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BMJ. 2003 May 31;326(7400):1171-3.

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

Author information

  • 1Medical Products Agency, Box 23, S-751 03 Uppsala, Sweden. hans.melander@mpa.se

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.

PMID:
12775615
[PubMed - indexed for MEDLINE]
PMCID:
PMC156459
Free PMC Article

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