Healthy Skepticism Library item: 18938

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Roche Dogged by Rumors of Illegal Drug Promotion — but None Stick
BNet 2010 Nov 18
http://www.bnet.com/blog/drug-business/roche-dogged-by-rumors-of-illegal-drug-promotion-8212-but-none-stick/6492

Full text:

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:

The company received a Department of Justice subpoena for Rituxan documents in 2004. Genentech said “the civil matter is still ongoing” in 2008 (see page 101), just before it was acquired by Roche.
When the subpoena was first disclosed it was widely regarded as a probe into off-label selling.
Genentech has been sued by one of its own employees alleging Rituxan was promoted off-label.
And the Missouri federal case is not the only one filed by a patient alleging off-label Rituxan promotion.
There’s also plenty of research interest in off-label Rituxan use.
And Genentech’s employees gossip about the issue on Cafe Pharma, the anonymous bulletin board for pharmaceutical company employees.
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.