[e-drug] Evidence b(i)ased medicine

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E-drug: Evidence b(i)ased medicine
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BMJ  326:1171-1173 (31 May 2003)
 
Evidence b(i)ased medicine - selective reporting from studies
sponsored by pharmaceutical industry: review of studies in new
drug applications 
Hans Melander, Jane Ahlqvist-Rastad, Gertie Meijer, Bj?rn
Beermann

Correspondence to: H Melander hans.melander@mpa.se 

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. 
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