An AstraZeneca (AZN) executive warned in an internal email that the company's data did not show its antipsychotic drug Seroquel was superior to an older drug, Haldol, but the company promoted that notion anyway, according to documents in a lawsuit filed against the company.
The National Alliance on Mental Illness still maintains a web page about Seroquel suggesting that the AZ drug has fewer side effects than Haldol. BNET recently revealed that a NAMI board member was a paid consultant for AZ.
AZ's marketing of Seroquel is the focus of 14,444 lawsuits and the company has racked up $1.1 billion in potential legal liabilities over the drug. Plaintiffs allege that AZ failed to warn them that Seroquel caused weight gain and diabetes. AZ has settled some of the allegations against regarding mispricing of the drug, but vows to fight the other accusations. The company gave this statement (see comments below fir full statement):
AstraZeneca believes the totality of the science around Seroquel â€" including company-sponsored studies, research sponsored by the federal government, and physician experience â€" confirms it is an effective and appropriate treatment choice for patients with serious mental illness.A 2008 filing in the Seroquel cases describes a March 2000 meta analysis comparing studies of Seroquel to other drugs which. This chart describes the results of the analysis:
The safety and efficacy of Seroquel has been evaluated in clinical trials with thousands of patients and AstraZeneca has shared all required data with the FDA, both before and after the agency approved it as safe and effective.
John Tumas, AstraZeneca's U.S. publications manager for Seroquel, sent this email on March 23, 2000, to his colleagues, regarding the analysis:
(Click to enlarge.) BNET readers will remember that Tumas was also the writer of a 1999 email which chastised colleagues who had "buried" the results of three previous trials that were unfavorable to Seroquel. He wrote:
The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.AZ began promoting Seroquel as superior to Haldol in a May 2001 press release, on which the headline was:
Data Suggest SEROQUEL is More Effective than Haloperidol in Patients with Treatment-Resistant Schizophrenia.AZ also funded NAMI, according to NAMI's 2002 annual report. NAMI currently maintains a web page on Seroquel which says that the "most important" thing about Seroquel is its superior side effect profile to Haldol:
What is the most important information I should know about SeroquelÂ®?
Although less common compared with the other atypical antipsychotics, some people may develop side effects known as "extrapyramidal" effects (for example: restlessness, tremor, stiffness) or tardive dyskinesia (slow or jerky movements that one cannot control). These adverse effects are likely to be less severe and occur less often than with the older antipsychotic medications (for example: HaldolÂ® [haloperidol], ProlixinÂ® [fluphenazine], ThorazineÂ® [chlorpromazine]).The suit alleges that AZ justified claiming Seroquel was superior to other drugs with a new concept: "unsurpassed efficacy." What was the definition of "unsurpassed efficacy"? The suit alleges:
Geoffrey Birkett, former Global Vice President of Central Nervous System Product Marketing, testified that ... the phrase meant "in the correct patient treated for the correct indication at the correct dose Seroquel is highly effective and there's nothing more effective."
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