Furious Seasons

August 24, 2007

The Bipolar Tweens: Risperdal's At The Party, So Are Sycophants

Two days ago, the FDA approved the atypical antipsychotic for use in treating schizophrenia in children and teens aged 13 to 17 years old and in treating bipolar disorder in children and teens aged 10 to 17 years old. Several readers have written to ask me what I think. I apologize for the delay in addressing this. I somehow pulled a muscle in my back on Tuesday and spent two days in epic pain (the price of no health insurance and the DEA telling docs what to prescribe for pain). I know quite a few of you out there are pissed off about the FDA's move.

On one hand, I don't think the approval is that big of a deal. Why? Risperdal is going off-patent later this year (it gets patent protection into 2008 for kids) and it's been so widely used off-label in children and teens that I do not think a new indication late in its product life will change much in the way of clinical reality or sales. I haven't chased down the studies used in the approval process, so if someone knows what they are, please pass them along. (Maybe some of my readers from Mass General and J&J would like to help with that.) I also think that FDA criteria for what gets approved are so loose that I could get whiskey approved as a treatment for depression. I'm only half-joking.

I do find it hard to figure out why J&J would spend tens of millions to get Risperdal approved when it has very little time to recoup its investment. When companies spend money like that, they have their reasons. And that brings me to another point.

What concerns me, on the other hand, is that the approval opens the door for the company to openly advertise Risperdal--a drug that I think is unwarranted for anything other than short-term use in bipolar disorder--as a safe and effective treatment for America's bipolar tweens. By which I mean the 10-year-olds to 14-year-olds being diagnosed with bipolar. I'm less concerned about the approval for schizophrenia because there just are not that many people in their early teens who develop schizophrenia. But bipolar disorder is a growth industry in children and teens and you can bet that J&J is going to market the hell out of Risperdal in ads and direct-to-physician sales calls. There will be lots of imaging ads about the disorder and so on. I can assure J&J that my readers are going to keep a close watch on how the company markets this drug for these children.

Apparently, John McManamy--a blogger and author of Living Well with Depression and Bipolar Disorder--is already pitching in to help J&J. In a recent post, he chides the media for describing the antipsychotic as "powerful," basically accusing them of engaging in scare tactics. I don't know what other term you would use to describe an antipsychotic. On their faces, these drugs are powerful, the sledgehammers of psychiatry. But I guess if you speak in front of a bunch of NAMI groups, as John does, then former reporters, as John is, begin practicing a different kind of journalism. And listening to a certain kind of parent to the exclusion of others.

He also goes out of his way to defend Joseph Biederman, the don of the Harvard bipolar child mafia, and kisses up to the Papaloses, authors of The Bipolar Child, to a degree that isn't worth commenting upon. What's funny is that the Risperdal approval isn't technically applicable to the bipolar children (aged 0 to 10 years old) about whom there is much controversy. Speaking of Biederman, Stepahny at Soulful Sepulcher has been doing yeowoman's work digging into the doctor's publication history on ADHD and bipolar disorder. Here's one of her many posts on this topic.

BTW, I am well aware that Risperdal was only approved for short-term (ie, acute) use in bipolar disorder, but as many of us know that translates into doctors who will let patients stay on it for years instead of taking a patient off the drug after seeing whatever short-term results. They do this at their patients' peril, given the drug's ability to cause EPS and neuroleptic malignant syndrome. Sadly, I experienced both after using the drug for a time. I think parents who let their tweens and teens with bipolar disorder stay on this drug for more than a couple of month risk injuring their own children. Oh, yes, Risperdal packs on the pounds, has a black box warning or two, and screws with heart patterns.

The drug is powerful stuff, after all.

I wonder how all the autistic kids who've used the drug have turned out.

UPDATE: Speaking of sycophants, the American Psychiatric Association is out with a statement in which it "applauds" Risperdal's approval. I've never known the APA to tout medication approvals this way before, so I must ask, WTF?

Posted by Philip Dawdy at August 24, 2007 12:05 AM

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Comments

I suggest that even schizophrenia is overdiagnosed in children (though I don't deny that a rare child can have auditory and/or visual hallucinations) and once a child is told they are schizophrenic, they in essence become schizophrenic. The diagnosis itself leads to such drugging to such an extent that the child's mental growth is retarded, sort of like people who are addicted to alcohol and other drugs who find that when they "sober up" they are at the emotional age they were at when they began using the drugs addictively, or like the person who, depressed at the death of a spouse, begins taking ssri's and so fails to grieve. He still grieves when the initial buzz of the ssri wears off. Sad stuff this drugging of kids. But you guys know all of this.

Posted by: Sally at August 24, 2007 07:06 AM

Phillip,

I have to agree with you on this. I posted again after a month or so off, because the new indication disturbs me in a way reminiscent of your past postings on the topic of not quite bipolar.

I spent time on that criteria, and you never responded or I missed where you picked the winner for that new disorder.

As for this posting, I think you are on the money. It will be used long term, and for kids with personality disorders or substance use issues or whose parents just don't like them and can find a doctor willing to do what they want: chemically restrain their kids.

Thanks Phillip for the good fight, and I hope your back gets better. Go to BC. They will treat you for free and I will visit you :)

Posted by: Dr. Black Kitty at August 24, 2007 08:35 AM

Outspoken semi-rant ahead:

Well could it be that they are all just toasting and cheering that their professions have all been validated? it kinda wipes the slate clean from 8 years ago when Risperdal was given to my daughter for OCD at age 11.[as in now it's not off-label use] They just needed to cover all of the bases, and one thing that is still missing is the DSM Holy Grail with "real" Childhood Bipolar Diagnostic Criteria in it that will no doubt discuss crying babies and toddlers who need naps, but will end up being dx Bipolar instead. I wish I was a fly on a wall at these closed door cork popping events. $$$$$
As a side note, I have witnessed autistic children experience increased agitation while prescribed Risperdal for melt-downs that are quite common, yet parents feel pressure to conform their children at school to reduce outbursts. That's another day post for SURE.

AND, as far as long-term use? the psych docs already use antipsychotics long-term in addition to [most typically] Depakote for bipolar disorder in kids. That's why my daughter was on Zyprexa for 6 years--and it was "maintaining" a misdiagnosis! Then of course there's Seroquel....

Posted by: Stephany at August 24, 2007 09:41 AM

McManamy also says, "who are ostracized by kids their age"--my daughter was called "The Beast" at age 13 in Junior High due to her 50lb. weight gain on antipsychotics. There were no lunch tables of friends for her, and she didn't want to explain she was on medications. We also had no idea the weight gain in the year 2000 was due to Zyprexa, and before that Risperdal.She ate lunch in the counselor's office. Times haven't changed in Junior High lunchroom cliques. Here's what I think about McManamy's post.

Posted by: Stephany at August 24, 2007 10:59 AM

My daughter was diagnosed as bipolar last year. The doctor put her on risperdol for a short time. He said that it was only for use while she was in a manic phase. We took her off of it once her mania was over. My daughter has also gained a little weight after taking the lithium and risperdol. I didn't worry too much at the time since she was very small to start with. She now exersises allot and rides her bike 3 miles to work each day.

Posted by: Brenda at August 24, 2007 05:20 PM

HI,
Bi-Polar disorder, the name of a marketing device and nothing more. The marketing of toxic waste directed at children is a farce and tragedy of major proportions.
There are no medical tests for this (or any other DSM label) and therefore Respirdal is just some dangerous drug and nothing more.
Depression is the name for the state of mind that is the natural consequence of being kicked in the ass one time too many by life and coming to the conclusion that you are to blame for the misery in your family (and the world) and feeling helpless to do anything about it. Guilt, shame, and despair are not illnesses and best resolved with understanding and kindness rather than drugs.
Mania used to be as rare as hens teeth until people started taking antidepressants by the ton. Joe Glenmullen, M.D., a psychiatrist at Harvard believes that most of the highs associated with depression are the result of over stimulation by SSRI drugs such as Paxil, Prozac and the like.
Visit me at blogtalkradio.com/storiesweliveby for more. On Monday the 27th at 4:30 PM I'll discuss the myth of addiction.
Larry

Posted by: Larry at August 25, 2007 09:12 AM

Caught in the undertow of the rip tide in the name of PHARMA$$. There is more to this than addiction and behavior control by parents.

The focus needs a spotlight where it belongs.

FDA.Pharmaceutical companies.Peer reviewed and self-appointed authority.

Something has gone wrong here. It sure as HELL is taking Americans, the so-called liberal thinkers and thought leaders to figure it the fucking hell out.

Posted by: Stephany at August 25, 2007 06:58 PM

I don't think it will change much. My 7 yo son was prescribed it - and not for short term use, either. He actually took half the prescribed dose and I saved the other against the day my health insurance ran out ($185 a month ain't cheap!)

It IS powerful stuff. It seems to have "rebooted" his system so other stuff works now (or maybe the natural stuff would have worked all along, I don't know.)

I DO think BP exists in children (I can recall having BP episodes as a child as well) but it is definitely overdiagnosed and drugs are given first thing, when IMO drug therapy is more beneficial to the caregivers and school teachers than to the child. I could have all the drugs I wanted for him, but insurance limited the amount of therapeutic visits to learn coping strategies.

Risperdal was the FIRST (and only) med we tried.
Now I buy stuff at Vitamin Shoppe and we have only had two raging episodes at all in the past 12 months (vs. several hours per day without supplements).

I think it's a CYA move, or perhaps a step in a plan to make a slight variation of Risperdal and patent that.

Posted by: Milehimama at August 25, 2007 08:39 PM

that variation of risperdal has already been created--it's called Invega.

Posted by: Gianna at August 27, 2007 07:27 PM

The studies cited by the FDA in approving Risperdal for schizophrenia and bipolar disorder in children are discussed in this FDA report:

www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf

The FDA tells us the safety for schizophrenia was based on 3 studies. One was placebo-controlled (6 weeks), one low-dose controlled (8 weeks), and one open-label (6 months).

The safety for bipolar disorder was also based on 3 studies. One was placebo-controlled (3 weeks), one was the same "long-term" open-label study mentioned above (6 months), and one was a "pharmacokinetic" study (length of study not mentioned).

WHY DID THE FDA OMIT THE LENGTH OF THIS STUDY? THE ANSWER CAN BE FOUND IN ANOTHER FDA DOCUMENT:

http://www.fda.gov/cder/foi/esum/2007/020272s046_risperidone_clinpharm_BPCA.pdf

"The population pharmacokinetic study was done in 472 children and adolescents patients, ages 6-18. Study durations were from 12-21 days."

THERE YOU HAVE IT:

AS LITTLE AS 12 DAYS! 3 WEEKS AT THE MOST!

This allows the FDA to declare with a straight face:

"There were no reports of tardive dyskinesia in the pediatric study populations."

If you want to see the real-world incidence of tardive dyskinesia caused by Risperal in children, you won't find it ANYWHERE on the FDA web site. But you will find a glimpse here:

http://www.psychdrugdangers.com/risperdal.html

For a real-world look at Risperdal prescribing patterns in a state Medicaid program, go here:

http://www.psychdrugdangers.com/psychotropicages0-18.html

The above web page lists all 7,327 New Jersey Medicaid Risperdal prescriptions for children under age 18 written in 2006. The Risperdal prescriptions are sorted by age and dosage.

Note the number of children on Risperdal rises steadily until ages 11 or 12, then the numbers begin to decline. This is NOT because the number of children on antipsychotics begins to decline. Risperdal is the GATEWAY antipsychotic, but after a year or two the kids are often switched to a different antipsychotic (usually Seroquel or Abilify first, then Zyprexa or Geodon, and/or back to Risperdal later).
Meanwhile all sorts of other psychiatric drugs are thrown into the mix, and before you know it these kids are REALLY sick... thanks to the wonders of modern medicine, and thanks to all the doctors who write all the prescriptions, and thanks to all the taxpayers who foot the bill.

In October 2006 the FDA approved Risperdal for autistic irritability in children, based on two 8-week trials of 76 kids on Risperdal and 80 kids on placebo, detailed here:

http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf

Adverse Reaction Risperdal Placebo
Tremor 12% 1%
Dystonia 12% 6%
Automatism (tics) 7% 1%
Dyskinesia 7% 0%
Parkinsonism 8% 0%

Reviewing these trial results, I have a question:

How is it that 6% of the kids on placebo develop dystonia, while only 1% develop tremor? Can anyone out there offer possible explanations???

One more thing:

The average dose in the Risperdal autism trials was under 2mg/day. The FDA approved Risperdal for kids over age 5, 0.5 mg/day for 15-20 kg body weight, and 1mg/day for those over 20 kg. Look again at the New Jersey Medicaid prescriptions for Risperdal, and count the number of 2mg, 3mg and 4mg scrips. Not to mention all the kids under age 5 on doses ranging from 0.25mg to 3mg.

When the FDA approves a psychiatric drug at a certain dose for a certain age, history shows that doctors often ignore the FDA guidelines.

On the subject of Risperdal's pediatric dosage, the author of the FDA report had this to say:

"While I believe we should certainly label the drug with the information learned from the clinical trials, and even identify target doses of 3 mg/day for pediatric schizophrenia and 2.5 mg/day for pediatric bipolar I disorder, I think it would be too restrictive to the prescriber to limit the dose to a maximum when we know that doses up to 6 mg/day were also shown to be efficacious in the same studies that demonstrated efficacy for the lower dose ranges."

Yes that's what FDA Deputy Director, Dr. Mitchell V. Mathis really said. You can read his full report here:
www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf

Ben Hansen
Traverse City, Michigan

Institute for Nearly Genuine Research
www.bonkersinstitute.org

Posted by: Ben Hansen at August 28, 2007 08:21 AM

Ben references Risperdal being a 'gateway antipsychotic' and he is correct. In the last 8 years[since 1999] that was the way it went with my daughter. BUT the main key point to note here regarding that thought is that Risperdal like any other anti psychotic is followed by "whats popular" or basically the latest and greatest Pharma release and rush from reps to the psych offices with samples and DTC.
My daughter went from Risperdal>Zyprexa>Abilify>Seroquel. It follows the same path as the drug popularity contest.

What is happening with Risperdal now, is it has received an official stamp of approval from the FDA that covers most bases. Autistic kids, bipolar kids---you know all of the kids that had been rx Risperdal prior to off-label use. There's a lot more to this--generics, long term injection, etc.

The bottom line is that antipsychotics just got mainstreamed into society. That never goes back. It's here to stay: medicating kids age 10 or even younger--just like the high price of auto gas. Society gets pissed off and then moves on.

Guess what? the kids that suffered harm[or death] can't move on. There is something WRONG about that. Right? But in general, this is where we really are just preachin' to the choir here.
Sad, but true.

Posted by: Stephany at August 28, 2007 04:48 PM

Re: psych med use in children:

Look how long we have all been writing about antipsychotic use in children...this article from August 2007 speaks volumes.

Posted by: Stephany at December 2, 2008 12:50 PM