Wednesday, Oct 28th, 2009
Internal documents acquired as part of a series of lawsuits show that pharmaceutical giant AstraZeneca planned as early as 2001 to market its antipsychotic drug Seroquel for uses not approved by the FDA.
Under U.S. law, drug makers are prohibited for marketing their drug for any use not approved by the FDA. Doctors are still permitted to prescribe drugs, however, for any use they wish.
Seroquel (generic name quetiapine) was approved for the treatment of psychotic disorders in adults in 1997. In 2001, the FDA extended this approval to cover schizophrenia. In 2004, it was approved for use of bipolar mania, and in 2006 it was approved for bipolar disorder.
Yet AstraZeneca is now the defendant in thousands of lawsuits claiming, among other allegations, that the company actively marketed the drug for use in children and adolescents, and also sought to market it as a treatment for dementia in the elderly.
In some of the retrieved documents, AstraZeneca employees and employees of a consulting firm hired by the company reference plans to “broaden Seroquel use on- and off-label,” specifically mentioning adolescents and people suffering from Alzheimer’s or Parkinson’s disease. Areas where the company could promote this use are listed, including sales calls and meetings with medical professionals or patient advocacy groups.
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In a 2001 public relations plan, the company says that it seeks to “encourage and support [Seroquel] use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly.” The document calls for “aggressive market penetration” of the drug in the demographics of adolescents, the elderly and bipolar patients.
This came five years before the drug’s approval as a treatment for bipolar disorder. To date, the drug has never been approved for use in children, adolescents or patients with dementia or Parkinson’s disease.
AstraZeneca has applied for FDA approval to use Seroquel as a treatment for adolescent schizophrenia and acute bipolar mania in children and adolescents. No antipsychotic drugs have yet been approved for use in children, as there is nearly no evidence on their safety or effectiveness in that population.
The Seroquel lawsuits are only one of a number of recent scandals in which pharmaceutical giants have been accused of illegally promoting off-label drug use. Eli Lilly recently agreed to pay a $1.42 billion settlement to end charges that it promoted its antipsychotic Zyprexa (olanzapine) off-label.
AstraZeneca is also facing almost 10,000 lawsuits filed by more than 15,000 people who claim that they suffered from serious side effects of Seroquel, including diabetes, weight gain and a dangerous disorder known as tardive dyskinesia, which the company knew about but actively concealed.
Tardive dyskinesia is an incurable neurological disorder that causes involuntary grimacing and muscle spasms. Although atypical antipsychotics such as Seroquel are supposed to pose a lower risk of the condition than older drugs, some researchers suspect that the drugs simply have not been in use long enough for many cases of the condition to develop, as it normally takes prolonged drug use for tardive dyskinesia to emerge.
The first of the side-effect lawsuits was scheduled to go to trial on June 29, but the case was dismissed by the judge, who ruled that expert witness and endocrinologist Valerie Peck failed to disprove other risk factors that could have contributed to defendant Nina Scaife’s contraction of diabetes after taking Seroquel as an off-label insomnia treatment. Even though it has been conclusively proven that Seroquel can cause severe weight gain and diabetes, the court system requires each plaintiff to prove that the drug caused their individual health problem.
Internal documents acquired as part of these lawsuits reveal that AstraZeneca knew of the increased risk of weight gain and diabetes associated with Seroquel as early as 1997, but continued to deny the connection to doctors.
Sources for this story include: online.wsj.com.
This article was posted: Wednesday, October 28, 2009 at 4:50 am