Janet Gildner calmly lay down on the train tracks and waited to die.

Soon she felt the tracks singing and the earth rumbling. The train was upon her. Then came footsteps and shouting and the realization that she wasn't dead. She was still conscious, under the train, and half of her left leg was gone.

What Gildner now refers to as "the train incident" of 2002 wasn't her only attempt to kill herself, or her last episode of depression. Knowing that, and knowing that antidepressants, talk therapy and shock treatments have given her nothing but temporary relief and unpleasant side effects, Gildner fears she soon will be in that terrible place again.

So she's trying a controversial therapy called vagus nerve stimulation, or VNS. It was approved in July by the U.S. Food and Drug Administration for some of the toughest patients psychiatrists see: adults with "treatment-resistant depression," meaning their illness is chronic and they have failed to get better after trying at least four medications.

The device used in this therapy was approved for treatment of epilepsy in 1997, although scientists don't know exactly how it works to prevent seizures.

Critics contend there is not enough proof yet that it relieves depression. But for patients like Gildner, who has lapsed into suicidal depression four times in eight years, VNS is well worth trying.

"I'm very hopeful it'll prevent me from having a relapse," said Gildner, 49, a telephone operator and receptionist from Upper Moreland Township, Montgomery County.

In late November, she had the VNS device - a flat, round pacemaker-like generator measuring two inches in diameter - surgically implanted in her chest, above the heart. Thin wires inside it were threaded under her skin to the vagus nerve on the left side of her neck. The device was programmed to stimulate the nerve every five minutes for 30 seconds at a time. The nerve leads to parts of the brain thought to control mood, motivation, sleep and appetite, all critical areas affected by depression.

Using a gadget that looks like a wand, her doctor periodically adjusts the settings of the battery-powered device, made by Cyberonics Inc. of Houston. Using a special magnet, Gildner also can stop and restart it.

Studies suggest that if the therapy works, Gildner may not feel an effect for six months to a year. That may sound slow and iffy to the uninitiated, but Gildner and her psychiatrist, John J. Worthington of Abington Memorial Hospital, know what's at stake for her.

"These are people who are very frustrated. They've tried everything," said Worthington, who acknowledged that he is a Cyberonics stockholder.

Doctors at the University of Pennsylvania and in cities around the country are beginning to offer VNS to patients. Penn psychiatrist John P. O'Reardon welcomes it as a way to help patients who otherwise have few options.

"They're stuck like a stuck switch. They can't get out of their depression no matter what the effort," said O'Reardon, director of Penn's Treatment Resistant Depression Clinic. O'Reardon, who has no financial ties to the firm, has seven patients with the implant, including Kim Gillies, 41, of Center City.

"Nothing else has worked for me, so you do have to kind of hold on to hope," said Gillies, who has had recurring depression since age 14.

But some advocates for consumers and the mentally ill are alarmed.

In a letter last May, Public Citizen, the Washington-based watchdog organization founded by Ralph Nader, questioned the effectiveness of the device and the soundness of the studies Cyberonics submitted to the FDA. Agency advisers also expressed concerns about the studies' methodology and results. At one point, the FDA rejected the VNS application - only to reverse itself in July.

Peter Lurie, a physician and deputy director of Public Citizen's health research group, said the studies lacked a true comparison group and other valid research elements. The probability of a placebo effect - stemming from the therapy's novelty, the surgery involved, and the electrical stimulation - also was high, he said.

"I think a lot of people are going to have their hopes raised inappropriately, and they'll end up paying for a device that almost certainly does no good and may well have some harms," Lurie said.

Cost of the surgery and the device can run $40,000, and insurance companies don't routinely cover it. Possible side effects include voice alteration, hoarseness, shortness of breath, difficulty swallowing, coughing, and neck pain.

Company studies showed no sexual dysfunction or memory impairment, and minimal sleep disturbance and weight gain, which are commonly associated with antidepressants or shock therapy.

Linda Andre, of the nonprofit Alliance for Human Research Protection in New York, called VNS "the latest moneymaking gimmick" designed to rapidly expand Cyberonics' market. Thirty-thousand epilepsy patients worldwide use its device; more than four million Americans suffer chronic depression, Cyberonics has said. VNS is the only product Cyberonics makes.

Company officials were unavailable for interviews, but in a statement earlier this month, Pamela B. Westbrook, chief financial officer, said, "The FDA approval itself speaks to the safety and efficacy of VNS therapy for treatment-resistant depression."

The firm now is studying VNS as a potential treatment for anxiety disorders, Alzheimer's disease, bulimia and migraines, she added.

Charles E. Donovan 3d of St. Louis considers himself living proof of VNS' therapeutic value. Last month, he self-published Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression, to "reach out to severely depressed people."

Since joining a Cyberonics depression study and having the device implanted in 2001, Donovan said, "improvement has been very gradual. Uptick, uptick, uptick."

"VNS has saved my life," he said.

Gildner has read Donovan's book and hopes her experience will mirror his. She's also taking a new antidepressant - so far, so good - and relying on the support of her husband of 26 years, her college-freshman son, and her Christian faith.

"I am doing well," she said.

For more news or to subscribe, please visit http://www.philly.com

PsycPORT® is a product of the American Psychological Association created to provide quick access to mass-media information related to psychology.
®2006 American Psychological Association
Last updated: 01/28/2006 - 08:28 AM