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)

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)

Undeniably, a strikingly higher number of people die with direct health care provider involvement in Canada’s euthanasia regime, euphemistically termed “Medical Assistance in Dying” [MAiD], than un...

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.

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)

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)

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)

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place (...) increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns. (shrink)

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place (...) increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns. (shrink)

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)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least (...) 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

We thank Leo Lam and Taylor Nichols for their response 1 to our paper ‘COVID-19 vaccine boosters for young adults: a risk–benefit assessment and ethical analysis of mandate policies at universities’. 2 In our paper, we demonstrate that the risk–benefit calculus to mandate boosters for young adults aged 18–29 is a net risk intervention. The authors assert that we have made three inappropriate comparisons of benefits versus risks of the mRNA vaccine booster dose in this age group. We provide our (...) response to each below. We erred on the side of overestimating benefits of the booster dose against severe COVID-19 in this age group and still found net harms to outweigh net benefits. The conclusion of our paper holds, and university booster mandates for young people were—and remain—unethical. COVID-19 hospitalisations prevented versus booster serious adverse events (SAEs) For the first comparison, we weighed predicted hospitalisations prevented... (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)

1. On 30th July 2021, the historian of philosophy Michael Alexander Stewart, ‘Sandy’ for colleagues and friends, died peacefully, leaving unfinished the redaction of a volume in which he intended t...

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)

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)

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 paper, we carry out a critical analysis of the concept of technology in the current design of the bio-based economy (BBE). Looking at the current status of the BBE, we observe a dominant focus on technological innovation as the principal solution to climatic instability. We take a critical stance towards this “ecomodernist” worldview, addressing its fundamental assumptions, and ofer an underarticulated explanation as to why a successful transition toward a sustainable BBE—i.e. one that fully operates within the Earth’s (...) carrying capacity—has not yet been reached. Bernard Stiegler has developed a philosophical perspective on the concept of economy, broadening it to include the human condition through the notion of desire. This theory can help to obtain a more profound understanding of why ecomodernist strategies are dominant today. Stiegler’s theory of the libidinal economy ofers an analysis of controlled and exploited human desire as a primary driver behind modern techno-economic structures. Our hypothesis is that a critique of contemporary technofxism as a critique of libidinal economy is a necessary step to take in the discussion around the BBE as a concept, if the BBE is ever to bring about a system that can truly operate within the Earth’s carrying capacity. (shrink)

Swear words of English and French, both real and fictional ones, significantly tend to contain the least sonorous consonants, compared to the rest of the lexicon. What can explain the overrepresentation of such sounds among swear words? This might be a case of sound symbolism, when sounds are unconsciously associated with a meaning. We examine the pragmatic vs. semantic nature of the meaning involved, as well as two explanations in terms of iconicity. This unusual sound-meaning pairing would involve an emotional-contextual, (...) non-truth-conditional meaning, and be powerful enough that it influences a strong sociolinguistic convention – which words are swear words and which ones are not – suggesting that sounds convey meaning in yet unsuspected ways. (shrink)

This article has two general aims. It first of all critically reconsiders the empirical turn’s dismissal of transcendentalism in the philosophy of technology, in particular through the work of Ihde and Verbeek, and defends the continuing relevance of the notion of the transcencental in thinking about technology today, illustrating this mainly through a reading of Stiegler’s understanding of the human condition as a technical condition and his view of human (noetic) evolution as proceeding from a process of technical exteriorization. The (...) crucial issue that is missed by postphenomenology and the empirical turn is that technology itself in its empiricity occupies the (periodically changing) place of the transcendental. It thus fails to consider the transcendental operativity of technical artifacts within its own empiricist stance. Secondly, it argues for the continuing importance and usefulness of the idea of Technology with a capital T, equally discarded by the representatives of the empirical turn, in particular against the emerging backdrop of the Anthropocene as the age of decisive anthropogenic forcing of the planet and the growing dominance of what has recently been called the technosphere in Earth system science. With Stiegler I show that a proper, inherent dynamic of technology must be acknowledged historically, anthropologically, techno-evolutionarily as well as (techno)phenomenologically. I conclude by demonstrating that our time of planetary crisis summons us to redirect our attention to technology from the empirical to the transcendental, and from the micro-level to the macro-level again. (shrink)

Hume considered his Enquiry Concerning the Principles of Morals to be one of his best works. In it he offers his most elegant and approachable account of the origins and scope of morality. With the hope of reaching a broad audience, he argues that morality is neither rigid nor austere, but is rather a product of sentiments that all human beings share, and which they are naturally inclined to recognize and act upon. In this Critical Guide, a team of distinguished (...) scholars discuss each section of the Enquiry, its place in Hume's philosophy as a whole, and its historical context; their topics include the nature of morals, talents and moral virtues, benevolence, sympathy, and the sources of moral disagreement. The volume will be valuable for scholars and advanced students working on Hume. (shrink)

Why is religion such a widespread human experience? In enlightenment Scotland, philosophers had already attempted to answer this question turning to natural histories of mankind, and to a careful analysis of the human mind and of those cognitive capacities responsible for religious-type beliefs and attitudes. This early approach is also echoed today, as scholars from the cognitive sciences seek to show how religious-type beliefs and practices are produced either directly or as a by-product of natural cognitive processes. Others continue to (...) study the dependence of religious beliefs on cultural traditions, symbolic meanings and ritualistic practices. The authors of this special issue continue this discussion, focusing on specific topics and challenges posed by current studies on religion as a natural phenomenon. (shrink)

In this reply I try to show that, contrary to Milberry’s apparent assertion, the general intellect of the multitude does not have the explanatory robustness she accredits to it. Digital network technologies are currently overwhelmingly effective in proletarianizing and disempowering the cognitariat and only an active technopolitics of deproletarianization could reverse this hegemonic situation. In my response to Verbeek, I attempt to correct his misinterpretation of the Stieglerian approach as being dialectical in nature and show that, far from reinstating the (...) humanist dichotomy between human beings and technologies, my analysis assumes their original, albeit fundamentally ambiguous and even ‘uncanny’ [unheimlich] interconnection. I conclude with pointing out some implications of this view for a ‘really realistic’ political theory of technology. (shrink)

In this paper, we carry out a critical analysis of the concept of technology in the current design of the bio-based economy (BBE). Looking at the current status of the BBE, we observe a dominant focus on technological innovation as the principal solution to climatic instability. We take a critical stance towards this “ecomodernist” worldview, addressing its fundamental assumptions, and offer an underarticulated explanation as to why a successful transition toward a sustainable BBE—i.e. one that fully operates within the Earth’s (...) carrying capacity—has not yet been reached. Bernard Stiegler has developed a philosophical perspective on the concept of economy, broadening it to include the human condition through the notion of desire. This theory can help to obtain a more profound understanding of why ecomodernist strategies are dominant today. Stiegler’s theory of the libidinal economy offers an analysis of controlled and exploited human desire as a primary driver behind modern techno-economic structures. Our hypothesis is that a critique of contemporary technofixism _as_ a critique of libidinal economy is a necessary step to take in the discussion around the BBE as a concept, if the BBE is ever to bring about a system that can truly operate within the Earth’s carrying capacity. (shrink)

In this dialogue with Yuk Hui, Pieter Lemmens explains the discipline called philosophy of technology and gives a concise overview of the most important contemporary approaches within this field. He also offers a critical evaluation of what are probably the two most salient characteristics of contemporary philosophy of technology, the so-called “empirical turn” and the “ethical turn,” which are deeply related and partly reflect the discipline’s on-going alignment with the global neoliberal agenda of exclusively profit-driven technological innovation. He also (...) critically reflects on recent developments in the molecular and informational life sciences such as genomics, metabolomics, bioinformatics and synthetic biology. (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)