{"id":41470,"date":"2013-11-11T22:24:01","date_gmt":"2013-11-12T03:24:01","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=41470"},"modified":"2013-11-11T22:30:18","modified_gmt":"2013-11-12T03:30:18","slug":"off-to-juvey","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/11\/11\/off-to-juvey\/","title":{"rendered":"<em>off to juvey&#8230;<\/em>"},"content":{"rendered":"\n<div align=\"justify\"><sup><em>Almost two years ago, I went to Austin Texas for the <strong><font color=\"#200020\">Allen Jones and the State of Texas v. Janssen<\/font><\/strong> Trial. At that time, I&#8217;d been writing about the psychopharmaceutical industry and its alliances with academic psychiatry for a couple of years, and I&#8217;d corresponded some with Allen Jones &#8211; the whistle-blower who exposed the TMAP scam in which large State Health systems were directing their doctors to use expensive medications under patent over low-priced equivalent generics &#8211; a very strange thing. Why did I go? I think it was because reading about all of this stuff in a cabin in the mountains didn&#8217;t make it real. After forty years practicing medicine in multiple settings, I&#8217;d never seen anything close to what I was reading about. My specialty, psychiatry, was front and center in a sea of corruption and I didn&#8217;t know it.<\/em><em> The trip worked, because on the plane home I knew it, and to be honest, it was much worse than I thought. But that&#8217;s old news. So, in my last post [<\/em><em><a href=\"http:\/\/1boringoldman.com\/index.php\/2013\/11\/10\/what-has-been\/\"><em>what has been&hellip;<\/em><\/a>], I said a couple of things about the future, about what I think needs to be done:<\/em><\/sup><\/div>\n<ul><sup>          <\/p>\n<li>\n<div align=\"justify\"> <em>there&rsquo;s a long history of erroneous attempts at solving what seems the  impossible dilemma when entrepreneurialism collides with rational health  care and medical ethics, and the territory between scorched earth and   sleeping with the enemy remains to be defined.<\/em><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em>Why have so many attempts at reform met with such regular failure?<\/em><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em>&#8230;no matter what we do, it has to include both the resources and the&nbsp;  mandate for oversight &ndash; indefinite, ongoing oversight. No more honor  system and grand rhetoric. There&rsquo;s just not enough honor in the  marketplace to get the job done.<\/em><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em>Companies  don&rsquo;t commit fraud &ndash; people do. It&rsquo;s part of that &quot;cost of  doing  business&quot; argument that&rsquo;s so regularly mentioned that it&rsquo;s become  a  figure of speech. This is the door we haven&rsquo;t opened that can&rsquo;t  continue  to stay closed.<\/em><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><em>&#8230;there&rsquo;s  plenty of out-right crime accompanying the distortions in  clinical trial  reporting, libraries filled with incriminating  subpoenaed documents,  but no punishment of the perpetrators on the  books. The only pertinent  question here is why hasn&rsquo;t it happened? <\/em><\/div>\n<\/li>\n<p>         <\/sup><\/ul>\n<div align=\"justify\"><sup><em>Yesterday, I read through the charges in the case against Jansssen that just settled for $2.2 B: <a href=\"http:\/\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf\" target=\"_blank\">United States of America v. Janssen Pharmaceuticals Inc<\/a> and saw another loud example of why I said those things, why I&#8217;m using phrases like &quot;scorched earth&quot; and talking about &quot;out-right crime&quot; &#8211; why I said &quot;There&rsquo;s just not enough honor in the  marketplace to get the job done.&quot;<\/em><\/sup><\/div>\n<hr size=\"1\" \/>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=5\"><img decoding=\"async\" width=\"500\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/jnj-00.gif\" \/><\/a><\/p>\n<p align=\"justify\" class=\"small\">Reading this now, I wonder why the approval was so broad [&quot;management of the manifestations of psychotic disorders&quot;] to start with. It was twenty years ago, and I think that&#8217;s the way most people were thinking about the antipsychotics then, but even at that, it seems like a blanket approval and we know it&#8217;s exactly what Janssen had in mind. To quote sales rep <a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/post.php?post=41470&#038;action=edit&#038;message=10\">Tone Jones<\/a> from the Texas trial, &quot;<em>You can&rsquo;t be a billion dollar drug in a 1% market<\/em>.&quot; Schizophrenia is that 1% market, and Janssen had its sights set much higher. In a later communication, the FDA confirmed the breadth of the Approval, but cautioned about the elderly once again, and insisted that Janssen note that the studies were done in short-term Schizophrenia trials. Then, in 1999, the FDA reviewed what Janssen was actually doing and issued a fairly firm &quot;halt&quot; order:    <\/p>\n<p align=\"center\"><a target=\"_self\" href=\"http:\/\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=8\"><img decoding=\"async\" width=\"500\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/jnj-0.gif\" \/><\/a><br \/>               <sup><strong><font color=\"#200020\">DDMAC<\/font><\/strong> =  Division of Drug Marketing, Advertising and Communication [FDA] <\/sup><\/p>\n<p align=\"justify\" class=\"small\">The back story here is that Janssen was cutting all kinds of deals to get Risperdal on the formularies and prescribed in beaucoups nursing homes. I&#8217;m going to leave you to look at that part yourself, but think Omnicare and think really big money. The FDA Approval probably was too broad in the first place. I think they were thinking about adults, where antipsychotics used in Schizophrenia have long been used for other conditions &#8211; like Acute Mania. But the FDA left a crack in the door for treating kids and the aged, and Janssen was racing through it by this time. When cautioned, Janssen pushed back, relying on the original wording, but they had also played it straight and applied for approval in the elderly. The FDA said &quot;no,&quot; and brought up unexplained deaths:    <\/p>\n<p align=\"center\"><a href=\"http:\/\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=8\" target=\"_blank\"><img decoding=\"async\" width=\"500\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/jnj-1.gif\" \/><\/a><\/p>\n<p align=\"justify\" class=\"small\">So by 1999, the FDA had said &quot;no&quot; to dementia and had issued a threat. Selling Risderdal&reg; as a treatment in dementia was not okay. Maybe there was a loophole to start with, but no longer. In fact, in March 2002, the FDA changed the approved indication to &quot;treatment of Schizophrenia [see <a href=\"http:\/\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=8\" target=\"_blank\">item 26<\/a> in the complaint].<\/p>\n<p align=\"justify\" class=\"small\">What happened next is easily summarized [see <a target=\"_blank\" href=\"http:\/\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=9\">pages 9<\/a> and <a target=\"_blank\" href=\"http:\/\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=10\">10<\/a> in the complaint]. In March 2003 the FDA requested a warning on the label about increased risk of stroke in the elderly, and added another in November, 2003 about Diabetes. In December, 2003 the FDA approved Risderdal&reg; for short term treatment of Mania. Finally, in April 2005, the FDA required a <strong><font color=\"#200020\">Black Box Warning<\/font><\/strong> for all Atypical Antipsychotics, highlighting the risk of increased mortality in elderly patients with dementia-related psychosis. And the following month, they turned down yet another request for Risderdal&reg;&#8217;s use in the elderly, this time in Alzheimer&#8217;s disease.<\/p>\n<p align=\"justify\" class=\"small\">In summarizing, the FDA cut them some slack and didn&#8217;t complain about Janssen&#8217;s opportunizing on a loophole. What they don&#8217;t say is that Janssen was pushing Risderdal&reg; for agitation, hostility, psychosis, etc, all the while getting it onto eldercare facilities&#8217; formularies. In many places, Risderdal&reg; was almost a routine drug in these institutions. Janssen was raking in the money from this enterprise throughout this whole story.   <\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=11\"><img loading=\"lazy\" decoding=\"async\" width=\"500\" height=\"98\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/jnj-1-5.gif\" \/><\/a>   <\/p>\n<p align=\"justify\" class=\"small\">The behavior of Janssen was unaffected by these actions of the FDA. Their marketing Risderdal&reg; for the elderly, if anything, escalated as the FDA continued to try to get it under control.   <\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=16\"><img decoding=\"async\" width=\"500\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/jnj-2.gif\" \/><\/a><\/p>\n<p align=\"justify\" class=\"small\">They recommended Risderdal&reg; for non-psychotic behaviors for which it was never approved, and continued to push it for psychotic symptoms after the drug&#8217;s indications were refined to specifically discourage this use. And they knew what they were doing the whole time.  <\/p>\n<p align=\"center\"><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/www.justice.gov\/opa\/documents\/jj\/janssen-info.pdf#page=18\"><img decoding=\"async\" width=\"500\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/jnj-3.gif\" \/><\/a><\/p>\n<hr size=\"1\" \/>\n<p align=\"justify\">I apologize for the length of this post. I just couldn&#8217;t think of any way to shorten it. There are several points I&#8217;m trying to make. Janssen knew what it was doing. The FDA may have been slower than we would&#8217;ve have liked, but they were clear &#8211; and Janssen just kept on going. The dangers of Risderdal&reg; to elderly patients became increasingly clear &#8211; and Janssen just kept on going. When things were coming to a head: the FDA was after their Eldercare plans; Allen Jones had filed his TMAP suit; the man in charge of Risderdal&reg;, Alex Gorsky who headed the Risderdal&reg; operation, had exited to Europe  &#8211; and Janssen just kept on going. Nothing stopped them and this settlement won&#8217;t stop them if they&#8217;re in a similar situation in the future. The money is just too big. So I stand by &quot;<strong><font color=\"#200020\"><em>There&rsquo;s just not enough honor in the  marketplace to get the job done<\/em><\/font><\/strong>&quot; and there never will be. And whatever we are doing now isn&#8217;t enough to get the job done either. The FDA and the DOJ gave it the old college try here.  <\/p>\n<div>I&#8217;m lead to two conclusions. <\/div>\n<ul>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">First, in our negotiations with the pharmaceutical industry [and the KOLs], I&#8217;m closer to scorched earth than on any other issue I can think of. I&#8217;m not a scorched-earth kind of guy, but it&#8217;s clear that no matter what they say or even what they mean now, in the heat of battle when they can smell the profits, this story is typical of how they act &#8211; over and over &#8211; all of them. It&#8217;s not a question of trust. It&#8217;s evidence based!<\/font><\/strong><\/div>\n<\/li>\n<li>\n<div align=\"justify\"><strong><font color=\"#200020\">Second. This story is missing teeth. Put the executives in jail  [and the KOLs]. Take all the ill-gotten profit instead of a piece. Pull the drug&#8217;s patent protection. Do whatever it takes to stop the game playing with people&#8217;s health and lives. When we work with adolescents, we try to rehabilitate them, but at some point we throw in the towel, and it&#8217;s off to juvey. Our jails aren&#8217;t that overcrowded. There&#8217;s room for plenty of these guys&#8230;<\/font><\/strong><\/div>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Almost two years ago, I went to Austin Texas for the Allen Jones and the State of Texas v. Janssen Trial. At that time, I&#8217;d been writing about the psychopharmaceutical industry and its alliances with academic psychiatry for a couple of years, and I&#8217;d corresponded some with Allen Jones &#8211; the whistle-blower who exposed the [&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_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-41470","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41470","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=41470"}],"version-history":[{"count":50,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41470\/revisions"}],"predecessor-version":[{"id":41520,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/41470\/revisions\/41520"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=41470"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=41470"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=41470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}