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Conflicts of interest when medical writers work for commercial sponsors. Liz Wager Publications Consultant Two distinct problems. Ghost writing / ghost authorship Undisclosed conflicts of interest. CSE White Paper.

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Conflicts of interest when medical writers work for commercial sponsors

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    1. Conflicts of interestwhen medical writers work for commercial sponsors Liz Wager Publications Consultant

    2. Two distinct problems • Ghost writing / ghost authorship • Undisclosed conflicts of interest

    3. CSE White Paper • Ghost authorship = a failure to disclose a contribution that would meet ICMJE criteria for authorship • For example …undisclosed contributions of medical writers to the draft of a manuscript

    4. WAME policy statement • Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself • WAME considers ghost authorship dishonest and unacceptable

    5. Ghost busting is easy!

    6. WAME contd • To prevent some instances of ghost authorship, editors should make clear in their journal's information for authors that medical writers can be legitimate contributors and that their roles and affiliations should be described in the manuscript

    7. How about CoI disclosure?

    8. CSE White Paper • Authors should disclose all sources of funding (government, corporate, other) and any products or services (such as materials and equipment, statistical analysis, and scientific writing) provided by third parties in the course of doing the research and reporting the findings (medical writing, statistical analysis)

    9. EMWA guidelines • Vague acknowledgements of the medical writer’s role, such as ‘providing editorial assistance’ should be avoided • Involvement of med writer AND funding source should be acknowledged e.g. 'we thank Dr Jane Doe who provided writing services on behalf of XYZ Pharma'

    10. Good Publication Practice for pharma companies (GPP) • The Acknowledgments section of a paper should list those people who made a significant contribution to the study but do not qualify as authors. It should also be used to acknowledge the study's funding and the company's involvement in the analysis of the data or preparation of the publication unless this is apparent from the list of contributors/authors

    11. The Lancet Role of medical writer or editor • Was a medical writer or editor involved in the creation of your manuscript? If yes, we need a signed statement from the corresponding author to include the name and information on funding of this person

    12. Jnl of General Internal Medicine • Anyone, including freelance writers and writers from communication and education companies, who contributes to reviewing the literature or drafting a manuscript must be listed as an author and complete a conflict of interest statement • Alternatively, such persons can be listed in the Acknowledgments, including the conflict of interest information

    13. Jnl of General Internal Medicine • Commissioning of manuscripts by for-profit companies is allowed, but persons contributing to the content of the manuscript must be listed as authors or be acknowledged, and the precise financial relationships, direct and indirect, between the parties involved must be explicitly described. Failing to do this will result in rejection of the manuscript.

    14. Why do we need writers? • "I never cease to be amazed by the general inability of physicians, other health professionals, and scientists to communicate through the written word" • Cathy DeAngelis • Foreword to 10th Edition of AMA Style Manual

    15. Are writers' CoIs worse than other people's? Sponsors pay: • investigators (directly or indirectly) • employees (often involved in study design) • statisticians • journals (page charges / OA fees)

    16. an author/investigator receiving major pharma research funding plus honoraria, speaker fees, etc. a professional writer hired by the sponsor probably working for several companies ? Is there a difference between:

    17. What if: • Writers had professional accreditation? • Drug companies and agencies endorsed GPP, EMWA, etc. guidelines? • Jnls promoted GPP, etc. via instructions? • Jnl editors asked more searching questions about role of medical writers?

    18. The ideal world no ghosts fulldisclosure