Last Updated Dec 5, 2008 10:27 AM EST
BNET readers know this is only the latest stepping stone on the highway to hell that is AZ's marketing of Seroquel, which brought in $4.03 billion in revenue last year. On Seroquel, 2.4 percent of people who began treatment with normal levels of sugar in the blood became technically diabetic after 52 weeks. Only 1.4 percent of patients given a placebo showed the same increase in blood-sugar levels. An expert testified that it is almost 70 percent more likely people taking Seroquel would develop diabetes. So here's some history on the unfolding Seroquel fiasco:
The news comes on the same day as the FDA cited AZ for mismarketing Seroquel to doctors based on unapproved uses. An FDA warning letter to the company states:
On Thursday, January 3, 2008, at approximately 3:00 p.m., a sales representative from AZ in the [redacted] made an unsolicited sales call to a physician at his office. The representative stated that Seroquel was approved for treatment of major depressive disorder... Seroquel and Seroquel XR are not FDA-approved for the treatment of MDD. Therefore, the oral statements made by the sales representative and the information provided in the January 4, 2008, mailng, misleadingly suggest a new "intended use" for Seroquel and Seroquel XR. ... the drugs are therefore misbranded.Oddly, the evidence FDA provides for this suggests the opposite. The medical liaison's note to the doctor states:
AstraZeneca does not recommend the use of SEROQUEL or SEROQUEL XR in any other manner than as described in the enclosed prescribing information. ... SEROQUEL is not indicated for the treatment of major depressive disorder.To compound matters, Ed Silverman at Pharmalot reported recently that some reps at AstraZeneca were urged to use Winnie the Pooh characters as sales aids for Seroquel.
"the idea was conveyed at a national sales meeting and on field rides with sales reps, who were told to use Tigger as a bipolar patient and Eeyore -- the down-in-the-mouth donkey -- as a depressed patient. The reps were allegedly encouraged to use Tigger dolls as giveaways, for instance."AZ says it is investigating the incident.
There is already downward sales pressure on these products. An FDA panel in November rejected a proposed routine monitoring of the safety of all anti-psychotics in children and instead discussed stronger language on their labels and active discouragement of doctors using the drugs on children, particularly for off-label treatments such as ADHD.
And back in 2006, the FDA asked AZ to stop circulating a sales aid which minimized the side effects of Seroquel. That letter stated:
This piece is false or misleading because it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia, and the bolded cataracts precaution.To give you a sense of the potential scale of AZ's problem, Eli Lilly paid $1.2 billion to settle 31,000 similar claims regarding its antipsychotic, Zyprexa. Johnson & Johnson also faces claims over Risperdal.
Image by Flickr user Stephen Witherden, CC