AstraZeneca Under Legal Fire Over Seroquel

British drug maker AstraZeneca has been subpoenaed by two states in conjunction with the sale, safety, and marketing of its antipsychotic <"http://www.yourlawyer.com/topics/overview/seroquel">Seroquel. Last month, the company received a subpoena from the California Attorney General’s office, this one coming shortly after the Alaska Attorney General’s office issued its own subpoena. They are also the subject of an informal inquiry by the U.S. Securities and Exchange Commission. The SEC is looking into allegedly improper payments made to doctors and government representatives outside the United States.

Last week, the company announced a 30 percent gain in third-quarter net profit to $1.59 billion, attributing its success in part to expanded use of Seroquel for the treatment of manic bipolar disorder. In 2005, sales of Seroquel totaled about $2.76 billion. Earlier this month, the FDA officially approved the drug for the treatment of bipolar depression. It had already been approved for schizophrenia, and now it is the only drug approved for both depressive and manic bipolar behavior. Seroquel and Nexium, an ulcer drug, account for more than half of AstraZeneca’s sales.

The reasons for the subpoenas are unclear at this time. Recently, studies have questioned the effectiveness of Seroquel in the treatment of various ailments. A new study published in the New England Journal of Medicine found “no significant differences” between the effectiveness of atypical antipsychotic drugs and that of placebos in the treatment of Alzheimer’s patients who suffer from psychosis, aggression, and agitation. Since Seroquel and other atypical antipsychotics often come with dangerous side effects, researchers questioned whether they should be used at all for Alzheimer’s patients.

Only the week before the NEJM study, a study published in the Archives of General Psychology and funded by the British National Health Service found that costly second-generation antipsychotic drugs such as Seroquel and Zyprexa are no more effective than older, cheaper drugs in the treatment of schizophrenia. Many medical professionals pointed to aggressive marketing tactics by AstraZeneca and other drug producers as one of the reasons why atypical or second-generation antipsychotics command such a large market share.

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