‘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

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

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

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

What is it like to be a doctor in immigration detention centres?

I am often asked questions about my work as a general practitioner in the Christmas Island and Nauru immigration detention centres. Are the conditions as bad as they say? Is the health care adequate? Are they genuine refugees? What are the people like? I often don’t know what to say, and wonder whether my answers are ever sufficient. Words often seem inadequate to describe what I saw, or the ways in which my experience continues to impact upon me. Are the conditions bad? Absolutely. Imagine tents at a grungy music festival, but without the festivity and enclosed by wire. Imagine a world that has a 500m radius and is characterized by bleakness and oppressive humidity. And then imagine living there, for months on end, with no purpose or direction, unable to leave and not being told if you ever will. Is the health care adequate? Definitely not. But arguably this is impossible to provide in such remote and underdeveloped centres, where the primary purpose is not health but segregation and isolation. Are they genuine refugees? I have no idea because I never asked, and as a doctor who sat beside Ahmed, or Leila, or Antony I didn’t really need to know. So what are “they” like? And what is it like to be their doctor? As a practitioner working in a detention centre you see many shocking departures from the ordinary – men with their lips sewn closed with thread from a blanket, women drinking from bottles of shampoo, children with weeping sores and no shoes, people hurting themselves to express their pain. In each case you try and do what you can to treat both the physical consequences of living in harsh environments and the mental anguish caused by losing hope

SensaSlim goes SLAPP, public interest crusader cops a legal whack

The SensaSlim company’s recent defamation suit against Dr Ken Harvey of La Trobe University highlights some of the regulatory problems facing complementary products in Australia. Dr Harvey initiated a complaint against the weight loss advertisements of SensaSlim in March this year with the Complaints Resolution Panel (CRP), which deals with complaints about breaches of the Therapeutic Goods Advertising Code 2007. The complaint was also sent to the Therapeutic Goods Administration (TGA) (which did not acknowledge it) and the Australian Competition and Consumer Commission (ACCC), which is now taking action against the company. The hearing is being held in a Federal Court in New South Wales tomorrow. There are also allegations the original research which validates the product is fabricated. Dr Harvey’s complaint alleged SensaSlim’s advertisements breached a number of sections of the Therapeutic Goods Advertising Code 2007; the substance of Dr Harvey’s complaints was that he could find no evidence to justify the sensational claims made for the product. On the 31 March Dr Harvey was served with a warning to withdraw his complaint. SensaSlim also threatened AusPharm with legal action for publishing an account of the complaint. When Dr Harvey refused to withdraw his complaint he was served with a defamation claim for $800,000. Of particular interest is the effect the defamation claim has on the complaint lodged with the CRP. Basically, it stops the CRP investigation in its tracks

Epidemic ethics: four lessons from the current Ebola outbreak

The extent of the current Ebolavirus outbreak in West Africa has belatedly focused the attention of non-governmental organisations, local and Western governments, and international media. What we haven’t caught up with though, is the extent to which these outbreaks and their devastating effects are predictable and preventable. The spread of Ebola virus occurs because health infrastructure in the region is fragmented, under-resourced, or non-existent. And the therapeutic response to the illness is constrained by failure of markets to drive drug and vaccine development that would help the world’s poorest people. Resource constraints This is the largest known Ebola virus outbreak, with more than 1,800 cases and 1,000 deaths so far. But the actual number of people affected and mortality rates are uncertain because laboratory diagnosis is limited and only severe cases are admitted to hospitals. Apart from its longevity and extent, what distinguishes this outbreak is that, for the first time, there’s a prospect of drugs and vaccines to treat and prevent the disease. But these important therapeutic milestones don’t alter the fact that the outbreak will not be controlled by drugs. Rather, what’s required is strict infection control and quarantine. Person-to-person spread of Ebola virus, by contact with blood, body fluids or tissues of an infected person (mainly in the late stages of disease or after death) is not particularly difficult to prevent by well-established infection prevention measures that should be routine practice in any modern hospital. Unlike influenza, for instance, Ebola virus doesn’t spread by coughing or during the incubation period. So the current hospital outbreaks are related to inadequate health-care resources rather than a particularly high level of infectiousness

Ebola, Ethics, and the Question of Culture (Editorial)

The Ebola virus disease (EVD) epidemic in Western Africa has, in recent months, aroused growing alarm in Western countries. Attention has been drawn to the threat posed to the inhabitants of the region by what has undoubtedly become a major health emergency. As the death toll has mounted, increasingly strident calls for action have been voiced by nongovernmental organizations (NGOs) and international agencies active in the area, such as Médecins Sans Frontières and the World Health Organization and, more recently, even by the U.S. president

Consent to Biobank Research: Facing Up to the Challenge of Globalisation

There is broad agreement that open-ended consent to research involving banked specimens and associated data is morally justifiable. Importantly, this approach is justifiable if, and only if, clear mechanisms are in place for 1.ethical and scientific oversight, and 2. ongoing communication with tissue donors. The problem for those in favour of open-ended consent for research is that biobanks have the greatest potential as resources for translational research if they are networked - both nationally and internationally. And as networks, by definition, require that custodianship of samples be relinquished at some point, this makes it difficult, if not impossible, to guarantee sound ethical and scientific oversight and to promise ongoing communication with donors. Unless the reality of globalisation is addressed head on, even the most thoughtful ethical proposals, such as that put forward in this article, will soon be obsolete.NHMR