The Zyprexa Chronicles: Connecticut Sues Lilly Over Zyprexa

The state now becomes the tenth in a string of states suing the maker of Zyprexa. It's the usual set of allegations, as WSJ's Health Blog notes, and then there is some eye-popping detail:

"Connecticut is looking to recover more than $190 million the state spent on Zyprexa over many years, on the grounds that Lilly illegally marked the drug for unapproved uses and concealed risks associated with the drug.

"'The illegal marketing campaign exploited children and senior citizens — causing severe weight gain, diabetes and cardiovascular problems,' Blumenthal said in a statement. 'This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies.'"

The state AG's office put it a lot more aggressively in a press release:

"Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children."

That sounds tasty. Then there's this:

"'The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems,' Blumenthal said. 'This scheme involved payments to public officials, bogus educational events 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.

"'Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa.

"'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 abandoned 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.'"

Payoffs? Ghostwritten articles? Marketed for indications for which the drug was not approved? The state is suing partially under the federal RICO Act (Racketeering Influenced and Corrupt Organizations Act), which was a law originally designed to prosecute criminal organizations such as the Mafia.

These are the words and deeds of Connecticut's AG Richard Blumenthal, who I assume has the evidence to back these allegations. I point this out because I know if I posted this entry over on Daily Kos, then some concern trolls would swing by and accuse me of murder for suggesting that there's anything wrong with Zyprexa or other psych meds. Well, guess what? I am not the one making these allegations. An elected official is. Just as in the cases of Arkansas with Risperdal and Montana and Utah with Zyprexa.

But there's more:

"Under the façade of independence, doctors at "educational" forums urged peers to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, while omitting details about serious side effects; and public officials in various states promoted Zyprexa for unapproved uses in adolescents at detention centers and nursing homes.

"In reality, Eli Lilly paid these "independent" physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties.

"In some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants and other compensation.

"Eli Lilly also illegally promoted Zyprexa for the treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders and generally as a mood stabilizer. Zyprexa has never been approved by the FDA for any use in children, not even for children with schizophrenia or bipolar disorder."

And:

"PEER-SELLING ENTERPRISE: Lilly compensated medical marketing firms and several physicians who routinely promoted Zyprexa to peer physicians in venues nationwide. Physicians who attended "educational" events were deceived into thinking that the events were independent of Eli Lilly. Conspiring physicians concealed information about the efficacy of Zyprexa in off-label uses and dangerous side effects, as well as the doctors' financial ties with Eli Lilly.

"THE ROLE OF PHARMACIES: Eli Lilly targeted pharmacies, particularly those that serviced long-term care facilities. Typically, an Eli Lilly sales representative and a pharmacy would agree that the pharmacy formally request funding from Eli Lilly in order to present an "educational program" - for example, a program on the treatment of dementia.

"Both the pharmacy and the Eli Lilly representative would agree that the program include a presentation by a doctor - hand picked by Eli Lilly - who would promote off-label use of Zyprexa for dementia. The Eli Lilly sales representative would file a formal request funds from Eli Lilly for an educational grant. Eli Lilly would issue a check to the pharmacy and the pharmacy would issue a check to the doctor, concealing compensation from Lilly to the physician.

"PUBLICATION ENTERPRISE: Eli Lilly created a "Publication Enterprise" that hired writers to create articles, and then paid specialists to "author" the articles. The articles only included favorable results of Eli Lilly's own internal trials, and suppressed unfavorable results, including a clinical trial that failed to show Zyprexa's efficacy for bipolar disorder.

"PUBLIC PAYER ENTERPRISE: Eli Lilly captured the Medicaid and Medicare markets by paying officials in various states, paying them substantial sums of money to spread falsehoods regarding the efficacy, safety and side effects of Zyprexa and to promote off-label use. Eli Lilly targeted those who oversaw treatment for people with serious mental illness, including patients in mental hospitals and clinics who are on Medicaid - among the largest users of antipsychotic drugs. Lilly also influenced prescribing physicians to over-medicate senior citizens in nursing homes and adolescents in detention centers with antipsychotics."

I cannot wait to see a copy of the complaint itself. Some these accusations involving Zyprexa, kids and ADHD can be little else but allegations involving Big Pharma's end of the bipolar child paradigm. Keep in mind that since the alleged bipolar child diagnosis doesn't officially exist in the DSM (yet) that many of these kids with alleged childhood bipolar disorder (which is to say many of the boys with alleged childhood bipolar disorder) are being carried on states' Medicaid books as having an ADHD diagnosis (or ODD or conduct disorder).

So, yeah, this will be a fun trial.

Interestingly, someone at Lilly told the AP:

"A spokeswoman for Eli Lilly says that the claims in the lawsuit are without merit and the company is committed to high ethical standards and to promoting medications only for approved uses."

Oh, please. I wonder how much Big Pharma's spinmeisters get paid. See these posts to get a sense of the merits of Lilly's response and its promotion of the drug only for approved uses.

Meanwhile, trial continues in Alaska in that state's case against Lilly. There's not much to report there so far, except an expert witness for the state is getting $600 an hour and a juror dropped out of the case due to a dental emergency. Expect more interesting news when Lilly puts on its defense, likely beginning sometime next week, and its witnesses face cross examination by lawyers who stand to make tens of millions of dollars if they win the case for the state. That ought to be interesting.

No word on the previously rumored settlement between Lilly and the feds and a combine of others states considering similar lawsuits against Lilly over Zyprexa. I bet everyone is sitting back and watching how Alaska plays out.

Posted by Philip Dawdy at March 12, 2008 12:05 AM
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