A letter to the editor in today’s The Boston Globe by Janet Wozniak suggests that since the U.S. Food and Drug Administration (FDA) approved the use of two atypical antipsychotic medications last year for pediatric bipolar disorder, it is proof the disorder exists:
The FDA approvals of Risperdal and Abilify for this purpose not only suggest that at the proper dose, these atypical antipsychotic medications are safe and effective for use as indicated, but affirm that the FDA accepts the validity of pediatric bipolar disorder and the need to treat it.
Tortured circular logic notwithstanding, the writer — the director of (surprise, surprise!) the pediatric bipolar disorder program at Mass. General — knows that the FDA is not any kind of scientific arbiter of research into diagnoses.
The FDA has for decades widely accepted that there may be childhood versions of adult disorders (and adult versions for childhood disorders, most famously attention deficit disorder). Nobody has denied that there may indeed by a childhood version of bipolar disorder, only that the criteria to meet such a disorder are not widely accepted nor official. And therefore, prescribing these medications, while FDA-allowed, doesn’t mean we automatically should. Especially since there have been zero long-term studies conducted on teens or children with these medications. Children and teens, as the writer knows, are more susceptible to anything that might negatively impact their still-developing brains. Can the writer say with 100% certainty that these drugs, when given to a teen, won’t cause some cognitive or memory issue 10 years from now? No, and neither can anyone else.
When patients suffer, and available treatments are lacking, it is the job of experts to innovate and explore new options for hope. The approval of these drugs in children has followed the conventional and widely accepted path that begins with observations in a limited number of patients followed by small but systematic observational studies that are then validated by large, controlled trials.
According to the FDA, however, the latter is not entirely true for Risperdal’s approval:
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
That study included just 169 teenage subjects (not the 400 alluded to in Janssen’s press release on the approval; the additional subjects come from other studies submitted as proof of its effectiveness but that the FDA did not consider). The other studies were all open-label studies, meaning everybody knew they were receiving an active medication.
So the reality is that it only takes a medium-sized trial of 169 subjects for all of 3 weeks to get additional approvals from the FDA for a drug. Hardly overwhelming evidence.
The letter was in response to Arnold S. Relman’s op-ed 2 weeks ago which was commenting upon the alleged inappropriate pharmaceutical payments made to 3 prominent psychiatrists at Mass. General (which just also happens to be Janet Wozniak’s institution… coincidence?).
The fact is, pediatric bipolar disorder is not officially recognized by the only diagnostic system in use in the U.S. today, and its inclusion in the next revision of the system is not at all clear. Just because the FDA approves a drug for it doesn’t change this fact.
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I should also mention that the letter writer, Janet Wozniak, is a prominent researcher in the area of pediatric bipolar disorder (meaning that she has a lot of her own reputation on the line for this condition). She is also a colleague (and sometime co-author) with Joseph Biederman, the single researcher who appears in nearly every study conducted on pediatric bipolar disorder.
That’s also the same Joe Biederman who recently failed to report $1.6 million over 7 years of drug company payments. You know, the same drug companies who owe much of their expanded market in bipolar pediatrics to Biederman. See the NY Times for the coverage:
http://www.nytimes.com/2008/06/08/us/08conflict.html?em
This is the guy who’s been pushing the pediatric bipolar disorder diagnosis. One who apparently in the back pocket of the same pharmaceutical companies who benefit financially from his research. Sickening? You bet.
Having worked on an early-psychosis team (bipolar), I can assure you that we find what we look for and believe to be true (read: bias). And this is true for child protection, psychiatry… all of mental health. Clients have very little understanding about the politics that inform many of our decisions.
Well, I have a child that is 9 who is bi-polar. His first mediacation wa resperidal. It took him getting in trouble for some one to actually tell what he had. Now that I know he is bi-polar I can cope better and adjust. He is now on 3 different types of medication. Right now he is in a treatment center. He was so lout of control that even mental health professsionals couldnot handle him. I think the fact that he was so showing sysmptoms of bi-polar it had them in a confused mood. I knew in my heart all of his actions were not just behavoiral and he could control them. Like I said it took them until he got in trouble with the courts to get him the help he needed. I tried every thing therapy, entensive case management and all. Everyone kept saying what are you going to do when he is teenager. I was trying to get intrevetion before then. Get him on the right path while he was young. I think it floored them that I was trying so hard at being able to handle him and get him the help he needed. I started getting hlep for him when he was 3. He started seeinga a therapist at the age 4. like Isaid I knew something else was going on with him. It was until he was sent to a treatment center last year that anyone told me he was bipolar.
My daughter is almost eleven years old and was first diagnosed with A mental disorder when she was three. We went thru many different medications and psychotherapy. She has been hospitalized five times in six years. We have struggled with being thrown out of school and daycare several times. I have tried so many different medications together with mood stabilizers as well as ADHD meds. Day after day it has been an uphill battle. I am becoming more and more desperate everyday for someone to help us. I am tired of doctors using my daughter as a guinea pig for trying a new medication everyone they hit the market.