BMJ issued a press release today after a reanalysis of the antidepressant paroxetine (Paxil) concluded the drug is neither safe nor effective for adolescents with depression. The reanalysis conducted by a team of independent researchers contradicts the original study paid for by the drug manufacturer, known as Study 329.
The following excerpts were reported in the BMJ press release:
In 2001 SmithKline Beecham, now GlaxoSmithKline (GSK), funded a study (known as Study 329) to compare the effectiveness and safety of the antidepressant drugs paroxetine and imipramine with placebo for adolescents diagnosed with major depression.
It reported that paroxetine was safe and effective for adolescents and was published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001.
The study was criticised 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 $3bn in part for fraudulently promoting paroxetine.
Using previously confidential trial documents, they reanalysed 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 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.
Dr Fiona Godlee, The BMJ Editor-in-Chief says publication of the reanalysed data from Study 329 “sets the record straight” and “shows the extent to which drug regulation is failing us.”
It also shows that the public and clinicians do not have the unbiased information they need to make informed decisions. She calls for independent clinical trials rather than trials funded and managed by industry, as well as legislation “to ensure that the results of all clinical trials are made fully available and the individual patient data are available for legitimate independent third party scrutiny.”
For the full press release click here →