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More Seroquel Documents Unsealed

Mar 3, 2009 | Parker Waichman LLP

Unsealed documents have revealed that the antipsychotic drug Seroquel may not be as effective as older drugs.  According to a report in The Wall Street Journal, the documents show that AstraZeneca produced an analysis of studies that found Seroquel to be less effective than one of the medications it was supposed to improve upon.  This analysis contradicts some of AstraZeneca's promotional materials for Seroquel, the Journal said, which tout the drug as working as well - or better - than older antipsychotics.

AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the drug’s diabetes risk.  Several states that have also sued AstraZeneca have charged that the company illegally promoted Seroquel for unapproved uses.  As we reported previously, documents unsealed in the course of litigation appear to back up these claims.

Additional documents, including those  related to AstraZeneca's efficacy analysis, were unsealed last Friday as part of the litigation, the Journal said.  The analysis, which was produced in 2000, involved a dozen different Seroquel studies.  According to The Wall Street Journal, the analysis concluded that Seroquel did not work as well  haloperidol, a 50 year old generic drug.

Even so, a slide from 2003 AstraZeneca PowerPoint presentation directly contradicted the analysis' findings by stating:  "Head to head with haloperidol, Seroquel offers the same -- or better -- efficacy and the added advantage of a significantly better clinical response."

Other documents indicate that doctors at AstraZeneca debated how the analysis should be handled, the Journal said

Last week, Bloomberg.com detailed other unsealed documents that seemed to indicate that AstraZeneca tried to hide information that confirmed a link between Seroquel and diabetes.  These included a February 1997 e-mail from an AstraZeneca official said that the company had engaged in a “great smoke-and-mirrors job” in dealing with U.S. and Canadian investigators regarding a trial that didn’t produce favorable results on the issue of weight gain and Seroquel.

In a December 1999 email, the company’s publication manager  wrote that  AstraZeneca “buried” disappointing results on weight gain and diabetes from  three clinical trials.  The same email also faulted AstraZeneca for having  “cherry picked” data from one of those studies for use in a presentation, Bloomberg said.

According to The Wall Street Journal, documents among those unsealed Friday also indicated that AstraZeneca was not forthcoming about Seroquel, weight gain and diabetes.  According to one document, the company used a case study involving a single Seroquel patient who lost weight to promote the drug.  But a company email indicated that the link between Seroquel and the patient's weight loss was overstated.


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