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Editorial Note: By 2002 GlaxoSmithKline had done 3 studies in children who were depressed and described all three to FDA as negative. As an old post on Bob Fiddaman's blog reproduced here outlines, several years later they undertook another study in children in Japan. Regular readers of this blog will know how I broke the news back in 2009 regarding GlaxoSmithKline's attempts … [Read more...] about Study 329 in Japan

Editorial Note: This post by Johanna Ryan looks at an element of the defense offered by Neal Ryan and others, namely that by the standards of the time the authors of 329 weren't doing much wrong. Getting real about clinical research The controversy over “Study 329” on the effects of Paxil in teen depression has raised questions about the state of ALL medical research. What … [Read more...] about Study 329: By the Standards of the Time

A few weeks ago I was asked to review Good Pharma by Don Light and Antonio Maturo. The published review appears in TES - here. It makes a great foil to the Data Wars post earlier this week. The problem was deciding if the title for this post should read Minions no Longer or Underlings no Longer - let me know your thoughts. Review Whatever you think of his politics, there was … [Read more...] about Study 329: Minions No Longer

Sensing the end of the Roman Republic and unhappy at the approach of Empire, Cassius approached Brutus to save the Republic. "The fault, dear Brutus, is not in our stars, But in ourselves, that we are underlings." The Republic was a Democracy, with a Government answerable to its Electors. Caesar’s conquests meant that the Roman Government was now responsible for swathes of … [Read more...] about Study 329: Data Wars

What happened to those suicidal in study 329? In May 2014, the RIAT team asked GSK what the children who became suicidal in the course of Study 329 have since been told. (Marty Keller's "take" on this is at the bottom). The consent form says that anyone entering the study would be treated just the way they would be in normal clinical practice. In Study 329, the children … [Read more...] about Study 329: MK, HK, SK, GSK & History

The Letter below from Marty Keller and colleagues was sent to many media outlets, to retraction watch, and to professional organizations on Wednesday. Paul Basken from the Chronicle for Higher Education asked me for a response which I sent about an hour after receiving the letter. This response is from me rather than the 329 group. This and other correspondence features and … [Read more...] about Study 329: MK, HK, SK and GSK

Study 329 has just gone live. The Restoring Study 329 article with its appendices, data, history, accompanying feature by Peter Doshi and editorial by David Henry can be found on the Restoring Study 329 site Study329.org. Here are the key findings at present. Efficacy Harms Background At present The note above says "Here are the key findings at present". You can … [Read more...] about Study 329

The text below reproduces the latest page from the Study329.org site. The links mentioned here will become live on the site once Restoring Study 329 is published late Wednesday - early Thursday next week. In 2004 as part of the resolution of a fraud action taken by New York State, GlaxoSmithKline agreed to post the data from all their studies on the Company Website. They … [Read more...] about Study 329: The Data

If someone were to ask the surviving authors of Study 329 the question: "Knowing what you know now, if you had to do it over, would you agree to participate in that study again?", many would probably say no. The real title of Study 329 was “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression, A Randomized Controlled Trial”. It was published in the Journal of … [Read more...] about The Troubled Life of Study 329: Consequences of Failure to Retract

    MARTIN B. KELLER, M.D.   Brown University Martin B. Keller Professor Emeritus of Psychiatry and Human Behavior Martin_Keller@brown.edu Martin Keller has made major research contributions to the understanding and treatment of mood disorders. He has performed research on the longitudinal course and neuropsychopharmacology of affective disorders … [Read more...] about Original Study 329 Team