{"id":4685,"date":"2011-02-17T08:47:00","date_gmt":"2011-02-17T13:47:00","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4685"},"modified":"2011-02-17T09:41:48","modified_gmt":"2011-02-17T14:41:48","slug":"selling-seroquel-i-background","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/02\/17\/selling-seroquel-i-background\/","title":{"rendered":"selling seroquel I: background&#8230;"},"content":{"rendered":"<div align=\"justify\">After being approved by the FDA in 1997, <strong><font color=\"#6600ff\">Seroquel <\/font><\/strong>joined the ranks of the Atypical Antipsychotics used to treat Schizophrenia. After a time, the NIMH funded a large study to compare the Atypicals that included one of the first generation neuroleptics, <strong><font color=\"#0000ff\">Trilafon<\/font><\/strong> [perphenazine] &#8211; the <strong><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa051688#t=articleTop\" target=\"_blank\"><font color=\"#200020\">CATIE<\/font><\/a><\/strong> study. That study&#8217;s primary outcome measure was simple:<\/div>\n<ul>\n<div align=\"justify\"><sup>We hypothesized that there would be significant differences in the  overall effectiveness of olanzapine, perphenazine, quetiapine,  risperidone, and ziprasidone in treating schizophrenia that reflected  variations in efficacy and tolerability. The primary outcome measure was  the discontinuation of treatment for any cause, a discrete outcome  selected because stopping or changing medication is a frequent  occurrence and major problem in the treatment of schizophrenia. In  addition, this measure integrates patients&#8217; and clinicians&#8217; judgments of  efficacy, safety, and tolerability into a global measure of  effectiveness that reflects their evaluation of therapeutic benefits in  relation to undesirable effects.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><strong><font color=\"#6600ff\">Seroquel<\/font><\/strong> [Quetiapine] didn&#8217;t fare so well:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"519\" vspace=\"5\" height=\"155\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/catie-1.gif\" \/><\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"5\" height=\"271\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/catie-2.gif\" \/><\/div>\n<div align=\"justify\">A finding not remarkably different from that of the &quot;buried&quot; <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong> <strong><font color=\"#200020\">Trial 0015<\/font><\/strong> from a decade before [still &quot;buried&quot; when <font><strong><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa051688#t=articleTop\" target=\"_blank\"><font color=\"#200020\">CATIE<\/font><\/a><\/strong><\/font> was published in 2005]:           <\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"519\" height=\"270\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/study-15-1.gif\" \/><\/div>\n<div align=\"justify\"><img loading=\"lazy\" decoding=\"async\" width=\"200\" hspace=\"4\" height=\"180\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/seroquel.gif\" \/>In an earlier series, I mused guiltily that had I been on the F.D.A. Panel evaluating <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong>, I might&#8217;ve thought, &quot;<em>No great shakes, but let&#8217;s give &#8217;em a shot. If it&#8217;s no good, doctors won&#8217;t prescribe it and the patients won&#8217;t take it.<\/em>&quot; Well that didn&#8217;t happen. <font><strong><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa051688#t=articleTop\" target=\"_blank\"><font color=\"#200020\">CATIE<\/font><\/a><\/strong><\/font> showed what we would&#8217;ve known from <strong><font color=\"#200020\">Trial 0015<\/font><\/strong> [had we seen it], the Schizophrenic patients stopped taking it over the other choices, new drugs <u>and<\/u> old. But the sales of <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong> had risen and would continue to rise. While it&#8217;s tempting to look into the issue of weight gain, for the moment I&#8217;m going&nbsp; to stick with the sales side of the equation. It&#8217;s obvious that this drug isn&#8217;t a personal favorite, but I hope I laid out the basics fairly. The graph on the right is not explained by <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong>&#8216;s stellar performance in Schizophrenia. In fact, a widely known study like <font><strong><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa051688#t=articleTop\" target=\"_blank\"><font color=\"#200020\">CATIE<\/font><\/a> <\/strong><\/font>didn&#8217;t slow the sales<font color=\"#6600ff\"><strong> <\/strong><\/font>of <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong> at all, because by 2005, their market share likely didn&#8217;t have much to do with it being used to treat Schizophrenia.<\/div>\n<p>      <\/p>\n<div align=\"justify\">This <a href=\"http:\/\/psychrights.org\/research\/Digest\/NLPs\/Seroquel\/090520UnsealedSeroquelExhibits\/Research%20Control\/Goldstein07.pdf\" target=\"_blank\"><u><strong><font color=\"#200020\">email response<\/font><\/strong><\/u><\/a> to a researcher who was requesting funding from <strong><font color=\"#200020\">Zeneca<\/font><\/strong> several months after the F.D.A.&#8217;s approved <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong> might seem odd or even Machiavellian to a Basic Scientist, a Practicing Clinician, or a patient-to-be, but if your business is selling the product, it makes perfect sense:<\/div>\n<div align=\"center\"><img decoding=\"async\" vspace=\"5\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/sell-seroquel-1.gif\" \/><\/div>\n<div align=\"justify\"><img loading=\"lazy\" decoding=\"async\" width=\"200\" hspace=\"4\" height=\"93\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/sell-seroquel-2.gif\" \/><strong><font color=\"#200020\">Zeneca<\/font><\/strong> had poured years and a lot of money into getting their drug approved. Now it was time to focus on reaping the benefits of their hard work. This email mentions <strong><font color=\"#6600ff\">Seroquel<\/font><\/strong>&#8216;s starting place &#8211; <strong><font color=\"#0000ff\">Clozaril<\/font><\/strong> [Clozapine]. Clozapine was the first Atypical Antipsychotic. It had been around for decades. It is a potent antipsychotic that has less neurotoxicity [EPS or Tardive Dyskinesia] than the first generation neuroleptics, but has other big problems &#8211; weight gain, Diabetes, and Bone Marrow toxicity [Agranulocytosis] which can be fatal. Schizophrenia can be a malignant disease. The early name was Dementia Praecox, and one of the characteristics was an early death. In some patients, Clozapine works when all others fail, and in an intensely suicidal or catatonic patient, the risks are offset by the potential gain. So the drug is available with strict monitoring of the Bone Marrow status &#8211; rarely used. But Clozapine has remained the marker &#8211; a drug with less neurotoxicity and potent antipsychotic prowess. Thus, it has been the force propelling the development of the Atypical Antipsychotics &#8211; searching for a &quot;safe Clozapine.&quot; The fact that there <u>is<\/u> a more potent drug is a beacon for researchers to find one that can be used safely, and routinely.<\/div>\n<p>    <\/p>\n<div align=\"justify\">In 1997, <strong><font color=\"#200020\">Zeneca<\/font><\/strong> now had a new drug [derived from Clozapine] that was less neurotoxic, and not toxic to the bone marrow, but as we now know had some of Clozarpine&#8217;s other downsides [weight gain and Diabetes], and was not a particularly potent antipsychotic. So <strong><font color=\"#200020\">Zeneca<\/font><\/strong> had a challenging marketing task ahead of them&#8230;<\/div>\n<hr size=\"1\" \/>\n<div><strong><font color=\"#200020\">Flash<\/font><\/strong>: This just in [hat tip to Martha]:<\/div>\n<blockquote>\n<div align=\"center\"><strong><font color=\"#300030\"><a href=\"http:\/\/www.businessweek.com\/news\/2011-02-17\/astrazeneca-said-to-pay-150-million-to-settle-seroquel-suits.html\" target=\"_blank\">AstraZeneca Said to Pay $150 Million to Settle Seroquel Suits<\/a><br \/> Bloomberg Business  Week<\/font><\/strong><br \/> By Jef Feeley<br \/> February 17, 2011<\/div>\n<p align=\"justify\" class=\"indent\">AstraZeneca Plc agreed to pay $150  million to settle more lawsuits claiming its antipsychotic drug Seroquel  causes diabetes, <strong><font color=\"#200020\">pushing the amount the drugmaker has paid to resolve  cases over the medicine to almost $350 million<\/font><\/strong>, people familiar with the  accords said. AstraZeneca, the U.K.&rsquo;s second-biggest drugmaker,  will resolve about 6,000 cases alleging the company knew Seroquel could  cause diabetes and failed to adequately warn patients, two people  familiar with the settlements said. They spoke on the condition of  anonymity because they weren&rsquo;t authorized to speak publicly about the  accords. The cases settled for an average of about $25,000, the people  said.<\/p>\n<p align=\"justify\" class=\"indent\">     The settlements signal AstraZeneca is seeking to  put the Seroquel litigation behind it as it works to overcome setbacks  in its drug-development pipeline, said Jeremy Batstone-Carr,  London-based analyst for Charles Stanley &amp; Co., who rates the  drugmaker&rsquo;s shares as &ldquo;accumulate.&rdquo; &ldquo;Legal cases represent one of the great  imponderables that can act on shareholder sentiment,&rdquo; Batstone-Carr  said. &ldquo;You try to clear the decks and get investors as great a degree of  certainty as possible.&rdquo;<\/p>\n<div align=\"justify\" class=\"indent\">     The settlement, which resulted from a  court-ordered mediation, leaves AstraZeneca now facing only about 4,000  Seroquel claims, the people said. The London-based drugmaker announced  last summer it had resolved about two-thirds of the 26,000 suits over  the drug that had been filed in courts around the U.S&#8230;<\/div>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>After being approved by the FDA in 1997, Seroquel joined the ranks of the Atypical Antipsychotics used to treat Schizophrenia. After a time, the NIMH funded a large study to compare the Atypicals that included one of the first generation neuroleptics, Trilafon [perphenazine] &#8211; the CATIE study. That study&#8217;s primary outcome measure was simple: We [&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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-4685","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4685","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=4685"}],"version-history":[{"count":0,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4685\/revisions"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4685"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4685"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4685"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}