I want to be happy

A controversial new device for hard-to-treat depression is stirring up hope and debate

O, The Oprah Magazine, November 2005

ABOUT 20 PERCENT OF PEOPLE with severe depression find no relief from conventional therapies, which means that nearly four million Americans suffer from a disabling condition that can't be eased with cognitive therapy, medication, or even electroconvulsive (shock) treatments. Nothing novel has come onto the scene in more than a decade, leaving both patients and doctors feeling helpless and exhausted. But earlier this year, the FDA provided a glimmer of hope: It approved the use of a permanent, pacemaker-like device called a vagus nerve stimulator (VNS) for people with treatment-resistant depression. While the VNS offers potential help for millions, some experts are calling the FDA approval premature. Here's what you need to know:


The VNS--first approved for epilepsy in 1997--is a large disc implanted under the skin in the upper chest (about where you put your hand when saying the Pledge of Allegiance). Thin wires carry electrical pulses from the device to the vagus nerve in the neck, which leads to areas of the brain thought to play a role in mood regulation. Side effects are relatively minor, such as a hoarse voice and throat tickle.


Most experts agree that in order for a therapy to be approved, especially for an illness as complicated as depression, it should show a clear benefit through research in which neither researchers nor their subjects know who's getting the real treatment (a double-blind, placebo-controlled trial). The only such study to date showed no significant difference between people with a working implant and those with a deactivated one. "I don't think we have evidence of efficacy," says Richard P. Malone, MD, a psychiatrist at Drexel University College of Medicine in Philadelphia and a member of the FDA panel that reviewed the VNS. Of the seven voting members on the panel, Malone was one of two dissenting votes.


Some people have clearly been helped by VNS treatment, says Sarah Lisanby, MD, a psychiatrist at Columbia University Medical Center in New York City and chairperson of the American Psychiatric Association's committee on electroconvulsive therapy. Lisanby enrolled some of her patients in early VNS trials, in which 40 percent of the participants found relief. Six years later, some are still benefiting. She notes that the VNS is not a cure and will probably never be a stand-alone treatment. But, she asks, "what are the alternatives?"


It's a difficult decision: outpatient surgery, an iffy outcome, and implanted wires that are difficult to remove, weighed against the possibility--however weak--of real relief. Advocacy groups, such as the National Mental Health Association, are not taking an official position. But even the FDA panel's chairwoman, Kyra Becker, MD, a neurologist at the University of Washington in Seattle, says that she and other committee members would like to see results from another trial before the VNS is adopted for widespread use. So while you or someone you know might be helped by the implant, approach it with caution and the knowledge that the VNS is still an experiment in progress.