Company files show debate on Seroquel uses and risks

TRENTON - Marketing executives at British drugmaker AstraZeneca P.L.C. for years blocked efforts by company scientists to raise concerns that the antipsychotic drug Seroquel caused weight gain and other problems, saying that would harm sales.

Internal documents released yesterday show the struggle within the company. The documents are part of ongoing lawsuits against AstraZeneca brought by patients who allege they were harmed by Seroquel, the company's blockbuster drug for schizophrenia and bipolar disorder.

Some of the internal e-mails and other documents show efforts to keep public information about Seroquel positive amid a spirited debate between the company's scientists and its marketing executives.

AstraZeneca is based in London and has U.S. headquarters in Wilmington.

Ed Blizzard, a Houston lawyer whose firm is helping to represent about 6,000 Seroquel plaintiffs, said data showing Seroquel was "not very effective" and had serious side effects were "either spun or skewed or outright concealed."

AstraZeneca spokesman Tony Jewell said that since the drug was approved late in 1997, the label or detailed package insert has stated that diabetes, high blood sugar, and weight gain have been observed in patients in clinical studies.

He noted that the U.S. Food and Drug Administration in the last several years has approved Seroquel as safe for new uses - bipolar mania, then bipolar depression, and then an extended-release version.

Other internal e-mails and planning documents suggest the company pondered uses for which Seroquel was not approved by the FDA, including in dementia patients, though none of the documents indicate the company actually marketed the drug for those uses.

Doctors are allowed to prescribe drugs for unapproved uses, but drugmakers cannot promote them for those uses.

According to the documents, a strategic plan dated 2000 suggested a "key success factor" would be to "broaden Seroquel use on and off label," specifically targeting educational programs "to share off-label data."

Seroquel was AstraZeneca's second-best-selling drug last year, generating sales of $4.5 billion.

U.S. District Judge Anne C. Conway in Orlando, Fla., who has been coordinating pretrial details of nearly 6,000 federal Seroquel lawsuits, is settling issues such as which of the many documents plaintiff lawyers obtained through pretrial discovery should be available for use in those trials and open to the public.

AstraZeneca has claimed its documents are confidential, but it agreed to release hundreds in February and 400 more yesterday.