{"id":26717,"date":"2012-09-02T23:39:12","date_gmt":"2012-09-03T03:39:12","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=26717"},"modified":"2012-09-03T15:15:14","modified_gmt":"2012-09-03T19:15:14","slug":"the-lesson-of-study-329-the-hurdles","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/09\/02\/the-lesson-of-study-329-the-hurdles\/","title":{"rendered":"the lesson of Study 329: the hurdles\u2026"},"content":{"rendered":"

Flash forward<\/font><\/strong><\/em>:<\/p>\n\n\n
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Breakthroughs in the Treatment of Child and Adolescent Depression & Anxiety<\/font><\/strong><\/u>
Children grow out of shoes and clothes, but the odds say it is unlikely they will outgrow depression. A depressed child is twice as likely to be a depressed adult, according to Dr. Karen Wagner, a leading child psychiatrist. Dr. Wagner spoke to Neuroscience consultants at the launch meeting in Los Angeles. Dr. Wagner is Director of the Division of Child and Adolescent Psychiatry and the Vice Chair of the Department of Psychiatry and Behavioral Sciences at the University of Texas Medical Branch. Her message about major depression was that "it is a lethal disorder and it requires treatment."<\/sup><\/font><\/div>\n
Threat of suicide<\/font><\/strong><\/u>
Dr. Wagner pointed out that depression in adolescents can lead to suicide for 2.5% of those diagnosed with depression. Left untreated, the percentage rises to 8% as they become adults. Obviously, therapy is needed and Paxil is one of the few pharmaceutical approaches that has safety and efficacy data to support its use in this patient population. And more data is on its way. As many of you know, SB is preparing an indication for adolescent depression for Paxil next year! SB’s clinical study demonstrating the success of Paxil in treating depression among adolescents will be published in a peer reviewed journal during first quarter 2000…<\/sup><\/font><\/div>\n<\/td>\n<\/tr>\n<\/table>\n

It’s hard to recapture the ethos of recent history. It’s still too nearby for editorializing. This is as close as I can get. It was extracted from a SmithKline Beecham newsletter, Nulli Secundus<\/em><\/font><\/strong><\/a><\/u> [second to none<\/em>] dated December 8, 1999. Dr. Wagner is showing a slide of all the drugs that were in clinical trials for pediatric depression and is proudly announcing that Paxil’s success would be published in a peer reviewed<\/em> journal, and would soon to be submitted for FDA approval<\/em> for adolescents [we now know from subpoenaed documents<\/font><\/strong><\/u><\/a> that a year earlier, SKB had decided that Study 329 was too weak to submit for approval, but let’s not be picky]. Notice the emphasis on peer reviewed journal<\/em>. Peer review is the stamp of approval throughout academia. It means that an article has been closely-read by other scholars in the field and approved as a meaningful contribution to the literature. By this time, it had taken on an additional meaning in psychiatry, particularly with industry-funded studies. It meant that the article was no longer relegated to the free throw-away medical journals that fill our mailboxes on the way to the waste-can. It was essentially certified as a non-advertisement [or at least that’s what it was supposed to mean]. Publication in a peer reviewed journal<\/em> and FDA Approval<\/em> mean the drug can be directly advertised [and in a practical sense mean millions, perhaps billions, in revenue for the life of the patent]. So maybe they wouldn’t submit Paxil to the FDA for adolescents after all, but with a published article, it might be prescribed widely "off-label."<\/p>\n\n\n
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SB’s advantage<\/font><\/strong><\/u>
Dr. Wagner said the window of opportunity is before SB. Several other competing SSRIs and other compounds have studies ongoing. But Paxil and Prozac are the only two SSRIs that have any published data to date and many physicians have already found success in treating adolescent patients with Paxil…<\/sup><\/font><\/div>\n<\/td>\n<\/tr>\n<\/table>\n

[Well. Maybe second to one<\/em>…]<\/p>\n

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Flash back<\/font><\/strong><\/em>:<\/p>\n

The Study 329 article had fallen on the first hurdle out of the gate when the Journal of the American Medical Association<\/font><\/strong>  turned it down, a submission in line with their longstanding plan<\/font><\/strong><\/u><\/a> of encouraging Primary Care Physicians to treat depression [with Paxil]. The reviewers<\/font><\/strong><\/u><\/a> pointed to the low HAM-D [12] cut-off, the effect of supportive care, the high Placebo response, the small or absent differences in rating scales, the significant incidence of Serious Side Effects with Paroxetine, and the inappropriate dosing of Imipramine. The rejection letter suggested submitting the article to the Archives of General Psychiatry<\/font><\/strong>. In a letter to Jim McCafferty of SKB, Sally Laden had other ideas<\/font><\/strong><\/u><\/a> [December 7, 1999]:<\/div>\n