Wednesday, 19 August 2015

'A Milestone in the Battle for Truth in Drug Safety' @DrDavidHealy Study 329

A Milestone in the Battle for Truth in Drug Safety: Dr David Healy, 17 August 2015:

Study 329: The final chapter coming soon
 
"Arguably the most controversial drug study ever, Study 329, published in July 2001:
  1. Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents;
  2. Is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
  3. 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;
  4. Resulted in a successful New York state fraud lawsuit against GSK;
  5. Resulted in 2012 in the biggest fine in corporate history – $3 Billion; and
  6. 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Unpublished and misreported studies make it difficult to determine the true value of a treatment.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 will be the first ever trial with two completely different takes on the same data.

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 trialshould shock all who care about integrity in drug safety. Find out the inside story when a new site, Restoring Study 329, goes live."

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