A new weight-loss device that scores high on the “yuck” scale may also score well on the effectiveness scale — at least in the short term.
The AspireAssist device lets an individual pump food out of his or her stomach directly into the toilet after a meal. The calories get flushed away before they can be turned into body fat. It’s a way of eating less without actually eating less. It was recently approved by the FDA for obese adults who haven’t been able to lose weight with other nonsurgical approaches.
Reactions to the device cover the spectrum. A Florida endocrinologist, Dr. Joseph Gutman, is putting together a group of physicians to sue the FDA to take it off the market. Some experts warn it won’t help sustain weight loss. Others think it has merit for people who need to lose weight but haven’t been able to with other methods.
Daniel B. Jones: Effective option or another failed weight-loss therapy?
Shelby Sullivan: I have tested this device and seen it work
Jayleen Grams: I would not recommend this device
Yoni Freedhoff: Weight bias colors the reception of a potentially effective device
Daniel B. Jones: It’s hard for me to imagine a new device starting off with more controversy than one that involves sticking a tube in someone’s stomach so they can drain food into a toilet as a way of preventing calories from fully entering the digestive system.
That said, there’s a logic to the system. It is an effective way of preventing the body from turning food into fat. We have been using tubes to drain food out of the stomach for hundreds of years, although not for weight loss. The AspireAssist device makes this relatively easy to do and regulates the process.
What sounds simple — remove food from the stomach — is likely to have complex effects on the digestive system and the body. In addition to removing undigested food, the device also siphons away stomach acids, which protect the integrity of the stomach, and salts, which the body needs to keep blood and other bodily fluids chemically and electrically balanced. How it will change the hormonal signals between the brain and the gut that regulate hunger is anyone’s guess.
The nutritionists I work with worry that the device won’t help its users learn how to eat more healthfully. I am concerned that it won’t be used as part of a fully integrated weight-loss program that includes how to eat and what to eat, not just how much to eat.
I think that people who want to or need to lose a lot of weight are curious about the device, while weight-loss experts are skeptical about it. We just don’t have enough data to evaluate how well it works, and how safe it is. It could turn out to be an effective option for some people just as easily as it could become yet another failed approach to weight loss.
Daniel B. Jones, MD, is director of the Weight Loss Surgery Center at Beth Israel Deaconess Medical Center in Boston and professor of surgery at Harvard Medical School.
Shelby Sullivan: I have worked with the AspireAssist device since 2009, helping refine its design and test it in clinical trials. It works, and I have seen many people swear by it because it helped them lose weight when nothing else had.
I’ve been disheartened to hear some people, including physicians, say that the device is “too easy” or it “gives a pass” to people with obesity. Such statements reflect the weight bias that is so prevalent in our country, and reinforces the fallacy that obesity is a moral failing or lack of willpower rather than a disease.
In the largest clinical trial of the device, people who used it lost 12.2 percent of their starting weight over a one-year period. Removing undigested food from the stomach accounts for some of that weight loss. But the behavioral changes needed to successfully use the device account for one-third to one-half of the weight loss. Users must eat slowly, chew their food extremely well, and drink water with their meals. This helps impose a kind of “mindful eating” that has by itself been shown to aid in weight loss or control.
Critics charge that the device gives people license to eat more. But we have seen the opposite — in successful users there’s a reduction in food consumption and an improvement in eating behaviors.
The AspireAssist device isn’t the only weight-loss therapy that relies on preventing food from fully entering the digestive tract. The fat-blocker orlistat (Alli, Xenical) prevents the intestines from absorbing fat. It is excreted — undigested — in the stool. A weight-loss surgery known as biliopancreatic diversion routes food around the small intestine, where most digestion and nutrient absorption takes place, and into the large intestine. This means that most food is excreted undigested. Yet neither of those approaches were met with the kind of scorn heaped on the AspireAssist device.
We need to get our minds around the fact that obesity is a disease and needs to be treated like one. If we develop therapies that are safe, induce positive changes in behavior, reduce overall food intake, and help people effectively lose weight, we should take them seriously.
Shelby Sullivan, MD, is assistant professor of medicine and director of bariatric endoscopy at Washington University School of Medicine in St. Louis. She reports no financial interest in the AspireAssist device or the company that makes it.
Jayleen Grams: Several years ago, a colleague emailed me an article about the AspireAssist device or something like it. Quite frankly, it seemed ridiculous. I was surprised to learn that the FDA had approved it, simply because I never thought I would see it again.
I am highly doubtful that it will be an effective or durable weight loss tool. First, bariatric surgery, currently the most effective and durable treatment for obesity, restricts food intake and interferes with the absorption of nutrients. However, we know that the weight loss and improvement in metabolic health seen after bariatric surgery are largely the result of hormonal changes that affect the central nervous system, the physiology of the gut, and more. This new device is more likely to mimic dieting or the now largely defunct adjustable gastric banding device, both of which have had poor efficacy and long-term success in individuals with obesity.
Second, although data from the clinical trial that led to FDA approval have not formally been published, they are on the company’s website. They indicate that 26 percent of the volunteers who received the AspireAssist device withdrew from the 52-week study before it ended. That means over one-quarter of people could pay for the device but end up getting no benefit from it. Top reasons cited for withdrawal were lack of time or motivation. Further, 93 of the 111 subjects experienced 228 adverse events in the first year. Only approximately half of the volunteers continued using the device after 52 weeks.
Third, the patient is likely to be responsible for paying for the cost of the device, its implantation, and follow-up visits. According to the device’s maker, the recommended follow-up is eight visits in the first year, four of those with laboratory tests, then quarterly visits after the first year. If not covered by insurance, that could end up being quite expensive.
Of course, FDA approval simply means that a device is approved for use, not that it is in any way a recommended treatment of obesity. There are unanswered questions about the effectiveness, durability, and patient tolerance of the device that need to be balanced with potential significant expenses. In other words, patients could spend a lot of money on something that, in the end, doesn’t work. I would not recommend this device and I have no intention of starting to implant it.
Jayleen Grams, MD, is an associate professor of surgery at the University of Alabama School of Medicine.
Yoni Freedhoff: The AspireAssist weight-loss device did not enjoy a warm welcome. It was hailed by some as physician-assisted bulimia, by others as a license to gluttony, and by most as just plain repulsive. Are these reactions fair?
With the exception, it would seem, of AspireAssist, medical devices and treatments tend to be evaluated on the basis of reported safety and effectiveness, not whether they offend someone’s sensibilities or play into hypothetical narratives. While long-term outcomes have not yet been published, the reported one-year results were extremely positive. The AspireAssist helped highly satisfied volunteers lose an average of 15 percent of their starting weights. Admittedly, these outcomes are industry published, not peer reviewed. They are not of remotely long enough duration to draw conclusions about the device’s true practical utility. But they are certainly an impressive first blush.
Screening prevented those with eating disorders from getting the device. Its use led to improvements in eating behaviors as a whole. And contrary to the notion that it would facilitate gluttony, the AspireAssist users decreased their overall food consumption.
So why was the AspireAssist the focus of so much vitriol? The answer may lie in the ugly sphere of weight bias whereby the public, and even health professionals, are comfortable moralizing about a condition that at its extreme often leads to marked decreases in the quality and quantity of life. Nearly 80 percent of chronic diseases such as high blood pressure, type 2 diabetes, osteoarthritis, heartburn, some cancers, and more are largely preventable or treatable by lifestyle changes. Yet only with obesity is there a sentiment that treatments shouldn’t be offered because, at least on paper, individuals can affect those changes themselves.
It’s not a lack of desire that stops people from losing weight, and society sees to it that those with obesity aren’t lacking in shame or guilt. If shame, guilt, or simple desire were sufficient to tackle this problem, there’s no doubt it would no longer exist.
Medicine’s job is to provide individuals with the means to treat their medical conditions. While it would be lovely if there were reproducible and sustainable means to help people modify their lives, don’t hold your breath waiting for them. Instead, let’s wait for actual long-term outcomes from the various drugs and devices launched for a myriad of diseases, including obesity, and judge them on the merits of their outcomes, not on the basis of a self-righteous, weight-biased double-standard.
Yoni Freedhoff, MD, is an assistant professor of family medicine at the University of Ottawa, the founder and medical director of the Bariatric Medical Institute in Ottawa, and author of the Weighty Matters blog.