A former Genentech employee has accused the company and marketing partner Biogen Idec of illegally promoting Rituxan as an off-label treatment for arthritis.
According to published reports, Paul McDermott, who worked for Genentech in Falmouth, Maine, from March 2004 until April 2005, filed a whistleblower lawsuit in July 2005 in US District Court in Maine alleging the companies’ marketing of Rituxan defrauded government healthcare programs. McDermott claimed that as a company liaison with physicians, he was directed to recruit doctors to advocate the use of Rituxan for rheumatoid arthritis. The suit also seeks unspecified damages on behalf of the government and an order that Genentech rehire McDermott and pay him back wages and other damages.
The suit hasn’t surfaced until now because it was filed under seal on behalf of the federal government.
Although doctors can legally prescribe drugs for unapproved uses, drug manufacturers are forbidden to promote their products for those uses.
In October 2004, Genentech received a subpoena from the US Attorney's office in Philadelphia seeking documents related to the promotion of Rituxan. Genentech is cooperating with that investigation, which it said is both civil and criminal in nature.
Meanwhile, Genentech has halted a clinical trial of Xolair as a treatment for peanut-allergy reactions, citing safety concerns not with the drug itself but with an allergy test.
The company said two children in the 150-person trial experienced “severe hypersensitivity reactions” when given a trace amount of peanut protein, an initial step designed to gauge the severity of a patient’s allergies. Cancellation of the trial means that an approved treatment for peanut allergies remains years away at the earliest.
Genentech made headlines earlier this month as its profit rose 64% in the fourth quarter of 2005. The company’s 2005 revenue reaching a record $6.6 billion, fed by the sustained growth of Rituxan, Herceptin and Avastin.