{"id":4587,"date":"2010-12-30T07:59:52","date_gmt":"2010-12-30T12:59:52","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4587"},"modified":"2011-01-26T17:13:57","modified_gmt":"2011-01-26T22:13:57","slug":"informed-consent","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2010\/12\/30\/informed-consent\/","title":{"rendered":"informed consent?&#8230;"},"content":{"rendered":"\n<div align=\"justify\"><img decoding=\"async\" width=\"160\" hspace=\"4\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/seroquel1.gif\" \/>So we had a <strong><font color=\"#200020\">New York Times<\/font><\/strong> front page ad for <strong><font color=\"#200020\">$eroquel XR<\/font><\/strong> that says &quot;<font color=\"#0a0a0a\">Adding <strong>SEROQUEL<\/strong><\/font> <strong><font color=\"#e4529a\">XR<\/font><\/strong> <font color=\"#0a0a0a\">for<\/font> <strong><font color=\"#0a0a0a\">depression<\/font><\/strong><font color=\"#0a0a0a\"> may<\/font><font color=\"#0a0a0a\"> help<\/font>.&quot; Down at the bottom it says &quot;<strong><font color=\"#e4529a\">Roll-over for MORE Important Safety Information<\/font><\/strong>&quot; in small print. As mentioned before in this blog, $eroquel is an Atypical Antipsychotic originally approved by the FDA for the treatment of Schizophrenia [1997]. Since then, it has been approved for other things but it has been at the center of innumerable suits for false advertising, and harming patients. For example, the manufacturer settled a suit for $520 M, but since they make $4-5 B from the drug yearly, what&#8217;s half a billion in the scope of things? Truth be told, $eroquel is a paradigmatic example of the excesses of PHARMA. Every piece of this ad is carefully and deceptively phrased:<\/div>\n<ul>\n<div align=\"justify\">&quot;<strong><font color=\"#0a0a0a\">ADDING<\/font><\/strong>&quot; : One way to increase sales of a drug is to get FDA approval for new uses. In this case, Astrazeneca got this drug approved for use in patients with <em>Major Depressive Disorder<\/em> [Severe Depression] who are <em>treatment resistant<\/em> to <em>monotherapy <\/em>[meaning they haven&#8217;t responded to SSRIs such as Prozac or Paxil].<\/div>\n<p align=\"justify\">&quot;<strong><font color=\"#0a0a0a\">SEROQUEL<\/font><\/strong>&quot; : $eroquel is an Atypical Antipsychotic approved for the treatment of Schizophrenia because these drugs may have less propensity to have neurological consequences [Tardive Dyskinesia]. It is less effective as an antipsychotic than the older drugs.                 <\/p>\n<p align=\"justify\">&quot;<strong><font color=\"#e4529a\">XR<\/font><\/strong>&quot; : Adding a time release pill is a way of having something new to sell. It adds little, if anything to the therapeutic effectiveness of the drug.                 <\/p>\n<p align=\"justify\">&quot;<strong><font color=\"#0a0a0a\">DEPRESSION<\/font><\/strong>&quot; : In the lay use of the term, depression can mean many things. ranging from &quot;unhappiness&quot; to debilitating illness. Major Depressive Disorder is a small percentage of the people who report being depressed.                <\/p>\n<div align=\"justify\">&quot;<strong><font color=\"#0a0a0a\">MAY HELP<\/font><\/strong>&quot; : While the studies justifying its use as an add on in Major Depression do  show statistical significance, I&#8217;ve never personally seen a case that either  I&#8217;ve treated or someone else has treated where adding this drug  mattered very much except mybe a good night&#8217;s sleep.  <\/div>\n<\/ul>\n<div align=\"justify\">And then there&#8217;s this &quot;<strong><font color=\"#e4529a\">Roll-over for MORE Important Safety Information<\/font><\/strong>&quot; part:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"5\" height=\"309\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/seroquel2.gif\" \/><\/div>\n<div align=\"justify\">$eroquel is an expensive medication:<\/div>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" vspace=\"5\" height=\"300\" border=\"1\" src=\"http:\/\/1boringoldman.com\/images\/seroquel3.jpg\" \/><\/div>\n<div align=\"justify\">And $eroquel is anything but a benign medication. It regularly causes weight gain sometimes leading to Type 2 Diabetes. It can cause irreversable Tardive Dyskinesia, etc etc. Note the following:<\/div>\n<blockquote>\n<div align=\"center\"><strong><a target=\"_blank\" href=\"http:\/\/www.nytimes.com\/2009\/10\/30\/business\/30drug.html\">AstraZeneca Pays Millions to Settle Seroquel Cases<\/a><br \/>                 New York Times <\/strong><br \/>                 By DUFF WILSON<br \/>                 October 29, 2009<\/div>\n<p align=\"justify\"> The pharmaceutical company AstraZeneca  said Thursday that it had reached a $520 million agreement to settle  two federal investigations and two whistle-blower lawsuits over the sale  and marketing of its blockbuster psychiatric drug Seroquel.<a name=\"secondParagraph\"><\/a> One of the investigations related to &ldquo;selected physicians who  participated in clinical trials involving Seroquel,&rdquo; AstraZeneca  disclosed in a government filing. The other case  related to off-label  promotion of the drug. <\/p>\n<p align=\"justify\">As a result of aggressive marketing,  Seroquel has been increasingly used for children and elderly people for  indications not approved by the Food and Drug Administration. Doctors are permitted to prescribe any approved drug for off-label uses. Seroquel was the top-selling antipsychotic drug in America. It had $17  billion in sales in the United States since 2004, according to IMS Health, a research firm&#8230;<\/p>\n<div align=\"justify\">Mr. Blizzard said he did not know what clinical trials  were part of the inquiry. But in one trial, known as Study 15, he  noted, an e-mail message showed a company official saying &ldquo;a great  &lsquo;smoke and mirrors&rsquo; job&rsquo;&nbsp;&rdquo; had been done on a &ldquo;buried&rdquo; study in 1997,  the year the F.D.A. approved Seroquel&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\"><img decoding=\"async\" hspace=\"4\" height=\"300\" border=\"1\" align=\"right\" src=\"http:\/\/graphics8.nytimes.com\/images\/2010\/10\/03\/business\/03pysch-graphic\/03pysch-graphic-articleInline-v2.jpg\" \/>While I would personally see this ad as false advertising, they&#8217;ve stayed inside the letter of the law [barely]. This ad is driven by this fact &#8211; <strong><font color=\"#200020\">&quot;Seroquel was the top-selling antipsychotic drug in America. It had $17  billion in sales in the United States since 2004.&quot;<\/font><\/strong> Since it is potentially toxic and probably only really useful in cases where the person taking it is psychotically depressed, it&#8217;s the kind of thing you might try if you&#8217;re treating someone like <strong>Virginia Woolf<\/strong> or <strong>William Styron<\/strong> [<a target=\"_blank\" href=\"http:\/\/en.wikipedia.org\/wiki\/Darkness_Visible_%28memoir%29\" title=\"Darkness Visible (memoir)\"><em><strong>Darkness Visible<\/strong><\/em><\/a>] &#8211; people with life-threatening Depressive Illness.<\/div>\n<p align=\"justify\">But this ad is aimed at a different group &#8211; the people who might read ads in the New York Times. And the point is to get someone who is depressed who hasn&#8217;t responded to an SSRI to mention it to their Primary Care Physician &#8211; neither doctor nor patient having read  <u><strong><a href=\"http:\/\/www.washingtontimes.com\/news\/2010\/aug\/30\/questions-loom-over-drug-given-to-sleepless-vets\/\" target=\"_blank\">Questions loom over drug given to sleepless vets<\/a><\/strong><\/u>,  <u><strong><a target=\"_blank\" href=\"http:\/\/www.dailymail.co.uk\/money\/article-1298789\/AstraZeneca-gives-investors-boost.html?ito=feeds-newsxml\">AstraZeneca gives investors a boost<\/a><\/strong><\/u>,  <u><strong><a target=\"_blank\" href=\"http:\/\/www.businessweek.com\/news\/2010-08-04\/astrazeneca-said-to-pay-55-million-over-seroquel.html\">AstraZeneca Said to Pay $55 Million Over Seroquel<\/a><\/strong><\/u>,  <u><strong><a target=\"_blank\" href=\"http:\/\/www.nytimes.com\/2009\/10\/30\/business\/30drug.html\">AstraZeneca Pays Millions to Settle Seroquel Cases<\/a><\/strong><\/u>,  or the countless other reports about Seroquel.<\/p>\n<div align=\"justify\">In medicine, we have a concept &#8211; <em>informed consent<\/em>. It means if something is risky, the patient is entitled to know those risks up front. That ad up there flies in the face of <em>informed consent<\/em>. And it sure flies in the face of <em>rational science<\/em>&#8230;<\/div>\n<hr size=\"1\" \/>\n<div align=\"justify\"><strong>UPDATE: <a href=\"http:\/\/1boringoldman.com\/index.php\/2010\/12\/30\/informed-consent\/#comment-187868\" target=\"_blank\">Commenter Ivan<\/a><\/strong> adds a few more <strong>$eroquel<\/strong> references for your holiday reading:   <\/div>\n<ul>\n<li>\n<div align=\"justify\"><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2009\/10\/nemeroff-seroquel-and-accme.html\" target=\"_blank\">Nemeroff, Seroquel, and ACCME<\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2009\/02\/buried-data-smoke-and-mirrors-job-and.html\" target=\"_blank\">&quot;Buried Data,&quot; a &quot;Smoke-and-Mirrors Job&quot; and a &quot;Positive Spin&quot; on a &quot;Cursed Study&quot;<\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2009\/05\/more-documents-about-selling-of.html\" target=\"_blank\">More Documents About the Selling of Seroquel Show How Research Was &quot;Subordinated to Commercial Goals&quot;<\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a href=\"http:\/\/hcrenewal.blogspot.com\/2009\/10\/more-on-misleading-promotion-of.html\" target=\"_blank\">More on the Misleading Promotion of Seroquel <\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a href=\"http:\/\/carlatpsychiatry.blogspot.com\/2009\/06\/geodon-ineffective-for-bipolar.html\" target=\"_blank\">Geodon Ineffective for Bipolar Depression; or, Watch ClinicalTrials.gov in Action!<\/a><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><a href=\"http:\/\/clinpsyc.blogspot.com\/2010\/03\/editorial-support-cme-and-primary-care.html\" target=\"_blank\">Editorial Support, CME, and the Primary Care Companion<\/a><\/strong><\/div>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>So we had a New York Times front page ad for $eroquel XR that says &quot;Adding SEROQUEL XR for depression may help.&quot; Down at the bottom it says &quot;Roll-over for MORE Important Safety Information&quot; in small print. As mentioned before in this blog, $eroquel is an Atypical Antipsychotic originally approved by the FDA for the [&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-4587","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4587","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=4587"}],"version-history":[{"count":0,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4587\/revisions"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4587"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}