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FDA, drug maker come under fire over secret test results

March 23, 2009 by  

FDA, drug maker come under fire over secret test resultsAstraZeneca and the FDA are facing criticism over antipsychotic drug Seroquel which numerous lawsuits allege causes metabolic disorders.

A case against the company will be heard in Delaware state court beginning June 29. It alleges that Seroquel has caused schizophrenic patients to develop diabetes, excessive weight gain and other metabolic conditions, according to

Meanwhile, the Washington Post has reported that a trial known as Study 15 was conducted in late 1990s, but its results were never disclosed to practicing physicians.

Instead, the drug gained an FDA approval, and has earned AstraZeneca nearly $12 billion in the past three years.

The findings have prompted some psychiatrists to chastise practitioners in the field as well as academics for allowing themselves to be influenced by the drug industry.

"The resources available for the care of our patients depend upon the public perception of the integrity of our profession," wrote the editor-in-chief and his colleagues in this month’s issue of the American Journal of Psychiatry.

"The subsidy that each of us has been receiving is part of what has fueled the excesses that are currently under investigation," they added.

An AstraZeneca spokesman defended the company saying it has disclosed the drug’s risks on its labels, and its attorneys have argued the reports submitted by medical experts are scientifically and legally insufficient to justify the claims, as reported by

However, the Washington Post says there is a growing expert consensus that newer antipsychotic drugs, which are 10 times as expensive, offer little advantage over older ones.

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