The controversy over the prescription drug, alosetron, is examined in order to investigate what is permitted to count as ‘therapeutic advance’ and ‘therapeutic breakthrough’ within pharmaceutical innovation and regulation. It is argued that those official accounting categories can mask very modest efficacy of some drugs by reference to the official techno-scientific evidence, thus leading to questionable acceptance of risks to public health. This is explained by: the drug availability options set by the commercial interests of manufacturers; the (...) FDA management's need to demonstrate rapid approval of therapeutic advances to their budgetary masters, especially in the context of patient demands for access to new drugs; and the increasing capacity of patient groups, sometimes in collaboration with pharmaceutical manufacturers, to challenge techno-scientific expertise and evidence with experiential testimony. It is concluded that regulatory policy-makers need much more sophisticated accounting systems for differentiating between drugs defined as significant therapeutic advances, and between drugs (‘therapeutic breakthroughs’ fast-tracked to treat serious or life-threatening conditions. Contrary to some STS analyses, the desirability of an ascendancy of patients’ anecdotal evidence in regulatory decisions for public health is questioned. (shrink)

Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the “golden years” of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical (...) innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments . Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions. (shrink)

The distinction between therapeutic and non-therapeutic research is a familiar one in research ethics. This chapter argues that the term “therapeutic research” is a misnomer. I consider two broad types of ostensibly therapeutic research: controlled trials, and innovative/experimental treatments. I argue that in the former case the term therapeutic research is a misnomer because no reasonable researcher can expect patients/subjects to derive any therapeutic advantage from being entered into an ethically conducted controlled trial. In (...) the latter case, while accepting that there may well be a reasonable expectation of therapeutic benefit from innovative treatments, I argue that the decision whether it is in the interests of a given patient to receive a given treatment is properly made on purely clinical grounds. There is no special feature of the research situation, in either of these types of case, which serves to ensure that participation, qua research subject, is in a patient’s interests. (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article (...) investigates the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.

This extended literature review proposes to present the trends in the therapeutic alliance, outcomes, and measures in the last decade within the premises of individual cognitive behaviour therapy and its innovations, used as an interventional measure in the context of child and adolescent mental health setting. A brief background of the rationale for conducting this literature search is presented at the start. This is followed by the methodology and design which incorporates the inclusion and exclusion criteria and the basis (...) for the same. The critical appraisal of the primary studies is presented in the literature review section with a brief description of the summary features of the studies in the study tables followed by the results and discussion of the study findings. To summarise, the literature review of primary studies conducted in the last decade demonstrates the need for further research to be conducted both in the field of CBT in children and therapeutic alliance, competence, and therapy outcomes, integrating perspectives in child development, carer alliance, and the social construct theory in children, to allow for further innovations in CBT in the context of increasing challenges in the current times of exponentially developing technology and its utility without compromising the quality of therapy. In conclusion, recommendations are made as a guideline for future studies and research in this field. (shrink)

Innovative healthcare technologies may raise ethical concerns which prevent their implementation for fear of unexpected or undesirable outcomes, even before they are introduced into usual clinical practice. Essential to innovation is therefore to analyze benefits and drawbacks from a multidisciplinary point of view (i.e., biomedical, social, financial). Value-based healthcare is currently the most comprehensive theoretical framework to evaluate the benefits of healthcare technologies on patients and society in the longer term. Technically, “the systematic evaluation of properties, effects and/or impacts (...) of health technologies” must be performed by validated procedures of Health Technology Assessment (HTA), supported by early HTA procedures to retrieve preliminary evidence and expert opinions. The aim of this study is to perform an early HTA of germline editing technologies in order to estimate their impact on patients and society, in light of the recent, controversial debate which followed the germline gene editing of human embryos. (shrink)

Synthetic biology, as an engineering approach to biological systems, has the potential to disruptively innovate the development of vaccines, therapeutics, and diagnostics. Data accessibility and differences in data-usage capabilities are important factors in shaping this innovation landscape. In this paper, the data that underpin synthetic biology responses to the COVID-19 pandemic are analyzed as positional information goods—goods whose value depends on exclusivity. The positionality of biological data impacts the ability to guide innovations toward societally preferred goals. From both an (...) ethical and economic point of view, positionality can lead to suboptimal as well as beneficial situations. When aiming for responsible innovation (i.e. embedding societal deliberation in the innovation process), it is important to consider hurdles and facilitators in data access and use. Central governance and knowledge commons provide routes to mitigate the negative effects of data positionality. (shrink)

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new (...) breakthrough biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment. (shrink)

The field of regenerative medicine has considerable therapeutic promise that is proving difficult to realize. As a result, governments have supported the establishment of intermediary agencies to “accelerate” innovation. This article examines in detail one such agency, the United Kingdom’s Cell and Gene Therapy Catapult. We describe CGTC’s role as an accelerator agency and its value narrative, which combines both “health and wealth.” Drawing on the notion of sociotechnical imaginaries, we unpack the tensions within this narrative and its (...) instantiation as the CGTC cell therapy infrastructure is built and engages with other agencies, some of which have different priorities and roles to play within the RM field. (shrink)

As the youngest work in the Platonic corpus, the Axiochus interacts with other texts in the corpus as well as with its contemporary philosophical milieu. How it does so, however, and what the purpose of the work is, is still unclear. This paper proposes a new theoretical approach to this text, arguing that the Axiochus anchors a number of innovations. It discusses three innovations in particular: the introduction of philosophical therapy in Platonism, the use of Epicurean arguments in Academic philosophy, (...) and a renovated Platonism on the contemporary philosophical scene. The Axiochus aims, so this paper argues, to make these innovations acceptable to different audiences by anchoring them in the Socratic dialogue and the therapeutic paradigm of philosophy, respectively. (shrink)

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs and the use of biological (...) therapeutics, stem cell-based therapies will have to pass through a series of controlled studies — initially to assess safety and toxicity, then efficacy and comparative efficacy — before they can be justifiably administered to patients outside a clinical trials context. (shrink)

The dangers presented by antibiotic resistance have now established themselves as a global health security issue. From an international policy perspective, three key pillars have been established: responsible access, conservation, and innovation. These pillars are intrinsically linked, meaning that any attempt to address one must take into account the implications for the other two.An urgent need exists to address the innovation failure in ABR. In the field of anti-bacterials, the pipeline remains anemic in terms of therapeutics with novel (...) mechanisms of action, new drug classes and strategies involving radically different, innovative approaches. The key reasons for this failure have already been well established. The slow development of new antibiotics is the result of a poor and uncertain commercial market and scientific challenges in research and development. (shrink)

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

Agro-ecological innovations aim at promoting sustainable agricultural practices that have long term benefits. However, farmers rarely adopt beneficial innovations in agro-ecology despite expressing an understanding of the benefits and a desire to do so. It has been argued that the farmers lack sufficient knowledge to implement complex innovations. We believe that in many cases such knowledge is necessary, but is ultimately insufficient for complex innovation adoption. We argue that in addition to knowledge and a desire to adopt an (...) class='Hi'>innovation, many farmers require a collaborative relation with an ally. We call this method the Alliance Approach to innovation. This approach is modeled after the therapeutic Alliance Approach at work in cognitive and behavioral sciences. We argue that using the Alliance Approach will not only prove effective in helping farmers adopt complex agro-ecology innovations, but also a better fit for the human centered development of capability approach human development, as it is likely to enhance both the well-being and agency of the farmers. (shrink)

In 2013 the Nuffield Council on Bioethics launched their report Novel Neurotechnologies: Intervening in the Brain. The report, which adopts the European Commission’s notion of Responsible Research and Innovation, puts forward a set of priorities to guide ethical research into, and the development of, new therapeutic neurotechnologies. In this paper, we critically engage with these priorities. We argue that the Nuffield Council’s priorities, and the Responsible Research and Innovation initiative as a whole, are laudable and should guide (...) research and innovation in all areas of healthcare. However, we argue that operationalising Responsible Research and Innovation requires an in-depth understanding of the research and clinical contexts. Providing such an understanding is an important task for empirical ethics. Drawing on examples from sociology, science and technology studies, and related disciplines, we propose four avenues of social science research which can provide such an understanding. We suggest that these avenues can provide a manifesto for empirical ethics. (shrink)

Los cambios asociados al envejecimiento y las posibilidades de satisfacción de las necesidades que de ello se derivan, hacen que en Chile los espacios comunitarios de atención y nuevas estrategias de intervención se transformen en una posibilidad para la mantención y la recuperación de la salud de las personas mayores. El objetivo fue identificar el valor terapéutico del "juego" en personas mayores, como un aporte con fines terapéuticos, especialmente en contextos de intervención en comunidad con esta población. El presente artículo (...) muestra los resultados de una investigación-acción-participativa con 12 personas mayores de 60 años, en siete sesiones, durante el año 2013 en la comuna de Valdivia, Región de Los Ríos. Se realizó un taller experiencial abierto, grupo de discusión y aplicación del test de Jugueteo. Se muestra el efecto de la vinculación comunitaria para la construcción de un significado positivo de la actividad lúdica. Se describen conductas de las personas mayores sobre la base de indicadores que evidencian el impacto en el desempeño de actividades terapéuticas. La sistematización de la investigación-acción-participativa muestra el significado atribuido a la actividad lúdica, por sobre la atribución a la recreación, la resignificación de espacios lúdicos dentro de lo cotidiano y comunitario, que permite pensarlo como estrategia terapéutica innovadora. Changes realted to aging and satisfaction possibilities derived from them, in Chile make the community settings of attention and new intervention strategies transform into a possibility for older people to maintain and recover health. The objective was to identify the therapeutic value of "play" in older people, as a contribution with therapeutic purposes, specially in intervention community-based settings with this population. The present study shows the results of a participative action research with 12 people over 60 years old, in seven sessions, during the year 2013 in Valdivia district, Los Ríos region. An open experiential workshop, a discussion group and the aplication of the Test of Playfulness were conducted. The results show the effect of communitary linkage to the construction of a possitive meaning of ludic activity. Older people behaviors are described using indicatiors that shows the impact of therapeutic activities on performance. Systematization of the participative action research shows the meaning attributed to ludic activity, over the atributtion to recreation, but rather to the finding of new meaning of ludic spaces within the community and daily life, that allows to see it as an innovative therapeutic activity. (shrink)

This article, corresponding to a part of the restitution of a financed international research project between France, Brazil, Canada, Italy and Belgium, aims to offer a modelisation and qualitative evaluation of mediation care settings based on an original methodological tool that involves identifying the typical games at the foundations of creativity, following a multidisciplinary perspective. Therapeutic mediations are settings or devices organised around a “pliable medium”, often artistic, like painting, modeling, writing, ​and theatre, which are very widespread in institutional (...) practices, both in France and abroad. The scientific objectives of this research consist in a multi-disciplinary exploration (anthropology, criminology, neuroscience, clinical psychology) of the process of creative symbolisation understood as a process of transformation involving play. According to this orientation, play can be defined as a psychic process whereby a subjective experience can be explored with pleasure, and consequently symbolised and appropriated. Our fundamental and original hypothesis is that play is at the source of the creative process, conceived as a work of metabolisation by the psyche of playful experiences during the different stages of life. The review of the understanding of play in psychoanalysis, anthropology, criminology and neuroscience emphasises the richness of this model and the importance of reflecting on the typical games in the field of psychic care. A clinical example of treatment in a pictorial therapeutic mediation setting of a child with psychotic disorders makes it possible to identify a number of typical games as well as the modalities of interpretation of the therapists through play. These multidisciplinary studies lead to the presentation of a general table of typical games, and these first results highlight the richness of identifying typical games in clinical settings. Ultimately, the multidisciplinary approach shows the interest of the model of play in the evaluation of therapeutic mediation settings, with a convergence of the different disciplines emphasising the pertinence of this model. The scientific impact of this research overlaps with its societal impact, through the development of innovative tools for evaluating therapeutic mediations, in order to take account of the evolution of the different forms of social expression of psychic suffering. (shrink)

Human skin produces numerous neurohormones and neuropeptides. Recent evidence has shown that the neuroendocrine regulation of human skin biology also extends to keratins, the major structural components of epithelial cells. For example, thyrotropin‐releasing hormone, thyrotropin, opioids, prolactin, and cannabinoid receptor 1‐ligands profoundly modulate human keratin gene and protein expression in human epidermis and/or hair follicle epithelium in situ. Since selected keratins are now understood to exert important regulatory functions beyond mechanical stability, we argue that neuroendocrine pathways of keratin regulation are (...) important for maintaining skin and hair follicle homeostasis. This invites innovative neuroendocrine therapeutic interventions for skin disorders characterized by abnormal keratin expression, ranging from psoriasis to genodermatoses, and for promoting skin wound healing and hair growth. This strategy can be probed in simple, but instructive and readily available human skin and hair follicle organ culture assays as ideal models for exploring this new neuroendocrine frontier in translational epithelial biology. (shrink)

Cet article interroge l’espace thérapeutique mouvant expérimenté dans une téléconsultation avec un couple. Il décrit les frontières polytopiques d’une séance online. Désormais, l’espace thérapeutique réunit trois lieux qui se superposent : chez le thérapeute, chez le patient et l’interface de rencontre, la plateforme numérique. L’auteure constate l’émergence d’une illusion partagée entre le thérapeute et son patient, favorisée par la superposition de deux mondes : virtuel et réel, dans l’écran et hors de l’écran. Le passage à une thérapie conjugale à distance (...) déplace les symptômes sur l’aspect territorial du cadre, tout en permettant de déployer un nouveau processus thérapeutique. Puisque les patients font entrer le regard du thérapeute dans leur habitat intérieur, la question du privé et de l’intime se pose : qu’est-ce qui est dévoilé? Le couple peut jouer avec la création de la mise en scène jusqu’à la « profanation rituelle », la transgression du cadre. L’article apporte une illustration clinique d’une « séance à l’envers ». (shrink)

The outbreak of the COVID-19 pandemic has accelerated the need for online counseling to preserve therapeutic processes that have begun face to face and to provide service to others in need during lockdowns. Previous studies underscored the importance of providing updated training as counselors frequently hesitate to use technological advances in therapeutic sessions. This study aims at reducing such barriers by revealing personal characteristics of future professionals that might inhibit or encourage their openness toward providing online counseling. To (...) this end, this study is focused on several precursors of openness to provide online counseling: preference to communicate emotions online, identification of emotional expressiveness advantages in providing online counseling, innovative behavior, creativity, and future problem-solving thinking skills. The question at focus is which constructs would be found contributive to students’ openness to provide online counseling. The sample included 277 undergraduate students who filled out questionnaires. Data were analyzed using Partial Least Squares Structural Equation Modeling. Our findings pointed to the centrality of students’ preference to communicate their emotions online in explaining their openness to conducting online counseling. This study might help pinpointing the adjustments curriculum designers should address to better reflect the intensive changes within the counseling field that necessitate transferring face-to-face skills to online settings. (shrink)

Simon Friederich’s Therapeutic Approach to quantum theory (QT) sheds new light on the status of the quantum state. In particular, Friederich presents revisionary ideas on how to exactly differentiate objective from subjective elements of the theory and thereby improves upon previous stabs at an epistemic interpretation of quantum states. The book not only provides interesting perspectives for the cognoscenti but is also written with sufficient care and free of unnecessary technicalities so as to be accessible and worth reading for (...) the physical layman interested in the foundations of QT. The main achievement of the book is an innovative outline for interpreting quantum states epistemically while avoiding many problems of previous attempts. (shrink)

Enhancing research and development and ensuring equitable pricing and access to cutting-edge treatments are both vital to a biopharmaceutical innovation system that works in the public interest. However, despite delivering numerous therapeutic advances, the existing system suffers from major problems: a lack of directionality to meet key needs, inefficient collaboration, high prices that fail to reflect the public contribution, and an overly-financialized business model.

We rarely acknowledge the achievements of doctoral candidates who fought with all they had but still lost the battle and dropped out – we know so little about what becomes of them. This reflective article is about the betrayals of PhD supervisors in one institution, the trauma and stigma of withdrawing from that institution, writing poetry as a coping mechanism and the triumph in completing a Thesis by Publication (TBP) in another institution. Thus, I build on Lesley Saunders’s idea about (...) using poetry to operate on ‘a personal capacity’ in educational research. Accordingly, I present an original autoethnographic poem and other poetic artefacts as well as reflections to sharpen the sociological eye of my story. In it, I merge two different segments of experiences in poetry – trauma and triumph – to draw an image of my doctoral journey, in the moment and in retrospection. By doing so, I illuminate the struggles involved in becoming an independent researcher. I also encourage practitioners to conceive that their negative experiences in doing educational research can be transformed into an achievement depending on the stand they take when faced with it. Certainly, poor academic performance can be closely associated with abandoning doctoral studies, but that is not always the case. Therefore, it is my hope that this autoethnographic work may instill hope in doctoral candidates who are still in the struggle to find a voice. (shrink)

IntroductionThis study reports the findings on how Child life specialists implemented an innovative approach to providing therapeutic support to pediatric patients.MethodsPart of a larger study that uncovered themes about CLSs’ experiences while working with MEDi®, this study reports the reflections that CLSs have about the process of implementation. Seven CLSs participated in semi-structured interviews. Content analysis was conducted on interview data and three themes were generated.ResultsThe first was in regards to the adoption process whereby CLS challenges, successes, and surprises (...) were revealed. Second, CLSs explained how using MEDi® aligned with the roles and responsibilities of their profession. The third area of understanding was in CLS explanation of the friendly emotional impact MEDi® seems to have on the hospital environment.ConclusionChild life specialists are encouraged to use the MEDi® robot to support children at the bedside. (shrink)

The Pfizer-BioNTech coronavirus vaccine is 90 percent effective in protecting against COVID-19. It would not have been possible without the tireless effort of Professor Katalin Karikó, a scientific innovator fitting the mold of dynamic inventor Arthur Diamond presents in his book, Openness to Creative Destruction Sustaining Innovative Dynamism. Not only did Professor Karikó persist in her beliefs in the therapeutic potential of synthetic messenger RNA over the course of four decades, but she did so despite the criticisms of other (...) scientists and despite lack of financial backing for large parts of her career. Professor Karikó is a good example of the unconventional picture that Diamond paints of entrepreneurs in a specific version of market capitalism he terms, innovative dynamism. Specifically, she is an example of someone who does not hold prevailing academic theories in too high a regard and instead privileges her tacit knowledge (knowledge gained from years of working with mRNA in the lab) to persist believing in the potential of a therapy that now could quite literally save the world. Most surprisingly, she, like most of the entrepreneurs surveyed in the book, seem not primarily motivated by profit, though the money their projects eventually attract is integral to disseminating their creative ideas to the masses. -/- Are the many examples offered by Diamond that are similar to Professor Karikó’s story evidence against the long-standing suspicion that there is something morally damning in the self-interested motivations of innovative entrepreneurship? Is it the case that others would have inevitably pursued the cure that Karikó pursued, regardless of economic system? In light of COVID-19 and other high-pressure situations, ought we to care how we constrain the innovators who develop solutions? Diamond’s case for the economic system, innovative dynamism, seeks to answer these and other important questions concerning our political and cultural treatment of innovators and entrepreneurs. This review critically assesses his efforts. I make my case by first reviewing the major argumentative structure of the book, then I summarize and evaluate the three major themes Diamond presents in the book: (1) what is innovative dynamism and who are its competitors, (2) what are the major benefits of innovative dynamism, (3) who is the innovative entrepreneur and how do we support him or her? (shrink)

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

This article deals with the integration of ethical reflection into the research practices of the project at the Lille Nord-Pas-de-Calais genopole: “Multifactorial genetic pathologies and therapeutic innovations”. The general hypothesis of this text is that changes in research practices in biology (mainly through the use of bioinformatics) imply changes in medical practices, which require critical reflection. This hypothesis could be broken down into three sub-hypotheses: (1) Research in biology is undergoing a complete transformation; (2) Research in biology is a (...) cultural practice, which cannot be reduced to a simple cognitive action; (3) Research in biology is a techno-scientific practice. As for the method, the aim of our research at the Medical Ethics Centre is to elucidate the philosophical and ethical range of biomedical practices. This work entails a double task for reflection. On the one hand, from the revelation of ethical tensions present in these practices, we have to think about what is at stake in these practices, and more broadly in society. On the other hand, we have to analyse the conditions enabling the actors to assume the significance of ethical reflection in their practices. The method set up to undertake this double task could be qualified as “narrative hermeneutics”, as its aim is to attempt to interpret the stakes in practices from proximity with these practices and from what their actors have to say about them. The text then goes on to analyse more specifically the emergence and place of bioinformatics in present-day biomedical research. (shrink)

Anouck Alary | : La transformation du sang placentaire en une précieuse source de cellules souches a donné naissance à partir des années 1990 à une industrie globale de conservation de sang de cordon ombilical faisant désormais concurrence à un large réseau de banques publiques de sang de cordon. Cet article explore les soubassements socioculturels liés à l’émergence de cette industrie et tente d’élucider les enjeux éthiques et politiques qu’elle pose. Si les banques publiques de sang de cordon sont porteuses (...) des valeurs d’altruisme et de solidarité nationale traditionnellement liées au modèle redistributif d’échange de sang et d’organes né après la Seconde Guerre mondiale, les banques privées renvoient, elles, à des formes de solidarité bien différentes. C’est effectivement sous couvert de la solidarité familiale et de la responsabilité morale des mères de protéger leurs enfants qu’elles définissent la conservation privée comme une forme d’ « assurance biologique » contre les risques à la santé de l’enfant. En permettant aux mères d’investir leurs tissus corporels à la fois dans le futur incertain de leurs enfants et dans des thérapies cellulaires expérimentales, ces banques promeuvent un nouveau modèle de participation du/de la patient.e à la coconstitution de futures innovations thérapeutiques. Nous inscrivons ce modèle de participation dans les reconfigurations contemporaines du biopolitique que le sociologue britannique Nikolas Rose voit s’incarner dans l’émergence d’une nouvelle forme de biocitoyenneté. L’article critique finalement ces services personnalisés en soulignant qu’ils ont le potentiel d’opérer de nouvelles formes de coercition sur les mères, dans un contexte sociopolitique caractérisé par une responsabilisation accrue des individus au regard de la « bonne gestion » de leurs risques à la santé. Ces services sont aussi jugés problématiques sur le plan éthique, au vu de leur incohérence avec un principe de justice distributive défendant l’accès égal pour chaque citoyen.ne à des soins de santé de base. | : Since the 1990s, the transformation of cord blood into a precious source of stem cells has given rise to a global cord blood bank industry, which is now competing with a large network of public cord blood banks. This article explores the sociocultural context surrounding the emergence of this industry and aims at elucidating the ethical and political concerns that this industry raises. Whereas public cord blood banks are purveyors of values such as altruism and national solidarity traditionally linked to the redistributive model of human blood and organ donation that emerged after World War Two, private banks engage very different forms of solidarity. It is indeed under the guise of family solidarity and mothers’ moral responsibility to do their best to protect their children that they come to define private preservation as a form of “biological insurance” against potential risks to their children’s health. By allowing mothers to invest their bodily tissues simultaneously in their children’s uncertain future and in experimental cell therapies, these banks promote a new model of patient participation in the development of future therapeutic innovations. This article analyzes this model as embedded in the contemporary reconfiguration of biopolitics that sociologist Nikolas Rose envisions as constituting a new form of biocitizenship. The paper finally casts a critical eye on these personalized services, in particular because of the new forms of social coercion on mothers that are brought about in a social and political context characterized by an increasing moral accountability of individuals with regard to the “good management” of their own health risks. These services also appear ethically problematic in relation to political demands of distributive justice—e.g., the ideal of equal access to basic health care for every citizen. (shrink)

The subject of this article are the definitional and regulatory aspects of experimental (or innovative) therapies, understood either as new and unproven treatment methods that can be tested – and for this purpose used – also in clinical trials, or as applications of these new and unproven procedures in medical practice. After a short introduction, recalling one of the important sources of the concept of experimental or innovative therapy, which was the Belmont Report, I first discuss the problems related to (...) the definition of experimental therapy (as a new and nonvalidated medical procedure used to improve the patient's health), and then the controversial issues related to its regulation (including in particular the required control to which each such therapeutic intervention should be subject). Finally, I point out the importance of the discussions on experimental therapy reported in this article, conducted in other countries or in international contacts, for the necessary revision or reinterpretation of Polish regulations regarding therapeutic experiments. (shrink)

_Philosophical Delusion and its Therapy_ provides new foundations and methods for the revolutionary project of philosophical therapy pioneered by Ludwig Wittgenstein. The book vindicates this currently much-discussed project by reconstructing the genesis of important philosophical problems: With the help of concepts adapted from cognitive linguistics and cognitive psychology, the book analyses how philosophical reflection is shaped by pictures and metaphors we are not aware of employing and are prone to misapply. Through innovative case-studies on the genesis of classical problems about (...) the mind and perception, and on thinkers including Locke, Berkeley and Ayer, the book demonstrates how such autonomous habits of thought systematically generate unsound intuitions and philosophical delusions, whose clash with reality, or among each other, gives rise to ill-motivated but maddening problems. The book re-examines models of therapeutic philosophy, due to Wittgenstein and J. L. Austin, and develops an approach that may let us overcome philosophical delusions and the problems they engender. In this way, the book explains where and why therapy in called for in philosophy, and develops techniques to carry it out. (shrink)

Financing innovative and costly treatments in various therapeutic fields entails a number of problems in countries where costs are covered by public services. Providing these drugs is forcing actors to define the maximum sums of money society is willing to spend for given health improvements. This raises the question of whether maximum financing should vary according individuals’ circumstances, such as the rareness of a disease, lifestyles, social inequalities experienced over a life time, etc. This article examines a particular priority, (...) namely that given to the youngest patients, such prioritising usually refers to the “fair innings argument”. We question what could justify such a prioritization criterion. Three arguments are considered. At first we consider that FIA could be justified by the objective of equalizing the opportunities of well-being. Next, we proposed justifying the fair innings argument with the aim of equalizing the time provided to individuals to achieve their plan of life, in accordance with Rawls’s theory of justice as fairness. Finally, we proposed considering the FIA as being justified because of the goal of equalizing the time provided to individuals to accept death. These three arguments, of course, have many limitations, some of which we have highlighted. This article doesn’t aim to convince about the superiority of one argument over the other ones. We seek to contribute to the discussions which could happen on prioritization criteria regarding health care, by making explicit what could justify one specific criterion: the age criterion. (shrink)

This book presents an innovative reading of Daoist philosophy that highlights the critical and therapeutic functions of satire and humor. Moeller and D'Ambrosio show how the Zhuangzi expounds the Daoist art of "genuine pretending" the paradoxical skill of enacting social roles without submitting to them or letting them define one's identity.

Despite technological innovations, clinical expertise remains the cornerstone of psychiatry. A clinical expert does not only have general textbook knowledge, but is sensitive to what is demanded for the individual patient in a particular situation. A method that can do justice to the subjective and situation-specific nature of clinical expertise is ethnography. Effective deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) involves an interpretive, evaluative process of optimizing stimulation parameters, which makes it an interesting case to study clinical expertise. The (...) aim of this study is to explore the role of clinical expertise through an ethnography of the particular case of DBS optimization in OCD. In line with the topic of the special issue this article is a part of, we will also use our findings to reflect on ethnography as a method to study complex phenomena like clinical expertise. This ethnography of DBS optimization is based on 18 months of participant observation and nine in-depth interviews with a team of expert clinicians who have been treating over 80 OCD patients since 2005. By repeatedly observing particular situations for an extended period of time, we found that there are recurrent patterns in the ways clinicians interact with patients. These patterns of clinical practice shape the possibilities clinicians have for making sense of DBS-induced changes in patients’ lived experience and behavior. Collective established patterns of clinical practice are dynamic and change under the influence of individual learning experiences in particular situations, opening up new possibilities and challenges. We conclude that patterns of clinical practice and particular situations are mutually constitutive. Ethnography is ideally suited to bring this relation into view thanks to its broad temporal scope and focus on the life-world. Based on our findings, we argue that clinical expertise not only implies skillful engagement with a concrete situation but also with the patterns of clinical practice that shape what is possible in this specific situation. Given this constraining and enabling role of practices, it is important to investigate them in order to find ways to improve diagnostic and therapeutic possibilities. (shrink)

LANGUAGE NOTE | Document text in Chinese; abstract also in English. ECMO是一項高風險、高創傷、高消耗的創新技術，它能夠為新冠病毒肺炎重症患者提供挽救性治療°ECMO的治療目標是幫助患者恢復心肺功能，或者橋接最終治療，包括器械植入，或者器官移植等。然而，容易被忽視的 事實是，ECMO挽救了一些患者的生命，但也可能讓那些沒有康復機會的患者陷入醫療困境。於是，ECMO的臨床應用不得不面對一些反對意見，包括嚴重併發症危害患者生命安全、無效治療導致技術失敗，以及大量佔用資 源損害醫療公平等。ECMO技術的臨床應用應該在尊重生命價值和患者意願的基礎上，合理設置治療目標、確立可接受退出標準、妥善處理患者意願與ECMO設備撤除困境之間的倫理衝突，建立適度倫理框架以合理控制醫療 干預的邊界。 Characterized by high risk, high trauma and high consumption, Extra-Corporeal Membrane Oxygenation (ECMO) is an innovative technology that can be used as salvage therapy for COVID-19 patients. ECMO treatment can help restore patients' cardiopulmonary function or can bridge their final treatment, including device implantation or organ transplantation. However, although ECMO saves some patients' lives, it can also leave those with no chance of recovery in a medical dilemma. ECMO (...) is thus controversial: it is criticized for technical failures and ineffective treatments, and its use raises questions about medical equity. This paper argues that the clinical application of ECMO technology should be based on a respect for the value of life and the will of patients, reasonably set therapeutic goals, acceptable withdrawal criteria, proper management of the conflict between patients' desires and the medical dilemma, and the establishment of an ethical framework to control the limits of medical intervention. (shrink)

People are using innovative internet of things technologies to gain individualised management of their type 1 diabetes. The #WeAreNotWaiting movement supports them to build their own hybrid closed loop systems and access their real time blood sugar data via any web connected device. A small number of parents in Australia use such DIY looping systems to manage their child’s type 1 diabetes, but these systems have not been approved by the Therapeutic Goods Administration in Australia, creating ethical dilemmas for (...) clinicians about how to respond to the use of medical devices that are not registered on the Australian Register of Therapeutic Goods. This article considers whether the use of DIY looping is in the best interests of the child and, if not, whether intervention in parental decision making is justified to prevent harm to the child. It addresses the ongoing duty of healthcare professionals to provide care to children who are ‘looping.’ Reference is made to findings from a study, Personalised Closed Loop Systems for Childhood Diabetes, to illustrate stakeholders’ perceptions of benefits and harms of DIY looping systems. I conclude that the decision of parents to use DIY looping technology could be considered to be in a child’s best interests, broadly defined, and falls within the Zone of Parental Discretion, however healthcare practitioners who support parents may have professional concerns in doing so. (shrink)

Supernumerary robotic limbs are innovative devices in the field of wearable robotics which can provide humans with unprecedented sensorimotor abilities. However, scholars have raised awareness of the ethical issues that would arise from the large adoption of technologies for human augmentation in society. Most negative attitudes towards such technologies seem to rely on an allegedly clear distinction between therapy and enhancement in the use of technological devices. Based on such distinction, people tend to accept technologies when used for therapeutic (...) purposes (e.g., prostheses), but tend to raise issues when similar devices are used for upgrading a physical or cognitive ability (e.g., supernumerary robotics limbs). However, as many scholars have pointed out, the distinction between therapy and enhancement might be theoretically flawed. In this paper, we present an alternative approach to the ethics of supernumerary limbs which is based on two related claims. First, we propose to conceive supernumerary limbs as tools that necessarily modify our psychological and bodily identity. At the same time, we stress that such a modification is not ethically bad in itself; on the contrary, it drives human interaction with the environment. Second, by comparing our view with the extended mind thesis, we claim that the mediation through tools is crucial for the formation of novel meanings and skills that constitute human interaction with the world. We will relate the latter claim to enactivism as a helpful theoretical perspective to frame issues related to artificial limbs and, more in general, to technologies for augmentation. Based on this approach, we finally sketch some suggestions for future directions in the ethics of supernumerary limbs. (shrink)

Cortisone, initially known as ‘compound E’ was the medical sensation of the late 1940s and early 1950s. As early as April 1949, only a week after Philip Hench and colleagues first described the potential of ‘compound E’ at a Mayo Clinic seminar, the New York Times reported the drug’s promise as a ‘modern miracle’ in the treatment of rheumatoid arthritis. Given its high profile, it is unsurprising that historians of medicine have been attracted to study the innovation of cortisone. (...) It arrived at the end of a decade of ‘therapeutic revolutions’, kicked off by penicillin transforming the treatment of bacterial infections and ending with hopes of a revolution in the treatment of non-infectious, chronic inflammatory diseases. Despite these studies of cortisone’s introduction, few historians have taken the story forward and considered how cortisone was adopted and adapted into clinical practice. This article tells the longer of how the drug and its derivatives were taken from research laboratories and integrated into clinical practice; what has in recent decades become known as translational medicine. In exploring cortisone’s first decade in Britain, we focus specifically on its role in the treatment of RA. Our approach is always to consider cortisone’s use in the context of other treatments available to clinicians, and at local and national institutional settings. We do not discuss the many other therapeutic uses of cortisone, which ranged for topical applications for skin diseases to the management of cancers, especially childhood leukaemia, nor do we discuss its close analogue ACTH—AdenoCorticoTropic Hormone. We think there are lessons in our study for TM policies today. (shrink)

In recent years, neuroscience has been a particularly prolific discipline stimulating many innovative treatment approaches in medicine. However, when it comes to the brain, new techniques of intervention do not always meet with a positive public response, in spite of promising therapeutic benefits. The reason for this caution clearly is the brain’s special importance as “organ of the mind”. As such it is widely held to be the origin of mankind’s unique position among living beings. Likewise, on the level (...) of the individual human being, the brain is considered the material substrate of those traits that in combination render each person unique. In view of this preeminent significance of the brain, it is understandable that, in general, interventions into the brain are considered a delicate issue and that new techniques of intervention are scrutinised with particular care. However, in doing so it is important not to go to the opposite extreme and shy away from promising new therapeutic approaches for debilitating disorders of the brain. With respect to the new techniques of brain intervention a broad interdisciplinary perspective is required to discern irrational fear from justified concern. Hence, the Europäische Akademie established a project group consisting, on the one hand, of experts from different fields of medicine who have got first-hand experience of applying the techniques at issue and, on the other hand, of philosophers and a legal expert. The task of this team was to review the state of the art with respect to each single technique of intervening in the brain, to indicate future developments, and to address the ethical and legal issues common to all of them. The project’s outcome is the book at hand. (shrink)

For the past 40 years, the 14-day rule has governed and, by defining a clear boundary, enabled embryo research and the clinical benefits derived from this. It has been both a piece of legislation and a rule of good practice globally. However, methods now allow embryos to be cultured for more than 14 days, something difficult to imagine when the rule was established, and knowledge gained in the intervening years provides robust scientific rationale for why it is now essential to (...) conduct research on later stage human embryos. In this paper, I argue that the current limit for embryo research in vitro should be extended to 28 days to permit research that will illuminate our beginnings as well as provide new therapeutic possibilities to reduce miscarriage and developmental abnormalities. It will also permit validation of potentially useful alternatives. Through consideration of current ethical arguments, I also conclude that there are no coherent or persuasive reasons to deny researchers, and through them humanity, the knowledge and the innovation that this will generate. (shrink)

Machine Learning (ML) is on the rise in medicine, promising improved diagnostic, therapeutic and prognostic clinical tools. While these technological innovations are bound to transform health care, they also bring new ethical concerns to the forefront. One particularly elusive challenge regards discriminatory algorithmic judgements based on biases inherent in the training data. A common line of reasoning distinguishes between justified differential treatments that mirror true disparities between socially salient groups, and unjustified biases which do not, leading to misdiagnosis and (...) erroneous treatment. In the curation of training data this strategy runs into severe problems though, since distinguishing between the two can be next to impossible. We thus plead for a pragmatist dealing with algorithmic bias in healthcare environments. By recurring to a recent reformulation of William James’s pragmatist understanding of truth, we recommend that, instead of aiming at a supposedly objective truth, outcome-based therapeutic usefulness should serve as the guiding principle for assessing ML applications in medicine. (shrink)

In a first major study, the UK’s Royal Society found that 76% of people in the UK are in favour of therapeutic germline genomic editing to correct genetic diseases in human embryos, but found there was little appetite for germline genomic editing for non‐therapeutic purposes. Assuming the UK and other governments acted on these findings, can lawmakers and policymakers coherently regulate the use of biomedical innovations by permitting their use for therapeutic purposes but prohibiting their use for (...) enhancement purposes? This paper examines the very common claim in the enhancement literature that the therapy v enhancement distinction does little meaningful work in helping us think through the ethical issues, a claim that has significant implications for these lawmakers and policymakers who may wish to regulate genomic editing techniques to reflect the findings of this important study. The focus of this paper is on germline genomic editing as one of the main themes in this special issue. (shrink)

Amid the unrest, dislocation, and uncertainty of seventeenth-century Europe, readers seeking consolation and assurance turned to philosophical and scientific books that offered ways of conquering fears and training the mind—guidance for living a good life. _The Good Life in the Scientific Revolution_ presents a triptych showing how three key early modern scientists, René Descartes, Blaise Pascal, and Gottfried Leibniz, envisioned their new work as useful for cultivating virtue and for pursuing a good life. Their scientific and philosophical innovations stemmed in (...) part from their understanding of mathematics and science as cognitive and spiritual exercises that could create a truer mental and spiritual nobility. In portraying the rich contexts surrounding Descartes’ geometry, Pascal’s arithmetical triangle, and Leibniz’s calculus, Matthew L. Jones argues that this drive for moral therapeutics guided important developments of early modern philosophy and the Scientific Revolution. (shrink)

In Wittgenstein and the Study of Politics, Michael Temelini outlines an innovative new approach to understanding the political implications of Wittgenstein’s philosophy. Most political philosophers who have approached Wittgenstein have done so through the idea of therapeutic skepticism, implying politics that privilege conservatism or non-interference. Temelini interprets Wittgenstein differently, emphasizing his view that we come to understand the meanings of words and actions through a dialogue of comparison with other cases. Examining the work of Charles Taylor, Quentin Skinner, and (...) James Tully, Temelini highlights the ways in which all three, despite their differences, share a common debt to that dialogical approach.A cogent explanation of how Wittgenstein’s epistemology and ontology can shed light on political issues and offer a solution to political challenges, Wittgenstein and the Study of Politics highlights the importance of Wittgensteinian thinking in contemporary political science, political theory, and political philosophy. (shrink)

Background: Eye movement desensitization and reprocessing [EMDR] is an innovative, evidence-based and effective psychotherapy for post-traumatic stress disorder [PTSD]. As with other psychotherapies, the effectiveness of EMDR contrasts with a limited knowledge of its underlying mechanism of action. In its relatively short life as a therapeutic option, EMDR has not been without controversy, in particular regarding the role of the bilateral stimulation as an active component of the therapy. The high prevalence of EMDR in clinical practice and the dramatic (...) increase in EMDR research in recent years, with more than 26 randomized controlled trials published to date, highlight the need for a better understanding of its mechanism of action. Methods: We conducted a thorough systematic search of studies published until October 2017, using PubMed, ScienceDirect, Web of Knowledge and Scopus databases that examined the mechanism of action of EMDR or provided conclusions within the framework of current theoretical models of EMDR functioning. Results: Seventy-five studies were selected for review and classified into three overarching models; (i) psychological models (ii) psychophysiological models and (iii) neurobiological models. The evidence available from each study was analysed and discussed. Results demonstrated a reasonable empirical support for the working memory hypothesis and for the physiological changes associated with successful EMDR therapy. Recently, more sophisticated structural and functional neuroimaging studies using high resolution structural and temporal techniques are starting to provide preliminary evidence into the neuronal correlates before, during and after EMDR therapy. Discussion: Despite the increasing number of studies that published in recent years, the research into the mechanisms underlying EDMR therapy are still in its infancy. Studies in well-defined clinical and non-clinical populations, larger sample sizes and tighter methodological control are further needed in order to establish firm conclusions. (shrink)

This paper offers a different approach to writing about oneself—Stanley Cavell's idea of philosophy as autobiography. In Cavell's understanding, the acknowledgement of the partiality of the self is an essential condition for achieving the universal. In the apparently paradoxical combination of the 'philosophical' and the 'autobiographical', Cavell shows us a way of focusing on the self and yet always transcending the self. The task requires, however, a reconstruction of the notions of philosophy and autobiography, and at the same time the (...) destabilising of our conceptions of self and language. Cavell seeks to achieve this through the idea of finding one's voice, understood as an autobiographical exercise. This necessitates both negotiation of the inheritance from the past and innovation for the future, initiation into the language community and deviation from it. What this amounts to, in ways that the paper seeks to explain, is a process of the self and language in translation. This is a sense of 'translation' that is broader than the conventional understanding of the term. Such a conception can, it is argued, exercise a therapeutic effect on the self, destabilising the myth of self-identity. The implications of this account for the contemporary vogue for narrative in educational research, as well as for classroom practice, are considered. (shrink)

The ease and applicability of CRISPR/Cas9––a new and precise gene editing and reproductive technology––have garnered hype and heightened concern about its potential ‘unprecedented and horrific consequences’ and have led many scientific leaders to call for a moratorium on its research and use. CRISPR appears distinctly more controversial than previous technological innovations, with a greater reach and speed of human treatment and enhancement; however, we have seen similarly inflated hopes and fears in response to other medical innovations for well over a (...) century. One intervention that has both historically and recently incited alarm––vaccines––serves as a pertinent example of what could go wrong if a technology's reach is shortened due to inflated fears. By comparing the vaccine controversy and the CRISPR debate, we can help separate the hype from the realistic potential of these technologies. How our society grapples with such innovations will determine the extent to which their impact on our individual and collective health will be beneficial. We must recognise the need for a tempered approach to CRISPR conversation leading to regulation and ethical application. Although CRISPR's reach will continue expanding with ongoing research, thus requiring continuous evaluation, the lessons we have learned from the vaccine controversy demonstrate that our approach must not be to shut down regulation and application now, but to thoughtfully conjoin productive debate and action so that therapeutic gene editing can alleviate suffering as soon as possible without precipitating social outcomes we would belatedly deplore. (shrink)