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FDA approves a device for weight loss

Rating

3 Star

FDA approves a device for weight loss

Our Review Summary

The FDA announced January 14 that it had given the green light to EnteroMedics’ Maestro Rechargeable System, an implantable medical device to reduce food cravings in obese adults. The device, a vagal nerve stimulator, was widely heralded last week as the first new medical device for obesity to be approved in a decade.

This story carefully and admirably explains the mechanics behind the device but falls short in describing the amount of weight loss achieved and the side effects — some of them serious — that occurred among the patient volunteers. It also neglects to mention which patients would not be good candidates for the surgery, of which there are many. The article also includes no views from independent experts. In related media coverage, such experts have drawn attention to a number of concerns about the device and how well it’s likely to work in the real world.

 

Why This Matters

Obesity is a well-known national and global problem. According to the CDC, one-third of adult Americans are obese, a condition which contributes to heart disease, stroke, type 2 diabetes and some forms of cancer. A successful intervention might save lives and lead to a significant reduction in health care spending.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story quotes the manufacturer of the device estimating a cost between $20,000 and $30,000 for the procedure. The story further notes that the intervention is not yet covered by private insurers or Medicare, but that the company is negotiating for coverage. The results of those negotiations will play a major role in the availability of the procedure.

This is sufficient for a satisfactory rating. We’d add that given the widespread use of cost sharing in today’s health insurance products, a procedure of this type will be quite costly to many by way of deductibles and co-insurance. A middle of the road estimate of these out of pocket costs would have been informative.

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

Not Satisfactory

The story provides statistics on the percentage of people who lost weight after one year of wearing the device — “38.3% of subjects who received the active Maestro device lost at least a quarter of their excess weight, and 52.5% of subjects lost at least 20% of their excess weight.”  But how much “excess weight” did these participants have when they started the study? Since we don’t know that number, we can’t calculate what “at least a quarter” of that weight amounts to. To make sense of this study for the average reader, the story could have said what a typical/average patient weighed at the start of the study and much weight they lost over the course of the study.

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

Not Satisfactory

The story does not mention any harms or potential drawbacks to the surgery, nor does it describe which patients should not get the surgery. The FDA announcement (from which this story is partially based) noted that serious side effects of the surgery included nausea, pain at the device implant site, vomiting, and surgical complications. Less severe side effects included pain, heartburn, problems swallowing, belching, mild nausea and chest pain. In addition, the company disclosed in its announcement that the therapy is not suitable for a wide swath of the patient population including those with cirrhosis of the liver, portal hypertension, enlarged esophageal veins, certain types of hiatal hernia; patients who may undergo magnetic resonance imaging (MRI) or diathermy; patients at high risk for surgical complications; and patients who have a other implanted medical devices such as pacemakers, implanted defibrillators and neurostimulators.

We would add that when you start tinkering with the vagus nerve, there could possibly be many adverse effects over time, especially cardiac-related. Twelve months is too short a timeframe to establish these types of harms.

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

Satisfactory

The story gives a very detailed and layperson-friendly description of how the device works, and notes that the FDA approval was based on a 12-month clinical trial that compared patients who received the active device with those who received a sham device. That’s enough for a satisfactory rating, but we think the story could have gone further in describing certain details and limitations of this research:

  • There was no mention of dropout rates or reasons for those dropouts.
  • While the length of the trial is mentioned (12 months), it is not mentioned that in obesity studies, that is pretty short and that patients often regain the weight that they’ve lost with longer follow-up.
  • The story didn’t note that patients in both study groups also received frequent, intensive weight loss counseling in addition to the active or sham device.
  • The story fails to mention that the device did not meet its primary endpoint — 10% greater weight loss in the active vs. sham device group — in the studies that formed the basis for the approval.

 

Does the story commit disease-mongering?

Satisfactory

The story does not engage in fear-mongering.

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

Not Satisfactory

We commend the story for actually talking with two experts who are knowledgeable about the device and related research. That being said, these experts were a senior executive with the device manufacturer and a researcher who conducted some of the studies leading to development of the device. They both have a vested interest in the success of the device. The story would have been stronger if it had chosen to interview an outside expert in gastroenterology, endocrinology or a related specialty to give an unbiased perspective on the device.

HealthNewsReviews.org offers a list of independent experts in many fields who are willing to provide an outside perspective on health news stories.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story references the other common treatments for obesity — bariatric surgery (the only other FDA-approved surgical intervention for obesity) and pharmacological treatments. The report also contains a brief discussion on how the device might compare cost-wise to gastric banding. However, the story does not discuss how the weight loss with this device compares with that of the other therapies. That information is crucial for readers to develop an informed opinion, and would have been easy to include.

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

Satisfactory

Although vague, the story reports when the procedure will likely be available based on the best source available — the manufacturer. The main reference to availability is a quote by the company spokesperson stating that the company hopes to have successful negotiations with insurers and Medicare concluded “later this year.” We’ll rate this sufficient for a satisfactory, but we’d note that the availability will also hinge on patient shared costs and hospital and physician training and location. In addition, low income and minority populations have higher rates of obesity and higher rates of Medicaid use. State Medicaid programs will likely not cover this or will at least establish some pretty restrictive criteria.

Does the story establish the true novelty of the approach?

Satisfactory

The story states that the device is the first medical device for obesity approved by the FDA since 2007.

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

Satisfactory

Since the story includes comments from expert interviews, we can be sure it wasn’t based entirely on a press release.

Total Score: 6 of 10 Satisfactory

Comments (4)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Gary Schwitzer

January 19, 2015 at 12:56 pm

If you read this story online, which is the way our review team found it, you saw a troubling example of the Tribune Company cross-promoting its properties. The Los Angeles Times’ effort was dragged down, online, because a KDVR Denver TV news story was plunked down in the middle of the online effort. The Times’ effort, as noted, had obvious strengths. The TV story did not. Read more here: https://www.healthnewsreview.org/2015/01/tribune-company-drags-down-la-times-health-news-effort-by-plunking-tv-story-inside-of-it/

Reply

Lily O'Hara

January 26, 2015 at 10:36 pm

It seems as though your own reviewers are making some of the mistakes that are strongly criticized when they appear in the media; the primary mistake being association does not equal causation. In the ‘Why this Matters’ section above you state that ‘Obesity is… a condition which contributes to heart disease, stroke, type 2 diabetes and some forms of cancer.’

If you did a little deeper you will find that the ‘obesity (as defined by BMI >30) causes disease’ belief is highly questionable. Even the CDC refrains from using the term ’causes’ and hedges its bets with wording such as ‘obesity-related diseases’ and ‘diseases associated with obesity’. Relationships and associations are absolutely not the same as causality, as your reviews so often point out.

As a primer on some of the empirical concerns about the ‘obesity causes disease’ belief and other problems with the weight-centred approach to health, see the following paper by Bacon and Aphramor:

http://www.nutritionj.com/content/10/1/9

Reply

Deb Burgard, PhD

January 27, 2015 at 9:59 am

Agreeing with Dr. O’Hara here – ” In the ‘Why this Matters’ section above you state that ‘Obesity is… a condition which contributes to heart disease, stroke, type 2 diabetes and some forms of cancer.’ ”

Because higher weight is correlated with lower socioeconomic status, weight cycling, being more likely to experience weight stigma, racism, and sexism, and because controlling for these factors and physical activity levels vastly attenuates the association of higher weight with disease, it is a problem to attribute all of these health issues to having more fat cells. Right now, all of the health issues that are really caused by poverty, stress, stigma, and lack of social support can be framed as “obesity-related” and as long as we are doing that we fail to address the actual problems.

The almost ubiquitous and unquestioned assumption that higher weight itself “causes” disease (or is a disease in itself!) adds to the already considerable weight stigma that higher weight people face.

PS Thank you for noting that this trial, like most, is far too short to demonstrate effectiveness in weight loss. Because the typical period of weight cycling is longer than 1 year, studies should include weight trajectories at least 2-5 years post intervention. This should be a standard for all research claiming a weight loss benefit.

Reply