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The widely prescribed antidepressant paroxetine — sold under the names Paxil, Aropax, and Seroxat — has been found to be neither a safe nor effective treatment for depression in adolescents, according to a new reanalysis of research initially published in 2001.
The new paper is published today in the BMJ. It contradicts the findings of the original study, which was funded by the drug’s manufacturer and concluded that paroxetine was safe and effective in treating major depression in children and teenagers.
This new analysis “sets the record straight,” as per the journal’s editor-in-chief, Dr. Fiona Godlee.
It is the first published reanalysis of a drug trial by a group of researchers collaborating on an initiative called RIAT (Restoring Invisible and Abandoned Trials), an effort aimed at officially correcting abandoned or misreported studies to ensure doctors and patients have the most accurate information.
The original research, published in the Journal of the American Academy of Child and Adolescent Psychiatry, was funded by SmithKline Beecham, now called GlaxoSmithKline (GSK). Referred to in the scientific community as Study 329, it has received a lot of criticism over the years. An officer from the United States Food and Drug Administration even deemed it a “failed trial” after a 2002 investigation.
The New York State Attorney General’s Office sued GSK in 2004, accusing the company of misrepresenting data on the antidepressant, which it said had been prescribed off-label to over two million children and teens in the U.S. after the publication Study 329 and a subsequent marketing campaign.
In 2012, GSK agreed to pay a $3 billion fine, in part, for fraudulently promoting Paxil.
Yet, through all of this controversy — and despite many calls that the original study is retracted — the authors of Study 329, as well as the journal that published it, stood by their findings.
That is why Jon Jureidini, a professor at the University of Adelaide in Australia, took on the task of leading the RIAT team in reanalyzing the study.
Jureidini and his crew got access to previously confidential documents to reexamine the data from the original study. Their new analysis showed that paroxetine was no more effective at treating major depression in teenagers aged 12-18 than the placebo pill used in the study.
They also found that the harmful side effects linked to the antidepressant were underreported in the original study, as the initial researchers incorrectly coded the adverse effects. In the most glaring instance, they incorrectly referred to a suicide attempt as “emotional lability,” the RIAT researchers found.
Therefore, Jureidini and his team found a more significant risk of suicide associated with paroxetine than the original authors concluded.
“This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them,” Jureidini said in a statement.
The FDA necessitates all antidepressants come with a warning of the increased risk of suicide for children and adolescents. But Dr. John M. Nardo, a retired psychiatrist and member of the RIAT research team, told CBS News that there had been some pushback against this warning, and he says the new findings confirm the requirement for it.
“You need to be informed. With every medication, you need to think about the risk and the benefit,” he said. “If you are going to give this medicine to a teenager, you need to tell the parents and the kids all the possible side effects, and you need to watch them. I hope that at the very least, this [new study] will add to the information base of patients, as well as doctors, and hopefully, it’ll help cut down on the over-medicalization of kids.”
Ivan Oransky, M.D., the vice president, and global editorial director of MedPage Today, who chronicles scientific mistakes and misconduct at Retraction Watch, calls RIAT a crucial initiative. “Science correcting itself is a good thing,” he told CBS News.
When it comes to this specific drug, Oransky noted, “there have already been serious FDA warnings against prescribing Paxil to kids and teens. So, this new analysis, which concludes that Paxil is not effective in treating kids and teens anyway, may not change what’s actually prescribed to kids.”
In an emailed statement, GSK said it supported the RIAT team “carry out their reanalysis by providing access to the detailed data from the original trial,” reflecting the drug company’s “commitment to data transparency.”
GSK also said the findings “appear to be in line with the longstanding view that there is an increased risk of suicidality in pediatric and adolescent patients given antidepressants such as Paxil. This is widely known, and clear warnings have been in place on the product label for more than a decade. As such, we don’t believe this reanalysis affects patient safety.”
In an essay accompanying the research, Peter Doshi, associate editor for the BMJ, says the new paper “has reignited calls for retraction of the original study and put additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing.”
More generally, the RIAT research team says they hope their study sets a precedent for further reevaluations of other misreported studies and calls for all clinical trials to be opened up for independent third-party scrutiny.
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