A whistleblower has taken Biogen Idec and its partner Genentech to court for allegedly promoting their Rituxan product for use in rheumatoid arthritis before winning approval for this indication.
The complaint, brought by former Genentech employee Paul McDermott, suggests that the two companies defrauded healthcare programmes by encouraging prescribing of Rituxan (rituximab) for an unapproved use. It also alleges that McDermott was fired by his employer as a direct result of reporting the practice to executives at Genentech. McDermott worked for the US biotech from March 2004 until April 2005.
Biogen Idec and Genentech have filed for approval of Rituxan as a second-line biologic treatment for RA in patients who do not respond with anti-tumour necrosis factor alpha drugs, such as Schering-Plough’s Remicade (infliximab), Amgen’s Enbrel (etanercept) and Abbott Laboratories’ Humira (adalimumab). The application has been fast-tracked for approval in the USA.
This is not the first time that promotional practices for Rituxan, which is approved to treat non-Hodgkin’s lymphoma, have been under the microscope. In October 2004, Genentech received a subpoena from the US Attorney General’s office in Pennsylvania, requesting information concerning the promotion of Rituxan in an investigation that was both civil and criminal in nature.
The penalties for this type of activity can be severe. Earlier in 2004, Pfizer was forced to pay a $430 million dollar fine over its off-label marketing of Neurontin (gabapentin).
Former Biogen exec settles insider trading suit
Meanwhile, in another unwelcome incident for Biogen Idec, former general counsel Thomas Bucknum has settled an investigation into insider trading by paying a $3 million fine.
The probe, brought by the Securities & Exchange Commission, claimed that Bucknum sold off stock ahead of the public disclosure that Biogen Idec’s psoriasis drug Tysabri (natalizumab) was to be withdrawn from sale because of concerns over its safety. Bucknum has neither admitted nor denied wrongdoing in settling the case.
Tysabri was removed from sale last February by Biogen Idec and partner Elan after the drug was linked to the rare brain disease PML (progressive multifocal leukoencephalopathy). Earlier this week, the companies said they expect a ruling on whether the drug can return to market by March.
