{"id":7126,"date":"2011-04-10T16:22:30","date_gmt":"2011-04-10T20:22:30","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=7126"},"modified":"2011-04-11T01:52:18","modified_gmt":"2011-04-11T05:52:18","slug":"stard-too-important-to-ignore","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/04\/10\/stard-too-important-to-ignore\/","title":{"rendered":"STAR*D: too important to ignore&#8230;"},"content":{"rendered":"<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" height=\"108\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/tmap-2.gif\" alt=\"Programs derived from TMAP\" title=\"Programs derived from TMAP\" \/><\/div>\n<div align=\"justify\">I made an earlier analogy that the <strong><font color=\"#300030\">STAR*D<\/font><\/strong> story is like falling down Alice&#8217;s rabbit hole. But that metaphor hasn&#8217;t held up under scrutiny. A rabbit hole is enclosed.&nbsp;<strong><font color=\"#300030\">STAR*D<\/font><\/strong> just won&#8217;t fit. It keeps on growing. It needs a bigger place &#8211; like&#8230; well, sort of like the wide open spaces of Texas. As a matter of fact, whistleblower, <a href=\"http:\/\/psychrights.org\/Drugs\/AllenJonesTMAPJanuary20.pdf#page=3\" target=\"_blank\"><u>Allen Jones<\/u><\/a>, opened his statement about TMAP [the Texas Medication Algorithmic Project] with something he called the &ldquo;A Texas Primer&rdquo;:<\/div>\n<ul>\n<div align=\"justify\"><sup>&bull; Texas is uniquely suited for the pharmaceutical industry to develop a marketing scheme of the depth and proportion of TMAP. The industry needed to create an aura of legitimacy and a body of favorable data to advance its marketing aims. It needed universities, prisons and hospitals. The industry also needed a friendly Legislature to initiate such an extensive program&#8230;.<\/sup><\/div>\n<div align=\"justify\"><sup>&bull; &#8230;one former Texas legislator, Tom Robbins, was annoyed that his colleagues seemed to pass legislation that they had not even read, let alone understood. To prove a point he introduced a resolution to honor Albert de Salvo.<\/sup><\/div>\n<ol>\n<div align=\"justify\"><em><sup>&ldquo;This compassionate gentleman&#8217;s dedication and devotion to his work has enabled the weak and the lonely throughout the nation to achieve and maintain a new degree of concern for their future. He has been officially recognized by the state of Massachusetts for his noted activities and unconventional techniques involving population control and applied psychology.&rdquo;<\/sup><\/em><\/div>\n<\/ol>\n<div align=\"justify\"><sup>The Resolution passed with a unanimous vote. Albert de Salvo was, of course, the Boston Strangler&#8230;<\/sup><\/div>\n<div><sup>&bull; Texas Governor George W. Bush supported Texas Mental Health Parity legislation in 1997 that required private industry to provide increased insurance coverage for mental health treatment, including mental health drugs. Texas passed legislation expanding Medicaid coverage of mental health drugs to persons who would not otherwise qualify under Medicaid guidelines&#8230;<\/sup><\/div>\n<div align=\"justify\"><sup>&bull; TMAP opened the doors of the Texas prison system, juvenile justice system and Texas state mental health hospitals to the unlimited influence of major pharmaceutical companies in expanding the usage and marketing of their most expensive drugs&#8230;<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Of course the forces behind <strong><font color=\"#300030\">STAR*D<\/font><\/strong> didn&#8217;t arise with the Texas Medication Algorithmic Project, but Texas did provide the climate and the space they needed to flourish. Where else, but a State that would mindlessly honor the Boston Strangler, would anyone overlook a program that was so obviously a scheme to sell expensive drugs to a public health-care system? conceived and financed by the people who made the drugs? <sub>[see <u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/08\/the-singapore-sojourn-ask-alice\">the singapore sojourn? ask Alice&hellip;<\/a><\/u>]<\/sub><\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"7\" height=\"110\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/tmap-3.gif\" alt=\"Companies funding TMAP\" title=\"Companies funding TMAP\" \/><\/div>\n<div align=\"justify\">John Rush was the TMAP Project Director and Madhukar Trivedi was the Major Depressive Disorder Module Director, both in the Department of Psychiatry at The University of Texas Southwestern Medical Center at Dallas. Their algorithms embraced Risperdal, Zyprexa, Seroquel, Geodon, Depakote, Paxil, Zoloft, Celexa,  Wellbutrin, Zyban, Remeron, Serzone, Effexor, Buspar, Adderall, and  Prozac &#8211; and avoided the generics. <sub>[<u><a target=\"_blank\" href=\"http:\/\/www.cchrint.org\/psycho-pharmaceutical-front-groups\/tmap\/#_ednref26\">ref<\/a><\/u>]<\/sub><\/div>\n<ul>\n<div align=\"justify\"><sup>For Medicaid in Texas, TMAP meant crippling health care costs. Medicaid  spending on five antipsychotic drugs skyrocketed from $28 million in  2002 to $177 million in 2004&mdash;almost $700 million combined. That did not  include care for those who are in state institutions. According to Alan  Jones, by early 2001, TMAP and TCMAP had bankrupted the Texas Medicaid  program and the budgets of the state&rsquo;s mental health and prison systems.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">In this version of evidence-based medicine, diagnosis was by DSM\/SCID, treatment was directed by TMAP\/TCMAP\/TIMA algorithms, initialed rating scales were the coming way to follow patients [analogous to &quot;lab work&quot; in mainstream medicine]. It&#8217;s hard to know whether the push towards treatment of the mentally ill by Primary Care Physicians arose independently within the TMAP\/Dallas group, or whether it was inserted by the campaigns within industry [Lilly&#8217;s Viva Zyprexa, GSK&#8217;s Nemeroff\/Shatzberg textbook, etc]. Whichever the case, that was definitely on the table in the <strong><font color=\"#300030\">STAR*D<\/font><\/strong> protocols.<\/div>\n<p align=\"justify\">These days, it&#8217;s becoming fashionable to consider many of the Y2K psychopharmacology-types as <u>only<\/u> shills for PHARMA, but I&#8217;m not sure that&#8217;s right. I think they really believed the atypical antipsychotics [SGAs] were <u>the<\/u> new solution to psychosis, and that some version of the new antidepressants [SSRIs, etc] were <u>the<\/u> solution to depression, <u>and also<\/u> they became willing shills for the Pharmaceutical Industry. In Texas, those beliefs became public policy under Governor Bush connecting a two-way spigot between government and PHARMA via TMAP [more one way than the other]. John Rush&#8217;s Co-Director Steven Shon hit the road and sold the idea to 16 other States [traveling on PHARMA&#8217;s nickle, as it turns out]. Meanwhile, in 2001 the idea went to Washington with President Bush as the <em>New Freedom Commission<\/em> and <em>TeenScreen<\/em>.<\/p>\n<div align=\"justify\">The NIMH funded two ambitious studies around Y2K to look at the SGAs and the AntiDepressants &#8211; <strong><font color=\"#330000\">CATIE<\/font><\/strong> and <strong><font color=\"#200020\">STAR*D<\/font><\/strong>. By my read, <strong><font color=\"#330000\">CATIE<\/font><\/strong> was a study that tested a hypothesis, <strong><font color=\"#200020\">STAR*D<\/font><\/strong> was a polemic that chased a conclusion. The difference was apparent in the subtext of their acronyms.           <\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"5\" height=\"91\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/star-d-6.gif\" \/><\/div>\n<div align=\"justify\">Training residents in the 80s, I noticed that many went through a moral period when they were angry at the patients&#8217; poor compliance with neuroleptics. I used to say, &quot;You know, Schizophrenia isn&#8217;t a Haldol deficiency. You try some yourself and let me know how it goes [they never did].&quot;&nbsp;<strong><font color=\"#330000\">CATIE<\/font><\/strong> started there and measured &quot;take-ability&quot; &#8211; a wise decision. The SGAs were no more &quot;take-able&quot; than <strong><font color=\"#330000\">CATIE<\/font><\/strong>&#8216;s sole FGA. Around the same time, the reports began to mount that the SGA&#8217;s decreased incidence of old side effects [EPS, TD] was offset by their new problem &#8211; the metabolic syndrome. But I&#8217;m getting ahead of myself.<\/div>\n<p align=\"justify\">When Rush and Trivedi conceived the <strong><font color=\"#200020\">STAR*D<\/font><\/strong> trial, they incorporated the whole TMAP gestalt &#8211; permissive enrollment, primary care facilities [18\/41], treatment with complex layers of simplistic algorithms, follow-up with an &quot;E.T. phone home&quot; rating scale [created for the occasion and validated in the 11th hour]. It was as big as the State of Texas where it originated and as brash as the Governor they sent to Washington. But in the seven years it took to do that study, things began to change. During the <strong><font color=\"#200020\">STAR*D<\/font><\/strong> study, TMAP came under fire when Allen Jones blew his whistle in a 2004 lawsuit in Texas. By 2006, TMAP Evangelist Steven Shon hit the road again &#8211; this time allowed to resign rather than be fired. TMAP got quiet and TCMAP was disbanded. Suits against the drug companies for suppressing dangerous side effect data and deceptive marketing were gathering steam. Kingpin Psychiatrists like Charlie Nemeroff were beginning to be exposed and there was a groundswell of anti-psychopharmacology sentiment arising from multiple foci. The climate was changing when <strong><font color=\"#200020\">STAR*D <\/font><\/strong>was finally published in 2006.<\/p>\n<div align=\"justify\">As for the <strong><font color=\"#200020\">STAR*D<\/font><\/strong> study itself, I think I&#8217;ve said all I know to say and gone as far as old man in a cabin in the woods can go [with only the Internet, an Ovid account, and some more informed new friends pointing the way]:<\/div>\n<ul>\n<div align=\"justify\"><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/03\/a-thirty-five-million-dollar-misunderstanding\"><strong><font color=\"#200020\">a thirty-five million dollar misunderstanding&hellip;<\/font><\/strong><\/a><\/u><\/div>\n<div align=\"justify\"><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/04\/my-old-greek\"><strong><font color=\"#200020\">my <em>old Greek<\/em>&hellip;<\/font><\/strong><\/a><\/u><\/div>\n<div align=\"justify\"><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/05\/a-slow-learner\"><strong><font color=\"#200020\">a slow learner&hellip;<\/font><\/strong><\/a><\/u><\/div>\n<div align=\"justify\"><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/06\/recalculating\"><strong><font color=\"#200020\">recalculating&hellip;<\/font><\/strong><\/a><\/u><\/div>\n<div align=\"justify\"><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/06\/still-recalculating\"><strong><font color=\"#200020\">still recalculating&hellip;<\/font><\/strong><\/a><\/u><\/div>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/04\/08\/the-singapore-sojourn-ask-alice\/\"><font color=\"#200020\">the singapore sojourn? ask Alice&hellip;<\/font><\/a><\/strong><\/u><\/div>\n<div align=\"justify\"><strong><u><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/04\/09\/the-appearance-of-conflict-of-interest\/\"><font color=\"#200020\">the appearance of conflict of interest&hellip;<\/font><\/a><\/u><\/strong><\/div>\n<\/ul>\n<div align=\"justify\">But I&#8217;ve gone far enough to know that<strong><font color=\"#200020\"> STAR*D<\/font><\/strong> was expansively planned, poorly executed, and deceptively reported. It was bad science because instead of starting with a question, it set out to prove an answer that was built on a set of unproven hypotheses and grandiose wishes &#8211; making things worse by using an idiosyncratic methodology that was equally speculative. And what they reported to the scientific community was just plain wrong. <\/div>\n<div align=\"center\"><img decoding=\"async\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/tmap-4.gif\" \/><\/div>\n<div align=\"justify\">Texas itself seems to have recovered. TMAP is long gone. They still talk about <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/09\/the-appearance-of-conflict-of-interest\/#comment-198503\"><u>alogorithms<\/u><\/a>, but in a different way. Texas Medicaid pays for <u><a target=\"_blank\" href=\"http:\/\/www.dshs.state.tx.us\/mhsa\/medicaldirector\/\">rational, generic medication<\/a><\/u> and you have to get the expensive drugs pre-approved. The whole agency that housed TMAP has been reorganized. Even the old TMAP procedure manuals seem to have have recently disappeared from sight [at least from the web <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/08\/the-singapore-sojourn-ask-alice\/#comment-198508\"><u>site<\/u><\/a>]. In 2008, the Dallas Psychiatry Chairman headed back east and TMAP\/<strong><font color=\"#200020\">STAR*D<\/font><\/strong> guru John Rush fled to Singapore to further the CRO&#8217;s meme to globalize clinical trials [rather than figure out how to do them]. Steven Shon is practicing in a suburb of Vegas and Allen Jones&#8217; <u><a target=\"_blank\" href=\"http:\/\/www.pharmalot.com\/2011\/03\/lawsuit-over-jj-risperdal-marketing-can-proceed\/\">suit<\/a><\/u> has recently broken out of a bottle-neck and is proceeding. Maybe Texas will get a rebate after all. And Senator Grassley&#8217;s investigations may have toppled only a few of the most egregious, but the ripples are still being felt. Even Governor\/President George Bush is finally back in Texas clearing away the brush on his ranch.<\/div>\n<p align=\"justify\">Should we let <strong><font color=\"#200020\">STAR*D<\/font><\/strong> slink into the shadows like TMAP? or Bush? If anyone asks my opinion, I&#8217;ll say that I don&#8217;t think so. That major report in the American Journal of Psychiatry [<u><a href=\"http:\/\/ajp.psychiatryonline.org\/cgi\/content\/abstract\/163\/11\/1905\" target=\"_blank\">Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report<\/a><\/u>] remains on the books, as does the editorial [<u><a target=\"_blank\" href=\"http:\/\/ajp.psychiatryonline.org\/cgi\/content\/full\/164\/2\/201\">STAR*D: What Have We Learned?<\/a><\/u>]. And their reported results continue to influence practice broadly in physician&#8217;s offices all over America [update: see <a target=\"_blank\" href=\"http:\/\/www8.utsouthwestern.edu\/utsw\/cda\/dept153397\/files\/169482.html#top\"><u>here<\/u><\/a>]. Pharmaceutical advertisements still promise more from the antidepressants and &quot;augmentation&quot; strategies than these medications really have to offer. <\/p>\n<div align=\"justify\">If Dr. Francis Collins of the National Institute of Health and Dr. Tom Insel of the National Institute of Mental Health are really the scientists they were hired to be and stand behind the names of the organizations they lead, they shouldn&#8217;t allow <strong><font color=\"#300030\">STAR*D<\/font><\/strong> to stand as an unfinished symphony. If its now defunct originating group won&#8217;t publish the promised results, then they should order a thorough investigation of the study and its primary data. After all, they own it. They paid for it to the tune of $35 Million. And if the American Journal of Psychiatry is to remain the primo scientific resource for the organization it represents and members it informs, it should join in that investigation and retract both the <strong><font color=\"#300030\">STAR*D <\/font><\/strong>report article and the editorial if they turn out to be as flawed as they appear to be. There&#8217;s no shame in going back and setting the record straight. The word &quot;ignorance&quot; is derived from the verb &quot;to ignore.&quot; <strong><font color=\"#300030\">STAR*D <\/font><\/strong>is way too important to just ignore&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>I made an earlier analogy that the STAR*D story is like falling down Alice&#8217;s rabbit hole. But that metaphor hasn&#8217;t held up under scrutiny. A rabbit hole is enclosed.&nbsp;STAR*D just won&#8217;t fit. It keeps on growing. It needs a bigger place &#8211; like&#8230; well, sort of like the wide open spaces of Texas. As a [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-7126","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/7126","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=7126"}],"version-history":[{"count":126,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/7126\/revisions"}],"predecessor-version":[{"id":9614,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/7126\/revisions\/9614"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=7126"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=7126"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=7126"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}