Ghostwriting: the importance of definition and its place in contemporary drug marketing
BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i4578 (Published 30 August 2016) Cite this as: BMJ 2016;354:i4578
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
I thank Alison Rapley and colleagues on behalf of the International Society for Medical Publication Professionals (ISMPP), the Global Alliance of Publication Professionals (GAPP) and the writer’s associations, for jointly considering my request for greater trade transparency.(1) I recognize the integrity of these correspondents and the honesty and professionalism of the writers. I consider the ethical difficulties of the sector to arise in large measure from differences between the cultural norms of business and those of medicine and science. I believe writers have a valid role in medicine provided it is properly attributed and disclosed, and would be pleased to advise the trade, and indeed the corporations, on ethical publication practices.
In my previous response to ISMPP and GAPP, I made a number of critical transparency requests in order to establish publicly where the trade draws the line between transparency and secrecy.(2) I thank all these trade associations for responding clearly and collectively. Considering these transparency requests in turn:
A. With respect to journal literature developed since 2000 with the goal of informing prescribing, the trade has not agreed to reveal:
(i) Exactly what has been published, i.e. provide a list of the articles it has developed.
(ii) The publication plans, key messages, educational objectives and other commercial considerations underpinning the development of this literature.
(iii) The names of the medical professionals and thought leaders it has worked with during this time, the projects they worked on and the products they helped market.
B. The trade has not agreed to identify any past ghostwritten articles it may know of, in which the role of writers is undisclosed. Neither has the trade agreed to encourage writers who know of such articles to identify them. It has not agreed to overlook confidentiality clauses which prohibit writers from identifying such articles.
C. For future journal articles to be placed in medicine’s public academic forum, the trade has not agreed to disclose the associated publications plans, scientific platforms or other strategic or marketing documentation informing this literature, or details of any intellectual property rights relating to content or drafts. Furthermore, the trade has not agreed to inform the public how much money, approximately, changes hands in the development of this these articles.
The trade’s collective refusal to meet these transparency requests is very clear and I commend the associations again for responding frankly. The line between transparency and secrecy in the respect of industry-financed, peer reviewed academic medical literature has been drawn, with an affirmation of continued, substantial commercial secrecy. It is for editors, readers, prescribers, patients and the public to decide if this is the kind of science and literature they want.
I also address two other points arising from this dialogue:
1. There is clearly a divergence between my opinions and those of the publications trade on what constitutes good attribution, disclosure and labelling in medical journal articles. I believe more needs to be done to foreground industry’s role and end the use of academics in an advocacy role. I believe writers should be credited as coauthors whenever they compose a manuscript or edit it for significant intellectual content – an approach taken by the journal Neurology (3). The trade associations disagree. One notable point is these correspondents’ repeated citation of the ICMJE in justification of their position. I have argued here and elsewhere that the ICMJE should review its Recommendations in respect of authorship, attribution, disclosure and labeling, given the potential vulnerability of the current guidance to misattribution and marketing.(4)
2. It is also clear that the trade associations differ with me on the definition of ghostwriting. I have argued that ghostwriting should be defined in terms of authorship; the associations believe it should be a matter of disclosure. As my article describes, Study 329, which is widely considered ghostwritten but in which the writer is disclosed in the small print, is a good test of these perspectives. In my opinion, Study 329 is ghostwritten despite the inconspicuous disclosure of the writer; but by the industry definitions provided in my article, it is not. Once again, this points to the need for the ICMJE to revise its authorship rules – to strengthen attribution, to do writers justice, and to ensure that a sensible definition of ghostwriting is restored within medicine.
References
1. Rapley A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-6 Accessed October 4 2016
2. Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-4 Accessed October 4 2016
3. Neurology. Information for authors. http://www.neurology.org/site/misc/auth2.xhtml
4. Matheson A. The ICMJE Recommendations and pharmaceutical marketing--strengths,
weaknesses and the unsolved problem of attribution in publication ethics. BMC Med
Ethics 2016;17:20
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.
I thank Jonathan Leo for his comments on my article. Leo and his colleagues have been pioneering critics of industry publications practices, and of the weaknesses in the current ICMJE guidance.(1) Their work is an significant point of reference in this field of ethics.
I concur with Leo’s comments, and highlight in particular his point that if writers who draft manuscripts are not listed as coauthors, then it is not only an injustice, but prevents reporting of their interests and lessens the overall visibility of industry’s role in the attribution, disclosure and indexing of the published work.
As my article relates, however, there are many conduits by which companies influence manuscripts and through which commercial bias may on some occasions enter the literature. Manuscript writing is one such conduit (notwithstanding the honesty and professionalism of the writers themselves) but so is simpler editing of manuscripts. Most commercial clinical trial manuscripts also include company employees as coauthors, and here too there is a means for the company’s perspectives to be reflected in the published article, whether these perspectives are objective and appropriate, or whether they are swayed by commercial interest. I list other conduits in my article, using the analogy of a “tool kit” by which companies in various ways can steer the content of manuscripts, and through which bias, which need not be conscious, may find its way into some industry literature.
The positive affirmation of one’s own research findings is a problem that has been documented in noncommercial as well as commercial research.(2) It is a greater problem in commercial research, however, because of its clear relationship with marketing and sales. The issue my article focuses on is not primarily, however, the risk of bias, but simply the need to ensure that the attribution of commercial literature truly reflects its provenance. There is much objective and important industry research, but commercial involvement and interests must be brought more conspicuously to the attention of readers than the current culture of attribution within medicine allows for. The inclusion of writers as coauthors when they draft manuscripts is one part of this, but more importantly, the overall system by which journal literature is attributed, labelled and indexed requires overhaul.
Finally, I agree with Leo that the ICMJE authorship requirements need revising, such that whoever drafts the manuscript or edits it extensively for intellectual content is required to be a coauthor. The case for this approach is now compelling, and it would put an end to the confusion over whether ghostwriting is a matter of nondisclosure of the individual who wrote the draft, or whether, as ghostwriting should correctly be considered, a matter of nonauthorship.
References
1. Leo, J, Lacasse, J.R., and Cimino, A.N. Why Does Academic Medicine Allow Ghostwriting? A Prescription for Reform. Society 2011. Accessed at: http://diginole.lib.fsu.edu/islandora/object/fsu:252737/datastream/PDF/view 3 October 2016.
2. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 2010;303:2058-64
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.
I thank Claire Barton for her considered response. I note that in contrast with the trade associations, Barton quite rightly uses the word “ghostwriter” as a description of writers who compose manuscripts, but who are not authors.
Barton provides further evidence of the perversity of excluding writers from coauthorship. She states: “Even when writing on very familiar topics, a straightforward trial report can take around 40-50 hours and a review article around 100-150 hours to write.” This is not clerical work, but that of highly intelligent and qualified individuals. The ICMJE rules denying them byline recognition as coauthors are insupportable.
I disagree with Barton, however, that my primary article paints a “murky picture of conspiracy and manipulation.” Rather, I view the shortcomings of industry literature as a cultural problem for which all major stakeholders are responsible. No objective reader could conclude that bias in respect of content or attribution is not a difficulty in some commercial articles, and my article considers how it gets into manuscripts. I identify several potential routes, one of which is writing, but this does not mean that writers are generally biased or dishonest. Rather, my article argues that writers are in general honest and professional. My article is highly critical, however, of campaigning by the publications and marketing trade in the domain of publication ethics, as illustrated by its efforts to change the definition of ghostwriting. Such activities do not portray the trade in an encouraging light.
With respect to Barton’s other points, she states that I fail to identify the driving force behind the use of ghostwriters, which she claims is “time.” In fact, my primary article states: “Ghostwriting .. remains widespread .. for reasons that have not changed— it delivers articles to order and on schedule, and ensures they are commercially useful, professionally finished, and, most importantly, attributed to academics.” Barton is right that time is an issue, but time is only one of several reasons why ghostwriting remains widespread.
I agree with Barton that company employees should be included as coauthors, as they currently are, although sometimes in fewer numbers than is warranted. As my article points out, however, company coauthors provide another potential conduit for commercial perspectives to enter some manuscripts. Furthermore, their presence is underplayed by generally placing them in the least conspicuous, mid-byline locations, whereas the first author in the large majority of cases is an academic. With regard to Barton’s discussion of “sources of support” statements, which are required by the ICMJE and used in some journals, these are better than nothing, but these statements overlook what should be critical disclosures – notably, whether a company instigated the work, whether it owns the data, and what product is being marketed.(1) Furthermore, companies are often not merely “sources of support” and do not just provide “funding” or “sponsorship”. They are often heavily involved in every stage – in effect they are the lead and corporate authors of these projects. Thus, the ICMJE’s own language of “support” and “funding” downplays their true role (1).
Barton disagrees with my claim that the academics who participate in industry projects are contingent. However, if the company has a drug entering clinical trials, it will look to select from a range of potential clinical research centres to partner with for the study, and the research will be done whichever centre happens to be picked. The design and analysis are frequently done or substantially steered by the company or its commercial contractors, sometimes with regulator input, and the company generally owns the data. The choice of academic centre has little bearing on these considerations, and the study will proceed and generate similar results whichever one is chosen. Similarly, if a company decides it is necessary to develop a review article on an “educational” theme related to its product, this decision may well be made before a particular academic author is selected. The academics who work on industry projects are generally honest and assiduous, but the instigation and framing of projects often comes from the companies. That is why it is unacceptable that published articles typically portray the academics as the leaders of the enterprise, and the companies as mere funders and junior colleagues.
Finally, Barton is correct to point out that not all writers work for industry. Many of them do, however, and I think in this respect Barton misunderstands the nature of marketing. Even when industry literature is wholly unbiased, the use of expert textual composition or editing and the scheduled production of journal articles constitute marketing, because they deliver the vendor’s data and clinical argument to the right customers, at the right time and in clear and logical, and therefore persuasive language. The ability of pharmaceutical companies to spend enormous sums generating such literature creates what I have referred to as “discourse bias” in distribution of published data and opinion.(1) Additionally, however, subtle bias may sometimes creep into this literature at the level of content, for instance in the framing of disease concepts and clinical challenges, and the consequent highlighting of certain product attributes and points of differentiation. Clinical trials designs, analysis and interpretation may also contain biases that feed into the process of manuscript development. Finally, attribution is often biased because it emphasizes the role of academics and underplays that of industry. Without any intent among writers to be biased, therefore, trade literature through these processes is shaped by marketing on many levels to serve the interests of commercial products.
I close by reflecting again that if Barton, a highly qualified pharmaceutical physician, is spending 40-50 hours writing manuscripts on subject matter she is familiar with, and 100-150 hours on review articles, it is absurd that the ICMJE seeks to deny her coauthor status. I disagree with some of Barton’s points, but commend her for using the term “ghostwriting” in the correct way, and believe her authorial work deserves byline recognition.
Reference
1. Matheson A. The ICMJE Recommendations and pharmaceutical marketing--strengths, weaknesses and the unsolved problem of attribution in publication ethics. BMC Med Ethics 2016;17:20
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.
The International Society for Medical Publication Professionals (ISMPP) and Global Alliance of Publication Professionals (GAPP) have already provided detailed responses to the issues raised in the article by Alastair Matheson. The American and European Medical Writers Associations (AMWA and EMWA) fully support these responses which were prepared by medical communications leaders who have been on the forefront of assessing and establishing ethical and robust professional standards. These standards included input from editors of first-tier peer-reviewed medical and scientific journals. There was no pharmaceutical industry review or input into these rapid responses.
Clearly Dr Matheson’s interpretation of what constitutes ethical transparency differs from that of these major medical communications organizations representing thousands of professionals working around the globe, as well as differing from that of the International Committee of Medical Journal Editors (ICMJE) who represent more than 500 medical journals.
The undersigned organizations have been working towards transparency and disclosure for more than 15 years and invite all interested parties with a stake in the future of effective and ethical medical publications to tender constructive suggestions directly to them.
Alison Rapley – President, European Medical Writers Association
Brian Bass – Past President, American Medical Writers Association
Al Weigel – President and CEO, International Society for Medical Publication Professionals
Serina Stretton – Global Alliance of Publication Professionals
Competing interests: This statement is provided on behalf of EMWA, AMWA, ISMPP and GAPP. It was reviewed and agreed by the full Executive Committee of EMWA. EMWA is a not-for-profit organisation whose funding comes primarily from members’ subscriptions and conference attendance. EMWA members come from the pharmaceutical industry, contract research organizations, medical communications agencies, nonprofit and government organizations, journal publishing, medical translations, academia, or work as freelancers. This statement was also reviewed by the Administrative Review Committee of AMWA. AMWA is a not-for-profit 501(c) (3) organization whose funding comes from member dues and educational programs. AMWA members work for pharmaceutical companies, universities and medical schools, hospitals, nonprofit organizations, government agencies, journals, and many other businesses and organizations. Many work as freelance writers and editors. Competing interests for GAPP and ISMPP were provided previously
Ghostwriting isn’t the problem. It used to be, until industry realized that all they had to do was disclose the involvement of industry-supported authors, hired to present a commercially-friendly spin to the manuscript. However, transparency does nothing to decontaminate the content; the spin is still there. The only solution is to prohibit the involvement of anyone with ties to industry in the writing of review articles and editorials, as our journal has done. (1)
Once distorted information makes it into the medical literature, the damage is done: other authors unwittingly incorporate it into other articles, spreading the distortions. For research studies, the task of journal editors is to vigilantly avoid hype, for example, not allowing statistical significance to imply clinical significant when none has been demonstrated. (2)
1. Siwek J. AFP's Conflict of Interest Policy: Disclosure Is Not Enough. Am Fam Physician. 2014 Feb 1;89(3):161-167.
http://www.aafp.org/afp/2014/0201/p161.html
2. Fugh-Berman A, Siwek J. Compromising the Medical Literature: The Hidden Influence of Industry-Biased Articles. Am Fam Physician. 2011 Sep 1;84(5):489-491.
http://www.aafp.org/afp/2011/0901/p489.html
Competing interests: No competing interests
I thank Al Weigel of the International Society for Medical Publication Professionals (ISMPP), and Serina Stretton and her colleagues from the Global Society of Publications Professionals (GAPP) for their comments. I have addressed most of their points in an accompanying response, but focus here on their claims about transparency in the commercial publications trade.
Weigel and Stretton both object to my article by emphasizing their trade’s commitment to “transparency”. My analysis shows, however, that modest transparency and small print disclosure, while better than nothing, paradoxically provides an apparatus for subtle misattribution, concealment and spin. My article discusses this as a cultural problem within medicine for which many stakeholders are responsible. It is important not to lay the blame at industry’s door alone. As Stretton rightly points out, it is journals that make authorship rules, and decide how disclosures should be presented to their readers. Table 2 of my article provides some useful suggestions to the editorial community.
More importantly, however, while I applaud Stretton’s and Weigel’s commitment to transparency, I remind them that the publications trade remains unacceptably secretive. Numerous articles are produced for journal publication every year, scientific platforms and publications plans are developed, academics are recruited to participate as authors, trade writers draft manuscripts, and substantial payments pass from corporations to agencies, but little of this activity is in the public domain. Indeed, the process has been characterized as ‘ghost management’ (1).
Commercial secrecy has no place in an open scholarly discourse. Since this literature has been placed within the public academic forum with the goal of informing treatment decisions, readers and their patients have a right to know exactly what commercial considerations were at work in its development, and who was paid by whom to create the material. This right extends not only to current literature, but to published literature with a potential bearing on clinical practice – conservatively, since the turn of the century.
I therefore invite Weigel on behalf of ISMPP’s sponsor companies, and Stretton and her GAPP coauthors on behalf of their own companies, to clarify on this forum what they believe should be transparent, and what should be secret, by responding to the following 5 requests:
1. Will your companies place in the public domain full lists of every journal article they have produced since 2000?
2. Will your companies place in the public domain all the publications plans relating to these articles, including supporting documentation on product positioning, scientific platforms, “educational objectives”, communication points and messages?
3. Will your companies name all academics and medical professionals they have worked with since 2000, including the projects and articles they worked on and the products they worked in connection with?
4. According to the trade definition of ghostwriting, have any GAPP or ISMPP companies, including your own and previous companies you have worked for, ever produced a ghostwritten article? Will you ensure these articles are all now identified, in order to help cleanse the medical literature? Do you also urge writers to bring any such articles to public attention, and will your companies disregard the confidentiality clauses writers have signed with them if they do?
5. Will your companies agree henceforth to place in the public domain:
A. Every publications plan they develop, including all supporting documentation relating to drugs, their scientific platforms and their positioning?
B. All outlines and drafts they developed for every article that secures publication?
C. The names of every academic expert they work with, including the projects they work on and the product being marketed?
D. Full details of intellectual property rights they or their clients hold in respect of research, data, documentation and draft publications?
E. The cash sum typically paid to them by pharmaceutical clients for each type of article and publications plan they develop, such that the public is aware how much money is changing hands in the development of this literature?
There can be no justification for sequestering the machinations of this trade from public view, especially when its output is lodged in open scientific discourse with the goal of influencing patient treatment. In my opinion, if the trade refuses greater transparency, it should be investigated by lawmaker committees – as indeed should the broader culture of commercialism and inadequate transparency within academic medical science and publishing. I await ISMPP and GAPP’s response to these requests for transparency with interest.
References
1. Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med. 2007 Sep;4(9):e286.
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.
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.
References
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.
Alastair Matheson paints a murky picture of conspiracy and manipulation in his article “A ghostwriter by any other name” and implies that use of ghost writers and/or failing to include them as co-authors, are methods the pharmaceutical industry uses to influence the scholarly literature for marketing purposes. However, he fails to identify the driving force behind the use of ghostwriters (time) and does not mention the fact that ghostwriters are used by organizations other than pharmaceutical companies, including academic groups and charitable institutions that sponsor clinical trials. All struggle with the time taken to write a publication. As a pharmaceutical physician specializing in oncology drug development for over 20 years, including more than 12 years as a freelance medical advisor, I have written, reviewed, and contributed to many papers and review articles. Even when writing on very familiar topics, a straightforward trial report can take around 40-50 hours and a review article around 100-150 hours to write. An additional 8-10 hours may be spent navigating the submission process and responding to peer reviewers' comments. Most clinicians, academics and company employees simply do not have this sort of time available. For those who do not have English as a first language (a common occurrence with larger, international trials), the help of a professional writer may be particularly welcome.
Matheson also implies some sort of wrong-doing in the process of publication planning, author selection, discussion, project briefings, and manuscript review by pharmaceutical companies, and the hands-on involvement in manuscript preparation by corporate employees and their inclusion as co-authors. However, such publication planning activities are routine for any organization wishing to publish the results of their research and not the exclusive domain of industry. Inclusion of company employees as co-authors when they have worked extensively on a trial, often exclusively over many years, is entirely within the spirit and letter of ICMJE recommendations and an important way of ensuring transparency, as well as giving credit where credit is due.
Matheson states “The ICMJE recommendations….require neither data ownership nor company interests to be disclosed.” However, ICJME recommends that the following be declared: “Sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design; collection, analysis, and interpretation of data; writing of the report; the decision to submit the report for publication; or a statement declaring that the supporting source had no such involvement” (1). These requirements come very close to those that Matheson advocates.
Matheson’s article contains other statements that are somewhat questionable on close scrutiny, for example: “a hallmark of commercial literature is that similar articles could have been produced using alternative academics”. A PubMed search for reviews of popular current topics (such as “immune checkpoint inhibitors”) reveals hundreds of reviews written by different academic authors - most of these appear to be straightforward attempts to summarise a complex and rapidly evolving therapy area with no apparent commercial input or bias.
Another problematic statement is: “The academic authors who provide ‘direction’ or ‘final’ say are often selected in advance and while their contributions are honest and substantial, this has little effect on the output anticipated by planners.” It is entirely logical and desirable for academic authors to be selected in advance of manuscript drafting (for example, when the trial is ongoing or nearing completion). Who would suggest that they were selected retrospectively (when the paper is written)? Furthermore, if their contributions are “honest and substantial”, how can it be true that this has little effect on the output?
Matheson concludes by suggesting changes to ICMJE authorship criteria including the granting of co-authorship to medical writers. Having worked with many talented medical writers, I welcome greater recognition of their invaluable work. However, including the medical writer in the list of co-authors rather than in a footnote or acknowledgments, regardless of whether they fulfill the other ICMJE criteria, seems likely to achieve little more than a steady increase in the number of authors on a paper.
REFERENCES
1. 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 19 September 2016)
Competing interests: I am a freelance medical advisor working in oncology drug development. In the last five years, I have acted as a consultant for the following organisations (in alphabetical order): Alactrita LLP, Astex Therapeutics Ltd, BerGen Bio A/S, Cancer Research UK Centre for Drug Development, EngMab AG, Inbiomotion SL, Michelangelo Foundation, Mosaic Biomedicals SL, Norgine Ltd, Ono Pharma UK Ltd, Piqur Therapeutics AG, Roche Products Ltd, SFL Services Ltd, Shionogi Ltd, and the Wellcome Trust Ltd. I am on the advisory board for SFL Services GmBH and own shares in GSK
Defenses of ghostwriting, as exemplified in two of the responses to Matheson’s paper, are endlessly creative (1-2). It is always interesting to see industry try and defend the idea that the authors of papers do not need to be listed on the byline. My colleague Jeff Lacasse and I have addressed this topic in several publications (3-5). Thanking writers for providing “editorial assistance” in the acknowledgments section of the paper instead of the authorship byline, essentially changes the rule of authorship attribution so that ghostwriting is acceptable. Listing ghost authors as editorial assistants allows pharmaceutical companies to publish articles with conflicts-of interest that are not transparently reported. Editorial assistants are not mentioned in the abstract, are not indexed in publication databases, are not mentioned in subsequent citations, and are never mentioned in news media accounts of the article. In other words, the fact that a pharmaceutical company directly co-authored the paper is concealed from view. That this is seen as acceptable in an era of increased disclosure of conflicts-of-interest is puzzling.
As Senator Charles Grassley stated, in a report from the Senate Committee on Finance titled, “Ghostwriting in the Medical Literature”: “Despite its acknowledgement of medical writers for ‘editorial assistance,’ the role of pharmaceutical companies in medical publications remains veiled or undisclosed.” (4)
Even medical writers acknowledge the reality. In communications with Forest Pharmaceuticals about the byline of a clinical trial of Citalopram in children, Mary Prescott of the Weber Shandwick states: “I don’t know that any decision has been made about who is going to write the manuscript (not to be confused with who is going to be the author[s] of the manuscript, which also isn’t decided, as far as I know) (6).”
To be honest I am not sure that trade groups should have a place at the table when it comes to deciding the proper definition of ghostwriting. This is an academic decision best left to the Journal Editors. It is unfortunate that the two responses that defend the practice of not listing corporate authors on the byline use ICMJE guidelines as support for their views. To improve the credibility of biomedical research eroded by ghostwriting, the ICMJE should revise their approach to regulating authorship. As authors submit manuscripts to medical journals, each author should be required to sign a statement guaranteeing that no ghost authors participated in authorship or co-authorship of the submitted article, and that all medical writers are listed as authors on the byline. This simple move forward could have profound consequences for the medical literature as a whole. Much progress has been made relatively quickly in identifying ghostwriting as a problem, and we are now on the verge of largely solving this problem—if those with editorial influence in academic medicine will insist on policies to ensure that there are no undisclosed conflicts of interest haunting the contemporary medical literature.
1. Stretton, S. Rapid Response BMJ 2016;354:i4578. Accessed at: http://www.bmj.com/content/354/bmj.i4578/rr-0 15 September 2016
2. Weigel, A. Rapid Response. BMJ 2016;354:i4578 Accessed at: http://www.bmj.com/content/354/bmj.i4578/rr 15 September 2016.
3. Leo, J, Lacasse, J.R., and Cimino, A.N. Why Does Academic Medicine Allow Ghostwriting? A Prescription for Reform. Society 2011. Accessed at: http://diginole.lib.fsu.edu/islandora/object/fsu:252737/datastream/PDF/view on 15 September 2016.
4. Leo, J, Lacasse JR. (2012), Medical Ghostwriting: A University-Sanctioned sleight of hand. Society 2012. Accessed at http://diginole.lib.fsu.edu/islandora/object/fsu:252736/datastream/PDF/view on 15 September 2016.
5. Leo, J and Lacasse, J. Ghostwriting and Academic Medicine. Chronicle of Higher Education. July 19, 2010. Accessed at: http://www.chronicle.com/article/ghostwritingacademic/123613 15 September 2016.
6. Jureidini, J. Amsterdam, J.D., and Leemon, M. The Citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterization, and academic malfeasance. International Journal of Risk and Safety. 2016;28 (1):33-43. Accessed at: http://content.iospress.com/articles/international-journal-of-risk-and-s... 15 September 2016.
Competing interests: No competing interests
Trade associations' joint statement on transparency in the commerical publications trade
The debate following my article has culminated in a very rare, and unaccommodating, joint public statement on transparency (1) by the three foremost trade associations of the commercial publications industry – the International Society for Medical Publication Professionals (ISMPP) and the European and American Medical Writers Associations (AMWA and EMWA).They have been joined in this statement by the Global Alliance of Public Professionals (GAPP), the most active advocacy group for the trade.
In this statement, these groups have given their official response to a series of specific transparency requests (2) which I made in order to clarify where the trade stood on secrecy and transparency in its development of medical journal articles. The trade chose to meet none of these requests, indicating its commitment to continued secrecy on these aspects of the medical publications business.
In particular, the trade did not agree to reveal any details of the commercial publications plans, scientific platforms, product positioning and key messages underpinning its past, and future, journal articles; nor did it agree to release details about its recruitment and use of “key opinion leaders”; nor details of intellectual property rights; nor any indication of how much money its companies receive from industry clients to plan and develop these articles. All this information is to be remain withheld from the readers of this literature and their patients.
Most remarkably, the trade did not agree even to disclose exactly what it has published. It did not agree to provide simple lists of its published output; it did not agree to disclose any secret ghostwriting it may be aware of in the published journal literature; and it did not agree to encourage writers to disclose such articles, or to waive their confidentiality agreements if they do so.
This affirmation of continued commercial secrecy on these aspects of medical journal literature – made directly to the medical community itself, in a leading medical journal – will be of broad ethical and policy concern. The joint statement ends by claiming the trade has been “working towards” transparency and disclosure for 15 years. There is clearly a long road yet to travel.
On other correspondence, I would like to thank Jay Siwek, Editor of American Family Physician, for his comments.(3) Among Dr Siwek’s many interesting points is that mere disclosure is not a solution to the problem of industry spin, since it does not “decontaminate the content.” I agree. Siwek calls for journals to refuse review articles or editorials from anyone with industry ties, and again I agree – although the greater problem lies, I think, in commercial clinical trials, in which academia has become increasingly assimilated into the commercial enterprise (4,5). Only independent academic research and reporting can guarantee freedom from commercial secrecy and spin. Industry research can be of great value, but whenever it partners with academia, we should move from a culture of small print disclosure to one of conspicuous commercial labeling, as my article describes.
Siwek also makes the point that “Once distorted information makes it into the medical literature, the damage is done: other authors unwittingly incorporate it into other articles, spreading the distortions.” This is true – and to bring my comments full circle, there can be few stronger examples of this than the attempted rebranding of ghostwriting itself. Through continued industry promotion, abetted by the errors of some editors (6), medicine was almost persuaded to accept the trade’s absurd, self-serving, disclosure-based definition, by which even Study 329 does not count as ghostwriting. I hope the risk of that perverse outcome has by virtue of this debate been diminished.
References
1. Rapley A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-6 Accessed October 4 2016
2. Matheson A. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-4 Accessed October 4 2016
3. Siwek J. Ghostwriting: the importance of definition and its place in contemporary drug marketing. Rapid Response. BMJ 2016;354:i4578. http://www.bmj.com/content/354/bmj.i4578/rr-5 Accessed October 4 2016
4. Matheson A. The disposable author: how pharmaceutical marketing is embraced within medicine's scholarly literature. Hastings Cent Rep. 2016;46:31-7.
5. Matheson A. Attribution, advocacy, disposable authors, corporate ghosts and cultural assimilation: new themes in the ethical critique of commercial medical literature. Medical Writing 2016;25(1)25-30.
http://journal.emwa.org/authors-and-authorship/attribution-advocacy-disp...
6. Laine C, Mulrow CD. Exorcising ghosts and unwelcome guests. Ann Intern Med 2005;143: 611-2
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.