{"id":50909,"date":"2014-10-20T13:39:16","date_gmt":"2014-10-20T17:39:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=50909"},"modified":"2014-10-28T12:32:29","modified_gmt":"2014-10-28T16:32:29","slug":"rather-than-micromanage","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/10\/20\/rather-than-micromanage\/","title":{"rendered":"rather than micromanage&#8230;"},"content":{"rendered":"<div align=\"justify\" class=\"small\">&ldquo;<em>APA has a role in shaping what future psychiatric practice looks like,&rdquo; Schatzberg stated. &ldquo;More needs to be done now if we are to have new treatments in the next decade for patients with psychiatric disorders.<\/em>&rdquo;<\/div>\n<div align=\"right\" class=\"small\"><em>Alan Schatzberg in <a href=\"http:\/\/psychnews.psychiatryonline.org\/newsArticle.aspx?articleid=1096598\" target=\"_blank\">APF Convenes Unique Pipeline Summit<\/a>, April 2012<\/em><\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/alert.psychnews.org\/2014\/10\/pipeline-and-innovation-for.html?utm_source=feedburner&#038;utm_medium=feed&#038;utm_campaign=Feed%3A+PsychiatricNewsAlert+%28Psychiatric+News+Alert%29\" target=\"_blank\">Pipeline and Innovation for Psychotropic Drugs Are Limited, Study Finds<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#000001\">Psychiatric<\/font><font color=\"#990000\">News<\/font><\/strong><\/div>\n<div align=\"center\" class=\"small\">October 17, 2014<\/div>\n<p align=\"justify\">As development of drugs to treat psychiatric disorders lags behind that of drugs for other illnesses, a recent <a href=\"http:\/\/ps.psychiatryonline.org\/article.aspx?articleID=1901666&#038;resultClick=1\" target=\"_blank\">study<\/a> published in <em>Psychiatric Services in Advance<\/em> sheds light on why the pipeline for psychotropic medicines is nearly empty.<\/p>\n<p align=\"justify\">Researchers from  Brandeis University and Truven Health Analytics led an investigation of  the current state of psychotropic drugs in the pipeline and potential  barriers that may keep these drugs from reaching distribution in the  United States&#8230; The analysis showed that  the pipeline for psychotropic drug development &mdash; 99 clinical trials were  included &mdash; is limited, with little product innovation evident. Most of the  examined drugs were a combination of existing of U.S. Food and  Drug&nbsp;Administration-approved medicines or individually approved  medicines that were being&nbsp;tested for new indications or delivery-system  approaches [such as an injectable version that is similar to an approved  oral form]. Only three drugs differed substantially from existing  drugs&#8230;<\/p>\n<div align=\"justify\">In an interview with <em>Psychiatric News<\/em>,  Alan Schatzberg, M.D., a professor of psychiatry at&nbsp;Stanford&nbsp;University  and former APA president, said that the departure by pharmaceutical  companies to&nbsp;develop innovative psychotropic medicines could result in  serious problems for the field of psychiatry, especially for patients. &ldquo;There is a number of  initiatives by various organizations to help with this problem,  including the European College of Neuropsychopharmacology, which is  working with companies to provide investigators with compounds that have  been shelved, and NIMH&#8217;s Research Domain Criteria [RDoC], which  promotes research on specific [and new] biological targets,&quot; he said.  Schatzberg emphasized that it will take a concerted effort on the parts  of governmental agencies, industry, as well as APA to advocate for  investment and innovative psychiatric drug development. &ldquo;Silence will  not be helpful to our patients,&rdquo; he concluded&#8230;<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">Since it became apparent in the summer of 2011 that the pharmaceutical industry was abandoning CNS drug development, there has been a frantic level of activity in the halls of psychiatry. For the previous two decades, organized and academic psychiatry had occupied itself with brain research and testing, commenting on, [and promoting] the CNS drugs that flowed from the industrial pipeline. After a period of panic and attempts to re-engage PHARMA, two threads emerged: changing the role of psychiatrists [<a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/10\/12\/the-sequel-i\/\">the sequel I&hellip;<\/a>] coming from the APA leadership; and relocating CNS drug development and research to various public institutions, shepherded by NIMH Director, Tom Insel. Over the last several years, in a series of blog posts Dr. Insel has described a number of strategies including the NIMH RDoC [<a target=\"_blank\" href=\"http:\/\/www.nimh.nih.gov\/research-priorities\/rdoc\/index.shtml\">Research Domain Criteria<\/a>] and many others now under a Translational Science umbrella in the NIH. If you check out the links, most will be familiar to anyone who periodically checks in with Dr. Insel&#8217;s blog:<\/div>\n<blockquote>\n<div align=\"center\"><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/research.html\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" width=\"271\" height=\"64\" src=\"http:\/\/1boringoldman.com\/images\/ncats.gif\" \/><\/a><\/div>\n<ol>\n<div><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/reengineering.html\">Re-engineering Translational Sciences<\/a><\/div>\n<ul>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/ncgc\/ncgc.html\">NIH Chemical Genomics Center<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/rescue-repurpose\/rescue-repurpose.html\">Repurposing Drugs<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/tissue-chip\/tissue-chip.html\">Tissue Chip for Drug Screening<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/exrna\/exrna.html\">Extracellular RNA Communication<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/drug-targets\/drug-targets.html\">Identifying and Validating Drug Targets<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/tox21\/tox21.html\">Toxicology in the 21st Century<\/a><\/li>\n<li><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/genome\/idg.html\">Illuminating the Druggable Genome<\/a><\/li>\n<\/ul>\n<div><a target=\"_blank\" href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/genome\/idg.html\">Strategic Alliances for Technology Transfer<\/a><\/div>\n<\/ol>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">Translational Science started its life as a concept meant to focus research on current medical needs and speed the research findings from the &quot;bench to the bedside.&quot; The problem that there were scant findings to translate didn&#8217;t seem to matter, and the term appears to have morphed into meaning &quot;<em>anything that people think is a good idea<\/em>&quot; &#8211; a politically correct tag like &quot;<em>evidence-based medicine.<\/em>&quot; Among the NCATS strategies, one stands out as a new addition &#8211; the IDG Project, AKA, <em> Illuminating the Druggable Genome<\/em> [an tongue-twister for the ages]:<\/div>\n<blockquote>\n<div align=\"center\" class=\"big\"><strong><font color=\"#200020\">Med Check<\/font><\/strong><\/div>\n<div align=\"center\" class=\"big\"><a href=\"http:\/\/psychnews.psychiatryonline.org\/newsarticle.aspx?articleid=1916851\" target=\"_blank\">NIH Initiates Program to Find Potential Drug Targets<\/a><\/div>\n<div align=\"center\" class=\"big\"><strong><font color=\"#000001\">Psychiatric<\/font><font color=\"#990000\">News<\/font><\/strong><\/div>\n<div align=\"center\" class=\"middle\">by Vabren Watts<\/div>\n<div align=\"center\" class=\"small\">October 17, 2014<\/div>\n<p align=\"justify\">According to the National Institutes of  Health [NIH], as many as 3,000 genes express proteins whose molecular  actions could be altered by medicines, yet only 10 percent of these  &ldquo;druggable genes&rdquo; are targeted by drugs that have been approved by the  Food and Drug Administration [FDA]. <\/p>\n<p align=\"justify\">The NIH recently announced the launch of  Illuminating the Druggable Genome [IDG], a three-year pilot project to  explore poorly understood genes that have the potential to be modified  by medicines. The IDG will target understudied genes of four important  protein families that may be affected by medications &mdash; nuclear receptors,  ion channels, protein kinases, and G-protein coupled receptors.<\/p>\n<p align=\"justify\">&ldquo;We have a gap in the drug-development  pipeline between what gene activities we know could be modified by  medication and what currently is targeted,&rdquo; said James Anderson, M.D.,  Ph.D., director of the NIH Division of Program Coordination, Planning,  and Strategic Initiatives. &ldquo;By focusing on understudied genes, we hope  to find potential targets for medications to treat or cure some of our  most burdensome diseases &mdash; and then share what we learn so that all can  build on this knowledge.&rdquo;<\/p>\n<div align=\"justify\">Primary funding for pilot awards is coming  from the NIH Common Fund, which supports high-impact pioneering research  in all divisions of NIH. Institutions granted awards will thoroughly  investigate potential gene targets and share what they learn on a public  resource that will help the larger scientific community build on the  findings through basic research and clinical translation.<\/div>\n<\/blockquote>\n<div class=\"small\">&#8230; and from the NCATS:<\/div>\n<blockquote>\n<div><a href=\"http:\/\/www.ncats.nih.gov\/research\/reengineering\/genome\/idg.html\" target=\"_blank\">Illuminating the Druggable Genome<\/a><\/div>\n<p align=\"justify\">Results from the Human Genome Project revealed that the human  genome contains 20,000 to 25,000 genes. A gene contains [encodes] the  information that each cell uses to make [express] a protein, which is  essential for the body to function properly. Abnormal protein expression  is associated with many human diseases, which makes proteins key  targets for therapeutic agents&#8230;<\/p>\n<p align=\"justify\">Approximately  3,000 genes are considered part of the &ldquo;druggable genome&rdquo;, a set of  genes encoding proteins that scientists can or predict they can modulate  using experimental small molecule compounds. Yet, only about 10 percent  of these genes encode proteins that have been targeted successfully by  an approved drug. Therefore, a large number of proteins remain for  scientists to explore as potential therapeutic targets. The vast  majority of the druggable genome encodes four key protein families:  G-protein-coupled receptors, nuclear receptors, ion channels and  kinases&#8230;<\/p>\n<div align=\"justify\">By expanding the  potential therapeutic space through the IDG program, NIH is clearing a  path for more efficient disease-related research and more effective  treatments for patients.<\/div>\n<\/blockquote>\n<div align=\"justify\" class=\"small\">There&#8217;s an unexamined inertia of motion in this narrative. The system apparently requires an endless influx of <em>new<\/em> drugs, and widespread panic ensued when that flow was interrupted, evoking these radical efforts to restore it. In fact, the majority of that stream of CNS medications for the two decades after 1987 [Prozac] wasn&#8217;t really <em>new<\/em> &#8211; but rather a set of variations on themes from the 1950s windfall of psychotropic drugs, engineered to be better tolerated. We didn&#8217;t hear much about the <em>old-ness<\/em> of these drugs, at least not in the foreground, until the supply was exhausted. Then we heard of little else, and the gears started whirring overtime for <em>new<\/em>, <em>novel<\/em>, <em>innovative<\/em> strategies to find <em>new<\/em> targets for CNS drug development.<\/div>\n<p align=\"justify\" class=\"small\">I did notice along the way that the last <em>new better drug<\/em> became the next <em>old obsolete drug<\/em> with some regularity. And with that came the illusion that the drugs were improving [I would now see it as more determined by patent life and advertising]. And in those salad days, psychiatry had developed a sizable commentator class &#8211; a group of academics who commented on the drugs, talked about what was coming next, wrote about the <em>neurobiology of<\/em> this or the <em>psychobiology of<\/em> that regularly. In my mind, I called it <em>future-think<\/em>, with the good stuff always lying just around the corner, but it never occurred to me that a house of cards might tumble if the <em>march of the new<\/em> ever came to an end. So now we&#8217;re <em>illuminating the druggable genome, repurposing existing drugs, building neuro-chips for in vitro assays, <\/em>and <em>revising diagnoses to fit drug effects<\/em> [RDoC] in an attempt to revitalize the previous flow of new treatments.<\/p>\n<p align=\"justify\" class=\"small\">There was another quote in that article about the 2012 Pipeline Summit that has also stayed with me:<\/p>\n<div align=\"justify\" class=\"small\"><em>&ldquo;There are huge unmet clinical needs in mental disorders and addiction. There should be tremendous interest in this area, but there is  not.&rdquo;<\/em>  <\/div>\n<div align=\"right\" class=\"small\"><em>Jeffrey Lieberman in <a href=\"http:\/\/psychnews.psychiatryonline.org\/newsArticle.aspx?articleid=1096598\" target=\"_blank\">APF Convenes Unique Pipeline Summit<\/a>, April 2012<\/em><\/div>\n<p align=\"justify\" class=\"small\">I thought that was an incredibly naive comment. One could say that about a million things in medicine. The comment implies that <em>&quot;if you need it, it will come&quot;<\/em>. Most scientific discovery doesn&#8217;t work that way. It&#8217;s closer to, &quot;<em>don&#8217;t push the river, it runs by itself.<\/em>&quot; There are places where mounting a huge effort in science speeds up the process, but those are areas where there&#8217;s a clear direction, and the task is working out the practical details [Manhattan Project, NASA, Salk Vaccine, DARPA, etc]. Their quest for genuinely new psychopharmacology starts from near zero. And the pharmaceutical industry has a <em>tremendous interest;<\/em> has been at it for years; and just couldn&#8217;t find a thread to pull that lead them anywhere. So whether you agree that <em>new symptomatic CNS drugs<\/em> are a critical national priority or not, the likelihood of locating them [if they indeed exist] may not be enhanced by NCATS, the RDoC, or any other directed research under NIH\/NIMH martial law. In fact, this forced march might squeeze out the guy who would notice something odd on a dirty petri dish [<a href=\"http:\/\/history1900s.about.com\/od\/medicaladvancesissues\/a\/penicillin.htm\" target=\"_blank\">Alexander Fleming Discovers Penicillin<\/a>].  <\/p>\n<div align=\"justify\" class=\"small\">There&#8217;s little to assure us that these efforts are not motivated by some desperate attempt to revitalize and perpetuate the KOL\/PHARMA Camelot that has long past its prime &#8211; another grant-driven effort that will attract the same tired researchers who have haunted the grant-recipient rolls for several decades with little to show for the dollars spent. Frances Collins [Dr. Genome] and Tom Insel [Dr. Clinical Neuroscience] have their fingerprints all over these programs. Isn&#8217;t it about time for them to pass the reins to some new blood whose leadership styles are less controlling and who have a better eye for picking independent and creative scientists to follow and support [rather than direct and micromanage]?<\/div>\n","protected":false},"excerpt":{"rendered":"<p>&ldquo;APA has a role in shaping what future psychiatric practice looks like,&rdquo; Schatzberg stated. &ldquo;More needs to be done now if we are to have new treatments in the next decade for patients with psychiatric disorders.&rdquo; Alan Schatzberg in APF Convenes Unique Pipeline Summit, April 2012 Pipeline and Innovation for Psychotropic Drugs Are Limited, Study [&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-50909","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50909","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=50909"}],"version-history":[{"count":56,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50909\/revisions"}],"predecessor-version":[{"id":51391,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50909\/revisions\/51391"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=50909"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=50909"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=50909"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}