The New York State Attorney is suing GlaxoSmithKline (GSK) over its alleged failure to disclose important safety and efficacy information concerning the use of its antidepressant paroxetine (Paxil in North America and Seroxat in the UK) by people under 18.
The case arose after a confidential GSK memo leaked to media (CMAJ 2004;170[5]:783) documented a 1998 clinical trial that concluded paroxetine had no beneficial effect in the treatment of adolescents. The authors of the report recommended GSK “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” Sales for paroxetine totalled nearly $4.97 billion worldwide in 2003.
The US and UK have already taken action (see above).
The New York State Attorney General announced June 2 it has filed a consumer fraud lawsuit against GSK for allegedly engaging in “repeated and persistent fraud by concealing and failing to disclose to physicians certain information about Paxil… .”
The concealed information “impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized public health and safety,” stated Attorney General Eliot Spitzer.
The state attorney's office is seeking restitution for New York State residents who bought paroxetine for their children. Rose Firestein, the lawyer handling the case, isn't sure how much that would total. At the earliest, the case will get to court within a year.
In a public statement, GSK said it has “acted responsibly ... in disseminating data from [pediatric] studies.” It says the leaked memo “is inconsistent with the facts and does not reflect the company position.”
In the UK, meanwhile, officials at the Medicines and Healthcare Products Regulatory Agency are investigating GSK over similar concerns. — Barbara Sibbald, CMAJ