Papers

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

BMJ 2003; 326 doi: http://dx.doi.org/10.1136/bmj.326.7400.1171 (Published 29 May 2003) Cite this as: BMJ 2003;326:1171
  1. Hans Melander, senior biostatistician (hans.melander{at}mpa.se)1,
  2. Jane Ahlqvist-Rastad, senior medical officer1,
  3. Gertie Meijer, documentalist1,
  4. Björn Beermann1, professor
  1. 1 Medical Products Agency, Box 23, S-751 03 Uppsala, Sweden
  1. Correspondence to: H Melander
  • Accepted 6 March 2003

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.

Footnotes

  • Contributors: HM, JA-R, and BB designed the study. GM performed the search for publications based on the data submitted to the Swedish drug regulatory authority. HM and JAR reviewed the submitted reports and the publications, and extracted the data. HM performed the statistical analysis. HM, JAR, and BB interpreted the results. All authors contributed to writing the paper. HM is guarantor for the study.

  • Funding None.

  • Competing interests None declared.

  • Accepted 6 March 2003
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