(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.

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.

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)

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)

Canada’s rapid rise in deaths from euthanasia and physician assisted suicide, termed Medical Assistance in Dying (MAID) in the country, now ranks it second only to the Netherlands in terms of MAiD deaths as percentage of overall deaths, with one province already hosting the highest rate of all jurisdictions in the world. Analyzing Health Canada’s annual MAID reports, which show that up to 336 out of 1837 providers are likely responsible for the majority of MAID deaths in a given year, (...) we discuss how the rapid increase likely reflects not a broad Canadian consensus but the capture of a policy-making and implementation process by a small group of activists and clinicians colonizing medicine to become an ideologically driven vehicle for expanding MAID access and delivery. As a remedy and to reprioritize patient safety and protection against premature death, a more transparent, relevant, and safeguarded compliance regime based on evidence-based, multi-perspective policy-making is needed. (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)

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 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 response1 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. For the first comparison, we weighed predicted hospitalisations prevented by one booster dose of BNT162b2 with vaccine-associated SAEs from the manufacturer’s randomised trial (3/5055).3 We found that the rate of expected SAEs would outweigh the benefits of the booster against hospitalisation by at least 18-fold. Lam and Nichols suggest that this was an inappropriate comparison, as not all SAEs result in hospitalisation. However, the definition of SAE as used in the trial included death, hospitalisation, disability, permanent damage, life-threatening event or condition, which required medical or surgical intervention to prevent a serious outcome.4 While all comparisons include some degree of incommensurability, comparing these SAEs with hospitalisations prevented by the booster is more reasonable than Lam and Nichols’ suggestion of comparing SAEs to infections prevented. The COVID-19 infection hospitalisation risk in this age group was <0.5% (or <1/200)5 even prior to widespread immunity, thus comparing SAEs to infection risk is entirely inappropriate. Furthermore, a booster dose will only offer transient (if any) protection against infection6 and cumulative infection rates …. (shrink)

Grandiose narcissistic traits refer to exploitative and arrogant attitudes, while vulnerable narcissistic traits entail hypersensitivity to judgment and low self-esteem. Little is known about how individuals with narcissistic traits can improve their attitudes toward themselves and others. The current research puts self- and other compassion forward as possible targets to alleviate some of destructive patterns of narcissism. Generally, self-compassion has previously been associated with beneficial effects on psychological wellbeing, while other compassion is advantageous for interpersonal relationships. This study explored the (...) relationship between narcissistic traits and the efficacy of experimental compassion inductions. Student and community participants completed grandiose and vulnerable narcissistic trait, SC and OC state questionnaires, and either an SC or OC induction. It was expected that individuals with higher narcissistic traits would benefit from the inductions and show higher SC after but would have greater difficulty showing meaningful increases in OC. The results indicated that individual differences in grandiose and vulnerable narcissistic traits are related to the magnitude of improvements following the inductions: the theorized lack of SC in individuals with vulnerable oversensitivity to judgment traits seems possible to be counteracted through different types of compassion exercises. Moreover, higher grandiose exploitativeness–entitlement and global vulnerable narcissistic traits related to less increases than others. However, directly inducing OC in individuals with these traits was linked to greater OC improvements than improvements after inducing SC. Overall, the present findings suggest that self-compassionate behavior can be improved in individuals with high oversensitivity and that other compassionate behavior could potentially be increased if, specifically, other compassion exercises are utilized when higher levels of certain narcissistic traits are present. (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...

In this article, M. Beatrice Fazi takes up Media Theory’s invitation to engage with Alan Díaz Alva’s analysis of her philosophical work on contingency in computation. The central argument of Fazi’s Contingent Computation: Abstraction, Experience, and Indeterminacy in Computational Aesthetics is that computation can be productive of ontological novelty. This piece revisits that argument in the light of the technological developments that have occurred since 2018, when the book was published. Focusing on generative artificial intelligence (generative AI), the article considers (...) how the concepts of generativity, aesthetics and contingency are tackled in the book and in present-day debates about generative AI systems. (shrink)

Introduction non technique à la Théorie de l'Information Intégrée de la conscience de Giulio Tononi. Traduction française de l'article de Hedda Hassel Mørch.

There is general acknowledgement that both the anterior cingulate and orbitofrontal cortex are implicated in reinforcement-guided decision making, and emotion and social behaviour. Despite the interest that these areas generate in both the cognitive neuroscience laboratory and the psychiatric clinic, ideas about the distinctive contributions made by each have only recently begun to emerge. This reflects an increasing understanding of the component processes that underlie reinforcement- guided decision making, such as the representation of reinforcement expectations, the exploration, updating and representation (...) of action values, and the appreciation that choices are guided not just by the prospect of reward but also by the costs that action entails. Evidence is emerging to suggest that the anterior cingulate and orbitofrontal cortex make distinct contributions to each of these aspects of decision making. (shrink)

Amazon Book Review Series of “Wild Wise Weird”.

Semantic Indexicality shows how a simple syntax can be combined with a propositional language at the level of logical analysis. It is the adoption of such a base language which has not been attempted before, and it is this which constitutes the originality of the book. Cresswell's simple and direct style makes this book accessible to a wider audience than the somewhat specialized subject matter might initially suggest.

We consider the desirability, or otherwise, of various forms of induction in the light of certain principles and inductive methods within predicate uncertain reasoning. Our general conclusion is that there remain conflicts within the area whose resolution will require a deeper understanding of the fundamental relationship between individuals and properties.

An emerging ethical philosophy in marketing is developing. This philosophy is based on quality-of-life studies which are becoming an important topic of research in behavioral and social sciences (basic and applied research). This paper addresses the QOL orientation in marketing from a decision-making perspective. Specifically, this paper shows how marketers can engage in strategic marketing planning guided by the QOL concept.

Television medical dramas sometimes depict medical professionalism and bioethical issues, but their nature and extent are unclear. The authors systematically analysed the bioethical and professionalism content of one season each of Grey's Anatomy and House M.D., two of the most popular current television medical dramas. The results indicate that these programmes are rife with powerful portrayals of bioethical issues and egregious deviations from the norms of professionalism and contain exemplary depictions of professionalism to a much lesser degree.

Under the assumption that all "rules" are recursive (ECT) the statement $\operatorname{Cont}(N^N,N)$ that all functions from N N to N are continuous becomes equivalent to a statement KLS in the language of arithmetic about "effective operations". Our main result is that KLS is underivable in intuitionistic Zermelo-Fraenkel set theory + ECT. Similar results apply for functions from R to R and from 2 N to N. Such results were known for weaker theories, e.g. HA and HAS. We extend not only (...) the theorem but the method, fp-realizability, to intuitionistic ZF. (shrink)

Bu makale, on sekizinci yüzyıl Osmanlı-Türk nazarî düşüncesinin önde gelen isimlerinden Mehmed Emin Üsküdârî’nin (ö. 1149/1736-37) uzaklıkların (mekândaki uzanımların) sonluluğu ve teselsülün geçersizliği problemlerine ilişkin kaleme aldığı Şerhu’l-Berâhîni’l-hamse risalesini şekil ve muhteva açısından incelemektedir. Sonsuzluk problemi çok katman- lı bir yapıya sahip olup isbât-ı vâcib başta olmak üzere teolojik, epistemolojik, ontolojik, ve kozmolojik birçok meselenin dayanak noktasını oluşturmaktadır. Erken dönemlerden itibaren farklı düşünce geleneklerine mensup âlimler tarafından ele alınan sonsuzluk problemi, müteahhir dönemde müstakil risalelerin telif edildiği kozmopolit bir kelâm-felsefe geleneği (...) haline gelmiştir. Müteahhir dönemin son temsilcilerinden Mehmed Emin Üsküdârî de bu konuya dair müstakil eser veren âlimlerden olmuştur. Söz konusu risale, sonsuzluk probleminin Osmanlı entelektüel düşüncesindeki konumunu ve izlerini görebilmek adına önemlidir. Üsküdârî, risalesinde uzaklıkların sonsuzluğu tartışmalarında burhân-ı süllemî ve burhân-ı müsâmeteyi; teselsül tartışmalarında ise burhân-ı tatbîk, burhân-ı tezâyüf, burhân-ı ‘arşî ve beraberinde Mirzâcân Şîrâzî (ö. 995/1587) tarafından zikredilen iki farklı burhânı esas almaktadır. Müellif, bu bağlamda konuya ilişkin zikredilen burhânların muhtasar ve müfit bir sunumunu yapmış ve anlatılan bazı hususları geometrik temsillerle desteklemiştir. De- ğerlendirme ve tahkik olmak üzere iki ana bölümden oluşan bu makale, müellifin zikri geçen burhânlara ilişkin değerlendir- melerini, ilgili burhânların tarihî serencamını ve süreklilik ve değişim noktasındaki farklılıklarını incelemektedir. (shrink)