Tuesday, March 16, 2010

AstraZeneca - Seroquel: it's nearly jury time

March 16 (Bloomberg) -- AstraZeneca Plc’s antipsychotic drug Seroquel helped cause a Vietnam veteran to develop diabetes, a lawyer for the man argued in the first case to go to trial over the medicine.

Researchers for AstraZeneca, the U.K.’s second-largest drugmaker, acknowledged as early as 2000 that Seroquel could affect users’ blood-sugar levels and lead to significant weight gain, attorney Jerry Kristal told jurors today in state court in New Brunswick, New Jersey.

“Their own top scientists have said there’s an association between Seroquel and diabetes,” Kristal said in closing arguments in Ted Baker’s case against AstraZeneca. Jurors may begin deliberating tomorrow.

Baker’s lawsuit is the first of about 26,000 over Seroquel to go to trial. Lawyers for Baker and other former Seroquel users contend London-based AstraZeneca mishandled the drug, ignoring or downplaying its links to diabetes and weight gain to protect sales.

AstraZeneca’s lawyers countered in their argument that studies found Seroquel doesn’t cause diabetes and Baker’s disease stemmed from his lifestyle and diet. Seroquel, with sales of $4.9 billion last year, is AstraZeneca’s second-biggest seller after the ulcer treatment Nexium.

“He was already on the way to diabetes before he started taking Seroquel,” Diane Sullivan, one of the company’s lawyers, told jurors today. “Type 2 diabetes is really, really common,” Sullivan added later. “People with Mr. Baker’s risk factors get diabetes every day.”

Workforce Reductions

AstraZeneca officials said this month that they will end research and development into psychiatric medications at the company’s U.S. headquarters in Wilmington, Delaware, as part of a companywide reorganization.

The drugmaker’s executives plan to eliminate 11 percent of AstraZeneca’s workforce by the end of this year as part of a restructuring that will cost $2 billion through 2013. The cuts would include 550 jobs in Wilmington.

AstraZeneca’s American depositary receipts, each representing one ordinary share, rose 8 cents to $44.39 at 4 p.m. in New York Stock Exchange composite trading. The shares fell 6.5 pence to 2,911 pence in London today.

Baker, a Vietnam veteran who contends he was taking Seroquel to deal with lingering effects of post-traumatic stress syndrome tied to his military service, is among thousands of people with claims pending in state court in New Jersey alleging that AstraZeneca misled U.S. consumers about the drug’s health risks.

Weight-Gain Documents

Earlier this month, a U.K. regulatory panel ruled that AstraZeneca didn’t accurately describe Seroquel’s side effects in an 2004 advertisement to doctors. The company declined to appeal that finding.

Baker’s lawyers argued that evidence in the case showed AstraZeneca executives resisted researchers’ calls to toughen the descriptions of side effects in Seroquel safety documents to protect sales.

When scientists pushed to have the word “limited” removed from Seroquel’s weight-gain description in internal documents, AstraZeneca’s marketers balked, Kristal said.

Documents show executives complained the alteration “is potentially damaging to Seroquel,” Kristal said. “That doesn’t sound like AstraZeneca is putting patient safety first.”

Financial considerations also prompted company officials to downplay Seroquel’s diabetes risks in reports to the U.S. Food and Drug Administration while warning each other about those risks in internal documents, Kristal said.

‘Negative Information’

AstraZeneca officials “didn’t want to share negative information about their drug” with regulators because “it affects sales,” he said.

Sullivan said in her closing argument that Baker had been suicidal and clinically depressed when he started taking Seroquel in 2000 at the behest of doctors at a Veterans Administration Hospital in Louisiana. Doctors saw immediate improvement, the AstraZeneca lawyer said.

“The truth is that Seroquel saved Mr. Baker’s life,” Sullivan said. “And what does AZ get for that? It gets hauled into this courtroom and accused of the worst kind of things.”

Sullivan urged jurors to “use your common sense” and reject Baker’s attempt to blame AstraZeneca for his medical condition.

“It’s human nature that when something bad happens, we try to find a villain, someone to blame,” she said.

The case is Baker v. AstraZeneca Pharmaceuticals LP, MID L 1099 07 MT, Superior Court of New Jersey, Law Division, Middlesex County (New Brunswick).

Bloomberg

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