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New stuff: The SmartPill

Rating

2 Star

New stuff: The SmartPill

Our Review Summary

This story reports on the recent FDA approval of a new swallowable recorder for measuring the rate of gastric emptying. However, this story focuses too much on the novelty of the device and does little to explain what this device can and can’t do.

The story does explain that the device can help diagnose gastroparesis, or slow gastric emptying, but doesn’t explain that the condition is usually not very serious. Instead, the story only mentions the severe end of the spectrum of this condition. Then it allows a company marketing person to say that “new clinical trials may prove that the pill also can be used to help diagnose constipation problems. ” That is disease-mongering. Not everyone walking around with constipation needs a test to diagnose what’s going on.

The story does not mention harms of the device nor does it mention the alternatives, including endoscopy. Although the story states that the device costs $500, there is no attempt to compare this cost to other existing tests and it does not address whether insurance companies will pay for the test.

Most importantly, the story does not comment on the strength of the available evidence or quantify the benefits of the device. It isn’t clear how this will help doctors or patients assess or manage GI problems. It also isn’t clear whether the device offers benefits relative to existing tests such as xray procedures or scope tests of the bowel. Furthermore, the story only quotes a company marketing person, and offers a link to the company website. The story should have quoted independent sources who could have provided some perspective.

While this was only a brief, it was too brief to offer much of value to the reader.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Although the story states that the device costs $500, there is no attempt to compare this cost to other existing tests and it does not address whether insurance companies will pay for the test.

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

Not Satisfactory

The story does not attempt to quantify the benefits. It isn’t clear how this will help doctors or patients assess or manage GI problems. It also isn’t clear whether the device offers benefits relative to existing tests such as x-ray procedures or scope tests of the bowel.

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

Not Satisfactory

The story does not mention any potential harms.

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

Not Satisfactory

The story does not comment on the strength of the available evidence.

Does the story commit disease-mongering?

Not Satisfactory

The story explains that “SmartPill can be used for diagnosing slow gastric emptying or gastroparesis. Diabetics and those with Parkinson’s disease often suffer from gastroparesis.” But not everyone with slow gastric emptying has such a severe case of gastroparesis that it warrants this kind of attention. There’s a spectrum of severity and the story only mentioned the severe end of the spectrum. When the story goes on to let a company marketing person say that “new clinical trials may prove that the pill also can be used to help diagnose constipation problems,” it worsens the disease-mongering effect. Not everyone walking around with constipation needs a test to diagnose what’s going on.

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

Not Satisfactory

The story only quotes a marketing representative of the company. The story should have quoted independent sources who could have provided some perspective.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does not mention the alternatives, including endoscopy or gastric emptying test.

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

Satisfactory

The story clearly states that this device was approved by the FDA last month. The story should have described when it will be available and how widely available it will be.

Does the story establish the true novelty of the approach?

Satisfactory

The story states that this is a new device. What isn’t clear is that there are other similar devices available (PillCam, for example), which do the same thing.

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

Not Applicable

There is no way to know if the story relies on a press release as the sole source of information, although with the only quote coming from a company marketing person, and a link offered to the company website, we are suspicious.

Total Score: 2 of 9 Satisfactory

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