{"id":66542,"date":"2016-06-27T13:34:02","date_gmt":"2016-06-27T17:34:02","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=66542"},"modified":"2016-06-27T14:16:28","modified_gmt":"2016-06-27T18:16:28","slug":"a-blast-from-the-past","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/06\/27\/a-blast-from-the-past\/","title":{"rendered":"a blast from the past…"},"content":{"rendered":"\n
I’ve been called out at times for focusing on these older Clinical Trials like Paxil Study 329 or the Citalopram CIT-MD-18 study. I’m kind of tired of talking about them myself. However, there are substantial reasons for dwelling on these trials. For one thing, we’re finally getting to see the back story – the raw data in Paxil Study 329 and the internal emails from the Citalopram CIT-MD-18 study. For another, these trials were very much in Dr. Karen Dineen Wagner<\/font>‘s memory at the recent APA Meeting<\/font> in Atlanta:<\/div>\n
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Child Psychiatrists Look at Specialty From Both Macro, Micro Perspectives<\/a><\/div>\n
PSYCHIATRIC<\/font>NEWS<\/font><\/strong><\/div>\n
by Aaron Levin<\/div>\n
June 16, 2016 <\/div>\n

Children are not just small adults, and clinical practice and the overall health care system need to take notice of that reality, said speakers at APA’s 2016 Annual Meeting in Atlanta in a session on child and adolescent psychiatry in the 21st century….<\/p>\n

In the clinic, managing mental illness in young people requires subtle but significant shifts in thinking, said Karen Dineen Wagner, M.D., Ph.D., a professor and chair of psychiatry and behavioral sciences at the University of Texas Medical Branch, Galveston…<\/p>\n

As for treatment, only two drugs are approved for use in youth by the Food and Drug Administration [FDA]: fluoxetine for ages 8 to 17 and escitalopram for ages 12 to 17, said Wagner. “The youngest age in the clinical trials determines the lower end of the approved age range. So what do you do if an 11-year-old doesn’t respond to fluoxetine?”<\/p>\n

One looks at other trials, she said, even if the FDA has not approved the drugs for pediatric use. For instance, one clinical trial found positive results for citalopram in ages 7 to 17, while two pooled trials of sertraline did so for ages 6 to 17. Another issue with pediatric clinical trials is that 61 percent of youth respond to the drugs, but 50 percent respond to placebo, compared with 30 percent among adults, making it hard to separate effects. <\/p>\n

When parents express anxiety about using SSRIs and ask for psychotherapy, Wagner explains that cognitive-behavioral therapy [CBT] takes time to work and that a faster response can be obtained by combining an antidepressant with CBT. CBT can teach social skills and problem-solving techniques as well. Wagner counsels patience once an SSRI is prescribed.<\/p>\n

A 36-week trial of a drug is too brief, she said. “The clock starts when the child is well, usually around six months. Go for one year and then taper off to observe the effect.” Wagner suggested using an algorithm to plot treatment, beginning with an SSRI, then trying an alternative SSRI if that doesn’t work, then switching to a different class of antidepressants, and finally trying newer drugs.<\/font><\/strong><\/p>\n

“We need to become much more systematic in treating depression,” she concluded.<\/div>\n<\/blockquote>\n
Not many days after Dr. Wagner’s lecture, we read a meta-analysis of antidepressants in youth by Cipriani et al in the Lancet<\/font> [Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis<\/a>] that included the reports listed in Wagner’s presentation that reached a very different conclusion:<\/div>\n
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When considering the risk–benefit profile of antidepressants in the acute treatment of major depressive disorder, these drugs do not seem to offer a clear advantage for children and adolescents. Fluoxetine is probably the best option to consider when a pharmacological treatment is indicated.<\/div>\n<\/div>\n<\/blockquote>\n
On the other hand, Wagner speaks of antidepressants as a first line treatment and suggests prescribing off-label based  on the RCTs that are well over a decade old, even including younger children in her recommendation. There’s no mention of the Black Box Warning or anything else that’s happened since then. Hers is an anachronistic<\/font><\/em> presentation, one that might have been given over ten years ago when hopes were higher for the antidepressant drugs in kids.<\/div>\n

But thinking further, that didn’t really capture the thrust of this presentation. Then it hit me, it was even older than that. The emphasis on coming on strong, using a sequence of drugs until you hit one that worked, treating for a long time, an algorithm [all without an evidence-base] – those things sounded like the catechism of John Rush and Madhukar Trivedi in their STAR*D<\/font> Protocol. And STAR*D<\/font> came directly from TMAP<\/font> [Texas Medical Algorithm Project]<\/font> – the industry seeded treatment scheme derived from Expert Opinion that required State Physicians to use on-patent drugs rather than Generics until it was finally exposed as corrupt by Allen Jones in 2004. <\/p>\n

And finally I remembered that there was a similar program for kids – TCMAP<\/font> [Texas Childrens Medical Algorithm Project]<\/font> and guess who were on the expert panel? Graham Emslie and Karen Dineen Wagner<\/font><\/strong>. Here’s what I said previously [the answers to those questions…<\/a>]:<\/div>\n
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Perhaps the biggest pharmaceutical scam to date was TMAP [Texas Medical Algorithm Project]. Before it was stopped, it had nearly bankrupted the Texas Mental Health system, had spread to 17 other States, and was on its way to Washington. It should make us all shudder when we hear the word "Guidelines." It was shepherded into being by John Rush<\/font><\/em> and Madhukar Trivedi<\/font><\/em> in Dallas. Basically, they controlled guidelines for the huge Mental Health system in Texas. It had a child piece [TCMAP] and Karen Dineen Wagner<\/font><\/em> and Graham Emslie<\/font><\/em>  were both involved in setting the Algorithms. The TMAP program was exposed in 2004 largely through the work of one man, Allen Jones<\/font><\/em>, an Inspector for the Pennsylvania OIG [who was fired for his work] but who never gave up. Below is just a snippet from a report he published on the Internet in 2004<\/a> with the bare bones of Dr. Wagner’s involvement [A more complete version about her goes from pages 10-14<\/strong>, and tells quite a story<\/u>]:<\/div>\n