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Knowledge of undisclosed corporate authorship (“ghostwriting”) reduces the perceived credibility of antidepressant research: a randomized vignette study with experienced nurses

Jeffrey R Lacasse*, Jonathan Leo, Andrea N Cimino, Kristen F Bean and Melissa Del-Colle

BMC Research Notes 2012, 5:490  doi:10.1186/1756-0500-5-490

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Response to GAPP Comment

Jeffrey Lacasse   (2012-12-14 15:45)  Arizona State University email

We appreciate the response [1] from members of the Global Alliance of Publication Professionals (GAPP) regarding our recent article on ghostwriting [2]. The GAPP website notes that GAPP's aim is to "Provide a timely and credible response to influential stories about medical publication professionals" [3]. The GAPP website is funded by the International Society for Medical Publication Professionals [4], which is in turn funded by pharmaceutical companies [5]. In other words, GAPP's mission is to lobby on behalf of medical writers and publication planners subcontracted by the pharmaceutical industry [6-9]. We appreciate that this is transparent on the GAPP website.

We have previously disagreed with one member of GAPP on the definition of ghostwriting [10]. We have called for medical writers who co-author journal articles to be listed on the authorship byline, consistent with scientific norms elsewhere [11], while Adam Jacobs has argued that listing medical writers in the acknowledgements section of a journal article they co-authored is appropriate. This raises an interesting question: Should we accept the definitions of ghostwriting and authorship put forth by medical writers as definitive or authoritative? To accept the argument put forth in the response to our article would require this.

Having said this, we believe in the value of criticism within science. We had modified vignettes from a previous study which had combined ghostwriting with financial conflicts-of-interest [12]. We had established face validity by surveying ghostwriting experts regarding the vignettes, of which 100% agreed with the statement, "This vignette accurately describes an incident of ghostwriting similar to those known to have occurred in real life." (In both articles, the fictional Dr. Harvey submits the manuscript to a journal as if he had written it himself, meant to communicate that he was the sole author). The response to our article essentially argues that our vignettes could have been clearer. The construction of vignettes is tricky and we benefit from this criticism. As we move beyond small pilot studies to more complicated designs with larger samples, we will ensure there is less ambiguity.

In our vignette, the marketing department is involved with the authorship of the paper. The medical writers respond by arguing, "industry best practice does not allow marketing staff to be involved in publications." Indeed, we did not base our vignette on current best practices, but on what has occurred in real life. For example, the 2004 Lexapro [escitalopam] Marketing Plan, an internal document, is an excellent source for anyone who believes that the marketing departments of pharmaceutical companies have not been involved with the creation of articles authored by medical writers. It states: "Bylined articles will allow us to fold Lexapro messages into articles on depression, anxiety, and comorbidity developed (or ghostwritten for) thought leaders." [13]. Regardless of current best practices, the literature contains many articles generated in this manner.

The medical writers mention other literature relevant to the larger issue of ghostwriting, an issue we have discussed elsewhere [11], but not relevant to this study. The goal was to examine clinician's reactions to the authorship issues known to have occurred in the antidepressant literature [9]. As a small pilot study, the study had limitations, which we explained - and thus when the authors summarize our limitations section, we agree with these points. However, in the last few paragraphs of their letter, they veer towards misunderstanding and perhaps even accusation.

We wrote that our study was underpowered according to our pre-study power analyses, but the fact that this highlighted as a weakness is puzzling. We planned for 95% power in our pre-study analyses, which required 35 participants per group. Our final sample was n=35 in one group, n=32 in the other. Thus, we did not quite reach our goal of 95% power. Had we failed to reject our null hypothesis on our primary outcome, a critique of power would make sense. But, we found a large effect size (p [less than] 0.001) on our primary outcome.

Finally, the authors question the integrity of our authorship byline, writing, "it is not clear that some of the authors would qualify as such under ICMJE criteria." We are unsure on what basis such a comment is based. Writing about authorship, we are hyper-vigilant about such issues. Each of our authors met ICMJE criteria; we disclosed their contributions in the routine manner. Similarly, we acknowledged Dr. Joseph Anson for his "helpful assistance" which led the authors to write, "we can only hope he didn't help write or edit the article, as his role and funding source were not disclosed." To be clear, one of us (JRL) spoke to Dr. Anson (a vignette expert) twice on the phone to brainstorm; he had no role in the writing or editing of the manuscript, which was an unfunded project.

Jeffrey R. Lacasse and Jonathan Leo


References

1. Global Alliance of Publication Professionals (2012). Comment on Lacasse et al. (2012).

2. Lacasse, JR, Leo, J, Cimino, AN, Bean, KF, Del-Colle, M. Knowledge of undisclosed corporate authorship ('ghostwriting') reduces the perceived credibility of antidepressant research: A randomized vignette study with experienced nurses. BMC Res Not 2012, 5(490).

3. Global Alliance of Publication Professionals (2012). GAPP Aims. http://www.gappteam.org/index.html

4. Global Alliance of Publication Professionals (2012). GAPP disclosures. http://www.gappteam.org/about/index.html#disclosures

5. International Society for Medical Publication Professionals (2012). Sponsors. http://www.ismpp.org/ismpp-sponsors

6. Sismondo S, Doucet M. Publication ethics and the ghost management of medical publication. Bioethics 2010, 24(6):273-283.

7. Fugh-Berman A, Dodgson S. Ethical considerations of publication planning in the pharmaceutical industry. Open Medicine 2008. Available: http://www.openmedicine.ca/article/view/ 118/215

8. Sismondo, S. Ghosts in the machine: Publication planning in the medical sciences. Social Stud Sci 2009, 39: 171-198.

9. Lacasse, JR, Leo, J. Ghostwriting at academic medical centers in the United States. PLoS Med 2010, 7(2): e1000230.

10. Jacobs, A. BMJ Rapid Response: Honorary and ghost authorship in high impact biomedical journals: A cross sectional survey. http://www.bmj.com/rapid-response/2011/12/08/re-honorary-and-ghost-authorship-high-impact-biomedical-journals-cross-sec

11. Leo, J, Lacasse, JR, Cimino, AN. Why does academic medicine allow ghostwriting? A prescription for reform. Society 2011.
doi: 10.1007/s12115-011-9455-2.

12. Lacasse, JR, Leo J. Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research. BMC Res Not 2011, 4(27).

13. Leo, J., Lacasse, JR. Ghostwriting. Encyclopedia of Critical Psychology. http://www.springerreference.com/docs/html/chapterdbid/306943.html

Competing interests

Competing Interests: JRL and JL are members of Healthy Skepticism, an international non-profit organization dedicated to reducing harm from misleading drug promotion.

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Clarification of Role of Professional Medical Writers

Arthur Gertel   (2012-12-14 15:41)  GAPP

Having read with interest the article by Lacasse, et al: Knowledge of undisclosed corporate authorship ('ghostwriting') reduces the perceived credibility of antidepressant research: a randomized vignette study with experienced nurses1, we were concerned that the authors had, by conflating industry sponsorship with ghostwriting, not accurately addressed the perception of credibility that they set out to measure.

Additionally, when authors use terms such as 'ghostwriting' incorrectly, there is a danger of further confusing an already confusing situation. A recent systematic review2 reinforces that whether and how researchers define ghostwriting can have a major effect on the conclusions. Lacasse, et al appear to use 'ghost authorship' and 'ghostwriting' interchangeably.

Lacasse, et al purported to have addressed a major limitation of previous research by designing their study to examine one independent variable only - the influence of ghostwriting. As the authors noted:

The major limitation of the [previous] study was that the conflict-of-interest (COI) conditions were bundled (there was no 'ghostwriting only' condition) so that the impact of financial COI or ghostwriting could not be identified separately. We therefore conducted a follow-up study examining the impact of ghostwriting alone on perceived credibility.

However, the authors' study was itself confounded by the assessment of at least three, and possibly four, independent variables, rather than by a discrete analysis of 'ghostwriting' alone. As the examples below reveal, the vignette used by Lacasse et al., bundled up much more than ghostwriting:

Guest authorship (i.e., where an individual is listed as an author who did not meet all of the authorship criteria).
Extract from Lacasse, et al. vignette: "Although he did not write the manuscript, Dr. Harvey agreed to be listed as the primary author of the study."
GAPP critique: This is NOT ghostwriting, but rather, guest authorship.

Ghostwriting (i.e.,where an individual who does not meet the all of the authorship criteria, but was involved in writing the manuscript, is not acknowledged as helping to write the manuscript and the funding source for their services is not disclosed).
Extract from Lacasse et al. vignette: "This study was written up by Biopsychiatric Pharmaceuticals, Inc., the company that makes Serovux."
GAPP critique: This COULD be ghostwriting, if the writer(s) and the funding source were not disclosed.

Hidden conflicts-of-interest (i.e., where relevant financial or non-financial interests of the authors are not disclosed).
Extract from Lacasse, et al. vignette: The marketing department did not want to list company employees as the only authors, because readers may notice that all of the authors work directly for the company that makes Serovux."
GAPP critique: This is NOT ghostwriting but this COULD be an example of conflicts-of-interest, if the funding source was not disclosed. Further, as industry best practice does not allow marketing staff to be involved in publications, this statement in the vignette is not consistent with current best practice.

Lacasse et al may have also examined ghost authorship; unfortunately, the vignette is ambiguous as it is not clear whether any of the company authors were omitted from the co-author list.

Ghost authorship (i.e., where an individual does meet all of the authorship criteria, but is not listed as an author).
Extract from Lacasse et al. vignette: "So, Biopsychiatric Pharmaceuticals, Inc. sent Dr. Harvey a pre-written manuscript, authored by employees of the company, and asked Dr. Harvey to be listed as first author."
GAPP critique: This is NOT ghostwriting but this COULD be ghost authorship, if some of the company employees who did meet all of the authorship criteria were not listed as co-authors.

Terms and their prospective influence on perceived credibility were thus no further elucidated by their bundling in the Lacasse study.

In the interests of perspective, it may have been helpful for Lacasse et al to have cited Wislar, et al3 and their survey, to help put the prevalence of ghostwriting into context. We would also hope that if Lacasse et al wish to help address ghostwriting, that they would encourage the use of the anti-ghostwriting checklist available gratis from PLoS Med4 .

Other concerns relate to the use of a scale that has not been formally validated; the fact that the study was admittedly underpowered, according to the pre-study power analyses; and speculative statements regarding the importance of the ghostwriting issue to practicing clinicians. In addition, it is not clear from the article how the term 'ghostwriting' was defined for participants in the study, an obviously important variable in assessing perception of impact. The questions posed by the two anonymous reviewers are also worthy of serious consideration, further stressing other variables that may have confounded the analysis of the discrete influence of perceived 'ghostwriting'.

Ironically, given the efforts being made to identify the specific contributions made by authors or those being acknowledged, particularly in terms of making sure writers are NOT ghostwriters, It is not clear that some of the authors would qualify as such under ICMJE criteria. Lacasse et al acknowledge Joseph Anson, but don't tell the reader anything about the contribution he made; we can only hope he didn't help write or edit the article, as his role and funding source were not disclosed.

With kind regards, on behalf of fellow GAPP members Dr Cindy Hamilton, Dr Adam Jacobs, Gene Snyder, and Professor Karen Woolley (www.gappteam.org).

Art Gertel

1 JR Lacasse, J Leo, AN Cimino, KF Bean, M Del-Colle, Knowledge of undisclosed corporate authorship ('ghostwriting') reduces the perceived credibility of antidepressant research: a randomized vignette study with experienced nurses. BMC Research Notes 2012, 5:490, 5 September 2012.
2 Stretton S, McGee S. Systematic review on the prevalence of ghostwriting: misleading, misguided, and mistaken `evidence' (abstract). Curr Med Res Opin 2012;28(suppl 1):S16.
3 Wislar JS, Flanagin A, Fontanarosa PB, Deangelis CD. Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ. 2011; 343: d6128.
4 Gotzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, et al. (2009) What Should Be Done To Tackle Ghostwriting in the Medical Literature? PLoS Med 6(2): e1000023.

Competing interests

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 organizations. GAPP members have, or do provide professional medical writing services to not-for-profit and for-profit clients.

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