Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical writer.
Citation: Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A, et al. (2009) What Should Be Done To Tackle Ghostwriting in the Medical Literature? PLoS Med 6(2): e1000023. https://doi.org/10.1371/journal.pmed.1000023
Published: February 3, 2009
Copyright: © 2009 Gøtzsche et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The authors received no specific funding for this article.
Competing interests: PCG and JPK have declared that no competing interests exist. KLW, EW, AJ, AG, and CH have published or presented papers on ethical medical writing practices, are active members of associations in Europe, North America, and the Asia Pacific region for professional medical writers, and provide professional medical writing services to authors from academic, biotechnology, medical device, or pharmaceutical organizations.
Abbreviations: ICMJE, International Committee of Medical Journal Editors; WAME, World Association of Medical Editors
Provenance: This Debate arose from an uncommissioned submission by Karen L. Woolley and colleagues. We commissioned viewpoints from Peter C. Gøtzsche and Jerome P. Kassirer. None of the viewpoints have been externally peer reviewed.
Scientific communication depends on trust. We should be able to believe what we read, and trust that knowledge when we plan experiments and treat patients. Unfortunately, we cannot. Conflicts of interest are ubiquitous; billions of dollars are being earned undeservedly by drug companies through flaws in research, research articles, reviews, and editorials; and many academic careers have also been built on doubtful evidence. The recent stream of books about the corruptive influence of money on health care research and practice, some of which have been written by editors of our most prestigious journals [1–3], illustrates just how bad the situation is.
Part of the problem is that good names give papers credibility. A colleague once told me that in his country it was more important to know the authors than the methods of a research paper, as some professors lent their names to almost anything if they were well paid. I have seen single-authored meta-analyses on drugs presenting sophisticated analyses that went far beyond the capability of the author, without a word about who did the analyses (and presumably even wrote the paper). Similarly, many drug reviews are unlikely to have been written by the authors, as these professors probably have more important things to do than writing book-length drug reviews in sponsored supplements or peripheral journals that few would ever read and that have no impact factor.
Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself [4]. It often occurs simultaneously with its opposite, guest authorship (sometimes called honorary or gift authorship), where the contributions of the named authors are so small, or nonexistent, that they do not merit authorship [5,6].
Court cases that allowed access to industry files have shown that ghost and guest authorship are common, even in our best journals [5,6]. But misappropriation of authorship is dishonest [4] and is regarded as scientific misconduct in some jurisdictions like Denmark, where the law states that misappropriation of author role, either deliberately or through serious neglect, is a type of scientific misconduct [7]. Regrettably, it is rarely detected. The involved parties have a common interest in secrecy, and junior researchers can ruin their careers if they reveal that the professor did not write the papers that bear his or her name. It is still commonly accepted that department chairs claim authorship of all papers emanating from the department, and newspaper articles celebrating a professor's 60th birthday may note that he or she has written more than 500 papers. The professor may have contributed, but almost certainly wrote only a minority of them.
To put it simply: if a cook isn't cooking, what is a cook then doing?
Ghostwriting debases fundamental tenets of the medical profession. It violates authors' personal integrity, responsibility, and accountability. More importantly, ghostwriting threatens the very fabric of science and thus the validity of our medical knowledge, and in doing so it jeopardizes patient care.
Denouncing ghostwriting is easy; defining its variants is not. At the extreme, ghostwriting is easy to define. Perhaps the most egregious example is that of a pharmaceutical company's marketing department promoting one of its products by carefully selecting positive reports and deemphasizing the product's risks, and then paying a well-known academic author to submit the paper for publication without attribution [6]. Few would disagree that this behavior is inappropriate, unprofessional, unacceptable, and potentially dangerous. Lesser degrees of ghost involvement in the writing process are also problematic, such as permitting the commercial sponsor of a clinical trial to collect and hold all of the trial's data, providing exclusive statistical expertise and final tables for publication, drafting a complete manuscript of a study it supported, or insisting contractually on the last say on the final manuscript's content and conclusions.
Other kinds of ghost involvement are more ambiguous. Is it acceptable to hire a science writer to interview a physician and write a paper on that subject, which the physician then calls his or her own? Is it appropriate for a scientist in a company to analyze a portion of evidence, write a draft of the information, and then for another author to incorporate that draft into a manuscript without crediting the scientist? Is it acceptable for a physician-researcher to pay someone to do the same? How much help with writing is okay? Where do we draw the line in some of these fringe areas of ghostwriting?
Because many interactions between academics and industry in developing, testing, and reporting on new products are desirable, such authorship definitions are critical. Unfortunately, there is not a great deal of uniformity among journals (the major publishing gatekeepers) in what constitutes an acceptable contribution. The guidelines of the ICMJE and WAME provide a good start [4,10]. They define an author as someone who has made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; has drafted the article or revised for important intellectual content; and has given approval of the final version. More stringent requirements may be necessary, however. Some journals require that authors have had full control of the primary data, have carried out the statistical tests themselves (e.g., JAMA), and have created tables and figures themselves. Others require that each author state the specific contributions they have made to the study or to the writing of the manuscript, and some journals publish these (e.g., BMJ, PLoS Medicine).
Other journals review components of study protocols that are vulnerable to manipulation by the sponsor and will only publish clinical trials that are registered in a public database endorsed by the ICMJE. Increasingly, journals require that the role of the study sponsor be transparent in manuscripts, and in addition will not accept papers unless the decision to publish is controlled by the researchers. Finally, one former editor, Richard Smith, thinks that the entire peer review system should be scrapped because of excessive industry influence on publishing [12]. He would replace the current system by an open, Web-based disclosure of protocols, data, and statistical assessment, with publication only of systematic reviews based on the study data [13]. These tactics go some way toward stemming ghost involvement in the publication process.
Any additional “cure” for ghostwriting must take into account its frequency and impact. Information from questionnaire studies suggests that authorship in up to 10% of published papers could be attributed to ghostwriters [14–17], although the fraction in industry-sponsored clinical trials in one study was considerably higher [5]. In trying to understand the prevalence, we are stymied because we just don't know what we don't know. Moreover, most of the data in these studies are self-reported, and the exact frequency of company-inspired writing is well hidden. And finally, the impact of ghostwriting is even more difficult to estimate. For this reason, we must be careful not to impose excessive regulations to solve problems that may not be threatening.
Nonetheless, editors of medical journals could devote more effort to define what constitutes appropriate and inappropriate participation in studies and manuscript preparation, especially by companies with products at stake. At the very least, editors can demand transparency. Who were the trial designers? Who were the trial conductors, the researchers, and the data managers? Who did the statistics? Who wrote the manuscript and who signed off on the final draft? Can all authors take public responsibility for their roles?
Overtly biased ghostwritten articles can cause patient harm; others damage the public's trust in both the pharmaceutical industry and the medical profession. Loss of trust may be ghostwriting's major victim. Neither the industry nor the profession can afford further damage to their reputations. Both should “just say no” to ghostwriting.
Professional medical writers have been recognized by medical journal editors as legitimate contributors to manuscripts [4,10], but concerns remain about “ghostwriting,” namely the failure to disclose such contributions. Professional medical writers, who must be distinguished from ghostwriters [18], could be valuable allies to those determined to eradicate ghostwriting. Professional medical writers have communication expertise and health care knowledge, and abide by ethical guidelines for medical writers. They assist authors to prepare documents (e.g., abstracts, slides, posters, and manuscripts), but ensure that the authors control the content and that appropriate disclosures of funding and involvement are made. We believe that professional medical writers can offer unique, and too frequently untapped, insight into how to address ghostwriting. We offer the perspective of professional medical writers on three strategies that have been considered for tackling ghostwriting.
In 2005, the Editorial Board of the Clinical Journal of Oncology Nursing tried to challenge ghostwriting by rejecting “… manuscripts that have been written by medical writers or communication companies” [19]. This strategy has not been embraced by many editors. Instead, the Council of Science Editors, the ICMJE, and WAME strive to discourage ghostwriting by requiring authors to disclose medical writing assistance and funding.
We support disclosure, rather than prohibition. Banning medical writers could have unintended consequences. For example, a ban could intensify the ethical and scientific problem of nonpublication. Only 50% of medical research results may ever be published in full [20], and limited writing time is one of the main reasons for nonpublication [16]. Professional medical writers can help authors avoid nonpublication by completing many of the time-consuming manuscript preparation tasks [18,21]. Encouraging, rather than banning, medical writer involvement may be particularly important for helping authors and sponsors reduce the rate of nonpublication (23%) associated with industry-sponsored clinical trials [22].
Banning medical writers could also reduce the quality of manuscripts, particularly if authors have limited time, manuscript writing experience, English language skills, or awareness of reporting guidelines. Professional medical writers have the specialist skills required to help authors communicate in a clear, concise, and credible manner, and to ensure manuscripts meet journal requirements [9,18,21,23,24]. Banning writers may increase the number of poorly prepared or noncompliant manuscripts—a prospect not likely to be welcomed by editorial staff or peer reviewers.
Just as some researchers need statistical assistance, some researchers need writing assistance. We, like the Council of Science Editors, the ICMJE, and WAME, believe that such assistance should be disclosed, but not banned.
We don't believe that more guidelines are needed; indeed, we assert that existing guidelines already emphasize the need for appropriate disclosure of writing assistance. The consistency among these guidelines is remarkable, given that they have been developed by different stakeholders, including journal editors [4,10], medical writers [9,18,21,23,24], and industry [25]. Despite these guidelines, the appropriate disclosure of medical writing assistance is low [16]. Many authors don't have the time or inclination to keep up-to-date with guidelines. In some instances, appropriate disclosure may only occur because professional medical writers alert authors to their responsibilities. Banning writers or creating more guidelines could exacerbate an already problematic situation. An alternative strategy is required to tackle ghostwriting.
One of the most practical ways to tackle ghostwriting could be the mandatory use of a checklist that could help editors detect ghostwriting and help authors avoid ghostwriters. We consulted professional medical writers and editors in Europe, North America, and the Asia Pacific region to develop a checklist (Table 1) that could be completed by all authors who used medical writers.