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The new results, published by The BMJ, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.
The widely used antidepressant paroxetine is neither safe nor effective for adolescents with depression, concludes a reanalysis of an influential study originally published in 2001. The new results, published by The BMJ, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.
This is the first trial to be reanalyzed and published by The BMJ under an initiative called RIAT (Restoring Invisible and Abandoned Trials), which encourages abandoned or misreported studies to be published or formally corrected to ensure doctors and patients have complete and accurate information to make treatment decisions.
In 2001 SmithKline Beecham, now GlaxoSmithKline (GSK), funded a study (known as Study 329) to compare the effectiveness and safety of paroxetine and imipramine with placebo. The study was criticized by the FDA in 2002, but during that year, over two million prescriptions were written for children and adolescents in the U.S. In 2012 GSK was fined $3bn in part for fraudulently promoting paroxetine.
The RIAT team, led by Prof. Jon Jureidini at the University of Adelaide, identified this study as an example of a misreported trial in need of restoration. Using previously confidential trial documents, they reanalyzed 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.
The reanalysis of Study 329 “illustrates the necessity of making primary trial data and protocols available to increase the rigor of the evidence base,” say the authors.
Also, Dr. Fiona Godlee, The BMJ Editor-in-Chief, has called 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.”
Liberating the data from clinical trials has the potential to benefit patients, prevent harm, and correct misleading research, writes Prof. David Henry at the University of Toronto, in an accompanying editorial. Data sharing is not without its risks, but the pay-off from a systematic effort to reactivate important clinical trials will be high and will further justify the original huge investments of time and money, he concludes.
In this video, Peter Doshi, Associate Editor for The BMJ, explains RIAT.
Read the full release.