Paroxetine, a psychiatric drug that claims to treat depression in children and adolescents, is actually not effective and is associated with serious side effects, say researchers at the University of Adelaide (UA) in Australia. The findings were announced on September 17, 2015, published in the journal BMJ.
Professor Jon Jureidini of the newly created Critical and Ethical Mental Health Research Group (CEMH) at the UA’s Robinson Research Institute led a team of international researchers in a re-examination of Study 329, a randomized controlled trial which evaluated the efficacy and safety of paroxetine, also known as Aropax, Paxil, Seroxat. Researchers compared the effects of the drug as a treatment for adolescents with major depression and a placebo. SmithKline Beecham (now GlaxoSmithKline) funded Study 329 and reported in 2001 that paroxetine was safe and effective.
Jureidin says that says that researchers and clinicians raised concerns about the study and how it was reported, but they could not identify all the errors because the data was not available for analysis. He says that it is important that past research study data and protocols are accessible to researchers to be reviewed and scrutinized. Study 329 was identified as being in need of review because the original funder did not want to revisit the trial.
“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 to only one person in the group of patients who took the placebo,” Jureidin said. “Our study also revealed that paroxetine was no more effective at relieving the symptoms of depression than a placebo.”
The reanalysis led researchers to different conclusions that the original paper. “We also learnt a lot about incorrect reporting and the considerable fall out that can be associated with distorted data,” Jireidin said.
Regulatory research authorities should mandate that all data and protocols are accessible to clinicians, he added. “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.”
The trial is the first to be re-analyzed and published by the BMJ under an initiative called RIAT (Restoring Invisible and Abandoned Trials). The initiative encourages abandoned or misreported studies to be formally corrected or published to ensure that patients and their doctors have accurate information about treatments.