{"id":57652,"date":"2015-06-07T15:01:16","date_gmt":"2015-06-07T19:01:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=57652"},"modified":"2015-06-07T15:01:16","modified_gmt":"2015-06-07T19:01:16","slug":"not-just-no","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/06\/07\/not-just-no\/","title":{"rendered":"not just &#8220;no&#8221;&#8230;"},"content":{"rendered":"\n<p align=\"justify\" class=\"small\">By the beginning of 2011, I was finally catching on to the extent of the the problem with the Psychopharmacology literature. I had written a sarcastic post about inventing a computer to generate Clinical Trials mixing every drug with every condition [<a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/27\/nimhreceptalator\/\" target=\"_blank\"><font color=\"#993399\">NIMH&middot;receptalator<\/font>&hellip;<\/a>] and I got a <a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/27\/nimhreceptalator\/#comment-190907\" target=\"_blank\">comment<\/a> from someone in Texas pointing out that such a computer program was already proposed. It was a paper by Madhukar Trivedi at UT Southwestern. He had written a computer program to implement an algorithm driven treatment of Major Depressive Disorder on an NIMH grant. The paper was talking about his attempted Clinical Trial [<font color=\"#200020\">IMPACT<\/font>] to test the algorithm. He&#8217;d had to abandon the Trial, because the clinic doctors wouldn&#8217;t use the computer unless Dr. Trivedi was there looking at them. In the paper, he was speculating about why they wouldn&#8217;t use it [strange bit of psychologizing for a biological psychiatrist, I thought]. Then I looked at his COI declaration [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/28\/evidence-based-medicine-i\/\" target=\"_blank\">evidence-based medicine I&hellip;<\/a>]&nbsp; and my jaw fell to the floor. That&#8217;s when I started blogging consistently about the pharmaceutical invasion of psychiatry. I&#8217;d never seen anything like that before.<\/p>\n<p align=\"justify\" class=\"small\">I had found that five year grant for <font color=\"#200020\">IMPACT<\/font> [<a title=\"Click to view Project  Details\" href=\"http:\/\/projectreporter.nih.gov\/project_info_details.cfm?aid=6681108&#038;icde=24892386&#038;ddparam=&#038;ddvalue=&#038;ddsub=&#038;cr=31&#038;csb=GNI&#038;cs=ASC\" target=\"_blank\">MH064062<\/a>] which had been paid out at a total of <strong><font color=\"#200020\">$3.3 M<\/font><\/strong> [which seemed like a lot for a study that never happened]. Working backwards got me to <font color=\"#200020\">STAR*D<\/font>. While it had &gt;100 articles, they never published the results of the Primary Outcome Variables &#8211; just some secondary rating scales [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/03\/a-thirty-five-million-dollar-misunderstanding\/\" target=\"_blank\">a thirty-five million dollar misunderstanding&hellip;<\/a>]. Yes, it cost <strong><font color=\"#200020\">$35 M<\/font><\/strong> in all and essentially told us very little about treatment. Moving further back in time, I ended up at <font color=\"#200020\">TMAP<\/font>, with Trividi in c harge of nthe Mood Disorder Algorithms. And that opened up learning about the biggest industry\/psychiatry scam of them all, <strong><font color=\"#200020\">TMAP<\/font><\/strong> &#8211; getting in-patent drugs into the State formularies was a gold rush for PHARMA. Somewhere back around 2008, John Rush left UT for the Duke Program in Singapore. At that time, Trivedi inherited all the NIMH Projects at UT. He finished up <font color=\"#200020\">CO-MED<\/font>, a negative study involving combining antidepressants. Then he got a NIMH Grant for a project of his own [<font color=\"#200020\">EMBARC<\/font>] to look for biomarkers that discriminated between Zoloft or Wellbutrin responders &#8211; a personalized medicine quest of dubious value at best. The NIMH has paid out <strong><font color=\"#200020\">$9+ M<\/font><\/strong> so far, the grant cycle has elapsed, and yet it&#8217;s currently listed as still recruiting on <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01407094\" target=\"_blank\">ClinicalTrials.gov<\/a>. Altogether, I&#8217;d say the four NIMH studies [<font color=\"#200020\">STAR*D<\/font>,<font color=\"#200020\"> IMPACT<\/font>,<font color=\"#200020\"> CO-MED<\/font>, and <font color=\"#200020\">EMBARC<\/font>] came to well over <strong><font color=\"#200020\">$50 M<\/font><\/strong> total.<\/p>\n<p align=\"center\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" height=\"300\" width=\"400\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/prefer-4.gif\" \/><\/p>\n<p align=\"justify\" class=\"small\">As you can see, it&#8217;s become something of a hobby of mine, following Dr. Trivedi&#8217;s projects since that first one in 2011. He&#8217;s very adroit at getting NIMH funding, though he&#8217;s less adept at finishing the projects. He actually completed <font color=\"#200020\">CO-MED<\/font> as advertised. Other than that, <font color=\"#200020\">STAR*D<\/font>,<font color=\"#200020\"> IMPACT<\/font>,<font color=\"#200020\"> and EMBARC<\/font> never got published as the completed research they were funded to be, though there were plenty enough papers generated by <font color=\"#200020\">STAR*D<\/font> for a small library<font color=\"#200020\">. <\/font>And <font color=\"#200020\">TMAP<\/font> just quietly faded away after almost bankrupting the Texas Mental Health budget [bailed out by Governor George Bush prior to leaving for Washington]. In Dr. Trivedi&#8217;s defense, the gross corruption and PHARMA collusion exposed had to do with the Atypical Antipsychotics rather than with Dr. Trivedi&#8217;s Antidepressant algorithms<font color=\"#200020\">, though I don&#8217;t know that the Antidepressant part of TMAP received a thorough vetting.<br \/>     <\/font><\/p>\n<div align=\"justify\" class=\"small\">But I never thought my hobby of following Trivedi&#8217;s projects would lead to this recent punch line:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/www.utsouthwestern.edu\/newsroom\/news-releases\/year-2015\/may\/apa-trivedi.html\" target=\"_blank\">Psychiatrist Dr. Madhukar Trivedi receives  American Psychiatric Association&rsquo;s top research award<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#000033\">UTSouthwestern Medical Center: Newsroom<\/font><\/strong><\/div>\n<div align=\"center\" class=\"small\">May 18, 2015<\/div>\n<p>      <\/p>\n<div align=\"justify\">DALLAS &ndash; Dr. Madhukar Trivedi,  Director of the Center for Depression Research and Clinical Care at UT  Southwestern Medical Center and an internationally recognized expert in  depression and mood disorders, is receiving the 2015 American  Psychiatric Association Award for Research, the Association&rsquo;s most  significant award for research. First awarded in 1949 as The Hofheimer Prize, the award is given in  recognition of a single distinguished contribution, body of work, or  lifetime contribution that has had a major impact on the field and\/or  altered the practice of psychiatry, according to the American  Psychiatric Foundation, which identifies the awardees. Dr. Trivedi,  Professor of Psychiatry and Chief of the Division of Mood Disorders at UT&nbsp;Southwestern, will present an honorary lecture May 18 at the APA Annual Meeting in Toronto&#8230;<\/div>\n<\/blockquote>\n<div align=\"center\"><a href=\"http:\/\/annualmeeting.psychiatry.org\/File%20Library\/Unassigned\/2015_AMG_Final.pdf#page=105\" target=\"_blank\"><img loading=\"lazy\" decoding=\"async\" height=\"195\" width=\"498\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/trivedi-3.gif\" \/><\/a><br \/> <sup>click on the graphic for the meeting guide<br \/> see page 105<\/sup><\/div>\n<blockquote>\n<div align=\"justify\">Dr. Trivedi previously served as one of the Principal Investigators  of the Sequenced Treatment Alternatives to Relieve Depression [STAR*D]  study, which at the time was the largest and longest study on the  treatment of major depressive disorder and is considered a benchmark in  the field of depression research. Dr. Trivedi also helped author innovative treatment guidelines called  the Texas Medication Algorithm Project [TMAP], a set of comprehensive  management tools for doctors treating severely mentally ill patients  within Texas&rsquo; publicly funded mental health care system.<\/div>\n<p>      <\/p>\n<div align=\"justify\">He also served as Principal Investigator for NIMH grants examining  treatment for chronic depression, identifying specific signaling  proteins found in blood cells that may predict whether a depressive  person will respond better to workouts or medications, a computerized  decision support system for depression, and one using specific  antidepressant combinations to increase remission rates by treating a  broader spectrum of depressed patients and by capitalizing on additive  pharmacological effects&#8230;  <\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">[Obviously, this narrative differs from my version]. I feel like a tabloid writer this week after the series on Dr. Wagner&#8217;s election as AACAP President and now Dr. Trivedi&#8217;s award. But there was something that happened in the world of psychopharmacology in the last twenty-five years that was unprecedented in my experience in medicine &#8211; maybe anybody&#8217;s experience. And while there are moves to set things straight, they&#8217;re still in their infancy. So here&#8217;s what I encountered on my first exposure to Dr. Trivedi&#8217;s work back 5 years ago [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/28\/evidence-based-medicine-i\/\" target=\"_blank\">evidence-based medicine I&hellip;<\/a>]:<\/div>\n<ul><sup><\/p>\n<div align=\"justify\"><strong><font color=\"#990000\">Competing interests<\/font><\/strong><\/div>\n<hr size=\"1\" \/>\n<div align=\"justify\"><strong><font color=\"#990000\">Madhukar H. Trivedi, M.D.<\/font><\/strong> has been a  consultant for <strong><font color=\"#200020\">Abbott Laboratories<\/font><\/strong>, Inc.; Akzo (<strong><font color=\"#200020\">Organon Pharmaceuticals<\/font><\/strong>  Inc.); <strong><font color=\"#200020\">AstraZeneca<\/font><\/strong>; <strong><font color=\"#200020\">Bayer<\/font><\/strong>; <strong><font color=\"#200020\">Bristol-Myers Squibb Company<\/font><\/strong>; <strong><font color=\"#200020\">Cephalon, Inc.<\/font><\/strong>;  <strong><font color=\"#200020\">Cyberonics, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Eli Lilly &amp; Company<\/font><\/strong>; <strong><font color=\"#200020\">Fabre-Kramer  Pharmaceuticals, Inc.<\/font><\/strong> <strong><font color=\"#200020\">Forest Pharmaceuticals<\/font><\/strong>; <strong><font color=\"#200020\">GlaxoSmithKline<\/font><\/strong>; <strong><font color=\"#200020\">Janssen  Pharmaceutica Products, LP<\/font><\/strong>; <strong><font color=\"#200020\">Johnson &amp; Johnson PRD<\/font><\/strong>; <strong><font color=\"#200020\">Eli Lilly &amp;  Company<\/font><\/strong>; <strong><font color=\"#200020\">Meade Johnson<\/font><\/strong>; <strong><font color=\"#200020\">Neuronetics<\/font><\/strong>; <strong><font color=\"#200020\">Parke-Davis Pharmaceuticals, Inc.<\/font><\/strong>;  <strong><font color=\"#200020\">Pfizer, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Pharmacia &amp;<\/font><\/strong>; <strong><font color=\"#200020\">Upjohn; Sepracor<\/font><\/strong>; <strong><font color=\"#200020\">Solvay Pharmaceuticals,  Inc.<\/font><\/strong>; <strong><font color=\"#200020\">VantagePoint<\/font><\/strong>; and <strong><font color=\"#200020\">Wyeth-Ayerst Laboratories<\/font><\/strong>.<\/div>\n<p align=\"justify\"> He has served on  speakers bureaus for <strong><font color=\"#200020\">Abdi Brahim<\/font><\/strong>; Akzo (<strong><font color=\"#200020\">Organon Pharmaceuticals Inc.)<\/font><\/strong>;  <strong><font color=\"#200020\">Bristol-Myers Squibb Company<\/font><\/strong>; <strong><font color=\"#200020\">Cephalon, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Cyberonics, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Forest  Pharmaceuticals<\/font><\/strong>; <strong><font color=\"#200020\">GlaxoSmithKline<\/font><\/strong>; <strong><font color=\"#200020\">Janssen Pharmaceutica Products, LP<\/font><\/strong>;  <strong><font color=\"#200020\">Eli Lilly &amp; Company<\/font><\/strong>; <strong><font color=\"#200020\">Pharmacia &amp;<\/font><\/strong>; <strong><font color=\"#200020\">Upjohn<\/font><\/strong>; <strong><font color=\"#200020\">Solvay Pharmaceuticals,  Inc.<\/font><\/strong>; and <strong><font color=\"#200020\">Wyeth-Ayerst Laboratories<\/font><\/strong>.<\/p>\n<div align=\"justify\"> He has also received grant support  from <strong><font color=\"#200020\">Bristol-Myers Squibb Company<\/font><\/strong>; <strong><font color=\"#200020\">Cephalon, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Corcept  Therapeutics, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Cyberonics, Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Eli Lilly &amp; Company<\/font><\/strong>; <strong><font color=\"#200020\">Forest  Pharmaceuticals<\/font><\/strong>; <strong><font color=\"#200020\">GlaxoSmithKline<\/font><\/strong>; <strong><font color=\"#200020\">Janssen Pharmaceutica<\/font><\/strong>; <strong><font color=\"#200020\">Merck<\/font><\/strong>; National  Institute of Mental Health; National Alliance for Research in  Schizophrenia and Depression; <strong><font color=\"#200020\">Novartis<\/font><\/strong>; <strong><font color=\"#200020\">Pfizer Inc.<\/font><\/strong>; <strong><font color=\"#200020\">Pharmacia &amp;<\/font><\/strong>;  <strong><font color=\"#200020\">Upjohn<\/font><\/strong>; <strong><font color=\"#200020\">Predix Pharmaceuticals<\/font><\/strong>; <strong><font color=\"#200020\">Solvay Pharmaceuticals, Inc.<\/font><\/strong>; and  <strong><font color=\"#200020\">Wyeth-Ayerst Laboratories<\/font><\/strong>.<\/div>\n<p><\/sup><\/ul>\n<p align=\"justify\" class=\"small\">The study chart above is all government funded research aiming to making direct recommendations to clinicians about how they should treat patients using Guidelines and Algorithms. <strong><font color=\"#200020\">It is not possible for someone with that level of Conflict of Interest to make unbiased recommendations. In my estimation, no-one with those competing interests should have ever received NIMH grant support in the first place.<\/font><\/strong><\/p>\n<p align=\"justify\" class=\"small\">At the&nbsp; <em><a href=\"http:\/\/brainnet.net\/media\/video_action.php?playfor=brainnet&#038;iframe=true&#038;width=770&#038;height=480\" target=\"_blank\">Mayflower Conference<\/a>, <\/em> on Personalized Medicine in October 2009, Dr Trivedi said:<em> &ldquo;&#8230; clinicians have to decide on  treatments and therefore the best goal, interim goal at least, we may  want to understand the pathophysiology better and I&rsquo;m not against that,  but I think <font color=\"#200020\">we<\/font> have to help clinicians decide on one versus the other treatment.&quot;<\/em> I disagree. The body of that work aims <em><strong><font color=\"#200020\">to tell<\/font><\/strong><\/em> clinicians what choices to make rather that give them the accurate efficacy, safety, and pathophysiologic information to make these decisions in concert with their patients. After reading that first article, I made this sketch:<\/p>\n<p align=\"center\" class=\"small\"><img decoding=\"async\" width=\"350\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/evidence-1.gif\" \/>&nbsp;<\/p>\n<div align=\"justify\" class=\"small\">Using a structured interview or questionnaire and a DSM-whichever, a computer algorithm informed by [<em><font color=\"#200020\">industry funded and managed<\/font><\/em>] clinical trials spits out treatments and tweaks things along the way. This whole line of thinking mimics that graphic. The only clinicians involved are the ones that create the computer&#8217;s algorithms [<em><font color=\"#200020\">with COI loading like the above<\/font><\/em>] and never meet the patients. So not just <em><strong><font color=\"#200020\">&quot;no&quot;<\/font><\/strong><\/em> &#8211; but <em><strong><font color=\"#200020\">&quot;hell no!&quot;<\/font><\/strong><\/em>. Practicing physicians don&#8217;t need recipes of questionable validity from compromised academics. We need accurate scientific information to allow us to do our jobs&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>By the beginning of 2011, I was finally catching on to the extent of the the problem with the Psychopharmacology literature. I had written a sarcastic post about inventing a computer to generate Clinical Trials mixing every drug with every condition [NIMH&middot;receptalator&hellip;] and I got a comment from someone in Texas pointing out that such [&hellip;]<\/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-57652","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/57652","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=57652"}],"version-history":[{"count":37,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/57652\/revisions"}],"predecessor-version":[{"id":57689,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/57652\/revisions\/57689"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=57652"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=57652"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=57652"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}