Lawmaker Asks NJ AG To Probe Antipsychotics
22 CommentsBy Ed Silverman // March 26th, 2008 // 12:48 pm
New Jersey’s Medicaid program spent more than $73 million on antipsychotic meds for children less than 18 years old between 2000 and 2007, according to state records, even though the drugs weren’t approved by the FDA for treating kids. And a state official acknowledges the drugs may have been prescribed for conditions other than schizophrenia and bipolar disorder, the approved uses.
And so a state legislator has written New Jersey Attorney General calling for an investigation. In a recent letter, Pat Diegnan, an assemblyman who has previously been outspoken about the use of these meds, wrote Anne Miligram to pursue an investigation of the “alleged misrepresentations concerning the safety and effectiveness of antipscychotic drugs,” which he first requested more than a year ago of her predecessor.
Several states are have filed lawsuits against drugmakers - Lilly, AstraZeneca and Johnson & Johnson - for alleged improper marketing and failing to disclose serious side effects, all of which prompted state Medicaid programs to overpay for the meds, which include Zyprexa, Seroquel and Risperdal. A few hours ago, Lilly agreed to pay $15 million to settle a lawsuit filed by Alaska, which claimed the drugmaker hid side effects caused by Zyprexa.
Whether such a small settlement will motivate other states to pursue investigations remains unclear. Alaska spent $40 million over five years on Zyprexa and so the recovery is modest, to say the least. A spokesman for NJ Attorney General Anne Milgram, who last year formed a task force to explore the relationship between drugmakers and docs, declined to comment.
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PBurns
Scale up the settlement. This is $15 million on an Alaska population base of 600,000 people. Weigh this case for the nation, and you have a $750 million settlement (the U.S. pop. is over 300 million). That’s starting to look substantive.
Add in the fact that future cases are likely to get bigger not smaller, as evidence tends to snowball up, not melt down. Lilly could not sustain ONE trial to the end without their witnesses crumbling. This was a BAD outcome for Lilly this early in the litigation arc.
And remember this is a *side effects* trial, not the False Claims Act case (that will easily top $1 billion), the individual liability cases (already $1.2 billion paid out and that number will rise), the class-action stock cases (unknown), or the third-party payor cases. Bottom line: Zyprexa litigation will cost Lilly over $5 billion.
And this is just Zyprexa. Seroquel and Risperdal have similar issues.
P.
Lisa Van S
PBurns,
Especially Children,..Which is what our NJ Legislators will be focusing on.
Dona Wheeler
It is a beginning. This pleases me, as I have wanted to advocate for kids who are treated for mental illness for over 3 year. asking my Dr, she told me, “parents don’t even want to believe that their kids are bipolar.” That is a good thing, because it has become an epidemic, and it must stop. With autism, bipolar, adhd, it is how Mom carries the child, [her diet and reactions to stress, ect] it is vaccines, it is diet, it is, childhood infections, it is over refined foods, it is social ills, and it is a lack of mind/spirit/body.
Let the drug companies pay up, be accountable, it is time. And I have been on most of these drugs myself, 14 years in a vicious circle, when as the above mentioned items were revelant, and I am an extreamely sensitive person, and I was 14 years ago, trusting of a shrink, my ex, the meds,and the system. It cost me 14 years, not to trust myself, the best line of defense is education, period.
Laurie
Thank you Assemblyman Diegnan!!!!!!!!!!!!
Joanne G. Cali
New Jersey should definitely take actions against this over-medicating, over-spending, and over-use of drugs on poor and foster children. It would be outrageous, now that we know this is happening behind the scenes, to ignore it and allow our tax monies to be spent for treatment of behaviors such as short attention spans, etc., with drugs. It seems as if every normal (ie widespread, visible throughout humanity) childhood (and adult) behavior is being labelled and drugged - to a great deficit of the available Medicaid dollars. Kids without parents to stand up for them, and the downtrodden poor will “yes” anything these unethical doctors prescribe. If we don’t call big Pharma to the Floor, then, guess what? They will continue to commit these offenses. $15 million may be “small”, but if all the states proceed, it will mount up to much more than a slap on the hand.
HorusCat
As usual, the blame-pharma-first crowd jumps right in…
Child psychs will use drugs off-label whether the drug is marketed to them or not. They are all trained in adult psychopharmacology and they can extrapolate to children. You can’t assume that just because a child psych uses a drug, it is because some drug rep told them to.
As for overuse of drugs in children, I don’t think you can blame big pharma for this. How about taking some of the rap yourselves? We live in a society that increasingly wants an easy fix to difficult problems. Exercise? Eat nutritiously? Quit smoking? Drink in moderation? Meditate, pray or do other stress-relief exercises? No, thank you, just give me a pill. Big pharma may be opportunistic, but I don’t think you can blame them for the average American’s desire for the quick and easy fix.
It is only natural that this mindset would trickle down to kids. The ADHD debate rages on, and I don’t sell those drugs, so I am relatively ignorant of the whole argument, but I can see both sides of that issue. I think parents and teachers are very quick to want to medicate what is probably normal behavior. I look at the rules in my kids’ school, and while my memory of elementary school is foggy, it seems like we had more leeway for just plain goofing around. My youngest regularly has recess taken away from him for talking in the hallway. Just talking, not screaming, running, laughing boisterously…and of course it doesn’t make much sense to me that in order to punish a kid with a lot of energy, you take away recess. But I digress. I don’t think you can blame big pharma for the rigid expectations that seem to reign in schools these days. And I’m not a teacher, so I don’t know how these rules evolved–they may make perfect sense.
On the other hand, my youngest tells me he can’t focus in school, he gets distracted, he can’t concentrate… The teacher tells me he just cannot seem to remain on task. I have seen him at home, and he does have what seems to be to be extreme difficulty focusing. I am going to have him tested for ADD, but not necessarily with medication in mind. We are implementing strategies both in and out of school to increase his discipline level, teach him to focus, reward him for good behavior, etc. etc. But if those fail, I may indeed medicate him.
But I am an upper-middle class mom well aware of the ADD-medication debate. What do you expect with children whose parents are absent, with no one to care about them or work with them? I don’t know that big pharma is out there telling the system to medicate these children–I think the system sees that as an easy fix.
The same holds true with the other behaviors that seem to attract a lot of medication solutions: oppositional-defiant disorder is a great example. I hear stories from my psychs about these kids that would make you pee in your pants–beating up their parents, tearing doors down in the house, you name it. I tend to think that the behavior results from poor parenting, but I don’t live there, so who knows. What is clear is that medicating the behavior works, whereas working with the kids to change the behavior is time-consuming and expensive.
I am not advocating willy-nilly medication in kids. I am simply arguing that it is facile and disingenuous to pin it all on pharma. To a great extent, I think pharma is an opportunistic scavenger–the tendency is there for parents, teachers, docs and bureaucrats to want the easy fix (medication), so pharma, like a vulture spying roadkill, swoops in to offer the solution.
I don’t know about other companies, but I know that my company is very vigorously training reps not to detail off-label.
I see a different side of this because I have an autistic son. His doctor prescribes Abilify for him, completely off-label, of course. It has been like a miracle, in terms of helping him socialize. He has friends, he has a “girlfriend” (he’s only 11, so it’s not a real girlfriend), he can work with his teachers…basically it means he can be mainstreamed in school. It’s not the only thing we do for him, of course. Therapy, tutoring, social skills classes, modeling social behaviors for him, it is all important for him. But I am glad that his doctor was forward thinking enough to try the Abilify.
Eric Townsend
It is gratifying to find an increased awareness of the “have a problem, take a pill” mentality and its liabilities. This problem has gone from minor to affecting the future of the human race. There is enough Prozac passed through peoples’ bodies to have a measurable effect in the ocean. Let’s just set aside the side effects which are downplayed by the pharmaceutical companies. What is the effect of the millions of drugs on the mental state of the people taking these drugs? Take Rytalin, which the Department of Justice, DEA, classifies as a type two drug along with various amphetamines. In cities like Montreal, it is the number one street drug. The DEA’s side-by-side test of Rytalin with cocaine showed no difference in apparent effect. This is a drug we’re giving to millions of school kids. The truth of the matter is you’ve got bored kids, kids too smart to sit still for the level of education given them, kids too slow to keep up and kids who had 4 cokes for breakfast before school instead of a real breakfast. Is the solution to give them a drug with suicide and violent (as in school shootings) behavior as side effects? The ones prescribing the drugs are also prescribing the current curricula which don’t fit the kids’ needs. The promises of the psychs and pharmaceutical companies are lies and a profound betrayal of those gullible enough, desparate enough to fall for them.
Matt
This is great news!
Roberta Galletti
It’s time we acknowledge the fact that all crimes and suicides that took place in these last years or maybe in this and the previous century were caused and dictated by the use of psycho-drugs……let’s stop this!
Lisa Van S
HorusCat
Are you advocating for the prescribing of Antipsychotics for Infants and Toddlers. If you are, than may I politely suggest that you worry about what goes on in your state. As a NJ Taxpayer I would prefer my tax dollars to be used for safer alternantives. I have “NO” respect for any Medical Professional who uses my hard earned tax dollars to maime or kill a child.
HorusCat
Lisa,
Do you really read posts, are do you just post stuff looking for fights? Not once in my post did I even mention infants and toddlers. So where did that come from? Like I said, you are looking for a fight.
Furthermore, nowhere in my post did I advocate widespread use of prescription drugs in kids at all. In fact, I explicitly stated that I am not advocating willy-nilly use of meds in kids. What I said, had you bothered to read it, is that I don’t think you can pin it all on pharma. I think that you have to look at the bureaucrats, the teachers and the parents, too. I pointed out my kids’ school as an example–it seems to me that rules and policies are so strict that a “normal” kid looks like a rabble-rouser when he talks in the hallway going from class to the lunchroom. I also pointed out that I think bad parenting results in kids who get labeled as oppositional-defiant (ODD)–and that from what I have seen, by the time these kids get to a child psych, they really are monsters. But I did not say I think this is a result of a chemical imbalance or anything like that, I said I think it is the result of bad parenting. I also think that it is a result of paying people to have babies (welfare), resulting in people having babies who have the parenting skills of eggplants. The kids are doomed from the beginning. I then pointed out that from a systems point of view, drugs are the easiest way out, because they do, indeed, work on the behaviors. Far better to disincentivize people from having kids they really don’t want, can’t afford and can’t parent. Far better to teach people parenting skills. I was pointing out that the entire system produces a situation where drugs are the easy out…and pharma swoops in to take advantage of that situation.
I was also making the point that regulating pharma won’t solve the problem, because doctors are independent thinkers capable of extrapolating a drug’s effects from adults to kids. They will try the drugs off-label because that is how they are trained to think. Anti-biotics are a good example. If anti-biotic Z works in strep, why not try it in sinusitis? Doctors do think of these things, you know, without the help of drug reps.
State and federal governments are pushing these lawsuits not out of concern for the patients, but because they need money. If you think otherwise, you are weirdly naive for such a cynical person.
Lisa Van S
HorusCat,
You mentioned children.. according to NJ Medicaid Psychotropic Drug Data: 0-12mos, 1 to 4 year olds are being prescribed at alarming rates, Antipsychotics, off-label for ADD/ADHD. I have one Question, Why? What are Physicians telling parents, and why is the Industry promoting antipsychotics for unapproved uses?
Extrapolating adult data for pediatrics. You wouldnt give an adult dose of Heparin to a child, so why give an adult dose of Zyprexa to a 2 year Old. Defies logic to me.
No fight here,..I did mention the word “politely” in my earlier post.
Lisa Van S
As far as money,… NJ Residents pay their taxes,..and the Taxpayers are footing the bill for dangerous, adult, medications,. for unnaproved uses in children. I commend Assemblyman Diegnan for asking NJ AG to Investigate, that’s what our legislators were elected to do.
HorusCat
Lisa,
I have no idea why a pre-schooler would be prescribed drugs for ADD, since technically you can’t diagnose the disease until a child is in school. School behavior is a key component of diagnosis of the disease–as far as I know. Like I have said before, ADHD drugs are not my thing, so I’m not up on the happenings in that area. I just know a little from my own questions about my own kids.
You are absolutely corrrect in questioning the use of psychotropic drugs in any child under school age. I cannot imagine what a 2 year old would present with to merit treatment with an anti-psychotic. Given this, I can assure you, almost guarantee you, that pharma is not pushing this. There are some places we just won’t go–I think I can safely say that about most of my colleagues. I have an antipsychotic which is not indicated for kids, so we don’t talk to child providers. Still, I know most of the drug reps with other companies, and I talk to the docs about what they are saying, and no one is talking about this age group of kids. Again, I would have to say this is bad parenting and bad doctoring–so don’t be too quick to push it all on pharma. I will make a point of asking my docs about this, because you have me curious. I just can’t imagine what is going on here.
As for dosing, you have to remember that psychotropic drugs act far differently than something like heparin. Kids metabolize drugs very quickly, so sometimes adult doses are used. Again, I am not selling my drug to child docs, so I wouldn’t know about the dosing of it (they are using it, although not to any great extent). I’ll have to ask. I know that my son takes an adult dose of Abilify==10 mg. The dose range goes from 2.5 to 30, so he is at the low end.
You have got me curious. I am seeing a group of psych residents for lunch. Several of them are doing child fellowships, and work at a very famous autism clinic here in town, as well as the state hospital. Of course, the hospital does not have kids under age 6, but the clinic might have patients that young. I will ask them about this and let you know what they say.
The thought of giving a 2 year old an antipsychotic gives me the chills.
HorusCat
Speaking of work, I had better get off my butt and go. I think I have that disorder Ed blogged about earlier…computeritis or whatever. I wish I could find someone to pay me for playing around on the internet all day.
HorusCat
Lisa,
Had an extensive talk with child psych fellows about treating very young kids with adhd drugs and antipsychotics. They all agreed that there are rare cases in which such treatment is necessary. They tend to be severely autistic kids who are injuring themselves (banging their head against the floor) or very aggressive and violent (biting, hitting, tearing things up). There are guidelines to follow for behavioral interventions, family interventions, etc.; drug therapy is last on the list. Risperdal is the usual choice, since they have the most research on that, and actually have the indication for age 5 and up.
As for ADHD, they said that what they see mostly in really young kids is hyperactivity, not inattention. Again, it has to be an egregious case–not just your typical rambunctious kid.
They all uniformly said that drug reps are not talking to them about these cases. Which makes sense–reps are going to talk about the situations where they have a chance to get significant sales. There is really no market for the very young child–from a purely cynical perspective, it would be a waste of time to talk about that area.
One of my docs did allude to some of his peers being very quick to jump to drugs. He was trying to be non-judgemental, but I think the implication was that maybe some are not exhausting the non-medication alternatives before they use drugs. Of course, this will happen with all age groups and all disease states, but I agree with you that it is particularly disturbing in the case of kids.
My point is that you may be jumping to conclusions based on one or two reports of these medications being used in kids. From what my docs were saying, at least here, it is not common. It surely is not desirable, but I don’t think you can say that it should never happen. If you have a child who is intent on injuring himself, it may turn out that medication is your only option. When I sold Zoloft, I was in the autism clinic and saw kids wearing helmets and restraints so that they could not hurt themselves. It is surely a terrible, no-win situation for the parents.
Steve
Lisa,
I’ve assembled a Not FDA-Approved for Pediatric Use page at http://www.psychdrugdangers.com/NotApprovedForPediatricUse.html listing those psychiatric drugs that are explicitly not approved for pediatric use by the FDA. It includes a link in the Medicaid Drug Uses and Payments menu for the Oct 2006 NJ Medicaid payments report that Laurie York obtained where approx 6,900 Rxs were reimbursed for these “off-label” uses (I know off-label is legal, but I don’t think the taxpayers should be forced to pay for them through Medicaid claims).
And see the Vermont Medicaid reports which clearly show that ADD and ADHD are common diagnoses in preschool children.
Patrick Dunaway
Unfortunately the drugging, and incorrect drugging of children, is just the tip of the pharma iceberg. The known and I qualify “known” statistics of pharma drugs, antipsychotics specifically, is approximately 63,000 suicides. The drug companies, as the tobacco companies did for years, have gone to incredible lengths to cover up the side effects of these drugs which they have known about for years. Currelty Eli Lilly (with former Nazi connections) has about 900 law suits for just one drug! Recently a drug salesman had a bought with his conscience and he wrote a book about how the big pharma companies push the drugs on the doctors and all of the tactics they use including lying and covering up the side effects of the drugs. In closing currently there are approximately 100,000 deaths per year in the us from “properly” prescribed drugs which also includes “antipsychotics”. The real issue here is the motivation of the drug companies but the media and the government are in bed with these guys due to big advertising bucks and campaign contributions. So it is great when you see the rare and unusual lawmaker who does not have their head in the sand about this epidemic problem.
So when are the lawmakers going to bring down the hammer on these scum bags?
For futther information on this issue go to cchr.org
Patrick Dunaway
HorusCat
Patrick,
You NEED medication. Get a grip. You lose all credibility when you rant like that.
Lisa,
I talked with my child psych fellows. They said that medication in such young children is definitely a very last resort. These docs are seeing the worst of the worst, of course, because it is a university setting. They said that one example of using an antipsychotic in a young child would be if the child is harming himself–i.e., banging his head on the floor hard enough to cause brain injury–or injuring others, biting, hitting, tearing things up. One of the docs said that there is a guideline they follow which begins with behavioral interventions, parental interventions, etc., with medication being the last step. Usually Risperdal, bec it is indicated in kids 5 and up. Now, these are severely autistic kids, not your run of the mill infant.
As for the ADHD drugs, he said it is usually hyperactivity that they are treating the young, young kids for. I did not ask him for a definition of hyperactivity. Again, there are parenting and behavioral interventions that they follow first.
One of the docs said that some of his colleagues are quick to use drugs–he was trying to be non-judgemental, but I think he disapproved. He did say, unequivocably, that no pharma rep has ever talked to him about medicating children this young. If you think about it cynically for a moment, there really isn’t much of a market there. If I have 45 seconds with a doctor, I am not going to talk about a 3 year old getting antipsychotics–there’s no return on investment there, not to mention it’s off-label.
I think you need to be careful about taking anecdotes of a couple of kids on antipsychotics and generalizing to assume that it is happening rampantly. What Patrick has to say is just nonsense. We shouldn’t throw the baby out with the bathwater. I can’t imagine what it would be like to have a child that is giving himself traumatic brain injury from banging his head against the floor or the wall at 2 years of age. I have seen older kids in helmets and restraints because of self-injurious behavior. Of course, they are usually MRDD and autistic and have severe problems. I would say that our doctors and our parents have to have some medication tools to deal with this.
fear 'n loafing
Nice try PD… now we invoke Godwin’s Law.
THIS THREAD IS CLOSED
R.S.
First parents or guardians should be questioning a doctor about any drug before they give it to a child or take it themselves for that matter, including antibiotics which are grossly overprescribed. Antipsychotics are used in some children to treat autism, my nephew has taken them. My sister greatly weighed the possible side effects against the good these drugs could do for my nephew and she researched them herself and made an informed decision. All drugs when introduced into the body can cause adverse effects, that should be a given. Second people wonder why drug prices are so high, perhaps turning on a tv and watching all the ads of lawyers trolling for clients in lawsuits against drug companies might play a role in it.
Before anyone jumps on me I am not saying they should investigate, I am saying lawsuits should be closely monitored and perhaps everyone shouldn’t climb on the bandwagon the minute a lawsuit is mentioned.