{"id":59735,"date":"2015-09-05T14:26:57","date_gmt":"2015-09-05T18:26:57","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=59735"},"modified":"2015-09-05T15:18:39","modified_gmt":"2015-09-05T19:18:39","slug":"the-growing-cry","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/09\/05\/the-growing-cry\/","title":{"rendered":"the growing cry&#8230;"},"content":{"rendered":"\n<ul>\n<div><sup><strong><font color=\"#200020\">em&middot;bar&middot;go<\/font><\/strong><\/sup><\/div>\n<div><sup><em>noun<\/em><\/sup><\/div>\n<ol><sup>   <\/sup><sup>     <\/p>\n<li>\n<div align=\"justify\">an official ban on trade or other commercial activity with a particular country.<\/div>\n<div align=\"justify\">&quot;an <strong>embargo on<\/strong> grain sales&quot;<\/div>\n<\/li>\n<p>     <\/sup><sup>   <\/sup><\/ol>\n<div><sup><em>verb<\/em><\/sup><\/div>\n<ol><sup>   <\/sup><sup>     <\/p>\n<li>\n<div align=\"justify\">impose an official ban on (trade or a country or commodity).<\/div>\n<div align=\"justify\">&quot;the country has been virtually <strong>embargo<\/strong>ed by most of the noncommunist world&quot;<\/div>\n<\/li>\n<p>     <\/sup><sup>     <\/sup><sup>     <\/p>\n<li>\n<div>seize (a ship or goods) for state service.<\/div>\n<\/li>\n<p>     <\/sup><sup>   <\/sup><\/ol>\n<\/ul>\n<div align=\"justify\" class=\"small\"><img loading=\"lazy\" decoding=\"async\" width=\"72\" border=\"0\" hspace=\"4\" height=\"72\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/embargo.gif\" \/>The video in the last post [<a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2015\/09\/04\/background-music\/\">background music&hellip;<\/a>] is of a talk Dr. Healy gave exactly a year ago when we first submitted our RIAT article about Paxil Study 329 to the <strong><font color=\"#0033ff\">British Medical Journal<\/font><\/strong> [BMJ]. If you watched it, you know that it&#8217;s a historical review of the Clinical Trial and the article that appeared in the <strong><font color=\"#aa3300\">Journal of the American Academy of Child and Adolescent Psychiatry<\/font><\/strong> [JAACAP] in 2001. Notice that he doesn&#8217;t talk directly about what we said in our article which is a second look at the data from that study. That&#8217;s because like most academic journals, the BMJ requests an <font color=\"#200020\">embargo<\/font> on discussing an article submitted for publication until it is either rejected or actually published. I hasten to add that this kind of <font color=\"#200020\">embargo<\/font> makes perfect sense to me for any number of reasons. So I&#8217;m not complaining.<\/div>\n<p align=\"justify\" class=\"small\"><img decoding=\"async\" border=\"0\" hspace=\"4\" height=\"50\" align=\"left\" src=\"http:\/\/1boringoldman.com\/images\/embargo-1.gif\" \/>But even though I understand and even approve of the <font color=\"#200020\">embargo<\/font>, that doesn&#8217;t mean that I enjoy waiting for publication to talk about our paper. I&#8217;ve been thinking about that Keller et al article for five years now, and actively working on our RIAT paper for two years. So it&#8217;s hard to think about much else these last several weeks [as in my recent posts are monotonous, mostly about RCTs]. But I&#8217;ll have to admit that the wait has had something of a positive effect in that it has focused my thinking onto an important topic. You guessed it &#8211; the topic is <font color=\"#200020\">embargo<\/font>s &#8211; and specifically on the pharmaceutical industry&#8217;s <font color=\"#200020\">embargo<\/font> on the primary data from their Clinical Trials.<\/p>\n<div align=\"justify\" class=\"small\">Since I was a late<strong><font color=\"#200020\">&middot;<\/font><\/strong>comer to the ways of Clinical Trials, it took me a while to catch up. After looking at more RCTs than I&#8217;d like to admit, I realized that they were a big problem. And I was frustrated that I couldn&#8217;t get at the actual data, but I assumed that industry&#8217;s <font color=\"#200020\">embargo<\/font> was something that was backed up by some Law or Act. But that wasn&#8217;t slightly right [<a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/10\/repeal-the-proprietary-data-act\/\">repeal the proprietary data act&hellip;<\/a>, <a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/11\/except-where-necessary-to-protect-the-public\/\">except where necessary to protect the public&hellip;<\/a>]. They keep the data from RCTs secret because they want to, not because they have a legal right to. It&#8217;s an <font color=\"#200020\">embargo<\/font> like our <font color=\"#200020\">embargo<\/font> on trade with Cuba or Iran, a power play designed to force a desired outcome. What desired outcome? To make us accept the version presented in some published [often deceitfully written] article in a journal. And now that I&#8217;m thinking about it, I&#8217;m not sure that <font color=\"#200020\">embargo<\/font> is the right maritime metaphor for their keeping the actual data secret. Maybe &#8230;   <\/div>\n<ul>\n<div><sup><strong><font color=\"#200020\">block&middot;ade<\/font><\/strong><\/sup><\/div>\n<div><sup><em>noun<\/em><\/sup><\/div>\n<ol><sup><\/p>\n<li>\n<div align=\"justify\">an act or means of sealing off a place to prevent goods or people from entering or leaving.<\/div>\n<div align=\"justify\">&quot;there was a <strong>blockade<\/strong> of humanitarian aid&quot;<\/div>\n<\/li>\n<p><\/sup><\/ol>\n<div><sup><em>verb<\/em><\/sup><\/div>\n<ol><sup>    <\/p>\n<li>\n<div>seal off (a place) to prevent goods or people from entering or leaving.<\/div>\n<div align=\"justify\">&quot;Blackbeard <strong>blockade<\/strong>d the Charleston Harbor&quot;<\/div>\n<\/li>\n<p>     <\/sup><\/ol>\n<\/ul>\n<div align=\"center\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" border=\"0\" height=\"163\" src=\"http:\/\/1boringoldman.com\/images\/blockade.gif\" alt=\"Blackbeard's blockade of the Charleston Harbor\" title=\"Blackbeard's blockade of the Charleston Harbor\" \/><\/div>\n<div align=\"justify\" class=\"small\">&#8230; would be a more accurate choice of terms. And what makes it worse, the regulatory agencies [<strong>FDA<\/strong>, <strong>EMA<\/strong>] have been enforcers of the <font color=\"#200020\">blockade<\/font> that keeps us from being able to examine the data for ourselves. Medicine is traditionally self-regulating. How can we do that if we can&#8217;t see the data? <img decoding=\"async\" width=\"90\" vspace=\"4\" border=\"0\" hspace=\"4\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/blockade-1.jpg\" \/>And so our article is about more than bringing the data from one Clinical Trial out into the daylight. It&#8217;s an example of what can be learned in general from the examination of the raw data when conducted by people who don&#8217;t work for the company [that&#8217;s us] &#8211; who don&#8217;t have the kinds of conflicts of interest that are ubiquitous in these Industry funded RCTs [that&#8217;s us too]. The goal is, of course, to add our voices to the growing cry to make the actual <font color=\"#200020\">raw data<\/font> available for every Clinical Trial&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>em&middot;bar&middot;go noun an official ban on trade or other commercial activity with a particular country. &quot;an embargo on grain sales&quot; verb impose an official ban on (trade or a country or commodity). &quot;the country has been virtually embargoed by most of the noncommunist world&quot; seize (a ship or goods) for state service. The video in [&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":[5],"tags":[],"class_list":["post-59735","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/59735","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=59735"}],"version-history":[{"count":33,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/59735\/revisions"}],"predecessor-version":[{"id":59768,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/59735\/revisions\/59768"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=59735"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=59735"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=59735"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}