Thomas Alured Faunce

Nanosilver and Global Public Health: International Regulatory Issues

Silver in nanoparticle form is used extensively worldwide in hospital and general practice settings, in dressings as a treatment for external wounds, burns and ulcers. Nanosilver is also an increasingly important coating over embedded medical devices, inhibiting the development of biofilm. Nanosilver disinfectant sprays and polymer coatings are being widely promoted as protective against viral infections. In addition, nanosilver is widely used for its antibacterial properties in food processing and packaging, as well as in consumer products used for domestic cleaning and clothing. This article argues that medical devices, therapeutic products, and domestic food and goods containing nanosilver, although offering therapeutic benefits, must be subject to precautionary regulation owing to associated public health and environmental risks, particularly from large volumes of nanosilver in waste water. The article first examines the use of nanosilver in a variety of contemporary medical and domestic products, the utilization of which may assist in resolving global public health problems, such as restricted access to safe food, water and medical care. It then discusses the mechanisms of toxicity for nanosilver, whether it should be classified as a new chemical entity for regulatory purposes and whether its increased usage poses significant environmental and public health risks. The article next critically analyses representative international regulatory regimes (the USA, EU, UK and Australia) for medical and domestic use of nanosilver. The conclusion includes a set of recommendations for improving international regulation of nanosilver.

Supporting whistleblowers in academic medicine: training and respecting the courage of professional conscience

Conflicts between the ethical values of an organisation and the ethical values of the employees of that organisation can often lead to conflict. When the ethical values of the employee are considerably higher than those of the organisation the potential for catastrophic results is enormous. In recent years several high profile cases have exposed organisations with ethical weaknesses. Academic medical institutions have exhibited such weaknesses and when exposed their employees have almost invariably been vindicated by objective inquiry. The mechanisms that work to produce such low ethical standards in what should be exemplary organisations are well documented and have been highlighted recently. The contribution of elements of medical training in eroding ethical standards of medical students have also been emphasised recently and strategies proposed to reduce or reverse this process. The ability to rapidly change the ethical and professional culture of graduate medical trainees may help to deal with some of the perceived problems of declining ethical standards in academic medicine.

Decision-Analytical Modelling in Health-Care Economic Evaluations

ObjectiveDecision-analytical modelling is widely used in health-care economic evaluations, especially in situations where evaluators lack clinical trial data, and in circumstances where such evaluations factor into reimbursement pricing decisions. This paper aims to improve the understanding and use of modelling techniques in this context, with particular emphasis on Markov modelling.MethodsWe provide an overview, in this paper, of the principles and methodological details of decision-analytical modelling. We propose a common route for practicing modelling that accommodates any type of decision-analytical modelling techniques. We use the treatment of chronic hepatitis B as an example to indicate the process of development, presentation and analysis of the Markov model, and discuss the strengths, weaknesses and pitfalls of different approaches.ConclusionsGood practice of modelling requires careful planning, conduct and analysis of the model, and needs input from modellers and users.

Practical virtue ethics: healthcare whistleblowing and portable digital technology

Medical school curricula and postgraduate education programmes expend considerable resources teaching medical ethics. Simultaneously, whistleblowers’ agitation continues, at great personal cost, to prompt major intrainstitutional and public inquiries that reveal problems with the application of medical ethics at particular clinical “coalfaces”. Virtue ethics, emphasising techniques promoting an agent’s character and instructing their conscience, has become a significant mode of discourse in modern medical ethics. Healthcare whistleblowers, whose complaints are reasonable, made in good faith, in the public interest, and not vexatious, we argue, are practising those obligations of professional conscience foundational to virtue based medical ethics. Yet, little extant virtue ethics scholarship seriously considers the theoretical foundations of healthcare whistleblowing. The authors examine whether healthcare whistleblowing should be considered central to any medical ethics emphasising professional virtues and conscience. They consider possible causes for the paucity of professional or academic interest in this area and examine the counterinfluence of a continuing historical tradition of guild mentality professionalism that routinely places relationships with colleagues ahead of patient safety. Finally, it is proposed that a virtue based ethos of medical professionalism, exhibiting transparency and sincerity with regard to achieving uniform quality and safety of health care, may be facilitated by introducing a technological imperative using portable computing devices. Their use by trainees, focused on ethical competence, provides the practical face of virtue ethics in medical education and practice. Indeed, it assists in transforming the professional conscience of whistleblowing into a practical, virtue based culture of self reporting and personal development.

Will International Human Rights Subsume Medical Ethics? Intersections in the UNESCO Universal Bioethics Declaration

The International Bioethics Committee (IBC) of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) is currently drafting a Universal Bioethics Declaration (“the declaration”). The content and even the name of the declaration has yet to be finalised, but it is expected to range widely over human and non-human bioethics. It appears likely to include many articles directly related to medical ethics. The declaration may well evolve, like the Universal Declaration of Human Rights, into a component of international customary law, or be the precursor to an International Convention on Bioethics. This article discusses whether this process will facilitate bioethics and, in particular, medical ethics, being subsumed by the normative system of international human rights.

'Atypical' antidepressants in overdose: clinical considerations with respect to safety.

The ‘atypical’ antidepressants comprise a heterogenous class with wide variation in presentation and management during overdose, both when compared with each other and with more traditional agents.Further toxico-epidemiological data are required to make definitive predictions about the clinical effects of most of these agents in overdose. Here, however, we review the available information in a manner intended to benefit both prescribers and clinical toxicologists.Our conclusion is that there can be no generic response by medical practitioners as to the ‘safety’ of these new antidepressants. Though undoubtedly exhibiting fewer problems in specific areas than some of the older classes of agents (e.g. arrhythmias with tricyclic antidepressants) each nonetheless presents unique safety problems.We experienced great difficulty obtaining accurate information from the manufacturers about the animal toxicity data upon which their recommended human dose limits were set. This highlights the uncertainties involved with too readily making ‘safety’ claims about these agents.The decision to prescribe ‘atypical’antidepressant medications alleged to be both efficacious and safe in overdose involves a medicolegal tension. This tension is between respecting patient autonomy through frank communication of the material risk of overdose and non-disclosure to avoid such harm.

Toxicological and public good considerations for the regulation of nanomaterial-containing medical products

Increasing research interest in the new and unusual properties of nanotechnology-related pharmaceuticals and medical devices has led to international and national reviews of safety regulation. Significant considerations emerging here are the relative paucity of metrological and toxicological data, as well as the absence of adequate funding and standardized approaches for its acquisition. Some areas are better researched, such as the toxicity of carbon nanotubes and use of engineered nanoparicle titanium and zinc oxides as broad-spectrum ultraviolet-blocking agents. Such in vitro studies do reveal concerns – for example, related to oxidative stress and granuloma formation – but their uncertain clinical ramifications may require more integration in preclinical drug discovery of research characterizing structure–toxicity relationships and limiting safety liabilities. Regulatory considerations for medically related nanoproducts should also involve improving cost-effectiveness systems and ensuring that industry involvement in standard-setting does not become a means of reducing competition. It is also important that nanotechnology policy and regulation encourages new models of safe drug discovery and development that are more systematically targeted at the global burden of disease.

Normative Role for Medical Humanities

Medical humanities remains to be thoroughly evaluated as a normative tool, a mechanism of critical reflection upon those fundamental human virtues and principles of conduct underpinning regulatory systems. So conceived, medical humanities may represent a tangible manifestation of what John Rawls in his Theory of Justice terms “reflective equilibrium.” Ronald Dworkin calls a similar jurisprudential approach “law as interpretation,” as it involves the judiciary attempting to discern and render coherent the mass of normative principles upon which their community has reached apparent consensus. The criticisms by legal postivists of such normative techniques appear to have dimmed somewhat with the passage of legislation such as the Human Rights Act 1998 (UK) and the New Zealand Bill of Rights Act 1990 (NZ) which encourage the judiciary and legislatures to engage in international normative consensus on a grand scale. The project to rigorously expose the theoretical foundations of medical humanities to jurisprudential, philosophic and regulation-theory analysis could see it emerge as an important strategy for awakening and supporting that sense of conscience which the foundational ethical codes and the central instruments of human rights, place at the heart not only of rule obedience, but norm development.

Pharmaceuticals, Intellectual Property and Free Trade: The Case of the US-Australia Free Trade Agreement

Australia did poorly in several key areas of the recently completed free trade agreement with the US. It failed to insulate the Pharmaceutical Benefits Scheme (PBS) from significant change, and conceded to increased intellectual property standards. The PBS, as a system of effective bargaining with multinational pharmaceutical firms, has been deeply compromised and higher drug prices can be expected over time. The intellectual property chapter strengthens the position of patent owners and undermines the evolution of a competitive generics industry. These developments are part of a broader and internationally coordinated strategy being pursued by pharmaceutical multinationals to globalize and strengthen patent rights and monopoly profits.

Developing and Teaching the Virtue-Ethics Foundations of Healthcare Whistle Blowing

Healthcare whistle blowing, despite the benefits it has brought to healthcare systems in many developed countries, remains generally regarded as a pariah activity by many of the most influential healthcare professionals and regulatory institutions. Few if any medical schools or law department health law and bioethics classes, teach whistle blowing in a formal sense. Yet without exception, public inquiries initiated by healthcare whistle blowers have validated their central allegations and demonstrated that the whistle blowers themselves were sincere in their desire to implement the fundamental virtues and principles of medical ethics, bioethics and public health law. In many jurisdictions, the law, this time remarkably in advance of professional opinion, has offered legislative protection for reasonable allegations of whistleblowers made in good faith and in the public interest concerning a substantial and imminent threat to public safety. One reason for this paradoxical position, explored here, is that healthcare whistle blowing lacks a firm virtue-based theoretical bioethical and jurisprudential foundation. The hypothesis discussed is that the lack of this bioethical and jurisprudential substrate has contributed to a situation where healthcare whistle blowing suffers in terms of institutional support due to its lack of academic legitimacy. This article commences the process of redressing this imbalance by attempting to lay the theoretical foundations for healthcare whistle blowing. As a case study, this article concludes by discussing the Personal and Professional Development course at the ANU Medical School where healthcare whistle blowing is a formal part of a virtue-based curriculum that emphasises the foundational importance of conscience. Illustrative elements of that program are discussed.