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A team of international researchers have re-examined a study that found a psychiatric drug a safe and effective treatment for depression in adolescents, with vastly different results.
They found the drug paroxetine to be ineffective and associated with serious side effects.
The team, led by professor Jon Jureidini, from the University of Adelaide’s Critical and Ethical Mental Health Research Group at the Robinson Research Institute, reanalysed Study 329, a randomised controlled trial funded by SmithKline Beecham (now GlaxoSmithKline), which was reported in 2001 as having found that the drug paroxetine was effective and safe for depression in adolescents.
Jureidini said: “Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren’t able to identify all of the errors in the published report.”
“It wasn’t until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviours, compared with only one person in the group of patients who took the placebo,” he said. “Our study also revealed that paroxetine was no more effective at relieving the symptoms of depression than a placebo.”
He said prescribing this drug might have put young patients at unnecessary risk from a treatment that was supposed to help them.
Jureidini added that the reanalysis of Study 329 taught the team a lot about incorrect reporting and the considerable fallout that can be associated with distorted data. He is calling on regulatory research authorities to mandate that all data and protocols be accessible. “Although concerns about patient confidentiality and ‘commercial in confidence’ issues are important, the reanalysis of Study 329 illustrates the necessity of making primary trial data available to increase the rigour of evidence-based research.”
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