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BMJ 2009; 339 doi: (Published 19 November 2009) Cite this as: BMJ 2009;339:b4816

Litigation uncovers biased reporting of gabapentin trials

Research documents made public during legal proceedings against drug manufacturers provide useful insights into the subtle (and often advantageous) changes that can occur between the protocol stages of a trial and final publication. When researchers recently scrutinised industry sponsored trials evaluating off-label use of gabapentin, they found that in eight of 12 trials the primary outcome in the published paper was different from the primary outcome specified in the protocol. In five trials, primary outcomes specified in the protocol were missing from the published paper. In six trials, the published paper reported a completely new primary outcome. In two trials, the primary outcome specified in the protocol was relegated to a secondary outcome in the published paper. The treatment effect (measured by the P value) and the primary outcome matched in just one of nine trials that were published in full.

Secondary outcomes were even less consistent—122 of the 180 secondary outcomes listed in trial protocols were omitted from published reports.

This kind of selective reporting isn’t confined to industry sponsored trials, say the authors, but it generally distorts the published evidence in favour of the treatment under investigation—in this case gabapentin. Systematic reviews should be updated when protocols and unpublished trials are released through litigation. In the meantime, journal publication “should not be used as a marketing tool for off-label drug use.”

Resistant swine flu emerges in Canada

Doctors in Quebec, Canada, report the emergence of pandemic influenza resistant to oseltamivir in a 59 year old man. He began taking oseltamivir as post-exposure prophylaxis after his son developed laboratory confirmed pandemic H1N1 influenza A (swine flu). Twenty four hours later the man developed symptoms himself. A nasopharyngeal aspirate taken at the end of the week contained the same pandemic strain of H1N1 that infected his son. But whereas the son’s virus had been …

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