AstraZeneca Accused of Hiding Seroquel Dangers

May 25, 2009 Bipolar blog FDA Seroquel

AstraZeneca plays hot potato with Seroquel side effects. Here are the highlights from the article (bold and italic text added by me):

AstraZeneca E-mails Show Debate on Seroquel Risks
Associated Press – May. 20, 2009

TRENTON, New Jersey–Marketing executives at British drug maker AstraZeneca PLC for years blocked efforts by company scientists to raise concerns the antipsychotic drug Seroquel caused weight gain and other problems, saying that would harm sales, plaintiff lawyers say.

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

Seroquel was AstraZeneca’s No. 2 drug in sales last year, with revenue of $4.5 billion.

In a chain of e-mails in one document, a scientists’ safety evaluation committee in June 2000 recommended removing “limited” before the words “weight gain” in the list of Seroquel side effects, because many patients gained significant weight.

Marketing staff suggested trying other explanations, such as whether patients took other drugs that could be blamed. One marketing executive, Medical Affairs Manager Richard Owen, then wrote that such a change “is potentially damaging to Seroquel.”

The change in the drug’s label was finally made in 2002. That was after Barry Arnold, the vice president for clinical drug safety, complained repeatedly to the physician in charge of Seroquel drug safety about “Commercial (executives) having such an influence.”

Yet soon after the label change, AstraZeneca trademarked the term “weight-neutral” as an advertising slogan for Seroquel, Blizzard noted. He said data showed about one-quarter of patients taking Seroquel increased their weight by more than 7 percent. (Note that this is only the 7% weight gain noted during the study which is a much shorter duration that typical treatment.)

Later in 2002, Simon Hagger, global brand manager for Seroquel, e-mailed nearly 20 marketing staffers to say “we are under clear instruction from the highest level within AstraZeneca at this time not to discuss details surrounding trial 41,” outside the company. That patient study, concluded that year, found elevated levels of blood sugar.

In April, a panel of FDA scientific advisers said Seroquel’s side effects, including weight gain, high blood sugar and potential heart problems, were too troubling to make it a first choice against depression or anxiety. On a split vote, the panel said Seroquel could be used as an added therapy for patients taking other medicines but not getting relief from depression. The FDA has yet to issue a final ruling.

AstraZeneca faces roughly 15,000 lawsuits over Seroquel, about 60 percent of them in state courts. The first state trial is set to begin in Delaware on June 29. No federal trials have been held yet.

You have to register (it’s free) to see the whole article. I can’t say enough bad things about antipsychotics, myself, but definitely worse than the drug are the marketers and executives that try to hide the dangers to thrust the horrible side-effects onto an unsuspecting public. Nail their asses to the wall say I.

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