A Cyberonics device for epilepsy is safe enough to treat chronically depressed patients, despite concerns over how much relief it could provide, a U.S. Food and Drug Administration panel of outside experts said on Tuesday.
A Cyberonics device for epilepsy is safe enough to treat chronically depressed patients, despite concerns over how much relief it could provide, a U.S. Food and Drug Administration panel of outside experts said on Tuesday. While data showed some impact for those most severely depressed, the panelists said muddled results made it difficult to determine if the pacemaker-like implant or other factors were at work. But the device — called VNS Therapy — was safe despite “some annoying side effects,” said panel chair Kyra Becker, a neurologist at the University of Washington in Seattle. The device, which is surgically implanted to deliver electrical pulses to the brain, is already cleared for epilepsy. The FDA usually, but not always, follows the advice of its outside experts. The panel’s 5-2 recommendation is vital to expanding Cyberonics’ sales potential. Analysts say the chronic depression market could be as much as 10 times larger than the one for epilepsy. “It is their growth opportunity for the future. This market may take a little time to develop but it will ultimately be a very attractive market for devices,” said analyst Jan Wald of A.G. Edwards, adding it was “unclear that it’s going to be smooth sailing with the FDA.” Some panel members suggested the company conduct double-blind, randomized placebo studies to gain clearer data. Psychiatrist John Rush of University of Texas Southwestern in Dallas, who conducted some depression studies for Cyberonics, said researchers were “now in a position where that could be done.” But such studies would yield little additional information and were not necessary, he said, adding they would deny chronically depressed patients immediate help. Other panelists agreed the acute need to help those patients outweighed the data problems. At the meeting, a number of patients told the panel through hoarse voices — one of the most common side effects – how the device had given them hope to live.In one group of 342 patients studied, 68 percent suffered voice problems while another 29 percent reported coughing. Other reactions included breathing difficulties and heart problems, studies showed. FDA staff also told the panel the number of suicides or attempted suicides were “enough to make us concerned.” In the same 324 patients, 3.5 percent tried to kill themselves. Despite the risks, the patients said they were desperate for help. “I had nothing to lose,” said patient Carmen McGuffy, explaining why she sought the surgical option that is already approved for depression in Europe and Canada. The FDA outside experts agreed but recommended several conditions along with the approval, including proper education for surgeons, psychiatrists and other doctors as well as a patient registry to collect more data. Panel members also said the device should only be used for patients who did not respond to at least four other types of therapy. (Source: Reuters Health News: June 2004)