualize a dynamic and inclusive understanding of personal identity within multicultural democracies such as South Africa, which will draw on both the liberal and communitarian traditions' respect for the project of self. A preliminary lay out for such a project emerges from a literature survey of recent, primarily South African publications on identity and culture, and it suggests that selfhood depends on: a) virtues, cultivated within cooperative communities which allow for effective freedom; b) (...) a venture into existential uncertainty, which alleviates that fear of loss of identity that is supposedly central to many multicultural conflicts; c) the hermeneutic construction of identity through narratives that allow for a plurality of voices; and d) the creative transcending and re- interpretation of values and traditions. The authors contend that such an under standing of identity goes some way towards addressing the question of the way that diverse personal and group identities are to be accommodated in South Africa's multicultural democracy, and to re thinking the unity which underlies diversity without resorting to liberalism's reduction of personal identity to rational autonomy. S. Afr. J. Philos. Vol.20(3) 2001: 35-54. (shrink)

continent. 1.2 (2011): 129-135. Introduction Vincent W.J. van Gerven Oei Successions of words are so agreeable. It is about this. —Gertrude Stein Nachoem Wijnberg (1961) is a Dutch poet and novelist. He also a professor of cultural entrepreneurship and management at the Business School of the University of Amsterdam. Since 1989, he has published thirteen volumes of poetry and four novels, which, in my opinion mark a high point in Dutch contemporary literature. His novels even more than his poetry are (...) criticized for being inaccessible, which I generally take to be a compliment. It would be like saying that Fernando Pessoa is inaccessible, which he is not. Neither is Wijnberg. When we think of the combination economist-poet we are immediately reminded of the American poet Wallace Stevens, who, as the story goes, had two stacks of paper on his desk, one for contracts, one for poems. We also know that Stevens wrote on the economy and that questions of economy and insurance surface at multiple points in his poems. The following text is a very preliminary attempt to point at the intersections between poems, novels, business, and poetry in Wijnberg’s work. On the back cover of his novel De opvolging ( The Succession , 2005), Wijnberg states the following: “[This is] a novel for whomever is interested in the workings of a company as much as in the workings of a poem.” Wijnberg thus claims that the way in which a company “works” may be similar to the way in which a poem “works.” The question is the obvious one, what does this similarity consist in? De opvolging tells the story of company in which bosses and company doctors, secretaries, children, clowns, and beggars have tons of meetings, recite poems, perform plays, tell jokes, and succeed each other, climbing up and down in the company’s hierarchy. De opvolging is a novel in which the career of people follows the career of words. It resonates with Gertrude Stein's sentences, "Grammar. What is it. Who was it" (1975, 50). The words in Wijnberg's poems are like he characters in his novel. And if we keep in mind this allegorical reading of De opvolging , which is obviously only one of the possible readings, we may be able to understand some aspects of Wijnberg’s poetry. A repetition is already a pun. Look, that word is trying it again, as if it is afraid that by not doing it it would give up the hope that it will ever be able to do something. A pun is the opposite of the first word coming to the mind of someone who shouts it when he suddenly discovers something. (104) The repetition, the succession of the same word, is already a pun, a joke. The succession of the father by the son after the revolution is a joke. "Look he's trying it again!" The essence of a joke is a repetition. Archimedes’ “Eureka!” is its opposite. Poems can easily become jokes, depending on the way the words follow and repeat each other. In De opvolging , the careers of the bosses, good and bad secretaries, and company doctors easily become jokes, as they are “afraid that by not doing it [they] would give up the hope that [they] will ever be able to do something.” Not only the repetition, but also the distance and difference between the words in a poem, their cause and effect relations can be read as company relations. This becomes clear when we, for example, read the first lines of the poem “Cause, sign” from Het leven van ( The Life Of , 2009). A sign lets know what is going to happen, a cause lets it happen. If the sign also lets happen there is no reason to isolate it, because then I would isolate some- thing only because it’s different for me. If I didn’t have to write this myself, but would have secretaries to whom I could dictate it, I would be able to say more about it. (49) Upon reading the first two lines we can already conclude that any word may be cause or sign or both. If a sign is also a cause there is no reason to discriminate it, yet to the poet they are still different. This difference only becomes expressible the moment he would have a secretary. Just like in De opvolging , the secretary introduces a distance; not in a company but in a poem. Hence the difference between “good” and “bad” secretaries in a company, where the good secretary of one boss may be the bad secretary of another one. The more we can say about the bosses of the company, or signifiers of the poem, the greater the distance we introduce between them and us. We should take serious the relation between Wijnberg’s novels and poems. Although they operate on different scales, they explain and converse with each other. Another example may be the novel Politiek en liefde ( Politics and Love , 2002), which deals with the relation, precisely, between politics and love. In the novel, Nicolai, a lieutenant in the Dutch army, is sent to Africa on a military mission. Upon leaving a receives a letter from his father. Dear son, Don’t do anything stupid before your father has advised you to do so. Your mother asked me to write a wise letter. I have been looking for wisdom for half a day and haven’t found much. If you borrow a small amount from a bank you become the bank’s slave, but if you borrow a couple of millions and spend them as quickly as possible the bank becomes your slave. What I want to say is that you have to return from Africa in good health, and before you know it the world will be your slave [....] Signed with a kiss from your father. (88) The line, “If you borrow a small amount from a bank you become the bank’s slave, but if you borrow a couple of millions and spend them as quickly as possible the bank becomes your slave,” returns as the title of poem in Het leven van: “If I borrow enough money the bank becomes my slave” (12-3), which elaborates this theme. So both in the way that these poems are structured and in their subject matter, they refer to the structures of our economy, to the ever-continuing line of CEOs succeeding each other like words, to the distance between them introduced by bureaucracy, and giving and receiving as economical and poetical acts. Poem and economy map onto each other, as in another episode from De opvolging : Edward reads two of the beggar’s poems about presents. Of a holiday nothing remains, except for memories, and if some of them are bad I’d rather forget them all; if I get a present I’d rather get something that’s useful to me for a long time. If I may choose, I choose what I can use longest, long enough to partially forget that this was the present, because it feels bad when nothing is left of it. […] Giving away becomes destruction in the stock destruction economy [ voorraadvernie -tigings-economie ], that is a gift economy [ geschenkeneconomie ], encountering for the first time an economy in which there’s selling and buying on markets. Instead of destroying supplies someone can also quickly say that they aren’t worth anything anymore; if someone wants to take them I’d gladly give him something extra. In a stock destruction economy he is someone who each day wants to work more hours than his colleagues. If around a company there is a gift economy in which someone’s rank is determined and made visible by the gifts someone can give someone else, a company will be more often character- ized by an invisible or unclear system of ranks. (152) Two poems about gifts present two different economical models, described by Wijnberg with the terms “stock destruction economy” and “gift economy.” Here we immediately recall the opposition introduced by George Bataille’s work on the concept of expenditure in The Accursed Share , where a “general economy” would surpass the stock destruction economy based on scarcity (capitalism) and become a gift economy (potlatch) and an egalitarian (communist) society. These claims are made both on the level of the poems and in their discursive explanation. They follow each other and on each other. I would like to finish this introduction to Wijnberg’s writing with a translation from his novel De joden ( The Jews , 1999), which develops the story of Hitler abdicating as chancellor of the Third Reich, appointing philosopher Martin Heidegger as his successor. In a conversation with two Russian actor-spies, sent by Stalin to figure out the situation, philosopher Walter Benjamin describes the abdication scene. Maimon: You were there when Hitler resigned? Benjamin: In the room we’re right now. The desk and the chairs are new. After his resignation Hitler would like to take his furniture to his new house. Martin naturally agrees. It is a sunny day. Martin is very nervous and complains about the heat. Martin is wearing his best dark blue suit, not his professor’s robe. Hitler is wearing his uniform. We enter the room and Hitler gets up and embraces Martin. Martin is not very good at embracing. Hitler shakes his hand. Hitler’s cap is on the desk. The cap has a metal lining. Hitler has strong neck muscles. Hitler says: A man is unclean. He takes a bath. Does he make the bath water unclean? I say: a man is unclean. He steps into a river. A little further a man steps into the river; does he become unclean? Hitler nods. I say: a man is standing in music. Another man hears the music but also sees the first man moving on the beat of the music in a way that he is certain that the music would excite different feelings in him if he wouldn’t to see the first man. Hitler says: a man is clean, listens to music, is suddenly touched and he doesn’t know by what. The conversation ends in the way you know it ends. Hitler picks up his cap from the desk and puts it on Martin’s head. (73-4) Aware of the never ending debate on the question of Heidegger’s involvement in the Nazi regime, Wijnberg has the audacity to present the arguments of complicity in the religious terminology of cleanliness and uncleanliness, while at the same time recalling overtones of Hitler’s supposed love for Wagner, suggesting a relation between Benjamin and Hitler, and so on. The space of this introduction is to small to treat a novel like De joden , a reading of which together with passages from Philippe Lacoue-Labarthe's Heidegger, Art, and Politics: The Fiction of the Political , Jacques Derrida's Of Spirit , Christopher Fynsk's Heidegger: Thought and Historicity , and Avital Ronell's The Telephone Book would be extremely elucidating and potentially open new avenues in thinking Heidegger's emphasis on poetry after the fall of the Nazi empire. But at this point we will have to curb our curiosity and follow the poet himself. The themes of the relation between business and poetry, but also Chinese landscape painting, love, Indian and Japanese poetry, and Western philosophy are analyzed and assimilated in Wijnberg’s work without ever losing the clarity of expression. It may be that, according to Alain Badiou, the “Age of the Poets” is over, but its end (Paul Celan) has exactly brought a new balance between philosophy and poetry, and it is this playful, but nonetheless serious balance that makes one hope that one day Wijnberg’s complete oeuvre might become available to readers across the planet. Tiranë, Albania February 15, 2011 English translations (all of them translated by David Colmer, who is preparing an English collection of Wijnberg’s poems entitled Advanced Payment ): Poetry International Words Without Borders Green Integer Review from Het leven van ( The Life of ) THE LIFE OF KANT, OF HEGEL As if every day he takes a decision that is as good as when he’d been able to think about it all his life. The life of Kant, of Hegel, the days of the life of, select three or four of them. Tell what he has discovered during those days as if he were the last one who knew so little. Give me something that I can cancel against then I can prepare myself for it. The reward is that I may continue with what I’m doing, it doesn’t matter how long it takes. This has nothing to do with everything remaining the same if I say that I no longer want anything else. I wouldn’t be able to say in which one and the other occur in a way that I if I knew something to cancel that one against it wouldn’t be possible now. The stars above my head and being able to say what belongs to what if I’ve let them in. FOLLOWING MY HEART WITHOUT BREAKING THE RULES Observing the rules without observing the rules by going where the rules no longer apply. I could also observe the rules there by applying them to what at great distance may resemble what the rules are about. But why would I do that, not to confuse someone who is seeing me from a great distance? Behind this morning the morning prepares itself when the rules are everything I have. IF I BORROW ENOUGH MONEY THE BANK BECOMES MY SLAVE A bank lends me money, if I don’t pay it back they tell my boss that he has to pay them my salary. But they have to leave me enough to eat and sleep and an umbrella when it’s raining. They can also empty my house, the furniture isn’t worth a lot, but every little helps. Each morning I leave for work, if I don’t start early they’ll soon get someone else, no bank will lend me money when the sun is shining. My boss has given me a cat to raise as a dog. Of course I know that it won’t work out, but I’ve asked for a week—maybe the cat gets lucky, maybe I get lucky. My hands around a cup of coffee, before I leave for work, warm-empty, cold-empty, as if hidden in the mist over a lawn. What I make when there’s no work left for me, I’m ashamed to say how little it is. Once I’m outside I check it, if they watch out of the window they can see me doing it. Suppose it is so much that I’d stay counting for hours, it’s getting dark and I’m still there. They stay watching for a while once they’ve finished their work, but have to go home, I get that, sure, I could also go home and continue counting there. If it’s too little running back immediately won’t help, because nobody’s there anymore, and if I come back tomorrow I may have spent what’s missing tonight. Going somewhere where it’s warm enough to walk around without clothes during daytime, it helps me to know that something’s more there than here. For someone like me there’s work anywhere, it shouldn’t take a week to find work for me there. Three times work and a home close to work, I may choose one and try for a week whether I want to stay there. If at the end of the week I don’t want to stay I’m back on the next day, then it was a week’s holiday. RULES If that’s against a rule, it’s yet another one that I cannot observe, or only so briefly that I cannot re- member it later. Anyways the rules are only there to help me remember what I need in order to do better what I do. In that respect there’s no difference between the rules that I find in a book and the rules that I think of early in the morning. I know that because I’ve made a rule just now nothing has yet to observe it. CAUSE, SIGN A sign lets know what is going to happen, a cause lets it happen. If the sign also lets happen there is no reason to isolate it, because then I would isolate something only because it’s different for me. If I didn’t have to write this down myself, but would have secretaries to whom I could dictate it, I could to say more about it. If something is taken away from me I consider how it would be if the opposite had been taken from me. That is what causes or signifies what is farthest away from what is caused or signified by what has been taken away from me. note: For the translations of “The life of Kant, of Hegel” and “If I borrow enough money the bank becomes my slave” I was able to consult David Colmer’s wonderful translations. (shrink)

Research Objective: This study focuses on ADs in the Netherlands and introduces a cross-cultural perspective by comparing it with other countries. Methods: A questionnaire was sent to a panel comprising 1621 people representative of the Dutch population. The response was 86%. Results: 95% of the respondents didn't have an AD, and 24% of these were not familiar with the idea of drawing up an AD. Most of those familiar with ADs knew about the Advanced Euthanasia Directive (AED, 64%). Both low (...) education and the presence of a religious conviction that plays an important role in one's life increase the chance of not wanting to draw up an AD. Also not having experienced a request for euthanasia from someone else, and the inconceivability of asking for euthanasia yourself, increase the chance of not wanting to draw up an AD. Discussion: This study shows that the subjects of palliative care and end-of-life-decision-making were very much dominated by the issue of euthanasia in the Netherlands. The AED was the best known AD; and factors that can be linked to euthanasia play an important role in whether or not people choose to draw up an AD. This differentiates the Netherlands from other countries and, when it comes to ADs, the global differences between countries and cultures are still so large that the highest possible goals, at this moment in time, are observing and possibly learning from other cultural settings. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...) RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

Lon Fuller, one of the great American jurists of this century, is often remembered only for his stand on the morality of law in the Fuller-Hart debate. Rediscovering Fuller considers the full range of Fuller's writings, from his early engagement with legal fictions and his critique of legal positivism to his later work on implicit law and the art of institutional design. Contributors from the fields of both civil law and common law argue that Fuller's insights are highly relevant to (...) contemporary concerns. The book contains essays by K. Winston, D. Dyzenhaus, P. Cliteur, F. Schauer ("Beyond the Fuller-Hart Debate"), P. Westerman, W. van der Burg, D. Luban ("Moralities of Law"), G. Postema, P. Teachout ("Implicit Law"), R. Macdonald, W. Witteveen, J. Allison, M. Hertogh, K. Soltan ("The Art of Institutional Design"), J. Allan, F. Mootz, J. Vining ("Law's Dialogue"), and a preface by Ph. Selznick. "At some point in the future, when we become more open to the moral relevance of social inquiry, more empirical in our study of philosophical issues, more capable of uniting moral and social theory, Lon Fuller's work will stand as a landmark. This volume will help show the way." —Ph. Selznick. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do just that.MethodsWe extracted (...) the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to (...) the forgoing of life-prolonging treatments and assistance in suicide by others than physicians. Of the articles with euthanasia as the main topic, 36% described euthanasia in the context of a terminally ill patient, 24% for older persons, 16% for persons with dementia, and 9% for persons with a psychiatric disorder. The most frequent arguments for euthanasia included the importance of self-determination and the fact that euthanasia contributes to a good death. The most frequent arguments opposing euthanasia were that suffering should instead be alleviated by better care, that providing euthanasia can be disturbing, and that society should protect the vulnerable.ConclusionsOf the newspaper articles, 24% uses the term ‘euthanasia’ for practices that are outside the scope of the euthanasia law. Typically, the more unusual cases are discussed. This might lead to misunderstandings between citizens and physicians. Despite the Dutch legalisation of euthanasia, the debate about its acceptability and boundaries is ongoing and both sides of the debate are clearly represented. (shrink)

The history of the dyestuffs industry during the period 1775–1860 is interesting for three reasons. In the first place it was in connection with the manufacture of synthetic dyestuffs, begun in 1856, that the industrial research laboratory and the organization scientist first unmistakably appeared in the last decades of the nineteenth century. Secondly, there are the enigmas of W. H. Perkin, the man who discovered and manufactured the first coal-tar colours, but who retired somewhat abruptly from the industry in 1874: (...) just after the synthesis of alizarine. Thirdly, the dyestuffs industry was in intimate association with the textile industries which had for a long time been subject to frequent radical scientific and technological innovation. Among the most important of these we may mention John Smeaton's classic paper of 1759 on the maximum work obtainable from a given fall of water: a problem important not only for the abstract science of mechanics, but also for the design of waterwheels—the main source of power for the early textile mills. (The waterwheel was not, during the eighteenth century, the epitome of the quaint and picturesque: it was in the van of scientific and technical progress.) Again, the textile industries were quick to employ the Watt rotative engine; previously a two cylinder Newcomen engine had been tried out. Bleaching powders, based on Scheele's discovery of chlorine and its properties, were rapidly adopted: in this context one cannot help contrasting the indifference of medical science to Davy's early suggestion of using nitrous oxide as an anaesthetic; or Faraday's comment in 1818 on the anaesthetic power of sulphuric ether. The textile industries saw, over this period, a rapid succession of new machines, the pace of invention being so hot that in 1832 Charles Babbage reported that machines became obsolete long before they wore out. A Salford cotton mill was the first industrial establishment to use gas lighting: James Thomson, calico printer, introduced gas lighting to the town of Clitheroe when he installed it in his works. And there were many other important technical and scientific innovations. It was to supply these industries, so well accustomed to change, that the synthetic coal-tar dyestuffs were introduced from 1856 onwards. It is interesting that, so far as we can see, the appearance of these synthetic dyestuffs was the last in the series of major innovations in the textiles and related industries: at least until recent times. (shrink)