Ghost writers need to be more visible
BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39104.595463.94 (Published 25 January 2007) Cite this as: BMJ 2007;334:208
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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
Competing interests: No competing interests
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 My website is correct but a bit out of date (mea culpa) --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.
Competing interests: No competing interests
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
[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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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.
Competing interests: No competing interests
Author's Response
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.
Competing interests: No competing interests