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An Alzheimer’s study that included just 3 people: Does that warrant consumer news coverage?

Rating

3 Star

Categories

Brain 'Pacemaker' Might Help Slow Alzheimer’s

Our Review Summary

This story reports on a “proof of concept” study of deep brain stimulation (DBS) to improve behavioral and cognitive function in Alzheimer’s patients, which involves implanting an electrical pulse generator under the skin to alter brain activity.

To its credit, the story cautions that this is not anywhere close to being a readily available treatment. However, it neglects significant potential harms of using an implantable device and isn’t completely clear on the lack of a proven benefit. We think this study was one of those that isn’t quite ready for a consumer news audience; it’s just too preliminary and has the potential to stoke false hope.

 

Why This Matters

Authors of this study point out that Alzheimer’s disease is not just a memory problem but rather presents a host of cognitive and behavioral impairments, and even “small treatment advances” could have a meaningful impact by delaying their progress. DBS has been widely used with patients with Parkinson’s disease and other conditions, they say, and research suggests the technique can improve cognitive, behavioral and functional impairments. Also, any treatments involving medical devices should include cautions about potential harms, as described in our toolkit on medical device safety.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story doesn’t talk about the cost of this device. Deep brain stimulation surgery for Parkinson’s disease costs $35,000 to $50,000, according to the National Parkinson Foundation.

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

Not Satisfactory

This study wasn’t designed to prove a benefit, although the story could have explained that more clearly. We’re rating this Not Satisfactory because it confuses readers with a headline stating the device “might help slow Alzheimer’s,” while the story itself focuses on the clinical outcomes of the three patients in the study, citing “signals” that the device slowed two patients’ decline, for example. The fact that two of the three patients declined at slower rate compared to 96 patients in a database doesn’t say anything about whether the device is really effective. Even so, there’s no specific data on how those patients’ outcomes differed and what was measured.

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

Not Satisfactory

The story doesn’t completely drop the ball, stating side effects “included hot flashes, heart palpitations and burning sensations in the skin, which were reversed by adjusting the DBS settings.” But any story on an implantable medical device should caution readers about the risks of surgery to both install and remove it and mention that medical devices are not required to undergo rigorous safety tests before they are allowed on the market. The lead’s assertion that the device “may be safe” neglects the inherent risks of implantable devices.

The story left out another known risk of deep brain stimulation: depression. All three subjects were treated with antidepressant medication. Although, as the study authors note, the DBS may not have caused the depression–it is common in dementia, and treating it can improve people’s cognitive and functional abilities. Such as described for patient “LaVonne.”

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

Not Satisfactory

It’s questionable whether this study should have been brought to the attention of consumer news readers as the quality of the evidence showing it works—much less is safe–is too preliminary. This concept was tested on just three people, far too few for anyone to have any idea if it will work. Had the story been framed differently–without the overly hopeful headline and intro paragraph–and instead explored the science behind DBS and the challenges of studying it in Alzheimer’s patients, it might have rated Satisfactory on this criterion.

We did appreciate the fairly prominent placement of a caveat that “it’s far too early to know whether it has value for people with Alzheimer’s” and the caution further down that a trial comparing it with a placebo device is needed.

But, the story includes an anecdote of a patient who “regained” her cooking skills and improved her ability to perform other tasks while on the study without explaining that it’s unclear whether the DBS had an impact on the progression of her disease. It also could have been the medication she was on, for example.

Does the story commit disease-mongering?

Satisfactory

The story states: “More than 5 million Americans have Alzheimer’s — a number that could rise to 16 million by 2050, according to the Alzheimer’s Association.”

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

Satisfactory

The story includes a useful comment from Keith Fargo, who directs scientific programs and outreach for the Alzheimer’s Association, that it’s “much too early” for for patients or caregivers to seek out this device.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions that “medications for Alzheimer’s target brain chemicals involved in memory.”

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

Satisfactory

We like the prominent placement of the caveat that “it’s far too early to know whether it has value for people with Alzheimer’s” and it’s “not something patients can ask their neurologist for.” It also mentions DBS “would not be for everyone” including people who are frail or have other serious medical conditions.

Does the story establish the true novelty of the approach?

Satisfactory

The story lets us know that this therapy is used in Parkinson’s patients, and that this small pilot study is exploring its potential for Alzheimer’s disease. It says the study highlights that “Alzheimer’s disease is more than just amnesia” and “problems with abilities like judgment and planning can actually be more challenging.”

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

Satisfactory

The story draws from sources other than a Ohio State Wexner Medical Center news release.

Total Score: 6 of 10 Satisfactory

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