A Plan So Crazy It Just Didn't Work: How J&J Got Busted Selling an Epilepsy Drug as a Weight-Loss Product

Last Updated May 4, 2010 5:19 PM EDT

Just when you think you've seen every crazy scheme that drug companies use to push pharmaceuticals for unlawful "off-label" purposes, along comes a new one: Johnson & Johnson (JNJ)'s $81 million settlement for its mismarketing of the epilepsy drug Topamax.

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
  • obesity
  • type 2 diabetes
  • bulimia and binge eating
The Tourette's "study" J&J used to persuade docs had only two patients in it. The PTSD study had 34 patients -- far too few to be statistically significant. (For a drug that carries a risk of bindness through glaucoma.)

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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Image by Flickr user nomadiclass, CC.