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Mood Machine

Rating

5 Star

Mood Machine

Our Review Summary

This is a thorough and well-researched story. Clearly laying out the apparently dubious benefits and definite downsides to the implantable vagus nerve stimulator (VNS), this article describes the ‘unusual circumstances’ of the device’s FDA approval last summer and reviews the limited and unconvincing evidence of its effectiveness at treating intractable depression. The piece cites both satisfied and dissatisfied patients as well as skeptical providers and those who assert the device is worth a try for those who’ve exhausted other options. Woven throughout are details of the possible harms of the device, including the very likely chance that it may not ease depression at all.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story explains the cost of the device and of the implantation procedure. It also explains that some insurers are reluctant to reimburse for this technology.

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

Satisfactory

The story does a good job giving details of trial data.

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

Satisfactory

Very thorough discussion of potential harms. The story mentions cardiovascular problems that can be life-threatening. It says the device must be replaced every five years or so when the battery runs low. The story also profiles a patient who “frequently lost her voice while she was talking and felt a persistent constriction in the back of her throat. Both are common side effects of VNS treatment.” It states that “Worsening depression and suicide attempts were reported by one-third of patients in one study funded by Cyberonics, according to data presented to the FDA.” The story also suggests that while the device generator may be removed from the chest of a person who wants to stop VNS use, the “electrodes in her neck must remain forever; doctors tell VNS patients that removing them is too risky because tissue grows around them As a result, VNS recipients cannot undergo a full body MRI or therapeutic ultrasound.”

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

Satisfactory

Notes both randomized and non-randomized results, with caution about interpretation.

Does the story commit disease-mongering?

Satisfactory

No evidence of disease mongering. The story did not exaggerate or misrepresent depression or suicide,

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

Satisfactory

Patients, providers, FDA spokesperson, device manufacturer, skeptics and supporters are interviewed or cited.

Does the story compare the new approach with existing alternatives?

Satisfactory

There is mention of psychotherapy, electroconvulsive therapy and antidepressants but few details are given about these options.

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

Satisfactory

The story explains how many Americans have had the device implanted (more than 550 since FDA approval), how many are waiting insurance company approval (7,000), and how many Washington, DC-area physicians have been trained in the use of the device (more than 3,700).

Does the story establish the true novelty of the approach?

Satisfactory

The story makes it clear that the device was approved by the FDA in late 2005.

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

Satisfactory

There is no evidence that this story relied on a news release.

Total Score: 10 of 10 Satisfactory

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