Monday, 20 June 2016

Prescribing Daily Stomach Pumping to Fat People

WTFThe FDA has approved a device called the AspireAssist, in which a thin tube is placed in the patient’s stomach that connects to a button on the outside of their stomach.  After each meal the patient uses the tube and a handheld device to pump up to 30% of the meal out of their stomach and into the toilet. I’m going to address the claims on their website, but first I want to talk about a misconception

[Trigger Warning – Eating Disorder talk for the next two paragraphs] The company that makes it claims that it isn’t an “assisted bulimia” device because they say in their fine print that it shouldn’t be used by people with bulimia.  That is, of course, ridiculous and it’s certainly possible that this device my be used by people dealing with bulimia and/or my perpetuate the development of bulimia.  But it should be clear this isn’t actually medically induced bulimia.  Bulimia, like all eating disorders, is a complex bio/psych/social illness.  Purging is one of the behaviors associated with Bulimia as well as other eating disorders, but it shouldn’t be confused with the illness itself and purging in this way, rather than through the use of vomiting, creates different possible issues/side effects.

My concern here is that this is another example of  prescribing to fat people what we diagnose in thin people. If someone says that they are evacuating food after every meal we shouldn’t treat it like a red flag for thin people, but a good idea for fat people – it should be considered a red flag behavior for someone of any size. Eating disorders are often confused for simply behaviors, or people become more “fascinated” with the behaviors/symptoms than they are compassionate to the person with the ED, so I think it’s important not to reinforce those misconceptions and issues because it leads to difficulties for people with EDs being taken seriously, getting treatment, and getting that treatment paid for.

I also want to be clear that I’m not against the people who individually choose to use it – their body, their choice.  I’m against the fact that a for-profit company is misleading people about what this device can do, and will be making money off the backs of anti-fat panic, not concerned with the fact that one of the side effects of their contraption is death.

Now, let’s talk about what the company who created these devices says, and what is actually true:

The AspireAssist has been studied in hundreds of patients in both the US and in Europe. In a large U.S. clinical trial with 171 participants, people using the AspireAssist lost 3 times as much weight as people who received only lifestyle counseling. The most successful patients – those who aspirate regularly and learn to make healthier choices – have lost 100% of their excess weight with the AspireAssist and have maintained that weight loss for more than four years so far. Compared to other approaches, the AspireAssist has similar results without requiring invasive alterations to the anatomy or digestive process

Sources: US PATHWAY Study (n=171): Data presented at Digestive Disease Week, May 2016 by C. Thompson; Pending publication; Completers only. European data collected from Sweden, Spain, Czech Republic, Germany, Austria, Italy. N=80 at year 1 and n=25 at year 2 (ongoing studies, completers only included).

Here they use two of the most common tricks weight loss companies use to mislead us about outcomes. The first is to only study patients for a short time (from a few months to a couple of years) but define that as “long term” when, in fact,  most people are able to temporarily change their weight during a year, and then they gain the weight back between years 2 and 5, often regaining more than they lost. That US Clinical trial they talk about only studied the first year.

The second trick is to only include those who completed the trial so there is no follow up with those who dropped out (and possibly didn’t lose weight, or began to regain, or had side affects so horrible that they didn’t think any outcome was worth it.)  They cite a two year study that included 80 people in the first year, but was down to 25 people at year two, that means that almost 70% of the group dropped out, but they want us to be convinced by the average of what happened with 31.25% of the participants and ignore what happened to 68.15%.  As to their claim of people who have lost 100% of their “excess weight” and maintained it for four years, I can find absolutely no research anywhere on their site or anywhere else to back up that claim. I left to wonder if they are holding up a couple anomalies as the norm, or just completely making stuff up.

The AspireAssist allows patients to remove about 30% of the food from the stomach before the calories are absorbed into the body, causing weight loss. You’ll also need to chew carefully and eat mindfully, which helps give time for the fullness signals from your stomach to reach your brain.

Because aspiration only removes a third of the food, the body still receives the calories it needs to function.

First let’s realize that they are just assuming that fat people don’t need the nutrition from 30% of what we eat, regardless of what we eat, how much, our physical activity level etc. Well, either that or they just think it’s fine for us to be malnourished as long as we’re becoming thinner.  Second, when they say you need to “chew carefully” it’s because the tube is only 6mm  and larger chunks of food can get stuck in the tube which, if the patient can’t clear it with water, requires another trip to the doctor.

In addition to the machine, people also get “lifestyle counseling”

This therapy is used in conjunction with lifestyle counseling. This program combines one-on-one counseling and group support meetings to encourage healthier food choices, smaller portion sizes, and increased physical activity.

There is not a single study that suggests that this type of counseling leads to long term weight loss or better health, but that doesn’t matter since they can just blame the fat people when it doesn’t work. In the US a panel that recommended this type of therapy also acknowledged that “One problem with its recommendation was that no studies have shown such intensive programs provide long-term health benefits.” and yet the Federal Task Force still recommended it.(One wonders, if one of the problems is that there is no reason to believe this will work, does it really matter what the other problems are?) But none of that is getting in the way of Aspire charging $8,000 to $13,000 for it according to Aspire spokeswoman Christy Kaupinen.

Consider your schedule at work, at home, on weekends, and with your family or friends. Although missing an aspiration occasionally is OK, the most successful patients aspirate three times per day, almost every day.

You have to wait 20-30 minutes after each meal, and it then takes 5-10 minutes to drain the food into the toilet (after people gain competency, it takes longer in the beginning,) which they recommend patients do three times a day.  That’s 7.5 to 15 HOURS A MONTH that a patient will spend in the bathroom. I don’t know about you, but I haven’t been sitting around thinking “Man, I have 7.5-15 hours a month that I would love to spend in the restroom.” Plus there’s the time and expense of having to go back to the doctor every 5-6 weeks because the device is created to stop working until you replace a part that is designed to wear out for this purpose.

Let’s talk about side effects:

 

Here’s what the FDA press release said:

Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea.

The endoscopic surgical placement of the gastric tube is associated with risks, including sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the lining of the abdomen, sores on the inside of the stomach, pneumonia, unintended puncture of the stomach or intestinal wall and death.

Risks related to the abdominal opening for the port valve include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall. All have the potential to necessitate removal of the device. After device removal, there may be a risk of persistent fistula, an abnormal passageway between the stomach and the abdominal wall.

…and death.  …and death.  …and death. Once again it seems that in the “War on Obesity” they want us thin or they want us dead and they don’t seem to much care which it is, as long as they can make a tidy profit along the way.  And since the approval came on the basis of a study that only included 111 people using the device and 60 in a control group, who knows what side effects we’ll find if, heaven forbid, this thing gets into wide use.

It doesn’t have to be this way.  We can stop buying into the idea that”thin by any means necessary” to be the same thing as healthy.  We could refuse to participate in interventions that are extremely profitable for others, and potentially deadly for us.  We could insist that the discussion be about actual health – with all of its facets and complications – instead of about risking our actual health and even our lives in an attempt to manipulate our body size. We could say enough if enough and that, as long as they want a “war on obesity” we will give them one.

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