Industry Supported Editorial Assistance: The Debate Continues

14 January 2013

Editor’s Note: Here is the latest installment of a debate over industry-sponsored editorial assistance between Tom Yates, a UK-based physician critical of the role of industry in medical publishing, and Karen Wooley, who owns a medical education company and is a representative of the the Global Alliance of Publication Professionals (GAPP). (The previous installments of the debate can be found here and here.)

Karen Wooley responds to questions raised by Yates in the earlier posts:

Dear Editor,

Although the Global Alliance of Publication Professionals (GAPP) cannot answer the questions that Mr Yates posed directly to Isabelle Leach and PAREXEL, we welcome the opportunity to answer the questions you have asked.
1. What expertise do publications professionals have in the field about which they are writing?
This question provides a great platform to identify the expertise that professional medical writers do and (typically)* do not bring the publication process. Professional medical writers have scientific communication expertise; the authors have therapeutic area expertise. These areas of expertise complement each other. Is it helpful for a medical writer to be familiar with the therapeutic area? Yes. Is it necessary? No. The authors take full responsibility for the content;* the medical writer’s role is to ensure that content is communicated in a timely and compliant manner. The situation with professional medical writers is analogous to the situation with statisticians. Statisticians do not need to be therapeutic area experts – the authors do. Statisticians need to excel at their job; so, too, do medical writers. Manuscripts are often a team effort and, increasingly, professional medical writers are part of the manuscript team.

Notably, the international competency model for professional medical writers does not list the need for therapeutic area expertise, but it does include a long list of competencies for scientific communication (eg, knowledge of regulatory, publication, and style guidelines; English language skills; computer skills, project management skills; attention-to-detail etc…).1

* If a professional medical writer does have recognized expertise in a therapeutic area (eg, worked as a clinician in that area or completed their PhD or post-doctoral studies on the topic) or was instrumental in data collection (eg, for a systematic review manuscript), the writer may meet the criteria for authorship. If so, the medical writer should be listed as an author.

2. Can Woolley point to industry-sponsored publications that do not recommend prescribing a drug manufactured by the sponsor?
Yes. The following papers do not recommend prescribing a drug manufactured by the sponsor. Please note that these papers were identified through a quick search of MEDLINE – a proper search of the literature would no doubt identify others.