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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

Rapid Response:

The bottom line – publications, or public relations?

I will not dwell on the content of this drug industry/journal editor “joint perspective” on adverse event reporting.[1] Its call to retire the phrase “generally well tolerated” is welcome; its emphasis on “clinically relevant” adverse events may raise concerns. But my concern is with the interests this project serves.

I acknowledge the probity of everyone involved in the project, their careful thinking and commitment to improving journal publications. The top-line goals are plainly worthwhile. But why were the authors all industry executives and journal editors? Why did the editors not insist experts in clinical trials and drug harms take part? Why not industry critics? Why, above all, should it be considered the business of scholarly journal editors not merely to talk to drug executives, but to craft exclusive “joint perspectives” with them?

To address these questions, we must consider not only this project’s top line goals, but also the bottom line – its commercial functions. It has become a common strategy in contemporary capitalism for corporations to court public trust by means of well-publicized and sincere outreach programs, dialogues, worthy projects and superficial reforms. Such practices are referred to within the corporate branding sector as “reputation management”, “stakeholder engagement” and “brand alignment”.[2-4] The Medical Publications Insights and Practices (MPIP) initiative, which instigated this project, is in my evaluation consistent with these PR trends.

MPIP was created by drug companies and marketers specializing in publications.[5] Both profit from the drug publications trade. MPIP is sincere in its stated goals and these have value, but it also performs legitimizing functions for this trade. There could be no better means of building legitimacy than an article proclaiming unity between the drug industry and journal editors – better still, one published in a prestige journal, and it can be no surprise that the letters “BMJ” are currently up in lights on the MPIP homepage.[6]

That might not please the BMJ; but the truth is that many publishers solicit industry patronage, whether from advertising or by leveraging publications. Sage, one of the publishers with an editor-coauthor on this project, “offers a full range of marketing solutions to help you connect with the decision makers and influencers in your field of expertise. Our sales team will work with you to develop an integrative marketing approach that delivers the maximum impact for your product.”[7] Another, Wiley, “can develop a customized communications plan to support your promotional and publication strategy.”[8] The drug companies, marketing agencies and publishing houses are the triumvirate who control and thrive on the trade in industrialized medical knowledge. Theirs is certainly a joint perspective.

How, then, did this “joint perspective” on adverse events come about? It was an MPIP operation, planned, bankrolled and managed by drug companies and their agents, with input from marketers, publishers and selected editors. It is not explained on what basis these particular editors were enlisted, but while they made substantial contributions at various points, the first draft was written without their participation.[1] These are enduring arrangements: each year MPIP initiates a project, editors are recruited and a fresh joint perspective is crafted and publicized. Past output has been criticized for commercial expediency.[9,10]

My chief concerns with this project, then, are that despite meritorious top-line goals, it has an unreasonably restricted authorship, and does not adequately relate its commercial and PR dimensions. As a supporter of innovative pharmaceutical research, I encourage my industry friends to continue their drive to improve publications, but always to describe commercial functions with unsparing candour, and as conspicuously as those “BMJ” letters are chalked up on their website.[6]

It is also notable that none of the editors serving as a coauthor on this article reports any competing interests. While I have no doubt they all made what they considered to be full and careful disclosures, this raises questions about the breadth of disclosures that should be considered appropriate in a project like this.

Consider first that many publishers seek drug industry patronage. Editors appointed or employed by such publishers should therefore, in my opinion, disclose their employment status and their employer’s interest. Dr Berlin, the courteous corresponding author, has related to me that flight and hotel expenses for editors were paid for by journal publishers. This too should in my opinion be reported.

Second, considering that this project was drug industry financed, planned, managed and drafted, with drug industry coauthors and drug industry-relevant output, my view is that drug industry payments to authors should be declared. According to Sunshine Act data, Dr Haller received US$82,859 in payments and expenses for various activities during 2013-15,[11] the most recent years for which data are available, albeit not directly from MPIP proprietor companies. During the same period, the data indicate that Dr Citrome received US$1,313,274, the largest payments being for consultancy and promotional speaking in relation to various drugs.[12] This total includes, by my calculation, $107,578 from Janssen, $37,473 from Takeda and $33,903 from Merck. These companies are members of MPIP, their employees contributed to the roundtable meeting and Janssen and Takeda employees are coauthors on this very paper.

I have every confidence in the integrity of the authors, but it would appear we do not share a joint perspective on what disclosures are clinically relevant.

It has not escaped my notice that another scheme which MPIP is running at the moment is called “Transparency Matters.”[6]

Much has been said about the use of “key opinion leaders” (KOLs) by marketing. I do not direct this comment to this particular article, but editors should take care not to find themselves functioning as KOLs, if not in the promotion of drugs, then in the promotion of the commercial medical literature trade.

Richard Smith famously wrote that “medical journals are an extension of the marketing arm of pharmaceutical companies.”[13] But if I may conclude with a jot of badinage, then it is not Smith’s words that wrestle their way into my soul, but those of the late MP and diarist, Alan Clark: “it is never the slightest use telling people who they shouldn’t go to bed with.”[14]

References

1. Lineberry N, Berlin JA, Mansi B, Glasser S, Berkwits M, Klem C, Bhattacharya A, et al. Recommendations to improve adverse event reporting in clinical trial publications: a joint
pharmaceutical industry/journal editor perspective. BMJ. 2016 Oct 3;355:i5078.

2. Globescan: Reputation. http://www.globescan.com/expertise/reputation.html. Accessed March 6 2017.

3. Globescan: Stakeholder Engagement. http://www.globescan.com/capabilities/stakeholder-engagement.html. Accessed March 6 2017.

4. The Reputation Institute: Brand Alignment. https://www.reputationinstitute.com/consulting/brand-alignment. Accessed March 6 2017.

5. About Medical Publications Insights & Practices. https://www.mpip-initiative.org/about.html. Accessed March 6 2017.

6. Medical Publications Insights & Practices. https://www.mpip-initiative.org. Accessed March 6 2017.

7. Sage Publishing. Advertising & Promotion. https://us.sagepub.com/en-us/nam/advertising-and-promotion. Accessed March 5 2017.

8. Wiley Online Library. For Advertisers & Corporate Partners. http://olabout.wiley.com/WileyCDA/Section/id-390236.html. Accessed March 5 2017.

9. McHenry L, Jureidini J. On the Proposed Changes to the Credibility Gap in Industry-Supported Biomedical Research: A Critical Evaluation. Ethical Human Psychology and Psychiatry 2012; 14:156-161.

10. Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. BMJ. 2016 Aug 30;354:i4578.

11. Dollars for Docs: Daniel G Haller, MD. https://projects.propublica.org/docdollars/doctors/pid/119489. Accessed March 6 2017.

12. Dollars for Docs: Leslie CItrome, MD. https://projects.propublica.org/docdollars/doctors/pid/171564. Accessed March 6 2017.

13. Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005 May;2(5):e138.

14. Clark A. Diaries: In Power, 1983-1992. London, Phoenix, 1994; entry for May 15 1990.

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.

06 March 2017
Alastair Matheson
Independent consultant
None
Toronto, Canada