{"id":48196,"date":"2014-07-20T08:00:57","date_gmt":"2014-07-20T12:00:57","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=48196"},"modified":"2014-07-20T01:31:59","modified_gmt":"2014-07-20T05:31:59","slug":"retire-the-side","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/07\/20\/retire-the-side\/","title":{"rendered":"retire the side…"},"content":{"rendered":"\n
I will admit that it’s hard for me to write about this particular recurrent topic without sarcasm [I’ll give it a shot, but will likely fail]. The topic is an NIMH Study called EMBARC<\/a> [Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression] being conducted by Madhukar Trivedi [NIMH Project Number: \t1U01MH092221-01<\/a>] [ClinicalTrials.gov Identifier: NCT01407094<\/a>]. This is part of a series of studies that date back to the TMAP program in the 1990s:<\/div>\n
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TMAP [Texas Medical Algorithm Project] was a program that began a push to medicate by algorithm. It was used by industry to get public funded systems to use in-patent medications rather than generics of equal effectiveness – and died a painful death when exposed by whistle-blower Allen Jones. But the idea of creating algorithms for treatment lived on in STAR*D with TMAP veterans John Rush and Madhukar Trivedi from UT Southwestern in charge. It was a complex scheme that had algorithms for sequencing antidepressants in an attempt to enhance the effectiveness of medicating depression. It was a $35 M NIMH project that generated hundreds of papers [now largely forgotten for good reason] and uninterpretable results. Dr. Trivedi had an NIMH Project of his own, supplying a computer program for clinicians to use picking treatments [IMPACTS], but that study was never completed because the clinicians wouldn’t use the computers [cost $2.7 M]. Failing at sequencing and computerizing, their next NIMH funded study tried various combinations of antidepressants [CO-MED]. It was a negative study.<\/div>\n

In the first decade of this century, there was a preoccupation with the idea that more efficacy could be extracted from these antidepressants. By the end of the decade, sequencing, augmenting, and combining had each failed to produce the dreamed of enhancement, and so for a time, researchers had a love affair with "personalized medicine" – coming up with some test that would predict response to one or the other antidepressants. It would seem like sequencing and combining would’ve answered that question, but apparently not. At the time, it was thought that genotyping would be the key [but anything would’ve done]. The Australian Brain Trainer, Evian Gordon, gathered one group of KOLs and began the iSPOT study<\/a>. And Dr. Trevidi was funded for an NIMH study, EMBARC, to look for biomarkers that predicted drug response. His study started with Placebo, Citalopram [Celexa®<\/font><\/strong>], and Bupropion XL [Welbutrin XL®<\/font><\/strong>], but the Citalopram was replaced for unknown reasons with Sertraline [Zoloft®<\/font><\/strong>] not long after the study began. It was funded from September 30, 2010 through June 30, 2014. The NIMH web site has the following data available for funds allotted: <\/p>\n

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That comes to $9,199,613 so far. The overall cost to the NIMH for the four funded studies in the figure above [STAR*D<\/a>, IMPACTS<\/a>, CO-MED<\/a>, and EMBARC<\/a>] exceeds $50 M. Some time back, I had added a note to my calendar that EMBARC ended on June 30, 2014. My prediction was that it would not be completed – based on Dr. Trivedi’s poor track record and my own conviction that it wouldn’t show anything of any value just based on reading the protocol. While that cynical prediction remains an open question, the study should now be completed and yet it is still listed as "recruiting."<\/p>\n

I doubt seriously that there’s anyone on the planet waiting to have a biomarker test to decide between Zoloft®<\/font><\/strong> and Welbutrin XL®<\/font><\/strong> for a depressed patient, particularly with a ~$10 M price-tag. TMAP was a scam; STAR*D was a bust; IMPACTS never even got off the ground. CO-MED flat-lined. Can EMBARC live up to that record? [I warned you I couldn’t contain the sarcasm]. It’s stories like this that account for my negativity about Dr. Insel’s NIMH. These people have been funded for a series of ill-conceived, badly designed, and poorly executed studies one after another for a decade and a half to the tune of $50 M. There’s just no need for that. STAR*D produced hundreds of forgettable papers, but never even really reported on what the study proposed to find out. Insel’s NIMH famously selects the directions for research rather than selecting from among the creativity of researchers own proposals. They chase things like personalized medicine<\/em>, algorithmic medicine<\/em>, measurement based medicine<\/em>, translational medicine<\/em>, RDoC<\/em>, etc. – fads that come and go – <\/em>and genomics<\/em>, proteonomics<\/em>, neuroimaging<\/em>, connectomics<\/em> – shiny objects that have appeared in view. And the same people get funded over and over, like the examples mentioned above, independent of their track records.<\/p>\n

These attempts to turn clinical psychiatry into algorithms for medications driven by symptoms, often gathered by questionnaires, have yielded nothing. Worse, they trivialize both the human experience of patients and the practitioners’ efforts to help them. Let’s hope that the chart up there has finally run out of iterations and we can retire the side…<\/div>\n","protected":false},"excerpt":{"rendered":"

I will admit that it’s hard for me to write about this particular recurrent topic without sarcasm [I’ll give it a shot, but will likely fail]. The topic is an NIMH Study called EMBARC [Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression] being conducted by Madhukar Trivedi [NIMH Project Number: 1U01MH092221-01] […]<\/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":[2],"tags":[],"class_list":["post-48196","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/48196","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=48196"}],"version-history":[{"count":19,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/48196\/revisions"}],"predecessor-version":[{"id":48224,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/48196\/revisions\/48224"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=48196"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=48196"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=48196"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}