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Research Article

Ghost Authorship in Industry-Initiated Randomised Trials

  • Peter C Gøtzsche mail,

    To whom correspondence should be addressed. E-mail: pcg@cochrane.dk

    Affiliation: Nordic Cochrane Centre, Copenhagen, Denmark

    X
  • Asbjørn Hróbjartsson,

    Affiliation: Nordic Cochrane Centre, Copenhagen, Denmark

    X
  • Helle Krogh Johansen,

    Affiliation: Nordic Cochrane Centre, Copenhagen, Denmark

    X
  • Mette T Haahr,

    Affiliation: Nordic Cochrane Centre, Copenhagen, Denmark

    X
  • Douglas G Altman,

    Affiliation: Centre for Statistics in Medicine, Oxford, United Kingdom

    X
  • An-Wen Chan

    Affiliation: Department of Medicine, University of Toronto, Canada

    X
  • Published: January 16, 2007
  • DOI: 10.1371/journal.pmed.0040019
  • Published in PLOS Medicine

Reader Comments (2)

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Criticism is unwarranted: Please read our paper again

Posted by plosmedicine on 31 Mar 2009 at 00:13 GMT

Author: Peter Gøtzsche
Position: Director, MD, DrMedSci, MSc
Institution: Nordic Cochrane Centre
E-mail: pcg@cochrane.dk
Additional Authors: Hróbjartsson A, Johansen HK, Altman DG, Chan A-W
Submitted Date: September 12, 2007
Published Date: September 12, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

The critique of our paper by Barton Moffatt is unwarranted as we have already addressed the issues he raises. In reply, we therefore quote from our paper:

"[Our] criteria were an operationalisation of the guidelines published by the International Committee of Medical Journal Editors [4], which state that an author is someone who has made substantive intellectual contributions to a published study. Furthermore, authorship credit should be based on (1) substantial contributions to concept ion 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."

"We believe that all who contribute in a major way under both (1) and (2) should be authors."

"Our criteria are similar to those used in two previous surveys of authors [1,6], and by these criteria we found evidence of ghost authorship in 75% of the articles."

"These findings are in sharp contrast to a survey, with a 75% response rate, of 704 authors of manuscripts submitted to the BMJ and the Annals of Internal Medicine (only a minority of which were randomised trials), which found that statisticians and similar methodologists who had made a significant contribution at some stage of the research process were authors in 86% of the cases [7].

"We take issue with this widespread practice of not including statisticians as authors for reports of randomised trials. Multicentre trials are often complex and generate large datasets, and the trials we reviewed were no exception [3]. Furthermore, the statistical report is a fundamental part of the research that has a crucial influence on what is written in the publication. Omission of a company statistician, usually also from the acknowledgment section, deprives readers of a key insight into the role of the company, although it is sometimes evident that reports of industry-sponsored trials contain sophisticated statistical analyses that are beyond the capabilities of the authors [8]. We cannot exclude the possibility that data analyses in some of the trials, and corresponding sections in protocols, were performed by company employees who were named authors but not statisticians, but it is unlikely since the pharmaceutical corporations usually have strong departments of statistics [8]."

"We believe it is wrong to deny a person who has contributed substantially (e.g., by performing the statistical analyses and by writing the statistical report) the opportunity to comment on the paper and finally approve of it, thereby fulfilling all three criteria for authors defined by the International Committee of Medical Journal Editors [4]."

Finally, we do not agree that contributorship lists are not useful. When authors have declared publicly in what ways they have contributed to the paper, it is possible for others who are familiar with the study to protest if some of these declarations are wrong, e.g. in a letter to the editor.

No competing interests declared.