Under a new initiative to publish corrections to misreported trials, the prestigious medical journal The BMJ (formerly known as the British Medical Journal) has published a study showing that the popular antidepressant paroxetine is neither safe nor effective for adolescents with depression.
The original, influential study was published in 2001. It was funded by major pharamecutical maker SmithKline Beecham, now GlaxoSmithKline (GSK). Known as Study 329, it compared the effectiveness and safety of the antidepressant drugs paroxetine and imipramine with placebo for adolescents with major depression. It reported that paroxetine was safe and effective for adolescents and was published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001.
The new results, published by The BMJ on 16 September, contradict the original research. Using previously confidential trial documents, the researchers led by Adelaide University professor Jon Jureidini, reanalysed the original data and found that neither paroxetine nor high dose imipramine was more effective than placebo in the treatment of major depression in adolescents. The authors considered the increase in harms with both drugs to be clinically significant. They conclude that "paroxetine was ineffective and unsafe in this study."
Paroxetine is sold in the US under the brand name Paxil. Its patent expired in 2003 and since then it is a commonly prescribed generic, including in India. It belongs to a class of chemicals known as SSRI's - selective serotonin reuptake inhibitors. Serotonin is a neurochemical that is thought to induce a feeling of wellbeing and happiness. The drug encourages reabsorption of serotonin produced by the body.
In an accompanying article, Peter Doshi, Associate Editor for The BMJ says the new paper "has reignited calls for retraction of the original study and put additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing."
He points out that the original manuscript was not written by any of the 22 named authors but by an outside medical writer hired by GSK. And that the paper's lead author - Brown University's chief of psychiatry, Martin Keller - had been the focus of a front page investigation in the Boston Globe in 1999 that documented his under-reporting of financial ties to drug companies.
The study was criticised by the Food and Drug Administration (FDA) in 2002. Yet, that year, over two million prescriptions were written for children and adolescents in the United States. In 2012 GSK was fined a record $3bn in part for fraudulently promoting paroxetine.
Doshi also details the refusal of the American Academy of Child and Adolescent Psychiatry to intervene and retract the paper, and Brown University's silence over its faculty's involvement in Study 329.
Dr Fiona Godlee, The BMJ Editor-in-Chief says publication of the reanalysed data from Study 329 "sets the record straight" and "shows the extent to which drug regulation is failing us." It also shows that the public and clinicians do not have the unbiased information they need to make informed decisions.
She calls for independent clinical trials rather than trials funded and managed by industry, as well as legislation "to ensure that the results of all clinical trials are made fully available and the individual patient data are available for legitimate independent third party scrutiny."
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