{"id":27292,"date":"2012-09-13T11:31:49","date_gmt":"2012-09-13T15:31:49","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=27292"},"modified":"2012-09-13T11:37:10","modified_gmt":"2012-09-13T15:37:10","slug":"eyes-wide-shut-open-iv","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/09\/13\/eyes-wide-shut-open-iv\/","title":{"rendered":"eyes wide <strike>shut<\/strike> open IV&#8230;"},"content":{"rendered":"<p align=\"justify\">In the last post, I compared several graphs from the same study [X065 Lilly]. If, however, you look over the&nbsp; <a href=\"http:\/\/www.lillytrials.com\/\" target=\"_blank\"><u><strong><font color=\"#200020\">whole report<\/font><\/strong><\/u><\/a> for study X065, the graphs and the tables don&#8217;t match. My point is not to debunk the article. I can&#8217;t really do that because there are so many conflicting sources of information on the same study. My point is that looking over the article itself and all of the information on their Clinical Trials site doesn&#8217;t resolve anything for me. It leaves me in the dark. Do I believe the tables? Which graph gives a true representation of the information? I can&#8217;t know the answer to those questions. As a clinician, my question&nbsp; is digital. Should I recommend that the depressed adolescent sitting in front of me try Prozac to relieve his\/her depressive symptoms? Would I give it to my own child were she depressed? <\/p>\n<div align=\"justify\">And, by the way, who funded the study? The article says &#8211;<\/div>\n<ul>\n<div align=\"justify\"><sup>This study was supported by grants MH-39188 (Dr. Emslie) and MH-41115 (Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas) from the National Institute of Mental Health, National Institutes of Health, Bethesda, Md.<\/sup><\/div>\n<\/ul>\n<div align=\"justify\">&#8211; yet it is included on the Lilly Clinical Trial site as a Lilly Clinical Trial and was submitted to the FDA as a Lilly Trial. It was done between 1991 and 1994, and was not registered on ClinicalTrials.gov [which came into being in 1997]. This is the <a target=\"_blank\" href=\"http:\/\/en.wikipedia.org\/wiki\/ClinicalTrials.gov\"><u><strong><font color=\"#0066ff\">Wikipedia<\/font><\/strong><\/u><\/a> version of the history of ClinicalTrials.gov:<\/div>\n<blockquote>\n<div align=\"justify\"><sup>As a result of pressure from HIV-infected men in the gay community,  who demanded better access to clinical trials, the U.S. Congress passed  the Health Omnibus Programs Extension Act of 1988 (HOPE or <span class=\"external text\">Public Law 100-607<\/span>) which mandated the development of a database of AIDS Clinical Trials Information System (<span class=\"external text\">ACTIS<\/span>).  This effort served as an example of what might be done to improve  public access to clinical trials, and motivated other disease-related  interest groups to push for something similar for all diseases. The Food and Drug Administration Modernization Act of 1997 (FDAMA or <span class=\"external text\">Public Act 105-115<\/span>)  amended the Food, Drug and Cosmetic Act and the Public Health Service  Act to require that the NIH create and operate a public information  resource, which came to be called ClinicalTrials.gov, tracking drug  efficacy studies resulting from approved Investigational New Drug (IND)  applications (<span class=\"external text\">FDA Regulations 21 CFR Parts 312 and 812<\/span>).  With the primary purpose of improving access of the public to clinical  trials where individuals with serious diseases and conditions might find  experimental treatments, this law required information about:<\/sup><\/div>\n<ol><sup>      <\/p>\n<li>\n<div align=\"justify\">Federally and privately funded clinical trials;<\/div>\n<\/li>\n<li>\n<div align=\"justify\">The purpose of each experimental drug;<\/div>\n<\/li>\n<li>\n<div align=\"justify\">Subject eligibility criteria to participate in the clinical trial;<\/div>\n<\/li>\n<li>\n<div align=\"justify\">The location of clinical trial sites being used for a study; and<\/div>\n<\/li>\n<li>\n<div align=\"justify\">A point of contact for patients interested in enrolling in the trial.<\/div>\n<\/li>\n<p>      <\/sup><\/ol>\n<div align=\"justify\"><sup>The National Library of Medicine in the National Institutes of Health  made ClinicalTrials.gov available to the public via the Internet on  February 29, 2000.  In this initial release, ClinicalTrials.gov primarily included  information about NIH-sponsored trials, omitting the majority of  clinical trials being performed by private industry. On March 29, 2000  the FDA issued a Draft Guidance called <span class=\"external text\">Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank<\/span> and put into In) with the hope that this would increase use by industry. After <span class=\"external text\">a second draft guidance<\/span> was released in June 2001, a final guidance was issued on March 18, 2002 titled <span class=\"external text\">Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions<\/span>. The <span class=\"external text\">Best Pharmaceuticals for Children Act of 2004<\/span> (BPCA or <span class=\"external text\">Public Law 107-109<\/span> amended the Public Health Service Act to require that additional information be included in ClinicalTrials.gov. As the result of toxicity tracking concerns raised following  retraction of several drugs from the prescription market,  ClinicalTrials.gov was further reinforced by the Food and Drug Administration Amendments Act of 2007 (FDAAA or <span class=\"external text\">U.S. Public Law 110-85<\/span>) which mandated the expansion of ClinicalTrials.gov for better tracking of the basic results of clinical trials, requiring:<\/sup><\/div>\n<ul><sup>      <\/p>\n<li>\n<div align=\"justify\">Data elements that facilitate disclosure, as required by the FDAAA, as well as operations of ClinicalTrials.gov; and<\/div>\n<\/li>\n<li>\n<div align=\"justify\">&quot;Basic results&quot; reporting.<\/div>\n<\/li>\n<p>    <\/sup><\/ul>\n<\/blockquote>\n<div align=\"justify\"><strong><font color=\"#200020\">ClinicalTrials.gov<\/font><\/strong> has been with us for 15 years. It&#8217;s a very good thing, though the Results Database is woefully unenforced at present. Properly used, it would resolve issues like Study X065 above. Hopefully <strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2012\/09\/08\/the-test-act\/\"><u><font color=\"#200020\">the TEST Act&hellip;<\/font><\/u><\/a><\/strong> will add in some teeth and help put a stop to the deliberate confusion. While I would personally prefer subject level data like that belatedly provided by GSK [<a target=\"_blank\" href=\"http:\/\/www.gsk.com\/media\/paroxetine.htm\"><u><strong><font color=\"#ff4400\">Paroxetine and pediatric and adolescent patients<\/font><\/strong><\/u><\/a>] for their Paxil studies, the current version in ClinicalTrials.gov would certainly be an improvement. Likewise, I&#8217;d like to see results publicly available prior to publication or FDA Approval, if feasible. But I&#8217;m not complaining. Anything would be better than what we have!  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>In the last post, I compared several graphs from the same study [X065 Lilly]. If, however, you look over the&nbsp; whole report for study X065, the graphs and the tables don&#8217;t match. My point is not to debunk the article. I can&#8217;t really do that because there are so many conflicting sources of information on [&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-27292","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/27292","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=27292"}],"version-history":[{"count":9,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/27292\/revisions"}],"predecessor-version":[{"id":27301,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/27292\/revisions\/27301"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=27292"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=27292"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=27292"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}