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

Where to now for health-related journal peer review?

Peer review of health-related manuscripts has enormous power in determining what is published in health-related journals, and what makes its way into health policy and clinical practice. However, peer review is at times ethically problematic and not always effective in achieving its goals. Over the past 25 years, a large number of debates about, and studies of, the peer review process has been published. Despite this, there is limited agreement about the strengths and weaknesses of peer review, and limited evidence about whether peer review achieves its goals and whether interventions to improve it have been successful. The authors argue that this state of affairs is not acceptable and that there is a need to systematise efforts to understand and improve the review process

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

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

Off-label promotion of prescription medicine: is it ever justifiable?

Off-label promotion has attracted intense scrutiny from regulators in recent decades resulting in many pharmaceutical companies paying hefty penalties for illegal marketing practices. At the same time, the pharmaceutical industry has accused governments of applying double standards by encouraging the use of cheaper off-label alternatives to registered treatments, and defended their ‘right’ to promote off-label drugs on freedom of speech grounds. However, the debate about off-label promotion and the prescribing that results has largely failed to address the issue that really matters – what impact does off-label promotion and prescribing have on patients and the health system? In this paper we explore the benefits and problems with off-label prescribing in order to determine whether off-label promotion is ever justified, and if so, under what conditions. KEYWORDS: off-label; promotion; misbranding; regulation; pharmaceutical industry; prescribin