December 17, 2008

Allegation: J&J Defrauded Texas In Risperdal Use

Many of you are already aware of the two-year-old lawsuit brought by the State of Texas against J&J/Janssen over allegations that the drugmaker worked to influence the Texas Medication Algorithm Project to favor its star atypical antipsychotic Risperdal and made payoffs to state officials, among other allegations. A similar children's medication project is under investigation by state officials.

Yesterday, the state amended its complaint to include allegations that the company gave out false marketing materials and used fake advocacy groups to get its then-expensive drug (which is now a generic) used in the state MedicAid program. Although the state isn't naming names in its complaint (who is the mysterious fake advocacy group?), the complaint is worth reading. You can download it from the Dallas Morning News' website.

I've read the complaint and it's the usual set of allegations that J&J/Janssen took a drug designed to treat schizophrenia--not a very efficacious drug at that--and pressed to have it used off-label in adults and children for a number of other indications. In the process, the company used state officials as pitchmen for its drug and somehow got its drug on the children's list--which was never implemented and was recently suspended altogether--eight years before it was approved for use in kids and teens by the FDA. Earlier this year it was revealed that Texas officials and researchers wanted to use McDonald's gift certificates as inducements to get kids on medication trials.

According to the paper, Janssen strongly denies the allegations.

"Janssen officials vehemently deny they have done anything improper in Texas and are fighting the suit, in which the state seeks to recover millions of dollars. Kara Russell, a spokeswoman for the New Jersey-based company, said that Janssen is cooperating with the investigation, but that the allegations are untrue.

"'We are committed to high ethical standards and responsible behavior,' she said. 'We take this obligation very seriously.'"

It'll be interesting to see where this all winds up. Earlier this year, the former head of TMAP, John Rush, slinked off from Texas to Singapore.

Posted by Philip Dawdy at December 17, 2008 12:01 AM
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Comments

I wonder what will happen to psychiatry once they run out of expensive medications to sell and force on the mentally ill.

Posted by: mark p.s.2 at December 17, 2008 04:27 AM

I told one of Rush's cronies they'd never get away with it!

Posted by: s at December 17, 2008 05:04 AM

fake advocacy groups
Wow!
They are everywhere!

Posted by: Ana at December 17, 2008 05:37 AM

To be more precise, I made it clear that the odds were very low.

Posted by: s at December 17, 2008 06:32 AM

Mark, then we'll move on to orthomolecular psychiatry.

Posted by: Carl at December 17, 2008 12:02 PM

The pharmaceutical industry is a billion dollar business, there is no way it will ever disappear.

Posted by: Stephany at December 17, 2008 02:09 PM

Orthomelcular Psychiatry may be less dangerous physically, but its just as dangerous ideologically, suffers from the same poor science regular psychiatry does, and turns our faces away from what causes the majority of what gets called mental illness -- bad federal, state, community, and cultural policies, inadequate and dangerous communities, inadequate and dangerous families, etc. yes, its less dangerous than regular psychiatry, which isnt saying a whole lot.


But little children dont needd to be pumped full of mega doses of vitamins either. They need better homes and communities, and the whole counrty could beenfit from better nutrition -- but that isnt whats key here.

lock a baby monkey in a box for two weeks.

does anyon agree?

Posted by: JC at December 17, 2008 02:42 PM

Reading the complaint, I think the evidence points straight to NAMI. The complaint does not allege creation of "phony advocacy groups" -- it does, however, say the company "funded and deployed" existing advocacy groups, and "shaped their message", to advance its commercial interests. NAMI's 2006 "Report Card on the States" gave Texas a "C" (actually pretty good... Illinois and Iowa got F's, and only a couple of states scored B's). It listed as a key "plus" in Texas' column the creation of TMAP and the loosening of restrictions on antipsychotic meds. Here in Illinois their biggest campaign in recent years has been to keep Zyprexa on the state Medicaid formulary. Yep, put my money on NAMI.

Posted by: Johanna at December 17, 2008 04:16 PM

I'm sorry everyone but I am just PISSED OFF today at all this psych med bullshit that has gone down in my life, I swear to god. I was on Risperdal for a few days and it made me nervy and act bizarrely and I finally ended up having a nervous breakdown (in the middle of the movie "Transformers") and my family had to come and rescue me.

I'm just angry that I thought these pills could work for me. I know they work for some and god bless you if you do. I wish I was like you but instead I get side effect and go insane and it's to the point where I don't know who i am anymore.

I'm just fed up.

Posted by: David at December 17, 2008 08:30 PM

What is so frustrating is how biased information makes it into these treatment guidelines which essentially sells the notion that these treatments will work when in fact they often fail to work. It gives the notion that these conditions can be successfully treated with the current available medications or psychotherapy. But for too many people that is not the case and little unbiased research is spent to find new treatments be it medication, psychotherapy, or whatever else.

Posted by: Tony at December 18, 2008 10:04 AM

And let's not forget the story of Dr. Stefan Kruszewski

http://www.bmj.com/cgi/content/full/329/7457/69

Posted by: Doug Bremner at December 18, 2008 10:48 AM

Hello Philip,
No need to actually post this comment, I just wanted to let you know, the link to the children's investigation isn't working correctly. It's just got a bit of extras on the end (removed here): http://www.furiousseasons.com/archives/2008/08/fraud_investigation_of_texas_kids_mental_health_program.html


Posted by: spiritual_emergency at December 18, 2008 10:16 PM

I was on Risperdal when I was 14. The side effects were really bad. Risperdal was the worst drug I was ever on. I was 14 years old and taking Risperdal and experiencing horrible side effects. I was never warned of them and had no idea what was going on. The doctor told my parents about how safe it was and didn't inform them of the side effects. It is completely unfair that at 14 years old I was put on this dangerous antipsychotic for anxiety. I was on Risperdal for eight months when I was 14 and it was awful. The worst drug ever. This was in January 2002, before it was approved by the FDA for use in teenagers. Risperdal was a horrible drug and it's wrong that so many teenagers had to be exposed to it like I did. I've been off of Risperdal for seven years and am now off of all drugs. I was on so many different drugs during my teenage years and Risperdal was by far the worst. I'm much better now, seven years later. However, I am going through intense anxiety and i became anorexic.

Posted by: PrincessMoon at December 28, 2008 06:00 PM
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