The hazards of off-label promotion

An off-label medical device promotion that killed.  The story points out that, atypically, patients were denied even the appearance of informed consent—though one has to wonder whether many patients can do more than go along with their doctors’ advice even when they know the use is off-label.

One particularly interesting portion from the Forbes piece, which seems to be online only:

The culture of orthopedic surgeons is particularly aggressive. Predominantly male, "orthopods" are the jocks of the surgical world. Sales representatives tell stories of doctors playing loud rock music in the operating room and throwing instruments at the wall when they get frustrated. Several surgeons tell Fortune they simply don't have time to pore over labels. Lambert offers a blunt appraisal: "'Off-label' is not at all a pejorative term -- it's almost the opposite. Reading the label is for people who read labels."

Surgeons don't always listen to the FDA, but they do heed the young sales representatives who bring them devices and routinely watch them operate. "It sounds ridiculous, because here's a guy who went to medical school and did his residency, and he's listening to some guy in the back of the room," says one former Synthes salesperson. Another adds: "It's not uncommon to have a surgeon with a drill in his hand, about to drill a hole, looking over his shoulder at you saying, 'Is this right?'"

The story also provides insights into why the market doesn’t constrain false or unproven claims, despite huge potential back-end liability in cases like this one: firms are made of people, and individual people both have different incentives than the firm as a whole and, not unrelatedly, deep capacities to read evidence optimistically even as patients are dying.  Indeed, one of two case examples in a brochure given to surgeons promoting the product came from a woman who’d died on the operating table—though the brochure didn’t say that.