Artykuł dotyczy instytucji pozarejestracyjnego stosowania produktów leczniczych oraz problemów w rozgraniczeniu sytuacji, w których taka forma leczenia ma charakter terapii innowacyjnej od normalnej praktyki leczniczej. Poruszona została kwestia istotnego ryzyka kwalifikacji rutynowej terapii przy użyciu produktów leczniczych jako eksperymentu medycznego oraz relacja pomiędzy pojęciem aktualnej wiedzy medycznej a Charakterystyką Produktu Leczniczego. Omówione zostały trudności w ustaleniu, czy proponowany sposób leczenia jest metodą nową lub częściowo wypróbowaną oraz przedstawiono postulat zwiększenia aktywności lekarskich towarzystw naukowych w tym zakresie. Przedstawiono implikacje kwalifikacji leczenia (...) off-label jako eksperymentu leczniczego w zakresie konieczności uzyskania opinii komisji bioetycznej oraz zawarcia ubezpieczenia odpowiedzialności cywilnej podmiotu przeprowadzającego eksperyment medyczny oraz ich wpływ na bezpieczeństwo pacjenta, bezpieczeństwo prawne lekarza oraz dostępność do świadczeń medycznych. (shrink)

The following text is a voice in the discussion around normative problems of innovative therapies. It particularly refers to the problem of the relationship between therapeutic experiment and the research purpose of a physician's action, also discussed in this issue in the article by Rafał Kubiak "A few comments on the background of the article »Off label - practical consequences of unclear legislation«.”.

The following text is a voice in the discussion around normative problems of innovative therapies. It refers to problems related to the amendment to the Polish Act on the Professions of Physician and Dentist, particularly to therapeutic experiment category, also discussed in this issue in the article by Maria Gutowska-Ibbs: “Off-label - practical consequences of unclear legislation.”.

Polish medical law does not explicitly regulate the possibility of off-label use of medicines. Such procedures therefore raise doubts in medical practice, where medicines are often prescribed beyond the Characteristic of Medicinal Product. This phenomenon particularly affects the treatment of children, as there is a lack of registered medicines in this age group, but they are registered for use in adults. Since such treatment goes beyond the scope of registration, a dilemma arises as to whether it is permissible and, if (...) so, under what conditions and whether sanctions are imposed on the medical professional using the off-label medicine. These issues are addressed in an article by Dr Maria Gutowska-Ibbs, entitled 'Off label - practical consequences of unclear legislation". The present study complements these considerations and is in part an ad vocem statement. The article attempts to differentiate between the use of off-label medicines and medical experiments, following the criterion of the purpose for which a given medical action is performed. The limits of admissibility of such actions under criminal law are also discussed in more detail. Off-label treatment is considered through the prism of the required precautionary rules, compliance with which is the antithesis of inadvertence. It is assumed that if the drug was administered in accordance with current medical knowledge and the treatment is adequate to the patient's condition, there is no violation of these rules, which excludes the imputation of inadvertence. An extensive section of the study is devoted to the issue of the patient's consent to treatment outside the indications. Above all, it emphasises the need to explain in detail to the patient the circumstances of prescribing such a drug and, on this basis, to obtain informed consent. It also stresses the importance of the written form of consent, which can have a significant evidentiary impact in potential litigation. (shrink)

La discussione generale sulla filosofia della scienza contemporanea è complicata dal numero e dall’eterogeneità delle scienze, mentre lo studio di temi specifici porta inevitabilmente a dissertazioni specialistiche che mancano nel dare ragione della trama di senso sottostante. Questo Piccolo trattato di epistemologia intende occupare uno spazio vuoto, proponendo alcuni temi chiave per la comprensione dei meccanismi alla base della conoscenza scientifica: i rapporti tra filosofia e scienze, siano esse naturali o umane; la complessa relazione tra fatti e valori; la distinzione (...) tra scoperta e giustificazione; la necessità di un discorso etico sulla ricerca, che chiami in causa categorie come fiducia, empatia, altruismo ed egoismo. Con un approccio chiaro e rigoroso, il volume intende rivolgersi a quell’ampia fascia di pubblico interessata alle tematiche centrali dell’epistemologia, della filosofia e delle scienze. (shrink)

In this conceptual article, we argue that defining corporate social responsibility and corporate social irresponsibility as opposite constructs produces a lack of clarity between responsible and irresponsible acts. Furthermore, we contend that the treatment of the CSR and CSI concepts as opposites de-emphasizes the value of CSI as a stand-alone construct. Thus, we reorient the CSI discussion to include multiple aspects that current conceptualizations have not adequately accommodated. We provide an in-depth exploration of how researchers define CSI and both identify (...) and analyze three important gray zones between CSR and CSI: the role of harm and benefit, the role of the actor and intentionality, and the role of rectification. We offer these gray zones as factors contributing to the present lack of conceptual clarity of the term CSI, as a concept in its own right, leading to difficulties that researchers and managers experience in categorizing CSI acts as distinct from CSR. (shrink)

In this paper, we analyze the role of science and technology studies journal editors in organizing and maintaining the peer review economy. We specifically conceptualize peer review as a gift economy running on perpetually renewed experiences of mutual indebtedness among members of an intellectual community. While the peer review system is conventionally presented as self-regulating, we draw attention to its vulnerabilities and to the essential curating function of editors. Aside from inherent complexities, there are various shifts in the broader political–economic (...) and sociotechnical organization of scholarly publishing that have recently made it more difficult for editors to organize robust cycles of gift exchange. This includes the increasing importance of journal metrics and associated changes in authorship practices; the growth and differentiation of the STS journal landscape; and changes in publishing funding models and the structure of the publishing market through which interactions among authors, editors, and reviewers are reconfigured. To maintain a functioning peer review economy in the face of numerous pressures, editors must balance contradictory imperatives: the need to triage intellectual production and rely on established cycles of gift exchange for efficiency, and the need to expand cycles of gift exchange to ensure the sustainability and diversity of the peer review economy. (shrink)

This work proposes an analysis of the cognitive and motivational components of hope, its basic properties, and the affective dispositions and behaviors it is likely to induce. In our view current treatments of hope do not fully account for its specificity, by making hope overlap with positive expectation or some specification of positive expectation. In contrast, we attempt to highlight the distinctive features of hope, pointing to its differences from positive expectation, as well as from a sense of successful agency, (...) optimism, trust, and faith. Fear and anxiety are also addressed, and the latter is analyzed as a state of mind implying both fear and hope. Finally, the relationship between hope and motivation is explored, and “active” hope is compared with “passive” hope. Some concluding remarks summarize the results of our analysis, and stress the role of hope in fostering the individual’s well-being. (shrink)

In this paper I analyze Kant’s ideas about eating and drinking. First, I show that gluttony and drunkenness are considered ways to oppose to the duty to oneself as an animal being. Second, I claim that for Kant there is a healthy way of having meals, which consists in eating together with friends. Then I indicate that Kant accepts that one can drink at dinner parties but has to avoid drinks that lead to drunkenness and unsocial behavior. In this sense, (...) he draws a classification of the various kinds of alcoholic drinks, according to their potential harm. Afterwards, I illustrate how Kant’s own intimate life was a daily practice of his thoughts on dietetic conceptions and on what is better for digestion and health. To conclude, I mention the idea of a philosopher’s medicine of the body and why a strict diet should be avoided. (shrink)

Alongside the renowned male pioneers of medical cytogenetics, many women participated in investigations at the laboratory bench and the bedside, both in Europe and the Americas. These women were committed to this new biological and clinical practice—cytogenetics, the origins of contemporary genetic diagnosis—and contributed to the creation of new biological concepts and settings centered on the study of chromosome imaging. This paper will review the contributions made by a group of woman scientists from a wide geographical distribution, situating their names (...) and research agendas within the history of a field dating back to early plant and insect cytogenetics. Rather than an exhaustive compendium of women geneticists, this essay presents a kind of historical reconstruction that can be achieved by placing women at center stage in their geographies and networks of circulating cytogenetic knowledge and practices thereby relating a history of genetic images though the work carried out by women, retrieving their agency and constructing an inclusive history of an influential contemporary biomedical practice as it gained increasing influence in the laboratory and the clinic. (shrink)

Most scholars of emotions concede that although cognitive evaluations are essential for emotion, they are not sufficient for it, and that other elements, such as bodily feelings, physiological sensations and behavioral expressions are also required. However, only a few discuss how these diverse aspects of emotion are related in order to form the unity of emotion. In this essay I examine the co-presence and the causal views, and I argue that neither view can account for the unity of emotions. In (...) particular, both views face the problem of fortuitous connection, and, as a result, they fail to identify and distinguish an emotion from other mental states. Consequently, they fail to account for our first person authority over our emotions. I finally argue that only an internal, conceptual relation between the cognitive/evaluative and affective/physiological aspects of emotion can avoid such problems, and suggest that the Aristotelian distinction of form and matter can provide such internal relation. (shrink)

What are intuitions? Do they exist as distinctive mental states? Do they have an epistemic function? Can we discern specific features that characterize intuitions? Questions like these are widely d...

Following the declaration of the COVID-19 outbreak as a global pandemic in March 2020, a state of alarm was decreed in Spain. In this situation, healthcare workers experienced high levels of stress, anxiety and depression due to the heavy workload and working conditions. Although Spain experienced a progressive decline in the number of COVID-19 cases until the last week of May and the work overload among health workers was substantially reduced, several studies have shown that this work overload is associated (...) with the later emergence of psychological symptoms induced by stress. The aim of the present study was to evaluate the levels of stress, anxiety, depression, post-traumatic stress and compassionate fatigue in health professionals. The sample consisted of 973 health professionals 16.5% men, 82.9% women, and one non-binary person. The data were collected through an online questionnaire sent to the participants by e-mail. DASS-21 was used to measure anxiety, stress and depression, PCL-C to measure post-traumatic stress and ProQOL -vIV to measure compassion fatigue. In addition, other descriptive variables that could be related to these levels of psychological symptomatology were evaluated. The results reveal that after the work overload experienced during the COVID-19 pandemic, healthcare workers report psychological symptoms, post-traumatic stress and compassion fatigue. It is therefore recommended that these professionals be provided with psychological help in order to reduce the emotional impact of COVID-19, and consequently improve their mental health. (shrink)

Motor learning can be defined as a process that leads to relatively permanent changes in motor behavior through repeated interactions with the environment. Different strategies can be adopted to achieve motor learning: movements can be overtly practiced leading to an amelioration of motor performance; alternatively, covert strategies (e.g., action observation) can promote neuroplastic changes in the motor system even in the absence of real movement execution. However, whether a training regularly alternating action observation and execution (i.e., Action Observation Training, AOT) (...) may surpass the pure motor practice (MP) and observational learning (OL) remains to be established. To address this issue, we enrolled 54 subjects requiring them to learn tying nautical knots via one out of three types of training (AOT, MP, OL) with the scope to investigate which element mostly contributes to motor learning. We evaluated the overall improvement of each group, along with the predictive role that neuropsychological indexes exert on each treatment outcome. The AOT group exhibited the highest performance improvement (42%), indicating that the regular alternation between observation and execution biases participants toward a better performance. The reiteration of this sequence provides an incremental, adjunct value that super-adds onto the efficacy of motor practice or observational learning in isolation (42% > 25% + 10%, i.e., OL + MP). These findings extend the use of the AOT from clinical and rehabilitative contexts to daily routines requiring the learning and perfectioning of new motor skills such as sports training, music, and occupational activities requiring fine motor control. (shrink)

'Ethics' was not developed as a separate branch of philosophy in Buddhist traditions until the modern period, though Buddhist philosophers have always been concerned with the moral significance of thoughts, emotions, intentions, actions, virtues, and precepts. Their most penetrating forms of moral reflection have been developed within disciplines of practice aimed at achieving freedom and peace. This Element first offers a brief overview of Buddhist thought and modern scholarly approaches to its diverse forms of moral reflection. It then explores two (...) of the most prominent philosophers from the main strands of the Indian Buddhist tradition – Buddhaghosa and Śāntideva – in a comparative fashion. (shrink)

This paper focuses on Aristotelian phronesis and aims at highlighting its nature as an eye on particulars with general ends in sight. More specifically, it challenges the particularistic interpretation of phronesis and Aristotelian ethics in order to argue for a “qualified generalism.” After sketching a radical Particularistic Reading (PR), the paper defends an interpretation it calls the Priority of Particulars Reading (PPR). First, it shows how PPR effectively accounts for the Aristotelian priority assigned to practical perception while at the same (...) time counterbalancing that priority by means of two interpretive strategies. Then it offers further support to PPR by appealing to its own reading of Aristotle's phronesis. It aims to show that it is possible to defend a legitimate form of PPR without ending in holding PR, and that Aristotle's own theory and work ground the moderate reading. Finally, it draws some implications by analyzing educational practice. (shrink)

This paper presents an overview of my work in philosophy from my first book on Friedrich Schiller and the political sublime to my most recent project on listening to traumatic forms of violence. Starting with a reflection on the autobiographical character of philosophy, I propose to take up the question of an aesthetic dimension of philosophical critique, where aesthetics is understood as an always already embodied perspective on the world, on truth, and on philosophical activity, as well as an always (...) already political realm, where the distribution of sense pre-determines our approach and articulation of experience. Departing from aesthetics understood and deployed as critique, the paper moves on to ask about the specific frameworks of sense or grammars that determine in advance the conditions of audibility in the realms of memory-building and history-making—particularly in those contexts where historical, political, and institutional forms of violence produce silencing and erasure. Putting in dialogue the latter with decolonial studies, I interpret “traumatic violence” as a colonizing form of violence, understanding that one of its central aspects is that it is not only an assault on life but on the conditions of production of sense that make life legible as such. In this context, my project on grammars of listening seeks to carefully unpack these complex intersections while also explaining why I believe that a radical form of listening is an essential subversive/imaginative strategy against traumatic/colonial violence. (shrink)

In the 1980s, new reproductive technologies such as in vitro fertilisation and embryo transfer became commercially available in the United States, and somatic cell nuclear transfer—the cloning process by which Dolly the Sheep would be conceived in 1996—was in its experimental phase. While anxieties concerning these new technologies escalated in the popular sensorium, Laurie Anderson explored the phenomenon of cloning in a short musical film called What You Mean We? (1986) in which Anderson consults a design team to clone herself (...) in order to manage her demanding workload. The videographic image of the clone is Anderson herself, performing in drag, and her clone’s body is partially created through the use of a pitch shifter which changes Anderson’s voice to that of the cloned—but ostensibly male—version of herself. In this article, I investigate Anderson’s technological consideration of the body, which extends beyond her own corporeality, to interrogate the biological and affective capacities of clones. I consider how Anderson addresses the convergence of reproductive technologies, the market and the creation of subjects within this market as participating in a shift in how voices are heard, governed and reproduced in the latter half of the twentieth century. (shrink)

This article exposes the neoplatonic element present in the metaphysics of causality elaborated in the seventeenth century by Leibniz. It explains this question in relation with medieval Neoplatonism, whose metaphysics of the Verb appears as the nucleus of the explanation of the relationship between causality and otherness.

Las fuentes de la revelación han afirmado siempre la presencia salvífica del Espíritu Santo más allá de los límites del antiguo y del nuevo Israel. Este artículo es un intento por percibirla en las ceremonias religiosas de los pueblos indígenas y mestizos del Sur Andino Peruano. Para alcanzar su objetivo, considera las circunstancias que acompañaron el anuncio del Evangelio en América y encuentra en la Carta a los Hebreos una clave para comprender e interpretar el proceso de inculturación del cristianismo (...) en los ritos dedicados a la Madre Tierra. Frente a la idolatría tributaria de la muerte, estos antiguos cultos aparecen como núcleos generadores de vida, que revelan la intervención providente de Dios en situaciones de sufrimiento injusto. (shrink)

Existen insospechados parecidos de familia. En sus clases de Ciencia y Filosofía Política en la Universidad de Yale, Seyla Benhabib suele insistir en que las personas se terminan pareciendo mucho más a sus propias instituciones que a los Estados o a las naciones en las que viven. Esta aseveración resulta inquietante. De todos es sabido que podemos identificarnos más o menos con nuestra propia nación, pero la idea de que, en verdad, todos vayamos a terminar pareciéndonos mucho más a ciertas (...) instituciones solo es comparable a una de esas experiencias culinarias que proporciona Dabiz Muñoz, calificadas por él mismo como “de romperte la cabeza”. Laureado con el Nobel en 1993, el economista e historiador Douglass C. North sostuvo que los seres humanos idean las instituciones para crear orden, reducir la incertidumbre y estructurar la interacción socio-política. (shrink)

Al comienzo del De Visione Dei ,Nicolás de Cusa nos pone ante un icono del mirar divino y nos invita a una experiencia muy personal, a una acción inicialmente envuelta en la reflexión metafórica, la contemplación mística. Trabajando con la metáfora de la mirada, el Cusano nos sitúa ante la mirada del creador y la mirada de la creatura. En De Visione Dei, el mirar divino es creador y amante. El mirar de Dios ve, crea y ama. De esa manera, (...) el presente trabajo procurará reflejar la importancia del mirar, intentando trazar en el De Visione Dei una relación entre la unidad de la mirada del creador y la multiplicidad de la mirada de la creatura. (shrink)

The article by Gustavsson et al 1 addresses the important question how to handle new medications with focus on drug candidates that reduce Aβ or tau in the brain, for individuals with Alzheimer’s disease, where the need for a disease-modifying drug is enormous. There are several ethical issues to deal with. The challenges and ethical implications associated with whom should be eligible for treatment are thoroughly discussed in the article. Should treatment only be available to those with mild symptoms and/or (...) to those with no symptoms but with risk for AD? Where do we draw the line between who will be eligible for treatment and who will not? Who will be responsible for the prioritisation? There are many ethical problems with both population screening and screening of those with high risk well discussed in the article. Indeed, the first immunotherapy drug Aducanumab was approved by the US Food and Drug Administration in …. (shrink)