{"id":54998,"date":"2015-03-08T14:02:11","date_gmt":"2015-03-08T18:02:11","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=54998"},"modified":"2015-03-08T14:41:00","modified_gmt":"2015-03-08T18:41:00","slug":"a-crying-shame","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/03\/08\/a-crying-shame\/","title":{"rendered":"a crying shame…"},"content":{"rendered":"
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I was pleased to get responses to that old feeling…<\/a> and impossibility…<\/a><\/a>. In the end, Medicine and Psychiatry are clinical sciences and these are the kinds of topics we need to hear about and pass on – a withdrawal syndrome and a not so benign treatment. This morning, this was in my email in-box, and the bold, underlined title of this Free CME<\/font><\/em> [Continuing Medical Education<\/font>] credited activity<\/em>, Adherence, Recovery, and the Role of LAIs in Schizophrenia<\/font><\/strong><\/u> caught my eye. I’ve learned that the most important thing on the page is usually the smallest, but it didn’t bring anything to mind:<\/div>\n
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It wasn’t that hard to figure it out. A year ago, the FDA approved Abilify Maintena®<\/a>, a Long Acting Injectable [LAI] version of Aripiprazole<\/font> [see here<\/a>] [speaking of small print, "Otsuka" is at the very bottom of the page]. The study leading up to FDA approval is pretty much as expected for an industry-funded Clinical Trial [Otsuka]:<\/div>\n
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Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study<\/a>.<\/div>\n
by Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, and Kane JM.<\/font><\/strong><\/div>\n
British Journal of Psychiatry.<\/font><\/strong> 2014 205[2]:135-44.<\/div>\n
[clinicaltrials.gov: NCT00706654<\/a>][with results<\/a>]<\/div>\n
[full text on-line<\/a>]<\/div>\n<\/blockquote>\n
They took patients stabilized on oral Abilify® and then divided them into three group: Oral Abilify®, Abilify Maintena® therapeutic dose, and Abilify Maintena® homeopathic dose. Abilify Maintena® was non-inferior to [the same as] Oral Abilify®:<\/div>\n

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The authors in red<\/font><\/strong> are either heavily industry-funded by or employees of Otsuka, The Study Director was Otsuka employee, Raymond Sanchez. There were 98<\/font><\/strong> clinical trial sites, and an army of editorial assistants and consultants suggesting that it was ghost-written and ghost-analyzed. The senior listed author, John Kane<\/a>, is in charge of the influential ACA funded NIMH RAISE<\/a> study of the treatment of First Episode Schizophrenia. This study analysis seemed legit to me. <\/p>\n

Except for the fact that the industry credits scrolled by like at the end of a Hollywood Blockbuster, and I kind of wonder why the industries were mostly for-hire<\/em> or why they even bother to list academic authors as anything other than ticket holders for admission to an academic journal, my point really isn’t about Abilify Maintena® or even Long Acting Injectable<\/font> antipsychotics. It’s about advertisement and conflicts of interest. Continuing Medical Education<\/font><\/strong> was made a requirement for licensure in my medical lifetime. The intent was to insure that as doctors age, they are kept abreast of the rapidly changing medical\/scientific landscape. And our peer reviewed medical journals perform the same function. Traditionally, individual physicians paid for both – CME presentations and our Journals. But sometimes they are free<\/em>… <\/p>\n

So last time, we had an LAI paper from an author at the Rand Corporation on the Janssen payroll [impossibility…<\/a>]. Now comes a Free CME<\/font><\/em> that was "supported by an independent educational grant from Otsuka America Pharmaceuticals, Inc<\/font>", who happen to have a new LAI on the market [Abilify Maintena®], approved by the FDA based on an industry study with senior author John Kane, who happens to be funded himself by Otsuka, who happens to direct an NIMH Project treating Schizophrenia being picked up<\/a> already by SAMHSA’s Block Grant program, who happens to write about the drugs used to treat Schizophrenia<\/a>, and who was skeptical about Tardive Dyskinesia<\/a> as far back as 1982.<\/p>\n

So we wonder who is on the faculty of this Free CME<\/font><\/em>?  So I clicked on the link to Adherence, Recovery, and the Role of LAIs in Schizophrenia<\/a>:<\/div>\n
Faculty<\/font><\/strong><\/div>\n