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Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity

McGoey, Linsey and Jackson, Enily (2009) 'Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity.' Journal of Medical Ethics, 35 (2). pp. 107-112. ISSN 0306-6800

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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.

Item Type: Article
Uncontrolled Keywords: Humans; Paroxetine; Antidepressive Agents, Second-Generation; Drug Approval; Disclosure; Drug Industry; Bioethical Issues; Ethics, Medical; Moral Obligations; Clinical Trials Data Monitoring Committees; Clinical Trials as Topic; United Kingdom
Subjects: H Social Sciences > H Social Sciences (General)
K Law > K Law (General)
R Medicine > R Medicine (General)
Divisions: Faculty of Social Sciences
Faculty of Social Sciences > Sociology, Department of
SWORD Depositor: Elements
Depositing User: Elements
Date Deposited: 17 Jan 2013 15:58
Last Modified: 06 Jan 2022 13:29

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