AstraZeneca Knew Seroquel Risks For Years

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ohmyThe drugmaker was aware that its antipsychotic causes diabetes as far back as 2000, according to documents filed yesterday in a federal court in Tampa, Florida, Bloomberg News reports. For instance, Wayne Geller, AstraZeneca’s global safety officer, concluded there was “reasonable evidence to suggest Seroquel therapy can cause” diabetes and related conditions, and he drew his conclusions after reviewing studies and internal trials, the documents show.

The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses who would testify on behalf of plaintiffs at a trial set to begin in February 2 based on a lawsuit filed by Linda Guinn of Palm Bay, Florida. Only portions of the documents were shown in court, the filings remain sealed at the request of the drugmaker, which faces about 15,000 lawsuits.

Guinn claimed she developed diabetes after taking Seroquel which, like Lilly’s Zyprexa and Johnson & Johnson’s Risperdal, is one of a newer class of antipsychotics. However, thousands of consumers have sued the drugmakers, claiming they hid risks and marketed them for unapproved purposes. Lilly has paid $1.2 billion to settle 31,000 claims by individuals.

In a January letter, the FDA asked AstraZeneca to provide an analysis of all its clinical trials relating to Seroquel, Paul Pennock, the plaintiffs’ lawyer, yesterday told US District Judge Anne Conway. The drugmaker responded with an analysis showing 2.4 percent of people who began treatment with normal sugal levels in the blood became technically diabetic after 52 weeks. Normal levels are less than 100 milligrams per 10 deciliters. Someone is labeled diabetic with a reading of 126 milligrams.

That result, compared to 1.4 percent of patients given a placebo who showed the same increase in blood-sugar levels, Plunkett testified, makes it almost 70 percent more likely that people taking Seroquel would develop diabetes than people who weren’t taking the drug. “It’s clear this compound Seroquel can cause diabetes,” Laura Massey Plunkett, a human risk assessment specialist, who read in court from the company report. “I don’t think there is any real controversy about that.”

AstraZeneca lawyer Jane Thorpe said that was just a part of the company analysis and data showed no significant increases when all people who had a sugar reading of less than 125 milligrams were included. Thorpe also questioned Plunkett’s conclusions, saying she relied only on studies that supported her views and ignored those that didn’t show an increased tendency for people taking Seroquel to develop diabetes.

Studies have shown that Seroquel and other atypical antipsychotics are associated with an increased risk of diabetes. These studies prompted the FDA to require AstraZeneca and other drugmakers to warn doctors of the risks in September 2003, Bloomberg notes. AstraZeneca doesn’t intend to settle these lawsuits, a spokesman tells Bloomberg. “We intend to litigate these cases on the merits.”

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  1. http://www.moneyam.com/action/news/showArticle?id=3468534 (off-label intended use of Seroquel)

  2. Hi Dan,

    Yes, I posted about this development this morning. The link below includes links to the FDA letter and the AZ material…

    http://www.pharmalot.com/2008/12/astrazeneca-rep-pitched-seroquel-for-depression/

    Cheers
    ed

  3. You can bet they did! And they still promoted off-label to make much more money! Why? because they don’t care about people as much as they care about money! It’s what’s wrong with Big Pharma.

  4. Is anybody else seeing a big difference between what AZ’s Global Safety Officer is saying in the first paragraph and what their lawyer is saying in the next-to-last? He says it does cause diabetes and she says it doesn’t? I thought it customary to get the story straight before you go to court.

  5. Harpy — The honest comment from Geller was (I’m guessing) part of some internal email exchange back in 2000 that was supposed to never see the light of day. Thorpe’s comment is nothing more than spin. Never the twain shall meet.

  6. Ah, that’s where I was tripping up. Thank you, Blue Dog Dem.

  7. Obviously, we learn again why the discovery process of civil liability is so important re: knowing the actual risks and benefits of certain drugs.

    And FDA preemption, also yet again, shows itself to be the ethically and rationally perverse doctrine it has always been.

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