On 2017 Aug 24, Serina Stretton commented:

Choi et al’s commentary, rightly condemns the practice of ghost writing in the peer-reviewed literature. Ghost writing (undisclosed contributions from individuals who DO NOT meet authorship criteria) and ghost authoring (undisclosed contributions from individuals who DO meet authorship criteria) are unethical practices and should be eradicated [1,2]. Here we address several of Choi et al’s assertions about the roles and responsibilities of professional medical writers (PMWs) and authors, and provide evidence of how PMWs can help deliver timely and accurate dissemination of clinical trial data.

As acknowledged by Choi et al and multiple editor organizations, including the International Committee for Medical Journal Editors (ICMJE) [1], the Council for Scientific Editors (CSE) [3], and the World Association of Medical Editors (WAME) [4], PMWs (individuals who do not meet authorship criteria and who declare their involvement in the acknowledgements) have a legitimate and valuable role in assisting authors disclose findings from clinical trials in the peer-reviewed literature. Publications involving PMWs are of higher quality compared with publications not involving PMWs or compared with publications that are not funded by industry; they can be more rapidly accepted through the peer-review process [5], more consistently meet the requirements set by international reporting guidelines [6, 7], contain significantly fewer non-prespecified outcomes [8], and are less likely to be retracted due to misconduct [9]. These outcomes are the result of authors working with PMWs who receive mandatory training on ethical publication practices and international reporting requirements from their employers and industry funders [10-12].

Choi et al put forward the scenario whereby authors play a seemingly passive role in the development of peer-reviewed manuscripts funded by the pharmaceutical industry. At worst, Choi et al assert that authors do not have access to raw data, may never have seen their publication before submission, and that industry-funded publications involving medical writers are riddled with embedded marketing messages. These assertions appear to absolve authors from any responsibility or accountability that they have as authors [1, 13]. Earlier this year, the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) released a joint position statement outlining the respective roles of authors and PMWs [14]. As required by the ICMJE [1] and upheld by the AMWA-EMWA-ISMPP joint position statement, authors must provide 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. These last two requirements challenge Choi et al’s assertion that authors have no control over the content of their publications. Indeed, when working with PMWs, the PMW’s roles are to assist authors disclose their findings in a timely, ethical, and accurate manner, and to ensure that authors and sponsors are aware of their obligations, that author contributions during development of the manuscript are documented, and that the writer’s and sponsor’s involvement and funding are disclosed transparently and appropriately [12, 14]. In these ways, the PMW serves as a “gatekeeper” of compliance with widely-accepted standards of authorship.

We caution against conflating “ghost authorship” with “ghost writing”. Choi et al state that despite increased awareness of the need to avoid the unethical practice of ghostwriting, the prevalence remains high. In support of this, the authors cite Wislar et al’s survey of honorary or ghost authorship from 2008 [15], which showed that an individual who merited authorship was excluded from the author byline in 7.9% of articles. However, the prevalence of ghostwriting (an unnamed individual who participated in the writing) in this survey was far lower at 0.2%. In addition, findings from a systematic review of the literature suggest that the reported prevalence of ghostwriting in the medical literature can vary, but is on the decrease [16].

Choi et al finish by calling for a ban on “any manuscript that is discovered to be written by people other than the named authors”. We certainly agree if the assistance provided by other people is not disclosed transparently within the manuscript. However, we disagree that a ban on ethically conducted and appropriately acknowledged PMW assistance is warranted. We strongly urge authors and sponsors to select and work with PMWs on the basis of a proven track record and commitment to ethical and transparent publication practices. In addition, we urge authors to 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; Julia Donnelly, Julia Donnelly Solutions Ltd, Ashbourne, UK.

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] www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html; 2016 [accessed 08.06.17] [2] Gøtzsche PC et al. PLoS Med 2009;6:e23. [3] Council of Science Editors. White Paper on Publication Ethics - Council of Science Editors, http://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics/; [accessed 08.17.17]. [4] World Association of Medical Editors. Policy Statement: Ghost writing initiated by commercial companies, http://www.wame.org/about/policy-statements#Ghost Writing; 2005 [accessed 08.17.17]. [5] Bailey, M. AMWA J 2011;26(4):147-152 [6] Gattrell W et al. BMJ Open. 2016;6:e010329 [7] Jacobs A. Write Stuff 2010;19(3):196-200 [8] Gattrell W et al. ISMPP EU Annual Meeting 2017 [9] Woolley KL et al. Curr Med Res Opin 2011;27(6)1175-82 [10] www.ismpp.org/ismpp-code-of-ethics [accessed 08.06.17] [11] www.amwa.org/page/Code_of_Ethics [accessed 08.06.17] [12] Wager E et al. BMJ Open. 2014;4(4):e004780 [13] Battisti WP et al. Ann Intern Med. 2015;163(6):461-4 [14] www.ismpp.org/assets/docs/Inititives/amwa-emwa-ismpp joint position statement on the role of professional medical writers_january 2017.pdf 2017 [accessed 08.06.17] [15] Wislar JS et al. BMJ 2011;343:d6128.4-7 [16] Stretton S. BMJ Open 2014;4(7): e004777.

On 2017 Aug 24, Serina Stretton commented:

Choi et al’s commentary, rightly condemns the practice of ghost writing in the peer-reviewed literature. Ghost writing (undisclosed contributions from individuals who DO NOT meet authorship criteria) and ghost authoring (undisclosed contributions from individuals who DO meet authorship criteria) are unethical practices and should be eradicated [1,2]. Here we address several of Choi et al’s assertions about the roles and responsibilities of professional medical writers (PMWs) and authors, and provide evidence of how PMWs can help deliver timely and accurate dissemination of clinical trial data.

As acknowledged by Choi et al and multiple editor organizations, including the International Committee for Medical Journal Editors (ICMJE) [1], the Council for Scientific Editors (CSE) [3], and the World Association of Medical Editors (WAME) [4], PMWs (individuals who do not meet authorship criteria and who declare their involvement in the acknowledgements) have a legitimate and valuable role in assisting authors disclose findings from clinical trials in the peer-reviewed literature. Publications involving PMWs are of higher quality compared with publications not involving PMWs or compared with publications that are not funded by industry; they can be more rapidly accepted through the peer-review process [5], more consistently meet the requirements set by international reporting guidelines [6, 7], contain significantly fewer non-prespecified outcomes [8], and are less likely to be retracted due to misconduct [9]. These outcomes are the result of authors working with PMWs who receive mandatory training on ethical publication practices and international reporting requirements from their employers and industry funders [10-12].

Choi et al put forward the scenario whereby authors play a seemingly passive role in the development of peer-reviewed manuscripts funded by the pharmaceutical industry. At worst, Choi et al assert that authors do not have access to raw data, may never have seen their publication before submission, and that industry-funded publications involving medical writers are riddled with embedded marketing messages. These assertions appear to absolve authors from any responsibility or accountability that they have as authors [1, 13]. Earlier this year, the American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) released a joint position statement outlining the respective roles of authors and PMWs [14]. As required by the ICMJE [1] and upheld by the AMWA-EMWA-ISMPP joint position statement, authors must provide 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. These last two requirements challenge Choi et al’s assertion that authors have no control over the content of their publications. Indeed, when working with PMWs, the PMW’s roles are to assist authors disclose their findings in a timely, ethical, and accurate manner, and to ensure that authors and sponsors are aware of their obligations, that author contributions during development of the manuscript are documented, and that the writer’s and sponsor’s involvement and funding are disclosed transparently and appropriately [12, 14]. In these ways, the PMW serves as a “gatekeeper” of compliance with widely-accepted standards of authorship.

We caution against conflating “ghost authorship” with “ghost writing”. Choi et al state that despite increased awareness of the need to avoid the unethical practice of ghostwriting, the prevalence remains high. In support of this, the authors cite Wislar et al’s survey of honorary or ghost authorship from 2008 [15], which showed that an individual who merited authorship was excluded from the author byline in 7.9% of articles. However, the prevalence of ghostwriting (an unnamed individual who participated in the writing) in this survey was far lower at 0.2%. In addition, findings from a systematic review of the literature suggest that the reported prevalence of ghostwriting in the medical literature can vary, but is on the decrease [16].

Choi et al finish by calling for a ban on “any manuscript that is discovered to be written by people other than the named authors”. We certainly agree if the assistance provided by other people is not disclosed transparently within the manuscript. However, we disagree that a ban on ethically conducted and appropriately acknowledged PMW assistance is warranted. We strongly urge authors and sponsors to select and work with PMWs on the basis of a proven track record and commitment to ethical and transparent publication practices. In addition, we urge authors to 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; Julia Donnelly, Julia Donnelly Solutions Ltd, Ashbourne, UK.

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] www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html; 2016 [accessed 08.06.17] [2] Gøtzsche PC et al. PLoS Med 2009;6:e23. [3] Council of Science Editors. White Paper on Publication Ethics - Council of Science Editors, http://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics/; [accessed 08.17.17]. [4] World Association of Medical Editors. Policy Statement: Ghost writing initiated by commercial companies, http://www.wame.org/about/policy-statements#Ghost Writing; 2005 [accessed 08.17.17]. [5] Bailey, M. AMWA J 2011;26(4):147-152 [6] Gattrell W et al. BMJ Open. 2016;6:e010329 [7] Jacobs A. Write Stuff 2010;19(3):196-200 [8] Gattrell W et al. ISMPP EU Annual Meeting 2017 [9] Woolley KL et al. Curr Med Res Opin 2011;27(6)1175-82 [10] www.ismpp.org/ismpp-code-of-ethics [accessed 08.06.17] [11] www.amwa.org/page/Code_of_Ethics [accessed 08.06.17] [12] Wager E et al. BMJ Open. 2014;4(4):e004780 [13] Battisti WP et al. Ann Intern Med. 2015;163(6):461-4 [14] www.ismpp.org/assets/docs/Inititives/amwa-emwa-ismpp joint position statement on the role of professional medical writers_january 2017.pdf 2017 [accessed 08.06.17] [15] Wislar JS et al. BMJ 2011;343:d6128.4-7 [16] Stretton S. BMJ Open 2014;4(7): e004777.