Unsealed documents raise Seroquel questions

AstraZeneca told sales reps to downplay the risk of diabetes in patients taking its antipsychotic drug Seroquel, newly unsealed court documents show. "Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile," according to a transcript of a voicemail sent to salespeople. The message then instructed representatives to "refocus the [sales] call" away from diabetes to the drug's tolerability, the transcript shows.

But the documents also show that a company physician had already said that a link between Seroquel and diabetes was "probable in some individuals," the Wall Street Journal reports. "There is reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes melliutus in certain individuals," Dr. Wayne Geller wrote in a 2000 position paper sent to Dutch regulators.

The company, though, says that the position paper was "an initial draft" that was later revised "after rigorous discussion of the scientific evidence." Dr. Geller himself said in a 2008 deposition that his statement about the diabetes link was "an artifact of an earlier discussion document." And an AstraZeneca spokesman points out that diabetes has been on the list of Seroquel side effects from its launch, though the label has since been updated to include stronger warnings of weight gain, diabetes and hyperglycemia. One of those beefed-up warnings was added last month, the court document show.

The documents--which AstraZeneca had fought to keep private--are sure to create a brouhaha as the company faces more than 9,000 lawsuits from patients who say they were injured by Seroquel. Two of those cases were dismissed for lack of evidence earlier this month, and another 2,300 were also dismissed. Meanwhile, states have sued the company seeking redress for medical expenses paid for patients who allegedly developed complications from using the drug.

It's hardly the first time a drugmaker has seen a backlash from internal documents made public in the course of legal proceedings. It's not even the first time an antipsychotic drug was the subject of that backlash: As you know, leaked Eli Lilly documents showed that the company played down the risks of its antipsychotic Zyprexa.

- read the Wall Street Journal story
- see the Philadelphia Inquirer article on the new warning

ALSO: AstraZeneca announced that FDA is asking for more information on a potential new indication for Seroquel XR in general anxiety disorder. Report