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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, 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.
            --
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          • (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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