Implantable Device to Ease Depression Sparks Controversy

TALLAHASSEE, Fla. – 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 if 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, the device's makers 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 in Florida and elsewhere for acceptance by doctors and from the insurers and government agencies that pay for health care.

Some patients, desperate for anything to alleviate their depression, 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. 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.

Inman took a chance, having the device implanted without knowing if she could get reimbursed. She got her claim in before First Coast made its decision not to cover the treatment in Medicare, when it was considered on a case-by-case basis. And she was reimbursed for it.

Wayne Goodman, a psychiatrist whose patients are trying it, acknowledges it will take time to know how effective it is, and that it may not help every one.

"But that said, you're dealing with a condition in a group of patients that are really quite hopeless and prone to suicide," said Goodman, the chairman of the Department of Psychiatry at the University of Florida. "And having an option that may help is a very important tool ... even if it helps just 30 percent of patients."

Goodman has been paid to give talks for Cyberonics, the Houston-based maker of the device, on its use, but he says all the money has gone to his university so he has no financial incentive to promote it. The company also funded some research on the device that Goodman was involved in.

Cyberonics has embarked on a highly aggressive push to get it accepted by insurers that has included a public relations blitz. Vice president Sean Lunney said the company isn't making a profit yet -- but says patients are why the doctors at Cyberonics are so zealous.

But critics question whether it should have even been approved by the FDA.

"I understand they're suffering terribly -- the question is, will they suffer less because a device that does not work is offered to them?" asked Dr. Peter Lurie, deputy director of health research for Public Citizen.

The U.S. Senate Finance Committee earlier this year looked into why the FDA approved the device against the recommendation of some of its advisory scientists. The panel wrote that "concerns persist that the FDA's standard of reasonable assurance of effectiveness may not have been met."

But observers say that slowly, the idea of using nerve stimulation to treat depression is gaining supporters.

"The (doctors) that have performed the procedure and the ones that are comfortable with what the clinical data show are increasingly comfortable recommending it to more patients," said Thom Gunderson, a Piper Jaffray analyst who tracks medical device companies. "But currently, the number of doctors in that category is sparse."

"It's a brand new category of therapy -- psychiatry has not traditionally treated any of the psychiatric disorders with an implantable medical device," Gunderson said. "It's going to require some education."

While the debate goes on, patients simply wait for it to work and hope someone will pay for it.

"Time will tell," said Inman. "I have nowhere else to go."