CONTACT: Public Citizen

The decision by the U.S. Food and Drug Administration (FDA) to approve the Vagus Nerve Stimulator (VNS) for treatment-resistant depression is one of its most questionable regulatory decisions made by the agency in recent memory. As a consequence of the FDA’s data-free decisionmaking, hundreds of thousands of patients with severe depression are likely to undergo surgery to implant a device that has not been proved to work.

This device was a resounding failure in its main clinical trial. And the other main analysis by Cyberonics Inc., the device’s manufacturer, was deemed “highly questionable” by the FDA’s statistical reviewer. No adequately controlled long-term trials have addressed the FDA reviewer’s safety concerns, which stem from cases of worsening depression, suicide and sudden death among patients who received the device.

Devices for which medical claims are made should meet the same approval criteria as drugs. In effect, the FDA has lowered the approval bar for this device. There is simply no convincing evidence that this device works. Until and unless such data are generated, patients are better off without this device.

VNS is an electronic device implanted surgically at the base of the neck that sends pulses of electricity into the brain and elsewhere in the body every five minutes. It was deemed not-approvable by the FDA in August 2004 due to a lack of convincing evidence that the device is effective and concerns that it may actually worsen depression in some patients. However, in the absence of substantially new data, the FDA reversed its position and on Friday approved the device. In May, The Wall Street Journal reported that the Senate Finance Committee was examining the FDA’s handling of Cyberonics’ application.

###