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FDA Approves Implantable Vagus Nerve Disruptor For Weight Loss

The L.A. Times reports that for the first time since 2007, the FDA has approved a weight loss device (as opposed to a weight-loss drug), an implantable device called the Maestro Rechargeable System. Using electrical leads implanted just above the stomach and a regulator carried under the skin near the ribcage, the device suppresses signals carried by the vagus nerve. ... The device adopts a variant of a "neuromodulation" technique long used in the treatment of epilepsy: by applying intermittent bursts of electrical current to the vagus nerve, it disrupts the signals that prompt the stomach to relax, expand and prepare for an influx of food. ... The FDA approved the use of the device in adult patients with a body mass index, or BMI, between 35 and 45, who have at least one other obesity-related condition, such as type 2 diabetes.

15 of 168 comments (clear)

  1. Worst idea ever. (Well, one of them). by Anonanonaon · · Score: 5, Interesting

    The vagus nerve does a lot of really cool things which don't get a lot of appreciation.

    Cats purr to self-stimulate it. That's what they're doing when they make that noise. And you can do it also. It orders the mind, creating calm and clarity. When you're affronted with terror or high emotion, "pipe breathe" and within half a minute, you're in the zone, able to think and react with calm precision to high-stress situations. And that's just *one* thing.

    So yeah, let's allow big pharma to cyberman our core nervous apparatus for something as incredibly stupid as a weight loss gimmick.

  2. You gotta be kidding me... by crazybit · · Score: 5, Interesting

    Affecting a nerve to help people regulate their hunger and help them loose weight? There is already a way of doing that and it's called Leptin. Leptin is the hormone that regulates hunger by stimulating receptors in the hypothalamus. When someone suffers from leptin resistance, he will eat all day. The fix? bye bye sugars, bye bye inflammatory foods, bye bye foods with anti-nutrients.

    I lost 100lb resetting my leptin cycle, I stopped eating all day and simply wasn't hungry anymore. No will power, no pills, nothing... the anxiety for food just went away.

    Here is a nice article with 29 scientific references that explains exactly the importance of Leptin Cycle
    And here is a nice video from Stephan Guyenet, Ph.D. explaining it too

    Affecting a whole big nerve instead of changing eating habits is a really really bad idea

    --
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    1. Re:You gotta be kidding me... by citizenr · · Score: 4, Insightful

      Too cheap, cant package in a neat marketable device, get lost!

      --
      Who logs in to gdm? Not I, said the duck.
    2. Re:You gotta be kidding me... by Cantankerous+Cur · · Score: 5, Informative

      That's bullshit. Obese people have pretty much the same metabolism as skinny people. It's not your "metabolism" that makes you obese, it's how much and what you eat.

      No, it really is quite dependent on biology. There are numerous studies on twins that clearly show that it's governed by far more than just calories in == calories out. http://www.gatsby.ucl.ac.uk/~p... , http://www.nytimes.com/1990/05...

  3. I need that by Tablizer · · Score: 4, Funny

    I have a Vegas Nerve. Lost a lot of money on blackjack and hookers.

  4. Re:Worst idea ever. (Well, one of them). by PolygamousRanchKid+ · · Score: 4, Funny

    Cats purr to self-stimulate it. That's what they're doing when they make that noise.

    So when I see some fat folks purring, I will know that they are using this device . . . ?

    It will be on the side effects list: "Makes you purr."

    --
    Schroedinger's Brexit: The UK is both in and out of the EU at the same time!
  5. Re:Fatties, just eat less by silfen · · Score: 3, Insightful

    If these devices help reduce obesity, they're saving lives, and that's a good thing.

    Most obesity is due to poor nutrition and lack of exercise. Changing nutrition and exercising costs nothing and has numerous health benefits. Giving people an inferior, costly, and risky substitute for a simple and effective solution is not a good thing.

  6. Re:Worst idea ever. (Well, one of them). by AmiMoJo · · Score: 3, Insightful

    Obesity is a major health problem in much of the western world. It's nice to just blame fat people for lack of willpower or moral fibre when you are controlling it, but that doesn't help anyone. Anything that can seriously help people control their weight isn't a gimmick, it's a fix for one of the most common and serious health issues we face.

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  7. Just World Fallacy vs. Vanity Industrial Complex by retroworks · · Score: 4, Interesting

    Well, I don't know who to root for. I completely distrust the medical/cosmetic industry when it comes to selling solutions, especially for cosmetic issues (and this may be mostly health now, but don't kid yourself where it will be funded). On the other hand, the trolls who say it's all will power and fat is purely moral don't have much science behind them, and appear more motivated by "just world fallacy" reasoning (if a person is ill, and it isn't me, they more likely somehow deserve it). Both cost us money, over-prescription, and people who try to "believe-away" real health problems with high society costs.

    As for the people who smugly think it's justice for affluent societies like USA, look at how obesity rates rise in nations which go from very poor to moderately poor. Africans, Asians, Latinos, and Europeans are not immune to unintended consequences. News Flash: As the threats of starvation subside, threats of overconsumption increase.

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  8. Re:Worst idea ever. (Well, one of them). by GrumpySteen · · Score: 4, Interesting

    The implants have been used to control certain forms of epilepsy for some time. The side effects are known, which is how the possible use for weight control was discovered.

    This isn't some random shit that someone started doing, so take your idiotic fear-mongering elsewhere.

  9. Re:Panic attacks pandemic by GrumpySteen · · Score: 3, Interesting

    That's funny. These implants are already used to control certain forms of epilepsy and the problems that you're so certain will happen haven't happened.

  10. Re:Worst idea ever. (Well, one of them). by Anonymous Coward · · Score: 5, Interesting

    , teenagers jumping off cliffs

    That is an unfortunate side effect of improving someone's condition with severe depression. I've been there, when you're so depressed you don't want to get out of bed or do anything, barely having motivation to eat. Suddenly with an SSRI, and some other alternatives in principle as it isn't just the drug, you have energy and motivation to do things. Some people use that energy and motivation to fix some of the issues and improve their environment to remove things reenforcing their depression, to get their life back in shape. Others who were previous suicidal but too depressed to actually give a damn or motivate themselves to do anything also now have motivation to do what they think they want.

  11. Re:Worst idea ever. (Well, one of them). by denzacar · · Score: 3, Informative

    Anything that can seriously help people control their weight isn't a gimmick, it's a fix

    This is closer to a gimmick. And a dangerous one at that.
    From TFA:

    In a 12-month clinical trial considered by the FDA, 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. On average, weight loss in those subjects with an active device was about 8.5% greater than that seen in subjects who received a Maestro electrical pulse generator that was not activated.
      ...
     
    While the cost of the device has not yet been set, Lea said that getting the device implanted and activated will likely cost "somewhere between $20,000 and $30,000"--an amount that is more than gastric banding but less some of the most complex gastric bypass surgery.

    Over a year, on average, it increases the weight loss by "about 8.5%" compared to an implant which was turned off.
    And, it works for about half the people.

    I.e. For the people who have been losing weight through other means, 92.2% of the weight loss is attributable to FACTORS OTHER THAN THE IMPLANT.
    "About 8.5%" increase is about 7.8% of the new total.

    All that at the yet unknown cost of MAYBE $20-30k, invasive surgery and most importantly - randomly fucking about with one's nervous system.
    They are patching-in this implant to jam that same network which we KNOW to be a major neurological pathway and of huge importance "in the bidirectional communication of the gut-brain axis and...useful therapeutic adjuncts in stress-related disorders such as anxiety and depression".

    That thing severing of which causes mice to give up and surrender in stressful situations?
    They are flooding that with jamming signals during the hours when one is awake.
    What could possibly go wrong, right?

    And to achieve what? A sense of satiety.
    Because as we all know, we eat ONLY when we are hungry and we intake food by volume, regardless of the calories.
    100 grams of Nutella and 100 grams of cucumbers is the same to us.
    We just need to get our stomach to think it is stuffed with SOMETHING - and then we will stop gaining weight.

    At least according to the logic behind this "50-50 chance for 8.5% increase in the effectiveness of dieting" gimmick which works by jamming one's nervous system.

    That $30000 spent would be better invested into healthier food and exercise.
    Heck... it's TWO annual federal minimum wages in the USA.
    One could literally spend a year on that money doing nothing but working on their health.

    --
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  12. Re:Worst idea ever. (Well, one of them). by Oliver+Wendell+Jones · · Score: 3, Insightful

    Back in 2000 I started taking an OTC weight loss pill that contained Ephedrine. It completely killed my appetite. Often times at work I would only notice it was lunch time because it had gone quiet as everyone had left for lunch. Without intentionally changing my diet, with the exception of ditching soda for iced tea, I lost 85 pounds in 10 months. I still continued to eat the same foods, but didn't snack or eat other than meal time because I had no desire for food. I did not exercise at all, unless you count the walk back and forth to my car in the parking lot... Once I stopped taking those pills, I slowly put the weight back on and by the time it became an issue the FDA had banned the sale of Ephedrine based diet pills. I tried the new non-Ephedrine version of the pill and it simply didn't work - I was still hungry and wanted to snack. If they could implant something in me that gives me the same lack of appetite, I would sign up for it in a heartbeat.

    --
    A computer once beat me at chess, but it was no match for me at kick boxing -- Emo Phillips
  13. Re:Worst idea ever. (Well, one of them). by shaitand · · Score: 3, Interesting

    I think he means we should restructure our health system in such a way that there is no big pharma or at least so that the size of the company offers no advantage. We need some major reforms in healthcare here in the states. With most of it being run by non-profits or at least a viable and equally competitive path being run by non-profits. This is true for all tech development.

    Either way, there SHOULD be federal support for this, but only in the sense of loans from the federal reserve at the same rates and terms given to banks. This kind of development is of clear targeted benefit to our society in a far more obvious way than lining the pockets of wealthy bankers.

    Let's say I'm someone who is capable of producing a drug or thinks I am. I should be able to use the local biology lab (akin to a library, either private non-profit or city sponsored) to develop it and perform the research I need. I should of course have to pay for access and when I submit a request for new equipment, whether or not to acquire that equipment should be a question posed to the existing membership along with how much it will increase dues and how long it's expected to increase them. Of course, I should always have the option of donating equipment myself. All members must be human persons (including partnerships) or non-profits (with no management salaries in top 10% income brackets). The requirement is that if developed further you must use "in system" facilities for manufacture and distribution and the lab will own the ip and all profits after costs will go to the inventor or non-profit that developed the drug but other members would be able to utilize the IP royalty free. Everyone is assigned a development log for every project and everything they do, every piece of equipment they use goes in and results are logged there. Including anything they do on their own without using lab equipment.

    Trials and testing and advertising for the same. The same kind of thing. Centralize the costs but require those using the system to pay the costs. Streamline the process to parallel FDA approval and go through FDA approval using template requests and submissions. Members pay dues while using the process. The previous log is required and access is only to individuals and non-profits. Members vote on whether to proceed on studies and any study that hasn't met the minimum requirements for their study (animal trials on X subjects for Y time for instance) can't have it put to a vote unless they submit for an exemption and provide justification.

    Manufacture, Advertising, sales, and distribution. This would need to be a national non-profit. Drugs would be sold with a fixed markup over a fair estimate of costs (30% is typical markup in a retailer). When patents expire drugs would continue to be made available at cost only without the markup as long as they are viable. If a capacity increase is needed or better equipment of some type, it goes to a vote of members with patents in the system. Want to pull a drug? It goes to a vote among the members of the system.

    In the end, it costs what it costs and those costs are spread out among everyone developing drugs and those people get all the profits. Since all costs come from federal loans it's very easy to determine them. Divide up the total loan payment among the total number of mg/ml of drug produced and let the more expensive vs less expensive to produce drugs live with the average. It's better than all the min/maxing and duplicate charging games that result from any other way.