Report: AstraZeneca Knew Of Diabetes Problems With Seroquel As Early as 2000

Bloomberg is reporting that AstraZeneca officials knew of diabetes risks associated with the use of its atypical antipsychotic Seroquel as far back as 2000. The news comes thanks to a small set of documents presented in open court yesterday in Tampa, Fla. as part of pre-trial arguments in a federal lawsuit against the drug company.

"AstraZeneca Global Safety Officer Wayne Geller concluded there was 'reasonable evidence to suggest Seroquel therapy can cause' diabetes and related conditions, according to documents presented yesterday in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.

"The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug’s effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company."

Interestingly, the FDA last January asked AstraZeneca to provide an analysis of its clinical trials of Seroquel.

"AstraZeneca responded June 26 with an analysis that showed 2.4 percent of people who began treatment with normal levels of sugar in the blood became technically diabetic after 52 weeks. Normal levels are less than 100 milligrams per 10 deciliters. Someone is labeled diabetic with a reading of 126 milligrams, said Laura Massey Plunkett, a human risk assessment specialist, who read in court from the company report.

"That result, compared to 1.4 percent of patients given a placebo who showed the same increase in blood-sugar levels, Plunkett testified, makes it almost 70 percent more likely that people taking Seroquel would develop diabetes than people who weren’t taking the drug.

"'It’s clear this compound Seroquel can cause diabetes,' she said. 'I don’t think there is any real controversy about that.'"

Seroquel had over $4 billion in sales last year and is commonly used on-label in treating schizophrenia, bipolar disorder and bipolar depression. Off-label, the drug is widely used to treat dementia, anxiety, sleep problems and depression. It's used in adults and children. The company has applications before the FDA to have the drug approved for depression and anxiety.

A company spokesman told Bloomberg that it won't settle pending cases against it, as has Eli Lilly to the tune of about $1.3 billion in connection with Zyprexa lawsuits, but that it will "litigate these cases on the merits."