We wish it had spent more time with the actual evidence behind these devices, though, especially given the apparently low number of participants in the studies.
Obesity is a major health challenge in the United States and increasingly becoming a challenge around the world. A recent study estimated that 1 in 10 adults worldwide or more than half a billion adults are obese. If clinicians and policymakers are going to alter the course of this epidemic, they need tools that work. Whether this pacemaker actually works or just serves as a distraction from other proven weight loss methods remains to be seen. We wish that reporters covering the latest in weight loss fads would hold companies more accountable for documenting both the benefits and the harms in absolute terms.
We saw the sky part and heard angels singing when we saw the cost information provided in clear, comprehensive terms. “In Britain, the pacemaker costs about 15,000 pounds ($24,040), including the keyhole surgery used to implant it.” We do wish, though, that the story had not relied on the device maker’s president for a price comparison. It says, “Intrapace President Chuck Brynelsen said that’s comparable to other weight loss surgeries.”
As noted above, the real benefits and harms of these devices are not quantified in any meaningful way, which is disappointing.
The story really let the company off the hook here and did some of their marketing for them. it says, “Other surgical approaches to weight loss come with serious side effects. People who have their stomach stapled or have a gastric band must eat smaller amounts of mostly low-fat foods, because their stomachs can’t accommodate or process large volumes. If they overeat, they will feel nauseous, vomit, or suffer from other problems. The most serious side effect seen in the pacemaker has been an infection linked to surgery.” The story should have presented a side by side comparison of the benefits, risks and harms associated with the two surgeries. It might have been hard to come up with such estimates though because the evidence base is so weak for the pacemaker. That would have been important to note as well.
This is one of the areas where the story falls down. All readers told is that “So far, about 65 patients in two studies have received the device from U.S. pacemaker manufacturer Intrapace. Only about half of those have had the pacemaker for at least a year, and most lost about 20 percent of their weight and kept it off.” That’s simply not good enough, especially given the wide range of treatment options for obesity. Patients deserve a critical look at the evidence.
We wish the story had broken down some details, such as:
The story does a great job avoiding disease-mongering.
The story brings in some strong outside voices and takes care to explain that they are not involved in the studies or tied to the company. For example, it quotes Stephen Bloom, an obesity expert at Imperial College in London and says he “is not connected to Intrapace or the clinical trials. “Bloom, however, questioned whether the device would work long-term, as people might eventually get used to the electrical pulses and keep eating anyway,” the story says. The story even surprised us by getting the company’s president to say the same thing. “Brynelsen said the battery in the device lasts about five years and it will be up to patients how long they want to keep the pacemaker. “We don’t know if patients will see (the stomach pacemaker) as a bridge to recovery or whether this is a crutch they will need for the longer term,” he said.”
The story does mention that there are other types of surgery, but it doesn’t really compare the existing alternatives. It could have compared availability, costs, efficacy, and safety. The story does not do a good job comparing the device to non-surgical alternatives either, and, by using an anecdotal framing for the story, may leave readers with the wrong impression. It says in the lead, “Patrick Hetzner tried diets and exercise, just about everything short of stomach stapling to lose weight. Nothing worked. Five months ago he tried something new: a stomach pacemaker that curbed his appetite.Since having it implanted, Hetzner, a 20-year-old Munich mailman, has knocked off more than 10 kilos (22 pounds) from his earlier weight of 104 kilos (229 pounds).” That was only five months ago. Ask some of the people who were hooked on the Atkins diet a few years ago if they kept all that weight off. Relapse is a huge problem for both diets and devices. Changing behavior is hard, too, but we would have liked to have seen a better discussion of why diet and exercise might not work for a subset of people.
The story carefully explains the market status of the device. It says, “Since being approved by Britain last month, the device is available for sale across the European Union.” Later it adds, “The device is authorized for sale across the EU, though the company is first targeting weight loss clinics in Britain, Germany and Spain. It also plans to submit the device for approval in the U.S. once it has more data, and hopes it will be available there in 2014.” Perhaps the most important detail is this one: “The pacemaker hasn’t yet been implanted commercially in Europe, but Intrapace is in talks with clinics interested in offering it.” We wonder if the market isn’t speaking here. Often by the time a new device or drug are approved there is a pent up demand and surgeries would have been scheduled immediately. If the company is still negotiating with clinics, it might be a sign that clinicians have serious doubts, similar to the ones voiced in the story.
The story does establish the novelty of the device, pointing out “Other stomach pacemakers are on the market but most are used to relieve symptoms like nausea and vomiting, not to fight obesity.”
The story does not rely on a news release.