Medical writing is, essentially, technical writing with the objective of communicating medical information to healthcare professionals and/or the general public. There are many genres of medical writing. One of the more technical forms of medical writing – which is the focus of this article – is the reporting of clinical research studies in medical journals.
Published medical research has power: doctors rely on them to make decisions about medicines and how they treat patients. The quality of the research, the journal, the authors and the way the study is reported further adds to a paper’s integrity and, ultimately, its ability to influence medical practice. Getting it wrong, therefore, can potentially have dire consequences.
In comparison, advertising material prepared by pharmaceutical companies – clearly distinguishable by logos, colors and branding – can be taken for what it is: a promotion of a company’s medicine; that’s the job of an advertisement. So the notion that research articles are ghost written with the ulterior intention to promote is, understandably, disconcerting.
Authorship and Medical Ghostwriting
A medical ghostwriter is an individual who contributes to the writing or content of a paper, but whose efforts are not acknowledged in the published article (Langdon-Neuner, WAME). The question is: why?
Who authors these articles, or rather those that are acknowledge as authors, has been subject to ongoing controversy. Authorship indicates accountability for the article’s content; i.e. the accuracy of the data – and usually includes those who have conducted the research, designed the study, and collected and analysed the data. So authorship for research articles means more than the act of writing the manuscript. Accordingly, the International Committee of Medical Journal Editors (ICMJE) require three criteria to be fulfilled for an individual to qualify as an author:
- substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data
- drafting the article or revising it critically for important intellectual content
- final approval of the version to be published.
As medical writers do not usually meet all three requirements, they do not get listed as authors. To address this issue the ICMJE guidelines and various other Associations – World Association of Medical Editors (WAME), American Medical Writers Association (AMWA), European Medical Writers Association (EMWA) – advise authors to disclose the identity of the individuals who provide writing assistance and the entity that financially support the study. (Hamilton, Jacobs, WAME). However, as there are multiple stages in preparing a manuscript, more prescriptive guidance is required on who, what and how to acknowledge at each stage of preparation; e.g. acknowledging those who wrote the first draft to those who give approval of the final manuscript (Langdon-Neuner).
Nevertheless, despite these guidelines ghostwriting continues to occur. There are potentially four reasons for not acknowledging receipt of writing assistance (Langdon-Neuner):
- embarrassment of receiving assistance
- true ignorance of the need to disclose
- journals are less willing to publish authors for receiving assistance
- to surreptitiously market drugs.
Whatever the grounds, ghostwriting is unethical; even more so when patient safety is forsaken for dollars: ghostwritten articles may mislead doctors about the actual risk and benefits associated with medicines, potentially resulting in harmful treatment decisions being made. Wyeth was investigated for such practice; it was accused of engaging a medical communications agency to write an article to downplay the risk of breast cancer associated with its hormone replacement treatment, Premarin; and for publishing it under the name of a medical researcher, with no acknowledgment of the medical communications agency (Guilliat).
How Common is Medical Ghostwriting?
To what extent ghostwriting occurs is unclear, as it is difficult to detect. The literature reports somewhere between 11-50% (Langdon-Neuner), although this figure would include all reasons for ghostwriting, not just the deliberate intent to slant a paper for commercial reasons. Recent research by EMWA and AMWA has indicated that ghostwriting has become substantially less common over the last few years (EMWA).
Is it Okay to Use a Medical Writer?
There is nothing wrong with using a professional medical writer and accepting financial assistance from pharmaceutical companies, as usually without either a lot of valuable research may not get published. Professional medical writers offer expertise, quality and speed, and produce clearly written articles. However, transparency is essential. An author, working with a professional medical writer, must (Langdon-Neuner, Moffat, Woolley):
- have control of content
- have access to the raw data
- ensure the data is correctly reported
- ensure any writing, editorial and funding assistance is appropriately acknowledged.
Eradicating the Ghosts
Acknowledgment eradicates ghosts; however, this is not as straightforward as it seems. For transparency to occur, all parties involved – researchers, doctors, pharmaceutical companies, writers, editors and journals – need to embrace and demand it – that’s the challenge.
It is recognized, by the various associations, that more work needs to be done on:
- detecting ghostwritten articles,
- educating on the importance of acknowledging contributions, and
- providing definitive guidelines to be able to do so.
References:
EMWA (European Medical Writers Association). http://www.emwa.org/Home/Ghostbusting.html (Accessed 14 April 2010)
Guilliat R. (Journalist). Ghost Stories in The Weekend Australian Magazine, April 3-4 2010. Available online: http://www.theaustralian.com.au/news/features/ghost-stories/story-e6frg8h6-1225848936455 (Accessed 14 April 2010)
Hamilton CW, Royer MG et al. AMWA Journal. 2003;18:13-16.
ICMJE (International Committee of Medical Journal of Editors). Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication: ethical considerations in the conduct and reporting of research. Available online: http://www.icmje.org/ethical_1author.html (Accessed March 2010)
Jacobs A, Wager E. Curr Med Res Opin. 2005;21:317-322.
Langdon-Neuner E. Mens Sana Monographs 2008; 6 (1): 257-273.
Moffatt B and Elliott C. Perspectives in Biology and Medicine 2007; 50:18-3.
WAME (World Association of Medical Editors). Policy statement – ghost writing initiated by commercial companies. Available online: http://www.wame.org/resources/policies (Accessed 14 April 2010)
Woolley KL. CHEST 2006; 130: 921-923
Lesh Karan - Lesh is a professional writer and editor. She has a background in pharmacy and pharmaceutical science, and is currently studying ...
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