FDA Panel Recommends Device for Depression
Experts Want Device Restricted to Most Severely Ill Patients
Safety in Question continued...
Twenty-five patients using VNS also attempted suicide in several company studies. The experts acknowledge that suicide is a common risk in severely depressed patients but say they are still worried about the product's safety.
"There's enough to make us concerned that there might be something to participation in suicide with this device," says Michael J. Schlosser, MD, an FDA medical officer.
Some members of the advisory panel urged the company to perform more randomized studies comparing patients using VNS to those getting traditional antidepressant treatment.
Others cautioned that requiring more studies could deprive very sick patients for whom other treatments do not work.
"I'm concerned about the potential burden to patients who might not be able to receive a viable treatment for this very severe illness," says Fochtmann, a psychiatrist from the State University of New York in Stony Brook.
A. John Rush, MD, a psychiatrist at the University of Texas Southwestern Medical Center in Dallas and a Cyberonics consultant, says approving VNS is appropriate even though the company did not submit a randomized, controlled study as is customary with most FDA approvals.
"If we help one in four or one in five ... that is a home run in a patient population where we just don't see [improvement] in the long run," he says.