Ghost authorship of industry funded drug trials is common

January 15, 2007

Ghost authorship is the failure to name, as an author, an individual who has made a substantial contribution to a scientific article. A study of 44 industry-initiated trials from Denmark in the 1990s found evidence of ghost authorship for 33 trials, which increased to 40 if a person qualifying for authorship was just acknowledged rather than being named as an author.

The researchers, led by Peter C. Gøtzsche from the Nordic Cochrane Centre, Copenhagen, Denmark, studied all published industry-initiated randomised trials approved in 1994-1995 by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in Denmark. They compared the full trial protocols (which were written before the trial was begun) approved by these ethical committees with the primary scientific report which resulted from these trials, and which was published in a peer-reviewed journal.

Ghost authorship was defined as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. Of the 44 trials included, 43 were initiated by one of 26 multinational pharmaceutical firms and one by a local company.

In 31 trials, the ghost authors identified were statisticians. Eight publications acknowledged the assistance of statisticians, and four acknowledged the assistance of medical writers. Conversely, although all published reports had clinicians as authors no trial protocol or publication stated explicitly that the study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. It was also unclear whether clinicians had contributed to the protocols.

This study is the first that has systematically examined the prevalence of ghost authorship using a cohort of protocols and corresponding publications. The authors conclude that "ghost authorship in industry-initiated randomised trials is very common, and we believe that this practice serves commercial purposes". They go on to urge that in order to reduce the prevalence of ghost authorship existing guidelines, such as those drawn up by the International Committee on Medical Journal Editors, World Association of Medical Editors and European Medical Writers Association are followed. This action could increase the chance that publications accurately, fairly, and comprehensively reflect the data collected from trials

A related perspective by Liz Wager, an independent editorial consultant, who has been involved in drawing up guidelines for medical writers, discusses the implication of these findings further.
-end-
Citation: Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, et al. (2007) Ghost authorship in industry-initiated randomised trials. PLoS Med 4(1): e19.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040019
PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-04-01-gotzsche.pdf
Related image for press use: http://www.plos.org/press/plme-04-01-gotzsche.jpg

- Caption: Ghost authors at work (illustration: Jacob Riis)

CONTACT:

Dr. Peter C Gotzsche
Nordic Cochrane Centre, Rigshospitalet 3343
Blegdamsvej 9
Copenhagen, 2100 O, Denmark
+45 35 45 70 04
pcg@cochrane.dk

Related PLoS Medicine Perspective article:

Citation: Wager E (2007) Authors, ghosts, damned lies, and statisticians. PLoS Med 4(1): e34. doi:10.1371/journal.pmed.0040034

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040034


PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-04-01-wager.pdf CONTACT:

Liz Wager
Sideview
Publications Consultant
19 Station Road
Princes Risborough, Bucks HP27 9DE, United Kingdom
+44-1844-275814
+44-1844-275034 (fax)
liz@sideview.demon.co.uk

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org

All works published in PLoS Medicine are open access. Everything is immediately available without cost to anyone, anywhere--to read, download, redistribute, include in databases, and otherwise use--subject only to the condition that the original authorship is properly attributed. Copyright is retained by the authors. The Public Library of Science uses the Creative Commons Attribution License.

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