Group Attacks Depression Device Approval

July 18, 2005 -- An FDA watchdog group criticized the agency's recent approval of a new electrical stimulation device for depression Monday. It says that the device has not been proven to work and may increase patients' risk of suicide.

The device, called a Vagus Nerve Stimulator (VNS), was approved for U.S. sales Friday. But Public Citizen, an FDA and medical industry monitoring group, says that the device does not meet government standards for safety and efficacy and has not been adequately studied.

The device is also the subject of an ongoing investigation on Capitol Hill, where some lawmakers are questioning its approval.

VNS is a small electrical generator that is surgically implanted under the skin, where it delivers an electrical pulse every five seconds through wires wrapped around the vagus nerve. The vagus nerve runs from the neck to the brain. The nerve is thought to have some control over mood regulation.

John O'Reardon, MD, a psychiatrist and a paid consultant for the manufacturer, called the approval "a reasonable scientific decision." Severely depressed patients run a long-term risk of suicide attempts of nearly 20%, meaning they are already in danger without treatment, says O'Reardon, chief of the treatment-resistant depression clinic at the University of Pennsylvania.

"It won't help every patient. If it helps 30% of my severely ill patients that makes them a lot better off then they were previously," O'Reardon says.

Device Rejected Last Year

FDA expert advisers voted 5-2 last year to recommend approval of the device for treatment-resistant depression despite a study showing it failed to help severely depressed patients after three months. In another study, 30% to 40% who used VNS for one to two years had some improvement in their depression, according to manufacturer Cyberonics Inc.

Several experts at the time expressed concern over data suggesting that some patients who use VNS could be at increased risk for worsening depression or even suicide.

Thirty-one of 235 participants in one study had bouts of deepening depression, many reporting more than one episode. Twenty-five patients using VNS also attempted suicide in several company studies.

The FDA rejected the device in August 2004, a decision that was appealed by the manufacturer. The agency defended the reversal, noting that the surgically implanted device was approved as a last resort for severely ill patients who get no help from other treatments.

Questioning Approval

Peter Lurie, MD, Public Citizen's deputy director, called the approval "one of the most questionable regulatory decisions made by the agency in recent memory.

"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."