Arkansas Sues AstraZeneca Over Seroquel For Illegal Marketing And Fraud

UPDATED: 1:48 p.m. PST with AZ's response.

Arkansas State AG Dustin McDaniel yesterday brought suit against AstraZeneca for illegal marketing and fraud, among other charges, in its sales of Seroquel to various agencies in the State. The suit, which somewhat echoes a lawsuit filed by McDaniel last fall against Janssen/J&J over its handling of Risperdal, another atypical antipsychotic, alleges that the company knew of risks associated with the use of the drug, primarily diabetes and weight gain, but did not properly warn physicians or the public. McDaniel alleges that the drug was unreasonably hazardous and dangerous.

Jim Minnick, a spokesman for AstraZeneca, responded to the suit in an email. "AstraZeneca denies the allegations brought by these lawyers. Seroquel has helped millions of people suffering from a variety of debilitating mental illnesses, and allowed them to lead meaningful lives. AstraZeneca will vigorously defend itself in this lawsuit."

The lawsuit is online here (1.5 MB .pdf).

There are several stinging accusations in the lawsuit, which primarily focuses on promotion of the drug for use in children and the elderly. Not that the state is ignoring accusations for how the drug may have been aimed at people diagnosed with schizophrenia.

"Seroquel's premarketing clinical trials did not support an assertion that it was less likely to cause extra pyramidal symptoms than traditional antipsychotics....Defendant's trials were designed to produce similar rates of EPS in patients sorted into placebo groups and those taking Seroquel."

And concerning diabetes and hyperglycemia:

"[T]hey implemented marketing strategies that blamed diabetes and hyperglycemia on the schizophrenic population at large rather than on Seroquel...despite the fact that defendant's own internal studies and adverse event data revealed that Seroquel increased the risk of diabetes, even among schizophrenics."

Among other things, the suit alleges that the company sought ghostwritten research and paid thought leaders to support AZ's marketing aims, that AZ failed to reveal material facts about hypotension and cataracts, that AZ knew the drug to be unreasonably hazardous and dangerous, that it illegally marketed Seroquel for use in children and elderly and for depression and other psychological conditions, that the company engaged in an "elaborate and clandestine promotion of Seroquel for non medically necessary uses," that AZ engaged in "illegal direct solicitation of physicians."

In addition to recovering costs of care for people who developed diabetes and other injuries, the state is seeking an injunction against AZ to stop its off label marketing of the drug.

I reported earlier today that the state had also sued Eli Lilly over Zyprexa. A spokesman for the AG tells me that that was an erroneous media report in Arkansas and that the state has not yet sued Lilly.