An antidepressant that has been prescribed to American teenagers for well over a decade has been declared both unsafe for adolescent use and no more effective than a placebo. The original trial data for the antidepressant drug paroxetine (also known as Pexeva and Paxil) was reanalyzed, and the results are enough to make parents shudder. A randomized-controlled trial of this kind has never been reanalyzed in this manner before. The new review of existing data looked at previously confidential documents from the original trial, and this startling new information has been published by the highly respected BMJ under its RIAT (Restoring Invisible and Abandoned Trials) initiative. The initiative that resulted in the new declaration about this commonly prescribed antidepressant has been established to reanalyze abandoned or misreported studies and formally correct them.
“Jureidini and his colleagues said that Study 329 contained numerous transcription errors and other problems that masked issues and violated the own company’s protocols for statistical analysis,” the Washington Post stated.
Glaxo SmithKline researchers said antidepressant Paxil is safe for teens. It’s actually deadly. http://t.co/T0dS7LdXfk
— Michael Cholbi (@MichaelCholbi) September 20, 2015
The teen use of paroxetine research was led by Prof. Jon Jureidini of the University of Adelaide. The original study was funded by the corporation that was at the time SmithKline Beecham, but is now GlaxoSmithKline (GSK). The original trial claimed that paroxetine, best known as Paxil, was both safe and effective for use by teens. That original study was known as 329, and it was published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001. A year after publication, the FDA said that “on balance, this trial should be considered as a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin,” but despite the FDA’s understanding that this trial’s conclusion had nothing to do with the actual data, still over two million prescriptions for the common antidepressant were written for American children and teens in the years that followed.
— New York Magazine (@NYMag) September 20, 2015
Using the exact same data as the original study, the new reanalysis found “paroxetine neither statistically nor clinically significantly different from placebo,” and the other antidepressant in the study, imipramine, was also no better than a placebo. As if that wasn’t bad enough, these drugs, during the trial, demonstrated clinically significant increases in negative side effects, including thoughts of suicide and suicidal behavior. Another point that came up with the new paper is that the original manuscript that was published was never actually written by any of the 22 different authors listed. It was actually written by a writer that worked for the drug companies. Three years ago, GSK was fined three billion dollars, in part for the fraud involving the promotion of the antidepressant paroxetine, according to Medical News Today.
According to the BJM, the marketing campaign declared that Study 329, the original safety and efficacy trial of paroxetine, declared the antidepressant as having “REMARKABLE Efficacy and Safety,” of course, what was remarkable was that it was never safe or effective for teens after all.
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