An action brought by the US ministers of Justice and Health has resulted in the firm AstraZeneca paying a heavy penalty for promoting Seroquel° (quetiapine) for indications other than those authorised.
Between 2001 and 2006, the firm promoted Seroquel°, licensed for the treatment of bipolar disorder and schizophrenia, for a number of other conditions including aggressive behaviour, Alzheimer’s disease, anxiety, fear, dementia, depression, and insomnia.
To prevent the case from going any further, AstraZeneca agreed on a deal to pay 300 million dollars to the federal government and 220 million dollars to the various plaintiff states: the actions were brought by public institutions, which prosecuted the firm for having illegally inflated public health insurance spending.
The public prosecutor also convicted the firm of paying kickbacks to doctors for writing articles (or even simply allowing their names to be used as a byline) or giving “continuing education” talks on the uses of Seroquel° for unapproved indications.
It is noteworthy that a government determined to recover sums wrongfully paid out from the public purse has succeeded in obtaining compensation from a pharmaceutical company.
But hopefully there are other means of avoiding this type of problem. For example, clinical research funded directly by the public purse rather than subcontracted to firms whose return on investment comes from drugs sales, would avert a great deal of abuse and fraud.
©Prescrire January 2011
"Targeting drug companies' bottom line" Prescrire Int 2011; 20 (112): 25 (pdf, free).