September 17, 2015 — Fourteen years after a major study concluded that Paxil (paroxetine) was safe for teenagers, a re-analysis of the same data concluded that the opposite is true.
Study 329 has been a source of controversy ever since it was published in 2001. It concluded that Paxil was safe and effective for teenagers, which led to a 36% in prescriptions from 2002-2003 — slowed only by a “Black Box” warning from the FDA in October 2004.
None of the 22 named authors actually wrote the study, but rather an outside medical writer hired by the drug-maker. The lead author, Dr. Martin Keller, had a history of under-reporting financial ties to drug-makers. At least five adverse events labeled “emotional lability” actually involved severe suicidal thoughts or attempts.
After years of wrangling, GlaxoSmithKline (GSK) finally provided independent researchers with raw data from the study.
The re-analysis was published in the British Medical Journal. According to the author of the analysis, Paxil was no better at treating depression than a placebo and serious side effects were downplayed:
“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 behaviors compared to only one person in the group of patients who took the placebo.”
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