When the cardiac pacemaker was designed decades ago for regulating the heartbeat of people suffering from arrhythmias, the device was resoundingly embraced by the medical community. People who had dealt with irregular heartbeats and the resulting risk of heart attack, had this revolutionary device implanted in their chests, and they suddenly felt as though they had a new lease of life. As medical technology has continued to evolve, other computer-aided medical devices have been designed and approved, for improving the quality of life of the people dealing with various debilitating conditions.
For people suffering from severe depression, the primary method of dealing with their condition on a personal basis, was with prescription medication. Now, the FDA has approved a new treatment for depression, that is non-pharmaceutical, and is a treatment of last resort for severely depressed people, who have run the gamut of pharmaceutical treatments without any success. A company called Cyberonics has created a product called the Vagus Nerve Stimulator (VNS), a device that's similar to a pacemaker, but it's implanted in the brain. The VNS is a tiny implant that delivers tiny electrical shocks to the brain, over and over again. The VNS has been sold since 1997 solely to control intractable (unending) epilepsy, but now the FDA has approved the device as a potential treatment for any of the estimated 4 million Americans suffering from depression, that is difficult or impossible to treat. However,there has been intense controversy over whether the device has really been proven to work.
"These are patients pretty much at the end of the line in terms of what treatment options are available to them," says FDA medical device chief Dr. Daniel Schultz, who said that despite initial skepticism within the FDA, he was convinced of the device's effectiveness by Cyberonics' research. Their research consisted of a study of 200 patients to see whether VNS succeeded in treating depression in patients who had not been successfully helped by other therapies. After three months of implant treatment, an FDA review last year found that there was no discernible difference in the patients' conditions, but Cyberonics says that a year later, a significant number of the test patients had realized an improvement in their depression. However, their research was not a randomized control study, and wasn't done according to standard scientific procedures, so critics questioned the validity of their results.
However, Cyberonics continued to track the VNS recipients in the original study, and two years later a third of the patients had realized some response, and 17-20% of the patients were completely in remission. Such positive results-combined with no negative results-had impressed Shultz enough for him to agree to FDA approval of the device. One of the complaints voiced most often by critics was that without comparing the tested patients to a control group of similar patients undergoing different types of therapies, it can't be determined for certain whether the VNS implant really helped, or the depression improved for some other reason.
Along with the FDA approval came warnings of some safety issues connected with VNS implants. The primary warning stems from the fact that a significant number of the patients in the study experienced temporary alterations in their voices, including hoarseness, raspiness, or faltering speech patterns. Other complications can include difficulty in breathing or swallowing. Among epilepsy patients receiving VNS implants, there have been several deaths reported, but no deaths were reported among patients in the depression study.
The FDA approval of VNS implants may be a welcome alternative for patients suffering from severe depression, if they want to try a non-pharmaceutical approach, unless they get more depressed by talking funny, after having their brain shocked continuously. But if brain electrocution makes them happy, they may actually enjoy sounding like Clint Eastwood.