Roche Dogged by Rumors of Illegal Drug Promotion -- but None Stick

Last Updated Nov 18, 2010 12:18 PM EST

There are plenty of reasons to suspect that Roche (ROG.VX) and its Genentech unit may have been promoting Rituxan illegally for "off-label" uses -- the company itself said it was being probed by Pennsylvania's U.S. Attorney's Office for allegedly doing that -- but mere suspicion isn't good enough for federal court: A Missouri judge has dismissed a case in which a patient died from taking Rituxan because the plaintiffs only alleged that it was "hard to believe" Genentech was not promoting the rheumatoid arthritis drug off-label.

Rituxan, which is primarily a treatment for a form of blood cancer, is also approved as a second-line treatment for rheumatoid arthritis, meaning that it should only be used if other treatments fail. That restriction limits its sales. Rituxan has a risk of serious side effects including a profound suppression of the patient's immune system and a devastating brain condition called PML. Mary Merrick received Rituxan as a first-line treatment in 2009 and died of PML the same year. Her family alleged that she would not have received the drug if Genentech were not promoting it off-label.

Rumors of off-label Rituxan promotion have dogged Genentech for years. Some examples:

But there's a big difference between rumors and fact, and that was the central issue in the dismissal of the Missouri case, which named Dorothy Guccione, Genentech's senior oncology clinical coordinator as a defendant. The judge ruled:
... Plaintiffs assert only that, based on information they obtained through the Genentech website, "it is hard to believe as the Senior Oncology Clinical Coordinator that [Guccione] is not involved in the marketing, administration, and sale of a drug prescribed by oncologists."
As the plaintiffs didn't bring forward any actual evidence alleging off-label activity, the case was dismissed.

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