{"id":8516,"date":"2011-05-06T18:33:51","date_gmt":"2011-05-06T22:33:51","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=8516"},"modified":"2011-05-06T18:33:51","modified_gmt":"2011-05-06T22:33:51","slug":"mud-mud-mud","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/05\/06\/mud-mud-mud\/","title":{"rendered":"mud + mud = mud&#8230;"},"content":{"rendered":"<div align=\"center\"><a href=\"http:\/\/www.hcp.med.harvard.edu\/ncs\/ftpdir\/NCS-R_Lifetime_Prevalence_Estimates.pdf\" target=\"_blank\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"5\" height=\"162\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/mood-1.gif\" \/><\/a><\/div>\n<div align=\"center\"><a href=\"http:\/\/www.hcp.med.harvard.edu\/ncs\/ftpdir\/NCS-R_12-month_Prevalence_Estimates.pdf\" target=\"_blank\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"5\" height=\"162\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/mood.gif\" \/><\/a><\/div>\n<div align=\"justify\">Do we believe that this category, Major Depressive Disorder, is a unity or a collage [those tables are pieced from the <a href=\"http:\/\/www.hcp.med.harvard.edu\/ncs\/index.php\" target=\"_blank\"><u><strong><font color=\"#200020\">National Comorbidity Survey<\/font><\/strong><\/u><\/a>]? I&#8217;m obviously in the collage camp &#8211; in fact, I can&#8217;t imagine otherwise. I guess I&#8217;m still arguing with the DSM III [which is now 31 years old]. And when I read those &quot;MDD is a growing public health problem &#8230; the World Health Organization predicts &#8230;&quot; introductory paragraphs in articles, I hear a sales pitch &#8211; little more. These days, when I read those things, I look in the Acknowledgments for a ghost-writer  and for who funded the study. But, for this moment at least, pharmaceutical marketing practices aren&#8217;t why I&#8217;m writing about this.<\/div>\n<p align=\"justify\">I&#8217;ve kind of wound down with obsessively going back through articles about these drugs. I&#8217;ve learned what I set out to learn [or maybe confirm]. There has been a lot of pseudo-science, just like the rest of you have been saying all along. But when I was reading through Dr. Trivedi&#8217;s write-up for his coming NIMH-funded personalized medicine study, I felt badly for him because he doesn&#8217;t stand much of a chance.<\/p>\n<div align=\"justify\">In <strong><font color=\"#200020\">STAR*D<\/font><\/strong>:<\/div>\n<ul>\n<div align=\"justify\"><sup>All participants provided written informed consent at study entry and at entry into each level and the follow-up phase. Only outpatients seeking medical care were eligible [i.e., symptomatic volunteers were excluded]. Participants met DSM-IV criteria for nonpsychotic major depressive disorder at study entry as determined by clinical diagnosis and confirmed with a DSM-IV checklist by the clinical research coordinator.<\/sup><\/div>\n<\/ul>\n<div>In <strong><font color=\"#200020\">CO-MED<\/font><\/strong>:<\/div>\n<ul>\n<div align=\"justify\"><sup>Potential participants were screened at each clinical site with each site&rsquo;s standard procedure [variable across sites]. Most sites used two to nine questions from the Patient Health Questionnaire. Patients identified by screening saw their study clinicians and clinical research coordinator to determine study eligibility following written informed consent. Participants Broad inclusion and minimal exclusion criteria ensured a reasonably representative participant group. The outpatient enrollees were 18&ndash;75 years old and met the DSM-IV-TR criteria for either recurrent or chronic [current episode lasting at least 2 years] major depression according to a clinical interview and confirmed with a DSM-IV-based symptom checklist completed by the clinical research coordinator. Eligible participants had to have an index episode lasting at least 2 months and had to score at least 16 on the 17-Item Hamilton Depression Rating Scale [HAM-D].<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Here are the study locations: <u><a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00021528?term=star*d&#038;rank=3&#038;show_locs=Y#locn\" target=\"_blank\"><strong><font color=\"#200020\">STAR*D<\/font><\/strong><\/a><\/u> and <a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00590863?term=co-med&#038;rank=1&#038;show_locs=Y#locn\" target=\"_blank\"><strong><u><font color=\"#200020\">CO-MED<\/font><\/u><\/strong><\/a>. In spite of the number of r\u00c3\u00a9sum\u00c3\u00a9s padded by <strong><font color=\"#200020\">STAR*D<\/font><\/strong>, I personally know of no enduring findings&nbsp; nor do I expect any from <strong><font color=\"#200020\">CO-MED<\/font><\/strong>. I suppose that they designed the studies, turned them over to the Clinical Research Centers, and awaited the data reports:<\/div>\n<ul>\n<div align=\"justify\"><sup>Clinical sites were selected on the basis of our prior experience and their performance in the Sequenced Treatment Alternatives to Relieve Depression trial to ensure [1] adequate patient flow, [2] committed administrative support, [3] adequate minority representation, and [4] adequate representation of both primary and psychiatric care sites.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Not mentioned is <strong>careful clinical evaluation<\/strong>. The results were two studies with big drop-out rates and missing data they had to bury in the write-ups, changing outcome measures along the way in one study. They and their friends have created a Clinical Research Industry that is an imprecise data mill. My guess is that&#8217;s one reason why their non-compliance and drop-out rates are so high. Likewise it doesn&#8217;t sound like their intake procedures are very exhaustive [or engaging]. <\/div>\n<p><\/p>\n<div align=\"justify\">I recently read a chapter Dr. Bernard Carroll wrote entitled <strong><font color=\"#200020\">Diagnostic Validity and Laboratory Studies: Rules of the Game<\/font><\/strong> in [<em>The Validity of Psychiatric Diagnosis<\/em>, edited by Lee N. Robins and James Barrett, Raven Press Ltd. New York, 1989]. Here&#8217;s one of the rules:<\/div>\n<ul>\n<div align=\"justify\"><em><strong>Rule #2:<\/strong> No biologic measure can in principle do better than the clinical independent variable against which it is compared.<\/em> This rule is a simple point of logic. It follows that if the &quot;gold standard&quot; clinical diagnosis is flawed, then the interpretation of laboratory measures will be compromised. In other words, laboratory measures can never &quot;outperform clinical diagnoses: they can only look worse&#8230;<\/div>\n<\/ul>\n<div align=\"justify\">So loose subject evaluation and engagement plus a loose, heterogeneous diagnostic category, in a study to explore objective correlations with laboratory tests is a formula for failure if there ever were one. Any research worth doing is worth personally watching over very carefully. When the data comes back mushy, it&#8217;s too late to do anything about the fog, and Trivedi&#8217;s recent outings have been just that &#8211; judging from the obscurity in the write-ups. It seems like his work fits the computer adage, &quot;garbage in. garbage out.&quot; Pity&#8230;  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Do we believe that this category, Major Depressive Disorder, is a unity or a collage [those tables are pieced from the National Comorbidity Survey]? I&#8217;m obviously in the collage camp &#8211; in fact, I can&#8217;t imagine otherwise. I guess I&#8217;m still arguing with the DSM III [which is now 31 years old]. And when I [&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-8516","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/8516","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=8516"}],"version-history":[{"count":11,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/8516\/revisions"}],"predecessor-version":[{"id":8527,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/8516\/revisions\/8527"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=8516"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=8516"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=8516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}