March 5 (Bloomberg) -- AstraZeneca Plc officials opposed changing the wording of the antipsychotic drug Seroquel’s internal safety documents about the amount of weight gained by some of the medicine’s users, an executive testified.
Dr. Wayne Geller, who once served as Seroquel’s global safety officer, told a New Jersey jury today some colleagues fought his June 2000 push to strengthen the company’s internal description of Seroquel’s side effects about weight gain.
Geller and other researchers wanted the word “limited” removed from the explanation of the drug’s potential for causing some users to gain weight. He testified in the trial of a lawsuit accusing the drug of causing a former user to gain weight and develop diabetes.
“I did question why the word limited was not taken out of the core-data sheet” about the drug, Geller told jurors. “I found out there were people from the commercial side who” opposed the change, he added.
Ted Baker’s case in state court in New Brunswick is the first of about 26,000 over Seroquel to go to trial. Lawyers for Baker and other former Seroquel users contend AstraZeneca mishandled Seroquel, ignoring or downplaying its links to diabetes and weight gain to protect sales.
The drug, with sales of $4.9 billion last year, is the London-based company’ssecond-biggest seller after the ulcer treatment Nexium.
Psychiatric Drugs
AstraZeneca officials said this week they will end research and development efforts into psychiatric medications at its U.S. headquarters in Wilmington, Delaware, as part of a companywide reorganization.
Company executives plan to eliminate 11 percent of the drugmaker’s workforce by the end of this year as part of a $2 billion restructuring, the cost of the savings program between now and 2013. The cuts would include 550 jobs in Wilmington.
The drugmaker’s lawyers told jurors in Baker’s trial last month that Seroquel doesn’t cause diabetes and the Vietnam War veteran’s weight-gain and disease stemmed from his lifestyle and diet. The company contends it provided adequate warnings about the drug’s risks on the medicine’s label and marketed it appropriately.
“From the very first label for Seroquel, AstraZeneca had in its label the risk of weight gain and the risk of diabetes,” Diane Sullivan, one of the company’s lawyers, told jurors in opening statements.
PTSD Problems
Baker, who served in the Navy in Vietnam, took the drug to deal with lingering symptoms of post-traumatic stress disorder and contends he wasn’t properly warned by the company about its risks, including weight gain and diabetes. The 61-year-old Baker, a Louisiana resident, sued AstraZeneca in July 2007 after taking the drug for three years.
Baker’s lawyers contend AstraZeneca sales managers opposed Geller’s push to strengthen Seroquel’s internal safety documents detailing weight-gain information to protect billions in sales. Geller is a medical director based in AstraZeneca’s Wilmington campus, company officials said.
Geller said today he pushed to change the language after reviewing side-effect reports that shows Seroquel could “produce significant weight gain in select individuals.”
The reports indicated that the average weight gain was 27 pounds, Geller acknowledged today.
Warning Labels
Jerry Kristal, one of Baker’s lawyers, asked the executive whether AstraZeneca sales managers opposed the word change because it would hurt Seroquel’s marketing plan.
“I don’t sit on the commercial side, so I don’t know how important the word limited was to them,” Geller said.
The core-data sheet is an internal document, which provides safety data that can be used in drug warning labels around the world, according toAstraZeneca officials.
Weight gain and increased blood-sugar levels have been tied to the development of diabetes. Former Seroquel users contend the company marketed Seroquel as having a minimal effect on users’ weight.
In 2000, Geller sent a “safety position paper” on Seroquel to Dutch regulators, who were reviewing the drug for the European Union. The paper warned regulators there was “reasonable evidence to suggest Seroquel therapy can cause impaired glucose regulation including diabetes.”
‘Mistaken Statement’
Geller acknowledged today he’d typed up the diabetes material for a draft version of the paper after reviewing of side-effect reports he’d received about Seroquel.
The doctor testified that he later revised his opinion about the drug’s potential for contributing to the development of diabetes and forgot to remove the language from the file.
“I confess in having left this mistaken statement in this paper,” he told jurors.
Mike Brock, an AstraZeneca lawyer, asked Geller during cross examination whether the company ever used the “limited weight-gain” language in Seroquel’s U.S. warning label. “It’s never been in there,” the doctor replied.
The case is Baker v. AstraZeneca Pharmaceuticals LP, MID L 1099 07 MT, Superior Court of New Jersey, Law Division, Middlesex County (New Brunswick).
To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, atjfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, atmcfisk@bloomberg.net.
http://www.bloomberg.com/apps/news?pid=20601202&sid=af7Ry8dsi97o
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