{"id":20585,"date":"2012-03-04T22:33:27","date_gmt":"2012-03-05T03:33:27","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=20585"},"modified":"2012-03-07T11:37:14","modified_gmt":"2012-03-07T16:37:14","slug":"red-alert","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/03\/04\/red-alert\/","title":{"rendered":"<font color=\"#990000\">red alert&#8230;<\/font>"},"content":{"rendered":"<div align=\"justify\">&nbsp;What&#8217;s the point about blogging about the pharmaceutical intrusion into the psychiatric literature? If it&#8217;s just to decry it, it&#8217;s something of a wasted effort. The point is to try to make transparent the things that went on unobserved and created the mess we are now faced with. Early detection is in my mind the key to any possibility of success in changing things. It is in that spirit that I&#8217;m recurrently posting about the Robert Gibbons article published on-line in last month. This post is further background information that I think might be pertinent. Here&#8217;s the abstract of his article as a reminder:<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/archpsyc.ama-assn.org\/cgi\/reprint\/archgenpsychiatry.2011.2048\" target=\"_blank\"><u><strong><font color=\"#200020\">Suicidal Thoughts and Behavior With Antidepressant Treatment<\/font><\/strong><\/u><\/a><br \/>                                                     <strong><font color=\"#200020\"><sup>Reanalysis of the Randomized Placebo-Controlled Studies of Fluoxetine and Venlafaxine<\/sup><\/font><\/strong><br \/>                                                       <sup>by Robert D. Gibbons, Hendricks Brown, Kwan Hur, John M. Davis, and <strong><font color=\"#990000\">J. John Mann<\/font><\/strong><\/sup><br \/>                                                       <strong><font color=\"#200020\">Archives of General Psychiatry<\/font><\/strong>. Online February 6, 2012.<br \/>                     [<a href=\"http:\/\/archpsyc.ama-assn.org\/cgi\/reprint\/archgenpsychiatry.2011.2048\" target=\"_blank\"><u><strong><font color=\"#200020\">full text on-line<\/font><\/strong><\/u><\/a>]<\/div>\n<p>                     <\/p>\n<div align=\"justify\"><sup><u><strong><font color=\"#200020\">Context<\/font><\/strong><\/u>:  The US Food and Drug Administration issued a black box warning for  antidepressants and suicidal thoughts and behavior in children and young  adults.<br \/>                      <u><strong><font color=\"#200020\">Objective<\/font><\/strong><\/u>:  To determine the short-term safety of antidepressants by standard  assessments of suicidal thoughts and behavior in youth, adult, and  geriatric populations and the mediating effect of changes in depressive  symptoms.<br \/>                      <u><strong><font color=\"#200020\">Data Sources<\/font><\/strong><\/u>:  All intent-to-treat person-level longitudinal data of major depressive  disorder from 12 adult, 4 geriatric, and 4 youth randomized controlled  trials of fluoxetine hydrochloride and 21 adult trials of venlafaxine  hydrochloride.<br \/>                      <u><strong><font color=\"#200020\">Study Selection<\/font><\/strong><\/u>: All sponsor-conducted randomized controlled trials of fluoxetine and venlafaxine. <strong><font color=\"#200020\">Data Extraction<\/font><\/strong>:  The suicide items from the Children&rsquo;s Depression Rating Scale&ndash;Revised  and the Hamilton Depression Rating Scale as well as adverse event  reports of suicide attempts and suicide during active treatment were  analyzed in 9185 patients (fluoxetine: 2635 adults, 960 geriatric  patients, 708 youths; venlafaxine: 2421 adults with immediate-release  venlafaxine and 2461 adults with extended-release venlafaxine) for a  total of 53 260 person-week observations.<br \/>                      <u><strong><font color=\"#200020\">Data Synthesis<\/font><\/strong><\/u>:  Suicidal thoughts and behavior decreased over time for adult and  geriatric patients randomized to fluoxetine or venlafaxine compared with  placebo, but no differences were found for youths. In adults, reduction  in suicide ideation and attempts occurred through a reduction in  depressive symptoms. In all age groups, severity of depression improved  with medication and was significantly related to suicide ideation or  behavior.<br \/>                      <u><strong><font color=\"#200020\">Conclusions<\/font><\/strong><\/u>:  Fluoxetine and venlafaxine decreased suicidal thoughts and behavior for  adult and geriatric patients. This protective effect is mediated by  decreases in depressive symptoms with treatment. For youths, no  significant effects of treatment on suicidal thoughts and behavior were  found, although depression responded to treatment. No evidence of  increased suicide risk was observed in youths receiving active  medication. To our knowledge, this is the first research synthesis of  suicidal thoughts and behavior in depressed patients treated with  antidepressants that examined the mediating role of depressive symptoms  using complete longitudinal person level data from a large set of  published and unpublished studies.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">I&#8217;ve already had a lot to say about it in these earlier posts:<\/div>\n<ul>\n<li><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/22\/significant-i\"><em><u><strong><font color=\"#200020\">significant<\/font><\/strong><\/u><\/em><u><strong><font color=\"#200020\"> I&hellip;<\/font><\/strong><\/u><\/a><\/li>\n<li>       <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/22\/significant-ii\"><u><strong><font color=\"#200020\"><em>significant<\/em> II&hellip;<\/font><\/strong><\/u> <\/a><\/li>\n<li>       <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/23\/significant-iii\"><u><strong><font color=\"#200020\"><em>significant<\/em> III&hellip;<\/font><\/strong><\/u> <\/a><\/li>\n<li>       <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/24\/coming-soon-2\"><u><strong><font color=\"#200020\">coming soon?&hellip;<\/font><\/strong><\/u> <\/a><\/li>\n<li>       <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/25\/waiting-game\"><u><strong><font color=\"#200020\">watchful waiting&hellip;<\/font><\/strong><\/u> <\/a><\/li>\n<li>       <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/29\/after-all\"><u><strong><font color=\"#200020\">smell a campaign&hellip;<\/font><\/strong><\/u><\/a><\/li>\n<\/ul>\n<div align=\"justify\">Why am I so stirred up about this article? First, Dr. Gibbons, a Biostatistician, has been stirred up about the black box warning about suicidal thoughts with antidepressants since 2004 when it became required on the SSRI drug labeling with various angles of attack &#8211; covered in earlier posts. Second, this article&nbsp; was published without data, with unintelligible tables, yet makes definite conclusions widely covered [<a target=\"_blank\" href=\"http:\/\/www.medscape.com\/viewarticle\/758917?src=mpnews&#038;spon=12\"><u><strong><font color=\"#200020\">Medscape<\/font><\/strong><\/u><\/a>, <a target=\"_blank\" href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736%2812%2960331-6\/fulltext\"><u><strong><font color=\"#200020\">Lancet<\/font><\/strong><\/u><\/a>, <a target=\"_blank\" href=\"http:\/\/articles.latimes.com\/2012\/feb\/06\/news\/la-heb-antidepressants-kids-20120206\"><u><strong><font color=\"#200020\">Press<\/font><\/strong><\/u><\/a>]: Here are a few of Dr. Gibbons&#8217; comments in these interviews:        <\/div>\n<ul>\n<div align=\"justify\"><strong><sup>&bull; &quot;The adverse event reports for suicidal thoughts and behavior showed a fairly small signal in children, but the prospective measurements showed no effect of treatment whatsoever. As a statistician, I put more weight in prospective data than these retrospective reports,&quot; he said.  &quot;The vote was 15 to 8, so some of the members of the committee, myself included, were not persuaded by those reports and felt that the black box warning was not warranted.&quot;<\/sup><\/strong><\/div>\n<div align=\"justify\"><strong><sup>&bull; The  impact of the &quot;black box&quot; warning, he  said, was to reduce  antidepressant prescriptions to kids &ndash; which was  correlated with an  increase in suicide rates in subsequent years.<\/sup><\/strong><\/div>\n<div align=\"justify\"><sup><strong>&bull; &quot;The greatest cause of suicide is   untreated or undiagnosed depression. It&rsquo;s very important that this   condition be recognized and appropriately treated and not discarded   because doctors are afraid to be sued.&quot;<\/strong><\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Here&#8217;s an article that cannot be vetted because its data is inaccessible, with a strong conclusion, one the author has been out to prove for six years, a conclusion he&#8217;s given as an expert&nbsp; legal witness, and a conclusion that would be favorable to pharmaceutical manufacturers. Which ones? The ones with in-patent antidepressants on the market today. The two main ones are Eli Lilly [<u><strong><font color=\"#200020\">Cymbalta<\/font><\/strong><\/u>] and Pfizer [<u><strong><font color=\"#200020\">Pristiq<\/font><\/strong><\/u>]. And which drugs did Dr. Gibbons study [from <strong><font color=\"#200020\">Medscape<\/font><\/strong>]?<\/div>\n<ul>\n<div align=\"justify\"><sup>&quot;We were interested initially in looking into the efficacy of  antidepressants, so we approached Eli Lilly to see if they would part  with all of their   longitudinal data from their randomized,  placebo-controlled trials, and remarkably, they said &#8216;yes,&#8217; &quot; said Dr.  Gibbons. &quot;We said that we were   going to analyze all the data and write  a paper and were not even going to show it to them, and they said  &#8216;fine&#8217;.&quot; Next, the researchers approached Wyeth with the same request and got the same reply. &quot;All of a sudden we had an awful lot of placebo-controlled,  randomized clinical trial data, complete longitudinal records for every  subject, and   we were able to ask questions about the efficacy of  antidepressants and whether or not that efficacy is moderated by the  severity of illness of the   patient and also whether or not there are  changes over time in suicidal thoughts and behavior, whether or not  those are the same in adults and   the elderly and children, and whether  or not any changes in suicidal thoughts and behavior are related to  changes in depressive severity,&quot; Dr.   Gibbons said.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">[Wyeth is now part of Pfizer]. So added to his strong opinions, and his having personally testified about those opinions as an expert witness, we have him studying older drugs made by the very two companies with current drugs on the market. So I then looked to see if those two manufacturers were aiming to try to get these new drugs approved for kids [from clinicaltrials.gov]:<\/div>\n<p>           <\/p>\n<div align=\"center\"><strong><font color=\"#200020\">PFIZER [WYETH]<\/font><\/strong><\/div>\n<ul>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00619619\"><u><strong><font color=\"#200020\">Study Evaluating Desvenlafaxine Succinate Sustained-Release [DVS SR] In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder<\/font><\/strong><\/u><\/a><br \/>                            <sup>&nbsp;&nbsp;&nbsp;&nbsp;COMPLETED <a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT00619619\"><u><strong><font color=\"#990000\">RESULTS<\/font><\/strong><\/u><\/a><br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Desvenlafaxine Succinate Sustained-Release Tablets [DVS SR]<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;Wyeth is now a wholly owned subsidiary of Pfizer<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;February 2008-November 2009<\/sup><\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" vspace=\"5\" height=\"268\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/des-1.gif\" \/><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00669110\"><u><strong><font color=\"#200020\">Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets [DVS SR] In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder<\/font><\/strong><\/u><\/a><br \/>                            <sup>&nbsp;&nbsp;&nbsp;&nbsp;COMPLETED <a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT00669110\"><u><strong><font color=\"#990000\">RESULTS<\/font><\/strong><\/u><\/a> <strong><font color=\"#200020\">C-SSRS<\/font><\/strong><br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Desvenlafaxine Succinate Sustained-Release Tablets [DVS SR]<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Wyeth is now a wholly owned subsidiary of Pfizer<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;May 2008-May 2010<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01371734\"><u><strong><font color=\"#200020\">A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD<\/font><\/strong><\/u><\/a><br \/>                            <sup>&nbsp;&nbsp;&nbsp;&nbsp;RECRUITING<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Desvenlafaxine Succinate Sustained-Release;   Placebo<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Pfizer<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;August 2011-August 2015<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01371721\"><u><strong><font color=\"#200020\">A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the  Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD<\/font><\/strong><\/u><\/a><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;RECRUITING<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;DVS SR<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Pfizer<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;February 2012-March 2016<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01371708\"><strong><font color=\"#200020\">A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD<\/font><\/strong><\/a><\/u><br \/>                            <sup> <\/sup><sup>&nbsp;&nbsp;&nbsp;&nbsp;RECRUITING<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;DVS SR<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Pfizer<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;January 2012-February 2016<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01372150\"><u><strong><font color=\"#200020\">A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD<\/font><\/strong><\/u><\/a><br \/>                            <sup> <\/sup><sup>&nbsp;&nbsp;&nbsp;&nbsp;RECRUITING<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;desvenlafaxine succinate sustained release; fluoxetine;   placebo<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;Pfizer<br \/>                            &nbsp;&nbsp;&nbsp;&nbsp;November 2011-August 2015<\/sup><\/div>\n<\/li>\n<\/ul>\n<div align=\"center\"><strong><font color=\"#200020\">ELI LILLY<\/font><\/strong>                        <\/div>\n<ul>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00849693\"><u><strong><font color=\"#200020\">A Study in the Treatment of Children and Adolescents With Major Depressive Disorder<\/font><\/strong><\/u><\/a><br \/>                          <sup>&nbsp;&nbsp;&nbsp;&nbsp;COMPLETED<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Placebo; fluoxetine; duloxetine<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Eli Lilly and Company<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;March 2009-September 2011<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00529789\"><u><strong><font color=\"#200020\">Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder<\/font><\/strong><\/u><\/a><br \/>                          <sup>&nbsp;&nbsp;&nbsp;&nbsp;COMPLETED <a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT00529789\"><u><strong><font color=\"#990000\">RESULTS<\/font><\/strong><\/u><\/a> <strong><font color=\"#200020\">C-SSRS<\/font><\/strong><br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;duloxetine<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Eli Lilly and Company<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;August 2007-September 2008<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00849901\"><u><strong><font color=\"#200020\">A Study in the Treatment of Children and Adolescents With Major Depressive Disorder<\/font><\/strong><\/u><\/a><br \/>                          <sup>&nbsp;&nbsp;&nbsp;&nbsp;COMPLETED<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Major Depressive Disorder<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;duloxetine; Placebo; fluoxetine<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;Eli Lilly and Company<br \/>                          &nbsp;&nbsp;&nbsp;&nbsp;March 2009-October 2011<\/sup><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">From the look of things, these seem like the kind of studies one does when winding up for an FDA appproval. They are particularly focusing on suicidal thought in the ones where their primary outcome is shown. They&#8217;ve been criticized&nbsp; for using items on the HAM-D or CDRS-S to assess suicidal thought, so they seem to be migrating to specific rating scales, in particular, the <a href=\"http:\/\/ajp.psychiatryonline.org\/article.aspx?articleid=181033\" target=\"_blank\"><strong><font color=\"#200020\">Columbia&ndash;Suicide  Severity Rating Scale [C-SSRS]<\/font><\/strong><\/a> which is in the process of being validated. It&#8217;s a clinician rated scale [even being developed for a <u><a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20553851\" target=\"_blank\">phone in system<\/a><\/u>]. Note that the last author on the Gibbons article [February 2011] and on the CSSR-S article [December 2011] are the same &#8211; <a href=\"http:\/\/asp.cumc.columbia.edu\/facdb\/profile_list.asp?uni=jjm&#038;DepAffil=Psychiatry\" target=\"_blank\"><u><strong><font color=\"#200020\">John J. Mann<\/font><\/strong><\/u><\/a>:<\/div>\n<ul>\n<div align=\"justify\"><sup>J. John Mann MD, is The Paul Janssen Professor of Translational  Neuroscience (in Psychiatry and in Radiology) and Vice Chair for  Research in the Department of Psychiatry at Columbia University. He is  Director of Research and Director of Molecular Imaging and the  Neuropathology Division at the New York State Psychiatric Institute. Dr.  Mann is trained in Psychiatry and Internal Medicine and has a Doctorate  in Neurochemistry. His research employs functional brain imaging,  neurochemistry and molecular genetics to probe the causes of depression  and suicide. Dr. Mann is the Director of the NIMH Conte Center for the  Neuroscience of Mental Disorders, and Past President of the  International Academy of Suicide Research. Dr. Mann has  published 458 papers and edited 10 books on the subjects of the biology  and treatment of mood disorders, suicidal behavior and other psychiatric  disorders. In private practice he specializes in the treatment of mood  disorders.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">Here&#8217;s the CSSR-S article recently published and the Columbia Video of the scale [proprietary]. It&#8217;s the scale used in the Emslie article on Lexapro reviewed earlier &#8211; the one I called a <u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/03\/02\/clinically-insignificant-study\/\" target=\"_blank\"><font color=\"#200020\">clinically insignificant study&hellip;<\/font><\/a><\/strong><\/u>:<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/ajp.psychiatryonline.org\/article.aspx?articleid=181033\" target=\"_blank\"><u><strong><font color=\"#200020\">The   Columbia&ndash;Suicide Severity Rating Scale: Initial Validity and Internal   Consistency Findings From Three Multisite Studies With Adolescents and   Adults<\/font><\/strong><\/u><\/a><br \/>                                                                                                <sup>by  Kelly  Posner, Ph.D.; Gregory K. Brown, Ph.D.; Barbara Stanley, Ph.D.;  David  A. Brent, M.D.; Kseniya V. Yershova, Ph.D.; Maria A. Oquendo,  M.D.;  Glenn W. Currier, M.D., M.P.H.; Glenn A. Melvin, Ph.D.; Laurence   Greenhill, M.D.; Sa Shen, Ph.D.; and <strong><font color=\"#990000\">J. John Mann, M.D.<\/font><\/strong><\/sup><br \/>                                     <strong><font color=\"#004400\">American Journal of Psychiatry<\/font><\/strong> 2011 168:1266-1277.<\/div>\n<p>                                     <\/p>\n<div align=\"justify\"><sup><u><strong><font color=\"#200020\">Objective<\/font><\/strong><\/u>:  Research on suicide prevention and interventions requires a  standard  method for assessing both suicidal ideation and behavior to  identify  those at risk and to track treatment response. The  Columbia&ndash;Suicide  Severity Rating Scale [C-SSRS] was designed to quantify  the severity of  suicidal ideation and behavior. The authors examined  the psychometric  properties of the scale.<br \/>                                     <u><strong><font color=\"#200020\">Method<\/font><\/strong><\/u>:  The CSSR-S&#8217;s validity relative to other measures of suicidal  ideation  and behavior and the internal consistency of its intensity of  ideation  subscale were analyzed in three multisite studies: a treatment  study of  adolescent suicide attempters [N=124]; a medication efficacy  trial  with depressed adolescents [N=312]; and a study of adults  presenting to  an emergency department for psychiatric reasons [N=237].<br \/>                                     <u><strong><font color=\"#200020\">Results<\/font><\/strong><\/u>:  The C-SSRS demonstrated good convergent and divergent validity with   other multi-informant suicidal ideation and behavior scales and had   high sensitivity and specificity for suicidal behavior classifications   compared with another behavior scale and an independent suicide   evaluation board. Both the ideation and behavior subscales were   sensitive to change over time. The intensity of ideation subscale   demonstrated moderate to strong internal consistency. In the adolescent   suicide attempters study, worst-point lifetime suicidal ideation on the   CSSR-S predicted suicide attempts during the study, whereas the Scale   for Suicide Ideation did not. Participants with the two highest levels   of ideation severity [intent or intent with plan] at baseline had  higher  odds for attempting suicide during the study.<br \/>                                     <u><strong><font color=\"#200020\">Conclusions<\/font><\/strong><\/u>:  These findings suggest that the C-SSRS is suitable for assessment  of  suicidal ideation and behavior in clinical and research settings.<\/sup><\/div>\n<\/blockquote>\n<p align=\"center\"><iframe loading=\"lazy\" src=\"http:\/\/blip.tv\/play\/hNVhgtv_aQI.html?p=1\" width=\"480\" height=\"300\" frameborder=\"0\" allowfullscreen><\/iframe><embed type=\"application\/x-shockwave-flash\" src=\"http:\/\/a.blip.tv\/api.swf#hNVhgtv_aQI\" style=\"display:none\"><\/embed><\/p>\n<div align=\"justify\">I have <u>no question<\/u> that these antidepressants can cause an agitated state called akasthisia that can be associated with exaggerated aggression and lethal thought. I&#8217;ve seen it happen myself. It&#8217;s uncommon but a big deal when it occurs. I am suspicious when someone tries to convince us that it doesn&#8217;t happen at all because the secondary gain is enormous &#8211; a huge pharmaceutical market. The other reason for my suspicion is obvious, I&#8217;ve seen akathisia occur in several adults and an adolescent with my very own eyes. I know Dr. Gibbons hasn&#8217;t seen it. He doesn&#8217;t see patients. I&#8217;m very suspicious of Clinical Trials as a way to study it, because the people who run them and write them up don&#8217;t see the patients either. They might be spread out all around the world [and the studies are funded by people who gain if it&#8217;s not seen]. I don&#8217;t even know if akathisia occurs at a rate that would appear in a statistical study.<\/div>\n<p align=\"justify\">So what is my conclusion? I don&#8217;t have one yet, but I have a high level of suspicion that the forces at work here are being driven rather than just serendipity. I&#8217;m suspicious that Dr. Gibbons fervor has a cause. I see two drug companies that stand to gain a lot by either pediatric approval or a lifting of the warning. I see a new suicidality scale being introduced and used in these studies, shepherded by the same author writing with Dr. Gibbons. I read the comments of a Biostatistician talking about physician motives and what needs to be done for patients &#8211; odd. And given the track record of this industry, in this specialty, in this time, I say that there&#8217;s enough here to try to keep this issue on the very front burner. On the other side of the coin, I don&#8217;t see a lot of evidence that these drugs are very effective in kids and adolescents in the published studies [<strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2011\/07\/22\/tuning-the-quartet\"><font color=\"#200020\">tuning the quartet&hellip;<\/font><\/a><\/strong>, <u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2012\/03\/02\/clinically-insignificant-study\" target=\"_blank\"><font color=\"#200020\">clinically insignificant study&hellip;<\/font><\/a><\/strong><\/u>] or in my own experience treating kids. <strong>Yes<\/strong>, I do use them. <strong>Yes<\/strong> I have seen them help, primarily in kids with an obsessive compulsive diathesis, but also at times with depression. But the idea that being careful with antidepressants in kids is depriving them of some kind of vital treatment is patently absurd from where I sit. Their effectiveness is such that one is glad when they do work [some], and hardly surprised when they don&#8217;t.  <\/p>\n<div align=\"justify\">I&#8217;m comfortable with the advice from <a target=\"_blank\" href=\"http:\/\/davidhealy.org\/coincidence-a-fine-thing\"><u><strong><font color=\"#200020\">Dr. David Healy<\/font><\/strong><\/u><\/a> who has been at the forefront of this issue from the beginning:<\/div>\n<ul>\n<div align=\"justify\"><strong><font color=\"#200020\"><sup>This is not an argument for not using Prozac. As I also mentioned in the  1991 letter to the BMJ:&nbsp; &ldquo;The significance of the emergence of  suicidality.. is that it can be anticipated and forestalled by warning  patients.&rdquo;<\/sup><\/font><\/strong><\/div>\n<\/ul>\n<div align=\"justify\">Every time I give an antidepressant to a young person I warn them, warn those around them, and give them my home phone number. It&#8217;s never a casual prescription. And as for Dr. Gibbons next installment due out any day, I&#8217;ll be reading it very carefully. This whole scenario has the feel of pharmaceutical sheenanigans to me&#8230;  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp;What&#8217;s the point about blogging about the pharmaceutical intrusion into the psychiatric literature? If it&#8217;s just to decry it, it&#8217;s something of a wasted effort. The point is to try to make transparent the things that went on unobserved and created the mess we are now faced with. Early detection is in my mind the [&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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-20585","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20585","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=20585"}],"version-history":[{"count":35,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20585\/revisions"}],"predecessor-version":[{"id":20725,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20585\/revisions\/20725"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=20585"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=20585"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=20585"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}