Healthy Skepticism Library item: 17871

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

Edwards J
A Plan So Crazy It Just Didn't Work: How J&J Got Busted Selling an Epilepsy Drug as a Weight-Loss Product
Bnet 2010 May 4
http://industry.bnet.com/pharma/10008022/a-plan-so-crazy-it-just-didnt-work-how-jj-got-busted-selling-an-epilepsy-drug-as-a-weight-loss-product/

Full text:

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.