{"id":16772,"date":"2011-12-01T17:16:20","date_gmt":"2011-12-01T22:16:20","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=16772"},"modified":"2011-12-01T18:06:37","modified_gmt":"2011-12-01T23:06:37","slug":"wait","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/12\/01\/wait\/","title":{"rendered":"wait…"},"content":{"rendered":"\n

This Latuda® story took some downward turns along the way. It started for me with an article in the American Journal of Psychiatry <\/font><\/strong>[Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study<\/font><\/strong><\/u><\/a>]. When I looked at the FDA approval data, the study that the article reported on looked a lot weaker than it looked in the AJP<\/font><\/strong> [ought to know by now…<\/font><\/em><\/a><\/em><\/strong><\/u>]. Later, I realized that one of the authors was a Vice President of a large Clinical Research Organization – Quintiles [an invisible empire II…<\/font><\/a><\/strong><\/u>]. So I looked again at the back story in more detail [in the shadows…<\/font><\/a><\/strong><\/u>], and it looked even shakier. I thought Quintiles had done the study. After that, I watched an infomercial<\/font><\/strong><\/u><\/a> put out by the manufacturer narrated by the lead author and noticed something that seemed awry [claiming to be the Principle Investigator], so I started looking at the details of the Clinical Trial and found that the study was actually conducted not by Quintiles, but by a Clinical Research Center in Chicago with an extremely checkered past [hiding uptown<\/em>…<\/font><\/strong><\/u><\/a>, hiding uptown<\/em>… [more]<\/font><\/strong><\/u><\/a>].<\/p>\n

There’s a lot to complain about here, and I’ve had my say about some of it in all those posts, but there’s one complaint that gets lost in all the ins and outs of the layers of deceit. I’m neither a muckraker nor an investigative reporter. I’m a doctor, a psychiatrist. And I see patients, some of whom have Schizophrenia, one of the real show-stopping illnesses that afflict human beings. And the next time I see a patient with a Schizophrenic Break whose life and family are in for a time of it [more than they know], I won’t know whether Latuda® would be a good choice for them or not. I read that article and everything that followed in part trying to figure out where the drug fits in the pantheon of antipsychotic medications. And I don’t know the answer.<\/p>\n

In all that reading and hopping around the Internet, I only found one person who seemed to be trying to answer the question, "Is Latuda® a good choice of medication for a Schizophrenic patient?" Her name was Cara Alfaro, Pharm.D.<\/font><\/strong>, the FDA reviewer. Here<\/font><\/strong><\/u><\/a>‘s what she said:<\/div>\n
\n
1.2 Risk Benefit Assessment:
Efficacy has not been established in this NDA submission. The safety profile is more similar to typical antipsychotics with significant akathisia, hyperprolactinemia, parkinsonian-adverse events and dystonias; many of which are dose-related. Lurasidone does not appear to have significant adverse impact on metabolic indices [glucose, lipids, weight, etc.]. Lurasidone may be associated with potentially significant hypersensitivity reactions. A comprehensive risk:benefit assessment is premature at this time.<\/font><\/strong><\/div>\n<\/blockquote>\n
Since she’s the only person in the whole group I trust, I’m going to do what she says – wait, until the next person with some integrity comes along and has something adult to say… <\/div>\n","protected":false},"excerpt":{"rendered":"

This Latuda® story took some downward turns along the way. It started for me with an article in the American Journal of Psychiatry [Lurasidone in the treatment of schizophrenia: a randomized, double-blind, placebo- and olanzapine-controlled study]. When I looked at the FDA approval data, the study that the article reported on looked a lot weaker […]<\/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-16772","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16772","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=16772"}],"version-history":[{"count":11,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16772\/revisions"}],"predecessor-version":[{"id":16786,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/16772\/revisions\/16786"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=16772"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=16772"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=16772"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}