Analysis

Finding studies on reboxetine: a tale of hide and seek

BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c4942 (Published 12 October 2010) Cite this as: BMJ 2010;341:c4942
  1. Beate Wieseler, deputy head of department of drug assessment,
  2. Natalie McGauran, researcher,
  3. Thomas Kaiser, head of department of drug assessment
  1. 1Institute for Quality and Efficiency in Health Care, Dillenburger Strasse 27, 51105 Cologne, Germany
  1. Correspondence to: B Wieseler beate.wieseler{at}iqwig.de
  • Accepted 16 August 2010

Beate Wieseler, Natalie McGauran, and Thomas Kaiser use their experience with the assessment of reboxetine to illustrate how publication bias affects health policy decisions and offer some solutions

The antidepressant reboxetine, a selective noradrenaline (norepinephrine) reuptake inhibitor, has been approved in several European countries (including the United Kingdom and Germany) since 1997. However, approval was declined in the United States in 2001. The German Institute for Quality and Efficiency in Health Care (IQWiG) report on the benefit and harm of newer antidepressants concluded in 2009 that, overall, reboxetine was both ineffective and potentially harmful.1 2

What is IQWiG?

  • An independent non-government and non-profit foundation (www.iqwig.de)

  • Established in 2004 as part of German healthcare reform

  • Mainly funded by a levy on inpatient and outpatient services

  • Produces health technology assessments on diagnostic or therapeutic interventions and health economic evaluations for the Federal Joint Committee (G-BA)—the statutory health insurance system’s main decision making body

  • Publishes evidence based consumer health information (www.informedhealthonline.org)

  • Appraises clinical practice guidelines

Data from the IQWiG report are published in the accompanying systematic review of reboxetine versus placebo and selective serotonin reuptake inhibitors for acute treatment of major depression, which includes previously unpublished data.3 An additional analysis of published versus both published and unpublished evidence shows that published evidence overestimates the benefit of reboxetine, while underestimating harm. These typical effects of publication bias have been identified (and in part quantified) not only in other research on antidepressants4 5 but in a wide range of treatments.6 7

Biased evidence may form part of a marketing strategy. Analyses of litigation documents, which are available at the Drug Industry Document Archive (http://dida.library.ucsf.edu), have shown how trials and journal publications are used as marketing tools to promote drug use.8 9 A striking example is the promotion of the …

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