Mental Health Blogs

Many of you know that an FDA advisory panel yesterday recommended that the agency approve Zyprexa, Seroquel and Geodon–atypical antipsychotics all–for use in teens 13 to 17 with schizophrenia and kids 10 to 17 with alleged pediatric bipolar disorder. I heard from a bunch of readers about how distressed they are over the committee’s finding and while there is something disgusting about the idea of these drugs being given to youths, the committee’s recommendation, which I expect the FDA to follow, may not actually mean too much in a real world way. That said, there are a couple of things that blow my mind about what’s gone on here.

I doubt that we’re going to see a massive consumer advertising campaign for any of these drugs–schizophrenia is rare and rarer in teens so there’s not much of audience to advertise to, and the doctors who would be targets of any direct to physician campaign (ie, psychiatrists) already likely know of the three drugs and have already prescribed them off-label for several years. On the pediatric bipolar front, in recent years the FDA has approved Risperdal and Abilify for this disorder and that hasn’t led to a DTC campaign that I’m aware of, so I’d be surprised if Lilly, AZ and Pfizer mounted a teens with bipolar ad campaign, especially since the drugs are already widely used off-label in teens and younger kids.

But the companies did go out of their way to run clinical trials for the drugs and those don’t come cheaply, so they’d likely want to see some kind of return on their investment, especially since Seroquel and Zyprexa go off-patent in 2011 and Geodon in 2012. Who knows, maybe we will get TV and magazine ads targeting “troubled” teens and angry adolescents?

What does blown my mind is that the members of the committee voted to approve drugs for a disorder–pediatric bipolar disorder–that doesn’t exist in the DSM and has such a shaky evidence base that it remains a controversial diagnosis within psychiatry. What’s more, pediatric bipolar disorder is a diagnosis largely ginned up and slapped together by researchers at Harvard (and elsewhere) who’ve literally been on the payroll of pharma for years, by the pharma companies themselves and then by the FDA itself. And now the committee’s recommendation is going to be decided upon by the FDA’s director of psychiatry products, Thomas Laughren, who several years ago helped researchers and pharma companies design the very clinical trials for the alleged disorder. Yes, my mind is blown.

What also shakes me up is that for this committee hearing a whole collection of mental health advocacy groups submitted a joint statement of support for the drugs (I’ve not been able to locate an online copy, but I can assure you it made the email rounds). That’s an unusual move, as I cannot think of the last time NAMI, Mental Health America (the old NMHA), the APA, the American Society for Suicide Prevention and so on issued such a statement for a drug’s potential approval (all of these groups get millions a year from pharma companies). I wonder what prompted them to do so this time out.

Obviously, there are a lot of other things to consider here (diabetes, brain shrinkage, etc.), but I’m going to leave it at that for now.

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3. JAMA Study Finds Explosive Weight Gain In Kids On Antipsychotics
4. Questioning Antipsychotics In Kids, SF Chron Supports Their Use
5. FDA Dubs Antipsychotics For Kids Effective With Substantial Risks