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Camryn Hansen
Camryn Hansen
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Seroquel Maker AstraZeneca Fighting to Keep Drug Studies, FDA Documents Secret to “Protect Public” – What are they Really Hiding?

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Seroquel, the blockbuster antipsychotic which brought in a full 14% of drug maker AstraZeneca’s $31.6 billion in sales last year, is only FDA-approved to treat schizophrenia and bipolar disorder. In the past few years, however, illegal off-label marketing for uses such as depression, insomnia, and childhood ADHD has spread its use 22 million patients, making it one of the best-selling drugs in the world.

More than 15,000 of these 22 million have filed over 9,000 personal injury lawsuits alleging not only that Seroquel caused them to develop diabetes, weight gain and other health problems, but that AstraZeneca knew as early as 2000 of Seroquel’s health risks and deliberately withheld these risks from patients and doctors. About 40 percent of the claims have been consolidated for pretrial motions in the US District Court for the Middle District of Florida.

AstraZeneca, a British company headquartered in Delaware, has already spent over $500 million defending itself against Seroquel claims. Up until now, a crucial part of its strategy has been insisting that millions of pages of company documents produced in discovery must remain under seal and unavailable for public scrutiny. AstraZeneca lawyers plan to argue at an Orlando hearing later this month that unsealing documents, including unpublished clinical trial data and letters from the FDA, may pose a threat to “a vulnerable patient population”; that keeping company information away from the public is actually an act of public protection.

“This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,” lawyers for the drugmaker said in a recent filing in federal court

AstraZeneca’s lawyers say the information to be discussed at the hearing scheduled Feb. 26 is so sensitive that the court should be closed to the public. “The potential harm of dissemination of documents at this stage in the litigation far outweighs the public’s right of access, particularly when trials in these cases are on the near horizon,” company lawyers said in a filing Feb. 6. “The whole picture will be presented to the public at once.”

The judge has not ruled on the request.

“They don’t want anybody to know about the side effects of their drug, and they’re keeping secret the results of studies from patients, their doctors and the FDA,” said Dr. David Egilman, clinical associate professor at Brown University’s Department of Community Health. “Saying they’re protecting the patient is a self-serving, fraudulent argument.”

Though Egilman is merely an observer of the Seroquel proceedings, he knows the power of sealed documents in drug liability cases. He played a key role when similar lawsuits were lodged against another mega-selling antipsychotic, Eli Lilly’s drug Zyprexa. As in the Seroquel cases, thousands upon thousands of patients claimed Zyprexa caused weight gain and diabetes.

Hired as an expert witness for the plaintiffs in Zyprexa cases, Egilman was given access to reams of internal Lilly documents that had been sealed by the court. The documents showed that the drugmaker had ignored evidence of diabetes among patients while pushing Zyprexa’s off-label use for anxiety and dementia. -Kris Hundley, St. Petersburg Times

California psychiatrist Dr. William C. Wirshing, a paid consultant for AstraZeneca who has prescribed Seroquel to as many as 5,000 patients, said in a pre-trial deposition that he has personally observed a strong link between Seroquel and diabetes/weight gain.

“You literally just got to watch them get bigger…it was riveting to me,” he said, estimating that several hundred of his Seroquel patients developed diabetes.

At the Orlando hearing, plaintiffs’ lawyers will argue that some AstraZeneca has no right to keep certain company documents—including letters from the FDA, unpublished drug study results, and sales reps’ notes on Seroquel marketing strategies—a secret from the public.

Related cases are pending in the states of Pennsylvania, Montana, Arkansas and South Carolina, who are all suing Astra­Zeneca for Seroquel’s off-label marketing. These cases may impact whether or not the sealed documents are ever opened to the public.