{"id":24456,"date":"2012-06-14T20:01:48","date_gmt":"2012-06-15T00:01:48","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=24456"},"modified":"2012-06-15T11:27:00","modified_gmt":"2012-06-15T15:27:00","slug":"entrpreneurialism-prior-to-investigation","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/06\/14\/entrpreneurialism-prior-to-investigation\/","title":{"rendered":"entrpreneurialism prior to investigation&#8230;"},"content":{"rendered":"\n<p align=\"justify\">A year ago, looking into the personalized medicine craze, I ran across an Australian Group, <a href=\"http:\/\/www.brainresource.com\/\" target=\"_blank\"><strong><font color=\"#660033\">Brain Resource<\/font><\/strong><\/a>, that seemed dead-set on turning the idea into an entrepreneurial block-buster with everything from Brain Training to MRIs. Here&#8217;s founder <strong><font color=\"#660000\">Evian Gordon<\/font><\/strong>, Guru\/Scientist\/Pitchman in a short video [notice the techno-voice, also there when he speaks at the end of the Mayflower Conference below]:<\/p>\n<p align=\"center\"><iframe loading=\"lazy\" width=\"400\" height=\"225\" src=\"http:\/\/www.youtube.com\/embed\/d3rFNCPSfCU?rel=0\" frameborder=\"1\"><\/iframe><\/p>\n<div>Even a year ago, this was no small enterprise with a wealth of products:         <\/div>\n<ul>\n<li><u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/19\/personalized-medicine-brainnet\/\" target=\"_blank\"><font color=\"#200020\">personalized medicine: BRAINnet&hellip;<\/font><\/a><\/strong><\/u><\/li>\n<li><u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/19\/personalized-medicine-the-brain-resources-company\/\" target=\"_blank\"><font color=\"#200020\">personalized medicine: the Brain Resources company I&hellip;<\/font><\/a><\/strong><\/u><\/li>\n<li><u><strong><a href=\"http:\/\/1boringoldman.com\/index.php\/2011\/04\/20\/personalized-medicine-the-brain-resources-company-ii%e2%80%a6\/\" target=\"_blank\"><font color=\"#200020\">personalized medicine: the Brain Resources company II&hellip;<\/font><\/a><\/strong><\/u><\/li>\n<\/ul>\n<div align=\"justify\">They had just done a whirlwind tour of the US [<u><strong><a target=\"_blank\" href=\"http:\/\/brainnet.net\/media\/video_action.php?playfor=brainnet&#038;iframe=true&#038;width=770&#038;height=480\"><font color=\"#660033\">The Mayflower<\/font><\/a><\/strong><\/u>] and recruited some of the usual suspects for their iSPOT study:         <\/p>\n<blockquote>\n<div align=\"center\"><u><strong><a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3036635\/\" target=\"_blank\">International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol<\/a><\/strong><\/u><br \/>                   <sup>    by Leanne M Williams,<strong><font color=\"#200020\"> A John Rush<\/font><\/strong>, Stephen H Koslow, Stephen R  Wisniewski, Nicholas J Cooper, <strong><font color=\"#200020\">Charles B Nemeroff<\/font><\/strong>, <strong><font color=\"#200020\">Alan F Schatzberg<\/font><\/strong>,  and  Evian Gordon<\/sup><br \/>                      <span class=\"citation-abbreviation\"><strong>Trials<\/strong>. <\/span><span class=\"citation-publication-date\">2011; <\/span><span class=\"citation-volume\">12<\/span><span class=\"citation-flpages\">: 4.<\/span>               <\/div>\n<p>        <\/p>\n<div align=\"justify\"><sup><strong>Background<\/strong>: Clinically   useful treatment moderators of Major Depressive Disorder (MDD) have not   yet been identified, though some baseline predictors of treatment   outcome have been proposed. The aim of iSPOT-D is to identify   pretreatment measures that predict or moderate MDD treatment response or   remission to escitalopram, sertraline or venlafaxine; and develop a   model that incorporates multiple predictors and moderators.<\/sup><\/div>\n<div align=\"justify\" class=\"sec\"><sup><strong>Methods\/Design<\/strong>:  The  International Study to Predict Optimized Treatment &ndash; in Depression   (iSPOT-D) is a multi-centre, international, randomized, prospective,   open-label trial&#8230;<\/sup><\/div>\n<div align=\"justify\" class=\"sec\"><sup><strong>Discussion<\/strong>: First   enrollment was in December 2008, and is ongoing. iSPOT-D evaluates   clinical and biological predictors of treatment response in the largest   known sample of MDD collected worldwide.<\/sup><\/div>\n<\/blockquote><\/div>\n<div align=\"justify\">The point is to send people to the lab for tests to select the correct anti-depressant based on some as-yet-to-be-defined profile. We haven&#8217;t heard so much from them of late in the psychiatric literature, but they haven&#8217;t gone away:<\/div>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/community.nasdaq.com\/News\/2012-06\/brrzy-initiating-coverage-of-brain-resource-analyst-blog.aspx?storyid=148178#ixzz1xnKIf0AX\" target=\"_blank\"><u><strong><font color=\"#200020\">BRRZY: Initiating Coverage of Brain Resource &#8211; Analyst Blog<\/font><\/strong><\/u><\/a><br \/>        <strong><font color=\"#200020\">NASDAQ<\/font><\/strong><br \/>       by Zacks Equity Research<br \/>       June 13, 2012<\/div>\n<p>      <\/p>\n<div align=\"justify\"><sup>We have initiated coverage of <strong>Brain Resource<\/strong> [<a href=\"http:\/\/www.nasdaq.com\/symbol\/brrzy\" target=\"_blank\"><u><strong>BRRZY<\/strong><\/u>]<\/a>.&nbsp; See below for access to our full 18-page report on the company which includes our financial model and provides further discussion about the company, their landmark iSPOT trial, current brain health products, market opportunities and growth strategy. Brain Resource is a San Francisco headquartered company focused on improving brain health.&nbsp; The company has established the first and largest standardized and integrated international human brain database which it leverages to provide products for the consumer, employer, and clinical markets.&nbsp; The company notes that their products have benefitted more than 50k end-users and have been utilized by more 30 multi-national corporate employers and hundreds of clinicians and researchers since the company&#8217;s founding over a decade ago. &nbsp; <\/p>\n<p>          Brain Resource has two businesses anchored off the same proprietary technology: Personalized Medicine Diagnostics and Brain Health Solutions. They expect to be the first company to lodge a brain biomarker based diagnostic with the FDA for personalized treatment prediction and also are the first company to penetrate U.S. corporates with a brain health offering.&nbsp; The currently commercialized products include two web-based products, WebNeuro and MyBrainSolutions.&nbsp; WebNeuro, currently used by insurance providers and clinicians, offers objective reports assessing cognitive strengths and weaknesses to help physicians make more informed decisions regarding patient care.&nbsp; Brain Resource notes that WebNeuro currently has more than 250 users and generated almost 11k reports in fiscal 2011 [6\/30\/2011].&nbsp; MyBrainSolutions online brain training, chiefly targeting the corporate employer market, aims to increase employee performance and productivity.&nbsp; Per Brain Resource, MyBrainSolutions has over 50k users and has been accessed more than 300k times.&nbsp; In the company&#8217;s half-year report, they list key goals for 2012\/2013 , including increasing the user base of its products to 1 million users and a five-fold increase of revenue from their web-products [excluding licensing income, web-based revenue was ~$650k in 2011]. &nbsp; <\/p>\n<p>          Brain Resource expects growth in MyBrainSolutions to come from an increase in the number of channel partners and employer clients.&nbsp; Meanwhile, WebNeuro&#8217;s functionality is expected to be substantially enhanced with the inclusion of biomarkers related to depression and ADHD.&nbsp; This will be the catalyst to driving growth of the personalized medicine business, Brain Resource&#8217;s major focus and the area that is expected to be the impetus to the company&#8217;s long-term revenue and earnings growth. Findings from the iSPOT trial will be used to develop these depression and ADHD biomarkers.&nbsp; iSPOT is the world&#8217;s largest clinical trial to predict treatment response in depression and ADHD.&nbsp; iSPOT-D [for depression] has enrolled over 1,700 patients and analysis started on the first 1,000 patients.&nbsp; Data from iSPOT-D was presented at two major U.S. medical conferences during 2011, including an invitation-only presentation at The American Conference of Neuropsychopharmacology in December and more recently formed a panel of presentations at NCDEU in Arizona.&nbsp; iSPOT-A [for ADHD], has enrolled approximately 500 patients to-date.&nbsp; Brain Resource is planning to submit study outcomes to the FDA for approval [likely via PMA] of a depression and an ADHD test in the near-to-mid term [discussions with the FDA regarding the regulatory approval pathway are ongoing]. &nbsp; <\/p>\n<p>          Aside from progress with iSPOT, other recent highlights include the sale of $10MM in convertible bonds to a large institutional investor, Och-Ziff Capital Management, the establishment of a joint-venture for the ADHD product which included a $4MM equity contribution from the JV partner [controlled by Och-Ziff], and an agreement with Aetna whereby the insurer will distribute the company&#8217;s web-products&#8230; <br \/>        <\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">The mixture of pop-psychology, Nemeroff-style neuroscience, media-savvy webinars and slides, invitations to places like ACN and NCDEU, and bit of NASDAQ thrown in on and the side flavored with large dollar figures produces a unique kettle of porridge looking like something from an old futuristic made-for-tv movie. In fact, their <strong><a target=\"_blank\" href=\"http:\/\/brainnet.net\/media\/video_action.php?playfor=brainnet&#038;iframe=true&#038;width=770&#038;height=480\"><font color=\"#660033\">Mayflower Conference<\/font><\/a><\/strong> from 2009 had that same look, with the likes of Jeffrey Lieberman [now APA president-elect], Nemeroff [in the year between Emory and Miami], and Madhukar Trivedi [Dr. Algorithm] strutting their stuff.<\/div>\n<p align=\"justify\"><strong><font color=\"#660033\">iSPOT<\/font><\/strong> purports to be looking for genetic polymorphisms and other markers that will help us choose antidepressants in advance. So, presuming that they find something, you&#8217;ll sign on to a web site to take a battery of tests [proprietary], send in a DNA sample, and get back a report that tells you whether you should take Celexa, Zoloft, or Effexor. I have no clue where the hypothesis that the response to antidepressants is genetic came from, but I&#8217;m betting heavily against any meaningful validity. This idea is also being pursued by Dr. Trivedi in his NIMH funded study, <a href=\"http:\/\/embarc.utsouthwestern.edu\/\" target=\"_blank\"><strong><font color=\"#660033\">EMBARC<\/font><\/strong><\/a>. This all follows the tradition of drug picking schemes that arose in the Clinical Guideline era of the mid-1990s &#8211; the one that produced TMAP and all the other <em>x<\/em>MAP progeny. The movers and shakers for this treatment by algorithm were <strong><font color=\"#660033\">John Rush<\/font><\/strong> and <strong><font color=\"#660033\">Madhukar Trivedi<\/font><\/strong>, then together at UT Southwestern: <strong><font color=\"#200020\">TMAP<\/font><\/strong>,<strong><font color=\"#200020\"> STAR*D, COMED<\/font><\/strong>, <strong><font color=\"#200020\">IMPACTS<\/font><\/strong>,<strong><font color=\"#200020\"> <\/font><\/strong>and now<strong><font color=\"#200020\"> iSPOT <\/font><\/strong>and<strong><font color=\"#200020\"> EMBARC<\/font><\/strong>.<\/p>\n<p align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"450\" height=\"263\" border=\"0\" src=\"http:\/\/1boringoldman.com\/images\/prefer.gif\" \/><\/p>\n<div align=\"justify\">Untold <strong><font color=\"#200020\">Millions<\/font><\/strong> of research dollars, a lot from government sources, have been spent chasing this idea that there&#8217;s some differential in the antidepressant response that can be reaped by sequencing, combining, testing, augmenting, computerizing, etc. <strong><font color=\"#200020\">Billions<\/font><\/strong> have been spent by patients chasing the same goal in private offices as their doctors change them from drug to drug to drug. Certainly, some patients attest to the fact that it took them a while to find the drug that helped, but the search didn&#8217;t come from the research chronicled above. It came from trial and error. And it&#8217;s not going to come from <strong><font color=\"#660033\">iSPOT<\/font><\/strong> or <strong><font color=\"#660033\">EMBARC<\/font><\/strong>, I can predict with high confidence. In fact, I predict a chapter in some future book about this entitled:<\/div>\n<div align=\"center\"><em><strong><font color=\"#330066\">insanity!<\/font><\/strong><\/em><br \/>   <sup><em><strong><font color=\"#330066\">doing the same thing over and over again, expecting different results&#8230;<\/font><\/strong><\/em><\/sup><\/div>\n<p align=\"justify\">So what&#8217;s wrong with all of this? It&#8217;s the kind of thing that has psychiatry in such a tangle right now. It&#8217;s the topic of David Healy&#8217;s book, <strong><font color=\"#990000\">Pharmageddon<\/font><\/strong>. It&#8217;s the infrastructure of Robert Whitaker&#8217;s book, <strong><font color=\"#200020\">Anatomy of an Epidemic<\/font><\/strong>. It&#8217;s the thing that poisoned the <strong><font color=\"#0000cc\">DSM-5 Task Force<\/font><\/strong>. It&#8217;s the reason that Tom Insel needs to be removed as <strong><font color=\"#0033ff\">Director of the National Institute of Mental Health<\/font><\/strong>. And it&#8217;s why my favorite politician is someone who has never had a single political thought that I agreed with [<strong><font color=\"#200020\">Senator Chuck Grassley<\/font><\/strong>]. It&#8217;s <strong><font color=\"#200020\">entrpreneurialism prior to investigation<\/font><\/strong>. It&#8217;s <strong><font color=\"#200020\">hypothesis disguised as fact<\/font><\/strong>. It&#8217;s <strong><font color=\"#200020\">science fiction masquerading as science<\/font><\/strong>.<\/p>\n<div align=\"justify\">I know that the people in St. Louis and Robert Spitzer never intended for this to happen, but it did. I doubt that Abraham Lincoln envisioned the Carpetbaggers that invaded the South after the Civil War. But whether by design or the law of unintended consequences, psychiatry was invaded by Carpetbagger Scientists after the DSM-Revolution and they continue to threaten the whole enterprise. <u><a href=\"http:\/\/www.brainresource.com\/\" target=\"_blank\"><strong><font color=\"#330066\">Brain Resource<\/font><\/strong><\/a><\/u> mixes speculative science with entrpreneurialism, wraps it in a modern media-rich package, and threatens to continue a tradition that needed to be retired long, long ago&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A year ago, looking into the personalized medicine craze, I ran across an Australian Group, Brain Resource, that seemed dead-set on turning the idea into an entrepreneurial block-buster with everything from Brain Training to MRIs. Here&#8217;s founder Evian Gordon, Guru\/Scientist\/Pitchman in a short video [notice the techno-voice, also there when he speaks at the end [&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-24456","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24456","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=24456"}],"version-history":[{"count":35,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24456\/revisions"}],"predecessor-version":[{"id":41720,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/24456\/revisions\/41720"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=24456"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=24456"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=24456"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}