Medical publication policies and guidelines offer a framework for best practices, but there may be situations when more than one approach seems reasonable. The primary purpose of “What Would You Do?” is to explore examples of such situations. With the limited information provided to interpret the scenarios, you may find yourself agreeing with one, more than one, or none of the proposed actions. And that’s the point ‒ you should debate, contemplate, and communicate (with a comment) before selecting your “best” answer.
Now let’s find out how you responded and read through some commentary (for context only; not meant to be comprehensive) to the below scenario:
You are the Publication Lead at a mid-size biotech company who is working with the scientific/medical writing team of your medical communications agency. The lead author of a meta-analysis manuscript received a rejection notice from a journal that stated “…although the topic may be of interest to the readership, the Editors are concerned about the perception of bias given the statement of funding support from the sponsor and the participation of a paid, professional medical writer.” The lead author has emailed all authors, sponsor, and medical communications agency suggesting that the manuscript be revised by the authors alone so that acknowledgement of the medical writer and funding from the sponsor to support medical writing can be removed prior to resubmission to a new journal.
A. Acknowledge and agree to the decision of the lead author if the other authors are aligned as well; provided they change the manuscript sufficiently, there is little choice but to comply with their direction.
B. Offer to appeal the original decision of the journal noting that medical writing with sponsor support is a widely accepted practice and there is transparent reporting of the relationship.
C. Offer to contact the editor of the new target journal to inquire if the acknowledgement of medical writing with sponsor support (as it is in the current draft) will influence the journal’s decision on the manuscript.
D. Remind the authors that medical writing support with funding from the sponsor must be acknowledged even if the manuscript is revised and reinforce with the authors that medical writing support with disclosure is a widely accepted practice.
A total of 150 people replied to this poll.
Historically, a primary concern with the use of medical writers stemmed from ghost-writing, a practice in which writers are paid (usually by industry sponsors) to develop peer-reviewed manuscripts published in medical journals with attribution and credit given to authors ̶ typically who are well-known in the field of clinical research, who may not have contributed to any of the writing. In addition, there is no disclosure that a paid third party was involved. Given that these peer-reviewed articles can be published in top journals, they influence doctors and policy makers in their decision-making, which ultimately impact patient and population health. Such ghost-written articles are perceived to be biased, with exaggerated focus on the positives of drugs/treatments without the appropriate balanced description of the negatives, which can have significant implications for providers, patients, payors, and manufacturers.
To address these concerns, best practices for the use of medical writers and transparent reporting of their involvement have been developed and are available. For example, there is a Joint Position Statement by the American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), and ISMPP on the role of professional medical writers in the development of medical publications (1). This Joint Position Statement outlines how the use of medical writers, with clear and transparent disclosure, have been shown to aid authors and study sponsors with disclosing their research at scientific congresses and in peer-reviewed journals in an accurate, timely, and ethical manner. In addition, International Committee of Medical Journal Editors (ICMJE) recommendations clearly acknowledge the role of medical writers and provide guidelines for proper disclosure of contributions, such as writing assistance for manuscripts and reporting of relationships, including whether the sponsor or authors paid for writing support of the manuscript (2). The significant takeaway is that use of medical writers has been an acceptable practice when the writing is done under the direction of the authors and there is proper disclosure and acknowledgement.
As illustrated by the most popular choice in the poll results, education on existing guidance and best practices is important. At this stage, the authors must disclose that a medical writer was involved in developing the manuscript, and it should be noted that most journals accept manuscripts developed with the support of medical writers under the direction of the authors. Once this is understood, the authors may choose to submit to another journal. While it is an option for authors to challenge the decision of the current journal, the editors are likely aware of existing guidance around the use of medical writers, and it could be that philosophically, the journal chooses not to publish certain types of manuscripts (such as reviews or meta-analyses, or even clinical study manuscripts) developed by medical writers due to perceived bias by its readership.
Eric Y. Wong, PhD, MBA, ISMPP CMPPTM, Janssen Global Services, LLC
This article was prepared by the author in his personal capacity. The opinions expressed within are the author’s own and do not necessarily reflect the views of Janssen Global Services, LLC.
References
- AMWA-EMWA-ISMPP Joint Position Statement: https://journal.emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statement-on-the-role-of-professional-medical-writers/
- Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated May 2022): http://www.icmje.org/icmje-recommendations.pdf