Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing
Alastair Matheson’s recent article presents a multitude of claims regarding the role of professional medical writers in publications arising from pharmaceutical industry-sponsored research. Many of these claims are not supported by evidence and have been addressed previously by GAPP (1, 2). At the core of Matheson’s article are claims that there is no distinction between ghostwriters and professional medical writers, and that the pharmaceutical industry uses medical writers to insert commercial messages into the peer-reviewed literature. We completely agree with and support the International Society for Medical Publication Professionals (ISMPP) response (12 September 2016) to Matheson’s claims that there has been no “rebranding of ghostwriting” by industry and that rather, “there has been a positive evolution of transparency and completeness in medical publications reporting industry research.” As GAPP has stated consistently, professional medical writers are NOT ghostwriters because they ARE transparent about their involvement, are strictly prohibited from ghostwriting, and work within ethical publication guidelines that require authors to contribute to and control the content at every step of the publication process (3-7).
Industry does not promote rebranding of the definition of ghostwriting to downplay the role of professional medical writers
As Matheson describes, the definition of ghostwriting was not developed by industry, but is based on the International Committee of Medical Journal Editors (ICMJE) authorship criteria that were developed by journal editors to better define the contributions of medical writers in medical publications. In contrast to Matheson, these criteria do not ban medical writers from authorship. Rather, the ICMJE recommend that the contributions of medical writers should be disclosed in the acknowledgements or, if all four ICMJE authorship criteria are met, in the author byline (8). To promote transparency, individual member professional organizations such as the International Society for Medical Publication Professionals and the American and European Medical Writers Associations uphold these criteria and further recommend disclosing any potential conflicts of interest (eg, funding) (3-5). As recommended by Matheson in Table 2, disclosure of the medical writing funding source helps ensure that companies’ commercial interests and the role of medical writers are fully highlighted - not downplayed.
Matheson attempts to diminish the efforts by industry to disclose their involvement by describing the acknowledgement section as “small print” and “inconspicuous footnotes”. However it is important to highlight that the acknowledgement section of a peer-reviewed manuscript is not a footnote, and how it is presented is not controlled by industry or medical writers, but is controlled by the journal and its publisher. Placement of acknowledgments is highly variable and can range from prominent display on the first page to complete absence; however, the more traditional placement is between the end of the text and beginning of the references. More recently, some publishers are now sharing acknowledgement and/or funding information online with the article abstract.
Medical writers are used to influence the scholarly literature for marketing purposes
We agree with Matheson that many professional medical writers are highly qualified, honest, and have high scientific literacy. However we reject his claim that seemingly all professional medical writers serve commercial interests and permit industry leverage over content. Professional medical writers from industry and communication agencies work within ethical guidelines and routinely receive mandatory training on ethical publication practices (3-6). Findings from the Global Publication Survey, which was conducted from November 2012 to February 2013, showed that although agency respondents were aware of requests from authors or sponsors that they believed to be unethical, most (93%) indicated that the requests were withdrawn after the need for compliance with guidelines was explained (6). These data do not support the perception that leverage over content by medical writers is widespread. However, they do show that there is still work to be done on eradicating unethical publication practices.
Professional medical writers have a valid and valued role in assisting authors to prepare high-quality manuscripts that meet ethical, publishing, and regulatory requirements (9-18). We agree with Matheson that the transition to electronic publishing is likely to change the way contributions, including those by medical writers, to industry-sponsored research and publications are reported. However, until alternative guidance is universally accepted, the ICMJE criteria remain the most widely accepted authorship criteria available.
1. Woolley KW, Gertel A, Hamilton C, Jacobs A. Should journals stop publishing research funded by the drug industry? BMJ 2014;348:g171 response.
2. Hamilton CW, Gertel A, Jacobs A, Marchington J, Weaver S, Woolley K. Mythbusting medical writing: Goodbye, ghosts! Hello, help! Account Res. 2016;23(3):178-194.
3. ISMPP International Society for Medical Publication Professionals. Code of Ethics. http://www.ismpp.org/ismpp-code-of-ethics (accessed 12 September 2016).
4. Hamilton CW, Royer MG. AMWA position statement on the contributions of medical writers to scientific publications. AMWA J 2003;18(1):13-16.
5. Jacobs A and Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21(2):317-21.
6. Wager E, Woolley KL, Adshead V, Cairns A, Fullam J, Gonzalez J, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4(4):e004780.
7. 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 12 September 2016).
8. Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, 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.
9. Bailey, M. Science editing and its effect on manuscript acceptance time. AMWA J 2011;26(4):147-152.
10. Breugelmans R and Barron JP. The role of in-house medical communications centers in medical institutions in nonnative English-speaking countries. Chest. 2008;134(4):883-885. doi: 10.1378/chest.08-1068.
11. Camby I, Delpire V, Rouxhet L, Morel T, Vanderlinden C, Van Driessche N, and Poplazarova T. Publication practices and standards: recommendations from GSK Vaccines' author survey. Trials 2014;15:446. doi: 10.1186/1745-6215-15-446.
12. Gattrell W, Hopewell S, Young K, Farrow P, White R, Wager E, and Winchester CC. 2015. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open. 2016;6:e010329 doi:10.1136/bmjopen-2015-010329.
13. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. Write Stuff 2010;19(3):196-200.
14. Lang TA. Assessing the productivity and value of a hospital-based editing service. AMWA J 1997;12(1):6-14.
15. Marchington JM and Burd GP. Author attitudes to professional medical writing support. Curr Med Res Opin 2014;30(10):2103-08.
16. Marušić A, Hren D, Mansi B, Lineberry N, Bhattacharya A, Garrity M et al. Five-step authorship framework to improve transparency in disclosing contributors to industry-sponsored clinical trial publications. BioMed Central Med 2014;12:197-206.
17. Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open 2014;4(4):e004780. doi: 10.1136/bmjopen-2013-004780.
18. Woolley KL, Lew RA, Stretton S, Ely JA, Bramich NJ, Keys JR et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin. 2011;27(6):1175-82.
Competing interests: GAPP is not a trade advocacy unit, it is a group of independent individuals who volunteer their time and receive no funding (other than website hosting fees from ISMPP). 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. Further details can be found at www.gappteam.org