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Geoff Smith,1 Jon Nilsen,1 Shawn Lee,1 Mee Rhan Kim,1 Dikran Toroser

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Geoff Smith,1 Jon Nilsen,1 Shawn Lee,1 Mee Rhan Kim,1 Dikran Toroser Monitoring the External Publication Environment (MEPE): Identifying and Communicating Significant Developments to NITOR O A M N A L Excellence Y Z In Medical E Key Stakeholders in a Corporate Setting Publishing MEPE 1 1 1 1 1 1 2 1 1 E M N R Geoff Smith, Jon Nilsen, Shawn Lee, Mee Rhan Kim, Dikran Toroser, Erica Rockabrand, Lucy Hyatt, Larry Kovalick, Juli Clark SU FO RE IN 1Amgen Inc., Thousand Oaks, CA, USA; 2Amgen (Europe) GmbH, Zug, Switzerland ABSTRACT METHODS RESULTS SUMMARY Objective: Knowledge of medical publication policies, issues, and trends is critical for Task Force Standard Review and Assessment Procedures Figure 1. Process Map Four Updates on Key Developing Issues Were Prepared by Figure 2. The Articles That Were the Subjects of the Updates • The rapidly changing environment of medical publishing requires that pharmaceutical executives and research and development personnel in the drug and • MEPE tracks trending issues in medical publications issued by: the MEPE Task Force Over the Past Year Had Comparable External Impact to Similar Articles companies relying on journal publications to communicate science-based device industries who provide input on industry-sponsored publications. A poster Ideal Timeline Person(s) Responsible Published in the Same Venue findings from their research activities keep aware of updates to presentation at ISMPP 2011 outlined our company’s efforts to provide such updates to – Journals Event MEPE Team Member 1. Merck amends publication policy to proactively provide study publication policies and current publication-related issues internal stakeholders by means of a dedicated task force. Our task force is now – Universities entering its third year of service. Identification or Other protocols for journal review 14000 • Our company has made use of a dedicated task force to rapidly identify Research Design and Methods: The Monitoring the External Publications – Medical centers In July 2011, Merck & Co. Inc. updated their publication policy to critical issues in medical publishing and communicate them to senior 12000 Environment (MEPE) task force was commissioned by our Scientific Affairs Medical – Industry groups (eg, PhRMA, EFPIA, IFPMA) provide increased transparency regarding reporting of clinical trial management with a planned turnaround time of approximately one week Writing department to identify, summarize, and communicate significant policy 11 • Through RSS feeds of journal tables of contents and news sources: Team Review results. In a press release, the pharma company indicated that they 10000 • A sampling of PLoS Medicine publications chosen by the task force for changes, issues, and trends related to publications and authorship in the and Triage for would proactively provide full copies of the study protocol and escalation to internal stakeholders was comparable in terms of external – Medical press End 1 Day MEPE Team scientific/medical literature. It also monitors important publication-related Novelty and No statistical analysis plan with all journal submissions resulting from 8000 interest to that of similar publications in that journal developments in the lay press as an indicator of public opinion. – Lay press Significance studies of investigational or approved products. • The periodic updates produced by the task force were rated as “very” or Results: The MEPE task force initiated processes to identify publication-related – Blogs/lobby groups 6000 developments with potential business impact. We have robust assessment and review “moderately” useful in terms of business impact by 96% of survey • Active participation in publication societies and professional organizations Yes procedures that allow us to triage, assess, summarize, and report this information to MEPE Team Member 4000 respondents, with no respondents rating them as “not useful” Write Summary 1 to 2 Days senior internal leadership within one week via periodic-focused email updates. In the – ISMPP Assigned as Writer 2. Recent articles call for increased transparency in the role of 3-month Page Views (Mean/SD) past year, we have provided four updates, which were evaluated as “very” or – American Medical Writers Association (AMWA) medical writers in pharmaceutical industry-sponsored 2000 “moderately” useful by 96% of survey respondents. Team Review CONCLUSION – Council of Science Editors (CSE) 2 Days MEPE Team publications Conclusions: The MEPE task force has provided value to key stakeholders by of Summary 0 identifying, summarizing, and communicating publication-related external events, • Ad hoc updates from colleagues in medical publishing In July and August 2011, two articles suggested that ICMJE author- Total HTML PDF • The MEPE task force, through identification and summarization of select (HTML + PDF) trends, and issues with potential business impact. • Google Alerts are assigned to team members for daily monitoring ship criteria were being misused to keep medical writers who provide articles and online communications, continues to raise awareness that 12,13 Types of Article Views (Table 1) Executive substantive input into publications off the author byline. The informs medical publishing decision making across our company 2 to 3 Days Department and Review and articles proposed specific changes to standards of practice, including Legal Remedies No Functional Area Heads PLoS Medical Ghostwriting Collection INTRODUCTION Approval the requirement that medical writers be listed as authors on the byline. Ghostwriting Collection (Stern and Lemmens) Honorary/Ghost Author Prevalence Legal Remedies REFERENCES Table 1. Google Alert Search Terms* Yes (Matheson, et al.) (Bosch, et al.) • Rapid changes in the field of medical communications include issues of Distribution to Total approximately 1. Wilkes M, Johns M. Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients medical ghostwriting and authorship contribution, protocol submissions, Medical ghostwriting Management Off-Label Prescriptions. PLoS Med. 5(11):e223.doi:10.1371/journal.pmed.0050223. Published November 11, 1 week 3. Recent article reports the prevalence of honorary and ghost potential financial conflicts of interest, and publication bias • PLoS publications selected for executive attention by the MEPE task 2008. Publication bias authorship in six high impact biomedical journals 2. Lacasse JR, Leo J. Ghostwriting at Elite Academic Medical Centers in the United States. PLoS Med. • Industry-sponsored publications in particular have come under increased force had similar numbers of HTML and PDF page views compared with 7(2):e1000230.doi:10.1371/journal.pmed.1000230. Published February 2, 2010. Publication planning In October 2011, four senior JAMA editorial staff published results scrutiny those for all PLoS publications related to medical ghostwriting 3. Fugh-Berman AJ. The Haunting of Medical Journals: How Ghostwriting Sold “HRT”. PLoS Med. from an author survey on the prevalence of honorary and ghost 7(9):e1000335.doi:10.1371/journal.pmed.1000335. Published September 7, 2010. Clinical trial posting 14 • Medical journals and professional societies have made changes to their authors in six leading general biomedical journals. They reported a 4. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al. Ghost Authorship in editorial policies in response Guest authorship Summary of Task Force Updates and Their Impact statistically significant decrease in ghost authorship from 12% in 1996 Figure 3. MEPE Updates Were Rated “Very Useful” by a Industry-Initiated Randomised Trials. PLoS Med. 4(1):e19.doi:10.1371/journal.pmed.0040019. Published to 8% in 2008, and a non-significant decline in honorary (guest) January 16, 2007. • In light of the negative perception/mistrust of industry involvement in Medical plagiarism • We summarize the four updates issued from the task force over the past Majority of Recipients 5. McPartland JM. Obesity, the Endocannabinoid System, and Bias Arising from Pharmaceutical Sponsorship. clinical publications, pharmaceutical companies need to maintain year and provide an assessment of the impact of the publications via authorship from 19% in 1996 to 18% in 2008. PLoS ONE. 4(3):e5092.doi:10.1371/journal.pone.0005092. Published March 31, 2009. Medical publication acknowledgements • Recipients of the December 2011 update were surveyed for their awareness of current developments in medical publishing to help with journal readership metrics and via an internal survey of update recipients 6. Wager E. Authors, Ghosts, Damned Lies, and Statisticians. PLoS Med. 4(1):e34.doi:10.1371/ related decision-making and anticipate needed process/policy changes Medical writing support response to the question: journal.pmed.0040034. Published January 16, 2007. – External validation – assessment of journal readership metrics 7. Logdberg L. Being the Ghost in the Machine: A Medical Ghostwriter's Personal View. PLoS Med. • To that end, the creation of a dedicated workstream to proactively identify Scientific publication acknowledgements “How useful are the periodic MEPE updates to your work, 8(8):e1001071.doi:10.1371/journal.pmed.1001071. Published August 9, 2011. • The subjects for two of the updates were publications in PLoS 4. Legal remedies proposed against guest authors of ghostwritten particularly in regard to your understanding of the publishing and rapidly communicate updates may be useful Pharmaceutical industry publications 8. Sismondo S. Ghost Management: How Much of the Medical Literature Is Shaped Behind
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