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

By H. Melander, J. Ahlqvist-rastad, G. Meijer, B. Beermann. British medical journal, 2003

648 citations recorded by the source corpus.

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.

Subfields: Pharmacology, Statistics and Probability, Toxicology

View Paper: https://www.semanticscholar.org/paper/7ea710ac1760f6d98e825f7d9996b351f9889c23

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Citations in the corpus

Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. (2007, background): “Authors or funders may have conflicts of interest that influence any of the following: the design of the study [228]; choice of exposures [228,229], outcomes [230], statistical methods [231], and selective publication of outcomes [230] and studies [232].”
Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? (2003, neutral): “Sample size Median (range)* 120 (10-14 046) 55 (12-497) 178 (13-82 892) 110 (11-3575)”
Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration (2008, background): “In the case of antidepressant medication, this limitation has been found to result in considerable reporting bias characterized by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies [5].”
Tricyclic antidepressant pharmacology and therapeutic drug interactions updated (2007, background): “One observer, Melander, has used the title ‘evidence b(i)ased medicine’ (Melander et al., 2003) to convey this notion, and there are some concerns that undue weight is being given to biased evidence (Goodman, 1999).”
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration (2007, positive): “Authors or funders may have conflicts of interest that influence any of the following: the design of the study (228); choice of exposures (228, 229), outcomes (230), statistical methods (231); and selective publication of outcomes (230) and studies (232).”
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. (2012, background): “It should be noted, however, that such analyses are often considerably ﬂawed [220].”