Seroquel's record of causing sudden cardiac death was even on the docket at last year's FDA hearings, which Stan and Shirley White and Janette Layne attended.
According to Dr. Wayne Ray, who testified before the FDA's Psychopharmacologic Drugs Advisory Committee, one study involving 93,300 users of antipsychotic drugs -- half of whom were on atypical antipsychotics -- showed that such users were at no less than double the risk of a "sudden, fatal, pulseless condition, or collapse " consistent with a ventricular tachyarrhythmia occurring in the absence of a known, non-cardiac cause."
Ray, professor of preventive medicine at Vanderbilt University School of Medicine, published the findings in an article titled "Atypical antipsychotic drugs and the risk of sudden cardiac death," in the New England Journal of Medicine last year.
When committee members asked Ray how AstraZeneca's own studies, presented earlier at the hearings, could show no risk -- like the White/Layne VA Inspector General report -- he said the drug company data were skewed by "Simpson's paradox," the same statistical manipulations that made Vioxx look safe.
But unwilling to let Seroquel's approval prospects sink just because it's dangerous, the FDA's Marc Stone, a medical reviewer, donned his AstraZeneca hat at the hearing in a presentation rebutting Ray's testimony.
How can it be known if the death certificates in these cases were accurate, he asked, when "paramedics are more likely to identify some deaths as sudden cardiac deaths?"
"Smoking as an important risk factor for sudden cardiac death is unlikely to appear in the Medicaid claims data used in this study," Stone said of Ray's findings. "How do we know smoking wasn't a factor in the deaths -- or that antipsychotic users aren't less likely to 'communicate symptoms of cardiac disease to medical personnel?'"
He also pointed out that "Mental illness severe enough to require antipsychotic drugs " may also increase the chances of someone being homeless or living alone with little social contact," apparently forgetting that the purpose of the FDA hearings was to approve Seroquel for non-mentally ill people with anxiety and depression.
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