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GENENTECH, BIOGEN IDEC PROMOTED OFF-LABEL USE OF RITUXAN, CLAIMS CITIZEN PETITION

February 28, 2006

Genentech and Biogen Idec allegedly paid doctors to promote an off-label use of their non-Hodgkin's lymphoma drug Rituxan as a treatment for rheumatoid arthritis (RA) and other conditions, according to a citizen petition filed recently by a researcher at a Chicago law firm representing a former Genentech employee who has sued the company.

According to the petition, Genentech and Biogen Idec solicited rheumatologists and gave them "monies and other considerations" to promote Rituxan (rituximab) to other rheumatologists as an off-label treatment for rheumatoid arthritis.

Michael Bannester, a researcher at the Chicago law firm Korein Tillery, filed the petition. The law firm represents former Genentech employee Paul McDermott, who has filed suit in the U.S. District Court for the District of Maine, charging that Genentech fired him on April 29, 2005, after he appealed to members of Genentech management to stop promoting off-label treatments.

"History has shown in the past that criminal investigations and fines are not sufficient to deter Genentech from repeatedly engaging in off-market labeling and promotion for products no matter what they are," Korein Tillery attorney George Zelcs told FDAnews.

Genentech representatives told FDAnews they were working on a response to the citizen petition. Biogen did not respond by press time.

The petition urges the FDA not to approve any new indications for Rituxan until the agency investigates the matter. The petition was filed on the eve of the agency's expected decision on whether to approve Rituxan for rheumatoid arthritis.

The petition also alleges that the two companies paid rheumatologists to publish articles drafted by Genentech and Biogen staff, and that the drugmakers set up a sham company through which they organized and held more than 20 roundtable dinners -- dinners that were presented as educational events held by an independent continuing medical education organization.

Genentech pled guilty in 1999 to off-label promotion of the human growth hormone product Protropin (somatrem) and paid $50 million as part of a plea agreement, according to the petition.

"Genentech and Biogen do not offer any drugs for sale that are FDA-approved for treating rheumatic diseases including arthritis or related disorders of joints, muscles and bones," the petition states. "Rheumatologists do not treat patients with non-Hodgkin's lymphoma. The only purpose for Genentech BioOncology or Biogen sales representatives to conduct in-office visits to rheumatologist offices is to solicit the illegal promotion of off-label uses of Rituxan for treating RA."

According to the petition, Genentech and Biogen created a nationwide network of personnel known as "professional education liaisons" and "clinical education liaisons," whose specific job was to market and promote the off-label sales of Rituxan -- not to educate physicians on legitimate uses of the drug.

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