'Good Mothering' or 'Good Citizenship'? Conflicting values in choosing whether to store or donate umbilical cord blood.

Umbilical cord blood banking is one of many biomedical innovations that confront pregnant women with new choices about what they should do to secure their own and their child’s best interests. Many mothers can now choose to donate their baby’s umbilical cord blood (UCB) to a public cord blood bank, or pay to store it in a private cord blood bank. Donation to a public bank is widely regarded as an altruistic act of civic responsibility. Paying to store UCB may be regarded as a “unique opportunity” to provide “insurance” for the child’s future. This paper reports findings from a survey of Australian women that investigated the decision to either donate or store UCB. We conclude that mothers are faced with competing discourses that force them to choose between being a “good mother” or fulfilling their role as a “good citizen”. We discuss this finding with reference to the concept of value pluralism. Keywords Mothers, Umbilical cord, Tissue banks, Social values, Capitalism, AustraliaNHMRC Project Grant 51241

Return of the Memento Mori: imaging death in public health.

Death has always held a morbid fascination for humans. Indeed, awareness of one’s own mortality may well be one of the defining features of the ‘human condition’ – symbols of death appearing in most civilizations since artefacts have been made. The Latin phrase memento mori, meaning literally ‘remember to die’, encapsulates a rich and varied artistic tradition, dating back to the Middle Ages, of figuring death by symbolizing its literal processes and remainders. From the decomposed effigies of 15th-century ‘cadaver tombs’, to the humorous medieval iconography of the skeletal danse macabre, the works of this genre draw on the destructive physical changes that are a part of our understanding of death. Prolific within its morbid imagery are the use of skull, skeleton and verminous or rotting flesh as ‘trope’ or symbol of the processes that eventually take away the person who lived, and who was once like us. At the height of its popularity between the 16th and 18th centuries, Church walls, tombs, jewellery, paintings, and so on frequently depicted death and decay. The entreaty to ‘remember’ death in memento mori was more than simply a call for ‘therapeutic contemplation’1 or the banal acceptance of the imminence of death; it was a call to piety, to conformity. Damnation would be added to death if the individual transgressed the rules of Catholic doctrine, such that scholars often trace a continuity between the motives of memento mori, and the biblical injunction: ‘Whatsoever thou takest in hand, remember the end, and thou shalt never do amiss’ (Ecclesiasticus 7:36).2 Even within the iconophobic Protestantism of the post-Reformation era, the memento mori trope persisted as a privileged mode of pious warning. In the visually secular effigy monuments of the Elizabethan gentry, inscriptions urging the reader to ‘(r)emember the last things and…not sin again’ signified that death would come to everyone – but only spiritual public health would reduce the risk of eternal punishment and separation from God.3 The memento mori trope survives into the present day, albeit in differing locations. Loosely discernible in the ‘corpse chic’ of contemporary haute couture, and entrenched within the aesthetics of punk and gothic subcultures, the skull and skeleton loom large as Western symbols of cultural rebellion.4 Similarly, the fully enfleshed ‘corpse’ continues to haunt the zone of 2 | P a g e contemporary representation – saturating the realm of Hollywood film and ‘hard news’ reportage alike, and asserting its dominance in forensics-inspired television programmes such as CSI. Representing death, it would seem, has never been more popular. Indeed, depictions of death have emerged as ‘mainstream advertising strategy’4 – their gore and horror satisfying a perverse voyeurism that many would attribute to the alienating effects of mass media saturation. While the ‘pornography’ of suffering5 in contemporary culture appears to have little in common with classical memento mori, if one looks closely, certain elements particular to this once-spiritual genre of death depiction can be unearthed, most notably in the secular arena of public health

Return of the Memento Mori: imaging death in public health.

Death has always held a morbid fascination for humans. Indeed, awareness of one’s own mortality may well be one of the defining features of the ‘human condition’ – symbols of death appearing in most civilizations since artefacts have been made. The Latin phrase memento mori, meaning literally ‘remember to die’, encapsulates a rich and varied artistic tradition, dating back to the Middle Ages, of figuring death by symbolizing its literal processes and remainders. From the decomposed effigies of 15th-century ‘cadaver tombs’, to the humorous medieval iconography of the skeletal danse macabre, the works of this genre draw on the destructive physical changes that are a part of our understanding of death. Prolific within its morbid imagery are the use of skull, skeleton and verminous or rotting flesh as ‘trope’ or symbol of the processes that eventually take away the person who lived, and who was once like us. At the height of its popularity between the 16th and 18th centuries, Church walls, tombs, jewellery, paintings, and so on frequently depicted death and decay. The entreaty to ‘remember’ death in memento mori was more than simply a call for ‘therapeutic contemplation’1 or the banal acceptance of the imminence of death; it was a call to piety, to conformity. Damnation would be added to death if the individual transgressed the rules of Catholic doctrine, such that scholars often trace a continuity between the motives of memento mori, and the biblical injunction: ‘Whatsoever thou takest in hand, remember the end, and thou shalt never do amiss’ (Ecclesiasticus 7:36).2 Even within the iconophobic Protestantism of the post-Reformation era, the memento mori trope persisted as a privileged mode of pious warning. In the visually secular effigy monuments of the Elizabethan gentry, inscriptions urging the reader to ‘(r)emember the last things and…not sin again’ signified that death would come to everyone – but only spiritual public health would reduce the risk of eternal punishment and separation from God.3 The memento mori trope survives into the present day, albeit in differing locations. Loosely discernible in the ‘corpse chic’ of contemporary haute couture, and entrenched within the aesthetics of punk and gothic subcultures, the skull and skeleton loom large as Western symbols of cultural rebellion.4 Similarly, the fully enfleshed ‘corpse’ continues to haunt the zone of 2 | P a g e contemporary representation – saturating the realm of Hollywood film and ‘hard news’ reportage alike, and asserting its dominance in forensics-inspired television programmes such as CSI. Representing death, it would seem, has never been more popular. Indeed, depictions of death have emerged as ‘mainstream advertising strategy’4 – their gore and horror satisfying a perverse voyeurism that many would attribute to the alienating effects of mass media saturation. While the ‘pornography’ of suffering5 in contemporary culture appears to have little in common with classical memento mori, if one looks closely, certain elements particular to this once-spiritual genre of death depiction can be unearthed, most notably in the secular arena of public health

Building Clinical Ethics Capacity, Final Report of the Developing Clinical Ethics Capacity in NSW Partnership project 2014

Clinical ethics support services are an established feature of health care in the US and Canada and are becoming so in the UK, France, Belgium and elsewhere in Europe. They are yet to be widely established in NSW or elsewhere Australia. Clinical ethics support typically involves the provision of expert ethics input into clinical education, policy development and the care of individual patients, particularly where this involves value, rather than clinical, or scientific, conflict. Ethics support is generally provided by an individual consultant, an ethics committee or some combination of the two. In its case consultation function, expert support is intended to clarify the values that are in tension and through promoting open and inclusive discussion, facilitate consensus on the appropriate next steps. Internationally, the guidance and recommendations issued by a support service on a particular case are, in most cases, advisory and not binding. Advocates argue that clinical ethics support is necessary because contemporary clinical work takes place in a technologically, socially and ethically complex environment. The medical encounter has become far more open to scrutiny and is accountable to a more diverse public holding often quite different interests, ideas and values. In a more pluralist society, professional training, professional codes and institutional polices aren’t sufficient to establish ethical practices and procedures or resolve the ethical dilemmas that arise in the care of individual patients. The ethics expertise provided by an ethicist or a panel of ethically trained clinicians is necessary to astutely appraise the values and arguments and generate consensus. Without such expertise the ethicality of practices cannot be assured. Clinical ethics support is intended to promote ethically sound clinical and organisational practices and decision-making and thereby contribute to health organisation and system quality improvement. The under-developed state of clinical ethics support in Australia and NSW prompted NSW Health, in partnership with the Centre of Values Ethics and Law in Medicine and the Centre for Health Law and Governance , to ask: 1. Do changes to the environment in which clinical practice occurs mean there is a need to change the way we deal with ethical dilemmas? 2. Is more formalised support for clinicians, when making difficult and possibly controversial ethical decisions, desirable or warranted? 3. If it is agreed that clinical ethics support should be enhanced, what model is most appropriate for local conditions?funding provided by the Centre for Epidemiology and Evidence, NSW Ministry of Healt

Community treatment orders in Australia: rates and patterns of use.

Objectives: Community treatment orders (CTOs) allow clinicians to provide unconsented outpatient treatment to people living with mental illness. Though controversial and of uncertain efficacy, CTOs are used throughout Australia and internationally. We sought to determine the prevalence of CTO use in Australian states and territories, and to examine changes in the pattern of use over time. Method: Australian state and territory mental health review tribunals and health departments were surveyed for the most recent annual data on the total number of CTOs made and the total number of individual people placed on a CTO. Results: Rates of CTO use range from 30.2 per 100,000 population (in Tasmania) to 98.8 per 100,000 population (in Victoria). Use of CTOs in Australia is high by world standards, appears to be increasing over time, and varies significantly across jurisdictions. Conclusions: The high (by world standards), increasing and variable use of CTOs in Australia is concerning and raises important implications for mental health policymakers and legislators. Current mental health policy activity, particularly the new National Mental Health Commission, provides a unique opportunity to enhance transparency and accountability if regular and nationally uniform CTO data are collected and publically reported. Key words: Community treatment order, compulsory community treatment, community mental health, legislation, polic

Dilemmas in the Compassionate Supply of Investigational Cancer Drugs

In Australia, patients who want to access medicines that are not yet approved have only two options: to enrol in a clinical trial if they are eligible, or obtain their medicine through ‘compassionate supply’, which is provided at the discretion of the manufacturer. In this article, we explore ethical issues associated with the provision of oncology medicines that are still in development, either prior to regulatory approval or government reimbursement. Keywords: ethics; evidence-based medicine; health services accessibility; oncolog

Evidence, regulation and “rational” prescribing: the case of gabapentin for neuropathic pain.

Rationale, aims and objectives: In 2004, the pharmaceutical company Warner-Lambert paid US$430million to resolve criminal and civil legal liability for aggressive off-label marketing of gabapentin. Perhaps surprisingly, however, regulatory and legal concerns regarding the marketing of gabapentin has not significantly impacted upon the attitude of physicians towards using gabapentin for neuropathic pain. In this paper we attempt to understand the reasons for this discrepancy between clinical practice and regulatory/legal concerns through an analysis of published discussions about gabapentin prescribing. Methods: We performed a qualitative empirical analysis of the published clinical debate surrounding the use of gabapentin for the management of neuropathic pain. Results: The ongoing use of gabapentin for neuropathic pain use was primarily driven by the perception that it was a safe, non-addictive drug with few drug interactions, by possible similarities between the physiology of chronic pain and other neurological conditions, by the well-established clinical precedent of using antiepileptic drugs in pain management, and by the lack of alternative options available in the market. Emerging evidence of lack of effectiveness and controversies about the integrity of the scientific record appeared to be of relatively little importance to practicing clinicians. Conclusions: Those who want to promote “rational” prescribing need to recognise that prescribing is driven by many factors other than epidemiological data and regulatory indications and that even intensely negative publicity about medicines may not penetrate clinical reasoning. This suggests that a range of measures may be needed to ‘incentivise’ rational prescribing and to promote research integrity. Regulators must be more sensitive to the contextual issues that are relevant to clinical practice when evaluating drugs for approval and developing guidelines. KEYWORDS: Chronic Pain; Neuralgia; Pain Management; Off-Label Use; Drug Industry; Physician’s Practice Patterns.NHMRC Project Grant (APP1059732); Wendy Lipworth is supported by a NHMRC Career Development Fellowship APP106356

Challenges to pharmaceutical policymaking: lessons from Australia’s National Medicines Policy

Objective: National medicines policies (NMPs) provide a means for governments to achieve their objectives in relation to pharmaceuticals and other medicines. This research aimed to identify challenges to implementing the objectives of the Australian NMP from the perspective of key stakeholders. Methods: In 2012 and 2103, we conducted 30 semi-structured interviews with stakeholders involved in the discovery, clinical testing, regulation and funding of medicines in Australia. We asked participants to describe their careers and to give their opinions on specific issues surrounding drug development, clinical research, regulation and subsidisation in Australia. Data were analysed using Morse’s outline of the cognitive basis of qualitative research and Charmaz’s outline of data analysis in grounded theory. The initial phase of “open coding”, revealed findings that could be mapped to three of the four objectives of the NMP. We then conducted “focused coding” for themes relevant to these objectives. Results: Participants identified many issues relevant to the ongoing evolution of the NMP, relating primarily to ongoing tensions between the commercial objective of ensuring a viable medicines industry, and the non-commercial objectives of ensuring that medicines are safe, effective and affordable. There were also a number of other challenges identified to the achievement of both the commercial and non-commercial objectives of the NMP. These included limits to government funding, globalisation, consumer advocacy, changing scientific paradigms and new information technologies. Conclusions: There are many issues that need to be addressed if policymakers are to achieve the best outcomes from the NMP. Tensions between the commercial and non-commercial objectives of the NMP suggest the need to ensure that one stakeholder group’s imperatives do not stifle those of other groups. At the same time, there are a number of emerging issues that are likely to concern all stakeholders equally, and these are both challenges and opportunities for new kinds of collaboration

Clinical Ethics Support in Contemporary Health Care

This chapter concerns current initiatives to create and maintain specialized services to help respond to ethical issues that arise in the practice of health care. These initiatives, the obstacles they face, and the controversies they engender should be of considerable interest to those concerned with the management of health care organizations. This is because ethics is and should be intrinsic to routine health care practice. Also, no less, it is because ethical disputes and controversies, even if they seldom occur, can severely disrupt the complex organizations that deliver health care in modern societies. Clinical ethics support services (CES services) are comprised of an individual or group, usually in an organization, who can provide a suite of services to support all stakeholders in identifying and managing the ethical issues that inevitably arise in the design and delivery of health care. While there is a degree of consensus about the potential value of such services, they are also the focus of ongoing theoretical, methodological and political debates. This chapter does not aim to resolve these debates. Rather, our aim is to provide health care managers with an account of how and why CES services are becoming a part of the contemporary organizational landscape of health care, and describe the concerns that bioethicists and observers and critics of bioethics have raised regarding their role, function, and dissemination. We first describe the origins of CES services, to provide a context for the following discussion about the goals, functions and models of support that exist across this discipline—drawing on some relevant examples. We then describe how CES services can be evaluated. Third, we discuss initiatives that aim to optimise quality of CES services and some of the criticisms and suspicions that these initiatives have engendered. Finally, we offer some reflections on the direction that CES services may take in the future