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  1. Compassionate use of psychedelics.Martin Šurkala & Adam Greif - 2020 - Medicine, Health Care and Philosophy 23 (3):485-496.
    In the present paper, we discuss the ethics of compassionate psychedelic psychotherapy and argue that it can be morally permissible. When talking about psychedelics, we mean specifically two substances: psilocybin and MDMA. When administered under supportive conditions and in conjunction with psychotherapy, therapies assisted by these substances show promising results. However, given the publicly controversial nature of psychedelics, compassionate psychedelic psychotherapy calls for ethical justification. We thus review the safety and efficacy of psilocybin- and MDMA-assisted therapies and claim that it (...)
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  • Bioethics of Public Policies. Ethical Standards in Crisis Situations.Antonio Sandu - 2020 - Postmodern Openings 11 (1Sup2):141-160.
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  • The Expanded Access Cure: A Twenty-First Century Framework for Companies.Alexandra Y. Murata & Stacey B. Lee - 2019 - Journal of Business Ethics 156 (1):155-171.
    Through expanded access protocols, the Food and Drug Administration (FDA) allows patients with serious or immediately life-threatening diseases access to experimental drugs outside the clinical trial setting when no satisfactory alternative treatment is available. While the FDA has established a mechanism for providing patients with unapproved drug access, the regulations do not require the pharmaceutical company to provide the drug. The drug company’s permission to use its experimental drug is a necessary prerequisite to using the FDA’s expanded access mechanism. Increasingly, (...)
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  • The Role of Physicians in Expanded Access to Investigational Drugs: A Mixed-Methods Study of Physicians’ Views and Experiences in The Netherlands.Eline M. Bunnik & Nikkie Aarts - 2021 - Journal of Bioethical Inquiry 18 (2):319-334.
    Treating physicians have key roles to play in expanded access to investigational drugs, by identifying investigational treatment options, assessing the balance of risks and potential benefits, informing their patients, and applying to the regulatory authorities. This study is the first to explore physicians’ experiences and moral views, with the aim of understanding the conditions under which doctors decide to pursue expanded access for their patients and the obstacles and facilitators they encounter in the Netherlands. In this mixed-methods study, semi-structured interviews (...)
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  • The Practice of Pharmaceutics and the Obligation to Expand Access to Investigational Drugs.Michael Buckley & Collin O’Neil - 2020 - Journal of Medicine and Philosophy 45 (2):193-211.
    Do pharmaceutical companies have a moral obligation to expand access to investigational drugs to patients outside the clinical trial? One reason for thinking they do not is that expanded access programs might negatively affect the clinical trial process. This potential impact creates dilemmas for practitioners who nevertheless acknowledge some moral reason for expanding access. Bioethicists have explained these reasons in terms of beneficence, compassion, or a principle of rescue, but their arguments have been limited to questions of moral permissibility, leaving (...)
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  • Compassionate use programs in Italy: ethical guidelines.Ludovica De Panfilis, Roberto Satolli & Massimo Costantini - 2018 - BMC Medical Ethics 19 (1):22.
    This article proposes a retrospective analysis of a compassionate use, using a case study of request for Avelumab for a patient suffering from Merkel Cell Carcinoma. The study is the result of a discussion within a Provincial Ethics Committee following the finding of a high number of requests for CU program. The primary objective of the study is to illustrate the specific ethical and clinical profiles that emerge from the compassionate use program issue. The secondary goals are: a) to promote (...)
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