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DBS may be administered by an electronic device, roughly the size of a pocket watch, which is implanted in the upper chest. Thin wires, similar to electrodes, run from the body of the device to the Cg25 region of the brain. A clinician can adjust the level of brain stimulation to improve a patient’s response. “It's sort of a pacemaker for the brain,” comments Dr. Peter Whybrow of UCLA, an expert on depression.
Yet, Dr. Mayberg is quick to point out that DBS should be considered a medical alternative only for the severely depressed. “You don’t operate on someone’s brain if there are other reasonable treatment options. But this is also a serious disease that leaves people morbidly sick for long periods of time.” In light of her research, she adds: “When you see these people living normal lives the way other people do, it is both sobering and humbling.”
However, mainstream clinical use of DBS devices is not yet permitted in the United States. In August 2004, the F.D.A. reviewed a similar product named the VNS Pulse 102. The manufacturer, Cyberonics, claimed that treatment-resistant depression could be remedied by stimulating the vagus nerves of the neck. They also recommended that the implantable device be used to treat chronic epileptics.
In addition to addressing a critical mental health problem, Cyberonics argued that DBS devices would have significant economic implications. A diagnosis of chronic, treatment-resistant depression typically costs the patient $42,000 per year, mostly due to treatments, accidents, and self-inflicted injuries. In contrast, the cost of the pacemaker and its implantation would cost about $20,000.
An expert panel advised the F.D.A. to approve of the VNS Pulse 102. The panel members argued that the biomedical device could serve as a last resort for severely depressed, treatment-resistant patients, especially those in danger of harming themselves. However, after much deliberation, the F.D.A. ruled that the company had not presented sufficiently convincing evidence of the pacemaker’s efficacy.
The initial enthusiastic response to the VNS Pulse 102 is testament to the medical community’s fervent desire to discover a cure for debilitating forms of depression. Deep brain stimulation may yet provide such a cure, but more research is needed before this innovative biomedical solution becomes the standard treatment for people whose other options have run out.
Michaela Panter is an editor of PH
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