by Laura C Collada Ali – Medical Writing & Scientific Manager, MedDev Day Scientific Coordinator at LS Academy

 

Why is it important to debunk medical writing myths?

Debunking medical writing myths is vital for promoting the role of professional medical writers and for countering misinformation that may hinder authors, pharmaceutical companies and medical device manufacturers from considering the use of medical writing support. It helps build a foundation of trust, knowledge, and evidence-based practices in healthcare, benefiting individuals and society.

 

Thus, we’re happy to contribute to the body of knowledge on medical writers’ role and debunk some of the most common myths about this fascinating profession.

 

Myth n. 1 – Medical writers are ghostwriters:

Within medical communications, the International Committee of Medical Journal Editors (ICMJE) published in the late 1990s a set of recommendations now adopted by most scientific journals. Among these, there are recommendations that the authorship be based on 4 criteria:

  1. “Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  2. Drafting the work or revising it critically for important intellectual content; AND
  3. Final approval of the version to be published; AND
  4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”

Further on the guideline, the ICMJE states:

Contributors who meet fewer than all 4 of the above criteria for authorship should not be listed as authors, but they should be acknowledged. Examples of activities that alone (without other contributions) do not qualify a contributor for authorship are acquisition of funding; general supervision of a research group or general administrative support; and writing assistance, technical editing, language editing, and proofreading.

Thus, medical writers fulfil the first part of the second criterion, ‘drafting the work (…)’ and should always be acknowledged and their name reported in the text.

Medical writers also have a role and should be acknowledged in regulatory writing. Indeed, regulations and standards have been pointing out the importance of the author of documents for long. That is the case, for example, in drafting Clinical Evaluation Reports for medical devices (MDR 2017/745) or in preparing Clinical Study Reports (ICH E3; Core Reference) or Clinical Investigation Reports (MDR 2017/745; ISO 14155:2020).

On another note, the European Medical Writers Association (EMWA) published a ghostwriting positioning statement aiming at addressing medical writers’ doubts about their role as authors. This statement affirms that 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 should be acknowledged, and EMWA discourages the term ‘ghostwriter’, as it implies that there is something secretive about the writer’s involvement. In the ending section of this blog, we report several references that talk about this topic.

Finally, be wary of a medical writer who describes him or herself as a ‘ghostwriter’ as this implies that the person is not updated on the latest standards of the medical writing profession.

 

 

 

References:

  1. 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.
  2. Woolley KL. Goodbye Ghostwriters! How to work ethically and efficiently with professional medical writers. Chest 2006;130:921-923.
  3. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin 2011;27:1175-1182.
  4. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. The Write Stuff 2010;19:196-200.
  5. EMWA’s positioning statement on Ghostwriting. Accessible here: https://www.emwa.org/about-us/position-statements/ghostwriting-positioning-statement/.
3 Medical Writing Myths Debunked - 1st myth - LS Academy