Complaint Filed Over Vagus Nerve Stimulator Ads

The watchdog group Public Citizen today filed a complaint with the FDA over advertising by the maker of the vagus nerve stimulator, Cyberonics. The complaint basically alleges that the company had overstated the device's benefits and hadn't talked about just how narrow an audience of depressives it was aimed at--ie, people with chronic disabling depression who had run through all their other options short of ECT. Apparently, the company made it sound like VNS would be good for far more cases of depression.

I congratulate Public Citizen for forcing this level of accountability into the psych game, especially since reviewers of the company's clinical data at the FDA felt that using the device presented limited efficacy. So let's not let these folks get away with distorted ads. They are certainly more honest about the limited audience in this press release. I cannot turn up a copy of the ad itself.

It is also the place of organizations like NAMI and NMHA to require the same level of accountability by pharma and device makers. But they haven't, probably because they are dependent on contributions from pharma companies.

Interestingly, in the same Reuters story on the complaint, an investment banker advised that shareholders dump their shares of Cyberonics in advance of the APA's upcoming convention. The reason: their belief that the device is no big deal. Which makes me think that someone will be presnting a damaging paper on VNS at the convention. Stay tuned.