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Doctor with industry ties call sleep apnea device ‘revolutionary’ and ‘a game changer’ in CBS News story

Rating

1 Star

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Sleep apnea patient finds rest with implant device: "It saved my life"

Our Review Summary

Inspire Therapy implant

The story focuses on one patient’s experience with a technology called Inspire, which is an implantable device used to treat one particular form of sleep apnea (obstructive).

While sleep apnea is a common problem in the United States, the story does little to place the work in context. Instead, the story cites a medical professional who calls it “revolutionary” and a “game-changer” without telling readers that the doctor is a consultant for Inspire. There is also no objective medical assessment of the device’s effectiveness, as the medical professional quoted is also the treating physician. It’s also not clear why the story came out now, given that Inspire has been on the market for a few years and that the evidence cited is from 2014.

 

Why This Matters

We are happy for any patient who has found relief for a medical problem. But the treatment that works for one patient may not work or even be appropriate for others. It is important for any story about medical treatments to offer detailed information about the costs, risks and benefits of a treatment, rather than relying on one person’s story. This is true for any treatment, but especially for medical devices, which are not tightly regulated by the FDA.

This story focuses on one person, but tells readers that Inspire “is offering hope for millions of patients with sleep apnea.” The story should let readers know whether that hope is justified, and also provide clarification regarding its potential benefit applies only to individuals with obstructive sleep apnea.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Here’s what the story says in regard to cost: “The device costs around $20,000 not including the surgery.”

This doesn’t adequately address two key points.

The first problem here is that an invasive surgery, such as this one, could be extremely expensive. Does it require the patient to be put completely under by anesthesia? Is it out-patient surgery, or would patients have to spend at least one night in a hospital? Details like that can make a huge difference in terms of cost.

The second, bigger problem is that the story doesn’t make clear that this is not a one-time cost. Inspire implants can malfunction, and the batteries in the implants will need to be replaced. For example, a 2010 study published in Sleep Medicine Reviews found that, out of eight patients, five experienced device malfunctions more than six months after implantation. There may have been improvements in the technology since that study was published, but there is still no acknowledgment that Inspire’s internal power supply would need to be replaced periodically — and neither the new battery nor the related medical procedure is likely to be free.

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

Not Satisfactory

Benefits are not quantified. Beyond one patient’s anecdotal experience, the story refers to a study that found “68 percent of patients experienced less sleep apnea after getting the implant.” How bad was the apnea before? How did the compare against a control group (if there was one)?

But there is virtually no information about the study, the extent of the improvement, how long it lasted, etc. More detailed information is needed here. However, the biggest concern here is that the story doesn’t make sufficiently clear that Inspire is designed to address just one particular type of sleep apnea. It does say that Inspire is for “moderate to severe cases,” but that’s pretty vague — and doesn’t address the core problems here. First off, there are two large classes of sleep apnea: obstructive (in which the airway becomes blocked) and central (in which the brain doesn’t send the appropriate signals for normal breathing). Inspire can only address obstructive sleep apnea. What’s more, it can only address some types of obstructive sleep apnea. For example, Inspire’s website notes that “Inspire therapy is not intended for patients with a complete concentric collapse at the level of the soft palate.” What exactly does that mean? How common is that condition? I wish the story had told us. What’s more, Inspire’s website also notes that “Inspire therapy has not been clinically tested in patients with a body mass index greater than 32.” In other words, no one knows whether Inspire would work on one of the groups of people at greater risk of sleep apnea.

There’s also this hyperbolic quote: “This has been revolutionary. It’s been a game changer,” Dr. Maurits Boon said. Considering the device doesn’t work for everyone, is expensive, invasive, and may cause side effects, it doesn’t seem revolutionary.

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

Not Satisfactory

The story notes that “like any surgery, there is risk of infection” when Inspire is implanted.

That isn’t enough. A check of FDA’s MAUDE database reveals patient complaints of slurred speech, difficulty breathing, and the device suddenly activating itself, among other problems.

In addition, there are questions particular to the use of an electrical device implanted in the chest — especially for a condition that is most common among patients who are “older, overweight and male” (as the story puts it). For example, can patients with pacemakers also use Inspire, or would they interfere with each other?

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

Not Satisfactory

Outside of one patient’s personal experiences, and a single, vague reference to a study in the New England Journal of Medicine, there is no discussion of evidence supporting benefits associated with Inspire. To be clear, we are not saying this evidence isn’t out there, we’re simply saying the story doesn’t tell us what that evidence is.

Does the story commit disease-mongering?

Not Satisfactory

The story only includes the perspective of one patient with very severe sleep apnea, but never clarifies how many people with sleep apnea have mild, moderate or severe sleep apnea. We’re left to assume it’s a whole heck of a lot of people, because the story says this new treatment “is offering hope for millions of patients.” This lack of clarity adds up to disease-mongering.

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

Not Satisfactory

The story cites only one expert source — and fails to tell readers that the source is a consultant for Inspire. In fairness, you won’t find that information on the doctor’s professional website. However, it is disclosed in a 2016 journal article by the doctor and one of his collaborators. If we could find that information (with a minimum of effort), we think its omission is a significant oversight.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does tell readers that CPAP, a widely used treatment for sleep apnea, did not work for the patient being profiled. However, the story doesn’t let us know how often CPAP is ineffective, whether there is any difference in effectiveness between CPAP and Inspire for most patients, or what other treatment options are available.

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

Satisfactory

It is clear from the story that Inspire is available.

Does the story establish the true novelty of the approach?

Not Satisfactory

This is a tough one. On the one hand, the story does clearly explain how the Inspire technology works — which is good. However, doesn’t state how this is different from any other treatment options — the only other option mentioned is CPAP. If Inspire takes a completely different approach from other treatment technologies, it’s important for the story to come right out and say so.

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

Satisfactory

The story doesn’t appear to rely on a news release. In fact, it’s not clear why the story is running now at all. Inspire was approved by the FDA in 2014 and has been on the market for quite some time.

Total Score: 2 of 10 Satisfactory

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