The Wall Street Journal (2/27, Wang, Johnson) reports that AstraZeneca "agreed to unseal Thursday" documents that show the company "instructed its US sales representatives to tell doctors that its powerful psychiatric drug, Seroquel [quetiapine], didn't cause diabetes even though a company physician had at one point stated years earlier that such a link was probable in some individuals." The company "had argued that the documents should remain under seal because they contained proprietary information that could hurt the company if it was revealed to competitors and could harm the public if interpreted out of context." But, after "negotiations with plaintiff's attorneys," AstraZeneca "agreed to make public most of the documents." The company currently faces "more than 9,000 lawsuits from patients who allege they have been harmed by Seroquel," most of which "have been consolidated into one group being heard in the Florida federal court." Meanwhile, several states have "sued AstraZeneca, alleging that they were bilked into paying for the medicine for off-label usage."
Bloomberg News (2/27, Feeley, Fisk) adds that, according to the "thousands of" unsealed documents, "unfavorable studies about...Seroquel were 'buried' by AstraZeneca." The documents also revealed that "the drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in "cherry picking" of data from one of those studies for use in a presentation." Meanwhile, the drugmaker "is urging the judge to continue the confidential designation on nine other files, including some that involve what AstraZeneca told foreign regulators." For its part, the company claims that it "has studied Seroquel extensively and shared all relevant and required data with the FDA -- both before and after the agency approved it as save and effective." The drug "is part of [a] class of newer antipsychotic drugs...which studies have linked to an increased risk of diabetes." Company "officials have vowed to defend the Seroquel cases 'on their individual merits' and have refused to settle any claims" so far.
AstraZeneca strengthens warning on Seroquel label. Bloomberg News (2/27, Feeley, Fisk) reports, "AstraZeneca PLC agreed to strengthen warnings on its antipsychotic Seroquel [quetiapine] at the request of US regulators," according to Stephen McConnel, a company lawyer. He added that the company "agreed to move a statement on risk of increased blood-sugar levels to the warnings and precautions section of" the label. Last month, "attorneys for plaintiffs suing AstraZeneca said...the US Food and Drug Administration wanted 'data for Seroquel-induced weight change and glucose changes,' risk factors for diabetes, moved up...from its 'vital signs' section," which the company has since changed. A company spokesman noted, however, that the "warning about Seroquel's effect on some users' blood-sugar levels 'has not changed.'"
According to the Philadelphia Inquirer (2/26, Hill), "The information about the label change surfaced at a federal court hearing on whether" AstraZeneca "would have to release documents from lawsuits filed by about 15,000 patients who say that taking Seroquel led them to gain weight and triggered diabetes." The AP (2/27) also covers the story.
Copyright © 2008 by Custom Briefings | 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191