Furious Seasons

November 26, 2007

Atypical Nation: Will States Lawsuits Lead To Battle Over Drugs?

Vaughan at Mind Hacks had a good post on the looming battle between makers of atypical antipsychotics and the various states who have sued them (11 so far), and the ones who are expected to in a multi-state action (25 more states or so). Here's an interesting bit:

"The most recent lawsuit from the state of Arkansas [pdf] alleges that, among other things, the drug company deliberately rigged their clinical trials to show less side-effects, failed to warn clinicians about the dangers and promoted their drug illegally.
"While people like psychiatrist David Healy have been making these allegations for years, the fact that a large number of US states are willing to take the allegations to court signals that we are about to see a huge battle, and hopefully a period of significant reform, in how drug companies develop, test and market their products."

As I've noted before, I consider it hugely significant that Arkansas made that allegation, as the state presumably has evidence to back up its assertion. I hope that evidence eventually becomes public in some fashion.

But my fear is that it won't, and that there may not be much of a battle at all. Why? Risperdal goes off patent in about one month--except for some extra and short-lived pediatric indications--so I'm not sure that Janssen/J&J has a huge incentive to fight Arkansas and the other states that are suing it in order to protect what is soon to be a generic product. It's likely much cheaper for the companies to settle the case (liability insurance will cover much of the cost), write an agreement in which they admit no fault and manage to deep six any documents and other evidence of bad behavior, and move onto Invega.

Zyprexa goes off-patent in 2011 and Seroquel is off-patent the same year as well (not sure about patents on Seroquel XR), so one wonders how much incentive those companies have to fight the state suits, or whether they will just settle the cases and move onto whatever is next for them.

Maybe I am a bit too cynical, but it wouldn't shock me if that's how things played out. After all, Lilly has already settled about $1.3 billion in lawsuits over Zyprexa. Why stop now?

As for reform in how pharma companies develop, test and market their drugs, that's only going to happen in the US if Congress and doctors raise a stink. So far, doctors and Congress are batting .000 on this one.

Posted by Philip Dawdy at November 26, 2007 12:05 AM

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Comments

They may only have indications that there was fraud involved, and hope to find more during the litigation.

Expecting the United States Congress to ever go after pharma companies in a serious way is as foolish as campaigning for good government in Palermo. The only hope I can perceive on the horizon is Rep Ron Paul, who would fight to abolish the FDA, and let society and individuals make their best guesses about what treatments are best.

The only thing worse than no FDA is a horribly corrupted FDA.

Posted by: Phil at November 26, 2007 09:18 AM

Where State AG's have sued to recover on behalf on Medicaid, are the plaintiff states doing anything with respect to prescribing practices, SGA utilization, monitoring for metabolic syndrome, etc? Wouldn't it be the epitome of irony if state Medicaid programs did absolutely nothing to address the very practices which underly the litigation.

Posted by: Joe at November 26, 2007 07:52 PM

I think you are right to be cynical. It's just a question of how much the companies ultimately have to shell out. Using Zyprexa as the model, the internal documents sit right on your website and are in the possession of every state that has brought suit as well as committees in the House and Senate. See anything happening? Any CRIMiNAL cases brought? With the living proof right here? FDA FOIA information showing the deaths? I'm with you - not holding my breath but seeing it more as the states getting their money back and a little ka-ching for the drug companies. Lilly's payout is a drop in their bucket and this one may be, too, unless a courageous AG takes it a step further and brings a criminal case. So far, nada.

Posted by: Sorrowful at November 26, 2007 08:18 PM

Being a state attorney general is no longer about serving justice, but about getting elected, and ONLY about getting elected.

Some people will not like to hear this, but there was a very good reason why our founding fathers did NOT allow the poor and uneducated to vote.

Posted by: phil at November 27, 2007 04:08 AM

Phil,

I'm not sure abolishing the FDA is the right thing to do and yet I'm with you in supporting Dr. Paul. We need a different system.

Our system doesn't work as is evidenced by the fact that even as the states bring these lawsuits, I believe all of the same states still legally force people in "assisted" outpatient therapy to take both zyprexa and risperdal. I don't think one of these states, being fully aware of the dangers of these drugs, has prohibited them from being prescribed, and as I said, forced in AOT. Forced "treatment" that doesn't work but in fact harms while shortening lifespan is torture.

Posted by: Sally at November 27, 2007 06:09 AM

Ben Hansen reported that Lilly has moved into 25 states to "manage" the meds of people with mental illness. Right. Do we think these states will make any changes? I believe a handful, at best, of the states have tried registries for Zyprexa, though banshees from NAMI have gone on the warpath about this. Now that we know that Risperodal is a close second in the lethal department, and is being given to children with autism and to adolescents, we can expect more child death. Notice the FDA having any hearings, or Congress? Definitely not a priority.

Posted by: Sorrowful at November 27, 2007 07:24 PM

It seems J&J is dropping risperidal production and substituting it with poliperidone a new drug which is similar to the first one

Posted by: rosumella at November 29, 2007 02:03 AM