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.
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.
The story does a good job giving details of trial data.
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.”
Notes both randomized and non-randomized results, with caution about interpretation.
No evidence of disease mongering. The story did not exaggerate or misrepresent depression or suicide,
Patients, providers, FDA spokesperson, device manufacturer, skeptics and supporters are interviewed or cited.
There is mention of psychotherapy, electroconvulsive therapy and antidepressants but few details are given about these options.
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).
The story makes it clear that the device was approved by the FDA in late 2005.
There is no evidence that this story relied on a news release.