488 research outputs found

    A defense of surgical procedures regulation

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    Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy of medical treatments and products. Regulatory agencies, such as the FDA, demand two full-fledged Randomized Clinical Trials demonstrating the safety and effectiveness of drugs to grant its marketing authorization. On the contrary, surgical treatments are left completely unregulated. There are several reasons explaining this difference, and all of them point to the difficulty of conducting well-designed RCTs in surgery. However, we argue that none of these arguments is decisive and that, under certain conditions, surgical RCTs can be morally justified and methodologically sound. Although ethical constraints restrict the number of testable surgical procedures, and surgical trials might not be as dependable as pharmaceutical RCTs, our analysis suggests that, in certain cases, it is possible to obtain high-quality evidence about the safety and efficacy of surgical procedures. Untested surgical treatments may prove to be ineffective and harm patients. Therefore, regulation of surgical procedures seems not only morally acceptable and able to provide reliable scientific evidence, but also desirable and justified from an ethical-political standpoint

    Introduction: Severe Uncertainty in Science, Medicine, and Technology

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    This Special Issue titled "Severe Uncertainty in Science, Medicine and Technology" aims to shed new light on the understanding of severe uncertainty and its multifaceted implications. The main idea of the papers of this collection is that, despite possible sophisticated statistical judgments towards future risks in science, medicine, and technology, severe forms of uncertainty still exist.While ignorance is usually assumed to be a total absence of knowledge, uncertainty often refers to the incompleteness of knowledge or information. In its extreme form, this is called "severe uncertainty" but is also known as "fundamental," "radical," "deep," "great," or "genuine" uncertainty

    CLINICAL TRIALS AND DRUG REGULATION: A PHILOSOPHICAL INQUIRY

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    This thesis is organized around two overlapping questions: (1) whether and how the current approach to the regulation of new medicines should be modified to manage issues generated by new biomedical products, and (2) whether this issue may be reduced to an epistemological and methodological analyses. I explore and discuss some philosophical issues related to these questions

    In the shadow of the church: the building of mosques in early medieval Syria

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    In his book In the Shadow of the Church: The Building of Mosques in Early Medieval Syria Mattia Guidetti examines the establishment of Muslim religious architecture within the Christian context in which it first appeared in the Syrian region, contributing to the debate on the transformation of late antique society to a Muslim one. He scrutinizes the slow process of conversion to Islam of the most important town centers by looking at religious places of both communities between the seventh and the eleventh century. The author assesses the relevancy of churches by analyzing the location of mosques and by researching phenomena of transfer of marble material from churches to mosques

    Disentangling Responsibility: Perspectives on Dementia Prevention From Stakeholders in Canada, Germany and Switzerland

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    ABSTRACT Dementia prevention has become a priority in medical research and public health. Various medical, social and environmental risk factors have been identified; however, medical studies, media discourses and health policies predominantly centre on individual‐level prevention and promote personal responsibility for maintaining cognitive health. This emphasis on individual preventive efforts faces increasing criticism for being ethically problematic, medically insufficient and reflective of a neoliberal responsibilisation of (cognitive) ageing. Our study, based on 64 semi‐structured qualitative interviews with stakeholders involved in dementia research, care and health policy from Canada, Germany and Switzerland, situates the preventive turn within contemporary ageing cultures and welfare policies. By examining the epistemic and normative arguments underlying current debates on dementia prevention, we illustrate how stakeholders justify both personal and governmental responsibilities in preventing dementia. Although managing and mitigating various risk factors throughout life is often framed as a matter of personal responsibility, many stakeholders advocate combining individual‐level prevention with population‐level efforts to address social inequalities that affect the risk of developing dementia. Drawing on the interview study, we highlight the importance of recognising the political and normative foundations and implications of dementia prevention strategies.Santé https://doi.org/10.13039/501100000156Canadian Institutes of Health Research https://doi.org/10.13039/501100000024Bundesministerium für Bildung und Forschung https://doi.org/10.13039/501100002347Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung https://doi.org/10.13039/50110000171

    The Main Faces of Robustness

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    In the last decade, robustness has been extensively mentioned and discussed in biology as well as in the philosophy of the life sciences. Nevertheless, from both fields, someone has affirmed that this debate has resulted in more semantic confusion than in semantic clearness. Starting from this claim, we wish to offer a sort of prima facie map of the different usages of the term. In this manner we would intend to predispose a sort of “semantic platform” which could be exploited by those who wish to discuss or simply use it. We do this by starting from a core distinction between the robustness of representations, which is a philosophy of science issue, and the representations of robustness, which instead pertains to science. We illustrate our proposal with examples from biology, physics and mathematics

    Why Genes Are Like Lemons

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    In the last few years, the lack of a unitary notion of gene across biological sciences has troubled the philosophy of biology community. However, the debate on this concept has remained largely historical or focused on particular cases presented by the scientific empirical advancements. Moreover, in the literature there are no explicit and reasonable arguments about why a philosophical clarification of the concept of gene is needed. In our paper, we claim that a philosophical clarification of the concept of gene does not contribute to biology. Unlike the question, for example, “What is a biological function?”, we argue that the question “What is a gene?” could be answered by means of empirical research, in the sense that biologists’ labour is enough to shed light on it

    RESVERATROL-INDUCED AUTOPHAGY CONTRIBUTES TO THE INHIBITION OF EPSTEIN BARR VIRUS REPLICATION IN BURKITT’S LYMPHOMA CELLS

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    RESVERATROL-INDUCED AUTOPHAGY CONTRIBUTES TO THE INHIBITION OF EPSTEIN BARR VIRUS REPLICATION IN BURKITT’S LYMPHOMA CELLS De Leo Alessandra (a), Colavita Francesca (a), Arena Giuseppe (b), Mattia Elena (a) (a) Dip. di Scienze di Sanità Pubblica e Malattie Infettive “Sanarelli”, Univ. di Roma “Sapienza” (b) Casa Sollievo della Sofferenza Hospital, CSS-Mendel Institute, Roma Presenting author: De Leo Alessandra, [email protected] We have previously examined the antiviral activity of resveratrol on the replication of Epstein Barr Virus (EBV), the etiologic agent of infectious mononucleosis and associated with several types of malignancies of epithelial and lymphoid origin. In a cellular context that allows in vitro EBV activation and lytic cycle progression through mechanisms closely resembling those that in vivo initiate and enable productive infection, we found that RV inhibited EBV lytic genes expression and the production of viral particles in a dose-dependent manner

    Does Independence Affect Regulatory Performance? The case of national competition authorities in the European Union

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    Despite having always been assumed to be true, a relationship between the independence of regulatory agencies and their performance has never been formally tested. This paper aims at verifying whether formal regulatory independence affects the performance of national competition authorities in the EU member states. The author presents and discusses a statistical analysis which shows that greater formal independence leads competition authorities to investigate more cases and to issue more decisions
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