The ghostwriters in the machine

Ghostwriting - undeclared authorship - is rife in industry-sponsored trials, which means clinicians "cannot always accurately judge or trust" the paper, according to a study published in PLoS Med (Gøtzsche P. C., et al. PloS Med., 4. e19 (2007)).

Researchers, led by Peter Gøtzsche from the Nordic Cochrane Centre, Copenhagen, Denmark, compared the protocols and publications for 44 trials initiated by the industry and approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994 to 1995.

They defined ghost authorship as when "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".

Gøtzsche and colleagues found evidence for ghost authorship in 75% of the trials.

This proportion increased to 91% when they included papers that acknowledged people who qualified for authorship (rather than the contributor appearing as an author). In most cases - 31 trials - the ghost authors were statisticians.

Eight and four publications respectively acknowledged the assistance of statisticians and medical writers. Gøtzsche and colleagues believe that as they had "very limited information to identify the possible omission of other individuals who would have qualified as authors" they probably overlooked some ghost authors.

"We take issue with this widespread practice of not including statisticians as authors for reports of randomised trials," Gøtzsche and colleagues comment. They remark that multicentre trials are often complex and generate large datasets and the statistical report "has a crucial influence" on the publication.

"Omission of a company statistician," they say "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".

An accompanying editor's summary comments that 'hiding' the role of statisticians, medical writers and so on "means that people who read the published paper cannot always accurately judge or trust the information presented within it, and competing interests may be hidden." Gøtzsche and colleagues suggest that following existing guidelines and making protocols publicly available would improve transparency.

By Mark Greener

Source: PharmaTimes