AstraZeneca Seems to Be Winning the War Against Seroquel

AstraZeneca seems to be winning its war against the 10,000 plaintiffs who claim Seroquel causes weight gain and diabetes. A judge ruled that there was not enough evidence that Seroquel triggered a woman’s diabetes because she was already unhealthy by the time she started taking the drug.

None of the cases alleging that AZ failed to properly warn patients about Seroquel’s side effects has gotten to trial, the company told BNET:

• AZ has won two summary judgments and a third was withdrawn.
• In Delaware, 108 cases have been dismissed (about 15 percent).
• In the federal multidistrict litigation, 1,881 cases (about 23 percent) have been dismissed either by the judge or by plaintiffs themselves.

AZ is also winning the war in the marketplace: sales of Seroquel rose roughly 10 percent in Q1 2009 to $1.1 billion despite terrible publicity surrounding the drug.

And it’s winning the war with regulators. The WSJ reported that an FDA panel agreed Seroquel was safe enough for children.

In today’s case, Judge Joseph Slights III ruled that as a medical expert could not say that Nina Scaife’s diabetes was specifically caused by the drug, her claim against AZ fails.

BNET first noted the decision on May 28; the judge released his full opinion June 9. This was the case in which AZ had argued in large part that because Scaife was black, and as black Americans have higher rates of diabetes, that this — among other reasons — was a more likely explanation of her condition.

Slights’ ruling mostly ignores the race angle (AZ opened its argument with that point) in favor of a close look at Scaife’s health.

Scaife was obese, she smoked, and had several knee surgeries that restricted her movement and caused her to lead a sedentary life. Her weight rose from 136 pounds in 1983 to 212 pounds in 2005, although she got back down to 160 in 2006.

In August 2003, she was prescribed Seroquel, and in 2004 was diagnosed with diabetes after gaining 19 pounds. Her diet consisted of “pasta, rice, doughnuts, slurpies, fish and fries from McDonalds and Burger King, chicken shrimp, and [a] lot of Chinese food.”

Slights ruled that although her diabetes came on after she started taking the drug, medical experts could not demonstrate that the drug was the specific trigger, given the rest of her health picture.

AZ will be particularly cheered by this section of the ruling, where Slights suggests that Seroquel plaintiffs may never be able to prove that the drug causes weight gain and/or diabetes:

Thus far, AZ has been careful to focus its specific causation attack case-by-case. It has yet to argue in motion papers that plaintiffs’ (collectively) specific causation case cannot withstand Daubert scrutiny in any case given the state of the existing science and the consistent physical and medical presentations of the plaintiffs in this litigation. Perhaps, for all concerned, it is time to call that question.

Hat tip to Pharmagossip for noticing that last part.

• Previously:
• AstraZeneca to Seroquel Patient: You Have Diabetes Because You’re Black
• Seroquel Trial: More Emails From MacFadden, AZ’s Sex-for-Studies Exec, Emerge
• AZ Seroquel Emails Detail Off-Label Promotion; What Did CEO Brennan Know?
• AstraZeneca Q1: Seroquel Sales Up; Faces 10,000 Lawsuits; Company Thinks It Will Beat the Rap
• AstraZeneca’s “Smoke and Mirrors” Man Has New Job in Medical Writing
• AZ Seroquel Trial: Was It “Ghostwriting” or “Professional” Writing?
• AstraZeneca’s Seroquel Research Director Confessed to Sex-for-Studies Affairs
• E-Mail: AstraZeneca Knew in 1997 that Seroquel Caused Weight Gain
• Exec Warned AZ on Negative Seroquel Results: “We Cannot Hide Them”; Info Later “Buried”
  
• AstraZeneca’s Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?
• FDA Asks AZ to Tighten Seroquel Label; 9,000 Lawsuits Start Trials Next Week
  
• The History of AstraZeneca’s Mismarketing of Seroquel
  
• FDA: J&J’s Risperdal and Lilly’s Zyprexa Are Over-Used in Kids
  
• AstraZeneca Allegedly Recruits Tigger and Eeyore to Sell Seroquel