Feature Research Conduct

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

BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4629 (Published 16 September 2015) Cite this as: BMJ 2015;351:h4629
  1. Peter Doshi, associate editor, The BMJ
  1. pdoshi{at}bmj.com

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

A major reanalysis just published in The BMJ of tens of thousands of pages of original trial documents from GlaxoSmithKline’s infamous Study 329, has concluded that the antidepressant paroxetine is neither safe nor effective in adolescents with depression.1 This conclusion, drawn by independent researchers, is in direct contrast to that of the trial’s original journal publication in 2001, which had proclaimed paroxetine “generally well tolerated and effective.”2 The new paper, published under the restoring invisible and abandoned trials (RIAT) initiative,3 has reignited calls for retraction of the original study, putting additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing.

Troubled from the start

Few studies have sustained as much criticism as Study 329, a placebo controlled, randomized trial of paroxetine and imipramine carried out by SmithKline Beecham (which became GlaxoSmithKline (GSK) in 2000). In 2002, a US Food and Drug Administration officer who formally reviewed the trial reported that “on balance, this trial should be considered as a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin.”4 Yet this same year, according to the New York State Attorney General’s office, which sued GSK, over two million prescriptions were written for children and adolescents in the United States, all off-label, after a marketing campaign that characterized Study 329 as demonstrating “REMARKABLE Efficacy and Safety.”

The disparity between what the manufacturer and study authors claim the trial found and what other parties say the data show was an important element in the US Department of Justice’s criminal charges against GSK. In 2012, …

View Full Text

Sign in

Log in through your institution

Free trial

Register for a free trial to thebmj.com to receive unlimited access to all content on thebmj.com for 14 days.
Sign up for a free trial

Subscribe