Study329.org: The Panorama Files (From Prof David Healy’s Blog)


http://davidhealy.org/study329-org-the-panorama-files/

Study329.org: The Panorama Files

August, 27, 2015 | Reply

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

ParoxetineWC
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Unpublished and misreported studies make it difficult to determine the true value of a treatment.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 this site goes live.

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2 comments

  1. julie wood

    Shelly Jofre was an award-winning journalist who lost her job with Panorama after that amazing and valuable 4-part series on Seroxat / Paxil (paroxetine). There is a whole system built around same very shaky premises in the drug safety business. In the US, Amarin has won an injunction against the FDA who wanted to prevent it marketing its drug for an unapproved/unproven (off-label) purpose. The public should be alarmed and outraged over Study 329 but the countervailing protective spin is so strong. It will be so good if the restored study can penetrate the first layer…

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