Re-Assessing a Ghost-Written Article on Paroxetine in Adolescent Depression

BMJ Evidence-based medicine blog. Primary Care Corner with Geoffrey Modest MD

BMJ published an article finding the lack of benefit of either paroxetine or imipramine in adolescents with major depressive disorder (see BMJ 2015;351:h4320). To me, this study was really interesting because it resulted from an initiative called RIAT (Restoring Invisible and Abandoned Trials), an attempt by an international group to challenge the selective reporting of outcomes of randomized controlled trials, either because the results were never published or were misreported.

In this case, the study (Study 329) was funded by a drug company (smithkline beecham), reported in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry, but “was largely ghostwritten, claimed efficacy and safety for paroxetine that was at odds with the data” (see Account Res 2008; 15: 152, which found that Study 329 showed “how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 of paroxetine pediatric use was negative for efficacy and positive for harm”). The concern was that this was an important article influencing the use of antidepressants, including paroxetine, in adolescents.

Carry on reading the full post here

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