Arguably the most controversial drug study ever, Study 329, published in July 2001:
Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents;
It is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
Though it was criticized by a few alert and concerned journalists and academics, their voices were buried by a tsunami of positive marketing and promotion by vested interests;
This promotion resulted in a successful New York state fraud lawsuit against GSK;
And resulted in 2012 in the biggest fine in corporate history – $3 Billion; and
Nevertheless, the study remains unretracted.
Paroxetine Names Around the World
In June, 2013 Peter Doshi and colleagues published “Restoring Invisible and Abandoned Trials: A Call for People to Publish the Findings” in the British Journal of Medicine (BMJ).
They referred to this proposed protocol as RIAT, and described its purpose as follows:
“Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.”
A team of researchers undertook to re-analyze the original data and publish a new analysis under the RIAT protocol.
In August, 2015, after a year and seven drafts, BMJ notified the team that their submission would be published in September, 2015.
This new study, Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trial, should shock all who care about integrity in drug safety. Find out the inside story when a new site, Restoring Study 329, goes live.
This will be the first ever that studies are published with two completely different takes on the same data.
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This blog is a slightly revised version of a blog
that appears on DavidHealy.org