Sealed Seroquel documents hearing is Thursday
A closely watched hearing will take place in a federal courtroom in Orlando, Fla., tomorrow [Thursday] over the extent to which AstraZeneca should be forced to divulge internal documents filed in connection with product-liability litigation over its Seroquel antipsychotic. About 6,000 lawsuits have been consolidated and allege the drugmaker failed to adequately disclose that the pill can cause serious weight gain and diabetes.
At issue is whether thousands of pages of material should be unsealed. Typically, numerous documents are sealed at the outset of such litigation under agreements between attorneys for defendants and plaintiffs, in part, to speed along the proceedings. Companies also seek to have documents sealed to avoid publicity, investigations and additional lawsuits.
But earlier this month, Bloomberg News filed a motion to have some of the Seroquel documents unsealed, citing ”the public’s right of access to judicial documents.” An AstraZeneca spokesman told BusinessWeek that releasing incomplete information could create a public health risk. However, Bloomberg argued that concerns about health risks are among the very reasons the documents should be unsealed.
Not surprisingly, the controversy is drawing parallels to the litigation over Eli Lilly’s Zyprexa, another antipsychotic linked to serious weight gain and diabetes. However, the Zyprexa lawsuits yielded an unexpected ruckus when David Egilman, a Brown University professor and an expert witness for the plaintiffs, leaked sealed Lilly documents to the media (background here).
Meanwhile, the Seroquel case is generating interest for yet another reason - allegations of sexual impropriety. An AstraZeneca employee, who was responsible for the drug in the United States, allegedly cavorted with a Seroquel researcher in the United Kingdom and a ghostwriter in the United States, according to court documents. You can read more about that here.
Update: AstraZeneca lawyer Stephen McConnell announced at the hear that AstraZeneca would release the documents, according to AmericanLawyer.com.
How marketing turned Zyprexa into blockbuster
Filed under: Government, Hot Health Headline, Pharmaceuticals
Ben Wallace-Wells of Rolling Stone uses the story of the rise of Zyprexa, Eli Lilly’s blockbuster schizophrenia treatment, to look into the marketing of medication, the history of anti-psychotic drugs and the ability of the FDA to serve as an effective watchdog without the resources to conduct independent trials. The magazine also provides an interview, in which Wallace-Wells tells a little more about the reporting that went into the extensive report and the conclusions he’d drawn from his research.
Eli Lilly staked its future on Zyprexa, even though it had been shown to cause dangerous side-effects like excessive weight gain and was only approved for the treatment of schizophrenia. The total market for the treatment of schizophrenia and related illnesses sits in the tens and hundreds of millions of dollars. Through off-label prescriptions, careful manipulation of government regulation and aggressive marketing emphasizing the drug’s novelty, Lilly eventually sold more than $4 billion worth of Zyprexa annually.
“The goal for sales reps, according to Lilly’s strategy document, was to ‘expand the market of Zyprexa by redefining how primary-care physicians help reduce mood, thought and behavioral disturbances.’”
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