Eight months ago the Food and Drug Administration (FDA) approved a pocket-watch-sized device billed as "a pacemaker for the brain," the newest cutting-edge treatment for as many as 4 million adults whose severe depression is not relieved by psychotherapy, drugs or even shock treatments.
Since then, more than 550 Americans have undergone surgery to have a vagus nerve stimulator (VNS) implanted in their chests to activate parts of their brains. However, the only rigorous clinical trial of the device -- which is approved to treat severe epilepsy -- failed to demonstrate effectiveness in alleviating depression.What happened to evidence-based medicine?
2 comments:
Your question seems especially apt given that FDA has also acted against scientific evidence in the other direction--ie, the refusal to license Plan B for OTC sales.
And. . . given that women are twice as likely to experience depression during thier lives (compared with men), this is an important issue for women's health.
Thanks for the personal insight, Herb -- I wonder would have compelled the reporter to give such a biased slant? Just a lack of understanding?
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