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Today’s papers, both in Philly and Cleveland, are reporting on a remarkable medical story. It’s as close to a resurrection as today’s scientific, secular world is likely to see. A man hospitalized in New Jersey, in a near-vegetative state for six years after being mugged, had his consciousness restored by deep brain stimulation.
The Neurological Restoration group at the Cleveland Clinic in Herrmann’s home town apparently achieved this near miracle by using a “pacemaker-like” device and to deliver electric current to the man’s thalamus. Supposedly there are as many as 400,000 patients in similar circumstances.
That’s great, even astonishing, news.
But we’re lawyers.
You know what lawyers do with great news. We look for legal angle. From the stories in our papers, we can’t tell exactly what this device is or who made it. It may be the same kind of deep brain stimulation equipment that’s used to treat Parkinson’s disease (it’s in the newspaper story – don’t presume that we know squat about this otherwise). There’s no indication that anybody’s sponsoring a clinical trial of the device. The doctors appear to have come up with this stroke of genius on their own.
That means it sounds like off-label use to us – the therapeutic use of an FDA approved drug or device for indications other than those for which it has been approved.
It pretty much has to be. Using medical devices to wake up vegetative patients has never been done before – that’s why it’s such big news. So we know the FDA’s never approved any device for this purpose. Nor do the news stories we’ve seen describe the trappings of an FDA-approved clinical trial. We wouldn’t expect to see that either, given the breakthrough nature of the procedure.
If it’s off-label use, that means that whoever manufactured this amazing device can’t say a word about it without running the risk of being branded a “criminal” or sued for somehow encouraging fraudulent payments by the government or other third party payers. You can’t promote off-label use – not even truthfully – under current law. And it’s not just the FDA. There’s a bunch of lawyers out there just chomping at the bit to sue you if you do.
We think that’s wrong. We think that’s unconstitutional (the first amendment protects truthful scientific speech). What’s worse, we think that prohibiting the truthful promotion of legitimate off-label uses kills people – or, here, sentences people to what many would consider a fate worse than death.
In a perfect (or at least better, since “perfect” wouldn’t have such catastrophic injuries) world, the manufacturer of the device responsible for this breakthrough should be shouting its success from the rooftops. In short, it should be promoting the bejeezus out of what its device can do. Even if the estimate of patients who could be helped is high by a factor of ten – that’s still ten times as many Americans as have been killed in Iraq.
Doing well and doing good are hardly incompatible – only our bollixed up approach to off-label use is.
Since the American newspaper stories that we’ve seen don’t even mention the manufacturer of the device. We had to go to Canada to find out who the mystery company is.
Off-label use – the next life it saves could be your own.