FDA Panel Backs Implant To Counter Depression (Despite Lousy Science)
“A surgical implant that stimulates the brain should get government approval to treat chronic depression, an expert panel of federal experts said yesterday — marking the first time an implanted device has been recommended for the treatment of a psychiatric disorder.
Using a technique known as vagus nerve stimulation, the device uses electrodes implanted in the neck to activate brain regions that are believed to regulate mood.
The decision by an expert advisory panel of the Food and Drug Administration came after a day of clashing scientific opinions about whether the data submitted by the manufacturer were adequate for approval. Proponents of the device prevailed, citing the desperate need of patients with chronic depression that does not respond to existing treatments. […]
Of 111 patients getting stimulation, 17 showed an improvement of at least 50 percent on a psychiatric scale of depression after 12 weeks. Of 110 patients getting “sham” treatment, only 10 showed similar improvement. The difference between the groups was not statistically significant, however.”
The ridiculous science here is obvious — how can the FDA approve a treatment that has been scientifically proven to be no better than placebo?? That’s what “not statistically significant” means — that there’s no significant difference between the treatment group and the placebo group. You might as well give people a sugar pill and say, “Here, try this, it’ll help!”
Grohol, J. (2004). FDA Panel Backs Implant To Counter Depression (Despite Lousy Science). Psych Central. Retrieved on February 12, 2016, from http://psychcentral.com/blog/archives/2004/06/17/fda-panel-backs-implant-to-counter-depression-despite-lousy-science/