Critics urge FDA to take stomach-pumping device off the market.

MelaniaTrump

FDA needs to keep it.
This was in a reuters video.
http://www.reuters.com/video/2016/07/27/critics-urge-fda-rethink-on-stomach-drai?videoId=369400816&videoChannel=118169&channelName=Editors'+Picks
I had to dig through the internet to find out who were these critics and what exactly they were saying.
“This will likely prove to be yet another in a long line list of misguided, unsuccessful and dangerous products for losing weight,” wrote Dr. Eva Trujillo, president of the Academy of Eating Disorders, in a draft of a letter to be submitted the FDA next week.
Other critics say the device mimics, promotes and could lead to potentially life-threatening disorders such as bulimia and binge-eating.
I disagree
1. It has been out for over 4 years and seems safe. How can it be unsafe besides an infection?
2. None of the trial people have developed an eating disorder or bulimia.
3. Three times less than the average weight loss surgery (important if your insurance will not cover it).
4. The lady on the video got rid of hypertension and type 2 diabetes. She called it life saving.
I say keep. It could really help many people.

Packerjohn

MelaniaTrump wrote: »

It could really help many people.

Putting the fork and spoon down could really help many people also, with no side effects.

Seriously though, not quite sure I stand on this. Interested to see comments.

gwynethsomeday

Wow. Thanks for sharing - never heard of this.

Strikes me as bizarre, but if it helps people regain their health....all good?

Sabine_Stroehm

Human bilge pump. Very odd when I think about it too much.

CipherZero

"Could lead to" == there is no evidence but it fits my narrative.

LINIA

Yes , it must be kept. Goodness knows, people need options.....it really seems that the critics just don't get it. For someone who has had ongoing issues due to being Obese, this is just one possible tool.

No problem that any of these candidates will develop bulimia, if they could have thrown up the calories of extra food, they would have already done so.

We have too many Naysayers and not enough compassionate helpers---- read, read, read!

BigGuy47

LINIA wrote: »

-- read, read, read!

Please do some reading for yourself.
http://www.aedweb.org/index.php/about-aed/about-aed-faq#What_is_AED

The naysayers and critics that you mention are medical professionals from around the globe with a common goal of helping those with eating disorders. It's a question of risk versus reward. Hypothetically, you give the pump to two patients. One of the patients loses weight and the other develops an eating disorder. Is that a fair ratio of risk/reward to give obese people more options?

I would argue that it's compassionate to be concerned that some people might develop an eating disorder from using the device.

lemurcat12

There's a prior discussion on this device in this particular section of the forum, possibly two.

I think it's odd and creepy-seeming, undecided on whether it should be a legitimate tool or not -- will let the medical folks battle that out -- but I would not use it.

MelaniaTrump

How can it lead to an eating disorder?
If the person was prone to purging, they would have been doing it before they got the device. I see this lower cost device helping people that desperately need help. I see absolutely no harm in keeping this device.

Unknown

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zoeysasha37

Self control is free. No need for a device when one learns self control

JustMissTracy

MelaniaTrump wrote: »

How can it lead to an eating disorder?
If the person was prone to purging, they would have been doing it before they got the device. I see this lower cost device helping people that desperately need help. I see absolutely no harm in keeping this device.

Sounds like a device meant to make lazy people feel they are doing something to help themselves. Control your food intake, move your body....that's really all it takes!!

NorthCascades

FDA approved it. The ship has sailed, let's not send a rowboat after it begging for it to come back to port.

Packerjohn wrote: »

MelaniaTrump wrote: »

It could really help many people.

Putting the fork and spoon down could really help many people also, with no side effects.

So would putting money in a 401(k). Let's stick to the topic at hand. A device that's been approved for obese people who've tried and failed at losing weight, and whose weight puts their health at serious risk.

Need2Exerc1se

MelaniaTrump wrote: »

1. It has been out for over 4 years and seems safe. How can it be unsafe besides an infection?
2. None of the trial people have developed an eating disorder or bulimia.
3. Three times less than the average weight loss surgery (important if your insurance will not cover it).
4. The lady on the video got rid of hypertension and type 2 diabetes. She called it life saving.
I say keep. It could really help many people.

Those are good points. I would never go for it personally, but it does seem a better option than bariatric surgery to me since it has less risk of negative side effects. As long as they continue to require medical supervision I'd say keep it as an option.

enterdanger

I don't see value in it. How does it teach you to eat healthy. Besides the bulimia issue what happens when you stop using this? Do you magically eat less and healthier? Probably not.

Christine_72

Isn't Bulimia/anorexia a mental disorder, and not something you just get overnight?
Speaking for myself, i know i don't have it in me to become anorexic or bulimic.

I hope i haven't offended anyone, def not my intention. But i am completely in the dark when it comes to eating disorders, and off the back of that comment i would think this stomach pumping device would be preferable and a go to for bingers/purgers.

Need2Exerc1se

enterdanger wrote: »

I don't see value in it. How does it teach you to eat healthy. Besides the bulimia issue what happens when you stop using this? Do you magically eat less and healthier? Probably not.

The device itself is not meant to teach healthy eating habits. It's only approved for those that have tried other methods of weight loss and failed and have a high BMI (>35 I think). It also stops working periodically forcing the user to keep doctor appts. so it can be reset. That is where the education should come into play. While it is somewhat disturbing to think that something like this is needed, g-tubes have a low risk of negative side effects and could be a safe and useful way to get weight under control while learning to eat healthily.

BigGuy47

From the video transcript:

(Dr. Christopher Thompson, Harvard Medical School), "It's one of the best ways to change your relationship to food because it does require a lot of work on the patient's part. It's not just a procedure that's done and then they're off and they don't think about it anymore. This is something the patient is going to be thinking of every day, multiple times a day. This is something that they are living with and it's a tool for them to lose weight and to kind of get a better understanding on how to eat properly." Lotta Bosnyak said learning that lesson was the hard part. She her 'ah ha' moment came when she realized she was eating a lot less because of the time it took to chew her food small enough to pass through the tube.

- - - - - - - - - - - - - - - - -

So, in the long term the patient becomes exhausted of the process; meticulously chewing their food and the post meal stomach draining ritual. The whole ordeal becomes such a PITA that the patient is willing to change they way they eat in order to put an end to the process. It seems like an elaborate form of CBT.

Paraphrasing Doctor Thompson, It works because it requires a lot of work of the patients part. Couldn't the same be said about the methods used by many of the successful people here on MFP? Weighing food, tracking calories, daily exercise, etc. All of these things require effort and commitment.

Change requires work. Some people are willing to put in work required after weight loss surgery, but they are unable to put in the work for non invasive methods of weight loss. I don't understand it, but I'll accept that we are all different.

chocolate_owl

When we're talking about bulimia, let's keep in mind that bulimia is not just vomiting to get rid of food. There's also exercise bulimia, where one exercises until the calories consumed are burned off. This could definitely become another form of bulimia with a different method on purging. And someone using this device for a long period of time could develop bulimia, where rather than sticking to the limits of the device, they abuse it because they've developed a compulsion to get rid of everything they ate. My understanding is there is a limit to the number of times the device can be used before a doctor resets it, so awareness of and responsibility for developing eating disorders falls squarely on the doctor's shoulders.

With regard to eating disorders, binge eating disorder is a bigger issue. There's a higher chance that people with BED (vs. those who might develop bulimia) would have interest in this device, and it's not a guarantee doctors will follow the rules and not approve a patient with BED for the device. So while the device would not be responsible for an eating disorder developing, it could make it easy for a patient to continue to engage in existing disordered behavior.

That said, I think the eating disorder argument is a weak one. BED is supposed to be screened for and not approved. Even if eating disorders do develop, it will be in relatively few patients. As discussed in the other threads, there are much more widespread issues, such as potential malnutrition (higher digestion rate of carbs than protein or fat), potential lack of education about proper eating habits so patients can eventually lose/maintain without the device, and the fact that a company rep has indicated that this device could be a long-term/lifetime thing (looking to create lifelong customers rather than reduce obesity, yes?). Also, when talking about the cost, the installation may be less than WLS, but how does the cost of doctor visits to reset it total up? Will there eventually be a need for replacement if you use it long enough?

I'm not 100% against it - people with the device AND a nutrition plan lost more than those with the nutrition plan alone, and maybe all some people need is a jump start. But I certainly wouldn't be comfortable encouraging a loved one to try it - this doesn't do much to change your eating habits or ideas about food. It will be interesting to see what the loss and maintenance rates are 10 years down the road...

DKG28

if someone's obesity is causing life-altering health issues, why not have options? Some people probably will do better with a physical change to their bodies to help with weight loss, rather than the elusive "will power" alone that's all in the head. Using this thing regularly is a tangible reminder of the reason why you needed it in the first place. But i can't help but think it will only give some of the users permission to eat more. The thing about WLS is that you physically can't overeat without getting sick....at least for a while. There are consequences for not following the accompanying diet. This thing has no consequences. And if i'm at work, i can't take another break 20 minutes after my meal break to empty the thing. I just had my break. But i'm sure if it catches on there would disability accommodations...

NorthCascades

enterdanger wrote: »

I don't see value in it.

It's helping people. How do you not see value in that?

MissusMoon

NorthCascades wrote: »

enterdanger wrote: »

I don't see value in it.

It's helping people. How do you not see value in that?

I believe the debate is in whether or not it is helping people.

fishgutzy

Just another way to practice bulimia. Purging is still purging. Just that this way doesn't erode the enamel on your teeth.

LINIA

@fishgutzy

Copied and pasted from above----why do you judge if it has been stated that it is a safe device..why judge others who need additonal assistance?

1. It has been out for over 4 years and seems safe. How can it be unsafe besides an infection?
2. None of the trial people have developed an eating disorder or bulimia.
3. Three times less cost than the average weight loss surgery (important if your insurance will not cover it).
4. The lady on the video got rid of hypertension and type 2 diabetes. She called it life saving.
I say keep. It could really help many people.

fishgutzy

@LINIA It is still purging. Eat and purge via a tube is still purging. As a recovering bulimic that spent a couple decades on the scarf and barf diet plan, I can call it what it is. Just because it is 'medically approved' doesn't mean it works long term. One still has to choose to make a life style change. A purging tube doesn't help with behavior changes.

CipherZero

fishgutzy wrote: »

@LINIA It is still purging. Eat and purge via a tube is still purging. As a recovering bulimic that spent a couple decades on the scarf and barf diet plan, I can call it what it is. Just because it is 'medically approved' doesn't mean it works long term. One still has to choose to make a life style change. A purging tube doesn't help with behavior changes.

Your beliefs do not trump proof, which the medical community and studies have.

TheLegendaryBrandonHarris

It's amusing to me...and exasperating...to see people who enjoy making decisions for other people.
Sure, you and your physician have decided on a plan of action, but let me elbow in with my two cents. Even though I don't know you or your situation or your history. Your compliance with my opinions must be mandatory.