Fox News story on gastric balloon: more superficial news that reads like paid content

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

Not Satisfactory

The story does not address benefits in any kind of meaningful way, much less offer any quantification of the benefits. Instead, the story tells readers what the “objective” of Orbera is. It also offers an anecdote from one patient who used Orbera and credited it with helping her lose weight. Is this one patient’s experience normal for other users of Orbera? The story doesn’t tell us. Other than this one patient’s testimony, the story offers no evidence that Orbera works at all, much less how well it might work. Is the weight loss short-term or long-term? Obesity is a chronic disease, but this device is temporary. How does that impact the patient’s weight in the long range?

The story also doesn’t tell readers how weight loss might be related to an individual’s actual health. Instead, it notes that Orbera should not be used by people who are “morbidly obese.” The story says Orbera is for people with a body mass index of 30 to 40 and “is meant for people looking for an extra jumpstart on a diet, whether the purpose is cosmetic or for health reasons.” Why that BMI range? Another question the story doesn’t answer.

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

Not Satisfactory

The story spends more time playing down potential risks than it does addressing what risks are posed by Orbera. Risks are summed up with a line that says: “The most common side effect of installing the balloon is nausea that lasts a few days.” It also says that patients are kept under “mild to moderate” sedation when Orbera is put into the stomach. The story adds that Orbera eliminates “risks involved with more invasive options,” effectively playing down the risks associated with sedation. The story also doesn’t address risks such as “vomiting, abdominal or back pain, acid reflux, influence on digestion of food, blockage of food entering the stomach, bacterial growth in the fluid filling the balloon which can lead to infection, injury to the lining of the digestive tract, stomach or esophagus,” etc. — all of which are discussed on Orbera’s website.

However, the most problematic line in the story related to harms states: “even if the balloon were to pop, the saline would be absorbed and pose no harm to the patient. The balloon would be removed in the same way it is at the six month mark.” Readers might think that this mean a popped balloon in the stomach is a trivial event. However, Orbera’s directions for use — which are also available online — note that “Bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal. The risk of obstructions may be higher in patients who have diabetes, a dysmotility disorder, or who have had prior abdominal or gynecological surgery, so this should be considered in assessing the risk of the procedure. Bowel obstruction can result in death.” Not necessarily such a trivial event after all.

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

Not Satisfactory

Other than one patient’s testimonial, the story offers no evidence that Orbera works at all. That’s about as unsatisfactory as it gets.

Does the story commit disease-mongering?

Not Satisfactory

A story can be guilty of disease mongering if it conflates a risk factor with a disease. This story clearly treats weight loss as the health goal, even singling out cosmetic reasons as a reasonable rationale for using Orbera. What’s more, based on this story, one could be forgiven for thinking that trying to lose weight is a health problem in itself. As the opening sentence notes: “America’s ongoing battle with weight-loss that [sic] has led to fad diets and invasive surgeries like gastric bypass and stomach stapling.” A doctor quoted in the story, who provides Orbera for his clients, says that Orbera may “be able to prevent young, healthy people from having these chronic diseases like diabetes and hypertension.” That would depend on how much weight the people lost, and how heavy they were to begin with. No one medical intervention is going to prevent chronic diseases associated with obesity — and it’s not clear from the story whether Orbera would help them lose weight in the first place.

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

Not Satisfactory

The story cites two sources. One is a pleased former patient who used Orbera. The other is a doctor who provides Orbera to his clients. There are no outside sources who can an offer impartial assessment of Orbera: it’s effectiveness, safety or novelty. And the story does not tell readers that the doctor offers Orbera to his clients (though a critical news consumer would probably guess). We only know because we went to his website (which the story links to).

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The only time alternative treatments are mentioned is when the story refers to gastric bypass and stomach stapling as “invasive surgeries” in the first sentence. There is no discussion of exercise and diet, other than in conjunction with Orbera. There is no discussion of how Orbera’s benefits compare to gastric bypass or stomach stapling. There is also no discussion of how Orbera differs from other gastric balloon procedures (more on that under “Novelty”).

Also, the way these other surgical alternatives are characterized in the story is misleading. Yes, they’re “invasive,” but they’re also clinically proven to help obese patients lose weight, keep it off, and live longer. We’re not sure if the same is true for Obrera, because this piece includes no discussion of clinically tested benefits. And, it should be noted that Obrera is invasive, too — after all, it involves placing a large foreign body in a person’s stomach.

Does the story establish the true novelty of the approach?

Not Satisfactory

This fails for a couple of reasons. First, the story does not explain how Orbera is different (if at all) from other gastric balloon techniques designed to aid patients with weight loss. For example, here’s a 2014 story from HealthDay News about a gastric balloon product called the ReShape Duo. Is this different from Orbera? Better? Worse? Safer? Cheaper? Exactly the same? Impossible to say. What’s more, the FDA approved Orbera in August 2015 — so why is Fox News running a story on this now? The story doesn’t tell us.