Critics Alarmed at Growing Use of Vagus Nerve Stimulation for Depression
Doctors at the University of Pennsylvania and elsewhere around the US are beginning to offer vagus nerve stimulation, a controversial and expensive new surgical implant, to patients suffering from treatment-resistant depression. While some patients swear by the device, critics point to the lack of clear scientific evidence that the $40,000 vagus nerve stimulation device alleviates depression at all.
As we reported last year, in July the US Food and Drug Administration approved a controversial new treatment for depression — vagus nerve stimulation. (See “FDA OKs Brain Stimulator for Depression” and “More on Vagus Nerve Stimulation for Depression”.) The controversial and expensive new treatment is rapidly gathering a following in the US psychiatric community, not to mention several patients who are able to afford the $40,000 price tag for the surgical implant:
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.
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.
Last month, the company’s chief financial officer, Pamela B. Westbrook, said, “The FDA approval itself speaks to the safety and efficacy of VNS therapy for treatment-resistant depression”. She also indicated that Cyberonics is now studying VNS as a potential treatment for anxiety disorders, Alzheimer’s disease, bulimia and migraines.
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This article was last reviewed by on Wednesday, 4th January 2006. You can leave a response below.
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21st June 2006
I would like to email patients who have received vns, as I am considering it. I have tried 50 different combinations of drugs that have all failed. I am a nurse practitioner and I want my life back. Please tell me how I can get in touch with patients who have had it implanted.
16th November 2007
How do you find a DR that does the vns implant? I believe it has some hope for me.
21st January 2008
I am the recipient of a VNS implant for depression. It was literally the only treatment left to me after 10 years of major depression, 12 suicide attempts, and 40 hospitalizations. THIS DEVICE WORKS! IT SAVED MY LIFE AND GAVE ME BACK A NORMAL LIFE WITHOUT IT I WOULD CERTAINLY BE DEAD. I am fighting Medicare for payment. People have to know this really works. But it’s all about money. If VNS is done the pharmaceutical companies would lose billions on medications that aren’t necessary anymore. So the insurance companies are refusing to pay.