Washington D.C.: Depressed teens shouldn't take the widely used antidepressant paroxetine as it is neither safe nor effective, as per a reanalysis of an influential study originally published in 2001.
The new results contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.
It is the first trial to be reanalyzed and published by The BMJ under an initiative called RIAT (Restoring Invisible and Abandoned Trials), which encourages abandoned or misreported studies to be published or formally corrected to ensure doctors and patients have complete and accurate information to make treatment decisions.
The 2001 study funded by SmithKline Beecham, now GlaxoSmithKline (GSK), was criticized by the Food and Drug Administration (FDA) in 2002. Yet, that year, over two million prescriptions were written for children and adolescents in the United States. In 2012, GSK was fined a record three billion dollars in part for fraudulently promoting paroxetine.
Using previously confidential trial documents, they reanalyzed the original data and found that neither paroxetine nor high dose imipramine was more effective than placebo in the treatment of major depression in adolescents. The authors considered the increase in harms with both drugs to be clinically significant.
They conclude that paroxetine was ineffective and unsafe in this study.
The reanalysis illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base, say the authors.
Fiona Godlee, The BMJ Editor-in-Chief, says publication of the reanalyzed data sets the record straight and shows the extent to which drug regulation is failing people. It also shows that the public and clinicians do not have the unbiased information they need to make informed decisions.
The study appears in The BMJ.