AZ, Seroquel and the Law

March 18th, 2009 | Sources: Wall Street Journal

Subjects:

In the summer of 2005, physicians were growing concerned that Seroquel, AstraZeneca’s $4.4 billion antipsychotic drug was causing their patients to gain weight, so AZ employee Christine Nee instructed her sales force to assure physicians there was no evidence its drug did that.

AZ“Our objective is to neutralize customer objections to Seroquel’s weight and diabetes profile…(and to then) refocus the call” Ney said.

The problem AZ’s got is that 5 years earlier, its drug-safety expert Wayne Geller told Dutch regulatory authorities there was “reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes mellitus in certain individuals.”

These tidbits were culled from 100 evidentiary documents unsealed last week as part of an agreement between the Swedish/British giant and thousands of plaintiffs who believe they’ve been harmed by Seroquel.

holdin'ourownsofarIt was not immediately clear how the new developments would affect the progress of the long, multi-theater legal battle, in which AZ had actually been doing pretty well for itself, thank you very much.

After many of the cases were consolidated in Florida’s US District Court, AZ scored a big win when the first 2 test cases were thrown out because the judge felt the evidence failed to prove Seroquel caused the plaintiff’s diabetes.

Next thing you know, 2,300 more cases were dismissed on similar grounds.

But AZ still faces battles in Delaware, Pennsylvania, Montana, Arkansas and South Carolina state courts, where among other things, states are claiming the drug giant bilked them into paying for off-label use of Seroquel.

AZ spokesperson Tony Jewell told the Wall Street Journal that, “from the time it was first approved, the Seroquel labeling alerted physicians that diabetes mellitus, hyperglycemia and weight gain had been observed in clinical trials. We’ve continued to update the label as the findings have developed.”

Jewell added that Geller’s document didn’t reflect AZ’s position when he wrote it. “In fact,” Jewell clarified, “it was not Dr. Geller’s ultimate view either. It was an initial draft for discussion purposes.”


 

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