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EMWA guidelines. Dr Adam Jacobs Dianthus Medical Limited, UK President of the European Medical Writers Association (EMWA). Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications.

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EMWA guidelines

Dr Adam Jacobs

Dianthus Medical Limited, UK

President of the European Medical Writers Association (EMWA)


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Jacobs A, Wager E.

European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications.

Curr Med Res Opin 2005;21:317–321


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Drug firms “hoodwink” medical journals

“A significant proportion of the articles in journals such as the New England Journal of Medicine, the British Medical Journal, and the Lancet may be written with help from medical writing agencies…They are no more than infomercials paid for by drug firms”

Healy (The Observer, 2003)


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Not in my name

“Last summer, I was asked … to author a review…. Well, not "author", exactly. The usual practice is for a complete article to be supplied; all I would have to do was review it and sign it off. ”

Fugh-Berman (The Guardian, 2005)


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The term “ghostwriting”

  • Implies the writer is invisible because

    • their work is not acknowledged or

    • it is purposely concealed

  • Should be avoided


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Advantages of using medical writers

  • Medical writers can

    • raise the quality of publications

    • accelerate the writing and publication process

  • Medical writers have

    • language and communication skills

    • expertise in presenting data

    • understanding of publication guidelines and conventions


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Development of the guidelines

4-round Delphi consultation process among members of EMWA’s ghostwriting task force

  • John Carpenter

  • Julia Donnelly

  • Julia Forjanic–Klapproth

  • Art Gertel

  • Geoff Hall

  • Anne Hudson Jones

  • Adam Jacobs

  • Sue Laing

  • Tom Lang

  • Elise Langon– Neuner

  • Liz Wager

  • Ruth Whittington


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Findings

  • Skilled medical writers are an important resource and can improve quality of scientific papers

  • Professional skills of medical writers are not widely recognised outside their own profession

  • Involvement of medical writers is not intrinsically unethical


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More findings

  • Important to avoid unethical ghostwriting

  • Involvement of medical writers should be fully transparent

  • Important to educate medical writers about ethical standards

  • Avoid the term “ghostwriting”!


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Development of the guidelines

  • Findings of Delphi consultation process formed basis of draft guidelines

  • Guidelines refined after consultation with

    • journal editors

    • academic investigators

    • medical writers working for pharmaceutical and communication agencies

    • EMWA members


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Position statement

“Medical writers have a legitimate role in assisting named authors in developing manuscripts for peer-reviewed journals and material for presentation at peer-reviewed scientific meetings”

“Such contributions and relevant information about funding should be openly acknowledged”


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Authorship status of medical writers

  • Medical writers should only be listed as authors if they fulfil authorship criteria of target journal

  • Most journals have adopted ICMJE criteria for authorship

  • As an author, the medical writer takes on public responsibility for the research


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Financial interests and funding

  • Follow guidelines for Good Publication Practice (GPP) for Pharmaceutical Companies

  • The contribution of the medical writer and their relationship to sponsor should be acknowledged


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Relationship between medical writers and named authors

  • Named authors should be involved at earliest possible stage

  • The content of a publication should be discussed with and approved by authors

  • The named authors have the final say


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Writers’ power!

  • Writers should resist attempts to do detailed work on a publication before the authors have been confirmed and the content of the proposed publication discussed with them


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Acknowledgement of medical writers

  • The involvement of medical writers and their source(s) of funding should be acknowledged either

    • as author or contributor or

    • in acknowledgement section: vague statements should be avoided

  • This ensures transparency and makes readers aware of potential conflicts of interest


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Writers’ professional and ethical responsibilities

  • All medical writers

    • should ensure publications are produced in responsible and ethical manner

    • should be aware of and advise about relevant guidelines

    • should ensure the publications are accurate and scientifically valid

    • should be aware of the extent of their expertise and ask for guidance from authors when necessary


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Conclusions

  • Journal editors, medical writers, and lay press all support transparency of authorship and the acknowledgement of the involvement of medical writers and their source(s) of funding

  • There is a need for an increased awareness of the EMWA guidelines


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Acknowledgements

  • I thank Dr Shanida Nataraja of Dianthus Medical Limited for preparing the slides for this talk


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