{"id":11446,"date":"2011-07-12T18:24:42","date_gmt":"2011-07-12T22:24:42","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=11446"},"modified":"2012-12-19T09:12:07","modified_gmt":"2012-12-19T14:12:07","slug":"trial-93-a-very-very-bad-penny","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/07\/12\/trial-93-a-very-very-bad-penny\/","title":{"rendered":"trial 93: a very<\/u> very<\/u> bad penny…"},"content":{"rendered":"\n

But if you think about it, what does the result of a Risperidone Trial in disruptive retarded kids have to do with bipolar disorder in children, even if it had shown what they claimed [which it didn’t]? Stay tuned…<\/font><\/em><\/p>\n

My layman’s reading of the clinical trial results of the Risperdal trials in children can be summed up as “Risperdal sedates mentally retarded children better than placebo.” No great mystery there…….No meaningful guidance either….. <\/font><\/em><\/div>\n
Allen<\/font><\/em><\/u><\/a> <\/div>\n

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Dr. Biederman and his associates were well established as the ADHD gurus, but had some interest along the way in childhood mania. How did that background interest make it to the front page? Here’s what he had to say about that in his 2009 deposition, responding to a question about his relationship with Janssen:<\/div>\n
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In essence, some doctors at his clinic gave Risperidone to some of the maybe<\/em> bipolar kids and they responded. At this point, I must interject that the children he was calling bipolar did not have a grandiose, euphoric mood; they did not have an episodic illness; now we hear that their response to the treatments for affective disorder didn’t exacly work. So, to be honest, whoever these kids were, the point is that their response to Risperidone caught the clinic doctors’ attention. I would say of this that the response to medication came first and diagnosis came later [though I’m sure he wouldn’t agree].<\/div>\n

Janssen didn’t bite, so Biederman did a study with Olanzapine in bipolar children. After Janssen failed to get approval for Disruptive Behavior Disorder, they did respond to Biederman – funding his J&J Center for Pediatric Psychopathology Research<\/font><\/strong> in 2002. He paid them back, by my reckoning, by signing on as an author to a a presentation at the 2002 AACAP Meeting [later published in 2006]. It’s the revived old study from a 1998 Trial of Risperidone in Disruptive Retarded kids – the one I’ve been ranting about as the bad penny. Besides the fact that he had nothing to do with that study, that it was ghost-written by Excerptia Medica, and that it had an error that dramatically fudged the results, there was something else to say about it. He was using a study of Disruptive Behavior Disordered kids to say something about the effect of Risperidone on kids with Bipolar Disorder. Did he think they were Manic? He didn’t say that. He just said it was good for symptoms affective and otherwise [best for otherwise]. There’s nothing bipolar specific<\/em> in what he says.<\/p>\n

Then at another time in the deposition he says:<\/div>\n
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Not so common after all, but that’s not my point. He says that people who don’t believe in bipolar disorder in kids use the same treatment, so why not call it bipolar? He’s got that absolutely backwards.<\/font><\/strong> There’s nothing about Risperidone or any Atypical Antipsychotic that has any specificity for bipolar disorder – by his own admission! He published Disruptive Behavior Disorder data himself to justify using Risperidone! Why would he say it’s a better idea to completely rewrite the diagnostic criteria for bipolar disorder so as to include all of these kids? That makes no sense. And then in his interview on 60 Minutes<\/font><\/strong><\/u><\/a> about the death of Rebecca Riley he says: <\/p>\n