part two: the dogma…

Posted on Monday 7 July 2014

Even though we know the long term consequences of using antipsychotics, most psychiatrists think that antipsychotics are helpful in controlling challenging/disruptive/oppositional behavior in intellectually impaired or autistic kids. Tyrer et al call it "Dogma," and that seems right [part one: the bind…]. Why do we think that? For one thing, we’ve seen antipsychotics used in out of control patients – mania, psychosis, the mentally impaired, agitated people of all kinds. It works in those circumstances if you give enough. But we’ve also been told repeatedly that it works in these circumstances with kids. When the first Atypical Antipsychotic [after Clozaril], Risperdal®, was approved, Janssen quickly began a Clinical Trial of the drug in Mental Retardation done by their Risperidone Disruptive Behavior Study Group:
They went for FDA Approval and were turned down. The study was published in 2002:
Here’s the Janssen business plan for 2002 lest you think the didn’t get mileage from that study [trial 93: a very bad penny…]:
    The clinical development program for RISPERDAL has yielded important new efficacy and safety data in the child and adolescent area. These efforts have previously been focused in the area of Disruptive Behavior Disorders and Subaverage IQ. Several trials, RI5-U5A-93 and RI5-CAN- 19 (as well as the open label 48 week follow up trials, USA-97 and CAN-20), initially designed to support filing for an FDA indication, have been completed and have yielded an impressive volume of new efficacy and safety data. Unfortunately, the FDA determined that Disruptive Behavior Disorder lacks the diagnostic specificity necessary to receive an approved indication. Nevertheless, these studies have contributed significantly to the clinical knowledge of RISPERDAL in the child and adolescent population, and provide a basis for ongoing medical education activities… It is expected that the request will include the following requirements:
      • Pediatric PK trial;
      • Adolescent schizophrenia trial; and
      • Pediatric bipolar trial.
    … the child and adolescent market is not driven by diagnosis, but rather by treatment of symptoms such as aggression, agitation, self-injurious behavior, and explosive rage. This lack of consistent diagnosis stems from a reluctance to "label" children at an early age, as well as a fundamental lack of consensus regarding the actual underlying disease states causing this symptomatic behavior. As a result, multiple diagnoses and comorbidities are the rule, rather than the exception in this area. These issues have influenced the clinical development process and limited the ability to achieve an FDA approved indication for RISPERDAL in children…
As it turned out, this focus on symptoms became an industry-wide meme and formed the nidus for the message from the sales reps who visited individual physicians. In the TMAP trial. we heard example after example of the detailing of clinicians who saw a lot of foster children. focusing on symptoms, not diagnosis. But then along came Dr. Joseph Biederman and the Bipolar Child craze. His notion that "super angry/grouchy/cranky irritability" was a symptom of Bipolar Disorder in Children gave broad license to prescribing antipsychotics to a whole new cohort of kids. In a move that seems almost too bizarre for words, that same study mentioned above was repurposed by Excerpta Medica and published under Dr. Biederman’s name as a study about treating these supposed affective symptoms in the newly created unofficial category of the Bipolar Child with Risperdal®:
The point here is that the pharmaceutical industry and particularly Janssen were vigorously detailing the Atypical Antipsychotics as a treatment for disruptive children including the mentally retarded, autistic, Bipolar, and psychotic groups without making much of a diagnostic distinction [bipolar kids: biedermania and super angry/grouchy/cranky irritability…]. They were essentially pushing treating the symptom of being a difficult child with antipsychotics.

My point in this post is that while I’m sure that Tyrer et al’s comment that "Drug treatment has been a mainstay for managing a common syndrome subsumed under the label ‘aggressive challenging behaviour’ since chlorpromazine was first introduced for its treatment over 40 years ago" is true, it was also actively amplified and reinforced during the period of aggressive marketing of the Atypical Antipsychotics. That these antipsychotic drugs are for treating disruptive challenging kids was oozing from every pore of the pharmaceutical companies that manufactured them, and that surely had something to do with that usage becoming "Dogma" – even though it was mostly an off label campaign. And the problem Tyrer et al addresses in their editorial spills over into any disruptive behavior in children – not just in mental retardation.

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