NJ Lawmaker Wants Probe Into Antipsychotics
34 CommentsBy Ed Silverman // September 3rd, 2008 // 10:54 am
Earlier this year, we noted that New Jersey’s Medicaid program spent more than $73 million on several 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 acknowledged the drugs may have been prescribed for conditions other than schizophrenia and bipolar I disorder.
The disclosure prompted a state legislator to demand an investigation by the state attorney general, who has been particularly quiet on the topic (back story). Now, yet another legislator is pressing the state’s Department of Health and Senior Services. In an August 20 letter, state Assemblyman Michael Doherty writes to the department’s commissioner that he wants to know when a policy was enacted allowing for such spending on the meds and the rationale for such a move. We are awaiting a reply from the department. UPDATE: We are told the letter was referred to the Department of Human Services, which oversees the state’s Medicaid program.
The issue is heating up in several states, where Medicaid spending on antipsychotics for unapproved uses in children and teenagers has been rising over the past few years (example and example). Several states have filed lawsuits. And a group of 15 states is compiling data and analyzing prescribing trends nationwide with an eye toward presenting a report to the the National Association of State Medicaid Medical Directors in November (back story).
Ima Misfit
Take it from an ex-J&J’r who actively promoted Risperdal for off-label use in children, as directed by J&J management; there are many internal documents at J&J that provide irrefutable evidence of their off-label marketing strategy.
Nathan
It’s not illegal or immoral to prescribe a drug “off label” — even if it violates a black box warning. That’s the doctor’s (and parent’s) judgement call.
So can someone please explain to me why there is all this hupla is? Why aren’t people upset over the medicaid funded off-label prescriptions of countless other drugs?
Chris
It is the promotion of off-label use by the pharma company that is the issue, not off-label use itself. This drug category has some of the most visible examples.
Lisa Van S
Attorney General Richard Blumenthal: Tuesday, March 11, 2008
“The illegal marketing campaign exploited children and senior citizens– causing severe weight gain, diabetes and cardiovascular problems,” Blementhal said.”This scheme involved payments to public officials, bogus educationalevents and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects.
“Eli Lilly adopted a sick marketing mindset: profits over patients, Sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abondened integrity and decency for self enrichment. My office will fight aggressively on behalf of Connecticut Citizens who continue to pay the price of Eli Lilly’s illegal senseless schemes.”
Nathan
If the issue is off-label promotion, then why aren’t they going after the pharma companies directly? Off-label promotion is clearly illegal. Instead they seem to be seeking a way to cut off spending on these drugs. Am I right or am I way off-base?
Anne
Nathan, read Lisa’s quote from AG Blumenthal from Connecticut. They are going after Lilly. And yes, it is also true that the atypicals are breaking the bank of Medicaid in many states. My hope is that AG Blumenthal, who filed a RICO, will take Syd Taurel and the boys to court for criminal acts. Many people have been killed by the drug.
Ima Misfit
Over the past five years J&J, Lilly, GSK, Pfizer and BMS have all received countless subpoenas from various DOJ offices, Senate and House committees and sub-committees, numerous Attorneys General, HHS and other government agencies.
The government knows very well the extent of the illegal activities used by Big Pharma to fraudulently push their goods. Our politicians know the damage Big Pharma has done to our pocket-books and our children.
The extent of these never ending investigations is well documented, so why the hell is it taking so long to hold these pharma goons accountable and to put a stop to the systemic healthcare fraud?
Some politicians; like Chuck Grassley, Henry Waxman, Bart Stupak - too name a few - are trying to hold the Pharma Manufacturers feet to the fire, but it seems that most politicians are bought and paid for by Big Pharma. None of them want to miss out on a sweetheart deal like the one former Congressman Billy Tauzin got shortly after he pushed through the MMA; a bill that gave Big Pharma a license to steal Billions of Dollars from US Taxpayers.
Nathan
Ima Misfit,
The other explanation is that the evidence just isn’t quite sufficient to prove their case in a court of law. But this is a free country. You are certainly free to believe that there is a conspiracy if you’d like.
Lisa Van S
Assemblyman Michael Doherty is my State Represenative, and I am so proud that he and his chief of staff, have taken the safety, of New Jersey’s most vulnerable population, our children in the Foster Care Program, very seriously.
Lisa Van S
Question For Dr. Bremner,
Is their a definition for Bipolarism?
laurie
“So can someone please explain to me why there is all this hupla is? ”
Because when you see the actual NJ Medicaid data with the ages that had this category of drug prescribed it’s astonishing. I’ve seen the list of drugs with ages …and was the one who requested it initially, and it’s eye opening.
Interesting side note..I had to pay a considrerable amount to have this data collected(Opra request) since it had never been collected, or looked at before. The legislature has gotten involved due to the money being paid(which was a different Opra request). I don’t know firsthand, but I have a pretty good idea that there are few other categories of off label drugs being prescribed that come up with a 73 million dollar annual total.
Nathan
Laurie writes:
“I have a pretty good idea that there are few other categories of off label drugs being prescribed that come up with a 73 million dollar annual total.”
That’s exactly my point - if there are multiple classes of drugs being prescribed off-label to the tune of $73 million, what makes you think that this is an excessive amount? What would be an acceptable figure in your mind? Zero?
laurie
” What would be an acceptable figure in your mind? Zero?”
When it comes to giving drugs to children that can be dangerous, ruin their future health and have have not been FDA approved due to lack of efficacy…yup, zero works for me!
Nathan
Laurie,
So, do you think that way for ALL off-label use of drugs, or only for antipsychotics? Should we just make off-label prescription illegal?
Ima Misfit
Nathan,
I turned over, to the Department of Justice, literally the entire database of one of the companies involved in fraud. The government knows very well the extent of the fraud, which is meticulously documented. Three years later the “investigation” is ongoing.
The DOJ spends most of their time in these ‘investigations” negotiating a settlement. All of the 73 pharma companies charged 7 years ago by the DOJ and dozens of A.Gs, for Medicaid & Medicare fraud, have been taking part in court ordered Alternative Dispute Resolution mediation for fourteen months now.
The recently settled Medicaid fraud case between States Attorneys General and Merck went on for over two years. The result? Merck paid $800 million and said they did nothing wrong. The executive felons at Merck kept their jobs - oh, a few ‘retired” - but none were charged criminally.
In the United States, justice is now negotiated behind closed doors by corporate felons and their pals at the DOJ.
US A.G. Michael Mukasey represented corporations charged with white collar crime when he was an attorney for Patterson, Belknap, Webb & Tyler(PBWT), before he was appointed Federal Judge in the Sothern District of NY, and for 1 yr. after he retired, before he was named A.G.
PBWT has represented J&J for decades and they’re currently representing J&J in the massive ongoing AWP fraud litigation.
In fact, for many years, Michael Mukasey and J&J’s Asst. General Counsel in charge of all J&J litigation, Taysen Van Itallie, worked together at PBWT.
Oh, and then there’s Russell Deyo; J&J’s VP General Counsel and Chief Compliance Officer. Deyo was an Asst. US Attorney in NJ before he got his gig with J&J. I’m sure he still has plenty of well placed freinds at the DOJ.
The Pharma Felons will eventually settle with the government for pennies on the dollar, and none of them will be charged with a crime. Meanwhile Nathan; if you or I were found to have defrauded Medicaid for as little as $20k, we’d have to pay it all back with huge penalties, and we’d spend the next few years in a federal penitentiary.
laurie
“So, do you think that way for ALL off-label use of drugs, or only for antipsychotics? Should we just make off-label prescription illegal?”
I think prescribing drugs that have not met the standard of FDA approval for a standard of efficacy and risk vs benefit is a dangerous practice in any drug class.
IF a patient chooses to use a drug for an off label use, is educated about risks and gives informed consent prior to using this drug, then it’s their choice. But prescribing a drug to an uninformed patient without making it clear that this is an off label use is never an ethical practice.
Nathan
Laurie writes:
“IF a patient chooses to use a drug for an off label use, is educated about risks and gives informed consent prior to using this drug, then it’s their choice. But prescribing a drug to an uninformed patient without making it clear that this is an off label use is never an ethical practice.”
I actually largely agree with you. But then why go after medicaid funding? Why not go after the prescribers? Cutting off medicaid funding for off-label prescriptions will surely cut out legitimate and life-saving treatments. Remember, many MANY cancers are treated off-label due to the fact that there just aren’t good drugs approved. I feel that is also true of these antipsychotics. Sure, they are off-label and unproven. But what alternative is there? Evidently the doctor feels that the APPROVED drugs out there are not very effective. Hence he/she is willing to take the risk on an off-label use. However, I agree with you that the doctor needs to make this clear to the parents/patients.
Mom
I notice that all of you who are against this have no idea what these off label uses are.
I have a child who is using these drugs off label. My child’s doctor made me aware that the use was off label. And I thank God that he is able to do so as these drugs have saved my child’s life.
Childhood mental illness and mood disorders are poorly understood, not recognized in the current DSM, and so good studies cannot be done as while everyone involved will agree that there is definitely something not right about that child, they don’t fit a clearcut diagnosis until after puberty. That makes it difficult to construct a study around.
The drugs do not fail efficacy in children, they just haven’t done the large scale studies required for a submission. Ask the moms of these kids who are prescribed off label if the drugs work or not and they will tell you that they do.
If any of you had a child who was suicidal and none of the antidepressants out there worked or worked without making your child go into a rage where the safety of everyone in house was at risk, you would also thank God that your child’s doctor prescribed off label. You would thank God that your child was alive, healthy, happy, and not living in an institution under suicide watch.
You should also thank God that you don’t know what that is like.
harpy
Nathan - I think part of the issue is that Medicaid is not a monolithic entity - each state has different rules for governance and there are also private Medicaid insurance providers (as I understand it). Plus, not all states approve payment for off-label prescriptions. If a drug is prescribed for a “non-indicated” condition, some providers can legally (or are even required) to refuse payment.
I don’t know where New Jersey draws its boundaries, but from the article it seems they’re not too keen on paying for off-label use.
Lisa Van S
Mom,
Are you saying that parents dont have a right to be informed? Is it your belief, that you, have the authority to make medical decisions on behalf of other parents, I dont believe you do.
truthman30
“I have a child who is using these drugs off label. My child’s doctor made me aware that the use was off label. And I thank God that he is able to do so as these drugs have saved my child’s life.
Childhood mental illness and mood disorders are poorly understood, not recognized in the current DSM, and so good studies cannot be done as while everyone involved will agree that there is definitely something not right about that child, they don’t fit a clearcut diagnosis until after puberty. That makes it difficult to construct a study around”
I would would be relieved that child “mental disorders” are not recognized (yet) in the current DSM (Sociopaths diagnostic manual)..
Ironic that you thank “god” for this, because if you researched the ethos, doctrine and history of psychiatry, you would discover that psychiatry itself is absolutely anti-soul, yet contradictory it behaves as if it has the powers to plat god with peoples lives…
Child psychiatry is in its early stages.. But..
As soon as the children’s lives become profitable enough psychiatry will be all too willing to “save them”..
And that day, is sadly, fast approaching..
A few questions though for those that may be interested in exploring..
How do we separate these “so called” child mental illnesses from what exists inherently in the child’s personality, learned behavior and reaction to environmental factors?..
When I was a kid, kids displayed all sorts of strange behavior, kids could be mean, kids could throw tantrums, kids were shy, kids were devious, kids were playful, kids started fights and some kids withdrew…It was all part of childhood in my day (and I’m not that old, just passed 30) ..
It seems that nowadays, with the advent of the psycho-pharmaceutical money machine, almost every child fits psychiatric diagnostic criteria..
Are children any different nowadays than before?..
Why the sudden huge increase in child bi-polar, ADHD, Child depression etc etc?.
Could it be anything to do with the pharmaceutical industries hunger to tap this huge market? And could it be to do with psychiatrists also hungry for new patients to exploit?..
The cynical amongst us might conclude that , a child on psychiatric drugs is potentially a life long customer of both psychiatry and the industry which supports it..
To diagnose children with “mental disorders” at stages of development which are completely normal to experience is very dangerous. In my opinion ,the “diagnoses” have dangers of becoming “self fulfilling prophecies” ..
fear 'n loafing
Mom, I hope you are as generous with your comments, when you son dies or reacts more violently that ever expected as a result of you and your doctor’s experimentation. I’m sure you have gone through harrowing times, but medicating your son’s undesired behavior as you have borders on abuse.
RobertD
Off-label usage is not inherently wrong. It’s just that where there is not a strong base of evidence doctors and their patients need to proceed with extra caution. The first check is why there are insufficient controlled studies to justify approval for use. There may be major practical or ethical problems with performing the required trials. This is a common problem in treatments for children where informed consent to expose children to randomised trials can be hard to get or justify. They may be economic barriers if the value of sales from the indication doesn’t cover the cost of the necessary trials and registration process. In either of these situation a doctor has to make a decision based on such information as is available, the alternative treatments available, and the seriousness of the patient’s condition.
However if the trials are practicable but have just not been done and properly reviewed then it it is difficult for a doctor to justify off-label use unless there are no other viable treatments.
It is important is not use legal processes to drive information about off-label use underground. In the absence of formal trials the cumulative anecdotal evidence from doctors providing off-label use is the best evidence available to guide future decisions. What is needed is a central repository for such reports and requirement to disclose information about off-label treatments and their outcomes. Periodic independent reviews of these reports could provide valuable guidance in areas where formal trials have not taken place.
Such a process would be valuable for pharma companies (and in their interest to provide financing) because it will enable a basis for responding appropriately to requests for information about off-label experience while keeping them rightly away from actively promoting any off-label use.
laurie
“In the absence of formal trials the cumulative anecdotal evidence from doctors providing off-label use is the best evidence available to guide future decisions.”
Sadly, that best evidence is dismissed as anecdotal(not scientific) by the FDA, and if there are ethical reasons to not do a clinical trial, how is prescribing to children outside of a clinical trial any less ethical??
RobertD
Laurie: When prescribing off-label outside of a trial situation the doctor, patient and parents are focused only on what is the best option for that particular patient in their specific situation. In a trial situation this choice is compromised by the trial requirements so that nobody knows which active drug or placebo is being administered and dosing schedules are constrained by trial protocols. There is an inherent conflict between the need of the patient to get the best treatment and the wider longer term needs of society to better understand what, on average, is the better treatment.
While controlled trials are very valuable they are not the only source of information on what are effective treatments. To treat them as the only basis for making decisions in all circumstances is just plan daft.
Lisa Van S
RobertD
“While controlled trials are very valuable they are not the only source of information on what are effective treatments”
No Placebo Controlled Studies; No FDA Approval.
Negative Placebo Controlled Studies; No FDA Approval.
Since when have Parents allowed Society to dictate or determine what is an effective treatment for their child.
Justice in Michigan
I think this has come up before, but does anyone know what percentage of rx’s are written for off-label purposes. I’d guess it’s enormous.
Also guessing it includes things like doxycycline for rosacea, “cortisone” injections for inflamed joints, etc. Would what is already known about such medications (a great deal) be enough to inform patients, even in the absence of approved indication?
Lori
The percentage of off-label scripts depends on the drug category. Some categories such as cancer drugs have very high off-label usage, while others have very low off-label use.
With regards to your second point, a blanket answer is probably not appropriate.
atlex
JiM,
The estimates I’ve seen suggest that off-label use is in the neighborhood of 20%-30%. However, much of that may be technically off-label, but quite accepted. In other words, there are large quantities of peer-reviewed data to support a product’s use in a condition, but, no pharma company has bothered getting an approval. This is not uncommon for for instance in older, generic cancer drugs. The more interesting figure would be the percentage of scripts for drugs when little data is available to support the off-label use. I suspect that this is far, far smaller, probably in the low single digits.
Atlex
Lisa Van S
Atlex,
Would you please e-mail me. I would like to seek your advice on an oncolgy issue.
Justice in Michigan
Thanks, Atlex. That was pretty much what I was guessing. It makes sense.
Lisa - I hope you’re OK.
laurie
“While controlled trials are very valuable they are not the only source of information on what are effective treatments. To treat them as the only basis for making decisions in all circumstances is just plan daft.”
Then why are controlled clinical studies the ONLY thing that the FDA looks at when a drug comes up for approval?
Why does the FDA dismiss their own Medwatch reports as “anecdotal”, when they are patients firsthand reporting of their experiences on a particular drug due to them not being “controlled reports”?
If a doctor is prescribing off label, without the patients knowledge, then he is in fact conducting his own trial without the rigors that the clinical trial system requires. This practice opens a pandoras box of misinterpretation of information based on one practitioners use.
We have drug approvals for a reason.
Sam
See http://www.psychdrugdangers.com/US/MedicaidPsychDrugPayments.html which lists the 2000-2007 Medicaid Payments for drugs that are not FDA-approved for pediatric use or have limited approval (this list is for all age groups; the pediatric portion is an estimated 12%), and see the National Summaries at the bottom of the States menu item > All Psychiatric Drugs which summarizes the $99.7 BILLION dollars in Medicaid Payments that have been made with the atypicals accounting for $37.3 Billion. Overall, Medicaid payments for psychiatric drugs have increase a whopping 4,772% since payments started in 1991 and these tables do not include those prescriptions that switched over to Medicare Part D in 2006.
As for pediatric abuse: if a drug is not FDA-approved for pediatric use, then doesn’t that mean that there is no “label” listing approved Indications that a doctor can then prescribe “off-label”?
The FDA says for many of these that “this drug is not approved for use in pediatric patients” (see http://www.psychdrugdangers.com/NotApprovedForPediatricUse.html for a complete list). Why? Because it has not been demonstrated that these drugs are effective and/or safe in pediatric patients. How is any off-label use (if “off-label” is even the correct term) justified?
Every one of these not FDA-approved psychiatric drugs have laundry lists of reported adverse reactions including suicidal and homicidal ideation, murders, suicides and deaths.
Why are my (and your) tax dollars being spent to pay for a completely unproven (as far as the FDA is concerned) “treatment”?
This isn’t “somebody elses” money that paid (and is paying) for these. Medicaid is fully State and matching Federal tax funded, so you either paid the full portion of the estimated $7 Billion in pediatric Rxs for unapproved drugs if the patient resided in your State, or you paid half with your Federal taxes if the patient resided in any other State.
marl
Most of these Psych drugs are NOT needed and the damage they do to the brain chemistry is tragic…. the damage to family relationships even worse.
See this blog…
http://blog.myspace.com/index.cfm?fuseaction=blog.ListAll&friendID=400510998
look at the videos and click on the links.
http://profile.myspace.com/index.cfm?fuseaction=user.viewprofile&friendid=400510998
NJ… stop drugging our kids, teens, moms, dads….society….all for big Pharm $$$$.