{"id":56792,"date":"2015-05-12T12:00:33","date_gmt":"2015-05-12T16:00:33","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=56792"},"modified":"2015-05-12T23:43:41","modified_gmt":"2015-05-13T03:43:41","slug":"prelapse-prequel2","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/05\/12\/prelapse-prequel2\/","title":{"rendered":"prelapse: prequel<sub>2<\/sub>&#8230;"},"content":{"rendered":"<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" height=\"223\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/injectables.gif\" \/><\/div>\n<p align=\"justify\" class=\"small\">Back in the 1970s, the depot injectable antipsychotics were around and much discussed as a solution to <em>non-compliance<\/em> in patients who had frequent relapses because as soon as they left the hospital, they stopped taking medications. <img decoding=\"async\" vspace=\"3\" hspace=\"4\" height=\"150\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/prolixin.gif\" \/>There were Prolixin Clinics, and visiting nurses who took the medication to the patients. It seemed to me that it sounded like a better idea than it was, at least in the inner-city environment where I worked. Besides the Big Brother [1984] feel to the scheme, many of the patients were as unlikely to show up for their monthly injection as they were to take their oral medication.&nbsp; In recent history, the <font color=\"#200020\">Long Acting Injectable <\/font>[<font color=\"#200020\">LAI<\/font>] Atypical Antipsychotics tend to be released late as the drugs go off-patent, presumably as a patent extension ploy [above]. <\/p>\n<p align=\"justify\" class=\"small\">The&nbsp; <font color=\"#200020\">PRELAPSE<\/font> study that I introduced in <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/05\/12\/56760\/\">prelapse: prequel<sub>1<\/sub>&hellip;<\/a>&nbsp; is unique in my experience. I was alerted to it by <font color=\"#200020\">Johanna Ryan<\/font> of <font color=\"#200020\">RxISK<\/font> and <font color=\"#200020\">Mad-in-America<\/font> in her well researched post [<a href=\"http:\/\/www.madinamerica.com\/2015\/05\/the-once-and-future-abilify-depot-injections-for-everyone\/\" target=\"_blank\">The Once and Future Abilify: Depot Injections for Everyone?<\/a>]. They are proposing to start off with a depot antipsychotic in first episode of Schizophrenia. I suppose the logic is to get off &quot;on the right foot&quot; by using a depot medication from the get-go to pre-empt any noncompliance problems. Their proposal is to divvy up clinical sites, half of which will use treatment-as-usual with oral antipsychotics of the clinician&#8217;s choice, and the other will use the injectable <font color=\"#200020\">Abilify Maintena&reg;<\/font>. They plan to compare the groups at two years.<\/p>\n<p align=\"justify\" class=\"small\">Well, out of the gate, that study doesn&#8217;t make much sense. First, do I want to commit a patient to maintenance antipsychotics the day I meet him\/her? What about the patients whose psychosis is short-lived and may never return?&nbsp; Brief Reactive Psychosis it&#8217;s called? What about at least giving the patient the chance to recover and remain medication-free if possible. The depot medications have traditionally only been used for patients who have a recurrent relapsing pattern and are medication non-compliant. And there are plenty of people who would see this scheme as &quot;forced drugging.&quot; But my complaint is something else, and why I started with the Dan Markingson story in <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/05\/12\/56760\/\">prelapse: prequel<sub>1<\/sub>&hellip;<\/a><strong><font color=\"#200020\"><\/font><\/strong>. When you treat a case of a first episode of Schizophrenia, you pick a drug and a dose, and monitor the response &#8211; adjusting the dose or changing drugs based on the patient&#8217;s clinical response. Some patients are very sensitive to the EPS symptoms or other side effects of one drug, and you don&#8217;t know that until you try. The goal is the minimum effective dose and that&#8217;s determined by usage. Some patients don&#8217;t respond to one medication, but another works just fine. With a depot medication, you&#8217;re committed from the start. <\/p>\n<p align=\"justify\" class=\"small\">That&#8217;s what I think happened to Dan Markingson. He was started on a fixed dose of a drug in a <font color=\"#200020\">blinded<\/font> study. I don&#8217;t think he ever fully responded. He needed a clinician who was on top of things and tried upping the dose, or changing drugs &#8211; the kind of medication <font color=\"#200020\">tweaking<\/font> that&#8217;s necessary with many of the drugs we use in medicine. With depot medication, that&#8217;s always going to be impossible. I&#8217;d never do what&#8217;s suggested in this study in the real world of clinical psychiatry. Since these depot medications have been around for at least forty years, why didn&#8217;t we think of doing this a long time ago? There must be some other factor in deciding to try this scheme in first episode cases.<\/p>\n<div align=\"justify\" class=\"small\">Well we know what that factor might be. <font color=\"#200020\">Abilify&reg;<\/font> is a blockbuster drug extraordinaire, topping the revenue charts with $5.7B in profits last year. And it&#8217;s about to go off-patent meaning that the generic version is just around the corner. We&#8217;ve already discussed the fact that <font color=\"#200020\">Otsuka<\/font> is submitting <font color=\"#200020\">Brexpiprazole<\/font> to the FDA for approval. <font color=\"#200020\">Brexpiprazole<\/font> is a kissing cousin to <font color=\"#200020\">Abilify&reg;<\/font> that they hope will help them hold on to some of the <font color=\"#200020\">Abilify&reg; <\/font>market share [see <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/22\/the-spice-must-flow-2\/\" target=\"_blank\"><em>the spice must flow&hellip;<\/em><\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/29\/machiavellian-medicine-lives\/\" target=\"_blank\">machiavellian medicine lives&hellip;<\/a>, and <a href=\"http:\/\/1boringoldman.com\/index.php\/2015\/04\/29\/chunk-of-change\/\" target=\"_blank\">chunk of change&hellip;<\/a>]. And this push seems to be in that same mold, extending the use of <font color=\"#200020\">Abilify Maintena&reg;<\/font> into the first episode cases. But there&#8217;s another big piece of this story that gets us into a Conflict of Interests realm. Stay tuned&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Back in the 1970s, the depot injectable antipsychotics were around and much discussed as a solution to non-compliance in patients who had frequent relapses because as soon as they left the hospital, they stopped taking medications. There were Prolixin Clinics, and visiting nurses who took the medication to the patients. It seemed to me that [&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":[5],"tags":[],"class_list":["post-56792","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56792","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=56792"}],"version-history":[{"count":23,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56792\/revisions"}],"predecessor-version":[{"id":56831,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/56792\/revisions\/56831"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=56792"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=56792"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=56792"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}