No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility

  title={No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility},
  author={Peter Doshi},
  journal={BMJ : British Medical Journal},
  • P. Doshi
  • Published 16 September 2015
  • Medicine
  • BMJ : British Medical Journal
As a new data analysis adds weight to calls for retraction of a paper on paroxetine in adolescents, Peter Doshi examines the resistance to action of a professional society, its journal, and an Ivy League university 
Restoring Study 329: Paroxetine neither effective nor safe for adolescents
A major reanalysis of Study 329, a Glaxo Smith Kline (GSK) randomised controlled trial (RCT) comparing paroxetine, imipramine and placebo published in the British Medical Journal (BMJ), has concluded
Study 329 and the use of paroxetine in child and adolescent unipolar depression
The authors demonstrated that the antidepressant is neither safe nor effective in adolescent depression, and highlighted the need of making primary trial data and protocols available to increase the thoroughness of the evidence.
The Ethical Judgment: Chemical Psychotropics
In the case of psychotropic and nootropic substances, evidence is abundant that the pharmaceutical industries are violating elementary ethical norms, implying a serious liability not only for company
2015: a year in review
  • S. Arie
  • Medicine
    BMJ : British Medical Journal
  • 2015
Sophie Arie looks back at some of the journal’s most important and widely read articles of 2015.
Just Evidence: Opening Health Knowledge to a Parliament of Evidence
This is the Accepted Manuscript of a published book chapter. The publisher's version appears in "Science, Information, and Policy Interface for Effective Coastal and Ocean Management", Chapter 14.
Liberating the data from clinical trials
Liberated trial data have enduring potential to benefit patients, prevent harm, and correct misleading research
MedEdTrials: Protocol registration for medical education research
This paper argues for the creation of such a registration site and agreement by medical education journals as a matter of ethical necessity.
Benefits, harms and evidence – reflections from UK primary healthcare
It is concluded that even perfect knowledge about benefits and harms requires to be translated in the context of the individual patient: it also requires to been interpreted according to what that persons’ wishes are.
The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States
All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.
The Sunshine Act: Moving Forward.


Restoring invisible and abandoned trials: a call for people to publish the findings
Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.
Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial.
Paroxetine demonstrated significantly greater improvement compared with placebo in Hamilton Rating Scale for Depression total score < or = 8, HAM-D depressed mood item, K-SADS-L depressed Mood item, and CGI score of 1 or 2.
Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base and access to primary data from trials has important implications for both clinical practice and research.