News & Opinion

Opinion / The FDA and conflicts of interests of clinical trial investigators

A new report by the Office of Inspector General at the US Department of Health and Human Services suggests that the FDA (the US Food and Drug Administration) is not effectively monitoring conflicts of interests of clinical trial investigators in new drug marketing applications submitted to them. The report, summarised in an article on Medscape, is available here.

Its top findings were:

Opinion / Why not make the COPE audit your New Year resolution?

We hope COPE members will find the new audit tool helpful. Journal Editors who were involved with the pilot said it was useful and one said it covered things she'd been meaning to do for ages! Although we're not asking you to share your findings with us (it's an audit not a survey), we would welcome any comments on how we could improve the audit, so I thought I'd start this blog string so you can add your comments or suggestions.

Opinion / Manipulation of physicians and journals: Neurontin discussed in the NEJM

Perspective in the New England Journal of Medicine on 8 January (not freely available, unfortunately) discusses the insights that have come from the documents made available as part of the litigation surrounding the off-label marketing of Neurontin (gabapentin). This is a very long-running story. However, the evidence still has the power to shock — for example, this quote in 1996 of an executive from the company selling gabapentin talking to a new recruit:

Opinion / Publication bias... again

Publication bias seems like a problem that just won't go away. PLoS Medicine published a paper (doi: 10.1371/journal.pmed.0050217) late last year that indicated that this practice is alive and well in what is probably the most concerning area of all, clinical trials.

Opinion / You are banned from submitting to this journal

A few days ago, a newly qualified doctor asked informally if he could submit a 'slightly modified' version of a paper he'd just submitted to my journal to the BMJ. I told him about the evils of multiple submission and warned him that some journal Editors, if they discover the subterfuge, may well ban the author from submitting to their journal for a number of years. This, indeed, was the punishment that an Editor-in-Chief — not amused by a recent case of multiple submission to his journal — suggested at a recent COPE forum.

Opinion / Authorship trivia

We believe the paper with the most authors ever recorded (a massive 2512!) is Aleph et al. Precision electroweak measurements on the Z resonance. Physics Reports 2006, 427:257–454 (available at http://arxiv.org/PS_cache/hep-ex/pdf/0509/0509008v3.pdf ) — unless somebody knows better...?

Opinion / How much do editors look for misconduct when they assess papers?

Lutz Bornmann and colleagues have tried to find out how much editors look for signs of research misconduct when assessing manuscripts. They reviewed 46 studies that reported editors’ and reviewers’ criteria for judging papers but found that none of the main criteria listed was related to detecting data falsification or fabrication. The paper is available at Scientometrics 2008, 77:415–32. doi: 10.1007/s11192-007-1950-2

Opinion / New version of the Declaration of Helsinki

Last month the World Association of Medical Editors announced the new version of the Declaration of Helsinki. This document, which was first drawn up in 1964, is essential reading for everyone doing research on human participants. The revision was the result of a huge amount of international consultation, and along with many other organisations, COPE provided input into this document.

Opinion / Editors and the pandemic of gift authorship

A while ago, I wrote a piece in the BMJ about gift authorship (doi: 10.1136/bmj.39500.620174.94). I wanted to share a real case with members and seek their opinion: a friend was asked to add the name of a senior surgeon on a submission to a surgical journal, even though the latter hadn’t contributed one jot to the research. I gave him some advice, which after careful consideration he discarded. Still in the early stages of his surgical career, he opted for self-preservation.

Opinion / More awareness of non-financial competing interests needed

A few weeks ago PLoS Medicine published an editorial on the thorny and confusing issue of non-financial competing interests.

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