‘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)

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

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

Characterising the seasonal and geographical variability in tropospheric ozone, stratospheric influence and recent changes

The stratospheric contribution to tropospheric ozone (O3) has been a subject of much debate in recent decades but is known to have an important influence. Recent improvements in diagnostic and modelling tools provide new evidence that the stratosphere has a much larger influence than previously thought. This study aims to characterise the seasonal and geographical distribution of tropospheric ozone, its variability, and its changes and provide quantification of the stratospheric influence on these measures. To this end, we evaluate hindcast specified-dynamics chemistry–climate model (CCM) simulations from the European Centre for Medium-Range Weather Forecasts – Hamburg (ECHAM)/Modular Earth Submodel System (MESSy) Atmospheric Chemistry (EMAC) model and the Canadian Middle Atmosphere Model (CMAM), as contributed to the International Global Atmospheric Chemistry – Stratosphere-troposphere Processes And their Role in Climate (IGAC-SPARC) (IGAC–SPARC) Chemistry Climate Model Initiative (CCMI) activity, together with satellite observations from the Ozone Monitoring Instrument (OMI) and ozone-sonde profile measurements from the World Ozone and Ultraviolet Radiation Data Centre (WOUDC) over a period of concurrent data availability (2005–2010). An overall positive, seasonally dependent bias in 1000–450 hPa (∼0–5.5 km) sub-column ozone is found for EMAC, ranging from 2 to 8 Dobson units (DU), whereas CMAM is found to be in closer agreement with the observations, although with substantial seasonal and regional variation in the sign and magnitude of the bias (∼±4 DU). Although the application of OMI averaging kernels (AKs) improves agreement with model estimates from both EMAC and CMAM as expected, comparisons with ozone-sondes indicate a positive ozone bias in the lower stratosphere in CMAM, together with a negative bias in the troposphere resulting from a likely underestimation of photochemical ozone production. This has ramifications for diagnosing the level of model–measurement agreement. Model variability is found to be more similar in magnitude to that implied from ozone-sondes in comparison with OMI, which has significantly larger variability. Noting the overall consistency of the CCMs, the influence of the model chemistry schemes and internal dynamics is discussed in relation to the inter-model differences found. In particular, it is inferred that CMAM simulates a faster and shallower Brewer–Dobson circulation (BDC) compared to both EMAC and observational estimates, which has implications for the distribution and magnitude of the downward flux of stratospheric ozone over the most recent climatological period (1980–2010). Nonetheless, it is shown that the stratospheric influence on tropospheric ozone is significant and is estimated to exceed 50 % in the wintertime extratropics, even in the lower troposphere. Finally, long-term changes in the CCM ozone tracers are calculated for different seasons. An overall statistically significant increase in tropospheric ozone is found across much of the world but particularly in the Northern Hemisphere and in the middle to upper troposphere, where the increase is on the order of 4–6 ppbv (5 %–10 %) between 1980–1989 and 2001–2010. Our model study implies that attribution from stratosphere–troposphere exchange (STE) to such ozone changes ranges from 25 % to 30 % at the surface to as much as 50 %–80 % in the upper troposphere–lower stratosphere (UTLS) across some regions of the world, including western Eurasia, eastern North America, the South Pacific and the southern Indian Ocean. These findings highlight the importance of a well-resolved stratosphere in simulations of tropospheric ozone and its implications for the radiative forcing, air quality and oxidation capacity of the troposphere

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

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