J Bioethic Inq
-
Medical Negligence Determinations, the "Right to Try," and Expanded Access to Innovative Treatments.
This article considers the issue of expanded access to innovative treatments in the context of recent legislative initiatives in the United Kingdom and the United States. In the United Kingdom, the supporters of legislative change argued that the common law principles governing medical negligence are a barrier to innovation. In an attempt to remove this perceived impediment, two bills proposed that innovating doctors sued for negligence should be able to rely in their defence on the fact that their decision to innovate was "responsible." A decision to innovate would be regarded as responsible if it followed a specified process. ⋯ These laws do not purport to and nor are they able to alter the obligations of individuals and companies under federal law. They are consequently unlikely to achieve their stated aim of expanding access to investigational products. This article argues that they nevertheless have a cogent rationale in so far as they highlight the need for rights-based reform to federal regulations governing access.
-
Review Comparative Study
Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.
Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. ⋯ We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.
-
Despite increased calls for hospital ethics committees to serve as default decision-makers about life-sustaining treatment (LST) for unrepresented patients who lack decision-making capacity or a surrogate decision-maker and whose wishes regarding medical care are not known, little is known about how committees currently function in these cases. This was a retrospective cohort study of all ethics committee consultations involving decision-making about LST for unrepresented patients at a large academic hospital from 2007 to 2013. There were 310 ethics committee consultations, twenty-five (8.1 per cent) of which involved unrepresented patients. ⋯ Substitute decision-makers who had been evaluated through the ethics consultation process and who made the final decision alone were more likely to continue LST than cases in which physicians made the final decision (50 per cent vs 6.3 per cent, p = 0.04). In our centre, the primary role of ethics consultants in decision-making for unrepresented patients is to identify appropriate decision-making standards. In the absence of other data suggesting that ethics committees, as currently constituted, are ready to serve as substitute decision-makers for unrepresented patients, caution is necessary before designating these committees as default decision-makers.
-
In attempting to provide protection to individuals and communities, childhood immunization has benefits that far outweigh disease risks. However, some parents decide not to immunize their children with some or all vaccines for reasons including lack of trust in governments, health professionals, and vaccine manufacturers. This article employs a theoretical analysis of trust and distrust to explore how twenty-seven parents with a history of vaccine rejection in two Australian cities view the expert systems central to vaccination policy and practice. ⋯ Accordingly, they saw vaccine recommendations in conflict with the interests of their child and "the system" underscored by malign intent, even if individual representatives of this system were not equally tainted. This perspective was common to parents who declined all vaccines and those who accepted some. We regard the differences between these parents-and indeed the differences between vaccine decliners and those whose Western medical epistemology informs reflexive trust-as arising from the internalization of countering views, which facilitates nuance.
-
Trust is central to the therapeutic relationship, but the epistemic asymmetries between the expert healthcare provider and the patient make the patient, the trustor, vulnerable to the provider, the trustee. The narratives of pain sufferers provide helpful insights into the experience of pain at the juncture of trust, expert knowledge, and the therapeutic relationship. While stories of pain sufferers having their testimonies dismissed are well documented, pain sufferers continue to experience their testimonies as being epistemically downgraded. ⋯ We also examine how healthcare institutions and practices privilege some kinds of evidence and ways of knowing while excluding certain patient testimonies from epistemic consideration. We argue that providers ought to avoid epistemic injustice in pain management by striving toward epistemic humility. Epistemic humility, as a form of epistemic justice, may be the kind disposition required to correct the harmful prejudices that may arise through testimonial exchange in chronic pain management.