Was AstraZeneca touting Seroquel for off-label uses? Or was it simply plotting to get FDA approval for new indications for the atypical antipsychotic? These are the essential questions posed by a mega-document dump today, in which plaintiffs lawyers in a Seroquel liability suit unveil company files that they say will bolster their case against the drugmaker.
According to the Wall Street Journal and Bloomberg, the documents include a plan to "broaden Seroquel use on and off-label." Docs are free to prescribe meds for indications not approved by the FDA, but drugmakers can't market their products for those "off-label" uses. Marketing advice from one Seroquel brand manager in 2002 included exhortations to "grease the skids for dementia" and to tout the drug for the elderly. Seroquel hasn't been approved for dementia treatment, and in 2005 got a "'black box" warning of increased risk of death among patients with dementia.
Meanwhile, the goals stated in a 2001 public relations plan included encouraging and supporting the use of Seroquel "outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly." Another goal: "aggressive market penetration" among adolescents, the elderly, patients with bipolar disorder, et al. At the time, the drug wasn't approved as a bipolar treatment, and still hasn't been approved for children or adolescents.
Tony Jewell, the AstraZeneca spokesman, told both news outlets that the documents refer to the company's plans to study Seroquel for additional indications and to ask FDA to approve those new uses. In 2004, FDA did extend Seroquel use to treating bipolar mania, and in 2006 as a treatment for bipolar disorder in general. The company has asked the FDA to bless the drug as a treatment for schizophrenia in adolescents, and for acute treatment of bipolar mania in children and adolescents.
- read the WSJ story
- see the article from Bloomberg