{"id":20308,"date":"2012-02-25T19:05:36","date_gmt":"2012-02-26T00:05:36","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=20308"},"modified":"2012-02-25T19:05:36","modified_gmt":"2012-02-26T00:05:36","slug":"15-years-of-study-15-and-counting","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/02\/25\/15-years-of-study-15-and-counting\/","title":{"rendered":"15 years of study 15 [and counting]&#8230;"},"content":{"rendered":"\n<div align=\"justify\"><strong><font color=\"#660033\">Stephany<\/font><\/strong> has some interesting things going on at <strong><font color=\"#660033\">Soulful Sepulcher<\/font><\/strong>. She&#8217;s been interviewing one of the attorneys involved in the Seroquel litigation about AstraZeneca&#8217;s lackluster payoffs, even though they got off light. It&#8217;s worth a look. And she brought up Study 15, the one that showed Seroquel to be inferior to the older drugs before Seroquel even came to market, 10 years before CATIE &#8211; a study they never published:<\/div>\n<ul>\n<li>\n<div><strong><a href=\"http:\/\/bipolarsoupkitchen-stephany.blogspot.com\/2012\/02\/astrazeneca-seroquel-diabetes.html\" target=\"_blank\">The AstraZeneca Seroquel diabetes litigation lawsuit: Interview with Attorney David Ennis <\/a><\/strong><\/div>\n<\/li>\n<li>\n<div><a href=\"http:\/\/bipolarsoupkitchen-stephany.blogspot.com\/2012\/02\/interview-with-seroquel-litigation.html\" target=\"_blank\"><strong>Interview with Seroquel litigation attorney David Ennis: Part 2 &quot;the evidence&quot; and Study 15<\/strong> <\/a><\/div>\n<\/li>\n<\/ul>\n<div align=\"justify\">Here&#8217;s the Memo and the graphs from Study 15 as a companion to her blog posts [from <a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/01\/02\/this-cursed-study\/\" target=\"_blank\"><u><strong><font color=\"#200020\">this<\/font><\/strong><\/u><\/a>]:<\/div>\n<blockquote>\n<p align=\"center\"><img decoding=\"async\" width=\"390\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/study-15-email.gif\" \/><\/p>\n<div align=\"justify\"><em>From 1993 through 1995, Astrazeneca undertook a  large, multi-center trial comparing one of the older antipsychotics,  Haldol, to several different dose ranges of their new drug, Seroquel [<a href=\"http:\/\/psychrights.org\/research\/Digest\/NLPs\/Seroquel\/UnsealedSeroquelStudies\/Study_015_CSR.pdf\" target=\"_blank\"><strong><font color=\"#200020\">Study 15<\/font><\/strong><\/a>].  This was prior to Seroquel&rsquo;s approval by the FDA. Study 15 didn&rsquo;t come  out like they wanted. The internal memo above is from a high ranking  Astrazeneca official praising AZ Physician, Lisa Arvanitis, for her  &lsquo;smoke-and-mirrors&rsquo; job in trying to discount the actual results  [&#8216;smoke-and-mirrors&#8217; in <strong><font color=\"#800000\">red<\/font><\/strong>]. As it turned out, Astrazeneca &quot;buried&quot; this study along with several others.<\/em><\/div>\n<ul>\n<div align=\"justify\"><strong><font color=\"#2e2618\"><sup>4.1.4 Summary of time to withdrawal \/ time to relapse<br \/>     There was no statistically significant dose  response among SEROQUEL groups in the time to withdrawal from the trial  in the intent to treat population, which was the primary efficacy  variable. Pairwise comparison showed no statistically significant  differences among any treatment group, including haloperidol, in the  time to withdrawal from the trial. There was also no statistically  significant dose.response among the SEROQUEL groups in the time to  withdrawal from the trial for psychotic relapse. Times to psychotic  relapse were generally longer in the haloperidol group.<\/sup><\/font><sup> <font color=\"#800000\">Pairwise  comparisons of the time to withdrawal for psychotic relapse revealed  statistically significant differences between the haloperidol group and  each SEROQUEL group. However, there was an imbalance in the reasons for  withdrawal from the trial between the SEROQUEL and haloperidol treatment  groups with proportionally more patients in the haloperidol group  withdrawing for adverse events. Since proportionally more censoring for  relapse occurred in the haloperidol treatment group, any contrasts  between the haloperidol and SEROQUEL groups for time to withdrawal for  psychotic relapse may not reflect true differences in the relapse  distributions among the groups and therefore are non.informative.<\/font> <font color=\"#2e2618\">Results  of the analysis of the time to withdrawal in the secondary population  showed a similar trend as seen in the intent to treat population. The  analysis of prognostic variables indicated that only the interaction  between treatment groups and the need for neuroleptic medication to be  tapered during Segment A were significantly associated with time to  withdrawal.<\/font><\/sup><\/strong><\/div>\n<\/ul>\n<div align=\"center\"><img decoding=\"async\" width=\"390\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/wp-admin\/..\/images\/study-15.gif\" \/><\/div>\n<div align=\"justify\"><em>Haldol won the trial <strong><font color=\"#200020\">hands down<\/font><\/strong>  &ndash; one of several examples of Astrazeneca suppressing it&rsquo;s own studies  because they didn&rsquo;t play well with their marketing strategy [<strong><a target=\"_blank\" href=\"http:\/\/psychrights.org\/research\/Digest\/NLPs\/Seroquel\/\">PsychRights<\/a><\/strong>  has a treasure trove of equally incriminating documents]. As we know,  Seroquel went on to be FDA approved with extension for a variety of  conditions. It&rsquo;s now the most lucrative of the Atypical Antipsychotics,  themselves the most lucrative drugs in the American pharmacopeia.<\/em><\/div>\n<\/blockquote>\n<div align=\"justify\">It&#8217;s been 15 years, and the damage from AstraZeneca&#8217;s deceit is still being felt&#8230;  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Stephany has some interesting things going on at Soulful Sepulcher. She&#8217;s been interviewing one of the attorneys involved in the Seroquel litigation about AstraZeneca&#8217;s lackluster payoffs, even though they got off light. It&#8217;s worth a look. And she brought up Study 15, the one that showed Seroquel to be inferior to the older drugs before [&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-20308","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20308","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=20308"}],"version-history":[{"count":3,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20308\/revisions"}],"predecessor-version":[{"id":20311,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/20308\/revisions\/20311"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=20308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=20308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=20308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}