Intended for healthcare professionals

Research Methods & Reporting

Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective

BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5078 (Published 03 October 2016) Cite this as: BMJ 2016;355:i5078

Journals can improve their Interests sections

I thank Dr Berlin for this response. I also commend the authors for augmenting the competing interest section of this article. Oversights and reinterpretations are not uncommon, and it is good unfussy everyday science to make corrections.

While expressing high regard for all the authors, I criticized this project's exclusive union between editors and executives, and argued that the interests in play needed clearer exposition. In closing, I would like to suggest that this latter problem is really an issue for our journals.

Interest declaration sections are unfrequented information sumps tacked onto the bottom of articles and clogged with small print. They provide only modest clarification, but a surfeit of so-called “moral licensing”.(1-4) I and others have argued they would be improved if they reported the interests of all stakeholders, including corporate entities, and not just the authors; if the most important interests were drawn conspicuously to the attention of readers; and if standing online registries of interests were established – these would greatly ease the glitch-prone task of documenting interests for journals and authors, and would be better for readers.(4-7)

A further useful step which would help reduce oversights and inconsistencies would be for journals to instruct authors jointly to review their completed interest forms, debate what should be considered competing interests, determine what should be specially highlighted to readers, and only then sign off the forms and the manuscript. Finally, the medical editorial community might find it useful to hold its own discussions on what constitutes a competing interest for an editor, particularly when acting as an author – this is still, I think, a grey area.

References

1. Kassirer JP. Commentary: Disclosure's failings: what is the alternative? Acad Med 2009;84:1180-1.

2. Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012;307:669-70.

3. Wilson M. The Sunshine Act: Commercial conflicts of interest and the limits of transparency. Open Med 2014;8:e10–e13.

4. Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. BMJ 2016;354:i4578.

5. Matheson A. The Disposable Author: How Pharmaceutical Marketing Is Embraced within Medicine's Scholarly Literature. Hastings Cent Rep 2016;46:31-7.

6. Matheson A. The ICMJE Recommendations and pharmaceutical marketing--strengths, weaknesses and the unsolved problem of attribution in publication ethics. BMC Med Ethics 2016;17:20.

7. Rasmussen K, Schroll J, Gøtzsche PC, Lundh A. Under-reporting of conflicts of interest among trialists: a cross-sectional study. J R Soc Med. 2015;108:101-7.

Competing interests: I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. Between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.

30 March 2017
Alastair Matheson
Independent consultant
Toronto, Canada