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Implant Device Can Treat Clinical Depression

Rating

1 Star

Implant Device Can Treat Clinical Depression

Our Review Summary

This story reports on vagus nerve stimulation (VNS) as a newer method for treating people with depression; however, it is currently approved only for people with treatment resistant depression, that is, depression that has not responded to trials of at least four medications and/or electroshock therapy. While the story does mention these other treatment options, it is out of balance when it portrays anti-depressant medications as “risky”. The surgery for VNS carries greater short-term risk than a trial of anti-depressant medications. The story also does not mention talk therapy, which when used in conjunction with medications may help people with clinical depression. The story also does not mention that VNS is typically used in conjunction with other forms of depression therapies, such as medication and talk therapy. No evidence is given to support the statement that most people with clinical depression never receive treatment.

The story does not provide quantitative evidence of the effectiveness of VNS in relieving depression or preventing suicide in people with treatment resistant depression, which does a real disservice to the viewer. The story does not explain the benefit of VNS over existing treatments for depression, or the clinical trials which showed no significant effect of the device.

The story mentions that changes in voice are the “only side effect” of VNS. This is not true. In clinical trials, side effects from vagus nerve stimulation included tickling in the throat, hoarseness or temporary change in voice tone, and shortness of breath upon exertion, and these were described as are mild to moderate. The story also does not discuss the potential harms of surgery and general anesthesia.

Lastly, the story does not provide the cost of the device or surgery for implantation, which is approximately $20,000. Patients also typically require regular visits to physicians for adjustments to the device. The cost of these follow-up visits is not mentioned. Even though the VNS candidate in this story could not get his health insurance to pay for this treatment, insurance benefits for VNS therapy vary by health plan. The comment that 12 people died because they did not receive a VNS device in a timely manner is an overstatement. We do not know that VNS therapy would have prevented their deaths.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not provide the cost of the vagus nerve stimulator (VNS) or surgery for implantation of the device, which is $20,000. Patients also typically require regular visits to physicians for adjustments to the device. The cost of these follow-up visits is not mentioned. Even though the VNS candidate in this story could not get insurance to pay for this treatment, insurance benefits for VNS therapy vary by insurance carrier. The comment that 12 people died because they did not receive a VNS device in a timely manner is an overstatement. We do not know that VNS therapy would have prevented their deaths.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The story does not mention the benefit of VNS over existing treatments for depression. Clinical trials on which the device was approved showed that there was a benefit in only about 3 out of every 10 people after about one year. Other therapies often need to be continued in conjunction with VNS. Also, the story states that the device saved this patients live “for sure”, which is not true.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story mentions that changes in voice are the only side effect of the VNS device. This is not true. In clinical trials, side effects from vagus nerve stimulation include tickling in the throat, hoarseness or temporary change in voice tone, and shortness of breath upon exertion, and these were described as are mild to moderate. The story also does not discuss the potential harms of surgery and general anesthesia.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story does not provide evidence of the effectives of VNS in relieving depression or preventing suicide in people with treatment resistant depression. The only controlled trial of this device showed no effect. The story does an important disservice because it does not report on the available evidence

Does the story commit disease-mongering?

Not Satisfactory

The story states that 40,000 people commit suicide each year. This number is high for the incidence of suicides in U.S, but the bigger issue is that depression and related suicidality is not solely responsible for these deaths. Also, depression may co-exist with alcohol and substance abuse, psychosis, or other mental or physical illnesses which may contribute to successful suicide attempts.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story relies on anecdotal information from one person for whom the VNS was a success. The physician interviewed is a psychiatrist treating this patient and he only describes how the device works, not the risks and benefits. Other perspectives from specialists in treatment resistant depression or VNS surgery are needed for greater perspective on this treatment.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does mention other treatment options for depression such as medications and electroshock therapy. However, the story is out of balance when it portrays medications as “risky”. The surgery for VNS implantation carries more short-term risk than a trial of most anti-depressant medications. The story also does not mention talk therapy, which when used in conjunction with medications may help people with clinical depression. The story does not mention that VNS is typically used in conjunction with other forms of depression therapies, such as medication and talk therapy. There is also no evidence given to support the statement that most people with clinical depression never receive treatment.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story does not mention that this device was approved in 2005. It is available for people only with treatment resistant depression, which is depression that has not responded to trials of at least four medications and/or electroshock therapy. The story also does not mention if it is available only at specialized centers or more widely available through community hospitals.

Does the story establish the true novelty of the approach?

Satisfactory

The story mentions that vagus nerve stimulation is a newer method for treating people with depression that has not responded to drugs or electroshock therapy.

Does the story appear to rely solely or largely on a news release?

Not Applicable

We can’t be sure if the story relied solely or largely on a news release, although it was based on the experience of only doctor and his patient at only one medical center.

Total Score: 1 of 9 Satisfactory

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