{"id":4613,"date":"2011-01-12T12:52:06","date_gmt":"2011-01-12T17:52:06","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4613"},"modified":"2011-01-12T12:56:40","modified_gmt":"2011-01-12T17:56:40","slug":"on-seroquel","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/01\/12\/on-seroquel\/","title":{"rendered":"on Seroquel&#8230;"},"content":{"rendered":"<div align=\"justify\">I don&#8217;t know how widely <strong><font color=\"#0066ff\">foodconsumer<\/font><\/strong> is read, so I reprinted this article <em>in toto<\/em> [reformatted to fit your screen]. It should be on the front page of the <strong>New York Times<\/strong> because it&#8217;s important and because Martha Rosenberg has created such a thorough timeline:<\/div>\n<blockquote>\n<div align=\"center\"><strong><a href=\"http:\/\/www.foodconsumer.org\/newsite\/Non-food\/Drug\/when_multi-use_of_pills_backfires_0111110101.html\" target=\"_blank\">Drug Tied to high blood pressure and obesity marketed for depression<\/a><br \/>       <font color=\"#0066ff\">foodconsumer<\/font><\/strong><br \/>        by Martha Rosenberg<br \/>       01\/11\/11<\/div>\n<p>  <\/p>\n<div align=\"justify\">First approved for schizophrenia in 1997, AstraZeneca&#8217;s  antipsychotic Seroquel has subsequently been approved for bipolar  disorder, as an add-drug for depression and for some groups of kids. Nor  is the public necessarily aware of the &quot;indication creep.&quot; Seroquel  approval for use in children in late 2009 was noted as a mere &quot;label  change&quot; on the FDA web site. Even though Seroquel is the fifth best-selling medication in the US  according to drugs.com, exceeded only by Lipitor, Nexium, Plavix and  Advair diskus, its safety, effectiveness, clinical trial and promotion  records are highly checkered.&nbsp;<\/div>\n<ul><sup><\/p>\n<div align=\"justify\">&bull; An original backer, psychiatrist Richard Borison, was sentenced to a  15-year prison sentence in 1998 for a pay-to-play Seroquel research  scheme.<\/div>\n<div>Its US medical director Wayne MacFadden had sexual affairs with two  different women involved with Seroquel research, say published  reports.&nbsp;<\/div>\n<div align=\"justify\">&bull; Chicago psychiatrist Michael Reinstein received $500,000 from  AstraZenenca and wrote 41,000 prescriptions for Seroquel reports the  Chicago Tribune and ProPublica.&nbsp;<\/div>\n<div align=\"justify\">&bull; Psychiatrist Charles Nemeroff who left Emory University in disgrace  after a Congressional investigation for unreported pharma income,  promoted Seroquel in continuing medical education courses according to  the web site of psychiatrist Daniel Carlat.&nbsp;<\/div>\n<div align=\"justify\">&bull; Florida child psychiatrist Jorge Armenteros was chairman of the FDA  committee responsible for recommending Seroquel approvals while a paid  AstraZeneca speaker himself, said the Philadelphia Inquirer in 2009.&nbsp;<\/div>\n<div align=\"justify\">&bull; Psychiatrist Charles Schulz&#8217; high profile pro-Seroquel  presentations are suspected of being colored by his AstraZeneca income  says the Minneapolis Star Tribune.&nbsp;<\/div>\n<div align=\"justify\">&bull; And unexplained Iraq and Afghanistan troop deaths are linked to Seroquel reported the Associated Press in August.&nbsp;<\/div>\n<p><\/sup><\/ul>\n<\/blockquote>\n<div align=\"justify\">These things should&#8217;ve lead to a thorough investigation of this drug and a suspension of further indications instead of this campaign [<strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2010\/12\/30\/informed-consent\">informed consent?&hellip;<\/a><\/strong>].<\/div>\n<blockquote>\n<div align=\"justify\">Now, as AstraZeneca rolls out its &quot;<strong><font color=\"#9900ff\">Still Trying to Get Ahead of  Your Depression<\/font><\/strong>&quot; campaign, there are new questions about Seroquel&#8217;s  safety and effectiveness.&nbsp;<\/div>\n<ul><sup><\/p>\n<div align=\"justify\">&bull; According to an FDA warning letter, an AstraZeneca sales  representative during an unsolicited sales call on January 3, 2008 sold  Seroquel as a treatment for major depressive disorder to a physician  before it was approved for MDD, an infraction which is illegal.&nbsp;<\/div>\n<div align=\"justify\">&bull; Once Seroquel was approved for depression (as an add-on treatment to an antidepressant for <font color=\"#0c4790\"><span class=\"kLink\">patients<\/span><\/font>  with major depressive disorder who not have an adequate response to  antidepressant therapy), its leave-behind sheets drew another FDA  warning letter.&nbsp;<\/div>\n<div align=\"justify\">&bull; AstraZeneca implied patients would achieve &quot;remission&quot; from  depression with Seroquel XR (extended release) as opposed to with an  antidepressant alone, says FDA &#8212; a claim not backed up by clinical  experience.&nbsp;<\/div>\n<div align=\"justify\">&bull; Seroquel&#8217;s effect on depression has only been demonstrated in two,  six-week trials FDA further said and six weeks is &quot;not a long enough  time period to adequately assess remission.&quot; (It was approved&#8230;why?)&nbsp;<\/div>\n<div align=\"justify\">&bull; Also the case study of &quot;Catherine F.&quot; depicted in leave-behind  sheets is inaccurate says FDA because it suggests Seroquel alleviates &quot;<font color=\"#0c4790\"><span class=\"kLink\">symptoms<\/span><\/font>  of sadness and loss of interest when this has not been demonstrated by  substantial evidence or substantial clinical experience.&quot; (It was  approved&#8230;why?)&nbsp;<\/div>\n<div align=\"justify\">&bull; Even AstraZeneca&#8217;s own briefing to the FDA committee in 2009 admits  a &quot;failed study&quot; in which both Seroquel and Lexapro &quot;failed to  differentiate from placebo&quot; which is Clinical Trial for &quot;didn&#8217;t work.&quot;&nbsp;<\/div>\n<div align=\"justify\">&bull; Nor did AstraZeneca adequately disclose Seroquel risks says FDA  which include increased mortality in elderly patients with  dementia-related psychosis, suicidality, neuroleptic malignant <font color=\"#0c4790\"><span class=\"kLink\">syndrome<\/span><\/font>, hyperglycemia and diabetes mellitus, hyperlipidemia, weight gain and other serious side effects.&nbsp;<\/div>\n<div align=\"justify\">&bull; In fact, in addition to risks like cataracts, seizures and  increases in blood pressure in children and adolescents, already on the  Seroquel label, FDA asked AstraZeneca to add the &quot;risk of EPS and  withdrawal syndrome in neonates&quot; a few months ago: movement disorders  which can affect mothers&#8217; <font color=\"#0c4790\"><span class=\"kLink\">babies<\/span><\/font> if the mothers are taking Seroquel and stop.&nbsp;<\/div>\n<p><\/sup><\/ul>\n<div align=\"justify\">Even without its depression indication, Seroquel is big business  for AstraZeneca, earning $4.9 billion in sales in 2009. It is the drug  that North Carolina&#8217;s Medicaid spends the most on: $29.4 million per  year, reports the Charlotte News and Observer. But adding the new indication to a drug whose dangers and  effectiveness have already been so misrepresented and occluded is just,  well, depressing.<\/div>\n<\/blockquote>\n<div align=\"justify\">I guess the stakes are so high that <strong><font color=\"#9900ff\">AstraZeneca<\/font><\/strong> is willing to gamble that losing another round of legal suits will be offset by increased profits. That&#8217;s not how <strong><font color=\"#200020\">healthcare<\/font><\/strong> is supposed to work&#8230; <\/div>\n","protected":false},"excerpt":{"rendered":"<p>I don&#8217;t know how widely foodconsumer is read, so I reprinted this article in toto [reformatted to fit your screen]. It should be on the front page of the New York Times because it&#8217;s important and because Martha Rosenberg has created such a thorough timeline: Drug Tied to high blood pressure and obesity marketed for [&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_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-4613","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4613","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=4613"}],"version-history":[{"count":0,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4613\/revisions"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4613"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4613"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}