On 2017 Aug 09, Serina Stretton commented:

Prasad and Rajkumar’s editorial on conflicts of interest (COI) published in the Blood Cancer Journal [1] explores how management of financial COI in academic oncology influences treatment decisions away from best patient care. We share Prasad and Rajkumar’s concerns about the potential negative influence of COI, irrespective of its source, but disagree that banning industry-funded PMWs is a reasonable or practical solution.

This year (2017) three leading professional organizations, the International Society for Medical Publication Professionals (ISMPP), the American Medical Writers Association (AMWA), and the European Medical Writers Association (EMWA), released a joint position statement reaffirming PMWs’ obligations to be transparent about their contributions and sources of funding, and to clearly delineate the respective roles of authors and PMWs [2]. Prasad and Rajkumar claim that publications written with assistance from industry-funded PMWs may not reflect authors’ views and that authors may feel unable to challenge inappropriate sponsor influence. These statements undermine the clear responsibilities and accountability that authors should uphold when publishing clinical data [3,4]. For example. as required by the International Committee of Medical Journal Editors [3] and upheld by the AMWA-EMWA-ISMPP joint position statement, authors must provide all of the following: early intellectual input to a publication, be involved in the drafting, approve the final version for publication, and agree to be accountable for all aspects of the work. It is the latter two requirements that counter Prasad and Rajkumar’s premise that authors have little opportunity to control the content of the manuscript. In contrast, PMWs who often do not meet authorship criteria, assist authors to disclose findings from clinical studies in a timely, ethical, and accurate manner; ensure that authors and sponsors are aware of their obligations; and document author contributions to the development of a publication [2,4]. To contribute value in these roles, PMWs regularly receive mandatory training on ethical publication practices from their employers and industry funders [5-7].

Of concern, Prasad and Rajkumar’s present misleading data to support their arguments for banning industry-funded PMWs. First, they state that “writing assistance” is common, citing prevalence data from a survey of honorary or ghost authorship by Wislar et al [8]. Honorary or ghost authorship occurs when an individual who merits authorship is excluded from the author byline. This is quite distinct from medical writers who not meet authorship criteria and (i) declare their involvement in the acknowledgements (PMWs) [3] or (ii) keep their involvement hidden (ghostwriters) [9]. Indeed, the prevalence of ghostwriting in the Wislar et al survey was 0.2% of articles, far lower than the 21% cited by Prasad and Rajkumar for ghost authorship. Second, Prasad and Rajkumar state that ghost authorship in industry-funded trials is far worse, citing a study by Gøtzsche et al [10]. However, Gøtzsche et al used a nonstandard definition of ghost authorship by extending the definition to undeclared contributions (either as authors or in the acknowledgments) from individuals who wrote the trial protocol and those who conducted the statistical analyses.

As acknowledged by Prasad and Rajkumar, there are multiple benefits to engaging a PMW in terms of time and readability [1]. More importantly, publications involving PMWs are of higher quality – they have a shorter acceptance time [11], are more compliant with international reporting guidelines [12, 13], contain significantly fewer non-prespecified outcomes [14], and have a lower rate of retraction due to misconduct [15] than publications without PMWs or with those that are not funded by industry. As such, it is entirely unreasonable to exclude PMWs as an option on the basis of their funding. We strongly advocate that PMWs are selected on the basis of a proven track record and commitment to ethical and transparent publication practices. In addition, we strongly recommend that authors become familiar with reporting guidelines and be aware of, and fully comply with their obligations and roles as authors.

The Global Alliance of Publication Professionals (www.gappteam.org)

Serina Stretton, ProScribe – Envision Pharma Group, Sydney, NSW, Australia; Jackie Marchington, Caudex – McCann Complete Medical Ltd, Oxford, UK; Cindy W. Hamilton Virginia Commonwealth University School of Pharmacy, Richmond; Hamilton House Medical and Scientific Communications, Virginia Beach, VA, USA; Art Gertel, MedSciCom, LLC, Lebanon, NJ, USA

GAPP is a group of independent individuals who volunteer their time and receive no funding (other than website hosting fees from the International Society for Medical Publication Professionals). All GAPP members have held, or do hold, leadership positions at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organisations. GAPP members have, or do provide, professional medical writing services to not-for-profit and for-profit clients.

REFERENCES [1] Prasad V, Rajkumar SV. Blood Cancer J 2016;6:e489 [2] www.ismpp.org/assets/docs/Inititives/amwa-emwa-ismpp joint position statement on the role of professional medical writersjanuary 2017.pdf 2017 [accessed 08.06.17] [3] www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html; 2016 [accessed 08.06.17] [4] Battisti WP et al. International Society for Medical Publication Professionals. Good Publication Practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461-4 [5] www.ismpp.org/ismpp-code-of-ethics [accessed 08.06.17] [6] www.amwa.org/page/Codeof_Ethics [accessed 08.06.17] [7] Wager E et al. BMJ Open. 2014;4(4):e004780 [8] Wislar JS et al. BMJ 2011;343:d6128.4-7 [9] Stretton S. BMJ Open 2014;4(7): e004777. [10] Gøtzsche PC et al. PLoS Med 2007;4:0047-52 [11] Bailey, M. AMWA J 2011;26(4):147-152 [12] Gattrell W et al. BMJ Open. 2016;6:e010329 [13] Jacobs A. Write Stuff 2010;19(3):196-200 [14] Gattrell W et al. ISMPP EU Annual Meeting 2017 [15] Woolley KL et al. Curr Med Res Opin 2011;27(6)1175-82

On 2017 Aug 09, Serina Stretton commented:

Prasad and Rajkumar’s editorial on conflicts of interest (COI) published in the Blood Cancer Journal [1] explores how management of financial COI in academic oncology influences treatment decisions away from best patient care. We share Prasad and Rajkumar’s concerns about the potential negative influence of COI, irrespective of its source, but disagree that banning industry-funded PMWs is a reasonable or practical solution.

This year (2017) three leading professional organizations, the International Society for Medical Publication Professionals (ISMPP), the American Medical Writers Association (AMWA), and the European Medical Writers Association (EMWA), released a joint position statement reaffirming PMWs’ obligations to be transparent about their contributions and sources of funding, and to clearly delineate the respective roles of authors and PMWs [2]. Prasad and Rajkumar claim that publications written with assistance from industry-funded PMWs may not reflect authors’ views and that authors may feel unable to challenge inappropriate sponsor influence. These statements undermine the clear responsibilities and accountability that authors should uphold when publishing clinical data [3,4]. For example. as required by the International Committee of Medical Journal Editors [3] and upheld by the AMWA-EMWA-ISMPP joint position statement, authors must provide all of the following: early intellectual input to a publication, be involved in the drafting, approve the final version for publication, and agree to be accountable for all aspects of the work. It is the latter two requirements that counter Prasad and Rajkumar’s premise that authors have little opportunity to control the content of the manuscript. In contrast, PMWs who often do not meet authorship criteria, assist authors to disclose findings from clinical studies in a timely, ethical, and accurate manner; ensure that authors and sponsors are aware of their obligations; and document author contributions to the development of a publication [2,4]. To contribute value in these roles, PMWs regularly receive mandatory training on ethical publication practices from their employers and industry funders [5-7].

Of concern, Prasad and Rajkumar’s present misleading data to support their arguments for banning industry-funded PMWs. First, they state that “writing assistance” is common, citing prevalence data from a survey of honorary or ghost authorship by Wislar et al [8]. Honorary or ghost authorship occurs when an individual who merits authorship is excluded from the author byline. This is quite distinct from medical writers who not meet authorship criteria and (i) declare their involvement in the acknowledgements (PMWs) [3] or (ii) keep their involvement hidden (ghostwriters) [9]. Indeed, the prevalence of ghostwriting in the Wislar et al survey was 0.2% of articles, far lower than the 21% cited by Prasad and Rajkumar for ghost authorship. Second, Prasad and Rajkumar state that ghost authorship in industry-funded trials is far worse, citing a study by Gøtzsche et al [10]. However, Gøtzsche et al used a nonstandard definition of ghost authorship by extending the definition to undeclared contributions (either as authors or in the acknowledgments) from individuals who wrote the trial protocol and those who conducted the statistical analyses.

As acknowledged by Prasad and Rajkumar, there are multiple benefits to engaging a PMW in terms of time and readability [1]. More importantly, publications involving PMWs are of higher quality – they have a shorter acceptance time [11], are more compliant with international reporting guidelines [12, 13], contain significantly fewer non-prespecified outcomes [14], and have a lower rate of retraction due to misconduct [15] than publications without PMWs or with those that are not funded by industry. As such, it is entirely unreasonable to exclude PMWs as an option on the basis of their funding. We strongly advocate that PMWs are selected on the basis of a proven track record and commitment to ethical and transparent publication practices. In addition, we strongly recommend that authors become familiar with reporting guidelines and be aware of, and fully comply with their obligations and roles as authors.

The Global Alliance of Publication Professionals (www.gappteam.org)

Serina Stretton, ProScribe – Envision Pharma Group, Sydney, NSW, Australia; Jackie Marchington, Caudex – McCann Complete Medical Ltd, Oxford, UK; Cindy W. Hamilton Virginia Commonwealth University School of Pharmacy, Richmond; Hamilton House Medical and Scientific Communications, Virginia Beach, VA, USA; Art Gertel, MedSciCom, LLC, Lebanon, NJ, USA

GAPP is a group of independent individuals who volunteer their time and receive no funding (other than website hosting fees from the International Society for Medical Publication Professionals). All GAPP members have held, or do hold, leadership positions at associations representing professional medical writers (eg, AMWA, EMWA, DIA, ISMPP, ARCS), but do not speak on behalf of those organisations. GAPP members have, or do provide, professional medical writing services to not-for-profit and for-profit clients.

REFERENCES [1] Prasad V, Rajkumar SV. Blood Cancer J 2016;6:e489 [2] www.ismpp.org/assets/docs/Inititives/amwa-emwa-ismpp joint position statement on the role of professional medical writersjanuary 2017.pdf 2017 [accessed 08.06.17] [3] www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html; 2016 [accessed 08.06.17] [4] Battisti WP et al. International Society for Medical Publication Professionals. Good Publication Practice for communicating company-sponsored medical research: GPP3. Ann Intern Med. 2015;163(6):461-4 [5] www.ismpp.org/ismpp-code-of-ethics [accessed 08.06.17] [6] www.amwa.org/page/Codeof_Ethics [accessed 08.06.17] [7] Wager E et al. BMJ Open. 2014;4(4):e004780 [8] Wislar JS et al. BMJ 2011;343:d6128.4-7 [9] Stretton S. BMJ Open 2014;4(7): e004777. [10] Gøtzsche PC et al. PLoS Med 2007;4:0047-52 [11] Bailey, M. AMWA J 2011;26(4):147-152 [12] Gattrell W et al. BMJ Open. 2016;6:e010329 [13] Jacobs A. Write Stuff 2010;19(3):196-200 [14] Gattrell W et al. ISMPP EU Annual Meeting 2017 [15] Woolley KL et al. Curr Med Res Opin 2011;27(6)1175-82