{"id":19016,"date":"2012-02-02T00:59:04","date_gmt":"2012-02-02T05:59:04","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=19016"},"modified":"2012-02-02T10:06:52","modified_gmt":"2012-02-02T15:06:52","slug":"deja-vu-again","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/02\/02\/deja-vu-again\/","title":{"rendered":"d\u00c3\u00a9j\u00c3\u00a0 vu again&#8230;"},"content":{"rendered":"<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"520\" vspace=\"7\" height=\"135\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/lat-2.gif\" \/>&nbsp;<\/div>\n<div align=\"justify\">The two drugs under consideration here are <strong><font color=\"#200020\">RISPERDAL&reg; CONSTA&reg;<\/font><\/strong>, an injectable version of Risperdal [monthly] approved by the FDA in 2003, and <strong><font color=\"#200020\">INVEGA&reg; SUSTENNA&reg;<\/font><\/strong>, an injectable version of <strong><font color=\"#500050\">PALIPERIDONE PALMITATE<\/font><\/strong> [9-hydroxy-risperidone] with a different delivery system approved by the FDA in 2009. Janssen has launched a campaign to help patients use their injectable drugs [<a target=\"_blank\" href=\"http:\/\/www.jnj.com\/connect\/news\/all\/janssen-connect-launches-in-california\"><u><strong><font color=\"#400040\">Janssen&reg; Connect&trade;<\/font><\/strong><\/u><\/a>] and another to teach doctors how to get patients to take these injectable drugs [<u><a target=\"_blank\" href=\"http:\/\/www.psychiatrictimes.com\/infocenter\/vital\/2\"><strong><font color=\"#400040\">VITAL&trade;<\/font><\/strong><\/a><\/u>].<\/div>\n<p align=\"justify\">This introduces a gigantic topic, polarizing at first breath, the source of a divisiveness that reaches into antiquity &#8211; what to do about Schizophrenia. But first, are these drugs efficacious? Are these drugs safe?<\/p>\n<div align=\"justify\"><strong><font color=\"#200020\">RISPERDAL&reg; CONSTA&reg;<\/font><\/strong><\/div>\n<ul>\n<div><a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2003\/21346_Risperdal%20Consta%20Long-Acting%20Injection_medr.PDF\" target=\"_blank\"><u><strong><font color=\"#200020\">FDA Medical Review<\/font><\/strong><\/u><\/a><\/div>\n<div><a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2003\/21346_Risperdal%20Consta%20Long-Acting%20Injection_medr.PDF\" target=\"_blank\"><u><strong><font color=\"#200020\">FDA Letter of Approval<\/font><\/strong><\/u><\/a><\/div>\n<div><a href=\"http:\/\/clinicaltrials.gov\/ct2\/results?term=risperidone+injectable\" target=\"_blank\"><u><strong><font color=\"#200020\">Clinical Trials <\/font><\/strong><\/u><\/a><\/div>\n<\/ul>\n<div align=\"justify\"><strong><font color=\"#200020\">INVEGA&reg; SUSTENNA&reg;<\/font><\/strong><\/div>\n<ul>\n<div><a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2009\/022264s000medr.pdf\" target=\"_blank\"><u><strong><font color=\"#200020\">FDA Medical Review<\/font><\/strong><\/u><\/a><\/div>\n<div><a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2009\/022264s000ltr.pdf\" target=\"_blank\"><u><strong><font color=\"#200020\">FDA Letter of Approval<\/font><\/strong><\/u><\/a><\/div>\n<div><a href=\"http:\/\/clinicaltrials.gov\/ct2\/results?term=PALIPERIDONE+PALMITATE\" target=\"_blank\"><u><strong><font color=\"#200020\">Clinical Trials<\/font><\/strong><\/u><\/a><\/div>\n<\/ul>\n<div align=\"justify\">Boring reading &#8211; this. There was less weight gain than I would&#8217;ve thought, and not as many cases of Diabetes or Tardive Dyskinesia. However, neither drug had long term data so who knows what will be reported down the line? One really odd thing. In the <a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2009\/022264s000medr.pdf#page=25\" target=\"_blank\"><u><strong><font color=\"#200020\">INVEGA&reg; SUSTENNA&reg;<\/font><\/strong><\/u><\/a> study, <strong><font color=\"#200020\">Benzodiazepines<\/font><\/strong> were allowed and liberally used to the tune of 60% of the patients [with people on Invega using them as much as the placebo group]. It was striking.<\/div>\n<p align=\"justify\">When it comes to the question of the psychotic Schizophrenic person, one has to always question whether you are doing something <em><strong><font color=\"#200020\">for<\/font><\/strong><\/em> the patient, <em><strong><font color=\"#200020\">with<\/font><\/strong><\/em> the patient, or <em><strong><font color=\"#200020\">to<\/font><\/strong><\/em> the patient. And often times, the patient himself isn&#8217;t much help, particularly under the sway of active hallucinations or compelling delusions. This is not, to me, something to be considered in a general way sitting in an armchair in your study. It&#8217;s something that has to be dealt with in proximity to the patient in question. Most people go through life neither experiencing nor being around active psychosis, and so thinking about the topic is uninformed by the disease in question &#8211; and in its more florid form, it&#8217;s a show-stopper. I remember my early days in psychiatry training in Grady Hospital in Atlanta. I thought of it as &quot;Fort Apache, the Bronx&quot; the name of a contemporary television show. On call at night, first he elevator bell would sound, and here would come a family or the police with some out of control, delusional person fighting and screaming. The staff who had been there for decades would settle things down, then I was supposed to do something definitive &#8211; like make a diagnosis, decide on a course of action, maybe sign commitment papers to force hospitalization. No matter what I did, somebody didn&#8217;t like it &#8211; the patient, the family, the police, the ward staff, sometimes even me.<\/p>\n<p align=\"justify\">After a time, it became easier, or at least clearer. The criteria were simple. Was the person mentally ill? yes\/no. Was the person immediately dangerous to himself or other people?&nbsp; yes\/no. That decision was going to be reviewed on the next day by someone higher up, and in a few days by a judge. I could answer those questions and didn&#8217;t have to deal with the fact that I was depriving a person of their civil liberties without due process of law for a day. I didn&#8217;t like doing it. Was I doing  something <em><strong><font color=\"#200020\">for<\/font><\/strong><\/em> the patient, <em><strong><font color=\"#200020\">with<\/font><\/strong><\/em> the patient, or <em><strong><font color=\"#200020\">to<\/font><\/strong><\/em> the patient? In those days, there was Dr. Thomas Szasz and a host of antipsychiatrists who said I was being an agent of the State, not a doctor. And on those long nights, it seemed like I was always riding against the waves. If I thought the patient needed hospitalization, they didn&#8217;t agree. If I thought the patient didn&#8217;t need to be hospitalized, they wanted in. The on-call room was next to the nursing station with a window overlooking I-75\/85. On several of those nights, I dreamed that it was falling off of the building and smashing onto the highway &#8211; a testimony to both what it&#8217;s like to be around that many psychotic people and my own wish to escape.<\/p>\n<p align=\"justify\">In the scope of things, those decisions that felt so cataclysmic in those early days were really not a problem for me. I could see that I was doing something <em><strong><font color=\"#200020\">for<\/font><\/strong><\/em> the patients after all. For one thing, they continued to be my patients and when they got better, we got on just fine. And I knew that had I seen them thirty years earlier, they would&#8217;ve ended up in Central State Hospital where way too many might have spent the majority of their lives suffering the kind of deterioration I read about in the older psychiatry texts and occasionally saw. I could see with my own eyes that the acute treatment of florid psychosis with neuroleptic medication was doing something <em><strong><font color=\"#200020\">for<\/font><\/strong><\/em> the patient. And even though I never particularly liked being in the situation of signing those papers, I came to agree that better someone like me than someone who didn&#8217;t know this strange illness called Schizophrenia inside and out [though I&#8217;ll admit to heavy reliance on the staff who had been there forever and just &quot;knew&quot; what to do].<\/p>\n<p align=\"justify\">But I never got there with the treatment of Chronic Schizophrenia. Schizophrenic patients are notoriously &quot;non-compliant&quot; in taking medication long term. There are plenty of reasons. The side effects or just how the stuff makes you feel is a rational reason. The medicine may ablate psychotic symptoms, but it doesn&#8217;t do much for the anhedonia [lack of pleasurable feelings] or other &quot;negative&quot; symptoms. But there are plenty of other reasons, like being controlled, poisoned, etc. And you don&#8217;t have to be around too long to realize that the florid symptoms have a positive &quot;feel.&quot; A delusion explains the confusing world. Or as a patient once said, &quot;You want to hear my voices? They keep me from feeling lonely out there on the road.&quot; So the treatment of acute psychosis had turned a chronic progressive illness for many into an illness where the psychotic symptoms remit, then return with another psychotic episode. And there&#8217;s little question that staying on medication lowers the frequency of relapses. And as the literature review <a target=\"_blank\" href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2003\/21346_Risperdal%20Consta%20Long-Acting%20Injection_medr.PDF#page=13\"><u><strong><font color=\"#200020\">here<\/font><\/strong><\/u><\/a> [<strong><font color=\"#200020\">RISPERDAL&reg; CONSTA&reg;<\/font><\/strong>] says, being on depot medication lowers the recurrence rate even more than counting on the patients to take it themselves. I expect that&#8217;s true. But I&#8217;m not sure we have the right to push constant medication. The courts don&#8217;t think so either. <\/p>\n<p align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"350\" height=\"192\" border=\"1\" src=\"http:\/\/1boringoldman.com\/images\/lat-3.jpg\" \/><\/p>\n<p align=\"justify\">So enter stage left, Janssen Pharmaceuticals who is offering to teach doctors how the be compliant with the injunction to keep people on medication by getting the patients to be on Long Acting Injectable Therapy [<u><a target=\"_blank\" href=\"http:\/\/www.psychiatrictimes.com\/infocenter\/vital\/2\"><strong><font color=\"#400040\">VITAL&trade;<\/font><\/strong><\/a><\/u>], and thereby get the Schizophrenic Patients to be more compliant. They&#8217;ve even put together a program to make it easier for patients [<a target=\"_blank\" href=\"http:\/\/www.jnj.com\/connect\/news\/all\/janssen-connect-launches-in-california\"><u><strong><font color=\"#200020\">Janssen&reg; Connect&trade; Launches In California<\/font><\/strong><\/u><\/a>].<\/p>\n<p align=\"justify\">Of course <strong><font color=\"#200020\">INVEGA&reg; SUSTENNA&reg; <\/font><\/strong>is a patent extender. Of course <a target=\"_blank\" href=\"http:\/\/www.jnj.com\/connect\/news\/all\/janssen-connect-launches-in-california\"><u><strong><font color=\"#400040\">Janssen&reg; Connect&trade;<\/font><\/strong><\/u><\/a> and <u><a target=\"_blank\" href=\"http:\/\/www.psychiatrictimes.com\/infocenter\/vital\/2\"><strong><font color=\"#400040\">VITAL&trade;<\/font><\/strong><\/a><\/u> are attempts to sell more drugs. That goes without saying. That&#8217;s their right. It&#8217;s what Janssen does. But there are other considerations. Even if neuroleptics were completely benign, I&#8217;m not sure I&#8217;d agree with &quot;forcing the issue&quot; of medication. Maybe people with Schizophrenia need a fling with psychosis every once and a while as relief from the blandness of their experience otherwise, who knows? I sure don&#8217;t, but I don&#8217;t have to think about such questions because <em><strong><font color=\"#200020\">neuroleptics [no matter what generation] are not benign<\/font><\/strong><\/em>. That part is clear as a bell. So if you are a Chronic Schizophrenic, is the injunction to <u>always<\/u> be on medication something that is being done  <em><strong><font color=\"#200020\">for<\/font><\/strong><\/em> you, <em><strong><font color=\"#200020\">with<\/font><\/strong><\/em> you, or <em><strong><font color=\"#200020\">to<\/font><\/strong><\/em> you? I can think of only a few situations where it&#8217;s that clear that it&#8217;s&nbsp; <em><strong><font color=\"#200020\">for<\/font><\/strong><\/em> you. And, by the way, these two drugs are targeted towards the Public Mental Health systems where most Schizophrenic patients receive treatment. There, it&#8217;s only clear that it&#8217;s good  <em><strong><font color=\"#200020\">for <\/font><\/strong><\/em>the bean counters who do cost accounting in public medicine.<em> Keep them on meds, lower hospital costs.<\/em><\/p>\n<hr size=\"1\" \/>\n<p align=\"justify\">I just sat through a trial in Texas about a company named Janssen Pharmaceuticals who took a drug called Risperdal that by all rights was only indicated in Adult Schizophrenia and turned it into a blockbuster yielding $30+ billion in profit by invading Public Health Systems and Child Psychiatry [even though there were essentially no FDA approvals for children] using methods that were criminal &#8211; jury-rigged guidelines, hired KOLs, off label promotion by Sales Reps. Now, I&#8217;m reading about a company called Janssen with a drug called something very like Risperdal [9-hydroxy-risperidone] that is only for a few people in Public Health Systems who have an uncommon illness [Schizophrenia] &#8211; a company who is off and running with a new, peculiar marketing campaign. I find that disturbing. I can see them pitching this stuff to Formulary Administrators and Public System upper eschelon. Steven Shon has already given it a shot with <strong><font color=\"#200020\">RISPERDAL&reg; CONSTA&reg;<\/font><\/strong> in the TMAP guidelines. I can see this being touted to people treating Foster kids and other kids. I called my last post <strong><font color=\"#200020\">d\u00c3\u00a9j&agrave; vu<\/font><\/strong> because it reminded me of the 1970s, but I&#8217;m also having TMAP <strong><font color=\"#200020\">d\u00c3\u00a9j&agrave; vu<\/font><\/strong> because it reminded me of the very recent weeks as well.<\/p>\n<p align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"272\" border=\"1\" src=\"http:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/3\/36\/Theprocessionofthetrojanhorseintroybygiovannidomenicotiepolo.jpg\/300px-Theprocessionofthetrojanhorseintroybygiovannidomenicotiepolo.jpg\" \/>&nbsp;<\/p>\n<div align=\"justify\">Beware of <em>companies-called-Janssen<\/em> bearing gifts <em>called-anything-like-Risperdal<\/em>. It&#8217;s likely another Trojan Horse&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; The two drugs under consideration here are RISPERDAL&reg; CONSTA&reg;, an injectable version of Risperdal [monthly] approved by the FDA in 2003, and INVEGA&reg; SUSTENNA&reg;, an injectable version of PALIPERIDONE PALMITATE [9-hydroxy-risperidone] with a different delivery system approved by the FDA in 2009. Janssen has launched a campaign to help patients use their injectable drugs [&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-19016","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/19016","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=19016"}],"version-history":[{"count":40,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/19016\/revisions"}],"predecessor-version":[{"id":19090,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/19016\/revisions\/19090"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=19016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=19016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=19016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}