Article Text

PDF
Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity
  1. L McGoey1,
  2. E Jackson2
  1. 1
    James Martin Institute, Saïd Business School, Oxford University, Oxford, UK
  2. 2
    London School of Economics and Political Science, London, UK
  1. Professor E Jackson, Law Department, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK; e.jackson{at}lse.ac.uk

Abstract

This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.

Statistics from Altmetric.com

Footnotes

  • Competing interests: None.

  • i Linsey McGoey interview with Kent Woods, January 2007.

  • ii We are grateful to Catherine Will for this point.

  • iii See also McGoey 2007, p226 for further discussion of these points.14

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.