June 11, 2009

Perspective On Antipsychotics For Kids FDA Panel Recommendation

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.

Posted by Philip Dawdy at June 11, 2009 12:03 AM
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These antipsychotics have been given to kids and teenagers with anxiety disorders and mood disorders and behavior disorders and emotional issues and addictions and everything for the last decade. They've also been most commonly used as add ons in SSRIs, even if you've only been on one. If a teenager who has anxiety or depression or ADD or OCD or generalized anxiety is not responding to an antidepressant, they put them on an antipsychotic like Risperdal or Seroquel or Abilify before trying any other antidepressants. I still don't know why I was put on antipsychotics as a teen, although for a short time, I was taken off them whenever there was a bad side effect. Kids and teenagers are more often given antipsychotics for off label uses then adults. Adults wouldn't want to take something like an antipsychotic, but they have no problem giving it to their kids. It's because of the whole image thing, a lot of parents are fine talking about how their kid has issues and needs these antipsychotics, but they wouldn't take them. Thing is, teens are never told what they were on antipsychotics. I didn't know I had been on antipsychotics until I had been off it for seven years. Luckily, my time on antipsychotics was short. My cocktails of meds were changed so often it was impossible to keep track of it. It won't really make a difference whether or not it's been approved by the FDA, kids are still being given antipsychotics even before SSRIs. Doctors love prescribing them to teens who have emotional issues. There are also more off label uses for this stuff, too. I didn't even know it wasn't approved yet it's so common. A lot of people think that the antipsychotic they were taking is an antidepressant or anti anxiety pill. Almost any teen who is taking an antipsychotic does not know that it's an antipsychotic, doctors never tell teens anything.

Posted by: Princess at June 11, 2009 12:41 AM

I'm still pissed, especially after the little Destiny incident.

Pediatric bipolar disorder my ass. In fact, any of these things, my ass! The only valid psychiatric diagnosis, in my opinion, is post-traumatic stress disorder-- these other things are just different manifestations of that.

Posted by: kimbriel at June 11, 2009 08:31 AM

I wonder how much, if any, open public testimony there was. I sure would like to know. It sounds like the powers that be (the groups that prepared the joint statement) were out in force to disempower the voices of any victims. I suspect that it may have been more difficult to round up relevant victims to testify in this case because these children are so desperately ill -- they can't testify themselves and the parents are too beaten down or brainwashed or medicated themselves to make the effort and of course a lot of the victims are in the custody of states in foster care programs etc. What a shame!

My main concern with this approval is not that it might lead to DTC advertising -- that's the last thing on my mind. No, I'm concerned that it puts the good housekeeping seal of approval on current clinical practices and accelerates and facilitates the trend towards blaming a kid's brain instead of familial, cultural and societal dysfunction and/or environmental and nutritional toxins etc. etc. No one is really asking why kids are exhibiting these symptoms to a degree never seen before and certainly no one is warning parents that ever trying to stop these drugs once started is a very daunting and formidable task for which there is no proper professional support anywhere. I am currently advising a mother whose daughter has been on Seroquel and Lamictal for about 4 months. If left up to the doctor he would stop her cold turkey from Seroquel once he got down to 50mg. Of course this is simply not going to work and before you know it she would be on even more Seroquel than she was before (150mg). They'd all be under the illusion that her symptoms are her disease coming back and on and on. I asked the mother to ask her doctor if he'd ever successfully gotten a child off antipsychotics once he'd started them. I have yet to get a reply. Can you imagine that I am the only resource this family has? And I am a complete lone voice in the wilderness. It would be a joke if it weren't so deadly serious. And of course there was never any hint that in the long term the drugs might lead to more psychological and physical harm, not less.

Posted by: Sara at June 11, 2009 10:01 AM

Joint Statement [MHA, NAMI, etc.] on Atypical Antipsychotic Use in Children, June 8, 2009.

Posted by: Joe at June 11, 2009 02:11 PM

And P.S. let's remember the important point that the advisory committee was basing its approval on evidence gathered in trials that were short term, probably no more than 8-12 weeks, and of course did NOT include what happened to the kids after that time. Withdrawal and how it affects symptoms that mimic the "diseases" that are supposedly being treated is probably the most serious issue related to these drugs and none of the trials or any trial anywhere addresses that at all.

Posted by: Sara at June 11, 2009 02:48 PM

Face it pharma won

Posted by: Stephany at June 11, 2009 07:33 PM

Sara,
Re: "I am a complete lone voice in the wilderness".

Thanks for being at least one. I'm too choked up to say more.

Posted by: Damaged at June 12, 2009 07:23 AM

Thanks for a good post. I agree with what you have to say about the drug companies, and the disastrous effects of the meds carelessly applied, especially to kids.

We have one of those unclassifiable but episodically desperately ill kids, 16, variously labelled by a string of shrinks, schools and hospitals as: ADHD, autistic, Asperger's, bipolar, psychotic, oppositional, depressed, etc. Being dutiful parents, we have taken him to psychiatrists, psychologists, social workers, and he has been prescribed just about every medicatiion under the sun since he was 6. He was hospitalized three times aged 8, psychotic and suicidal, and attends a therapeutic day program that has helped him more than any of the meds.

This post describes some of our efforts to help him and the disastrous effects of the wrong meds, http://dianaretriever.blogspot.com/2009/02/stimulant-use-and-psychosis.html

This one describes the degree to which a good doctor and therapeutic relationship have helped him http://dianaretriever.blogspot.com/2009/06/final-meeting.html

Posted by: retriever at June 13, 2009 09:23 AM

that is a very sad timeline, retriever. i hope the best for your son.

Posted by: Stephany at June 13, 2009 07:22 PM

i'm late in the talk about that joint statement those organizations wrote lobbying the FDA, and I am just disgusted too.

kids have NO chance with all of those public organizations pushing the (already conflicted) FDA for these drugs to be approved because they all are highly influential.

UGH!

Posted by: Stephany at June 16, 2009 06:11 PM

Thanks, Stephany. I think I could cope with imperfect medicines better if I believed that the doctors and academics were independent of the drug companies.

Posted by: retriever at June 17, 2009 07:09 PM

Obviously, Philip does not understand how the things work. The advisory committee consists mostly of the expert psychiatrists and is independent from the FDA officials. Thomas Laughren does not even chair the meetings, he and other FDA people only present their side. Please also remember that he was in favor of including suicidality warnings on antidepressants in 2004-2006. It is not forbidden for the FDA officials to attend conferences because they have to explain to the industry the details of what and how they intend to regulate.

Posted by: TSC at June 20, 2009 05:18 PM

I recently reviewed a study publish in 2008 on the neurodevelopmental effects of antipsychotics. While the subject was a model organism (a nematode) rather than human, there was clearly abnormal development of neurons. This study indicates that the effects of antipsychotics on children and teens may be permanent and profound. Although I am not familiar with how commonly such drugs are prescribed to young people, it surely seems that caution must be encouraged.

Posted by: Elisabeth S. at July 1, 2009 03:01 PM
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