{"id":20242,"date":"2012-02-25T10:00:44","date_gmt":"2012-02-25T15:00:44","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=20242"},"modified":"2012-02-29T04:30:37","modified_gmt":"2012-02-29T09:30:37","slug":"waiting-game","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/02\/25\/waiting-game\/","title":{"rendered":"watchful waiting&#8230;"},"content":{"rendered":"\n<div align=\"justify\">The last post, I said I was <em>obsessed<\/em>, but maybe I should have said <em>perplexed<\/em>. I just don&#8217;t understand the seven year hegira Dr. Gibbons has been on to disprove the need for the black box warning on the antidepressants about the possibility of treatment emergent suicidality in children and adolescents. His persistence transcends reason. It&#8217;s Gibbons that seems <em>obsessed<\/em>. Before detailing his journey, here&#8217;s another version of his public statements, this time in the <strong><font color=\"#200020\">Los Angeles Times<\/font><\/strong>:<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/articles.latimes.com\/2012\/feb\/06\/news\/la-heb-antidepressants-kids-20120206\" target=\"_blank\"><u><strong><font color=\"#200020\">Study questions antidepressant link to suicide in kids<\/font><\/strong><\/u><\/a><br \/>                           <strong><font color=\"#200020\">Los Angeles Times<\/font><\/strong><br \/>                           By Shari Roan<br \/>                           February 06, 2012<\/div>\n<p>                     <\/p>\n<div align=\"justify\"><sup>In  2004, the Food and Drug Administration announced that antidepressant  packages should carry a &quot;black box&quot; warning describing an increased risk  of suicide and suicidal thoughts in children and youths up to age 25.  The FDA action triggered a significant decline in antidepressant use  among children and teens. Now, however, an analysis suggests there is no reason to believe that antidepressants influence suicidal thinking in kids.<\/p>\n<p>                      The paper, published online Monday in the <u><strong><font color=\"#200020\"><a href=\"http:\/\/archpsyc.ama-assn.org\/\" target=\"_blank\">Archives of General Psychiatry<\/a><\/font><\/strong><\/u>,  analyzed data from 41 clinical trials involving more than 9,000 adults  and children. The adults were taking either the antidepressant  fluoxetine or venlafaxine. The children were taking fluoxetine (Prozac).  The study showed that adults had a decreased risk of suicidal thoughts  and behaviors while taking an antidepressant. Among children,  medications neither increased nor decreased suicidal thoughts or  behavior.<\/p>\n<p>                      The new study draws from a larger database than the  research performed in 2004 that led to the &quot;black box&quot; warning. However,  the data on children are limited to the one medication &#8211; fluoxetine. Several important points can be drawn from the new study, said the lead  author of the paper, Robert Gibbons, a professor of medicine, health  studies and psychiatry at the University of Chicago. It suggests that  antidepressants reduce suicide rates by treating the underlying  depression. If the treatment does not work, suicide risk remains the  same or rises.<\/p>\n<p>                      Moreover, antidepressants appear to affect children differently than adults with regard to suicide. &quot;Maybe children think about suicide in part because of depression, but  also maybe due to other reasons not related to depression that are not  affected by antidepressants,&quot; Gibbons said in a news release. <strong><font color=\"#990000\">The  impact of the &quot;black box&quot; warning, he said, was to reduce  antidepressant prescriptions to kids &#8211; which was correlated with an  increase in suicide rates in subsequent years.<\/font><\/strong><\/p>\n<p>                      &quot;I hope that the  warnings will not prevent depressed children and adults from getting  treatment for depression,&quot; he said. <strong><font color=\"#990000\">&quot;The greatest cause of suicide is  untreated or undiagnosed depression. It&#8217;s very important that this  condition be recognized and appropriately treated and not discarded  because doctors are afraid to be sued.&quot;<\/font><\/strong><\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">After the Black Box Warning was added in 2004, there was a determined effort to debunk it using a variety of data. Here are Gibbons&#8217; offerings:<\/div>\n<ul>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/15699293\"><font color=\"#200020\">The relationship between antidepressant medication use and rate of suicide.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Gibbons RD, Hur K, Bhaumik DK, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Arch Gen Psychiatry. 2005 Feb;62(2):165-72.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17074941\"><font color=\"#200020\">The relationship between antidepressant prescription rates and rate of early adolescent suicide.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Gibbons RD, Hur K, Bhaumik DK, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Am J Psychiatry. 2006 Nov;163(11):1898-904.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17592916\"><font color=\"#200020\">Association of suicide and antidepressant prescription rates in Japan, 1999-2003.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Nakagawa A, Grunebaum MF, Ellis SP, Oquendo MA, Kashima H, Gibbons RD, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;J Clin Psychiatry. 2007 Jun;68(6):908-16.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17606656\"><font color=\"#200020\">Relationship between antidepressants and suicide attempts: an analysis of the Veterans Health Administration data sets.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Am J Psychiatry. 2007 Jul;164(7):1044-9.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17728420\"><font color=\"#200020\">Early evidence on the effects of regulators&rsquo; suicidality warnings on SSRI prescriptions and suicide in children and adolescents.<\/font><\/a><\/strong><\/u> [see <u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/10\/27\/peaks-and-valleys\" target=\"_blank\"><font color=\"#200020\">peaks and valleys&hellip;<\/font><\/a><\/strong><\/u>]<br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Gibbons RD, Brown CH, Hur K, Marcus SM, Bhaumik DK, Erkens JA, Herings RM, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Am J Psychiatry. 2007 Sep;164(9):1356-63.<\/sup><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">At this point [2007], Gibbons was running with a herd of critics who filled the literature with data showing that antidepressant prescriptions for youth had plummeted after the warning [and they did] and that there was an uptick in adolescent suicides in 2004. I reviewed this flurry of articles and the people behind the campaign back in the Fall [worth a gander if you don&#8217;t know the history]:            <\/div>\n<ol>\n<ul>\n<li>\n<div align=\"justify\"><u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/10\/24\/15285\/\" target=\"_blank\"><font color=\"#200020\">the apogee&hellip;<\/font><\/a><\/strong><\/u><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/10\/24\/pretty-loud-coi\/\" target=\"_blank\"><font color=\"#200020\">pretty loud coi&hellip;<\/font><\/a><\/strong><\/u><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/10\/26\/tortured-numbers\/\" target=\"_blank\"><font color=\"#200020\">tortured numbers&hellip;<\/font><\/a><\/u><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><u><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/10\/27\/peaks-and-valleys\/\" target=\"_blank\"><font color=\"#200020\">peaks and valleys&hellip;<\/font><\/a><\/u><\/strong><\/div>\n<\/li>\n<\/ul>\n<\/ol>\n<div align=\"justify\">Here&#8217;s Gibbons&#8217; version of the graph from his last 2007 article:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"393\" vspace=\"5\" height=\"328\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/gibbons-2.gif\" \/><\/div>\n<div align=\"justify\">[In the links there are many others]. One fine uptick! Notice the ordinate scale sleight of hand [it doesn&#8217;t start with zero to enhance the small difference]. Here&#8217;s the punchline. When the CDC updated their statistics, voila`:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"246\" vspace=\"5\" height=\"234\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/reason-4.gif\" \/><\/div>\n<div align=\"justify\">So the controversy passed and the warning survived. Well, the controversy didn&#8217;t pass, it just became less noisy. But notice what Gibbons still says:<\/div>\n<ul>\n<div align=\"justify\"><sup><strong><font color=\"#990000\">The  impact of the &quot;black box&quot; warning, he  said, was to reduce  antidepressant prescriptions to kids &#8211; which was  correlated with an  increase in suicide rates in subsequent years.<\/font><\/strong><\/sup><\/div>\n<\/ul>\n<div align=\"justify\">It&#8217;s not true, but I guess old positions die hard. Time continued to pass, and Gibbons&#8217; publications continued off the grid:<\/div>\n<ul>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18092240\"><font color=\"#200020\">The role of randomized trials in testing interventions for the prevention of youth suicide.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Brown CH, Wyman PA, Brinales JM, Gibbons RD.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Int Rev Psychiatry. 2007 Dec;19(6):617-31.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18404622\"><font color=\"#200020\">Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Gibbons RD, Segawa E, Karabatsos G, Amatya AK, Bhaumik DK, Brown CH, Kapur K, Marcus SM, Hur K, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Stat Med. 2008 May 20;27(11):1814-33.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.annualreviews.org\/eprint\/3zrwxYaQ6xKHi2pXVdyK\/full\/10.1146\/annurev.publhealth.012809.103649\"><font color=\"#200020\">Post-Approval Drug Safety Surveillance.<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Robert D. Gibbons, Anup K. Amatya, C. Hendricks Brown, Kwan Hur, Sue M. Marcus, Dulal K. Bhaumik, and J. John Mann.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Annual Review of Public Health 2010 31:419-437.<\/sup><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21513361\"><font color=\"#200020\">Strategies for quantifying the relationship between medications and suicidal behaviour: what has been learned?<\/font><\/a><\/strong><\/u><br \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Gibbons RD, Mann JJ.<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Drug Saf. 2011 May 1;34(5):375-95.<\/sup><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">Now he returns with a vengeance:                                                          <\/p>\n<ul>\n<li>\n<div align=\"justify\"><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 \/>                             <sup>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<strong>Reanalysis of the Randomized Placebo-Controlled Studies of Fluoxetine and Venlafaxine<\/strong><br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;by Robert D. Gibbons, Hendricks Brown, Kwan Hur, John M. Davis, and J. John Mann<br \/>                             &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Archives of General Psychiatry. Online February 6, 2012. [<a href=\"http:\/\/archpsyc.ama-assn.org\/cgi\/reprint\/archgenpsychiatry.2011.2048\" target=\"_blank\">full text on-line<\/a>]<\/sup><\/div>\n<\/li>\n<\/ul><\/div>\n<div align=\"justify\">There&#8217;s an article in a big journal, press coverage, celebrity endorsements, and another article <em>coming soon<\/em>. It was cold and rainy here in the mountains yesterday and I occupied myself trying to vet this article [<u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/24\/coming-soon-2\"><font color=\"#200020\">coming soon?&hellip;<\/font><\/a><\/strong><\/u>]. Alas, it can&#8217;t be done &#8211; at least not by me, not from here. In some ways, it&#8217;s a unique article in that it has no <strong><font color=\"#200020\">data<\/font><\/strong>, only <strong><font color=\"#200020\">methods<\/font><\/strong> and <strong><font color=\"#200020\">conclusions<\/font><\/strong>. I tried requesting the data, then intuiting the data, but failed in both areas. I can make no sense of the tables in the paper. I&#8217;m not a rocket scientist, but I can usually get there by plodding &#8211; and my <em>plodder<\/em> failed me. So I know of no other thing to do except apply the time honored medical principle of <em><strong><font color=\"#200020\">watchful waiting<\/font><\/strong><\/em>. I would prefer <em><strong><font color=\"#200020\">benign neglect<\/font><\/strong><\/em>, but the topic matters way too much for such luxury, and ignoring this kind of thing is what helped get us where we are today [<u><strong><a href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2012\/02\/20\/no-further-comment\/\" target=\"_blank\">no further comment&hellip;<\/a><\/strong><\/u>].<\/div>\n<p align=\"justify\">Dr. David Healy who has been in the eye of this storm from the start has a lot to say about this paper [<a target=\"_blank\" href=\"http:\/\/davidhealy.org\/coincidence-a-fine-thing?utm_source=feedburner&#038;utm_medium=email&#038;utm_campaign=Feed%3A+DrDavidHealy+%28Dr.+David+Healy%29\"><u><strong><font color=\"#200020\">Coincidence a fine thing<\/font><\/strong><\/u><\/a>], and I expect will have even more to say as things progress [it&#8217;s one of the central topics of his new book, <u><a href=\"http:\/\/www.amazon.com\/Pharmageddon-David-Healy\/dp\/0520270983\" target=\"_blank\"><strong><font color=\"#990000\">Pharmageddon<\/font><\/strong><\/a><\/u>]. He points to Gibbons&#8217; use of rating scale numbers to indicate suicidal ideation, a heavily debunked method discarded long ago. He has a story about Gibbons&#8217; coauthor on another paper disavowing it. And, of course, there are the observations of <strong><font color=\"#200020\">G&ouml;ran H&ouml;gberg<\/font><\/strong> [covered in <em><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/22\/significant-i\"><u><strong><font color=\"#200020\"><em>significant<\/em><\/font><\/strong><\/u><\/a><\/em><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/22\/significant-i\"><u><strong><font color=\"#200020\"> I&hellip;<\/font><\/strong><\/u><\/a>,<em> <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/22\/significant-ii\"><u><strong><font color=\"#200020\"><em>significant<\/em><\/font><\/strong><\/u><\/a><\/em><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/22\/significant-ii\"><u><strong><font color=\"#200020\"> II&hellip;<\/font><\/strong><\/u><\/a>, and <u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/02\/23\/significant-iii\/\"><font color=\"#200020\"><em>significant<\/em> III&hellip;<\/font><\/a><\/strong><\/u>]. But as usual, Healy should be read as a primary source, not <em>in camera<\/em>.      <\/p>\n<div align=\"justify\">There is one thing that is included in Gibbons&#8217; article that we can comment on &#8211; his conclusions. He says that his data shows that the SSRIs decrease suicidal ideation in adults and the elderly. But that wasn&#8217;t true for youth:<\/div>\n<ul>\n<div align=\"justify\"><sup>In summary, we found that treatment with fluoxetine and venlafaxine decreased suicide risk in adult and geriatric patients and that the effect of treatment on depression severity appears to be the mechanism whereby antidepressants lower suicide risk in adult and geriatric patients. We found no evidence that fluoxetine increased risk of suicidal thoughts or behavior in youths.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">While I question his conclusion, even if it&#8217;s correct it doesn&#8217;t support his recommendations. If antidepressants don&#8217;t have a positive effect in kids, why give them in the first place? His own conclusions in the article certainly don&#8217;t support this comment:<\/div>\n<ul>\n<div align=\"justify\"><sup><strong><font color=\"#990000\">&quot;I hope that the  warnings will not prevent depressed children and adults from getting  treatment for depression,&quot; he said. &quot;The  greatest cause of suicide is  untreated or undiagnosed depression. It&#8217;s  very important that this  condition be recognized and appropriately  treated and not discarded  because doctors are afraid to be sued.&quot;<\/font><\/strong><\/sup><\/div>\n<\/ul>\n<div align=\"justify\">At this point, I&#8217;ll suppress responding to his dim, reductionistic view of physicians or his lack of credentials to even have an opinion about treatment recommendations. And I&#8217;ve run out of titles for blogs that say <em><strong><font color=\"#200020\">much ado about nothing<\/font><\/strong><\/em> or <em><strong><font color=\"#200020\">full of sound and fury, signifying nothing<\/font><\/strong><\/em>, so I&#8217;ll fall back to the medical principle of <em><strong><font color=\"#200020\">watchful waiting<\/font><\/strong><\/em> and do just that&#8230;    <\/div>\n","protected":false},"excerpt":{"rendered":"<p>The last post, I said I was obsessed, but maybe I should have said perplexed. I just don&#8217;t understand the seven year hegira Dr. Gibbons has been on to disprove the need for the black box warning on the antidepressants about the possibility of treatment emergent suicidality in children and adolescents. His persistence transcends reason. [&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-20242","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20242","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=20242"}],"version-history":[{"count":48,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20242\/revisions"}],"predecessor-version":[{"id":20266,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20242\/revisions\/20266"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=20242"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=20242"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=20242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}