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Misrepresenting harms in antidepressant trials

BMJ 2016; 352 doi: (Published 28 January 2016) Cite this as: BMJ 2016;352:i217
  1. Joanna Moncrieff, senior lecturer
  1. Division of psychiatry, University College London, London W1T 7NF, UK
  1. j.moncrieff{at}

New evidence from clinical study reports reveals misclassification, misrepresentation, and under-reporting of serious harm

People in the United Kingdom are consuming more than four times as many antidepressants as they did two decades ago.1 Despite this, we still do not fully understand the effects of these drugs, nor can we be confident about their risk-benefit ratio.

Unresolved problems include the nature and frequency of potential serious adverse effects such as self harming or suicidal actions, suicidal ideation, and aggression. In the linked paper, Sharma and colleagues use clinical study reports to explore such adverse effects.2 Clinical study reports are prepared by pharmaceutical companies for obtaining marketing authorisation. Guidelines on the contents and presentation of clinical study reports exist,3 but requirements are not mandatory. Consequently, although clinical study reports usually contain more data than published articles,4 the level of detail varies. Moreover, what is reported in the body of the clinical study reports may differ from data in …

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