The ethics of authorship and the systematic omission of statisticians
- From: "Gary" <LanceGary@xxxxxxxxx>
- Date: 19 Jan 2007 04:49:04 -0800
Authors, Ghosts, Damned Lies, and Statisticians
Elizabeth Wager
Funding: EW was paid a commission by PLoS to write this piece.
Competing Interests: 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.
Citation: Wager E (2007) Authors, Ghosts, Damned Lies, and
Statisticians. PLoS Med 4(1): e34 doi:10.1371/journal.pmed.0040034
Published: January 16, 2007
Copyright: © 2007 Elizabeth Wager. 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.
Abbreviations: ICMJE, International Committee of Medical Journal
Editors
Elizabeth Wager is a publications consultant, Princes Risborough,
United Kingdom. E-mail: liz@...
--------------------------------------------------------------------------------
Since the earliest peer-reviewed publications of the late 17th century,
conventions about the authorship of scientific papers-which were
generally anonymous and attributed to the sponsor (in those days,
usually the church or the king)-have evolved considerably [1].
Readers now want to know not only who paid for the research but also
who did the work. Transparency (i.e., full disclosure) is now
considered a moral responsibility, and many medical journals have
introduced mechanisms for increasing transparency [2]. The
International Committee of Medical Journal Editors (ICMJE) has also
issued guidance on who qualifies for authorship [3], and their criteria
have been updated and augmented several times in response to several
authorship scandals [4]. Yet problems with authorship persist.
A New Study on Ghost Authors
In a new study published in PLoS Medicine, Peter Gøtzsche and
colleagues compared research protocols with study publications to
examine the prevalence and nature of ghost authorship in 44
industry-initiated randomized trials [5]. They defined ghost authorship
as occurring when anybody who wrote the protocol, did the statistical
analysis, or wrote the manuscript was not listed as an author. Using
this criterion of ghost authorship (which is based, loosely, on the
ICMJE definition), they showed that 75% of the publications had ghost
authors and, in all cases, the ghosts were statisticians.
This study is unique in using information from research protocols
(which were provided by a Danish research ethics committee) to look for
evidence of ghost authorship. Previous studies have either contacted
named authors [6] or relied solely on disclosures in publications [7].
All methods have serious limitations. Named authors may be unwilling to
admit that deserving colleagues have been omitted from the author list,
and may also be reluctant to disclose the contributions of ghosts in
the acknowledgments section. Protocols, written at the start of a
study, might not record significant but unanticipated contributions or
changes in personnel.
Readers want to know who paid for the research and who did the work.
Another unusual feature of Gøtzsche et al.'s study is the focus on
statisticians. Most previous investigations and commentaries have
focused on the involvement of medical writers. Gøtzsche et al.
examined whether the person who wrote the protocol was included as an
author on the subsequent publication. However, only five of the 44
protocols had named authors (in all cases, employees of the sponsoring
company), and none of them were listed as authors or mentioned in the
acknowledgments in the publication.
Professional medical writers are often involved in writing protocols
and in preparing manuscripts for publication, but it has proved
difficult to determine the frequency of such involvement [7,8]. Writers
preparing protocols often work within the clinical or regulatory
affairs departments of the sponsor, while those developing publications
are more often freelance or employed by medical communications
agencies. In other words, the individuals who work on protocols are
usually not the same as those who prepare publications, so Gøtzsche
and colleagues' study probably underestimated the number of writers who
worked on the publications.
Are Medical Writers and Statisticians Truly Authors?
The question of whether writers merit authorship if they are involved
only at the publication stage of a study has not been resolved.
Guidelines from the European Medical Writers Association state that
such writers usually do not qualify for authorship although their role
should be acknowledged [9]. The ICMJE criteria state that all authors
should have made a substantial contribution not only to developing the
manuscript but also to other aspects such as collecting, analysing, or
interpreting the data [3]. It could be argued that the act of drafting
a manuscript always involves an element of interpretation, yet many
writers feel they do not fulfil the overarching principle that authors
should be able to take public responsibility for the study.
However, the role of statisticians is slightly clearer. The ICMJE
criteria state that involvement in data analysis (or study design) and
contribution to the manuscript is a qualification for authorship.
Gøtzsche and colleagues highlight what they call the "widespread
practice of not including statisticians as authors for reports of
randomised trials" and note that this "deprives readers of a key
insight into the role of the company." They urge editors to change
from the traditional system of simply listing authors' names to listing
individuals' specific contributions to research projects. Such a
"contributorship" system was proposed almost ten years ago [10] and
has been endorsed by the ICMJE [3], yet it has not been widely adopted
outside the largest general medical journals.
Listing contributions has many advantages. It makes it easier for
editors to detect ghost authors (if key roles such as data analysis or
drafting a manuscript are missing from the list) and guest authors (who
are listed despite having made little or no contribution to the study
or publication).
Implications of the Study
One clear implication of Gøtzsche et al.'s study is that the ICMJE
authorship criteria are widely ignored. This may not be surprising in
light of an earlier study that showed that 62% of a sample of 66
British academics disagreed with at least one aspect of the ICMJE
criteria [11]. However, Gøtzsche and colleagues' study is the first to
show how often statisticians are omitted from authorship lists. This
omission might suggest either that the ICMJE criteria should be revised
to reflect current thinking or that it should be more strongly
enforced. But journal editors are often not well placed to detect
authorship abuse (especially missing authors) and have a poor track
record in terms of educating contributors about authorship criteria. A
more pragmatic approach would be to adopt the contributorship system
and let researchers and readers make up their own minds about who
deserves to be listed.
In choosing the title for this article, I thought I'd adapt the
aphorism that there are three types of lie: lies, damned lies, and
statistics. But, writing a piece about authorship, I thought I should
check to see who coined this phrase. Ironically, the authorship of this
memorable quote is uncertain (although it has been attributed to
Benjamin Disraeli and was used by Mark Twain) [12]. Whoever the author
was, perhaps we should now admit that there are four types of lie:
lies, damned lies, statistics, and the authorship lists of scientific
papers, and that statisticians may be able to help prevent both the
third and fourth types.
References
Biagioli M (1998) The instability of authorship: Credit and
responsibility in contemporary medicine. FASEB J 12: 3-16. Find this
article online
Abbasi K (2004) Transparency and trust. BMJ 329.
doi:10.1136/bmj.329.7472.0-g.
International Committee of Medical Journal Editors (2006) Uniform
requirements for manuscripts submitted to biomedical journals: Writing
and editing for biomedical publication. Available:
http://www.icmje.org. Accessed 11 December 2006.
Huth E, Case K (2004) The URM: Twenty-five years old. Science Editor
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Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al
(2007) Ghost authorship in industry-initiated randomised trials. PLoS
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doi:10.1136/bmj.329.7478.1345. Find this article online
Jacobs A, Wager E (2005) European Medical Writers Association (EMWA)
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publications. Curr Med Res Opin 21: 317-321. Find this article online
Rennie D (1997) When authorship fails. A proposal to make contributors
accountable. JAMA 278: 579-585. Find this article online
Bhopal R, Rankin J, McColl E, Thomas L, Kaner E, et al. (1997) The
vexed question of authorship: Views of researchers in a British medical
faculty. BMJ 314: 1009-1012. Find this article online
Wikipedia (2006) Lies, damned lies, and statistics. Available:
http://en.wikipedia.org/wiki/Lies,_damned_lies,_and_statistics.
Accessed 11 December 2006.
Source: PLoS [Open Access]
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040034
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