Editorial: I was asked to MHRA (Britain's FDA) to give a 20 minute presentation on Spontaneous Reporting Systems to a group looking at a birth defect related issue. This is close to what was said - minor items like the HRT trials got lost in delivery. The Slides numbered in the text are attached Here. Are we anecdotes? On this first slide (1) you can see a recent article … [Read more...] about Motivation Is Worth More Than Expertise?
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The Ghost of Research Future
Editorial Note: This post is by Johanna Ryan. As with all posts by Jo, it unearths angles on current stories that everyone else seems to have missed. A column here last month followed the legacy of Study 329 into the present. By taking apart one 2015 study of Vraylar, a new antipsychotic, I tried to show that clinical research in 2015 is even more ghost-written, and more … [Read more...] about The Ghost of Research Future
Study 329: Big Risk
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
Study 329: BMJ Transparency
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
Study 329: 50 Shades of Gray
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
Study 329: Conflicts of Interest
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
Study 329 in Japan
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
Study 329: By the Standards of the Time
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
Study 329: Minions No Longer
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
Study 329: Data Wars
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