Flimsy Sanity: Risperdal Approved for Children

Flimsy Sanity

In individuals, insanity is rare; but in groups, parties, nations and epochs, it is the rule. - Friedrich Nietzsche

Friday, August 24, 2007

Risperdal Approved for Children

The FDA has approved using antipsychotics on children. Of course the drug dealers minimize the side effects like obesity and incontinence. Who cares if the fat kid pissing in the corner will be drugged for life, at least he is placid.

Robert Whitaker, science writer for the Boston Globe and author of the book Mad in America talks about psychiatric drugs in this interview:

RW: In reality, the common thread in all these different treatments was the attempt to suppress "mental illness" by deliberately damaging the higher functions of the brain. The stunning truth is that, behind closed doors, the psychiatric establishment itself labeled these treatments as "brain-damaging therapeutics." The first generation of antipsychotic drugs created a drug-induced brain pathology by blocking the neurotransmitter dopamine and essentially shutting down many higher brain functions. In fact, when antipsychotics such as Thorazine and Haldol were first introduced, psychiatrists themselves said that these neuroleptic drugs were virtually indistinguishable from a "chemical lobotomy."

This is a scientific question. We have a form of care where we’re using these drugs in an ever more expansive manner, and supposedly we have better drugs and they’re the cornerstone of our care, so we should see decreasing disability rates. That’s what your expectation would be. Instead, from 1987 until the present, we saw an increase in the number of mentally disabled people from 3.3 million people to 5.7 million people in the United States. In that time, our spending on psychiatric drugs increased to an amazing degree. Combined spending on antipsychotic drugs and antidepressants jumped from around $500 million in 1986 to nearly $20 billion in 2004. So we raise the question: Is the use of these drugs somehow actually fueling this increase in the number of the disabled mentally ill?

When you look at the research literature, you find a clear pattern of outcomes with all these drugs -- you see it with the antipsychotics, the antidepressants, the anti-anxiety drugs and the stimulants like Ritalin used to treat ADHD. All these drugs may curb a target symptom slightly more effectively than a placebo does for a short period of time, say six weeks. An antidepressant may ameliorate the symptoms of depression better than a placebo over the short term. What you find with every class of these psychiatric drugs is a worsening of the target symptom of depression or psychosis or anxiety over the long term, compared to placebo-treated patients. So even on the target symptoms, there’s greater chronicity and greater severity of symptoms. And you see a fairly significant percentage of patients where new and more severe psychiatric symptoms are triggered by the drug itself.

The FDA’s funding changed in the 1990s. An act was passed in which a lot of the FDA’s funding came from the drug industry: the PDUFA Act, or Prescription Drug User Fee Act. Basically, when drug companies applied for FDA approval they had to pay a fee. Those fees became what is funding a large portion of the FDA’s review of drug applications.So all of a sudden, the funding is coming from the drug industry; it’s no longer coming from the people. As that act comes up for renewal, basically the drug lobbyists are telling the FDA that their job is no longer to be critically analyzing drugs, but to approve drugs quickly. And that was part of Newt Gingrich’s thing: Your job is to get these drugs to market. Start partnering with the drug industry and facilitating drug development. We lost this idea that the FDA had a watchdog role. Also, in a human way, a lot of people who work for the FDA leave there and end up going to work for the drug companies. The old joke is that the FDA is sort of like a showcase for a future job in the drug industry. You go there, you work awhile, then you go off into the drug industry.

The children’s story is unbelievably tragic. It’s also a really sordid story. Let’s go back a little to see what happened to children and antidepressants. Prozac comes to market in 1987. By the early 1990s, the pharmaceutical companies making these drugs are saying, “How do we expand the market for antidepressants?” Because that’s what drug companies do -- they want to get to an ever-larger number of people. They saw they had an untapped market in kids. So let’s start peddling the drugs to kids. And they were successful. Since 1990, the use of antidepressants in kids went up something like seven-fold. They began prescribing them willy-nilly.
Now, whenever they did pediatric trials of antidepressants, they found that the drugs were no more effective on the target symptom of depression than placebo. This happened again and again in the pediatric drug trials of antidepressants. So, what that tells you is there is no real therapeutic rationale for the drugs because in this population of kids, the drugs don’t even curb the target symptoms over the short term any better than placebo; and yet they were causing all sorts of adverse events. For example, in one trial, 75 percent of youth treated with antidepressants suffered an adverse event of some kind. In one study by the University of Pittsburgh, 23 percent of children treated with an SSRI developed mania or manic-like symptoms; an additional 19 percent developed drug-induced hostility. The clinical results were telling you that you didn’t get any benefit on depression; and you could cause all sorts of real problems in kids -- mania, hostility, psychosis, and you may even stir suicide. In other words, don’t use these drugs, right? It was absolutely covered up.

The antipsychotics profoundly block dopamine receptors. They block 70-90 percent of the dopamine receptors in the brain. In return, the brain sprouts about 50 percent extra dopamine receptors. It tries to become extra sensitive. So in essence you’ve created an imbalance in the dopamine system in the brain. It’s almost like, on one hand, you’ve got the accelerator down -- that’s the extra dopamine receptors. And the drug is the brake trying to block this. But if you release that brake, if you abruptly go off the drugs, you now do have a dopamine system that’s overactive. You have too many dopamine receptors. And what happens? People that go abruptly off of the drug, do tend to have severe relapses... and that was understood by 1979, that you were actually increasing the underlying biological vulnerability to the psychosis. And by the way, we sort of understood that if you muck with the dopamine system, that you could cause some symptoms of psychosis with amphetamines. So if you give someone amphetamines enough, they’re at increased risk of psychosis. This is well known. And what do amphetamines do? They release dopamine. So there is a biological reason why, if you’re mucking up the dopamine system, you’re increasing the risk of psychosis. That’s in essence what these antipsychotic drugs do, they muck up the dopamine system.

Here’s just one real powerful study on this: Researchers with the University of Pittsburgh in the 1990s took people newly diagnosed with schizophrenia, and they started taking MRI pictures of the brains of these people. So we get a picture of their brains at the moment of diagnosis, and then we prepare pictures over the next 18 months to see how those brains change. Now during this 18 months, they are being prescribed antipsychotic medications, and what did the researchers report? They reported that, over this 18-month period, the drugs caused an enlargement of the basal ganglia, an area of the brain that uses dopamine. In other words, it creates a visible change in morphology, a change in the size of an area of the brain, and that’s abnormal. That’s number one. So we have an antipsychotic drug causing an abnormality in the brain. Now here’s the kicker. They found that as that enlargement occurred, it was associated with a worsening of the psychotic symptoms, a worsening of negative symptoms. So here you actually have, with modern technology, a very powerful study. By imaging the brain, we see how an outside agent comes in, disrupts normal chemistry, causes an abnormal enlargement of the basal ganglia, and that enlargement causes a worsening of the very symptoms it’s supposed to treat. Now that’s actually, in essence, a story of a disease process -- an outside agent causes abnormality, causes symptoms...It’s a stunning, damning finding. It’s the sort of finding you would say, “Oh Christ, we should be doing something different.” Do you know what those researchers got new grants for, after they reported that?
They got a grant to develop an implant, a brain implant, that would deliver drugs like Haldol on a continual basis! A grant to develop a drug delivery implant so you could implant this in the brains of people with schizophrenia and then they wouldn’t even have a chance not to take the drugs! Because that’s where the money was. And no one wanted to deal with this horrible finding of an enlargement of the basal ganglia caused by the drugs, and that is associated with the worsening of symptoms. No one wanted to deal with the fact that when you look at people medicated on antipsychotics, you start to see a shrinking of the frontal lobes. No one wants to talk about that either. They stopped that research.

(Side effects) Oh, you get tardive dyskinesia, a permanent brain dysfunction; and akathisia, which is this incredible nervous agitation. You’re just never comfortable. You want to sit but you can’t sit. It’s like you’re crawling out of your own skin. And it’s associated with violence, suicide and all sorts of horrible things...I think the newer drugs will eventually be seen as more dangerous than the old drugs, if that’s possible. As you know, the standard neuroleptics like Thorazine and Haldol have had quite a litany of harm with the tardive dyskinesia and all. So when we got the new atypical drugs, they were touted as so much safer. But with these new atypicals, you get all sorts of metabolic dysfunctions.
Let’s talk about Zyprexa. It has a different profile. So it may not cause as much tardive dyskinesia. It may not cause as many Parkinsonian symptoms. But it causes a whole range of new symptoms. So, for example, it’s more likely to cause diabetes. It’s more likely to cause pancreatic disorders. It’s more likely to cause obesity and appetite-disregulation disorders.

In fact, researchers in Ireland reported in 2003 that since the introduction of the atypical antipsychotics, the death rate among people with schizophrenia has doubled. They have done death rates of people treated with standard neuroleptics and then they compare that with death rates of people treated with atypical antipsychotics, and it doubles. It doubles! It didn’t reduce harm. In fact, in their seven-year study, 25 of the 72 patients died. You’re getting respiratory problems, you’re getting people dying incredibly high cholesterol counts, heart problems, diabetes. With olanzapine (Zyprexa), one of the problems is that you’re really screwing up the core metabolic system. That’s why you get these huge weight gains, and you get the diabetes. Zyprexa basically disrupts the machine that we are that processes food and extracts energy from that food. So this very fundamental thing that we humans do is disrupted, and at some point you just see all these pancreatic problems, faulty glucose regulation, diabetes, etc. That’s really a sign that you’re mucking with something very fundamental to life.

You’re touching on something (prescribing to children) now that is a tragic scandal of monumental proportions. I talk sometimes to college classes, psychology classes. You cannot believe the percentage of youth who have been told they were mentally ill as kids, that something was wrong with them. It’s absolutely phenomenal. It’s absolutely cruel to be telling kids that they have these broken brains and mental illnesses. There’s two things that are happening here. One, of course, is that it’s complete nonsense. As you remember as a kid, you have too much energy or you behave sometimes in not altogether appropriate ways, and you do have these extremes of emotions, especially during your teenage years. Both children and teenagers can be very emotional. So one thing that’s going on is that they take childhood behaviors and start defining behaviors they don’t like as pathological. They start defining emotions that are uncomfortable as pathological. So part of what we’re doing is pathologizing childhood with straight-out definition stuff. We’re pathologizing poverty among kids.

For example, if you’re a foster kid, and maybe you drew a bad straw in the lottery of life and are born into a dysfunctional family and you get put into foster care, do you know what happens today? You pretty likely are going to get diagnosed with a mental disorder, and you’re going to be placed on a psychiatric drug. In Massachusetts, it’s something like 60 to 70 percent of kids in foster care are now on psychiatric drugs. These kids aren’t mentally ill! They got a raw deal in life. They ended up in a foster home, which means they were in a bad family situation, and what does our society do? They say: “You have a defective brain.” It’s not that society was bad and you didn’t get a fair deal. No, the kid has a defective brain and has to be put on this drug. It’s absolutely criminal.

Let’s talk about bipolar disorder among kids. As one doctor said, that used to be so rare as to be almost nonexistent. Now we’re seeing it all over. Bipolar is exploding among kids. Well, partly you could say that we’re just slapping that label on kids more often; but in fact, there is something real going on. Here’s what’s happening. You take kids and put them on an antidepressant -- which we never used to do -- or you put them on a stimulant like Ritalin. Stimulants can cause mania; stimulants can cause psychosis... so the kid ends up with a drug-induced manic or psychotic episode. Once they have that, the doctor at the emergency room doesn’t say, “Oh, he’s suffering from a drug-induced episode.” He says he’s bipolar... they give him an antipsychotic drug; and now he’s on a cocktail of drugs, and he’s on a path to becoming disabled for life. That’s an example of how we’re absolutely making kids sick... There’s an astonishing number of kids being given Ritalin to cure hyperactivity. But what 10-year-old boy in a confined school setting isn’t hyperactive? You write that the effect of Ritalin on the dopamine system is very similar to cocaine and amphetamines... Ritalin is methylphenidate. Now methylphenidate affects the brain in exactly the same way as cocaine. They both block a molecule that is involved in the reuptake of dopamine... Now, methylphenidate was used in research studies to deliberately stir psychosis in schizophrenics. Because they knew that you could take a person with a tendency towards psychosis, give them methylphenidate, and cause psychosis. We also knew that amphetamines, like methylphenidate, could cause psychosis in people who had never been psychotic before.

So think about this. We’re giving a drug to kids that is known to have the possibility of stirring psychosis. Now, the odd thing about methylphenidate and amphetamines is that, in kids, they sort of have a counterintuitive effect. What does speed do in adults? It makes them more jittery and hyperactive. For whatever reasons, in kids amphetamines will actually still their movements; it will actually keep them in their chairs and make them more focused. So you’ve got kids in boring schools. The boys are not paying attention and they’re diagnosed with ADHD and put on a drug that is known to stir psychosis. The next thing you know, a fair number of them are not doing well by the time they’re 15, 16, 17. Some of those kids talk about how when you’re on these drugs for the long term, you start feeling like a zombie; you don’t feel like yourself.... There are some colleges where something like 40 to 50 percent of the kids arrive with a psychiatric prescription.

It creates customers for the drugs, and hopefully lifelong customers. That’s what they’re told, aren’t they? They’re told they are going to be on these drugs for life. And next thing they know, they’re on two or three or four drugs. It’s brilliant from the capitalist point of view. It does serve some social-control function. But you take a kid, and you turn them into a customer, and hopefully a lifelong customer. It’s brilliant. We now spend more on antidepressants in this country than the Gross National Product of mid-sized countries like Jordan. It’s just amazing amounts of money. The amount of money we spend on psychiatric drugs in this country is more than the Gross National Product of two-thirds of the world’s countries. It’s just this incredibly lucrative paradigm of the mind that you can fix chemical imbalances in the brain with these drugs. It works so well from a capitalistic point of view for Eli Lilly. When Prozac came to market, Eli Lilly’s value on Wall Street, its capitalization, was around 2 billion dollars. By the year 2000, the time when Prozac was its number-one drug, its capitalization reached 80 billion dollars -- a forty-fold increase.

So that’s what you really have to look at if you want to see why drug companies have pursued this vision with such determination. It brings billions of dollars in wealth in terms of increased stock prices to the owners and managers of those companies. It also benefits the psychiatric establishment that gets behind the drugs; they do well by this. There’s a lot of money flowing in the direction of those that will embrace this form of care. There’s advertisements that enrich the media. It’s all a big gravy train. Unfortunately, the cost is dishonesty in our scientific literature, the corruption of the FDA, and the absolute harm done to children in this country drawn into this system, and an increase of 150,000 newly disabled people every year in the United States for the last 17 years. That’s an incredible record of harm done.

And you know what’s interesting? No one says that the mental health of the American people is getting better. Instead, everyone says we have this increasing problem. They blame it on the stresses of modern life or something like that, and they don’t want to look at the fact that we’re creating mental illness.

12 Comments:

  • At 5:24 AM, Anonymous Anonymous said…

    As the interviewer said: Everyone gets rich -- the drug companies, the psychiatrists, the researchers, the advertising agencies -- and the clients get drugged out of their minds and damaged for life.

     
  • At 3:38 AM, Blogger Not Your Mama said…

    Well, mental illnesses do tend to be culture-specific so there is much truth there.

    The picture with medication is mixed though and one thing that study is not telling you apparently is that there are physical changes to the brain in untreated schizophrenia also. The general "dulling" of both symptoms and general affect are both long term results of the disease itself.

    Medicating children is always a last resort and should only be done in severe cases, most illnesses don't show up until teens to early adulthood. Severe mental illness in early childhood is fairly rare but there really are children who benefit from medication....maybe 1 out of 10,000 or maybe even 100,000. Another thing those numbers aren't telling you is that the overwhelming majority of children who require these type of medications are not kids riding their bikes down your street. They're usually children with other severe disabilities, and genetic syndromes they were born with. A large percentage are so severely impaired they are either institutionalized or at the least require 24 hour skilled, intensive care.

    A lot of the problem is we seem to have a lot of parents unable to cope these days....every other parent I meet claims their child has "ADD" or "ADHD" or whatever. If they were all correct that would put the rate of afflicted children at roughly 50% of the population. Not very likely.

     
  • At 5:51 AM, Blogger Flimsy Sanity said…

    Not your Mama: Actual brain changes in undrugged mental cases is really interesting. Can you point me to some literature on this? Since the antipsychotics have been administered for 50 years, untouched patients would be hard to find to actually compare the physical brain anomalies. I am not saying that mental illness does not exist, only that the current treatment exacerbates the problem.

     
  • At 6:29 AM, Blogger Flimsy Sanity said…

    Mad Crone has a really interesting theory of what causes schizophrenia on her latest posting.

     
  • At 4:24 PM, Blogger Not Your Mama said…

    http://archpsyc.ama-assn.org/cgi/content/abstract/58/2/148

    You can google a lot more, unfortunately most of the early studies done prior to standard use of neuroleptics are either not on-line or deeply buried somewhere. Back before neuroleptics "burnout" was the common end stage for schizophrenic patients. Somewhere around age 40 most would experience a subsidence of florid symptoms (ie: hallucinations/compulsions) and retreat to catatonia or at best, low level symptoms with some ability to function on a daily basis.

    There's still debate over how much damage/how early in the course of the disease and of course, how much potential benefits outweigh risks with medication. It isn't something most doctors take lightly at all.

    Sadly most of the serious over prescribing of these drugs comes from general practitioners in the community who are less familiar with them and/or psychiatrists with practices geared more towards the simply neurotic. Very, very few doctors in community practices have more than fleeting training and experience working with the seriously mentally ill. Many of them in fact DO NOT want to deal with seriously ill patients because they are much more difficult to work with and come with much greater legal liabilities.

    People who need help the most seldom get it and almost never before going through a great deal of suffering. By the time they get help it's usually because they've run afoul of our justice system.

     
  • At 5:04 PM, Blogger Flimsy Sanity said…

    Not Your Mama:That abstract does not say that the schizophrenics were free from neuroleptics. The debate is how much brain damage is done by the antipsychotics and blamed on the disease. Other studies show absolutely no differences between the brains of untreated schizophrenics and normals. That is why they don't do brain scans to diagnosis in the first place because the brain changes take place after they are medicated. I am not saying that mental illness does not exist, only that the current treatments are going down the wrong alley and never cure, only destroy brain function so that the patient is docile - in essence, a chemical lobotomy.

     
  • At 3:57 AM, Blogger liberated psych said…

    Actually recovery from schizophrenia is not that uncommon. Recovery is not likely for the homeless crazies because the stress level of living that way would make it impossible.

     
  • At 2:28 PM, Blogger Ben said…

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

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

    The FDA tells us that 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 (the length of this study was not mentioned).


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

    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 population, 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% of the kids on placebo 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 simply ignore the
    FDA guidelines.

    On the subject of Risperdal's pediatric dosage, the author of the FDA report cited earlier 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:
    http://www.fda.gov/cder/foi/esum/2007/020272s046s047,020588s006s037,021444s020s021_risperidone_clinical_BPCA.pdf

    Ben Hansen
    Traverse City, Michigan

    Institute for Nearly Genuine Research
    bonkersinstitute.org

     
  • At 3:56 AM, Blogger Flimsy Sanity said…

    Ben: Really interesting links. Thanks. I googled "first do no harm" and found out that doctors do not take that oath. PS: Your site is pretty funny in a sad way.

     
  • At 7:29 AM, Anonymous History Repeats said…


    This
    is a New York Times article about the use of atypical antipsychotics on children that should stop the misconception that the use of these powerful dangerous drugs on children is rare.

     
  • At 5:24 AM, Anonymous Anonymous said…

    because of my character, i would like to stay away from crowd for a long time/ they put me in hospital, they gave me risperdal, high dose 100 mg injection the month, and i m afraid to go and talk to this lady that prescribed me these, because if i get angry with all these crasy things, she will never reduce the dosage to me//i m so mad mainly for the kids of the world, and i really believe that there will be a big punishment from god for all these things//parents are unacceptable wich accept this medication for their kids//no matter what problems they face//
    anyone who doesnt react to all these things is lost for good//
    i m wondering what kids will be born from these kids, with the medication they take//me i m forty, i leaved my life, but them?
    we should do something more active//
    thanks everyone

     
  • At 5:56 AM, Anonymous Anonymous said…

    is there a scientest to tell us, if that unique instrument, the brain is it possible to rescheduled, after two or three years out of antipsychotics?
    i know well that we can cut heroin and cocaine without damage/or affect/ is this possible with the antipsychotics//please someone to answer this//

     

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