Blog RSSBlog.

10/11/2013

Binge and Vac: Clinical Trial for Stomach Vacuum

by Craig Klugman, Ph.D.

Imagine eating a big meal. You start with the shrimp appetizer, followed by a rich and creamy clam chowder, and a Caesar salad. Your main course is a large steak with buttered mashed potatoes and finished with a big piece of German chocolate cake. You may have consumed 2,000 calories or more in one meal and most people would probably feel stuffed. But not you. Instead you take out your handy aspiration device, connect it to your reverse percutaneous endoscopic gastrostomy (PEG tube) and flip on the vacuum. In a few minutes all of that food is sucked out of your stomach and into a disposable pouch. No pain and no gain.

This scenario may sound like science fiction, a dream come true, assisted bulimia, or an easy way to lose weight. The AspireAssistTM is currently undergoing clinical trials in 9 locations throughout the United States. Subjects undergo a short surgical procedure to install the PEG tube and then they can use the suction device in the comfort of their own home. You can watch a cartoon of the process here. You can eat everything you want and all you do is suck it out when you’re done. Actually, that’s not quite all as the company’s website says that the procedure should be accompanied by a change in lifestyle and learning how to eat.

Back in 1991, the National Institutes of Health released a consensus statement about the new gastric bypass surgery. After much deliberation, the review panel suggested that this procedure only be for the patient who could not be helped otherwise, was evaluated by a team of experts, and who would receive lifelong medical surveillance. There was ethical concern with this technique that person’s stomach is surgically and permanently made the stomach significantly smaller. Critics expressed concern about the side effects and about medicalizing obesity. As one article stated, such surgery was “the easy way out.”  After all, why diet, change your nutritional lifestyle, and exercise when you can go under the knife for $18,000 to $22,000? This surgery is only recommended for people with a BMI over 40 (a BMW over 30 is considered obese and greater risk for health problems. Morbid obesity is a BMI greater than 40.) if healthy, and 35 if also experiencing obesity-related health problems.  In the years since, obesity has become medicalized as a disease and bariatric surgery is an accepted “treatment.” Now it’s even considered an option for teenage obesity.

In the 1990s, laparoscopic gastric banding was developed where a band is surgically placed around the stomach to make that organ smaller. This surgery is recommended for people with a BMI over 40. This is less invasive that bypass and can be reversed.  The cost is higher at $17,000 to $30,000.

In both gastric surgeries, the side effects include bleeding, ulcers, obstructions, and death to name a few. Still, nearly 220,000 people each year undergo these procedures at a national cost of $1.5 billion. Bariatric surgery now has expert surgeons, specialized centers at major medical centers, and is even covered by some insurance.

The next development in this search for a “cure” for obesity is AspireAssistTM. According to the manufacturer’s website, users lose about 49% of their bodyweight with only 4% suffering from side effects (that comes out to 1 participant with side effects). Of course that data is based on the weight loss of 10 people (1 person who underwent surgery but did not complete the study) and the side effects of 24 people. One has to wonder why the weight loss results of 14 people were not included in those numbers.  An article in the journal Gastroenterology, reports on a study of 18 patients, half of whom got the vac and half who were taught how to change their eating and exercise. People in both groups lost weight in the first year and those with the device lost nearly 3 times the weight. Apparently, no one started a cycle of binge and purge and there were no adverse side effects. If it was safe in 10 (or 24?) people, then it must be fine. This is the only article so-far published.

Also disturbing is that a poster of this study presented at The Obesity Society in 2011 in which one of the listed academic authors is also a shareholder in the manufacturer (you can see this on their website). Can we say conflict of interest? Perhaps even more disturbing is that this author’s name does not appear in the published paper.

Let’s be real here. Beyond the “ick” factor involved, there is something severely disturbing when it is considered acceptable to be able to vacuum out of the contents of your stomach in order to lose weight. Every surgery, no matter how minor has risks. Does the harm of obesity related health outweigh the harm of this procedure? That remains to be seen.

Once you can simply suck out everything you eat, where’s the incentive to learn healthy eating habits. What’s the long term affect on nutrition and health? With other bariatric surgery procedures, you have to change how you eat because your stomach has a small capacity and if you eat too much, you risk death. With the vac system, the website says that subjects “gradually learn healthy behaviors.” Subjects are in this situation because they did not or could not adopt healthy eating behaviors in the first place, and we are to believe that after being given a get-out-of-jail free card, they will change. Seems unlikely.

A physician I spoke to about this surgery said that it seemed like “medicalized bulimia.” According to the National Library of Medicine’s MedlinePlus database, bulimia “Is an illness in which a person binges on food or has regular episodes of overeating and feels a loss of control. The person then uses different methods—such as vomiting or abusing laxatives—to prevent weight gain.” Perhaps that definition needs to be amended to “vomiting, vacuuming, or abusing laxatives.” Bulimia is a serious psychological condition that causes much harm and grief for those who suffer. So why did, Aspire Bariatrics felt it necessary to include a section in its FAQs on “how is this different from bulimia?” The website states that “bulimia is a psychological illness…is medically unsupervised…[and] one of the primary dangers of bulimia is the damage to the teeth and esophagus due to stomach acid.”  By this logic, as long as removing ingested food is (1) medically supervised and (2) avoids damage to teeth and the esophagus, then there is nothing wrong. I imagine that there will need to be very strong psychological screening of subjects (and someday potential patients) to be sure that no one gets this surgery who might have bulimic tendencies. Where is the ethical consensus statement on this technology?

I am not a fan of slippery slope arguments, but in this case, the danger of a surgery to help those who struggle with obesity could, overtime become acceptable for those who can and will pay for the ability to eat all that they want without risking their figure. If that seems farfetched, consider that some physicians are now performing bariatric bypass on two-and-a-half year olds.

The AspireAssistTM study requires that potential subjects have a BMI of 35. That would be a person 5’10” who weights 245 lbs. As stated above, other surgical techniques have higher thresholds. Only further study will show if the potential harm of surgery is outweighed by the risks of being obese and not succeeding with other methods of weight loss.

With this latest procedure, I have not seen the kind of outrage, concern, and ethical debate that surrounded the earlier two bariatric surgeries. Perhaps AspireAssistTM  is simply not well known enough to have called such moral scrutiny upon it. In less than 20 years, other forms of bariatric surgery have moved from being extreme surgeries for the hardest cases to being all-too-common. My fear is not that we have become immune to such “advances” in medicine, but that there might not be any moral outrage at all.

This entry was posted in Clinical Trials & Studies, Featured Posts and tagged . Posted by Craig Klugman. Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *