Alastair Matheson paints a murky picture of conspiracy and manipulation in his article “A ghostwriter by any other name” and implies that use of ghost writers and/or failing to include them as co-authors, are methods the pharmaceutical industry uses to influence the scholarly literature for marketing purposes. However, he fails to identify the driving force behind the use of ghostwriters (time) and does not mention the fact that ghostwriters are used by organizations other than pharmaceutical companies, including academic groups and charitable institutions that sponsor clinical trials. All struggle with the time taken to write a publication. As a pharmaceutical physician specializing in oncology drug development for over 20 years, including more than 12 years as a freelance medical advisor, I have written, reviewed, and contributed to many papers and review articles. Even when writing on very familiar topics, a straightforward trial report can take around 40-50 hours and a review article around 100-150 hours to write. An additional 8-10 hours may be spent navigating the submission process and responding to peer reviewers' comments. Most clinicians, academics and company employees simply do not have this sort of time available. For those who do not have English as a first language (a common occurrence with larger, international trials), the help of a professional writer may be particularly welcome.
Matheson also implies some sort of wrong-doing in the process of publication planning, author selection, discussion, project briefings, and manuscript review by pharmaceutical companies, and the hands-on involvement in manuscript preparation by corporate employees and their inclusion as co-authors. However, such publication planning activities are routine for any organization wishing to publish the results of their research and not the exclusive domain of industry. Inclusion of company employees as co-authors when they have worked extensively on a trial, often exclusively over many years, is entirely within the spirit and letter of ICMJE recommendations and an important way of ensuring transparency, as well as giving credit where credit is due.
Matheson states “The ICMJE recommendations….require neither data ownership nor company interests to be disclosed.” However, ICJME recommends that the following be declared: “Sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design; collection, analysis, and interpretation of data; writing of the report; the decision to submit the report for publication; or a statement declaring that the supporting source had no such involvement” (1). These requirements come very close to those that Matheson advocates.
Matheson’s article contains other statements that are somewhat questionable on close scrutiny, for example: “a hallmark of commercial literature is that similar articles could have been produced using alternative academics”. A PubMed search for reviews of popular current topics (such as “immune checkpoint inhibitors”) reveals hundreds of reviews written by different academic authors - most of these appear to be straightforward attempts to summarise a complex and rapidly evolving therapy area with no apparent commercial input or bias.
Another problematic statement is: “The academic authors who provide ‘direction’ or ‘final’ say are often selected in advance and while their contributions are honest and substantial, this has little effect on the output anticipated by planners.” It is entirely logical and desirable for academic authors to be selected in advance of manuscript drafting (for example, when the trial is ongoing or nearing completion). Who would suggest that they were selected retrospectively (when the paper is written)? Furthermore, if their contributions are “honest and substantial”, how can it be true that this has little effect on the output?
Matheson concludes by suggesting changes to ICMJE authorship criteria including the granting of co-authorship to medical writers. Having worked with many talented medical writers, I welcome greater recognition of their invaluable work. However, including the medical writer in the list of co-authors rather than in a footnote or acknowledgments, regardless of whether they fulfill the other ICMJE criteria, seems likely to achieve little more than a steady increase in the number of authors on a paper.
REFERENCES
1. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. Defining the role of authors and contributors. 2015. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/d... (accessed 19 September 2016)
Competing interests:
I am a freelance medical advisor working in oncology drug development. In the last five years, I have acted as a consultant for the following organisations (in alphabetical order): Alactrita LLP, Astex Therapeutics Ltd, BerGen Bio A/S, Cancer Research UK Centre for Drug Development, EngMab AG, Inbiomotion SL, Michelangelo Foundation, Mosaic Biomedicals SL, Norgine Ltd, Ono Pharma UK Ltd, Piqur Therapeutics AG, Roche Products Ltd, SFL Services Ltd, Shionogi Ltd, and the Wellcome Trust Ltd. I am on the advisory board for SFL Services GmBH and own shares in GSK
Rapid Response:
Re: A ghostwriter by any other name
Alastair Matheson paints a murky picture of conspiracy and manipulation in his article “A ghostwriter by any other name” and implies that use of ghost writers and/or failing to include them as co-authors, are methods the pharmaceutical industry uses to influence the scholarly literature for marketing purposes. However, he fails to identify the driving force behind the use of ghostwriters (time) and does not mention the fact that ghostwriters are used by organizations other than pharmaceutical companies, including academic groups and charitable institutions that sponsor clinical trials. All struggle with the time taken to write a publication. As a pharmaceutical physician specializing in oncology drug development for over 20 years, including more than 12 years as a freelance medical advisor, I have written, reviewed, and contributed to many papers and review articles. Even when writing on very familiar topics, a straightforward trial report can take around 40-50 hours and a review article around 100-150 hours to write. An additional 8-10 hours may be spent navigating the submission process and responding to peer reviewers' comments. Most clinicians, academics and company employees simply do not have this sort of time available. For those who do not have English as a first language (a common occurrence with larger, international trials), the help of a professional writer may be particularly welcome.
Matheson also implies some sort of wrong-doing in the process of publication planning, author selection, discussion, project briefings, and manuscript review by pharmaceutical companies, and the hands-on involvement in manuscript preparation by corporate employees and their inclusion as co-authors. However, such publication planning activities are routine for any organization wishing to publish the results of their research and not the exclusive domain of industry. Inclusion of company employees as co-authors when they have worked extensively on a trial, often exclusively over many years, is entirely within the spirit and letter of ICMJE recommendations and an important way of ensuring transparency, as well as giving credit where credit is due.
Matheson states “The ICMJE recommendations….require neither data ownership nor company interests to be disclosed.” However, ICJME recommends that the following be declared: “Sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design; collection, analysis, and interpretation of data; writing of the report; the decision to submit the report for publication; or a statement declaring that the supporting source had no such involvement” (1). These requirements come very close to those that Matheson advocates.
Matheson’s article contains other statements that are somewhat questionable on close scrutiny, for example: “a hallmark of commercial literature is that similar articles could have been produced using alternative academics”. A PubMed search for reviews of popular current topics (such as “immune checkpoint inhibitors”) reveals hundreds of reviews written by different academic authors - most of these appear to be straightforward attempts to summarise a complex and rapidly evolving therapy area with no apparent commercial input or bias.
Another problematic statement is: “The academic authors who provide ‘direction’ or ‘final’ say are often selected in advance and while their contributions are honest and substantial, this has little effect on the output anticipated by planners.” It is entirely logical and desirable for academic authors to be selected in advance of manuscript drafting (for example, when the trial is ongoing or nearing completion). Who would suggest that they were selected retrospectively (when the paper is written)? Furthermore, if their contributions are “honest and substantial”, how can it be true that this has little effect on the output?
Matheson concludes by suggesting changes to ICMJE authorship criteria including the granting of co-authorship to medical writers. Having worked with many talented medical writers, I welcome greater recognition of their invaluable work. However, including the medical writer in the list of co-authors rather than in a footnote or acknowledgments, regardless of whether they fulfill the other ICMJE criteria, seems likely to achieve little more than a steady increase in the number of authors on a paper.
REFERENCES
1. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. Defining the role of authors and contributors. 2015. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/d... (accessed 19 September 2016)
Competing interests: I am a freelance medical advisor working in oncology drug development. In the last five years, I have acted as a consultant for the following organisations (in alphabetical order): Alactrita LLP, Astex Therapeutics Ltd, BerGen Bio A/S, Cancer Research UK Centre for Drug Development, EngMab AG, Inbiomotion SL, Michelangelo Foundation, Mosaic Biomedicals SL, Norgine Ltd, Ono Pharma UK Ltd, Piqur Therapeutics AG, Roche Products Ltd, SFL Services Ltd, Shionogi Ltd, and the Wellcome Trust Ltd. I am on the advisory board for SFL Services GmBH and own shares in GSK