{"id":68335,"date":"2016-09-30T14:20:06","date_gmt":"2016-09-30T18:20:06","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=68335"},"modified":"2016-09-30T16:06:35","modified_gmt":"2016-09-30T20:06:35","slug":"the-petition-networkthe-movie-version","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/09\/30\/the-petition-networkthe-movie-version\/","title":{"rendered":"the petition – NETWORKthe movie<\/sub><\/em> version…"},"content":{"rendered":"\n

I’ve heard from several people that they’re not sure exactly what we’re asking Congress to do. Our narrative is long because it coveres many bases. Here’s the short version. We want Congress to mandate that the FDA talk to us directly through clinicaltrials.gov about the clinical trials of FDA regulated drugs. The drug and device manufacturers have created a whole fabulist industry that fills our journals with articles about clinical trials that are often\/usually inaccurate and used as marketing tools. Meanwhile the FDA, the only kid on the block that can actually see the data in the raw, watches all of this happening but does nothing. The public interface designed to give us an alternative to these journal articles, the NIH’s clinicaltrials.gov, has withered from disuse atrophy because nobody populates it on time [if at all] or checks up on it.<\/p>\n

We’re proposing that Congress give us an alternative to the jury-rigged articles published by industry in our journals. All the pieces to create that alternative system are already in existence. The NIH’s clinicaltrials.gov is a well designed system for telling us what we need to know. The FDA has access to all of the information about the clinical trials on FDA regulated drugs, submitted in applications for approval. If it’s not all there, they can suspend action until they get it. So we are asking Congress to make the NIH clinicaltrials.gov<\/font><\/em> the official interface between the FDA<\/font><\/em> and the physicians\/patients who need to know about these clinical trials. <\/p>\n

Clinical Trials reduce down to a simple process: <\/div>\n
    <\/p>\n
  • \n
    Create a Protocol that  defines the target population, the intervention(s) to be tested, and define the PRIMARY and SECONDARY OUTCOME  PARAMETERS and how they will be analyzed BEFORE the study begins. <\/div>\n<\/li>\n
  • \n
    Then do the study. <\/div>\n<\/li>\n
  • \n
    Perform the a priori<\/em> defined analyses on the a priori<\/em> defined PRIMARY and SECONDARY OUTCOME PARAMETERS [a priori<\/em> means BEFORE anyone gives the first subject the first pill]. <\/div>\n<\/li>\n
  • \n
    Display the RESULTS.<\/div>\n<\/li>\n

    <\/font><\/sup><\/ul>\n

    That’s what the FDA does and that’s what we all need to see. Our proposal asks Congress to mandate<\/font><\/em> that the FDA actively provide that information to us all along the way through the NIH interface clinicaltrials.gov.<\/div>\n

    We want the FDA to actively check that the original REGISTRATION on clinicaltrials.gov is filed before the study starts, that the PRIMARY and SECONDARY OUTCOME PARAMETERS and how they will be analyzed are clearly specified, and that the version on clinicaltrials.gov is the same as the version filed with the FDA [NDA and PMA trials]. We want the FDA to post a notice on clinicaltrials.gov that this has been done.<\/p>\n

    We want the same thing with the RESULTS. We want the FDA to actively check that the results are posted on clinicaltrials.gov for every trial submitted to the FDA at the time of submission. We want the FDA to insure that those results on clinicaltrials.gov are the same as those in the FDA analysis [the a priori<\/em> defined analysis of the a priori<\/em> defined the PRIMARY and SECONDARY OUTCOME PARAMETERS]. We want the FDA to post a notice on clinicaltrials.gov that this has been done.<\/p>\n

    The sponsors of these clinical trials have so far succeeded in their bizarre claim that the clinical trial data is proprietary. But they can’t claim that that’s true of their version of the results. These are FDA regulated drugs and those results are part of the regulatory process. While the FDA has no jurisdiction over journal articles, if the articles misrepresent the FDA certified results or include other parameters or analyses without clearly annotating them as non-protocol results, the FDA should have the injunction to act [false advertising]. <\/p>\n

    There’s more, but that’s enough. You get the drift. If the sponsors of these trials and the journals they publish in can’t give us accurate scientific reports on these crucial clinical trials, we are petitionong Congress to mandate that the FDA provide  it to us – <\/font>by law<\/em><\/font><\/strong>. Like many of you, we’re as… <\/font><\/p>\n

    … mad as hell and we’re not going to take it anymore! <\/font><\/strong><\/p>\n

    <\/div>\n
    …either! <\/font><\/div>\n","protected":false},"excerpt":{"rendered":"

    I’ve heard from several people that they’re not sure exactly what we’re asking Congress to do. Our narrative is long because it coveres many bases. Here’s the short version. We want Congress to mandate that the FDA talk to us directly through clinicaltrials.gov about the clinical trials of FDA regulated drugs. The drug and device […]<\/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-68335","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/68335","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=68335"}],"version-history":[{"count":17,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/68335\/revisions"}],"predecessor-version":[{"id":68352,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/68335\/revisions\/68352"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=68335"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=68335"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=68335"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}