Following a Canadian Supreme Court ruling invalidating an absolute prohibition on physician assisted dying, two reports and several commentators have recommended that the Canadian criminal law allow medical assistance in dying (MAID) for persons with a diagnosis of mental disorder. A key element in this process is that the person requesting MAID be deemed to have the ‘mental capacity’ or ‘mental competence’ to consent to that option. In this context, mental capacity and mental competence refer to ‘decision-making capacity’, which is (...) a distinct area of clinical study and research in the theory of informed consent. The purpose of this discussion is to bring several controversial but insufficiently acknowledged problems associated with decision-making capacity to the forefront of the proposed extension of MAID to persons diagnosed with mental disorders. Open-ended access to MAID by persons who suffer from mental health conditions already exists in Belgium and the Netherlands, where the issues raised here are equally relevant. In this paper, we highlight the serious limitations of relying on capacity assessments to allow access to MAID/Euthanasia. (shrink)

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge (...) deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect (...) what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)

Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.–Franz KaflaFor more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies (...) culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” in treating children and adolescents suffering from depression. (shrink)

Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.–Franz KaflaFor more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies (...) culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” in treating children and adolescents suffering from depression. (shrink)

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)

Volume 19, Issue 10, October 2019, Page 65-68.

(2002). Avoiding a Jekyll-And-Hyde Approach to the Ethics of Clinical Research and Practice. The American Journal of Bioethics: Vol. 2, No. 2, pp. 14-17.

In this paper we inquire into the fundamental assumptions that underpin the ideal of the Bio-Based Economy as it is currently developed . By interpreting the BBE from the philosophical perspective on economy developed by Georges Bataille, we demonstrate how the BBE is fully premised on a thinking of scarcity. As a result, the BBE exclusively frames economic problems in terms of efficient production, endeavoring to exclude a thinking of abundance and wastefulness. Our hypothesis is that this not only entails (...) a number of internal tensions and inconsistencies with regard to the ideal of BBE, but ultimately undermines the ideal itself, by pushing purported regenerativity into a cataclysmic and terminal discharge. We here point to the strategies that the BBE employs in this exclusion, the fundamental assumptions regarding the relation between energy and economy that underpin this endeavor, as well as to the resulting inconsistencies and their catastrophic consequences. We finally argue for the introduction of the presently excluded question of abundance and wastefulness and explore the implications of such a question for the ideal of a zero-waste humanity. (shrink)

This paper provides a phenomenological analysis of postphenomenological philosophy of technology. While acknowledging that the results of its analyses are to be recognized as original, insightful, and valuable, we will argue that in its execution of the empirical turn, postphenomenology forfeits a phenomenological dimension of questioning. By contrasting the postphenomenological method with Heidegger’s understanding of phenomenology as developed in his early Freiburg lectures and in Being and Time, we will show how the postphenomenological method must be understood as mediation theory, (...) which adheres to what Heidegger calls the theoretical attitude. This leaves undiscussed how mediation theory about ontic beings involves a specific ontological mode of relating to beings, whereas consideration of this mode is precisely the concern of phenomenology. This ontological dimension is important to consider, since we will argue that postphenomenology is unwittingly technically mediated in an ontological way. The upshot of this is that in its dismissal of Heidegger’s questioning of technology as belonging to “classical philosophy of technology,” postphenomenology implicitly adheres to what Heidegger calls technology as Enframing. We argue that postphenomenology overlooks its own adherence to the theoretical attitude and ultimately to Enframing, and we will conclude with calling for a phenomenological questioning of the dimension that postphenomenology presently leaves unthought, meaning that we will develop a plea for a rehabilitation of the ontological dimension in the philosophy of technology. (shrink)

This article deals with the biotechnology revolution in agriculture and analyzes it in terms of Bernard Stiegler’s theory of techno-evolution and his thesis that technologies have an intrinsically pharmacological nature, meaning that they can be both supportive and destructive for sociotechnical practices based on them. Technological innovations always first disrupt existing sociotechnical practices, but are subsequently always appropriated by the social system to be turned into a new technical system upon which new sociotechnical practices are based. As constituted and conditioned (...) by a technical system, human cultures are necessarily systems of care. Humans take care of themselves and the world through technologies. Agriculture is a very old system of care, stable for more than 10,000 years, but at the moment it is experiencing a profound rupture thanks to the invention of genetic engineering technologies, that promise to revolutionize it. However, their current deployment under capitalist conditions everywhere leads to processes of proletarianization, due to the fact that they enable the expropriation of farmers of the means of production, depriving them of the possibility of appropriating these new technologies and frustrating the invention of a new agricultural system of care. This has lead to a widespread rejection of the new technologies, which is a grave error though, as these technologies can become the basis of a new system of care. But only under the condition that they are wrought from corporate control and redeployed instead to initiate a process of deproletarianization. It is argued that current initiatives in open source and commons-based biotech are probably the most promising harbingers of such a process of deproletarianization. (shrink)

Abstract In this chapter, we challenge the presupposed concept of innovation in the responsible innovation literature. As a first step, we raise several questions with regard to the possibility of ‘responsible’ innovation and point at several difficulties which undermine the supposedly responsible character of innovation processes, based on an analysis of the input, throughput and output of innovation processes. It becomes clear that the practical applicability of the concept of responsible innovation is highly problematic and that a more thorough inquiry (...) of the concept is required. As a second step, we analyze the concept of innovation which is self-evidently presupposed in current literature on responsible innovation. It becomes clear that innovation is self-evidently seen as (1) technological innovation, (2) is primarily perceived from an economic perspective, (3) is inherently good and (4) presupposes a symmetry between moral agents and moral addressees. By challenging this narrow and uncritical concept of innovation, we contribute to a second round of theorizing about the concept and provide a research agenda for future research in order to enhance a less naïve concept of responsible innovation. (shrink)

: This article focuses on cognitive enhancement technologies and their possible anthropological implications, and argues for a reconsideration of the human-technology relation so as to be able to better understand and assess these implications. Current debates on cognitive enhancement consistently disregard the intimate intertwinement of humans and technology as well as the fundamentally technogenic nature of anthropogenesis. Yet, an adequate assessment of CET requires an in-depth and up-to-date re-conceptualization of both. Employing insights from the work of Bernard Stiegler, this article (...) proposes an organology and pharmacology of CE. What is typical about new CET is their interiorizing nature, which can be expected to fundamentally reshape organological configurations. Starting from the premise that CE is a phenomenon that predominantly unfolds within the current conjuncture of cognitive capitalism, I will present the issue of cognitive proletarianization as being of crucial importance for considering CE. I conclude by providing some methodological guidelines for the development of a positive pharmacology of CET and by suggesting that CET should be considered as technologies of the self sensu Michel Foucault. (shrink)

‘The art of living with ICTs ’ today not only means finding new ways to cope, interact and create new lifestyles on the basis of the new digital technologies individually, as ‘consumer-citizens’. It also means inventing new modes of living, producing and, not in the least place, struggling collectively, as workers and producers. As the so-called digital revolution unfolds in the context of a neoliberal cognitive and consumerist capitalism, its ‘innovations’ are predominantly employed to modulate and control both production processes (...) and consumer behavior in view of the overall goal of extracting surplus value. Today, the digital networks overwhelmingly destroy social autonomy, instead engendering increasing social heteronomy and proletarianization. Yet it is these very networks themselves, as technical pharmaka in the sense of French ‘technophilosopher’ Bernard Stiegler, that can be employed as no other to struggle against this tendency. This paper briefly explores this possibility by reflecting upon current diagnoses of our ‘technological situation’ by some exemplary post-operaist Marxists from a Stieglerian, pharmacological perspective. (shrink)

Life sciences and emerging technologies raise a plethora of issues. Besides practical, bioethical and policy issues, they have broader, cultural implications as well, affecting and reflecting our zeitgeist and world-view, challenging our understanding of life, nature and ourselves as human beings, and reframing the human condition on a planetary scale. In accordance with the aims and scope of the journal, LSSP aims to foster engaged scholarship into the societal dimensions of emerging life sciences (Chadwick and Zwart 2013) and via this (...) thematic series, the journal provides a podium for authors who intend to address concrete issues from a ‘continental philosophical’ perspective, which may in- clude (post)phenomenology, hermeneutics, dialectics, (post)structuralism, psychoanalysis, critical theory and similar approaches. The series aims to contribute to a diagnostics of the present and a prognostics of the future, focusing on critical normative challenges (such as embodiment, intimate technologies, social justice, biopower, nanomedicine, human enhancement and the anthropocene) and building on the work of key authors such as Hegel (1830), Heidegger (1953, 1953/1954), Bachelard (1938), Canguilhem (1975), Lacan (1966, 1969-1970/1991), Habermas (1968), Serres (1972), Foucault (1969), Žižek (2006/2009), Stiegler (2010), Sloterdijk (2001, 2009) and others, but targeting con- crete up-to-date events and case studies against the backdrop of broader developments within the techno-scientific culture. (shrink)

In this chapter, we challenge the presupposed concept of innovation in the responsible innovation literature. As a first step, we raise several questions with regard to the possibility of ‘responsible’ innovation and point at several difficulties which undermine the supposedly responsible character of innovation processes, based on an analysis of the input, throughput and output of innovation processes. It becomes clear that the practical applicability of the concept of responsible innovation is highly problematic and that a more thorough inquiry of (...) the concept is required. As a second step, we analyze the concept of innovation which is self-evidently presupposed in current literature on responsible innovation. It becomes clear that innovation is self-evidently seen as technological innovation, is primarily perceived from an economic perspective, is inherently good and presupposes a symmetry between moral agents and moral addressees. By challenging this narrow and uncritical concept of innovation, we contribute to a second round of theorizing about the concept and provide a research agenda for future research in order to enhance a less naïve concept of responsible innovation. (shrink)

In his moral psychology, Prof. Frankfurt pays special attention to two strongly related issues which should be given pride of place in every genuine account of human action and behaviour: these issues are the problem of personal autonomy and what I would like to call the problem of self-constitution. The first concerns the question what it means to be a fully human, rational agent, i.e., someone who is accountable for and in one way or another conscious of what he does (...) and desires; the second concerns the question how human beings become selves or persons with a particular identity, i.e., somebody who is not only accountable for and conscious of his or her own deeds, desires and preferences at a given time, but also able to identify with his or her personal life-history, as a through time related structure of deeds, beliefs, volitions, preferences and desires.In the following, I shall first of all formulate a rather free interpretation of the important and penetrating reflections of Prof. Frankfurt on the concept of care, which, as I understand it, accounts for the interdependence of autonomy and self-constitution. I shall then formulate a critical reflection and some related questions, more or less inspired by Charles Taylor’s investigations of the constitution of the self and the problem of rational autonomy. As is well known, Taylor has been partly influenced by Frankfurt’s writings on these issues, but of course — and that’s what my questions will be about — I leave it to Prof. Frankfurt to determine how well Taylor’s suggestive account of the constitution of the authentic self fits the Frankfurtian descriptive metaphysics of human mind and action. (shrink)

A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because they often have neither therapeutic nor diagnostic value, and because research participants may not realize this, which could compromise the validity of their consent to the procedure. In the first section of this paper, we describe the burdens, risks, and benefits associated with certain common invasive, nondiagnostic research procedures. We next (...) offer a series of arguments about the general properties of a valid consent for such procedures, and we close by examining what is currently known about consent quality for invasive research procedures when measured against the standards laid out in the second section. We conclude that there is little evidence to either confirm or dispel concerns about participants’ consent quality for protocols involving invasive, nondiagnostic research procedures. (shrink)

This article focuses on the interpretative complexities encountered in the work of Lidwien van de Ven. First, it aims to map out the always porous nature of the relationships between aesthetics, politics and religion that make up her palimpsest-like images. Second, it aims to tease out a three-part analytics of photography. Third, it attempts to flesh out a difficult notion of spectacle that is inherent to her wide-ranging practice, and which distinguishes her project from liberal photojournalism with its obeisance (...) to identity politics and its weak notion of ethics. Finally, it aims to isolate, within the dialectical machinery of spectacle that is so often put to work by western democracies, a pragmatic moment in our encounter with her photographs that has real political purchase. With a variable notion of close reading at the crux of the operation, the article probes the efficacy of this moment so akin to philosophical aesthetics. (shrink)

This article focuses on the power of technological mediation from the point of view of autonomist Marxism. The first part of the article discusses the theories developed on technological mediation in postphenomenology and critical theory of technology with regard to their respective power perspectives and ways of coping with relations of power embedded in technical artifacts and systems. Rather than focusing on the clashes between the hermeneutic postphenomenological approach and the dialectics of critical theory, it is argued that in both (...) the category of resistance amidst power-relations is at least similar in one regard: resistance to the power of technology is conceptualized as a reactive force. The second part of the article reads technological mediation through the lens of the antagonistic power-perspective on class struggle developed in autonomist Marxism. The outline of a provisional autonomist philosophy of technology is developed using Foucauldian dispositifs of biopower in contrast to the hermeneutic and dialectical approach. It is thus argued that resistance should here be understood in terms of practice that subverts the technically mediated circuit of production itself. (shrink)

Volume 25, Issue 4, August 2020, Page 3-8.

In the last couple of years, serious controversies have raised doubts over the reliability of research supporting the efficacy and safety of Selective Serotonin Reuptake Inhibitors, popular drugs used for the treatment of depression and a variety of related conditions. These controversies have also evoked concerns over the promotional tactics used by industry to promote these drugs. In another article in this volume, David Healy argues that the tactics highlighted by these and some other recent controversies in psychiatry have brought (...) medical research itself to the level of commercial publicity. In the following article, I provide some additional first-hand information about controversies in which David Healy was involved. I then situate these controversies within the context of the increasing commercialization of medical research. I discuss how the controversies highlight the failure of existing regulatory regimes in curbing inappropriate industry influence over research. I critically analyse some of the measures recently promoted by the medical research community, such as the introduction of a clinical trial registry, and I indicate why these measures are insufficient. In conclusion, I highlight how a more radical reform of the clinical trials scene is needed. (shrink)