Seroquel’s Maker ‘Buried’ Findings of Link to Diabetes for Years, Newly Released Court Documents Show

AstraZeneca, the pharmaceutical company behind the popular antipsychotic drug Seroquel, conspired to conceal negative study results showing the drug had caused weight gain and diabetes in some patients, according to newly released company emails and other documents.

Stacks of internal company emails, made public as part of a pending lawsuit against the company regarding alleged injuries linked to Seroquel, detail a pattern of withholding negative clinical study results and other documents which showed the company knew that people taking the drug had a greater risk of developing diabetes.

The trial on the lawsuit, the first of about 9,000 similar claims pending against Seroquel, is set to begin in Delaware state court in April. That trial could set the tone for thousands of similar cases pending against the drug company.

The first two Seroquel lawsuits filed in federal court in Florida were dismissed in January 2009 when a judge ruled that the plaintiffs in those cases had failed to prove that Seroquel contributed to their development of diabetes.

Seroquel, launched in 1997, is a blockbuster drug for AstraZeneca, with 2008 sales totaling $4.45 billion.

Drug Company Accused of “Cherry Picking” Positive Results

AstraZeneca is accused of withholding portions of results and other findings for at least three clinical trials of Seroquel. Instead of presenting the entire trial findings, company officials selected only positive data for use in a presentation, according to the released documents.

The company denies the allegations that it hid unfavorable study results and says it shared all relevant data and study findings about Seroquel with the proper authorities.

Emails Show Pattern of Deception

Thousands of AstraZeneca emails and other documents released as part of the Delaware lawsuit show the company intentionally failed to release negative findings on Seroquel for years as U.S. and Canadian officials were considering whether to approve the drug.

In one 1997 email, AstraZeneca official Richard Lawrence wrote that the company had engaged in a “great smoke-and-mirrors job” in dealing with U.S. and Canadian investigators on the results of one clinical trial. In 1999, another company official wrote that the company had “buried” the results of three clinical trials of Seroquel.

Also made public was a 2000 letter from Wayne Geller, the global safety officer for AstraZeneca, in which he acknowledged that researchers had found some links between diabetes and Seroquel. Dutch scientists had determined that “reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes mellitus in certain individuals,” Geller said.

In 2003, the FDA required the makers of Seroquel and other similar newer antipsychotic drugs to warn users about the increased risk of diabetes by taking the drugs. But attorneys for people now suing Seroquel over their injuries point to the string of incriminating company emails as proof that AstraZeneca knew for years before the FDA ordered warnings that Seroquel had led to life-threatening diabetes in thousands of people.

FDA Delays Approval of Extended-Release Seroquel

In other Seroquel-related news, the FDA has said it is not ready to approve AstraZeneca’s request to market Seroquel XR, the extended release version of the drug, for generalized anxiety disorder. The XR version is already approved to treat bipolar disorder and schizophrenia.

The FDA wants additional information on Seroquel XR before proceeding with approvals review to expand the use of the drug to treat generalized anxiety disorder, officials said.

New Documents Shine a Light

The AstraZeneca documents just released show a deep and persistent pattern of hiding negative test results for Seroquel in order to get the drug approved. Millions of people take Seroquel and many have developed life-threatening diabetes and other complications as a result. News that the company knew about the link between Seroquel and diabetes but buried the results of clinical studies for years is disturbing.

Hopefully, in the upcoming Delaware cases and thousands of other similar suits to come in state and federal courts, justice will be served for Seroquel’s victims.

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