{"id":47016,"date":"2014-06-09T20:24:30","date_gmt":"2014-06-10T00:24:30","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47016"},"modified":"2014-06-09T20:27:04","modified_gmt":"2014-06-10T00:27:04","slug":"the-wrong-compromise","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/06\/09\/the-wrong-compromise\/","title":{"rendered":"the wrong compromise…"},"content":{"rendered":"\n

Well, I didn’t know it when I wrote in the details…<\/a> and achilles’ heel…<\/a>, but I wanted to end with a conclusion before talking about the current controversies. It might be presumptuous of me to sound off about such things being just a retired doctor, but the Clinical Trials world has gotten itself in such a tangle, maybe as many outside views as can be mustered are a good thing. One part of this story that jumps off the page is how many attempts at reform have failed to rectify the many problems – things like ignoring reporting on clinicaltrials.gov. In fact, there are so many problems that a virtual cottage industry of technologies has developed to ferret them out. The state of play right now is a chess game between commercial and medicinal interests, both in terms of efficacy and of adverse effects – the Scylla and Charybdis of any medication.
<\/span><\/p>\n

My own thinking has hardened the more I’ve read actual Clinical Trials. The blinded part of the procedure is rigidly defined, but after the blind is broken, things become frazzled<\/font><\/strong>. The Results<\/font><\/strong><\/u> section of a published paper should be predetermined by the a priori<\/em> protocol-defined primary and secondary variables, as determined by the IPDs and CRFs prepared before the blind is broken, and analyzed as specified by the protocol. Creativity is not an invited guest. Anything less than this has no place in a scientific journal. We wouldn’t allow the kind of manipulation of data happening every day in our medical journals to go on with the O-Rings on our spacecraft or the brake systems in our cars, why should we do it with medications? There would be a lot fewer medications on the market and patients would be prescribed or take many fewer pills. The impact on the pharmaceutical industry as it now exists would be massive. Not a problem for science to deal with. Many patients and doctors are willing to operate with difficult Risk\/Benefit ratios in the face of dire medical illness, and that’s their prerogative. Even under those circumstances, they need accurate information to make those decisions.<\/p>\n

I’m afraid that I can’t get away from the idea that the manufacturers have no real seat at the table when the topic is the truth about the outcome of Clinical Trials. They just haven’t earned that right. By allowing this kind of sheenanigans to go on, we have elevated the Patent Medicines of old to the realm of scientifically approved therapeutics. While I agree that too much emphasis is placed on short-term Clinical Trials in the first place, that’s where we are right now and that’s what we need to clean up first. Since we know that the majority of the misinformation comes from either manipulating or suppressing the analysis that follows the unblinding of the data<\/font><\/strong>, the solution of full raw Data Transparency is a good one – allowing independent analysis of the results. But another solution would be to insist on independent analysis from the start. Since Adverse Effects are the weakest link in this process, they deserve special attention to insure accurate coding. If rigidly controlled outcome reporting makes drug development and manufacturing unprofitable, we’ll just have to find another approach to scientific therapeutics. We are under no obligation to support the pharmaceutical industry as it exists today.<\/p>\n

We’ve just made the wrong compromise…<\/div>\n","protected":false},"excerpt":{"rendered":"

Well, I didn’t know it when I wrote in the details… and achilles’ heel…, but I wanted to end with a conclusion before talking about the current controversies. It might be presumptuous of me to sound off about such things being just a retired doctor, but the Clinical Trials world has gotten itself in such […]<\/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":[2],"tags":[],"class_list":["post-47016","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47016","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=47016"}],"version-history":[{"count":12,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47016\/revisions"}],"predecessor-version":[{"id":47028,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47016\/revisions\/47028"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}