A pacemaker-like device which has to be surgically implanted called the vagus nerve stimulator was approved by a top federal medical official against the opinion of his scientific staff .
This device is used in the treatment of persistent depression. As it was no approved by the staff due to its ineffectiveness in its only clinical trial, it was rejected. Cyberonics Inc is the maker and planned to sell it for the treatment against depression. But Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the agency despite all these facts eventually decided to approve it.
AdvertisementSusan Bro, an F.D.A. spokeswoman, said that the device was approved because many people with persistent depression are on their way to institutionalization, because of the seriousness of their illness. To prevent it they had given approval for the device. She said that staff recommendations were overruled after assessing all data, expert opinion and medical need.
Robert P. Cummins, Cyberonics's chairman and chief executive, said that the investigators had failed to interview many experts on serious depression. He also said that the device was very safe and effective against the treatment of chronic or recurrent treatment-resistant depression.
The vagus nerve stimulator is surgically implanted in the upper chest, and its wires are threaded into the neck. Batteries in the device stimulate a nerve leading to the brain.
It was approved for the treatment of epilepsy in some patients. Common side effects are voice alteration, increased cough, shortness of breath, neck pain and difficulty in swallowing. In rare case reports of death, heart problems and vocal cord paralysis are also mentioned.
Cyberonics implanted the device in 235 patients and found only 30 % showed significant improvement after six months.