trial 93: a very very bad penny…

Posted on Tuesday 12 July 2011

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…

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…..

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:
In essence, some doctors at his clinic gave Risperidone to some of the maybe 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].

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 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 in what he says.

Then at another time in the deposition he says:
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. 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 about the death of Rebecca Riley he says:

    "Does it disturb you or worry you that many of these medications, most of these medications are being used off-label, and have not been tested in children?" Couric asks Biederman. "Yes. I recognize the fact that we have a gap in knowledge," Biederman says. "But the patients that come to me, and the families in tears and despair with these type of problems, I in good faith cannot tell them, ‘Come back in ten years until we have all the data in hand.’ I still need to use medicines that I am assuming that if they work in adults, with appropriate care and supervision, may also work in children."

While I have some empathy with this feeling, it has nothing to do with bipolar disorder or with Rebecca Riley. So he’s saying this in an interview about a kid who probably wasn’t sick in the first place! Had Rebecca Riley been called Disruptive Behavior Disorder rather than Bipolar, maybe the psychiatrist would’ve insisted on observing the child more and realized that the disease was in the parents – not the child [in tears and despair…].

So that’s why I’ve been so obsessed with Dr. Biederman’s bad penny study. He didn’t do the study, nor write the abstract, he probably didn’t write the article [and one wonders if he’d even read it]. But that aside, he published a study that says he’s using Risperidone because it calms down disturbed, out-of-control kids. That doesn’t make them bipolar. Their symptoms don’t say bipolar. Their response to medications used in bipolar disorder in adults doesn’t say bipolar. So what he did was to join Janssen’s campaign to make it easier to prescribe their drug to kids for behavior control [trial 93: a very bad penny…], whether that’s what he thought he was doing or not.

What difference does it make? It’s huge. I want psychiatrists who see very disruptive kids to have to agonize over every prescription they write for big time medications just like I have to. I want them to be sure about those "tears and dispair." I want them to spend time with the kid. And in those cases that come along where they do use these medicines, I don’t want them to be able to kid themselves that they’re treating some disease that they understand. And I guarantee that they won’t be routinely prescribing Atypical Antipsychotics to children irresponsibly, because justifying that use of medicine in court requires a lot of documentation. You need to be able to prove that the alternatives are worse – short term and long term.

I don’t know if Dr. Biederman is as morally challenged as some of his compatriots on Senator Grassley’s roster. But even if he’s not, he has been a major force in aiding and abetting PHARMA’s campaign to get kids on medications for their annual report’s bottom line without regard for the consequences. If he’s got half the sense he claims to have, he should’ve seen that from day one…
    July 12, 2011 | 6:53 PM

    Thank you for your 2nd toward last paragraph. That got me choked up and I want to thank you on behalf of my daughter, who would be a different person today if doctors did what you say re antipsychotics.

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