Friday, December 12, 2008

Psychopharmacology and the Evidence: Meeting our New Child Psychiatrist in Chief

UPDATE: The CBHI Provider Conference Call on CANS scheduled for Friday, December 12, 2008, from 12:00 p.m. to 1:00 p.m. has been postponed to January 9, 2009 from 12:00 p.m. to 1:00 p.m.

Much weather in New England today-  the road on which I travel was flooded today, sloowing traffic to a crawl and making me late to Pediatrics Grand Rounds.  Unfortunate, really, as I wanted to hear this one badly.  At UMass, Jean Frazier MD was recently appointed to be the Vice-Chair of Psychiatry and Chief of Child Psychiatry at UMass Medical School.  Her introduction to our Department (Pediatrics, please note) is a talk on the current state of the evidence in the use of atypical antipsychotics in children.  She is a careful researcher, who had one pretty straightforward message for all of us;  while there are a lot of small studies of the use of various atypical antipsychotics in the treatment of bipolar disorder, PDD/autism and early onset schizophrenia, the sample size in general has been small, the outcome measures are limited and that there is not a lot of evidence that the newer agents are really much better than the older medications.  We really need to be doing more studies to understand these medications.  
Her major interest is in the children who are, in the child psychiatry world, the sickest of the sick.  She seemed to be most excited about the TEOSS study,  a study of comparing the use of two of the new drugs(Risperidone and Olanzapine) against one of the first generation of antipsychotics (Molindone) in the treatment of psychosis in children, that was not funded through pharmaceutical funding.  They looked at medication impact, medication side effects and tolerance of long term treatment using a multi-arm randomized controlled trial.  They managed to enroll 119 patients, the largest non-pharma study of these really sick children.  They had lots of weight gain, particularly with olanzipine (Zyprexa), some akanthisa (restless leg syndrome) and elevation in prolaction. The medications are fairly similar treatment outcomes in all three agents .  (molindone: 50%; olanzapine: 34%; risperidone: 46%)   Her main conclusion with that none of these medications were the silver bullet and that these children are very sick, and that careful evaluation of side effects is at least as important as treating the symptoms.   This is the quality of research is really encouraging to see;  she seems a careful prescriber who is acutely aware of how our understanding of psychopharmocology needs to evolve over the next few years.

For clinical practice, she pointed out that, for most of us, we will never see a child with early-onset schizophrenia, and that, in the use of the second-generation antipsychotics for bipolar disorder, it is not clear that high doses of the medication are better.  She is concerned that we are creating a bit of public health problem, as weight gain and even metabolic syndrome, can happen within the treatment.  She urged us to monitor lipids, glucose and hemoglobin A1C, and really push the use of exercise.

One thing I did notice in her compilation of data:  the pharmaceutical industry does not do head to head comparisons of new medications with the older medications-  they will only fund comparisons with a placebo arm.  What is wrong with this, you may ask?  It makes it harder to do detailed comparisons of the relative advantages and disadvantages of the newer and the older (read generic and less costly) medications.  It seems to me, after listening to Dr. Frazier, that one thing that we could do in the government to lessen the "pro-pharma" bias of studies is to create regulations within the FDA that require such studies as a condition of approval.  Probably not as easy as it sounds, but worth pursuing.

It will be nice to have a researcher of this caliber in our midst.

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