Study 329

Editorial Note: The posts have gotten slightly out of sequence. This post should have preceded the responses from BMJ. It is the letter to which they were responding. This and other letters are on Study329.org. 8 July 2015 Dr Fiona Godlee Editor BMJ Dear Dr Godlee Re: "Restoring Study 329: A randomised, controlled trial of the efficacy and harms of paroxetine and … [Read more...] about Restoring Study 329: Letter to BMJ

Editorial Note: The letter from the Study 329 team to BMJ re Dr Loder featured in 50 Shades of Gray and in Conflicts of Interest. The actual letter and related correspondence is all on Study329.org.  The emails below and in the next post tell you what happened next. From: Jureidini, Jon (Health) Sent: Wednesday, 8 July 2015 10:32 PM To: fgodlee@bmj.com Subject: 329 and … [Read more...] about Restoring Study 329: Correspondence with BMJ Jul 15 to Jan 16

Editorial Note: This post offers our response to the Keller letter. It was published in BMJ in early February. Again all material is available on Study329.org. The response does not make much of the fact that not all of the Als in Keller et al have lined up to sign their letter. One of the intriguing points in all this is tracking the line taken by GSK and by Keller and … [Read more...] about Study 329: Response to Keller & Colleagues

Editorial Note: Following the publication of Study 329 Restored, Martin Keller and his co-authors gave an initial response in which they said Nobody Pinned Anything on Us and also that they would respond in more detail later. It took four months for this response to appear. Our Response will follow in the next post and after that we will update our background correspondence … [Read more...] about Study 329: Nobody Pinned Anything on Us

Editorial Note: This is the Fourth Crusoe Report. "Death waits for these things like a cement floor waits for a dropping light bulb" Big pharma Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake. Pharma began in the … [Read more...] about Study 329: Big Risk

Two weeks ago The BMJ ran an editorial by Richard Smith (former editor) and Fiona Godlee (current editor) on the retraction of a 1989 article by R K Chandra under the heading of A Major Failure of Scientific Governance. While making money from the publication of pharmaceutical company trials, and in the face of a complete failure by industry to adhere to basic scientific … [Read more...] about Study 329: BMJ Transparency

Editorial Note: None of these posts about Study 329 should be taken as representative of a RIAT view, especially this one. See Study 329: Conflicting Interests for a prequel to this post and to make sense of the last comment. Fiona Godlee to RIAT July 6 2015 Re: Study 329 Dear Dr Jureidini, “Many thanks for your letter. I quite understand you concerns. You are right to … [Read more...] about Study 329: 50 Shades of Gray

Email from Fiona Godlee (Editor of The BMJ) to RIAT July 6th 2015 Re: Study 329 Dear Dr Jureidini, Many thanks for your letter. I quite understand you concerns. You are right to say that there are few or no precedents against which to compare this article. We ourselves are feeling our way, both with the RIAT process since this is the first full RIAT research paper we … [Read more...] about Study 329: Conflicts of Interest

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