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New Device Reduces Seizures, No Surgery Required

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2 Star

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New Device Reduces Seizures, No Surgery Required

Our Review Summary

Electrical stimulation of the nerves for various therapeutic benefits is nothing new. There is a solid body of research showing that it can work for a range of disorders and there are many FDA-approved devices on the market. Here, though, NPR presented two sources — a patient and the doctor who invented a new device — as proof that a device with very limited evidence behind it can “reduce seizures (with) no surgery required.” We thought NPR’s listeners deserved more on:

  • evaluation of the very limited evidence
  • uncertainties – what isn’t yet known
  • the scope of benefits – in the limited experience so far (not just in the positive experience of one patient profiled)
  • independent perspectives.

 

Why This Matters

Epilepsy is a serious and debilitating disorder for millions worldwide and leads to 125,000 deaths every year. Patients need good alternatives to current surgical and pharmaceutical therapies. Whether the type of electrical stimulation discussed in this story will prove to be one of those options could be decades away, and patients should not be given false hope based on an entertaining but incomplete story.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story makes no mention of costs. There are similar devices in use, including one for epilepsy that is mentioned in the online story. Cost information should have been provided, at a minimum, for one of those devices.

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

Not Satisfactory

There is one attempt to quantify the benefits in the story. It says, “A study of 50 people with drug-resistant epilepsy found that the trigeminal nerve stimulator was able to greatly reduce seizures for about 40 percent of them.” This does not give people enough information to make an informed choice about their treatment options. For example, what does “greatly reduce” mean? Did people go from 10 seizures a week to one seizure? Did people stop taking their medications and only use the device or just reduce the amount of medicaiton, as the woman in the story did? To back up the headline that says “New Device Reduces Seizures, No Surgery Required,” we expect the story to quantify the scope of benefits better than it did.

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

Not Satisfactory

The story goes on at some length to talk about the side effects from drugs, yet allows the researcher/inventor to make the claim that there are no side effects from this device. With all the framing about the promise of the approach, we would hope for more discussion of what’s not known about safety profile after such limited experience to date. Even an additional line would suffice. We only hear the one positive patient’s experience.

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

Not Satisfactory

The only hint that listeners to this story might have had that the evidence for this device was thin was a reference to “a small study.” The online story doesn’t do much better, saying, “A study of 50 people with drug-resistant epilepsy found that the trigeminal nerve stimulator was able to greatly reduce seizures for about 40 percent of them.” That would mean that about 20 people had fewer seizures as a result of this device. There is no context around this claim. There is no mention of the study’s limitations. There  are no comments from experts in the field other than the device’s inventor.

Does the story commit disease-mongering?

Satisfactory

One of our reviewers thought that the the story bordered on disease-mongering by presenting epilepsy, in essence, as a disease where people have been painted into a corner and desperately need a way out and that he best way out is this one device.

But, in the end, the doorway into the story’s discussion of epilepsy is appropriate – “About 3 million Americans have epilepsy, and for about one-third of them, drugs alone do not control their seizure.”

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

Not Satisfactory

The story does not use any independent sources. It also does not make it clear whether Christopher DeGiorgio, a UCLA doctor who invented the device, will benefit from it financially. One can presume that he will, but the story should have made that clear.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does not adequately compare the device to alternatives and gives the impression that this is the best treatment choice. It says for example, “About 3 million Americans have epilepsy, and for about one-third of them, drugs alone do not control their seizures.” It does not say what the one-third referenced do to supplement the drugs. It tends to leave readers with the idea that for at least that subset of the patient population, this device is the only alternative.

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

Satisfactory

The story that aired said at the very end, “The device isn’t approved by the FDA yet. That’s probably several years off.” The accompanying online version of the story said roughly the same thing. Readers should have been told that they are very unlikely to be able to have this device prescribed for them unless they can find their way into a clinical trial. Nonetheless, we’ll give it the benefit of the doubt on this criterion.

Does the story establish the true novelty of the approach?

Satisfactory

We’ll give the story a satisfactory score because it at least explained the following:

“the trigeminal nerve stimulator is not the first time researchers have used electrical pulses to prevent seizures.In 2005, the FDA approved a device that stimulates another nerve that leads to the brain — the vagus nerve. But stimulating the vagus nerve requires surgery to implant a device near the collarbone.

The trigeminal nerve stimulator, in contrast, never penetrates the skin and is powered by an external device about the size of a large cell phone.”

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

Satisfactory

The story does not appear to rely on a news release.

Total Score: 4 of 10 Satisfactory

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