{"id":20909,"date":"2012-03-10T21:15:27","date_gmt":"2012-03-11T03:15:27","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=20909"},"modified":"2012-03-10T21:18:50","modified_gmt":"2012-03-11T03:18:50","slug":"more-clearly-ii","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/03\/10\/more-clearly-ii\/","title":{"rendered":"more clearly II…"},"content":{"rendered":"
In June 2009, the Institute of Medicine held a Workshop in Washington DC, CNS CLINICAL TRIAL: SUICIDALITY AND DATA COLLECTION<\/font><\/strong><\/u><\/a> [available on-line]. It was sponsored by an array of foundations and pharmaceutical companies, co-chaired by Dr. William Potter of Merck Research Laboratories and Dr. Robert Gibbons of the University of Illinois at Chicago. The topic was the FDA’s "black box" warning added to antidepressants in late 2004 [expanded in 2007]. All the principals were on the program – including Dr. Robert Gibbons and his senior author on these recent papers, Dr. J. John Mann, Dr. Kelly Posner of the C-SSRS, Dr. Thomas Laughren of the FDA – it was a regular Who’s Who from the world of suicidology. Obviously, the FDA meta-analysis was on the front burner [FDA Hammonds Review<\/font><\/strong><\/u><\/a>, published full text on-line<\/font><\/strong><\/a><\/u>] and Kaizar’s extension [Do antidepressants cause suicidality in children? A Bayesian meta-analysis.<\/font><\/strong><\/u><\/a>]. This is from the latter listing all the clinical trials in youths highlighted by yours truly [available on-line<\/font><\/strong><\/u><\/a>]:<\/div>\n
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If you look at the Prozac trials, they might look familiar from my futile attempts to figure out Dr. Gibbon’s data in advance [coming soon?…<\/font><\/a><\/strong><\/u>]. Three out of four of his selected studies are on the list [X065, TADS, and HCJE]. As you can see, two of those are suicidality neutral<\/em> [X065 and HCJE] but TADS is definitely not. Nowhere to be seen is Study LYAQ which he used in his recent meta-analysis.<\/div>\n

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And as long as we’re looking at this slide, Dr. Gibbons’ recent articles used data from the Effexor Adult studies kindly provided by Wyeth [Pfizer]. One wonders why he didn’t also include the data from the Effexor studies of MDD in youngsters? There are two studies [382 and 394] right up there, surely available for his meta-analysis. Well, I can think of two reasons right off the cuff. First, they are anything but suicidality neutral<\/em> [above]. And the second is in this FDA Effexor Medical Review<\/font><\/strong><\/u><\/a> from 2003 – both studies were efficacy negative<\/em>: <\/div>\n