Healthy Skepticism Library item: 1915

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B.
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
http://bmj.bmjjournals.com/cgi/content/full/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.

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