FDA approves chemical lobotomy for kids

Bloomberg News reported, "In trials, 27 percent of those receiving the highest dosage of Risperdal had symptoms of neurological side effects that cause involuntary jerking or movements, compared with 5 percent of patients on placebos."

According to Risperdal's FDA package insert, in two 8-week clinical trials of pediatric patients 46% of the kids on Risperdal suffered movement disorders including tremor, dystonia, automatism (tics), dyskenisia or parkinsonism, vs. 8% on placebo. That's a 475% greater risk for movement disorders in children on Risperdal!

The pediatric trial results are copied below.

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

RISPERDAL (risperidone)
Incidence of Treatment-Emergent Adverse Events in Two 8-Week, Placebo-Controlled Trials in Pediatric Patients with Autistic Disorder

Adverse Event RISPERDAL Placebo

Somnolence 67% 23%
Appetite increased 49% 19%
Confusion 5% 0%
Saliva increased 22% 6%
Constipation 21% 8%
Dry mouth 13% 6%
Fatigue 42% 13%
Tremor 12% 1%
Dystonia 12% 6%
Dizziness 9% 3%
Automatism 7% 1%
Dyskinesia 7% 0%
Parkinsonism 8% 0%
Respiratory infection 34% 15%
Weight increase 5% 0%
Tachycardia 7% 0%

Ben Hansen
Traverse City, Michigan

Why do you refer to Risperdal as 'chemical lobotomy'?

The term is sometimes used to refer to the class of drugs (the antipsychotics/ neuroleptics) to which Risperdal belongs.

I know how bad and wrong this statement is, but some extremely cynical part of me things: Good. With more kids on such drugs, it'll be fewer years before we have such obvious numbers of permanently disabled people whose brains have malformed under toxic medicating, less time until we have better funded longitudinal studies showing (oops!) these meds have serious neurodevelopmental issues in people of all ages, and oh, also, the lifetime outcomes turn out to be worse for people who's development is stunted or worse by drugs than those who had to endure emotionally turbulelent formative years or even psychotic breaks.

This is scarily reminiscent of the research data on the original neuroleptics, first available and public in 1958, suppressed, ridiculed, and actively opposed until massive class action law suits and a growing body of research showed just how widespread the damage was by the early 1980s. One big difference is that back then, there weren't tens of thousands of people writing scripts for children to be on these drugs. Science marches on...

"The term is sometimes used to refer to the class of drugs (the antipsychotics/ neuroleptics) to which Risperdal belongs."

By who? Scientologists? MindFreedom? Certainly not the millions of people who've benefitted from neuroleptics, many of whom I'm sure would be offended to hear themselves referred to as "lobotomized" because they take a medication which allows them to function. Nor by the mental health professionals who use these drugs in their practices, nor by the research scientists studying them.

It's offensive to consumers, an extremely inaccurate characterization of the drugs' mechanisms and effects, and sides with antipsychiatry denialists.

Some quick Googling finds the term "chemical lobotomy" used by antipsych sites to refer to thorazine (chlorpromazine) and not the SGAs, of which risperidal is one.

I sure hope you'll be more accurate with your terminology and sensitive to mental health consumers in future.

Sandra - chemical lobotomies are reversible. But I still wouldn't give them to my kids. Would you give them to yours?

many of whom I'm sure would be offended to hear themselves referred to as "lobotomized" because they take a medication which allows them to function.

What does offense have to do with whether the statements are correct?

In the case of antipsychotics, one of their effects is to derange the connections the frontal lobes and the rest of the brain. 'Chemical lobotomy' is quite accurate.

Yeah, as several people have said, Chemical Lobotomy is an inflamatory term used by the anti-psychiatric med crowd, and frankly very odd to see used on a neuro site.

So you're saying that a neuroscientist can't be skeptical of psychiatry? Why on earth not?

In the case of antipsychotics, one of their effects is to derange the connections the frontal lobes and the rest of the brain. 'Chemical lobotomy' is quite accurate.

Caledonian, would you give me a citation or some other way to find out more about this? I'm not disputing it, in fact I have some reason to think it's true, but corroboration would be useful. Thanks.

As someone who's taken atypical antipsychotics I find the term highly insulting. During my Seroquel tenure I was working on a PhD while getting certification in Mandarin Chinese. It helped me immeasurably. My brain seemed to be working quite fine.

I don't agree with the pediatric angle, but all the same. Your use of language is unacceptable and far from scientific. Cut out the pejorative slang and address the real issues.

Even worst-case, if there are brain developmental issues, they are extremely different--both qualitatively and quantitatively--than any form of lobotomy.

This is supposed to be a science site. I'd expect less prejudice and more empiricism.

Brad

Psychiatry isn't a science, and it isn't concerned with the scientific study of the mind.

Why in the world wouldn't you expect a neuroscientist (who is specially qualified to recognize just how much of past and present psychiatric claims are hogwash) to be skeptical and critical of the field?

Mo: if it were indicated I'd have no problem giving them to adolescents as approved by the FDA.

A neuroscientist being skeptical of psychiatry is akin to an ecologist being skeptical of global warming. For someone who wrote a long article on the history of lobotomies, I'd think you'd know the difference between a dopamine antagonist and a frontal leukotomy.

Using the term "chemical lobotomy" is a cheap conflation on par with Fox News, and debases the level of discourse. If you have a grievance with risperidal, why not just state it?

So you're saying that a neuroscientist can't be skeptical of psychiatry? Why on earth not?

Your credulous coverage of the knockout mouse model of OCD would seem to belie that skepticism...

A neuroscientist being skeptical of psychiatry is akin to an ecologist being skeptical of global warming.

Except that our best evidence indicates that global climate change is indeed happening, and is associated with human pollution, while our best evidence indicates that psychiatry is mostly a load of bunk.

Seems like a raging bushfire going on here. Well, risperidone an atypical antipsychotic, has been in the market for quite some time. Regarding the controversial nomenclature of 'chemical lobotomy', I would say that though this term is rather a 'neologism', the author has a definite right to add his own flavor to it. Don't we come across 'chemical sympathectomy' in the treatment of Buerger's disease for example?

A neuroscientist being skeptical of psychiatry is akin to an ecologist being skeptical of global warming.

Are you serious? How can one not be sceptical of a pseudoscience which still takes Freud's theories seriously?

I'm a little confused: what does Freud have to do with "chemical lobotomies"?

More than a little, I'd say.

I've reaped the benefits of atypical antipsychotics and several other medications over the years but I have no objection to throwing in a 'frightening' or 'offensive' term. The reality is us "lucky" one's are looking at living an average of 20 years less than the rest arguing such semantics. I'm 48 with 28 years invested - I'm holding my cards. But there's no room for complacancy or defensiveness when it comes to the next generation or the next. I find great hope in the neurosciences and in the shift from 'Dr. knows best' to recovery that is empowering some of us to expect so much more. We are going to accept such side affects and ultimately an early death? If so, we have already been successfully lobotomized.

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

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:

"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.

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

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:

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.

Ben Hansen
Traverse City, Michigan

_________________________________________________________

Psychiatry is to medicine what astrology is to astronomy.
-- Leonard Roy Frank

Bonkers Institute for Nearly Genuine Research
www.bonkersinstitute.org

You sure know how to poke the hornet's nest, don't you, Mo? ;)

Seriously, I agree with you, for a practical reason I rarely see brought up, and I'll try to explain. We all have to learn to live in our own heads and develop coping strategies for our personal psychological difficulties. Putting kids on pharmaceuticals interferes with that painful process.

A weak analogy: my mother never allowed me to skip grades in school (or be homeschooled) because she didn't want me to miss out on socialization. Not because it was "fun", but because I would need those high school traumas later to navigate the adult world, where so many people have barely advanced past cliquishness and jealousy. I hated high school, and I'm very thankful it's over, but I'm also glad I got the skill set I did from it.

Similarly, I'm glad no one tried to put me on pharmaceuticals when young. My personality and brain were changing so fast, had they been perturbed by drugs, how would I have ever figured out what my "baseline" was, or how to recognize the signs that I was in trouble? Not all psychoactive drugs can be taken indefinitely; patients usually need to be weaned off and/or switched to different medications during their lives. Don't they need some sort of baseline experience of who they are without drugs, to calibrate their responses to those medications? Even if they can't live that way for their entire lives?

Obviously imminent suicide would be an exception, but I'd hate to see medicating children or teenagers become routine, and I fear it already has.

Very interesting discussion. My story is not about children, but I do have recent experience with the effects of Risperdal on a young adult.

My daughter (age 24) was put on Risperdal (shots and pills) for one week in one hospital. She was then released to me, and I drove her 200 miles to my home. During that drive she became less and less able to function, was shaking mildly and drooling profusely. In the morning she could not swallow and could barely speak, but indicated that she wanted a shower. She was able to walk to the bathroom and step into the shower, but she could not turn on the water and she certainly could not wash herself. All the while, drool was spilling in a steady and uncontrollable stream from her mouth, which she could not even close at this point.

I immediately transported her to the emergency room of a local hospital. The staff there were incredulous that she had not taken more than what was prescribed to her. The psychiatrist who had seen her two weeks before at that same hospital was shocked to see the terrible change in her condition. She immediately put her on cogentin and began the process of detoxifying her, which took well over a month.

The doctor pronounced my daughter allergic to Risperdal and gave her a totally different diagnosis than the doctor at the other hospital. It was at this point that that I began to reassess my trust in these doctors and their medications.

After the weeks she spent recovering, with new meds that did not appear so toxic to her, my daughter seemed very healthy, happy and pretty much back to her old self. But because of a prior suicide attempt, she was committed and transferred to the state mental hospital.

I drove 10 hours to that hospital to visit my daughter one week after her transfer. There I learned that a nurse practitioner had changed all her meds upon her arrival (a real doctor had not even seen her there!). Guess what they wanted to put her on: Risperdal. Thank goodness she was able to tell them that she was allergic to it and was not forced to take it again.