Patients say device eases depression

TALLAHASSEE · About a decade ago, a clerk at a Gainesville motel noticed something about people who were staying there while participating in a trial of a device used to treat their epilepsy. They were strangely upbeat.



When the clerk mentioned that offhand to their University of Florida doctors, they wondered whether it might be more than optimism over their new treatment. Could the device, which stimulated a nerve in their neck, be changing their mood?

Ten years later, makers of the device have won federal Food and Drug Administration approval to use it to treat the estimated 6,000 Americans who suffer from depression so profound that it is resistant to treatment.



Now, the device, known as a vagus nerve stimulator, is at the center of a battle for acceptance by the insurers and government agencies that pay for health care.



Some patients say it's their only hope after years of failed therapies, from drugs to electric shock treatments. Makers of the device and, increasingly some psychiatrists, say it could prevent suicides.



But others in the medical community -- including some in the FDA -- believe there's no conclusive proof that it works, and it's simply false hope, at best.



Its FDA approval has been investigated by a committee in Congress, and the watchdog group Public Citizen has campaigned against the device, citing research that has shown some patients who have received it actually had worsening depression, and some tried suicide despite having received it.



While the FDA approved the device for the most difficult-to-treat depression patients, getting it paid for has been difficult. The contractor that makes decisions on what the federal Medicare program will cover in Florida, First Coast Service Options, recently decided the clinical evidence isn't conclusive enough to justify coverage.



"It is our hope that trial studies will be made available to patients, and sufficient positive data ... will allow FCSO to cover this service," the Jacksonville-based company said when its decision was announced.



Orange Park resident Cindy Inman is one of the about 100 Florida patients who have had the device implanted in their chest, it's wires snaking up toward the vagus nerve in the neck. She hasn't noticed any difference in her depression yet, after it was implanted in June. Still, after having tried various combinations of more than 30 drugs, she says this is her best hope.



"This was my last resort," Inman said. "I kind of felt like, it's either try this, or I knew I would kill myself."







The several thousand people nationwide with otherwise untreatable depression who have had the device implanted were either in trials or their private insurance companies agreed to pay for it. But while some major insurers have paid for the implant, most are now denying coverage. Some reimburse on a case-by-case basis. The device costs about $15,000, not including thousands more for the surgery.