A re-examination of a study initially published in the American Journal of Child and Adolescent Psychiatry in 2001 has some worrying results to report. It turns out that paroxetine, a popular anti-depressant, is not only ineffective, but also unsafe for treating children and adolescents. The medicine also proved to increase some of the teenagers’ risk of suicidal behavior.
The original trial’s findings were contradicted by a study issued in the British Medical Journal, establishing that the drug paroxetine was highly unsuitable and unsafe for treating severe depression in young people. The former drugs company SmithKline Beecham, now GlaxoSmithKline funded the initial study.
Called Study 329, GlaxoSmithKline’s research was heavily criticized, and the FDA issued a record $3 billion for “fraudulently promoting paroxetine.” Their trial is the first to be re-analyzed under the new policy that seeks to correct any misreported studies.
This re-examination was possible due to the release of previously confidential documents, and a new team of researchers took a hard look at the way the trial was conducted. Study 329’s aim was to test the safety and effectiveness of using imipramine and paroxetine, two anti-depressant drugs, in treatment for severely depressed adolescents.
When compared to a placebo, both imipramine and paroxetine proved to be no more effective. Moreover, both had caused increased harm measured in the teenager’s response, so much so that it became clinically significant. The new team led by Professor Jon Jureidini at the University of Adelaide concluded that “paroxetine was ineffective and unsafe in this study.”
The paroxetine group presented serious side-effects, such as suicidal ideation and behavior, while the teenagers in the imipramine group dealt with cardiovascular problems. In addition to requiring further investigations, such discoveries are expected to call for the original study to be retracted.
Re-examining the claims of Study 329 resulted in a second trial that concurs with the long-standing view that antidepressants like paroxetine are associated with an increased risk of suicidality in pediatric and teen patients. This move is part of the Restoring Invisible and Abandoned Trials project which seeks to make clinical trials more transparent and available to all.
According to a GSK statement, the second team of researchers had been offered helped in their analysis, as the drugs company provided access to the original trial’s data. Their response desires to reflect a renewed commitment to data transparency.
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