Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications

Any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.

Abstract

OBJECTIVES: To investigate the relative impact on publication bias caused by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies. DESIGN: 42 placebo controlled studies of five selective serotonin reuptake inhibitors submitted to the Swedish drug regulatory authority as a basis for marketing approval for treating major depression were compared with the studies actually published (between 1983 and 1999). RESULTS: Multiple publication: 21 studies contributed to at least two publications each, and three studies contributed to five publications. Selective publication: studies showing significant effects of drug were published as stand alone publications more often than studies with non-significant results. Selective reporting: many publications ignored the results of intention to treat analyses and reported the more favourable per protocol analyses only. CONCLUSIONS: The degree of multiple publication, selective publication, and selective reporting differed between products. Thus, any attempt to recommend a specific selective serotonin reuptake inhibitor from the publicly available data only is likely to be based on biased evidence.