Re: Ghostwriting: the importance of definition and its place in contemporary drug marketing
I thank Al Weigel of the International Society for Medical Publication Professionals (ISMPP), and Serina Stretton and colleagues from the Global Society of Publications Professionals (GAPP) for their comments. I have a high regard for the integrity those who work in the sector, and would be pleased to advise the trade on how to improve its publications.
I must first comment on the commercial interests of these correspondents. Weigel describes ISMPP as “a not-for-profit professional society with over 1,500 members involved in the publication of medical research”. In fact, while ISMPP engages in some creditable activities, such as driving modest improvements in trade practices, its accounts show that it receives more income directly from pharmaceutical and publications/marketing companies than membership fees (1). It clearly has an interest in the profits of the trade, and advocates on its behalf (2,3). ISMPP has, for instance, attempted to establish “a network of relationships on Capitol Hill”(2) stating on its website in respect of ghostwriting: “we need to develop relationships now – before there is a crisis!”(3)
Stretton states that “GAPP is not a trade advocacy unit, it is a group of independent individuals who… provide professional medical writing services to not-for-profit and for-profit clients.” The “independent individuals” who founded GAPP were in fact company owners and senior executives within the trade (4). Stretton’s wording places not-for-profit ahead of for-profit clients, but the dominant revenue source for these companies, including Stretton’s, is pharma. GAPP was established with the goal of rebutting negative stories, and claims to have “helped members of our profession by standing up for our profession”(4). This is manifestly trade advocacy. Indeed, GAPP has its own page in the ISMPP website’s “Advocacy” section, where it states: “GAPP is an advocate for ISMPP members” and adds that “ISMPP members can use GAPP articles to reinforce the value and ethics of publication professionals.”(5) Thus, even GAPP’s journal publications have an advocacy function.
I address these correspondents’ comments about transparency in an accompanying response, and focus here on their other criticisms:
1. Weigel and Stretton both claim there has been no “rebranding” of ghostwriting. It is clear, however, that there has. “Rebranding” refers to a strategic change in the image of a product or business, and I use it here to describe how the publications trade has sought actively to change perceptions of its ghostwriting practices, by changing academic and public understanding of ghostwriting. In 2005 one of GAPP’s future founders defined ghostwriting, correctly, as “where a professional medical writer prepares a manuscript on behalf of a named author, but the writer is not listed as an author”(6). Since 2005, however, the trade has promoted its self-serving disclosure-based definition. For instance, GAPP has made over 40 interventions since 2012 (7). GAPP states: “differentiating medical writers from ghostwriters has been a frequent theme”, and “although most of our activities have been reactive, we have started to be proactive… We have witnessed critics changing their minds… yes, they now accept that we should not be called ghostwriters!”(4) GAPP has also targeted editors: for instance, it has sent unsolicited line-by-line ‘corrections’ to at least one journal on its instructions to authors in respect of ghostwriting,(8) while Stretton has called on journals to refuse publication to articles citing ghostwriting prevalence figures not based on the industry definition (9). GAPP has developed many interventions using a prefabricated “list of communication points… and a list of references that could be used to provide evidence.”(4) No academic or editorial group conducts such systematic, sustained and formulaic intervention within academic discourse on an issue bound up with its own commercial interest, and certainly not on ghostwriting.
Marketers understand the importance of journal publications in shaping opinion. Trade comment and research in publication ethics is therefore likely to accumulate in scholarly journals, with respect to ghostwriting and other topics of commercial interest. I consider this an unwelcome trend that threatens to diminish publication ethics, just as research and comment relating to the marketing of drugs diminishes academic medical science.
2. Stretton et al refer to the ICMJE as a basis for the trade definition of ghostwriting. In fact, the ICMJE Recommendations make no mention of ghostwriting (10). The ICMJE legitimizes the exclusion of writers from the author byline, but that is a separate issue from whether or not writers thus excluded should be called ghosts. I refer readers to my article for further details. I have argued in this article and elsewhere that current ICMJE guidance succors marketing, and should be revised (11).
3. Stretton et al suggest I claim that “seemingly all professional medical writers serve commercial interests and permit industry leverage over content” and cite “the Global Publication Survey”, an ISMPP-funded trade study, to show this is not the case. In fact, the second part of my article discusses various conduits by which commercial spin can get into journal literature, of which writing is only one. My article does not claim that writers or any other of these conduits are always a source of bias, but it does claim that all of them are potential routes by which bias can, and sometimes does, enter commercial literature.
4. There is perhaps no clearer illustration of the absurdity of industry’s definition of ghostwriting than Study 329. As my article describes, this notorious example of ghostwriting is not counted as ghostwriting by industry definitions. As I also relate, however, the disclosure-based definition which excludes Study 329 first emerged in the writings not of marketers, but of some journal editors (12). This was a serious blunder which has been leveraged by the trade ever since.
In summary, industry ghostwriting remains widespread by the original, authorship-based definition; the trade has promoted a self-serving definition based on disclosure; writers while honest and professional constitute one potential route for bias to enter literature; and attribution, labeling and disclosure are seriously flawed – this is a broad cultural and conceptual problem for medicine and its journals, not just an issue for commerce.
1. ISMPP International Society for Medical Publication Professionals. 2014 Financial Statement. http://www.ismpp.org/assets/docs/ismp%20-%20fs%20-%20ye12-31-14_final_si... (accessed 19 September 2016).
2. Marchington J. ISMPP and advocacy for the medical publications profession. Curr Med Res Opin 2011;27 (Suppl 1): S5-S6.
3. ISMPP International Society for Medical Publication Professionals. Advocacy. http://www.ismpp.org/advocacy (accessed 19 September 2016).
4. Gertel A, Hamilton C, Jacobs A, Snyder G, Woolley KL. The Global Alliance of Publication Professionals: update on a small group with a big mission. AMWA J. 2013; 28(1):42-4, 47. http://www.amwa.org/files/AMWAJournalv28n1GAPPUpdate.pdf (accessed 19 September 2016).
5. ISMPP International Society for Medical Publication Professionals. Advocacy: GAPP. http://www.ismpp.org/gapp (accessed 19 September 2016).
6. Jacobs A, Carpenter J, Donnelly J, Klapproth JF, Gertel A, Hall G, et al. The involvement of professional medical writers in medical publications: results of a Delphi study. Curr Med Res Opin. 2005;21:311–6.
7. Global Alliance of Publication Professionals. http://www.gappteam.org (accessed 19 September 2016).
8. Global Alliance of Publication Professionals. Communication to Respiratory Care journal. http://gappteam.org/uploads/6/9/2/8/69287299/letter_respir_care_re_guide... (accessed 19 September 2016).
9. Stretton S. Systematic review on the primary and secondary reporting of the prevalence of ghostwriting in the medical literature. BMJ Open 2014;4:e004777
10. International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations).
http://www.icmje.org/recommendations (accessed 19 September 2016).
11. Matheson A. The ICMJE Recommendations and pharmaceutical marketing--strengths, weaknesses and the unsolved problem of attribution in publication ethics. BMC Med Ethics. 2016 Apr 4;17:20. doi: 10.1186/s12910-016-0103-7.
12. Laine C, Mulrow CD. Exorcising ghosts and unwelcome guests. Ann Intern Med. 2005;143(8):611-612
Competing interests: I am a supporter of innovative pharmaceutical research and have affection for, and friendships within, pharmaceutical corporations and also the marketing and publications trade, whose employees I consider to be ethical and professional. As stated in my article, between 1994 and 2012 most of my income came from consultancy and writing services provided to pharmaceutical corporations, either directly or via marketing agencies. In 2015 I acted as a paid expert witness on behalf of the plaintiffs in a US federal legal action against a drug company.