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Rapid Responses: Rapid Responses published:
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Invisible ink and invisible writers - common solution?
- Karen L. Woolley (28 January 2007)
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Replacing invisible writers with visible writers may require some panacea
- Ezekiel U Nwose (2 February 2007)
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Checklist for ghost detection
- Liz Wager, Adam Jacobs, Dianthus Medical Ltd, London (5 February 2007)
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Poachers and Gamekeepers
- John Stone (9 February 2007)
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Reply to John Stone
- Liz (Elizabeth) Wager (12 February 2007)
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Re: Reply to John Stone
- John Stone (13 February 2007)
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Author's Response
- Keith E Dawes (15 February 2007)
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Karen L. Woolley, A/Professor, Uni Qld Uni SC; CEO ProScribe Medical Communications, Queensland, Australia 4566
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The problems with invisible ink (nonpublication of research) and invisible writers (ghost writers) may share a common solution. Reduce the amount of invisible ink by replacing invisible writers with visible writers. Given that one-third to two-thirds of medical research may remain unpublished [1,2], primarily because researchers have limited writing time or expertise, we should support deserving researchers with professional medical writers who (and here is the clincher...) know how to work in an ethical and efficient manner. [3] If the unnecessary veil of secrecy surrounding medical writers was lifted, the appropriate and visible declaration of medical writer involvement in industry publications would increase from approximately 10%. [4] More importantly, the risk of nonpublication, due to limited writing time or expertise, could be reduced. A/Professor Karen Woolley (www.proscribe.com.au) References 1.Camacho LH, Bacik J, Cheung A, et al. Presentation and subsequent publication rates of phase I oncology clinical trials. Cancer 2005; 104:1497-1504. 2.Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 1996; 313:1245-1248. 3. Woolley KL. Goodbye Ghostwriters!: How to work ethically and efficiently with professional medical writers. Chest. 2006;130:921-3. 4. Woolley KL, Ely JA, Woolley MJ, Findlay L, Lynch FA, Choi Y, McDonald JM. Declaration of medical writing assistance in international peer- reviewed publications. JAMA. 2006;296:932-4. Competing interests: KW is a University lecturer in medical writing and employs PhD-qualified professional medical writers, who work for academic and industry clients. |
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Ezekiel U Nwose, Medical Scientist School of Community Health, CSU Albury, P.O. Box 789 NSW 2640 Australia
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The idea to reduce the amount of invisible ink by replacing invisible writers with visible writers is very laudable. However, it may require some panacea. There are undeniable issues of goal conflicts,1 legislation and politics.2 Take the conflicting reports on antioxidant vitamins for instance. Nutraceutical manufacturers are not required to perform the rigorous tests including clinical trials, which pharmaceuticals do. Yet, antioxidant vitamins C and E have toxicities that have been severally reported. The problem is: where is the insurance against dismissal, for the employee invisible writer that will visibly collaborate to compel his/her employer nutraceutical company to research into the antioxidant vitamin contraindications, which has been successfully lobbied against? It could be recalled that even the management of a journal can react against unfavourable editorial judgements.3 Ghost writings may be indeed an issue to address, but it would be imperative to consider this problem. References 1. Gal I, Prigat A. Why organizations continue to create patient information leaflets with readability and usability problems: an exploratory study. Health Educ Res. 2005; 20(4): 485-93. 2. Weaver P. Smart Medicine. Rutledge Hill Publishers 2004, pp 66 3. Ferriman A. AMA's scheme to protect JAMA's independence has drawbacks. BMJ 1999; 318(7199):1645 Competing interests: None declared |
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Liz Wager, Publications Consultant Sideview, Princes Risborough, HP27 9DE, UK, Adam Jacobs, Dianthus Medical Ltd, London
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We agree with Keith Dawes that everybody would benefit from increased transparency. Whilst guidelines for writers make this clear [1], we feel that journal editors also have an important role in achieving transparency. Although the statement from WAME (the World Association of Medical Editors) [2], acknowledging that professional writers may have a legitimate role to play, is helpful, editors need to educate authors and contributors and encourage more openness. Writers from Australia, UK and the USA are therefore developing a checklist for editors designed to help them achieve transparency and identify possible ghosts. The checklist is being discussed with journal editors and we hope to publish it in due course. Reference [1] Jacobs A & Wager E. EMWA guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21:317-21 [2] WAME statement www.wame.org Competing interests: We both work as medical writers and are co-authors of the EMWA guidelines |
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John Stone, none London N22
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I am getting ever more confused:- Challenged by me just over two years ago in Rapid Responses Adam Jacobs was unwilling to name a single article which he had co-authored and also defended practices which make my hair stand on end [1]. He remains shy about declaring which pharmaceutical companies he works for but in Journal of American Physicians and Surgeons he noted: "AJ's company regularly provides services to a variety of pharmaceutical companies, some of which make vaccines, including SmithKline Beecham and Aventis-Pasteur' [2]. There is no client information on his website [3]. Liz Wager lists as clients on her website Fujisawa, GlaxoSmithKline, Janssen-Cilag, Ortho-Biotech and the Royal Brompton Hospital [4] but not here. She is also a member of the BMJ Ethics Committee [5]. The Nordic-Cochrane study, just published Gøtzsche et al 'Ghost Authorship in Industry-Initiated Randomised Trials' is full of citations of Jacobs and Wager, and lists intriguinly 'Liz Wagner' as academic editor [6]. Is this a slip, a thinly disguised alias, or a different person? The journal of publication has an accompanying article by Elizabeth Wager 'Authors, Ghosts, Damned Lies, and Statisticians' [7] which states: "Elizabeth Wager is a medical writer and trainer for a variety of organizations, including pharmaceutical companies. She is a coauthor of the European Medical Writers Association guidelines for medical writers and Good Publication Practice for pharmaceutical companies, and occasionally receives payment for speaking about or providing training on publication ethics." [7] Acknowledging the help of ghosts is a limp response. They are either authors or not, and not including them or listing their competing interests leaves us as helpless as before. Nor is the generalised approach adopted by Wager and sometimes Jacobs sufficient: we need to see a proper list of patrons, and we need to know what the have worked on. This is anything but transparent, and we end with agencies which should be policing, collaborating. Even BMJ does not appear to know whether it is coming or going. [1]Rapid Response for Kamran Abbasi, 'Transparency and Trust': http://www.bmj.com/cgi/eletters/329/7472/0-g [2]http://www.jpands.org/vol9no4/correspondence.pdf [3]http://www.dianthus.co.uk/index.htm [4]http://www.lizwager.com/ [5]http://resources.bmj.com/bmj/about-bmj/ethics-committee/committee- members [6]http://medicine.plosjournals.org/perlserv/?request=get- document&doi=10.1371/journal.pmed.0040019 [7]http://medicine.plosjournals.org/perlserv/?request=get- document&doi=10.1371%2Fjournal.pmed.0040034 Competing interests: Autistic son |
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Liz (Elizabeth) Wager, Princes Risborough, HP27 9DE
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I am sorry that John Stone thinks our initiatives for improving transparency are unhelpful. Just for clarification, I'd like to respond to his queries. I am a freelance writer and trainer, so my list of clients can change from week to week. My website is correct but a bit out of date (mea culpa) -- however, the purpose of listing customers is to give an impression of some of the companies I have worked for, rather than to show all potential competing interests. Over the years I haved worked for dozens of companies, and I would have to update my website almost weekly to include everybody I have ever worked for. However, whenever I am involved with a particular project, I always ensure that any relevant competing interests are listed. My name is often mis-spelled and, once again, I am sorry I did not pick up this typo in PLoS as I was, indeed the academic editor for this piece. I will ask the journal to correct their mistake. Authorship remains a complex issue, but I still firmly believe that more transparency is needed. Listing medical writers is not a panacea but it does close one possible loophole through which a ghost might slip, if you'll pardon the mixed metaphor. Competing interests: I am a co-author of the Good Publication Practice (GPP) guidelines for pharmaceutical companies and of the European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. I occasionally run training courses which promote these (and other guidelines) and I sometimes get paid for these. |
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John Stone, none London N22
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I am grateful to Liz Wager for her elucidation. I note other problematic features to this matter, apart from the fact that her contribution to the Gøtzsche study was not ideally transparent. 1) The designation 'academic editor' suggests intellectual influence over the content. What is the difference between this and being an author, except that you might escape having to make a declaration? 2) One obvious competing interest as 'academic editor' was as co- author of guidelines suggested as a panacea in the study. Does this not go beyond any normal competing interest? 3) Why did not Cochrane avoid such an extreme conflict (that is a question for them)? 4) Should not guidelines be rules? 5) Would Wager say that the standards adopted by her co-author of the EMWA guidelines and the Rapid Response above, Adam Jacobs, (a) fall within the guidelines and are (b) acceptable? 6) Either way is this not simply a cosmetic device (and therefore retrograde)? Competing interests: Autistic son |
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Keith E Dawes, Medical Writer and Clinical Research Scientist PRA International, Reading, RG2 OTD
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I have read with interest the discussion between Liz Wager and John Stone, and would like to add my thoughts concerning ‘Authorship’. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals [1] from the International Committee of Medical Journal Editors states: ‘Authorship credit should be based on 1) substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.’ Whereas the Committee on Publication Ethics (COPE) Guidelines on Good Publication Practice [2] states that: ‘The award of authorship should balance intellectual contributions to the conception, design, analysis and writing of the study against the collection of data and other routine work. If there is no task that can reasonably be attributed to a particular individual, then that individual should not be credited with authorship.’ It also states that: ‘If professional writers employed by pharmaceutical companies, medical agencies, or other parties have written the paper, then their names should be included, and any conflicts of interest declared.’ When deciding on authorship for a paper - especially one where there is a large study group - there are a number of complex issues which need to be addressed. Often there is also a political component to these discussions. However I do not feel that professional medical writers should be included as authors in most circumstances but rather acknowledged. Medical writers should not be authors as they are often employed to work on a paper when the study has been completed, and do not contribute to the conception or design, or acquisition of data. The most important reason for being an author is intellectual property in the design, concept, performance and analysis/reporting of a trial. Even if a medical writer helped to draft the study protocol the ‘intellectual property’ still belongs to those who had the study concept, designed it and completed the work. Medical writers can belong to the study group, particularly if they contributed to discussions on study design, statistical analysis and helped write the paper. Only if a medical writer had a really significant input into a trial could they be considered as an author. 1) http://www.icmje.org/ 2) http://www.publicationethics.org.uk/guidelines Competing interests: I work as a medical writer. |
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