‘Interests’ in medicine and the inadequacy of disclosure

Many papers published in the academic press sink without a trace, making no impression on clinical practice, health policy or public discourse. While the narrative review of melatonin-based therapies for depression published in the Lancet by Professor Ian Hickie and Associate Professor Naomi Rogers (2011) is unlikely to generate significant changes in clinical practice, it has generated enormous professional and media debate about the extent and impact of conflicts of interest in medicine arising from the relationships between health professionals and the pharmaceutical industry. In the disclosure accompanying the review, which highlighted the potential worth of the drug agomelatine, manufactured by Servier, both authors disclosed financial and professional links with Servier. The responses to this review, and to the disclosures made by the authors in the Lancet, on health media websites, in the lay press and in social media, have been largely critical – making either empirical claims, that the authors misreported the tolerability and/or efficacy of agomelatine, or moral claims, that the authors were conflicted or biased, had not adequately disclosed the extent of their interests, or that they or Elsevier (the publisher of the Lancet) may have gained some benefit from the publication (Barbui and Cipriani, 2012; Carroll, 2012; Dunlevy, 2012; Griffiths, 2012; Howland, 2012; Jureidini and Raven, 2012; Lloret-Linares et al., 2012; Serfaty and Raven, 2012). In a spirited response, the authors defended both their analysis and their professional ethics, arguing that they had appropriately attended to the processes of disclosure required by the Lancet for all contributors (Hickie and Rogers, 2012)

Engaging transplantation ethics

Reviewed book: Ethical eye: Transplants, Peter Morris (editor). Strasbourg: Council of Europe, 2003 (258 pp). ISBN 92 871 4779 5. Through its Ethical eye series, the Council of Europe has addressed a number of recent developments in science and technology, including cloning and the human genome. The series aims to outline the ethical issues relating to each topic and to make these topics accessible to as wide an audience as possible. The most recent volume, edited by the eminent transplant surgeon, Sir Peter Morris, addresses the ethics of solid organ transplantation

Understanding selective refusal of eye donation: identity, beauty and interpersonal relationships.

Corneal transplantation is the most common form of organ transplantation performed globally. However, of all organs, eyes have the highest rate of refusal of donation. This study explored the reasons why individuals decide whether or not to donate corneas. Twenty-one individuals were interviewed who had made a donation decision (13 refused corneal donation and 8 consented). Analysis was performed using Grounded Theory. Refusal of corneal donation was related to concerns about disfigurement and the role of eyes in memory and communication. The request for donation therefore raised concerns about a potential adverse change in the ongoing relationship with the deceased, even in death. For those who refused donation, these concerns overshadowed awareness of need or benefit of transplantation. Adjusting the donation message to be more congruent with the real, lived experience of corneal donation may to some extent “prepare” individuals when the donation question is raised. Keywords Organ and tissue procurement; Tissue donors; Corneal transplantationOphthalmic Research Institute of Australia

Pharmaceutical industry support for continuing medical education: Is it time to disengage?

Over the past two decades, the relationship between the medical profession and the pharmaceutical industry has been a source of intense debate, largely because of concern that it may harm patients through inappropriate prescribing, increase the costs of health care through the unjustified use of expensive pharmaceuticals and ultimately subvert the (proper) goals of medicine, medical education and medical research.1–4 Recent well-publicised instances of companies using multiple means, including continuing medical education (CME), to promote off-label use of their drugs (including AstraZeneca, which paid US$520 million in 2010 to settle charges that it promoted unapproved use of the antipsychotic quetiapine, and Eli Lilly, which paid US$1.415 billion in 2009 in criminal and civil penalties for promoting off-label use of olanzapine) have only served to heighten concerns that doctors can be persuaded, through direct or indirect means, to further the commercial interest of the pharmaceutical industry.5 It is uncertain exactly how much money the pharmaceutical industry spends on promoting its products to medical practitioners through detailing, advertising, gifts and drug samples, and support for travel, scientific meetings and continuing medical education. But it is a very large amount – a recent estimate put it at more than $US50 billion per year in the United States alone, with at least$US1–2 billion being spent on CME – and it is effectiv

There’s more to Pradaxa’s problems than meets the eye

Pharmaceutical companies don’t have a particularly good reputation, for some very good reasons. But we can’t let suspicions about the motives of such companies cloud our assessments of drug safety because patients may also suffer. People with abnormal heart rhythms and other diseases that cause blood clots (thromboses) often require blood-thinning (anticoagulation) medications. For many decades, warfarin has been the most widely used such drug but it’s associated with a risk of bleeding (including fatal haemorrhage) and requires regular blood tests to monitor safety and efficacy. So the advent of new oral anticoagulant drugs was heralded as a major advance by both patients and clinicians – principally on the grounds that they appeared as effective as warfarin, may be associated with a lower risk of serious bleeding, and are cost-effective because patients don’t need ongoing blood monitoring. For these reasons, a number of these new drugs, including dabigatran (Pradaxa) and rivaroxaban (Xarelto) were fast-tracked through the regulatory approval processes in the United States and in New Zealand. Emerging problems But reports now suggest Pradaxa might be less safe than it appeared to be in clinical trials. Specifically, it’s claimed the drug may be responsible for higher-than-expected levels of abnormal bleeding, including hemorrhagic strokes, and that it may, in fact, be less safe than warfarin

Shifting power relations and the ethics of journal peer review

Background: Peer-review of manuscripts has recently become a subject of academic research and ethical debate. Critics of the review process argue that it is a means by which powerful members of the scientific community maintain their power, and achieve their personal and communal aspirations, often at others’ expense. This qualitative study aimed to generate a rich, empirically-grounded understanding of the process of manuscript review, with a view to informing strategies to improve the review process. Method: Open-ended interviews were carried out with 35 journal editors and peer reviewers in the UK, USA and Australia. Results: It is clear from this research that relations of power and epistemic authority in manuscript review are complex and dynamic, may have positive and negative features and that even where power is experienced as controlling, restrictive and illegitimate, it can also be resisted. Conclusions: The manuscript review process is best thought of not in terms of simple dominance of reviewers and editors over authors, but rather as a shifting ‘net’ of power relations. These complex power relations need to be understood if reviewers are to be encouraged to participate in the process and to do so in the the most ethical and effective manner

Anything but the eyes: culture, identity and the selective refusal of corneal donation

At the time that a patient is diagnosed as brain dead, a substantial proportion of families who give consent to heart and kidney donation specifically refuse eye donation. This in part may relate to the failure of those involved in transplantation medicine and public education to fully appreciate the different meanings attached to the body of a recently deceased person. Medicine and science have long understood the body as a “machine.” This view has fitted with medical notions of transplantation, with donors being a source of biologic “goods.” However, even a cursory glance at the rituals surrounding death makes it apparent that there is more to a dead body than simply its biologic parts; in death, bodies continue as the physical substrate of relationships. Of all the organs, it is the eyes that are identified as the site of sentience, and there is a long tradition of visual primacy and visual symbolism in virtually all aspects of culture. It therefore seems likely that of all the body parts, it is the eyes that are most central to social relationships. A request to donate the eyes therefore is unlikely to be heard simply in medical terms as a request to donate a “superfluous” body part for the benefit of another. That the eyes are not simply biologic provides one explanation for both the lower rates of corneal donation, compared with that of other organs, and the lack of adequate corneal donation to meet demand

Asylum seeker’s ‘brain death’ shows failure of care and of democracy

The news that Hamid Kehazaei, a 24-year-old Iranian asylum seeker detained on Manus Island, has been diagnosed as brain dead following his transfer to the Mater Hospital in Brisbane is a tragedy. That it is a tragedy for this young man and his family is unquestionable – but the extent of this tragedy may be much more pervasive than we realise. If the emerging details of his case are correct, Kehazaei developed septicaemia as a complication of cellulitis (skin and soft-tissue infection) arising from a cut in his foot. This, in itself, is disturbing. Severe infection can result in brain death – either from infection of the brain itself (meningitis, encephalitis or brain abscess), or from brain injury due to a lack of oxygen resulting from cardiac arrest (as appears to be the case here), or from reduced blood supply to the brain. Yet it is very uncommon, especially in a young, previously healthy man. Such a case could occur in Australia and has been described in 2012 in young Indigenous adults in Central Australia. Nevertheless, severe sepsis resulting from a foot infection is preventable. And a case like this occurring in an Australian national would raise serious questions about the appropriateness of the antibiotics used and the timeliness of care. Most cases of brain death result from traumatic brain injury, stroke or lack of oxygen to the brain following asphyxia, near-drowning, or prolonged cardiopulmonary resuscitation. What happened to Hamid Kehazaei raises concerns about the adequacy of care provided to him during initial treatment, including wound care and antibiotics, and how soon he was transferred to expert medical care, first to Port Moresby and subsequently to Brisbane. If this young man became ill and had his brain die while seeking asylum in Australia and while in our care, then we must examine the details of his case and ask ourselves not only whether it was preventable but whether our policies and processes actually contributed to his death

Anything but the eyes: culture, identity and the selective refusal of corneal donation

At the time that a patient is diagnosed as brain dead, a substantial proportion of families who give consent to heart and kidney donation specifically refuse eye donation. This in part may relate to the failure of those involved in transplantation medicine and public education to fully appreciate the different meanings attached to the body of a recently deceased person. Medicine and science have long understood the body as a “machine.” This view has fitted with medical notions of transplantation, with donors being a source of biologic “goods.” However, even a cursory glance at the rituals surrounding death makes it apparent that there is more to a dead body than simply its biologic parts; in death, bodies continue as the physical substrate of relationships. Of all the organs, it is the eyes that are identified as the site of sentience, and there is a long tradition of visual primacy and visual symbolism in virtually all aspects of culture. It therefore seems likely that of all the body parts, it is the eyes that are most central to social relationships. A request to donate the eyes therefore is unlikely to be heard simply in medical terms as a request to donate a “superfluous” body part for the benefit of another. That the eyes are not simply biologic provides one explanation for both the lower rates of corneal donation, compared with that of other organs, and the lack of adequate corneal donation to meet demand

Missing the point: Rogers v Whitaker and the ethical ideal of informed and shared decision making

The High Court's judgment in Rogers v Whitaker (1992) 175 CLR 479 has belatedly recognised as persuasive the values and attitudes of particular patients in what constitutes for them a significant treatment risk. The importance now attached to these subjective patient factors was shown in the High Court's determination that physicians now have a duty to disclose and warn regarding material risks specific to the particular patient. It is our belief that the Rogers v Whitaker emphasis on the requirements for disclosure underscores much of the misinterpretation of consent as a single event or action rather than as an ever-present sequela of a process which informs decision-making. What is required is a shift in focus from disclosure to understanding and from unilateral information-transfer to the integrated process of shared and informed decision-making