On 2016 Oct 01, Serina Stretton commented:

We read with interest Vera-Badillo and colleagues’ recent publication entitled Honorary and Ghost Authorship in Reports of Randomised Clinical Trials in Oncology [1], which appears to show that these unethical practices are highly prevalent in oncology trial publications. While we applaud the authors for conducting original research in this field, we are concerned that the nonstandard definitions used for ghost authorship may have skewed the results.

Vera-Badillo and colleagues assessed oncology trial publications where the trial protocol was available and contained a list of investigators. They defined ghost authorship as being present if an individual met one of the following criteria: “(i) investigators listed in the protocol were neither included as authors nor acknowledged in the article; (2) the individual who performed the statistical analyses was neither listed as an author nor acknowledged; (3) assistance of a medical writer was acknowledged in the publication.” No rationale or references were provided in support of this definition. However, while similar definitions have been used in some surveys of unethical authorship practices [2, 3], the definition provided by Vera-Badillo and colleagues is not uniformly accepted [4-7] and is not consistent with the International Committee of Medical Journal Editors (ICMJE) authorship criteria [8] or with the Council of Science Editors (CSE) definition of ghost authorship [9].

There may be many valid reasons why participating investigators or statisticians may not be eligible for authorship of publications arising from a trial [8]. Here, we would like to respond to Vera-Badillo and colleagues’ assertion that medical writers who ARE acknowledged for their contributions are ghost authors. As specified by the ICMJE, medical writing is an example of a contribution that alone does not merit authorship and, therefore, should be disclosed as an acknowledgement. Also according to ICMJE, appropriate disclosure of medical writing assistance in the acknowledgements is not ghost authoring unless the medical writer was also involved in the generation of the research or its analysis, was responsible for the integrity of the research, or was accountable for the clinical interpretation of the findings. In their publication, Vera-Badillo and colleagues reported evidence of ghost authorship in 66% of evaluated studies. Of these, 34% had acknowledged medical writer assistance. Clearly, inclusion of declared medical writing assistance as ghost authorship has inflated the prevalence of ghost authoring reported in this study. Failure to apply standardised definitions of ghost authorship, guest (or honorary) authorship, and ghostwriting, limits the comparability of findings across studies and can mislead readers as to the true prevalence of these distinct practices [10-12].

As recognised by the ICMJE [8], the CSE [9], and the World Association of Medical Editors [13], professional medical writers have a legitimate and valued role in assisting authors disclose findings from clinical trials in the peer-reviewed literature. Vera-Badillo and colleagues state in the discussion that medical writers either employed or funded by the pharmaceutical industry are “likely to write in a manner that meets sponsor approval”. No evidence is cited to support this claim. If sponsor approval requires accurate and robust reporting of trial results in accordance with international guidelines on reporting findings from human research [8, 14, 15], then yes, we agree. Professional medical writers employed or funded by the pharmaceutical industry routinely work within ethical guidelines and receive mandatory training on ethical publication practices [16-19]. Although medical writers may receive requests from authors or sponsors that they believe to be unethical, findings from the Global Publication Survey, conducted from November 2012 to February 2013, showed that most requests (93%) were withdrawn after the need for compliance with guidelines was made clear to the requestor [19].

By expanding the definition of ghost authorship to include disclosed medical writing assistance, Vera-Badillo and colleagues have inflated the prevalence of ghost authorship in oncology trial publications. Such an unbalanced approach has the potential to detract from the true prevalence of ghost authorship where an individual who is deserving of authorship is hidden from the reader.

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 roles 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] Vera-Badillo FE et al. Eur J Cancer 2016;66:1-8. [2] Healy D, Cattell D. Br J Psychiatry 2003;183:22-7. [3] Gøtzsche PC et al. PLoS Med 2007;4:0047-52. [4] Flanagin A et al. JAMA 1998;280:222-4. [5] Jacobs A, Hamilton C. Write Stuff 2009;18:118-23. [6] Wislar JS et al. BMJ 2011;343:d6128.4-7 [7] Hamilton CW, Jacobs A. AMWA J 2012;27:115. [8] http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html; 2015 [accessed 12.09.16]. [9] http://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics/; [accessed 13.09.16]. [10] Stretton S. BMJ Open 2014;4(7): e004777. [11] Marušić A et al. PloS One. 2011;6(9):e23477. [12] Marchington J et al. J Gen Intern Med 2016;31:11. [13] http://www.wame.org/about/policy-statements#Ghost Writing; 2005 [accessed 12.09.16]. [14] WMA JAMA. 2013;310(20):2191-4. [15] Moher D et al. J Clin Epidemiol. 2010;63:e1–37 [16] http://www.ismpp.org/ismpp-code-of-ethics [accessed 12.09.16]. [17] http://www.amwa.org/amwa_ethics; [accessed 12.09.16]. [18] Jacobs A, Wager E. Curr Med Res Opin 2005;21(2):317-21. [19]Wager E et al. BMJ Open. 2014;4(4):e004780.

On 2016 Oct 01, Serina Stretton commented:

We read with interest Vera-Badillo and colleagues’ recent publication entitled Honorary and Ghost Authorship in Reports of Randomised Clinical Trials in Oncology [1], which appears to show that these unethical practices are highly prevalent in oncology trial publications. While we applaud the authors for conducting original research in this field, we are concerned that the nonstandard definitions used for ghost authorship may have skewed the results.

Vera-Badillo and colleagues assessed oncology trial publications where the trial protocol was available and contained a list of investigators. They defined ghost authorship as being present if an individual met one of the following criteria: “(i) investigators listed in the protocol were neither included as authors nor acknowledged in the article; (2) the individual who performed the statistical analyses was neither listed as an author nor acknowledged; (3) assistance of a medical writer was acknowledged in the publication.” No rationale or references were provided in support of this definition. However, while similar definitions have been used in some surveys of unethical authorship practices [2, 3], the definition provided by Vera-Badillo and colleagues is not uniformly accepted [4-7] and is not consistent with the International Committee of Medical Journal Editors (ICMJE) authorship criteria [8] or with the Council of Science Editors (CSE) definition of ghost authorship [9].

There may be many valid reasons why participating investigators or statisticians may not be eligible for authorship of publications arising from a trial [8]. Here, we would like to respond to Vera-Badillo and colleagues’ assertion that medical writers who ARE acknowledged for their contributions are ghost authors. As specified by the ICMJE, medical writing is an example of a contribution that alone does not merit authorship and, therefore, should be disclosed as an acknowledgement. Also according to ICMJE, appropriate disclosure of medical writing assistance in the acknowledgements is not ghost authoring unless the medical writer was also involved in the generation of the research or its analysis, was responsible for the integrity of the research, or was accountable for the clinical interpretation of the findings. In their publication, Vera-Badillo and colleagues reported evidence of ghost authorship in 66% of evaluated studies. Of these, 34% had acknowledged medical writer assistance. Clearly, inclusion of declared medical writing assistance as ghost authorship has inflated the prevalence of ghost authoring reported in this study. Failure to apply standardised definitions of ghost authorship, guest (or honorary) authorship, and ghostwriting, limits the comparability of findings across studies and can mislead readers as to the true prevalence of these distinct practices [10-12].

As recognised by the ICMJE [8], the CSE [9], and the World Association of Medical Editors [13], professional medical writers have a legitimate and valued role in assisting authors disclose findings from clinical trials in the peer-reviewed literature. Vera-Badillo and colleagues state in the discussion that medical writers either employed or funded by the pharmaceutical industry are “likely to write in a manner that meets sponsor approval”. No evidence is cited to support this claim. If sponsor approval requires accurate and robust reporting of trial results in accordance with international guidelines on reporting findings from human research [8, 14, 15], then yes, we agree. Professional medical writers employed or funded by the pharmaceutical industry routinely work within ethical guidelines and receive mandatory training on ethical publication practices [16-19]. Although medical writers may receive requests from authors or sponsors that they believe to be unethical, findings from the Global Publication Survey, conducted from November 2012 to February 2013, showed that most requests (93%) were withdrawn after the need for compliance with guidelines was made clear to the requestor [19].

By expanding the definition of ghost authorship to include disclosed medical writing assistance, Vera-Badillo and colleagues have inflated the prevalence of ghost authorship in oncology trial publications. Such an unbalanced approach has the potential to detract from the true prevalence of ghost authorship where an individual who is deserving of authorship is hidden from the reader.

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 roles 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] Vera-Badillo FE et al. Eur J Cancer 2016;66:1-8. [2] Healy D, Cattell D. Br J Psychiatry 2003;183:22-7. [3] Gøtzsche PC et al. PLoS Med 2007;4:0047-52. [4] Flanagin A et al. JAMA 1998;280:222-4. [5] Jacobs A, Hamilton C. Write Stuff 2009;18:118-23. [6] Wislar JS et al. BMJ 2011;343:d6128.4-7 [7] Hamilton CW, Jacobs A. AMWA J 2012;27:115. [8] http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html; 2015 [accessed 12.09.16]. [9] http://www.councilscienceeditors.org/resource-library/editorial-policies/white-paper-on-publication-ethics/; [accessed 13.09.16]. [10] Stretton S. BMJ Open 2014;4(7): e004777. [11] Marušić A et al. PloS One. 2011;6(9):e23477. [12] Marchington J et al. J Gen Intern Med 2016;31:11. [13] http://www.wame.org/about/policy-statements#Ghost Writing; 2005 [accessed 12.09.16]. [14] WMA JAMA. 2013;310(20):2191-4. [15] Moher D et al. J Clin Epidemiol. 2010;63:e1–37 [16] http://www.ismpp.org/ismpp-code-of-ethics [accessed 12.09.16]. [17] http://www.amwa.org/amwa_ethics; [accessed 12.09.16]. [18] Jacobs A, Wager E. Curr Med Res Opin 2005;21(2):317-21. [19]Wager E et al. BMJ Open. 2014;4(4):e004780.