AstraZeneca “buried” unfavorable studies of its $4.4 billion blockbuster psychiatric drug Seroquel, according to internal documents released Friday in a legal dispute between the company and lawyers for thousands of people who sued the company because they said the drug caused diabetes and weight gain.
In one of the documents, a 1997 e-mail message, Richard Lawrence, an AstraZeneca official, praised Lisa Arventis, the company’s Seroquel project physician at the time, for minimizing adverse findings in a “cursed” study. He wrote: “Lisa has done a great ‘smoke-and-mirrors job!’ ”
Lawyers suing AstraZeneca, a British drug maker whose United States headquarters are in Delaware, said the documents show it tried to hide the diabetes link for nearly a decade.
“AstraZeneca knew about the risk of weight gain and diabetes in 2000 and not only failed to warn physicians and patients but marketed in a way that represented there was no risk,” Edward F. Blizzard, a Houston-based lead lawyer on the cases, said in a conference call with reporters.
Tony Jewell, an AstraZeneca spokesman, said the plaintiffs’ lawyers were trying the case in public because they recently lost their first two cases in court. Judge Anne C. Conway of Federal District Court in Orlando, Fla., dismissed them on summary judgment on Jan. 28 for lack of evidence that the drug caused diabetes in those two cases.
The plaintiffs’ lawyers said they would appeal those dismissals and that future cases might have stronger links.
Mr. Jewell also said AstraZeneca had fully informed the Food and Drug Administration of all relevant data before and after the drug was approved in 1997. AstraZeneca opposed public release of the internal documents, he added, because it might cause unnecessary confusion and alarm in patients.
Just before a court hearing in Orlando on Thursday, lawyers for both sides agreed to unseal 102 of 111 documents at issue in the case. They are among millions of pages of discovery material.
In another e-mail message, John Tumas, the company’s publications manager, wrote in 1999: “The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.” He said three drug trials had been “buried.” Referring to a fourth, he said, “We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.”
Seroquel, approved to treat bipolar disorder and schizophrenia, is among several so-called atypical antidepressants that have come under fire for side effects and off-label marketing for treatment of ailments like depression, insomnia, attention deficit disorder and dementia.
In addition to facing about 9,000 personal-injury lawsuits from more than 15,000 former users of Seroquel, AstraZeneca has said that federal authorities are investigating its marketing of the drug.
Also last week, AstraZeneca said the government had notified it that an F.D.A. expert panel would need to review Seroquel XR, an extended-release version of the drug, before it could be approved for depression and generalized anxiety disorder.
