Last Updated May 4, 2010 5:19 PM EDT
This time, the twist is that J&J's Ortho-McNeil unit didn't just push the envelope, it fed the envelope into a paper shredder. You know how sometimes someone comes up with a plan that's "so crazy it just might work"? There's a reason those plans never make it out of the conference room. Except at J&J, where the company's "consultants" promoted Topamax for any random condition -- Tourette's! Obesity! -- they could think of, thus maximizing their chances of getting caught.
Usually, when drug companies promote their products off-label, they do so for linked conditions. It's not completely unreasonable to suggest that a doctor try a depression drug in a patient with post-traumatic stress disorder if data says it might work -- the two conditions share some similar symptoms.
J&J, however, promoted Topamax for such a wild range of conditions, based on such thin evidence, that it was impossible not to notice that many of them were off-label. It is therefore not a surprise that the company was busted doing it.
I hesitate to give managers advice on how to skirt the law, but if you're considering using a "liberal" interpretation of how federal regulations affect your company you might want to at least stay close to the line you're crossing to preserve some plausible deniability. J&J's logic, on the other hand, was to pretend there was no line.
Topamax was only ever approved for seizures. Here's the list of conditions J&J actually promoted it for, according to the whistleblower who brought the case:
- alcohol dependence
- essential tremor
- diabetic neuropathic pain
- post traumatic stress disorder
- Tourette's syndrome
- obsessive compulsive disorder
- type 2 diabetes
- bulimia and binge eating
J&J's consultants -- doctors who were paid $500 just to show up to a meeting and give a talk, basically -- came up with comically implausible claims for their "evolving spectrum of clinical use." My favorite was the alleged Topamax weight-loss claim, which one speaker told his colleagues "is unlike other weight loss compounds -- this causes much more weight loss the heavier you are."
To quote Amy and Seth from Saturday Night Live: Really? J&J's epilepsy drug is the most effective weight loss product on the planet -- becoming more effective the worse the patient's condition is! -- and no one else noticed? Really?
There's little management wisdom to be gained from this other than that old chestnut about highway driving: You probably won't get a ticket if the cops see you doing 60 in a 55 mph zone. But if you blow by the cruiser at 90 mph, weaving in and out of traffic, expect to see flashing reds in the rearview mirror.
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