{"id":64299,"date":"2016-03-29T15:29:10","date_gmt":"2016-03-29T19:29:10","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=64299"},"modified":"2016-03-29T15:39:49","modified_gmt":"2016-03-29T19:39:49","slug":"a-parable","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/03\/29\/a-parable\/","title":{"rendered":"a parable…"},"content":{"rendered":"\n

A month ago I ran across a MEDPAGE<\/font> TODAY<\/font><\/strong><\/a> article about Vortioxetine<\/font> [Brintellix®<\/em><\/font>] and a hearing at the FDA [see indications…<\/a> and more vortioxetine story…<\/a>]. Brintellix®<\/em><\/font> had been approved by the FDA for use in Major Depressive Disorder in September of 2014. I  had previously run across it through a review article<\/a> in the Journal of Clinical Psychiatry<\/font> in December 2014 – a ghost-written garbled affair with multiple KOL guest authors [see the recommendation?…<\/a>]. It seems that the manufacturers [Takeda and Lundbeck<\/font>] had been planning for years to try to get it approved for treating the Cognitive Dysfuntion in Major Depressive Disorder<\/font>. That would be a new category for FDA Approval and would’ve become a strong selling point for this late-coming antidepressant. I found a recent article by Lisa Cosgrove et al who had done a case study of this particular drug and its approval process [Under the Influence: the Interplay among Industry, Publishing, and Drug Regulation<\/a>] that contained the results of both published and unpublished trials showing that in comparator studies, Brintellix®<\/em><\/font> had uniformly come up short. And I later read a blog on George Dawson’s Real Psychiatry<\/font> [Vortioxetine<\/a>] about it.<\/p>\n

The FDA originally looked unfavorably on approving Brintellix®<\/em><\/font> for Cognitive Dysfuntion in Major Depressive Disorder<\/font>, seeing it as an example of pseudospecificity<\/font><\/em>. But the manufacturers kept coming. In February 2015, there was a Workshop at the Institute of Medicine entitled Enabling Discovery, Development, and Translation of Treatments for Cognitive Dysfunction in Depression: A Workshop<\/a> moderated by Tom Insel [NIMH] and Thomas Laughren [formerly FDA’s director of psychiatry products]. After the workshop, the FDA agreed to reconsider, but only in a public hearing with an independent advisory committee. That happened on Feb 3, 2016 [2016 Meeting Materials, Psychopharmacologic Drugs Advisory Committee<\/a>]. It was an elaborate all day affair with presenters from all parties concerned. At the end of the day, the FDA Advisory Committee voted 8:2 in favor of recommending Approval. When I looked at the papers and the presentations, I disagreed. My reasons are cataloged in my second blog [more vortioxetine story…<\/a>]:<\/div>\n