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Medicine United States Technology

FDA Approves Implantable Vagus Nerve Disruptor For Weight Loss 168

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.
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FDA Approves Implantable Vagus Nerve Disruptor For Weight Loss

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  • by Anonanonaon ( 3425201 ) on Monday January 19, 2015 @02:54AM (#48848423)

    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.

    • by Anonymous Coward

      big pharma

      You mean we should only allow "small pharma" to produce weight loss devices? Why, because "big pharma" is too big to do it?

      • by shaitand ( 626655 ) on Monday January 19, 2015 @02:38PM (#48851467) Journal
        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.
        • by pnutjam ( 523990 )
          yeah, we need this for all types of small development. Maker space and labs in a library format.
    • The vagus nerve is an important physiologically but it's not endowed with magical properties. Just saying.

      • by Anonymous Coward

        The vagus nerve is an important physiologically but it's not endowed with magical properties. Just saying.

        No, but once again so called medicine is tending towards quackery by mucking about in systems in which they have no clue yet. Stimulation of the Vagus nerve is known to have both positive and negative effects on depression, epilepsy, heart rate, blood pressure, orgasms and a host of other fun stuff that can be awful or grand depending on how it works for the receiver. It's the same shotgun style approach they've been using with SSRI's all these years, the result of which has been a placebo effects, severe a

        • by Anonymous Coward on Monday January 19, 2015 @09:31AM (#48849445)

          , 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.

          • by sjames ( 1099 )

            Actually, that theory doesn't seem to explain observations. I have seen research that the suicidal ideation itself can be stimulated by SSRIs, not just the motivation to act on existing suicidal ideation.

            • As someone else who has been depressed, when the SSRI start working (& it can take 6 weeks IFF they work) you have energy and the ability to act that you didn't before.

              I wasn't suicidal during my depression and that did not change. It didn't change any of the times I had to switch medications (you have to taper off and go through depression before you start the next).

              I put my energies into things I wanted to do but couldn't with the depression. If I had been suicidal, maybe I would've tried.

              Instead I

              • by sjames ( 1099 )

                Yes, for people who actually need them, SSRIs can provide the motivation to do things as part of lifting the depression. But the research showed that for some people (fortunately not you), especially adolescents, they can actually cause suicidal ideation that was not there before.

          • It may lead to people thinking of suicide, also. If you're very depressed, you may well be resigned to how things are going. SSRI treatment can help you get less depressed, and this is good. Then, you hit something and feel like you're going back to the old depression. It's really easy to get determined not to go back into the old blackness, and decide to avoid it by any means possible. There's really only one way to assure that you're not going to get horribly depressed again.

            This is based on exper

        • by sjames ( 1099 )

          I'm always reminded of the old days when we would smack the TV to get the picture to stop rolling.

    • by PolygamousRanchKid ( 1290638 ) on Monday January 19, 2015 @03:39AM (#48848523)

      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."

    • by labnet ( 457441 )

      I've also been hearing about success in treating tinnitus by stimulation of the Vegas nerve.

    • 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.

      This sounds interesting.
      Do you have any links on this?

      • It's not exactly a new idea. Focusing on your breathing and controlling it distracts you from whatever is stressing you out and calms you. Pipe breathing is just a slightly different way of taking deep breaths to calm and relax yourself.

    • by AmiMoJo ( 196126 ) * <mojo&world3,net> on Monday January 19, 2015 @07:41AM (#48848997) Homepage Journal

      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.

      • by denzacar ( 181829 ) on Monday January 19, 2015 @10:09AM (#48849651) Journal

        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". [pnas.org]

        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.

        • by Oliver Wendell Jones ( 158103 ) on Monday January 19, 2015 @10:29AM (#48849765)
          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.
          • The implant does not cause the lack of appetite - it simulates the feeling of being full and prevents one from feeling "hungry", where hungry is synonymous with "empty stomach".
            It does not stop one from snacking NOR "treating" anxiety with food NOR absorbing calories through the stomach OR the intestines.

            Without intentionally changing my diet, with the exception of ditching soda for iced tea, I lost 85 pounds in 10 months.

            How much soda? Those are HUGE source of sugar. [sugarstacks.com]
            On top of that, CO2 in sodas increases the pressure and turbo-charges the reaction of absorption of those calories.

            Once I stopped taking those pills, I slowly put the weight back on

            Did you start drinking soda again and what ma

    • by GrumpySteen ( 1250194 ) on Monday January 19, 2015 @08:13AM (#48849101)

      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.

    • Small question, "what is pipe breathe?" I didn't see it in Wikipedia.
    • So yeah, let's allow big pharma to cyberman our core nervous apparatus for something as incredibly stupid as a weight loss gimmick.

      The summary is talking about people who are dying from their inability to control their appetite. Desperate times call for desperate measures.

      Altough real solution would be to treat sugar and fat as the dangerous, unhealthy, borderline poisonous substances they are. And at some point, we'll have to. Obesity epidemic - and all related metabological problems - are getting way ou

      • by sjames ( 1099 )

        Actually, recent research suggests that the fat-free craze ios a contributor to the rising obesity rate. Fats stimulate satiety.

    • by Evtim ( 1022085 )

      No need of big, medium or small pharma. Just cut the carbs, nothing more.

      For a medical reason I am now more than 6 months on "barely any carbs diet", which is extreme [no wheat, rise or barley, no sugar, very little fruit and no alcohol] and I would not recommend it for "just" weight loss but it showed me in practice what is going on here. From 94 to 76 kg [while working out like crazy to use some of the fat before it is gone] in weeks. Flat, and I do mean flat tummy. Energy level -- unbelievable! I have t

  • by lucm ( 889690 ) on Monday January 19, 2015 @02:55AM (#48848427)

    The science on this is not bullet-proof yet, but there are studies that link unexplained panic attacks and associated syndromes to vagus nerve problems. There are multiple theories, including one that proposes that physical symptoms of panic are experienced, and this triggers the psychological ones.

    I don't know if this thing will help fat people, but I'd bet a dollar on the fact that it will definitely boost sales of paxil and valium.

  • by Anonymous Coward

    It sound like a Klingon weapon.

  • by crazybit ( 918023 ) on Monday January 19, 2015 @03:20AM (#48848479)
    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 [authoritynutrition.com]
    And here is a nice video from Stephan Guyenet, Ph.D. explaining it too [youtube.com]

    Affecting a whole big nerve instead of changing eating habits is a really really bad idea
    • by citizenr ( 871508 ) on Monday January 19, 2015 @03:36AM (#48848521) Homepage

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

    • Diets and supplements is 10B a year industry and won't go away anytime soon. Also don't forget that average effects is not the same as specific effects. We know that metabolism variation among individuals is pretty huge.
      • Also don't forget that average effects is not the same as specific effects. We know that metabolism variation among individuals is pretty huge.

        That's partially true, the SPEED in which you can become insulin resistance varies (that's why you see people who can eat foods filled with anti-nutrients and don't easily become leptin resistant), but the mechanisms that causes it and the way of getting rid of such resistance is the same in all humans - unless u got a rare genetic desease or a damaged hypothalamus.

    • by Anonymous Coward

      Congratulations for you. Willpower can work.
      Apparantly for over a third of the US it does not though: http://www.cdc.gov/obesity/data/adult.html
      You're also discounting the fact that it's supplementary. A lot of medicine prescribed to diabetics actually increases the patients weight gain.

      These things tend to be expensive and used as a last resort where education, support, diet and exercise are not enough alone. If the research supports the devices effectiveness (and it must or it would not be approved) then

    • by AmiMoJo ( 196126 ) *

      Can you say more about how you did this "reset"? A quick google just brings up lots of bullshit.

      • by cdrudge ( 68377 )

        A quick google just brings up lots of bullshit.

        There's a reason for that...

  • Isn't that the G-spot?

    Wait, why am I asking about this on Slashdot?

  • I just registered "HackMyFoodDevice.com" to exchange ideas on how to fool that damn thing.
    People with the rubber bands around their stomach manged to defeat their overload and I am pretty sure we can as well.

    Come, visit and don't forget to walk by the buffet over there.....

  • I need that (Score:4, Funny)

    by Tablizer ( 95088 ) on Monday January 19, 2015 @03:29AM (#48848499) Journal

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

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

      If you enjoyed playing blackjack, and had a good time with the hookers, your money wasn't lost, it was well spent.

  • so effective! yeah, another scammy "study" from money-hungry academia
    • 8.5% is significant. Of course that is not a big enough difference to make this a first-line treatment, but it could be an important option for patients for whom other treatments have failed. No one is saying this is something that everyone should use to lose a few pounds.
  • by retroworks ( 652802 ) on Monday January 19, 2015 @07:53AM (#48849025) Homepage Journal

    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.

    • Well, I don't know who to root for.

      Don't worry - the tendency to see both sides of an issue is a genuine medical affliction brought on by an over-active brain. Soon they'll have an implant to help such people reduce every issue affecting the world to a simplistic false dichotomy, taking away the uncomfortable urge to try and deal with complexity.

      Meanwhile, you just need to rely on willpower to suppress your skepticism when reading stories like this.

  • In the sequel to Jumper [amazon.com], the bad guys control people with an implanted device that incapacitates them by stimulating their vagus nerves to make them throw up.

    Enough that it could kill them, since it doesn't have to stop, ever.

    No, thank you.

  • What is ironic is that Gastric Electric Stimulators [ucsfhealth.org] are used to ease the symptoms of gastroparesis [wikipedia.org], reducing nausea and allowing those patients to gain weight.

  • Eat better, exercise, and the weight will come off. Honestly, how fucking hard is that? I do this every day. The last thing people need is yet another gimmick.

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