Popular Antidepressant Found To Be Unsafe For The Adolescents

The earlier SmithKline Beecham paper on Study 329 had concluded that the drug was safe and effective for teenagers. “And I don’t know of any example where two studies in the literature with the same data ever reached opposite conclusions”.

In an essay accompanying the study, 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”.

YOU may never have heard of it, but Study 329 changed medicine. But after many years, the study has found that the drug was dangerously overstated. In the same year, over 2 million prescriptions for paroxetine were written for children and adolescents in the US.

The drug has been blatantly prescribed in billions by clinicians in the 1980’s and 90’s and was widely perceived to be beneficial in treating depression and was said to have minimal side effects in comparison to debilitating side effects seen in older medications for treating depression. The warning signaled a possible risk of suicidal thoughts among children and teens.

The reanalysis of Study 329 “illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base”, say the authors. GSK gave researchers permission to comb the company’s files on the original study, providing access to summaries, internal trial reports and patient-level data, The New York Times reports.

The trial was conducted between April 1994 and February 1998. It concluded that paroxetine was generally well tolerated and had similar side-effect rates to placebo pills.

The new reanalysis revealed that neither Paxil nor high-dose imipramine was more effective than a placebo in the treatment of major depression in adolescents.

Jon Jureidini, professor at the University of Adelaide’s Critical and Ethical Mental Health Research Group, said that the results of the said study were concerning because the drug was in fact not as effective as we may think. “In summary, to describe our trial as “misreported” is pejorative and wrong”, the researchers told the NYT in a joint statement. Some were categorized as “emotional lability” – the tendency to laugh or cry unexpectedly – and this masked differences in suicidal behavior between Paxil and placebo, the reanalysis found. And that the paper’s lead author – Brown University’s chief of psychiatry, Martin Keller – had been the focus of a front page investigation in the Boston Globe in 1999 that documented his under-reporting of financial ties to drug companies. The company has also faced a number of consumer lawsuits by parents of teens who said their children had serious reactions to the drug. “They have really done their work, and they’re realizing now that these problems occur so they’re taking more care”. The experts say that the results of the study must be well reviewed so as to correct any discrepancy from any of the subjects and contaminating factors. Because many factors could have contributed to that behavior, it is still far from clear who’s at risk. “As such, we don’t believe this reanalysis affects patient safety”.