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Solid reporting, but broader ethical/medical questions not addressed

Rating

4 Star

How Well Does the Newly Approved Weight-Loss 'Balloon' Work? Expert notes it will probably only be effective for short-term weight loss

Our Review Summary

This story describes a device, ReShape, inserted inside the patient’s stomach that appears to help with weight loss on a short-term temporary basis. Besides the gastric ulcers that struck more than one-third of patients in the study group, we think this device also may also represent a “harm” if it encourages patients down a short-term path rather then helping them make a long-term permanent change in their health. The small study described was financed by the device manufacturer.

 

 

Why This Matters

Weight scale w:beltThe story did a good job outlining some of the harms of the device, but the list of potential harms could have been even longer. If someone who is not “medically” obese pays for this device and this procedure and is exposed to risks for only a limited chance at a temporary benefit, is that a harm? This story does not answer that question. Let’s face it, whatever intervention a person undertakes to lose weight, that weight will return when the intervention ends. As a consequence, unless there’s a medical need for rapid weight loss, there’s a limited role for a by-definition temporary intervention, let alone one that confers real risk. So as good a job as the story did in covering the basics of what was behind the FDA’s approval, there could have been – and still could be – an important followup on some of these broader medical/ethical questions.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does discuss costs. The discussion would be better if it included the cost of implanting the device. The story only told the price of the device in Europe “average price is about $6,200, according to the manufacturer.” But it was not clear whether that price includes fees to the doctor and clinic for insertion and removal. And readers/consumers should also think about this: given the high likelihood of “intolerable” nausea, what is the impact this might have on lost work time?

We are not given context of prices for other procedures related to this one – such as bariatric surgeries.

 

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

Satisfactory

The story states “the ReShape system helped people more than double their weight loss compared to those trying to lose weight through diet and exercise.” We also also note that because previous studies on weight loss suggest that the average individual is hoping for a loss of 20% or more of presenting weight, “double” as a descriptor, when discussing very small losses, may be a bit loaded.

In the final paragraph, the story includes absolute values of weight loss:

“In the clinical trial, the 187 participants who used the device lost an average of more than 14 pounds, or about 7 percent of their total body weight. Patients who did not receive the device lost about half that amount of weight — just over 3 percent of their total body weight, the FDA said.”

Kudos to the writer for including the comments from the researcher who said the results may be temporary.

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

Satisfactory

The story explained that nausea that made some patients drop out of the study, and explained that gastric ulcers were seen in the stomachs of more than one-third of patients. Since the device appeals to a consumer who “does not qualify” for medical obesity treatment and has only temporary benefit, we believe the story should have quoted at least one critic.

Given that the patients in this study are those who “do not qualify” for the medical management of obesity, one might raise questions about the ethics of an intervention that isn’t medically indicated. Given the temporary nature of the device, the risks should be expected to outweigh the benefits – especially since the benefits in turn, unless marked behavior changes are permanently undertaken, will, by definition, be temporary. This can be viewed as an extreme intervention in the name of non-medically necessary weight loss – the kind of approach that runs the risk of encouraging people to pursue all sorts of nonsensical, and, at times, dangerous diets and interventions.

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

Satisfactory

The story correctly points out that this information is from an FDA news release, based on a summary of the clinical research. The story also identifies the research as funded by the device manufacturer.

 

Does the story commit disease-mongering?

Satisfactory

We will give the story the benefit of the doubt on this criterion, but in so doing, will try to raise reader’s awareness of a broader issue.

Despite the line that states the intervention isn’t medically necessary, the story doesn’t touch on the disease-mongering that can take place when messages imply that weight scales can measure health, and when people are medicalized simply on the basis of their weights.

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

Satisfactory

The story identifies the device manufacturer, ReShape, as the financial sponsor of the clinical research on their own device.  And it includes extensive quotes with an obesity surgeon who provides expert perspective on some of the limitations of the intervention.

 

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story skates very quickly by the notion that diet and exercise are alternatives to the ReShape device, as well as alternatives to bariatric surgery.  It would have helped to quote a psychologist or other expert on behavior change about what permanent value may or may not come from such a short-term weight loss.

To have a medical device, with very real risks, temporarily placed in someone’s stomach in the name of temporarily losing 7 more pounds than matched controls (whose weight losses may well be longer lived given they were fueled by behavior change) is not good medicine.  The story – perhaps through the input of an independent expert – could have made the point that well-supported behavior modification may have achieved the same result as the balloon intervention did.

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

Not Satisfactory

The story makes clear the device has just won FDA approval, and has been available in Europe. But the story doesn’t comment on what might be the obstacles to use in the US.  What training is required?  How many physicians have been trained?  How might availability be held back if (as the story appropriately suggests) patients have to pay cash for it? Are there any lessons from Europe that would educate American consumers?

 

Does the story establish the true novelty of the approach?

Satisfactory

The story makes clear the device just won FDA approval and works differently than others.

 

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

Satisfactory

The story does not rely solely on the release, but shows independent reporting.

[http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm456296.htm]

 

Total Score: 8 of 10 Satisfactory

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