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

BMJ. 2003 May 31;326(7400):1171-3. doi: 10.1136/bmj.326.7400.1171.

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.

Publication types

  • Review

MeSH terms

  • Depressive Disorder / drug therapy
  • Drug Evaluation
  • Drug Industry / economics*
  • Humans
  • Publication Bias*
  • Publishing / statistics & numerical data*
  • Randomized Controlled Trials as Topic / standards
  • Research / standards
  • Research Support as Topic*
  • Serotonin Uptake Inhibitors / therapeutic use*

Substances

  • Serotonin Uptake Inhibitors