{"id":66839,"date":"2016-07-09T21:40:54","date_gmt":"2016-07-10T01:40:54","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=66839"},"modified":"2016-07-10T01:48:09","modified_gmt":"2016-07-10T05:48:09","slug":"this-other-thing","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/07\/09\/this-other-thing\/","title":{"rendered":"this other thing…"},"content":{"rendered":"\n
After reading Karen Dineen Wagner’s 2013 deposition [author·ity…<\/a>], I looked back at that recent PSYCHIATRIC<\/font>NEWS<\/font> article about her presentation at the May APA meeting [see a blast from the past…<\/a>]. This time through, there were several things about it that got my attention. So here it is again for review:<\/div>\n
\n
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

… 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.<\/p>\n

“We need to become much more systematic in treating depression,” she concluded.<\/div>\n<\/blockquote>\n
And here’s the drug patent timeline for reference:<\/div>\n

<\/p>\n

• as mentioned, this is TMAP talk [early 90s] all over again …<\/font><\/strong><\/em><\/div>\n
The reason her presentation felt so "old<\/font>" was easy to figure out. It was ["old<\/font>"]. It was the recommendation that started with TMAP\/TCMAP 20+ years ago. After the warm glow that initially came with the SSRIs [Listening to Prozac<\/font>] wore off and it became apparent that the response rate was less than hoped, there were attempts to improve the results. In Texas, John Rush, Madhukar Trivedi, Graham Emslie, Karen Dineen Wagner, and others initiated what I call "algorithmic medicine<\/font><\/em>." The idea was that the tepid response was because the drugs weren’t given right. They advocated pushing the dose<\/font><\/em>, making sure patients stay on the drugs long enough<\/font><\/em>, following an algorithm to sequence different antidepressants or augment in treatment failures<\/font><\/em>, and treating to remission<\/font><\/em>. We mostly know of TMAP because it was the PHARMA-funded scheme to require using in-patent drugs in public clinics that almost bankrupted Texas Medicaid, but it was also a path intended to improve response. This notion lead to a series of NIMH studies:<\/div>\n

<\/p>\n

Wagner’s 2016 APA presentation sounded like a direct transcript from those days – in spite of the fact that none of the studies in between really bolstered the idea that this path lead much of anywhere. STAR*D<\/font><\/em> claimed to support sequencing, but it had methodologic problems, a huge dropout rate, and was never fully reported [see a thirty-five million dollar misunderstanding…<\/a>]. She mentioned none of this and, at least in the PSYCHIATRIC<\/font>NEWS<\/font> report, didn’t present her argument with evidence that her recommendations got results.<\/p>\n

• but there’s this other thing…<\/font><\/strong><\/em> <\/div>\n
The things that nagged at me and had me looking back at this report were first, her reference points, and then, what it didn’t say. <\/div>\n

She referred to the FDA Approved drugs ["fluoxetine for ages 8 to 17 and escitalopram for ages 12 to 17<\/font><\/em>"] and recommended not feeling limited to just these two – pointing out several clinical trials that were positive ["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<\/font><\/em>"]. She’s referring to studies in 2003 and 2004 where she is the first author, one being recently heavily criticized [see The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance<\/a>] and another also widely questioned [at least she left out Paxil Study 329]. So based on her own ghost written industry funded studies from twelve+ years ago, she is encouraging full speed ahead with the aggressive TMAP guidance.<\/p>\n

But, to be honest, that’s not what actually got my attention. It was what she didn’t mention. The most obvious thing is the Black Box Warning of potential suicidality in children and adolescents present since 2004. Then she refers to her short term clinical trials from early days, and nothing since then!<\/font><\/em> Both trials come up in the deposition, and her involement was slim to none, and she remembers nothing much about them. She discounts the FDA, evokes these two early ?? trials, and doesn’t mention anything else<\/font><\/em>. There’s no, "In our clinical experience…<\/font><\/em>" or "In follow-up long term studies…<\/font><\/em>" or "In the Galveston clinic, we’ve seen…<\/font><\/em>"<\/p>\n

• and another thing…<\/font><\/strong><\/em> <\/div>\n
I wasn’t in love with her recommendation to argue with skeptical parental concerns about using SSRIs in kids either. Based on the evidence, Wagner should be concerned too. And that just got added to the list of things that made me wonder why she was picked to give this update on the treatment of depression in kids at the APA, how she achieved the status of Key Opinion Leader…<\/div>\n","protected":false},"excerpt":{"rendered":"

After reading Karen Dineen Wagner’s 2013 deposition [author·ity…], I looked back at that recent PSYCHIATRICNEWS article about her presentation at the May APA meeting [see a blast from the past…]. This time through, there were several things about it that got my attention. So here it is again for review: Child Psychiatrists Look at Specialty […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-66839","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/66839","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=66839"}],"version-history":[{"count":19,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/66839\/revisions"}],"predecessor-version":[{"id":66860,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/66839\/revisions\/66860"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=66839"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=66839"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=66839"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}