Furious Seasons

November 21, 2007

Atypical Nation: J&J's Risperdal "Defective," Company Lied, Thousands Died

As I reported earlier, the State of Arkansas yesterday sued Janssen and its parent J&J over allegations concerning its atypical anti-psychotic Risperdal and how the company developed and marketed the drug. The lawsuit is a real eye-opener and confirms many things I've been saying on this site for over two years and for two years before that in print: there's something wrong with the atypicals and how deeply they've ended up embedded in American culture.

The suit alleges that, among other things, Janssen/J&J put a drug it knew to be defective on the market in 1994, even though it knew the drug was defective and after the company had, in the AG's account, cooked and jury-rigged results of pre-marketing clinical trials to make it look as though the drug had fewer extra-pyramidal side effects (EPS) than older anti-psychotics when in fact it had virtually the same EPS profile as older drugs. There are other allegations--off-label marketing for use in children and the elderly, a campaign of covering up the drug's side effects, allegations of kickbacks to doctors and so on--but they almost pale in comparison to the EPS allegations, which ought to make anyone wonder how the heck this drug got approved in the first place.

One of the charges against Janssen/J&J is for fraud. Sales of the drug in 2006 were $4.2 billion. Depending on who is estimating, Risperdal is the most used anti-psychotic in the world.

The EPS allegation, the first I've seen in any of the ongoing lawsuits against J&J, goes right to heart of why atypicals became so popular amongst doctors: they were supposed to cause fewer side effects (a la SSRIs versus older anti-depressants in the 1980s), and therefore docs could safely give them to patients of every stripe for long-term use. Use of the older anti-psychotics was tightly restricted by docs (except among schizophrenics) because they were felt to cause so much EPS (aka zombieism) that it would be unethical to hand them out to anyone but the very sickest of patients. But atypicals like Risperdal were supposed to be safe for one and all.

As it turns out, that was not the case. As a result, millions of people have paid a heavy price for using Risperdal--I am one of them--including at least 1,000 people who died as a result of using the drug, according to the FDA's adverse events database, as I have previously reported.

J&J and Janssen lied. People died, or were injured and sickened by the willful action of one of the largest pharmaceutical companies on Earth. That's the view of the Arkansas Attorney General Dustin McDaniel. Other states including Texas are suing J&J over Risperdal as well.

Anyone who thinks I have been too harsh in my commentary on these drugs, too rough on the pharma companies who make and market them, too tough on the doctors who gave them to patients like me and, as a a result, wrote me off as a wingnut, ought to read this (and other) lawsuits against the makers of these drugs and see just how wingnutty McDaniel is. Because he isn't. And neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and deception that have gone with the atypicals' use in America are right up there with the lies propagated about the use of cigarettes by American tobacco companies.

Now for a few particulars from the suit. First, the EPS allegations:

"Risperdal's pre-marketing clinical trials did not support an assertion that it is less likely to cause EPS than traditional antipsychotics....Defendants' trials were designed to produce similar rates of EPS in patients sorted into placebo groups and those taking Risperdal. In order to produce their desired result, defendants selected patients for the placebo groups that were already in the course of treatment with high doses of typical antipsychotics....
"Defendants claimed in their marketing that patients taking Risperdal were as likely to develop EPS as patients taking nothing and thus less likely to develop EPS than patients taking traditional antipsychotics."

That is a staggering accusation and I assume McDaniel has documents to back it up. So far Janssen and J&J have not commented on the suit or its allegations.

In 2002 and 2003, I experienced mild EPS on Risperdal after being on it at .5 mgs a day since December 2000, and took myself off the drug against my then-doctor's wishes (he insisted that EPS and other problems didn't occur on Risperdal). Just so you know my bias on this issue.

Other allegations:

"Janssen heavily marketed and promoted Risperdal [in the mid-1990s] for its approved indication, treatment of adult with schizophrenia, and for multiple non-medically necessary uses of the drug, for example, ADHD, depression, anxiety, mood disorder, bipolar disorder, and aggression associated with late-onset dementia."

I was pressed to take the drug off-label (my then-doctor never explained that part) three years before the drug received approval for use in bipolar disorder in 2003. Just so you know how I felt when I read the following:

"Despite having been on notice for years of the potential for deadly diabetes-related side effects, defendant opted for the bare minimum of clinical trials, of limited duration, such that no side effects were likely to be revealed."

The suit further alleges that J&J knew of weight gain and resultant diabetes issues with the drug but worked to conceal the drug's true safety profile. The state introduces evidence that in 1999, the FDA busted Janssen for marketing Risperdal for off-label use in the elderly and that the FDA informed Janssen it was engaged in "false and misleading" practices (see pages 9 and 10).

As part of its strategy in the 1990s to expand Risperdal's market beyond its approved use in schizophrenia, the suit alleges that:

"Defendants sough ghost written research and paid 'key opinion leaders' to support defendant's marketing aims. These 'key opinion leaders' were nothing more than third-party consultants and researchers who were put on defendants' payroll to support and lend credibility to defendants' specious scientific and marketing representations."

Can't wait to find out who the researchers were who helped them with bipolar disorder.

There is more evidence and allegations contained in this lawsuit. I'll get into those later.

For now, this: Attorney General McDaniel alleges that Risperdal was "defective, unreasonably dangerous and hazardous" and that Janssen/J&J knew this and put the drug on the market anyway. "At the time Risperdal was sold or placed on the market, it was in a defective condition and unreasonably dangerous to users and consumers."

In addition to allegations that the companies violated the state's Medicaid fraud laws, the state alleges that the companies violated the state's deceptive trade practices act, engaged in negligent behavior, and engaged in fraud and misrepresentation and "unjust enrichment."

Posted by Philip Dawdy at November 21, 2007 12:01 AM
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Comments

In August of 1999, my daughter was 11 years old. After an adverse reaction[suicidal ideation]on Imipramine, I took her to a psychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox, which accelerated her "thoughts", and the psych recommended hospitalization.THERE, inpatient at age 11--was where they put her on Risperdal. Her eyes locked looking up, she was so pale and couldnt move her legs--I thought she was dying. I was then clueless about psych meds, and trusted doctors.

I will never forget seeing her and thinking my 11 year old looked like she was dying. That was in 1999, what fucking nerve this company has to place my daughter at risk that way, and the smack in my face as a mother and for my daughter, is that Eli Lilly's Zyprexa is what replaced that Risperdal!

For reading about Biederman,Wozniak, Wilens and Spencer and the study for Risperdal use in kids way back in 1999, as well as how it was approved for use in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood Bipolar and just need not wonder any further, what my daughter's "OCD" dx "changed" to within weeks---yeah that's right, Childhood Bipolar Disorder, in 1999.

I hope this company and Eli Lilly are ready for a patient lawsuit, because I'm rolling up my sleeves.

They can fucking pay for her to live somewhere decent, for her long term care at age 19. I have to say, this is a topic everyone should not disregard, pay attention to these killers in our midst. I am lucky my daughter is alive, and at what cost!!?

I really do not want to visit her in a residential care facility at age 19 for Thanksgiving, and I am. Does anyone understand why this angers me.

Posted by: Stephany at November 21, 2007 08:52 AM

Phil, your analysis is missing, what I think, is the critical point, which is: disclosure of side effects of a particular drug, here Risperdal, is not a substitute for approval of the use of the drug in the first place. In other words, knowing all the bad effects of Risperdal cannot substitute for its governmental approval for consumers' use. The FDA, a governmental authority charged with monitoring the safety and effectiveness of medications, approved Risperdal. Other than a few warnings, the FDA has done nothing to stop its marketing, notwithstanding the fact that Risperdal was unnecessary at best (there are better or similar quality drugs on the market already), or dangerous (and should be banned) at worst. The FDA is not a party to the lawsuit. The plaintiffs in the lawsuits are not consumers but the states. The states are not representatives of consumers and whatever money they recover will go the states . The states are not seeking to ban Risperdal and if they did, they probably couldn't. What's this lawsuit is all about? It's about local governments seeing an opportunity to get some money out of drug companies. What the lawsuit doesn't address is that drugs are not securities; a prescribing information is not a prospectus; the concept of let the buyer beware (caveat emptor) can have no application to prescription medicines, that consumers cannot understand medications and that individual doctors are in no better position that consumers to understand medications either. What the lawsuit proves is that the FDA has failed consumers once again. So it's a useless exercise as far as individuals are concerned.

Posted by: Red Rover at November 21, 2007 09:03 AM

"What the lawsuit proves is that the FDA has failed consumers once again."

That's exactly right. So who really is at fault for innocent death and bodily injury to American citizens? Like Rebecca Riley?

Posted by: Stephany at November 21, 2007 10:51 AM

I was put on a very low dose of risperdal while inpatient for depression. Not psychosis. I had muscle spasms in my legs. I showed my psychiatrist, and he tried rubbing the spasming muscles to get it to stop - didn't work. He told me it would go away as my body adjusted to it. I refused to take any more for 3 reasons:
1. I wasn't psychotic
2. Muscle spasms aren't really all that comfortable.
3. I didn't want to be fat

Posted by: Lisa at November 21, 2007 11:54 AM

I think I like this McDaniel guy (assuming that he played a significant role in the wording of the Complaint). Either way, what this action should do is bring into the public domain a whole bunch of really useful documentation. Let's hope that McDaniel doesn't back down, if Janssen offers to settle.

This has to stop. I can barely believe that this is solely about money, and the protection of powered interests, and yet that appears to be the only explanation that wouldn't get one banged up in an institution! The sheer scale of the fraud is enough to have most people disbelieve it, and the fact that regulators and government departments have overseen it for years is a matter of grave concern. It reaches not only into government, but into academia and the financial markets (pharma stocks are a "banker," as you're probably aware.

The upshot is that there is a massive motivation to keep a lid on this nonsense, which the deaths of trusting patients just don't seem to begin to counteract. Personally, I don't expect anybody to do a damn thing about this, so I'm just going for routine humiliation, and if informing the public one by one in a sufficiently compelling way is the only way to undermine these bastards, then that's what I'm going to do.

I, for one, will not be told that the side effects I experienced on fluoxetine were my fault. And when those fuckers are lying on the floor screaming for release, and there's nobody there to help them, they'll know what it's like in the darkest of dark places that I've visited. And I'm going to leave them there, to find there own way out. Just as I was.

Matt

Posted by: Matthew Holford at November 21, 2007 02:59 PM

Janssen / J&J could always make a "cost saving" argument akin to that put forth by Phillip Morris. Sadly, here it might garner some support given that so few care that persons dealing with a mental illness die well before their time in this supposed Era of Wellness and Recovery.

Philip Morris Claims Smokers Help Economy, British Medical Journal, July 21, 2001.

Smokers are doing their country a huge favour by boosting tax revenue, dying early, and not drawing a pension, according to a report by the tobacco giant Philip Morris.

http://www.mindfully.org/Health/Tobacco-Helps-Economy.htm

Mortality and Medical Comorbidity Among Patients With Serious Mental Illness, Psychiatric Services, October, 2006.

Observed deaths in our patient population [20,018 patients admitted to an Ohio public mental health hospital between 1998 and 2002 ] were more than three times as high as expected, compared with the U.S. general population. The mean age at death for ODMH [Ohio Department of Mental Health] decedents was 47.7±15.3 years, corresponding to an average of 32.0±12.6 years of potential life lost per patient.

http://psychservices.psychiatryonline.org/cgi/content/full/57/10/1482

Posted by: Joe at November 21, 2007 04:08 PM

Ok now I am scared. I just started a new drug which as it would happen has a black box warning.

NOT ON THE CONTAINER, NOT IN ANY LITERATURE. I know this from a search.

All that is on the bottle is do not operate heavy machinery. As if they think I have a John Deere.

And when I told my\ new shrink today the suicidal ideation is getting worse, she said "we have a bed in the hospital for you".

Sigh. I am mad as hell, I am screaming, are these people at these drug companies think we are dumb??

Philip, keep up the good fight. I am so glad you don't kiss a** like another journalist or organizations I could name, but I;m a lady. We so rely on you for news. Just the fact's ma'am.

Posted by: susan at November 21, 2007 06:32 PM

Stephany: Have you thought about suing the psychiatrists involved in your daughter's treatment? The statute of limitations might run out on you if you don't.

Posted by: Red Rover at November 21, 2007 07:10 PM

Anyone who wants to know more about the horrors behind the approval of atypical antipsychotics should read Robert Whitaker's Mad in America. It's all there and it will leave you speechless. The fact the FDA is complicit in these shenanigans is mind boggling. I hope the lawyer in Arkansas gets his hands on it. Frontline also did an amazing documentary on clinical trials although it wasn't limited to psych drug trials which are the worst offenders. One day maybe criminal charges will be filed. As someone who lost a loved one to this poison I think they're overdue.

Posted by: Sara at November 22, 2007 08:39 AM

Then there's the theory advanced by an MD by the name of Kunin (google Kunin and tardive) that neuroleptics cause the tardive syndromes by leaching manganese out of the brain. Risperdal has a chemical structure similar to that of haldol.

Bizarrely enough, he's actually been able to help patients with an "intractable" illness. Imagine that!

Posted by: Jeremy at November 25, 2007 11:13 AM