There's a first for everything

For the first time a director at the FDA overruled the unanimous advice of his scientific and administrative staff and approved an implanted device designed to treat persistent depression. The device had failed the single clinical trial that was held. Yet, the spokesperson for the director said it was approved because many people with persistent depression "are otherwise on their way to institutionalization". This is sound testing and reasoning? Would you allow a doctor to use the device on someone you love? Would a good doctor want to use one?