FDA in doubt?

There appears to be some controversy at the FDA these days and it is disheartening to hear allegations of misconduct in the agency that is supposed to protect us from medical treatment fraud. This week a regulator of medical devices resigned in the midst of concerns that he was too friendly with the persons or companies that were trying to have their devices approved for use. In reading the story I became concerned because there was mention of an approval for a nerve stimulation device, [I believe this would be the vagus nerve stimulator and not the transmagnetic stimulation device], to be used in treatment resistant depression. Concerning because apparently there was doubt about the safety and efficacy of said device and an FDA panel strongly discouraged its approval. It was approved and it has been used and I know of people who had the procedure because I have worked in the psychiatry field.

I will tell you that I personally do not believe in either device and am pretty certain that there is skepticism on both. What concerns me is that I do not recall anyone telling the patients that there was a controversy on approval. I imagine that the law for informed consent does not demand disclosure of pre market concerns. Stories like this just add to the national distrust of the FDA and I don’t like that. I need to trust the FDA.

The VNS is implanted by surgery, the TMS is a magnet applied to the head to stimulate the brain during an out patient appointment. The VNS can be turned on and off after placement and was thought to be a adjunct or alternative to ECT or electroconvulsive therapy.