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posted by Fnord666 on Monday December 04 2017, @11:14AM   Printer-friendly
from the what-could-possibly-go-wrong dept.

"Cease & Desist" has not worked:

Despite a warning from the federal government about do-it-yourself gene therapy, two companies say they'll continue offering DNA-altering materials to the public.

The companies, The Odin and Ascendance Biomedical, both recently posted videos online of people self-administering DNA molecules their labs had produced.

Following wide distribution of the videos, the U.S. Food and Drug Administration last week issued a harshly worded statement cautioning consumers against DIY gene-therapy kits and calling their sale illegal. "The sale of these products is against the law. FDA is concerned about the safety risks involved," the agency said.

Does the Executive Branch want the market to decide, or not?


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  • (Score: 4, Insightful) by Gaaark on Monday December 04 2017, @11:48AM (1 child)

    by Gaaark (41) on Monday December 04 2017, @11:48AM (#604987) Journal

    It's only illegal if you have no money for bribes.

    --
    --- Please remind me if I haven't been civil to you: I'm channeling MDC. ---Gaaark 2.0 ---
    • (Score: 2) by DeathMonkey on Monday December 04 2017, @06:30PM

      by DeathMonkey (1380) on Monday December 04 2017, @06:30PM (#605177) Journal

      It's actually only illegal if you advertise a commercial product as a medical treatment or diagnostic tool.

      But hey, that doesn't make as good of a pithy, cynical, soundbite.

  • (Score: 5, Insightful) by takyon on Monday December 04 2017, @12:06PM (9 children)

    by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @12:06PM (#604988) Journal

    My body, my genes. Or any other genes.

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    • (Score: 2) by coolgopher on Monday December 04 2017, @12:12PM (4 children)

      by coolgopher (1157) on Monday December 04 2017, @12:12PM (#604989)

      Man, I don't know whether to mod you Insightful or Funny, so I'll comment instead.

      • (Score: 2) by takyon on Monday December 04 2017, @12:48PM (3 children)

        by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @12:48PM (#604998) Journal

        Mod it whichever way you please, but I am bng srs rght nw.

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        • (Score: 2) by JNCF on Monday December 04 2017, @02:01PM (1 child)

          by JNCF (4317) on Monday December 04 2017, @02:01PM (#605027) Journal

          Oh man, I think you hacked up your vowel gene partway through that post; you'd better CRISPR it back into one or both of your helices. Srsly!

          • (Score: 0) by Anonymous Coward on Monday December 04 2017, @02:46PM

            by Anonymous Coward on Monday December 04 2017, @02:46PM (#605054)

            Oh man, I think you hacked up your vowel gene partway through that post; you'd better CRISPR it back into one or both of your helices. Srsly!

            He can't, because CRISPR contains the vowel "I" which is no longer available to him :-)

        • (Score: 2) by EvilSS on Monday December 04 2017, @02:10PM

          by EvilSS (1456) Subscriber Badge on Monday December 04 2017, @02:10PM (#605030)
          Pat I'd like to buy a vowel...
    • (Score: 3, Interesting) by PinkyGigglebrain on Monday December 04 2017, @08:25PM (3 children)

      by PinkyGigglebrain (4458) on Monday December 04 2017, @08:25PM (#605258)

      And what if your genemodding your own body also alters something like a cold virus or the e-coli in your gut into something really nasty? If it just kills you no big deal since it was your choice to mod your own genes but if it jumps to other people then it sucks for everyone else. It is kind of like drinking or doing drugs, if you get drunk/stoned in, and stay in, your own home then fine. But if you get drunk/stoned and then go for a drive you put everyone else at risk and eventually people die.

      There needs to be some safety mechanisms in place.

      --
      "Beware those who would deny you Knowledge, For in their hearts they dream themselves your Master."
      • (Score: 3, Interesting) by takyon on Monday December 04 2017, @09:08PM (1 child)

        by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @09:08PM (#605295) Journal

        I'm not interested in safety mechanisms (also known as anti-science restrictions). I want innovation in bioengineering.

        People and companies already engage in risky behaviors that make diseases worse. For example, using too many antibiotics or using them incorrectly, or dumping medical waste products into rivers [theguardian.com]. Or hitting that Tinder/Grindr. By comparison, genemodding your own body is not likely to create a supervirus. Viruses are already great at mutating anyway. Altering a virus with the intent to make it more virulent could be an issue, and it's already leading to censorship or self-censorship [time.com].

        This technology will not be as easy to regulate as something like nuclear material, or even firearms (you can get some biological material through detectors, or just infect yourself). If the government wants to do something about this, they should pump more money into the CDC, NIH, etc. to create a universal flu cure or something.

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        • (Score: 0) by Anonymous Coward on Tuesday December 05 2017, @04:57AM

          by Anonymous Coward on Tuesday December 05 2017, @04:57AM (#605511)

          its good to want.

      • (Score: 0) by Anonymous Coward on Tuesday December 05 2017, @03:33PM

        by Anonymous Coward on Tuesday December 05 2017, @03:33PM (#605667)

        another dumb ass authoritarian. whatdya know

  • (Score: 3, Informative) by looorg on Monday December 04 2017, @12:22PM (14 children)

    by looorg (578) on Monday December 04 2017, @12:22PM (#604992)

    I'm not even quite sure what they are actually selling.

    Ascendance Biomedical
    http://www.ascendancebiomed.com/ [ascendancebiomed.com]
    Seems to offer somthing for Lung cancer (cimavax), something called Ovarian rejuvenation (not sure what that is but I guess it's restocking the eggshelf or something) and Senolytics (not sure what that was either, but according to wikipedia it's something about inducing death in certain cells, so you could stay young forever or kill of cancerous cells)

    The Odin
    http://www.the-odin.com/ [the-odin.com]
    The Odin seems a bit more mad scientist then Ascendance. They offer various "kits". Not sure exactly what they are offering, but it seems to be various yeast- and bacteria strains.

    Non of them seem to offer super-power genes or something that will make you smarter or change things. At least not as of yet.

    • (Score: 4, Informative) by takyon on Monday December 04 2017, @12:27PM (13 children)

      by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @12:27PM (#604994) Journal

      https://www.nextbigfuture.com/2017/11/diy-biohacking-with-crispr-gene-therapy-for-muscle-boosting-myostatin-inhibitor.html [nextbigfuture.com]

      Josiah Zayner is CEO of the biohacking-promoting startup The Odin.

      He has injected himself with performance enhancing gene therapy to grow larger muscles.

      He is selling a $20 myostatin inhibitor plasmid. This must be combined with a $300 gRNA in a plasmid that also expresses Cas9 which an be ordered online.

      Odin sells other gene kits.

      He has a DIY human CRIPR DNA guide.

      https://www.outsideonline.com/2238276/ultimate-life-hack [outsideonline.com]

      https://newatlas.com/home-crispr-gene-editing-kit/40362/ [newatlas.com]

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      • (Score: 2) by looorg on Monday December 04 2017, @12:31PM (12 children)

        by looorg (578) on Monday December 04 2017, @12:31PM (#604995)

        Question is: does it work? I missed that in the text about his glowing beer.

        • (Score: 2) by takyon on Monday December 04 2017, @12:50PM (2 children)

          by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @12:50PM (#604999) Journal

          In the last year or so the FDA has approved some gene therapies for living, breathing human adults.

          We can't say for sure whether his experiment will work, but that's the point of the self-experiment.

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          • (Score: 0) by Anonymous Coward on Monday December 04 2017, @03:45PM (1 child)

            by Anonymous Coward on Monday December 04 2017, @03:45PM (#605091)

            It's called being incredibly reckless and irresponsible. When gene therapies are approved, they know what they're dealing with both in terms of the DNA of the person as well as what the general effects of it are going to be.

            This is a case of companies engaged in illegal and unethical research on ignorant customers.

            And to make matters worse, because these aren't designed experiments, even if nothing particularly bad happens, we can't draw conclusions about what effect this might have on other people or no what sort of people shouldn't be using it. This is just bad.

            Self-experimentation is valuable, but this is so far beyond what you could reasonably expect somebody to do on their own that there's no value here. Self-experimentation is for things that are much lower stakes and more personal like figuring out what the best diet is for one person. There's plenty of variation without cutting out too many essential nutrients.

        • (Score: 3, Interesting) by VLM on Monday December 04 2017, @12:51PM (8 children)

          by VLM (445) Subscriber Badge on Monday December 04 2017, @12:51PM (#605001)

          The real question when you're selling to the general population of lifters is if a dose X works what happens when dumb lifters take one hundred times X, because the dumb ones do that with everything else they can consume. This malfunction is pretty much this is why we can't have basically harmless OTC 'roids. Also you give lifters a nice ergonomically and scientifically and engineering "safe" machine to lift with and roughly 95% of lifters will be "no brah I'm not using a machine I need max gainz" and then you tell them how to do it without destroying their body so again they do the opposite and round their back while lifting and then make the whole hobby look stupid because there they are in the ER (again).

          Well enough shitting on my hobby, gotta leave for the gym, its legs day. Realistically I'd say only 10% of my fellow lifters are morons, but sometimes I get a rant going.

          • (Score: 2) by fyngyrz on Monday December 04 2017, @01:32PM (4 children)

            by fyngyrz (6567) on Monday December 04 2017, @01:32PM (#605017) Journal

            Yes, and cheeseburgers! Too many cheeseburgers will KILL you!

            WE MUST LEGISLATE CHEESEBURGERS!

            Oh, wait. We could provide information, that is, educate, and then let people choose for themselves.

            Heresy, I know. Mother Government knows best. You can never have too many rules. WE MUST LEGISLATE CHEESEBURGERS!

            • (Score: 0, Informative) by Anonymous Coward on Monday December 04 2017, @03:47PM (1 child)

              by Anonymous Coward on Monday December 04 2017, @03:47PM (#605092)

              That's not even remotely the same thing. For the most part, there are plenty of warning signs before you eat so many cheeseburgers that it kills you. And if you eat too many, you have options for limiting the effects.

              This is something being done at the genetic level and if it doesn't work or causes problems, that's permanent. You don't get this long set of signs that things are going off the rails.

              But yes, clearly this is some sort of an evil conspiracy to force the government on people that don't need it. Moron. The fact that people are willing to pay to do this to themselves is a large part of why the FDA exists. Back before the FDA you'd have these sorts of snake oil treatments being distributed and many of them were dangerous, but nobody really knew because nothing was being tested in a rigorous way.

              • (Score: 2) by fyngyrz on Monday December 04 2017, @11:22PM

                by fyngyrz (6567) on Monday December 04 2017, @11:22PM (#605391) Journal

                Yes, mother. I'll be careful. Now fuck off.

            • (Score: 2) by FatPhil on Monday December 04 2017, @11:00PM (1 child)

              by FatPhil (863) <pc-soylentNO@SPAMasdf.fi> on Monday December 04 2017, @11:00PM (#605377) Homepage
              But cheeseburgers are legislated quite heavily. There are limits on what meats can be used, and how they should be processed, limits on hat additivews can be used, and laws regarding labelling. Believe it or not, there is an governmental administrative body that deals precisely with legislating food (and drugs).
              --
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              • (Score: 2) by fyngyrz on Monday December 04 2017, @11:21PM

                by fyngyrz (6567) on Monday December 04 2017, @11:21PM (#605390) Journal

                You can make your own cheeseburgers. Out of whatever you want. So, no.

          • (Score: 2) by JNCF on Monday December 04 2017, @02:20PM (1 child)

            by JNCF (4317) on Monday December 04 2017, @02:20PM (#605038) Journal

            The real question when you're selling to the general population of lifters is if a dose X works what happens when dumb lifters take one hundred times X, because the dumb ones do that with everything else they can consume.

            Evolution is bloody, and ever the Twain shall quethe: "censorship is telling a man he can't have a steak just because a baby can't chew it."

            Also you give lifters a nice ergonomically and scientifically and engineering "safe" machine to lift with and roughly 95% of lifters will be "no brah I'm not using a machine I need max gainz" and then you tell them how to do it without destroying their body so again they do the opposite and round their back while lifting and then make the whole hobby look stupid because there they are in the ER (again).

            Your "safe" machine doesn't require you to actually learn how to move your body in non-harmful ways while lifting heavy objects. This is okay if you just want to look cool, but if you want to gain useful strength you should know how to use it (I'm not assuming you don't).

            • (Score: 1, Informative) by Anonymous Coward on Monday December 04 2017, @03:39PM

              by Anonymous Coward on Monday December 04 2017, @03:39PM (#605088)

              Machines also generally are isolation-type exercises, and don't build the smaller muscles that provide stability and balance, and don't put as much pressure on bones and tendons, which can lead to issues when your muscles are disproportionately stronger than the joints and bones they're anchored to.

          • (Score: 2) by sjames on Monday December 04 2017, @06:16PM

            by sjames (2882) on Monday December 04 2017, @06:16PM (#605170) Journal

            The problem really applies to anything. Sell a lawnmower and some idiot will try to trim hedges with it. Sell a hair dryer and some idiot will try using it while still sitting in the tub. No amount of nerfing can save some people.

  • (Score: 3, Insightful) by EvilSS on Monday December 04 2017, @02:14PM (15 children)

    by EvilSS (1456) Subscriber Badge on Monday December 04 2017, @02:14PM (#605032)
    On the one hand, this is a new spin on the old snake oil, and can potentially kill people, either directly or by delaying them getting a treatment that might actually work. On the other hand it has the potential to prune quite a few idiots from society so.... yea torn.
    • (Score: 4, Informative) by takyon on Monday December 04 2017, @02:41PM (12 children)

      by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @02:41PM (#605050) Journal

      It's not necessarily snake oil.

      FDA Approves a Gene Therapy for the First Time [soylentnews.org]
      FDA Committee Endorses Gene Therapy for a Form of Childhood Blindness [soylentnews.org]
      FDA Approves Gene Therapy for Non-Hodgkin's Lymphoma [soylentnews.org]
      Gene Therapy for Spinal Muscular Atrophy Type 1 [soylentnews.org]
      Gene Therapy and Skin Grafting for Junctional Epidermolysis Bullosa [soylentnews.org]
      Gene Therapy Halts a Rare Brain Disease [soylentnews.org]
      Gene Therapy Cure for Sickle-Cell Disease [soylentnews.org]

      We've gone from 0 FDA-approved gene therapies a year ago to a rapidly increasing handful.

      We know that myostatin inhibition works:

      Scientists Create Extra-Muscular Beagles [soylentnews.org]
      "Double-Muscled" Pigs Created Using Simple Gene Modification [soylentnews.org]

      But these are examples of animals raised from engineered embryos or bred with the gene. Doing it to a fully grown human could be much harder or less effective. But if it does work, the effect could be easier to control or reversible.

      The guy is selling a variety of kits that do work (like making bacteria glow), and is testing his therapy on himself.

      If it at least appears to work, there will be no shortage of bodybuilders and athletes willing to test out the approach. On the shady side of athleticism, they are years ahead in terms of doping. People will determine if this is snake oil or not, and it will spread like wildfire if there are SICK GAINS, BRO.

      And that's just one specific and easily understood genetic change. More await.

      We should be happy to see people harm themselves in the name of science. It dodges ethical roadblocks by putting the patient in control. There is the possibility that we can learn from these mistakes, even if data collection and controls aren't rigorous. And true success can and will be replicated.

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      • (Score: 0) by Anonymous Coward on Monday December 04 2017, @03:50PM (1 child)

        by Anonymous Coward on Monday December 04 2017, @03:50PM (#605094)

        It is though, some of those snake oil treatments turned out to work, but most of them resulted in huge problems for people taking them. It wasn't uncommon for there to be actual poison in there.

        In this case, we don't know what the consequences are going to be, but we do know that they're not likely to be good. If they were likely to be good, these companies would be going through the FDA approval process so they could potentially charge a lot more money and bill insurance for the treatments.

        The fact that they're doing this illegal end-run around that process suggests that there's something wrong with the treatment or they lack the confidence that the treatment can meet current FDA standards.

        So yes, this stuff is almost certainly snake oil and it's completely disingenuous to suggest that this is the same as the other treatments that have been approved and tested.

        • (Score: 3, Insightful) by takyon on Monday December 04 2017, @04:03PM

          by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @04:03PM (#605103) Journal

          In this case, we don't know what the consequences are going to be, but we do know that they're not likely to be good. If they were likely to be good, these companies would be going through the FDA approval process so they could potentially charge a lot more money and bill insurance for the treatments.

          That process is expensive and slow.

          People who want to experiment on themselves should be able to do so. The companies in the summary will just make it more streamlined to do so.

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      • (Score: 2) by EvilSS on Monday December 04 2017, @03:58PM (9 children)

        by EvilSS (1456) Subscriber Badge on Monday December 04 2017, @03:58PM (#605099)
        You are putting words in my mouth. I didn't say all gene therapy is snake oil. That's like saying all drugs are useless because some crap boner pill sold online. What I am saying is that these unapproved, untested, direct to the consumer "gene therapy" products are going to turn out to be almost 100% crap. If the FDA doesn't crack down this is going to explode like the supplement market did in the 90's and 00's*, taking advantage of consumers who don't know better with sham products that don't do what they say. Only this time there is a real danger in harming the users.
        • (Score: 2) by takyon on Monday December 04 2017, @04:01PM (8 children)

          by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @04:01PM (#605101) Journal

          It doesn't stop at the level of "products". People will be able to order custom-made DNA and use it as they see fit.

          --
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          • (Score: 3, Funny) by c0lo on Monday December 04 2017, @04:16PM (3 children)

            by c0lo (156) Subscriber Badge on Monday December 04 2017, @04:16PM (#605105) Journal

            People will be able to order custom-made DNA and use it as they see fit.

            Why, actually I'm doing it every day!!!
            I even get it packed nicely from my butcher and use it in oral doses, after slightly grilling it both sides.
            The beef DNA I like best, but lamb is not far behind.

            --
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            • (Score: 2) by inertnet on Monday December 04 2017, @10:15PM (2 children)

              by inertnet (4071) on Monday December 04 2017, @10:15PM (#605350) Journal

              Why, actually I'm doing it every day!!!

              What a coincidence, I donate my genes almost every day.

              • (Score: 2) by FatPhil on Monday December 04 2017, @11:04PM

                by FatPhil (863) <pc-soylentNO@SPAMasdf.fi> on Monday December 04 2017, @11:04PM (#605380) Homepage
                Only your own genes? I tithe my internal biome too.
                --
                Great minds discuss ideas; average minds discuss events; small minds discuss people; the smallest discuss themselves
              • (Score: 2) by c0lo on Monday December 04 2017, @11:37PM

                by c0lo (156) Subscriber Badge on Monday December 04 2017, @11:37PM (#605400) Journal

                Don't worry, this too shall pass.
                Sooner that you may like.

                --
                https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
          • (Score: 2) by EvilSS on Monday December 04 2017, @04:33PM (3 children)

            by EvilSS (1456) Subscriber Badge on Monday December 04 2017, @04:33PM (#605118)
            OK, so first of all, that's still a product. If I order a custom tshirt, it's still a "product" being sold to me. Secondly, that just supports my point that these products will be dangerous if we don't apply some level of regulation to them. Genetics are not as cut and dry as a lot of people seem to think. Changes can have unexpected results that may not be immediately evident.

            Again though, go for it. If it works, great! If it kills you, also great! It's a win-win for society.
            • (Score: 2) by HiThere on Monday December 04 2017, @06:26PM (1 child)

              by HiThere (866) Subscriber Badge on Monday December 04 2017, @06:26PM (#605173) Journal

              These don't seem to be gene-line therapies, though, so the people are only hurting themselves. As long as nobody is paying them to do this, I don't see it as any worse than lots of other things people do that may hurt themselves, like mountain climbing or watching TV (sloth is deadly).

              OTOH, as you point out people don't really know the risks (do they ever?) and here they seem a bit more opaque than usual, so there should be mandated warnings intelligible to the average high school graduate. (I.e., pages of lawyer-speak shouldn't be valid.)

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              • (Score: 3, Insightful) by EvilSS on Monday December 04 2017, @07:13PM

                by EvilSS (1456) Subscriber Badge on Monday December 04 2017, @07:13PM (#605218)
                Like i said I'm torn. It's their bodies (well until they start giving this crap to their kids) so they should be able to do as they please. But without any regulation there is no way to know that people are getting what they are promised, that it's safe and/or effective, and what the known risks and side effects are. And you better believe the field will quickly fill up with companies out to make a quick buck scamming people vs making a difference.

                And before anyone goes all whataboutism on the current state of the pharma industry, do you think they would be BETTER without the regulations currently on them? Really??
            • (Score: 2) by takyon on Monday December 04 2017, @06:58PM

              by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Monday December 04 2017, @06:58PM (#605204) Journal

              I'd like to remind you that Odin is not selling a gene therapy. They are selling components that can be used to create a gene therapy.

              That should not be outlawed, no matter how unsafe it could be. If it is outlawed, I would encourage it to be circumvented by desktop-sized equipment capable of synthesizing DNA and creating plasmids. If it lands in the $1,000 to $20k range, it's within the reach of DIY bio home users and especially hackerspaces or small groups.

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    • (Score: 2) by Sourcery42 on Monday December 04 2017, @03:20PM (1 child)

      by Sourcery42 (6400) on Monday December 04 2017, @03:20PM (#605080)

      this is a new spin on the old snake oil

      Good, no one wants to oil a snake these days

      • (Score: 3, Funny) by etherscythe on Monday December 04 2017, @06:38PM

        by etherscythe (937) on Monday December 04 2017, @06:38PM (#605181) Journal

        You must be doing something wrong. Have you tried buying dinner first?
        *ducks*

        --
        "Fake News: anything reported outside of my own personally chosen echo chamber"
  • (Score: 3, Insightful) by meustrus on Monday December 04 2017, @04:36PM

    by meustrus (4961) on Monday December 04 2017, @04:36PM (#605121)

    Does the Executive Branch want the market to decide, or not?

    Not until they pay the free market tax, payable directly to campaign budgets on both sides.

    --
    If there isn't at least one reference or primary source, it's not +1 Informative. Maybe the underused +1 Interesting?
  • (Score: 0) by Anonymous Coward on Monday December 04 2017, @10:34PM

    by Anonymous Coward on Monday December 04 2017, @10:34PM (#605360)

    I'll show them all!

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