{"id":41189,"date":"2013-10-30T08:22:44","date_gmt":"2013-10-30T12:22:44","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=41189"},"modified":"2013-10-30T08:24:33","modified_gmt":"2013-10-30T12:24:33","slug":"the-best-predictor-4","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/10\/30\/the-best-predictor-4\/","title":{"rendered":"the best predictor&#8230;"},"content":{"rendered":"\n<div align=\"justify\">In September, I noticed yet another John Mann\/Robert Gibbons article in a major journal proposing that an FDA Warning be ignored [<a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/24030388\">Varenicline, Smoking Cessation, and Neuropsychiatric Adverse Events<\/a>] [<a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/09\/19\/very-monotonous\/\" target=\"_blank\">very monotonous&hellip;<\/a>]. I wrote then:<\/div>\n<blockquote>\n<div align=\"justify\"><font color=\" #7f6f57\">When you happen onto a really long blog post with lots of quotes, you  can usually count on the fact that the blogger is out to prove something  and getting his\/her facts in a row. I usually skip to the end [or move  on], being an impatient scanner myself. So I thought I&rsquo;d start with the  conclusion. <\/font><strong><font color=\"#200020\">Drs. Robert Gibbons and J. John Mann are making a career of  attacking the FDA&rsquo;s Black Box Warnings of potential suicidality from  certain medications. Their articles generally rely on special access to  datasets made available by pharmaceutical connections, yet they list  their research support as coming from public grants. It smells like  three day old fish to me, and I wonder why the journals keep publishing  them&#8230;<\/font><\/strong><\/div>\n<\/blockquote>\n<div>What I left out was the ad campaign that followed the articles about suicidality with Prozac&reg;\/Effexor&reg; [<a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3367101\/\"><u><strong><font color=\"#200020\">Suicidal Thoughts and Behavior With Antidepressant Treatment<\/font><\/strong><\/u><\/a>]:<\/div>\n<ul>\n<li>\n<div align=\"justify\" class=\"small\"><a target=\"_blank\" href=\"http:\/\/www.npr.org\/blogs\/health\/2012\/02\/06\/146481573\/a-fresh-look-at-antidepressants-finds-low-risk-of-youth-suicide\"><u><strong><font color=\"#200020\">A Fresh Look At Antidepressants Finds Low Risk Of Youth Suicide<\/font><\/strong><\/u><\/a><br \/>               NPR Health Blog by Alix Spiegel Feb 07,2012<\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\"><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 \/>                                            Los Angeles Times By Shari Roan February 06, 2012           <\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\"><a href=\"http:\/\/www.medscape.com\/viewarticle\/758917?src=mpnews&#038;spon=12\" target=\"_blank\"><u><strong><font color=\"#200020\">No Link Between Antidepressant and Suicide in Kids<\/font><\/strong><\/u><\/a><br \/>                  Medscape by Fran Lowry February 21, 2012<\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\"><a target=\"_blank\" href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736%2812%2960331-6\/fulltext\"><u><strong><font color=\"#200020\">Antidepressant-suicide link in children questioned<\/font><\/strong><\/u><\/a><br \/>     The Lancet by Sharmila Devi March 3, 2012 379:791.<\/div>\n<\/li>\n<li>\n<div align=\"justify\" class=\"small\"> <a target=\"_blank\" href=\"http:\/\/the-scientist.com\/2012\/05\/01\/data-diving\/\"><u><strong><font color=\"#200020\">Data Diving<\/font><\/strong><\/u><\/a><br \/>     The Scientist By Kerry Grens May 1, 2012<\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">  Now, with this most recent article attacking the FDA Warning about Chantix&reg;, we&#8217;re greeted with the same thing &#8211; an article in<strong><font color=\"#000000\"> Psychiatric<\/font><font color=\"#990000\">News<\/font><\/strong> that reads like something from one of those check-out counter magazines at the supermarket:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a target=\"_blank\" href=\"http:\/\/psychnews.psychiatryonline.org\/newsarticle.aspx?articleid=1762530\">Chantix Doesn&rsquo;t Appear to Cause Psychiatric Events<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#000000\">Psychiatric<\/font><font color=\"#990000\">News<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">by Vabren Watts<\/div>\n<div align=\"center\" class=\"small\">October 24, 2013<\/div>\n<p align=\"justify\">A  reanalysis of previous data on the neuropsychiatric effects of the  smoking-cessation drug Chantix may change some minds about its use. <strong><font color=\"#200020\">As Pfizer Pharmaceuticals pays out millions  of dollars in claims related to depression and suicide associated with  the antismoking drug Chantix, a study published September 13 in <em>AJP in Advance<\/em> found that the drug may be no more harmful than other smoking-cessation therapies.<\/font><\/strong><\/p>\n<p align=\"justify\">Researchers in the Department of Psychiatry  at the University of Chicago and at Columbia University conducted the  largest randomized controlled trial to date evaluating the safety and  efficacy of varenicline&mdash; a nicotine receptor partial agonist and the  active ingredient in the product Chantix. J.  John Mann, M.D., and Robert Gibbons, Ph.D., reanalyzed previous  data concerning varenicline and found it was not linked to suicide  events, depression, or aggression. According to study authors J. John Mann,  M.D., and Robert Gibbons, Ph.D., since the Food and Drug Administration  issued a black-box warning for Chantix in 2009, varenicline has been  extensively studied for its association with neuropsychiatric events,  but results have been inconsistent, and the studies have had major  limitations.<\/p>\n<p align=\"justify\">&ldquo;There are very few meta-analyses evaluating the effect of varenicline at a personal level,&rdquo; Mann told <em>Psychiatric News<\/em>.  He said that it is important to conduct more studies in clinical  settings with limited exclusionary criteria, which will allow  assessments of more-realistic outcomes. &ldquo;In reality, we see people who  want to quit smoking with unstable diabetes, heart disease, taking  medication for 10 different conditions. Conducting randomized controlled  trials in the clinic is important because the patterns of findings may  be different&rdquo;&#8230;<\/p>\n<p align=\"justify\">With information from more than 40,000  subjects, the authors reanalyzed data from 17 placebo-controlled trials  conducted by Pfizer to assess smoking abstinence, suicidal ideation,  depression, aggression, and nausea in participants with and without a  history of psychiatric illness. In addition, data from the Department of  Defense were evaluated to compare the rates of neuropsychiatric events  and psychiatric symptoms among military health system patients receiving  varenicline or nicotine-replacement therapy. The data showed that varenicline was highly  associated with inducing nausea among patients, but not with suicide  events, depression, or aggression. Current or past psychiatric illness  increased the risk of neuropsychiatric events equally among the  varenicline and placebo groups&#8230;<\/p>\n<p align=\"justify\">When <em>Psychiatric News<\/em> asked Mann  why he thinks thousands of varenicline users have reported adverse  psychiatric effects, he replied, &ldquo;People who smoke have more pronounced  aggressive and impulsive traits&mdash;smoking is associated with suicidal  behavior and mood change &mdash; [and] sometimes the side effects or adverse  effects reported are due to nicotine withdrawal or the loss of the  cognitive-enhancing effects of nicotine.&rdquo; Mann also noted that when any medication  receives negative media attention for adverse events, clinicians are  more likely to inquire about these side effects, and patients are more  likely to report them. &ldquo;Some reports are due to the patient being alert  to the possibility [of a side effect] and [thus] more likely to report  its occurrence, and sometimes the person feels that they have the  complication, but objective examination fails to confirm this,&rdquo; Mann  said.<\/p>\n<div align=\"justify\">  \t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t The study was funded by the National  Institute of Mental Health. Gibbons served as an expert witness for  Pfizer in a case related to varenicline and neuropsychiatric adverse  events. Pfizer provided no financial support.<\/div>\n<\/blockquote>\n<div align=\"justify\">Again, from <a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/09\/19\/very-monotonous\/\" target=\"_blank\">very monotonous&hellip;<\/a>:<\/div>\n<blockquote>\n<div align=\"justify\">It would appear that Dr. Gibbons and Dr. Mann never met an <strong><font color=\"#200020\">FDA Black Box Warning<\/font><\/strong>  they really cared much for. And as I said, there&rsquo;s more in common with  these three articles than just the shared authorship of Drs. Gibbons and  Mann and their monotonous opinion of FDA warnings. They had special  access to datasets to analyze, unavailable to the rest of us.<\/div>\n<\/blockquote>\n<div align=\"justify\">We can add something else &#8211; <font color=\"#200020\">an ad campaign based on an article in a medical journal<\/font>. For that matter, that little bit of mass psychoanalysis at the end explaining away patient reports sounds mighty familiar too. Since I have no way to vet this, &quot;Pfizer provided no financial support,&quot; I can&#8217;t follow up on my &quot;smells like  three day old fish to me&quot; comment. But I can say that Neurontin&reg;, Effexor&reg;, and Chantix&reg; are all Pfizer products. And I can reiterate my comment:<\/div>\n<blockquote>\n<div align=\"justify\">I object, however, to their releasing information the rest of us can&rsquo;t  see to Drs. Gibbons and Mann to publish with the COI burden they have  and absolutely no way for practicing or dissenting physicians to look  into things for ourselves. It&rsquo;s just not right. And, by the way, do our  public granting institutions keep up with where <strike>their<\/strike> our money is being spent?   <\/div>\n<\/blockquote>\n<div>There&#8217;s a saying, &quot;the best predictor of future behavior is past behavior,&quot; that belongs in here somewhere&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In September, I noticed yet another John Mann\/Robert Gibbons article in a major journal proposing that an FDA Warning be ignored [Varenicline, Smoking Cessation, and Neuropsychiatric Adverse Events] [very monotonous&hellip;]. I wrote then: When you happen onto a really long blog post with lots of quotes, you can usually count on the fact that 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-41189","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41189","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=41189"}],"version-history":[{"count":25,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41189\/revisions"}],"predecessor-version":[{"id":41215,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41189\/revisions\/41215"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=41189"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=41189"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=41189"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}