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Medicine United States

The Feds Are Officially Cracking Down on Basement Biohackers (gizmodo.com) 220

Kristen Brown, reporting for Gizmodo: The Food and Drug Agency has issued a stern warning to anyone who might be crazy enough to undertake gene therapy in the do-it-yourself fashion. Definitely don't do this at home, a statement released on Tuesday implies. And if you do, we'll throw every law we can at you. The FDA's deterrent comes on the heels of a brazen DIY gene therapy experiment, in which a 27-year-old software engineer injected himself with an unprove gene therapy for HIV designed by three biohacker friends. The first injection was streamed live on Facebook in October, and went viral after it was covered by Gizmodo. "You can't stop it, you can't regulate these things," patient zero, Tristan Roberts, told Gizmodo at the time. Apparently the FDA begs to differ.
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The Feds Are Officially Cracking Down on Basement Biohackers

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  • They can't stop it (Score:5, Insightful)

    by hawguy ( 1600213 ) on Wednesday November 22, 2017 @01:48PM (#55604893)

    They can't stop it, but just like drugs, they can drive it underground so people that choose to do this will be unable to seek medical attention without fear of being arrested.

    • by Luthair ( 847766 )
      Would you allow someone without a medical license to operate on you? I think the biohacker morons are likely the ones to face charges in this scenario, not the person injecting themselves.
      • Would you allow someone without a medical license to operate on you?

        So what if he did?

        A government issued license doesn't grant any special magical powers; it only tests basic competency (and depending on state, verifies schooling) in the field which is being licensed. IIRC, even with a medical license, nothing really stops a podiatrist from performing neurosurgery, so...

        • A podiatrists can not perform neurosurgery, it requires additional certifications that regional medical centers that are a certain grade of medical facility must have on staff at all times.

          Irrespective, licensure does not improve quality, it only limits supply. Thatâ(TM)s the goal of the AMA, to limit licensed doctors to drive up costs and therefore profits for its members, at the expense of unlicensed would-be practitioners and the customers of those being licensed.

          • by Anonymous Coward

            That is the purpose of the whole clinical trials regime enforced by the FDA. Big Pharma loves it, because it provides a big barrier to entry for upstart competitors.

            • Clinical trials do provide a barrier to entry, but if you think that's the main purpose of the way clinical trials are regulated - or even a large contributing factor - you're just wrong. Safety and efficacy of a new drug, device, or procedure are really important to get right.
          • by arth1 ( 260657 )

            A podiatrists can not perform neurosurgery, it requires additional certifications that regional medical centers that are a certain grade of medical facility must have on staff at all times.

            I think you confuse "may not" with "cannot".
            If I chopped my toe off out in the wilderness, I'd give it a try myself too.

            • by Altrag ( 195300 )

              You'd try giving yourself neurosurgery if you chopped off your toe? That doesn't seem terribly productive..

              • by arth1 ( 260657 )

                You'd try giving yourself neurosurgery if you chopped off your toe? That doesn't seem terribly productive..

                Even a very tiny chance to be able to get some nerves connected by doing what I've only read about would be better than nothing.

          • Irrespective, licensure does not improve quality, it only limits supply.

            Licensure improves average quality because it eliminates the lowest quality professionals from the labor pool.

            Lawyers, doctors, psychologists, and engineers can lose their livelihood due to poor skills, inadequate knowledge, or unethical behavior. Hell, most of the problems we have with the police are because a few assholes aren't afraid of being thrown in jail or kicked out of the profession.

            Sometimes the lack of a doctor will kill you. Sometimes a bad doctor will kill you. Licensing requirements, at their

      • Circumstances (Score:5, Insightful)

        by sjbe ( 173966 ) on Wednesday November 22, 2017 @02:13PM (#55605109)

        Would you allow someone without a medical license to operate on you?

        Under normal circumstances no but sometimes circumstances aren't normal. Sometimes the people with the medical license are prohibited from helping you by law or it costs too much to hire them. Sometimes people are curious or desperate or delusional. Sometimes people see a profit in doing things without a license. Quackery is a real thing (see homeopathy). If you have a condition that will kill you and the people with medical licenses won't help you, chances are good you'll look at other options you might not normally consider.

        • Look at it as a patient. Two options are presented:
          Doctor: Yeah, you have cancer. We can treat it. It's going to cost all your life savings and then some, and take a year at least. During which you are going to wish you are dead, because these chemo drugs are pretty nasty - expect to spend most of your time in bed or vomiting. Forget about work. But, if you go through all that, I think you've a fifty-fifty chance of not dying.
          Quack: Just take these pills and you'll be fine. Don't believe the medical establ

          • Re:Circumstances (Score:4, Informative)

            by gnick ( 1211984 ) on Wednesday November 22, 2017 @03:11PM (#55605669) Homepage

            Quack: Just take these pills and you'll be fine.

            Nobody would be stupid enough to believe that pills are going to cure their cancer. That requires magnets and crystals. A little pricey if you want them charged and balanced to conform to your chakra, but cheaper than chemo. Prayer is cheaper, but a proper faith healer might want a donation.

          • Look at it as a patient. Two options are presented:

            You presented those two options (interesting, the same number most shills present when arguing anything.) In reality, there are many more, such as: you have to spend your life savings for a drug which can be manufactured for pennies from the guy across town. Or: there's a treatment in R&D which appears safe but you can't get it before you die, but it's relatively simple to do and there's a fully-certified biohacker (hint: 90%+ of them are actually biotech majors) who will do it under the table becaus

            • This is basically the medical pot argument. You can go to a pain clinic, get hard core pain drugs that slowly destroy your body or you could smoke some pot.

              True story, a friend of mine told the pain clinic she was using a THC creme on her knee to help with the pain and that it was working great, the pain clinic said that by self treating they could no longer prescribe her pain meds. So now she can't get legal meds and is relegated to only the 'illegal' ones.

              • True story, a friend of mine told the pain clinic she was using a THC creme on her knee to help with the pain and that it was working great, the pain clinic said that by self treating they could no longer prescribe her pain meds. So now she can't get legal meds and is relegated to only the 'illegal' ones.

                Not in Washington State, Oregon, Colorado, and a growing (heh, growing...) list of others. Sessions/Trump/DoJ can not stop the tide from turning, there's just too much public interest and too much money to be had in state taxes.

                • True story, a friend of mine told the pain clinic she was using a THC creme on her knee to help with the pain and that it was working great, the pain clinic said that by self treating they could no longer prescribe her pain meds. So now she can't get legal meds and is relegated to only the 'illegal' ones.

                  Not in Washington State, Oregon, Colorado, and a growing (heh, growing...) list of others...

                  You are profoundly mistaken. Opioid painkillers are regulated directly by the Federal government, and state laws are irrelevant. They piss-test opioid patients in California, the home of medical cannabis, and where recreational pot is also now legal, and if they detect cannabis residue they cut off access to the opioid medication.

            • Or: there's a treatment in R&D which appears safe but you can't get it before you die, but it's relatively simple to do and there's a fully-certified biohacker

              Ah yes, the old '100 mpg carburetor' argument.

              Sure, 'simple' breakthrough that Big Pharma doesn't want to pursue for some reason or doesn't know about. But your neighborhood biohacker understands.

              Sorry, not buying it.

              • by hawguy ( 1600213 )

                Or: there's a treatment in R&D which appears safe but you can't get it before you die, but it's relatively simple to do and there's a fully-certified biohacker

                Ah yes, the old '100 mpg carburetor' argument.

                Sure, 'simple' breakthrough that Big Pharma doesn't want to pursue for some reason or doesn't know about. But your neighborhood biohacker understands.

                Sorry, not buying it.

                Or: there's a treatment in R&D which appears safe but you can't get it before you die, but it's relatively simple to do and there's a fully-certified biohacker

                Ah yes, the old '100 mpg carburetor' argument.

                Sure, 'simple' breakthrough that Big Pharma doesn't want to pursue for some reason or doesn't know about. But your neighborhood biohacker understands.

                Sorry, not buying it.

                The pharmaceutical industry is not the same as the automotive industry.

                The pharmaceutical industry spends billions of dollars to bring a treatment to market -- if there are only a few hundred or even a few thousand people that need that treatment, then there's no way to recoup their costs at a price that most people are willing or able to pay.

                Existing gene therapy treatments can easily reach into the $500K range or more - insurance companies may not cover it and few people can cover it themselves. But if a

        • by Luthair ( 847766 )
          The problem is that quacks convince people they're a legitimate and better optional that real professionals. Heck, there are a number of clinics today providing stem cell treatments that have not been shown to be effective. This is only going to get worse and health agencies around the world should crack down hard on people offering these treatments.
        • Sometimes........circumstances happen [youtube.com].
        • Sometimes the people with the medical license are prohibited from helping you by law

          This actually happens a LOT. The legal mainstream stuff is basically all that their license/insurance/institution allows them to practice. There are many treatments that have better risk/benefit ratios than the mainstream, but are under-developed, not widely studied, nor publicized and even if your doc does know of one that's applicable to you, odds are he's not going to even tell you about it because he's negatively incentivized to do so.

      • Would you allow someone without a medical license to operate on you? I think the biohacker morons are likely the ones to face charges in this scenario, not the person injecting themselves.

        You're assuming that it is two different people. If it's illegal and you have a terminal illness that you think it might help then you are likely going to do it yourself or find a close friend to help you. Just like medical marijuana and medical suicide, there is enough stuff on the web that someone can take care of it themselves with a little research.

      • by hawguy ( 1600213 )

        Would you allow someone without a medical license to operate on you? I think the biohacker morons are likely the ones to face charges in this scenario, not the person injecting themselves.

        Depends on the circumstances.

        If I was facing a fatal degenerative disorder with no real treatment, then I might be willing to experiment a little.

        In that situation, I might be willing to take some mystery pill that might cure me (or might kill me faster) versus a known fate of becoming bedridden as my body slowly dies over the next year. I can't count on a pharmaceutical company investing millions (or billions) of dollars to come up with a treatment for my disorder, so I have little to lose from going with

      • "Would you allow someone without a medical license to operate on you?"

        No, I would do it myself, as this guy did, which is perfectly legal.
        Just like you can buy lidocaine at Amazon and fix your own wounds.

      • Would you allow someone without a medical license to operate on you?

        Being treated by a biohacker is a high-risk strategy that will kill quite a few people, but patients for whom the cost and availability of treatment exceeds their means are going to try it. And it is in the high-risk field that the next breakthrough may come.

      • by arth1 ( 260657 )

        Would you allow someone without a medical license to operate on you?

        In many cases, yes. For small things, I would prefer not to pay thousands of dollars and risk hospital infections.
        For bigger things, I would prefer to go to a country that practices more modern medicine than here in the US, and where the doctors aren't affiliated with (read: owned by) hospitals and have to put the hospital's profit interests first, an insurance company's interest second, their own greed third, and my interest a distant fourth.

      • Would you allow someone without a medical license to operate on you?

        Like Richard Feynman said, if you're out in the jungle and you get malaria, and there is no modern clinic, go to the medicine man for treatment because he might have medicine that helps. It doesn't matter if he understands scientific reasons for putting the quinine bark in the medicine; it doesn't matter if he thinks that the dance he does afterwards chases the evil spirits out. The medicine in the bark will still work.

        biohacker morons

        Yeah, no way! I would be more likely to visit an unlicensed mafia clinic for open-heart s

    • I have a feeling that a lot of this is driven by the pharma industry who don't want deaths turning public (or investor and regulator) opinion on something.

      The case of Jesse Gelsinger, who died after some poorly designed experimental gene therapy, took the wind out of gene therapy's sails. Maybe it wouldn't have gone anywhere anyway, but with everyone too spooked to fund it anymore after one death, it definitely wouldn't.

      CAR-T too, more recently [xconomy.com]
  • by Penguinisto ( 415985 ) on Wednesday November 22, 2017 @01:50PM (#55604919) Journal

    On the one hand, I say let 'em do it. If they succeed, we have the potential for medical breakthroughs. If they fail, they win Darwin's Award. Either way, nobody gets hurt.

    On the other hand, I can see some sort of home-brew Resident Evil thing happening if things go wrong...

    Maybe limit it to certain lines of research/self-testing, and calling certain types and materials off-limits?

    • * should say, "nobody else gets hurt."

    • Re: (Score:2, Funny)

      by Anonymous Coward

      Homebrew gene therapies might cause long term genetic harm, pass on to children, polluting the gene pool. People will start demanding genetic testing of potential mates prior to breeding. Economic class divisions will be punctuated by genetic class divisions, with teeming masses of mutants laboring under the control of a group of a genetically-elite super-species.

      In short, it will be fucking awesome!

    • by djinn6 ( 1868030 )
      If you have a terminal disease and multiple doctors tell you they have no cure, I think it's fair for you to try it. Worst case is you die.

      I can see some sort of home-brew Resident Evil thing happening if things go wrong.

      Zombies aren't a thing IRL.

    • The problem is that no one really wants to die. Even people who jump off of bridges that manage to survive often say that they regretted the choice to jump afterwards.

      However, eventually you will start dying in a every real and immediate sense of the word and at that point you're gladly willing to do just about anything to prolong your life. That makes you incredibly easy to take advantage of in such a situation and why the government has clamped down not only on homebrew medicine like this, but even imp
    • Either way, nobody gets hurt.

      There is no guarantee this is the case; I think bio-hacking can be potentially very dangerous, much more so than, for example, nuclear industry. This is why I think it should be harshly regulated, at least at this time - until we develop better tools, processes or global knowledge to handle potential accidents.

      I know this sounds like a Luddite position, or like one of those fifties horror movies ending with the priest or the cop solemnly declaring "there are things Man was not meant to know". However, bio-

    • Terminally ill people (disease will kill them, no known cure) deserve to be able to experiment beyond the safe bounds of medical law. If it works they save countless other lives, if it fails at least they had hope in their final days.
  • by Osgeld ( 1900440 ) on Wednesday November 22, 2017 @01:52PM (#55604937)

    Worked for Steve Jobs!

  • "The first injection was streamed live on Facebook in October, and went viral after it was covered by Gizmodo."

    That seems like a strange interaction.
  • by Anonymous Coward on Wednesday November 22, 2017 @01:53PM (#55604957)

    There is no freedom without self ownership.

  • by Anonymous Coward on Wednesday November 22, 2017 @01:53PM (#55604961)
    I know someone who drove the development of a new genetic treatment for his son who had an incurable, fatal genetic disease. This person is extremely smart and well connected to genetic medicine experts. The treatments were successful in saving his son from a steady decline and early death, and are now being trialed in the US. He did what any parent would do to save his child's life, if they were in the same situation. But he knew the legal risk also, and most doctors didn't want to know about or support his efforts, for fear of legal repercussions. So he had to fly to a hospital in Mexico monthly to have the treatments administered. When the choice is between dying or facing some legal repercussions for trying to save a life, I think most of us would go with trying to save your own life, or the life of a family member. The FDA needs to back off.
    • by Opportunist ( 166417 ) on Wednesday November 22, 2017 @02:14PM (#55605115)

      The main problem with this is that for every smart genius with good connections to genetic experts, there's thousands of deluded parents who pump their kids full of bleach because some unscrupulous assholes want to make a quick buck pretending to be medical experts.

      I can see your point and I do agree that in this particular case it saved a life, but we have seen what damage patent medicine by self proclaimed medical geniuses can, did and still does.

      • The main problem with this is that for every smart genius with good connections to genetic experts, there's thousands of deluded parents who pump their kids full of bleach because some unscrupulous assholes want to make a quick buck pretending to be medical experts.

        Yup. Its called ... freedom and it is scary. "Its my body, my right"

        • I have no problem with you pumping bleach up your own asshole. I draw the line where you hurt your child.

      • The main problem with this is that for every smart genius with good connections to genetic experts, there's thousands of deluded parents who pump their kids full of bleach because some unscrupulous assholes want to make a quick buck pretending to be medical experts.

        In my mind, the main problem is treating an unattributed, totally anonymous post as factual.

  • by idontgno ( 624372 ) on Wednesday November 22, 2017 @02:00PM (#55605011) Journal

    No, not Hitler. But he did have a German name [wikipedia.org].

  • Let us say we enact a law making some act illegal. Let us also stipulate the SCOTUS agrees the law is constitutional. Now that act has a criminal and a victim.

    Enforcement is successful if the victim sides with the government. (theft, burglary, kidnapping, ...)

    If the victim sides with the criminal, it is extremely difficult to enforce the law. (contraband black market, vice laws, ...)

    If people randomly cook things up and inject themselves with it, it is difficult to stop it. Even if it is very dangerous

    • If the victim sides with the criminal, it is extremely difficult to enforce the law.

      Just because something is difficult to do, it doesn't mean that it is practically or morally wrong to do it. I could name a lot of difficult things that are very good to do.

      Right now, we're looking only at earnest, passionate hackers who are knowledgeable about biology. But if you let this become an unregulated market, you'll end up drowning in snake oil.

      I believe the government should make it possible for individuals and small labs to offer legitimate services, but it definitely needs to watch for abuses.

  • Cooking up meth in your basement is also illegal, but there doesn't seem to be any shortage of meth out there does it ?

  • You must be careful rushing wonder solutions without adequate testing. Thalidomide was supposed to be a wonderful solution to morning sickness for pregnant women. It never completed testing in the US, but was approved for use in Europe. Once in use, the women who took it were giving birth to children with horrendous birth defects. The testing done was only testing if it had any effect on the women taking it, and hadn't progressed to checking the effect on the unborn child.
  • Kind of reminds me in 1960, Eisenhower saying "beware of the military industrial complex", warning how the industry that supplies the government with the weapons of war, will figure out a way to have a sustainable war (the war on terror comes to mind), that NEVER ends, to keep the bullets, bombs & guns streaming. Same with the "war on cancer, AIDS, heart disease" etc. Why cure it, when they can continue to milk it forever with treatments that never cure it.
  • Considering the small but non-zero chance that one of these morons initiates something contagious and harmful, yes, I'm fine with the Feds cracking down on "basement biolabs".

    Go back to making custom party drugs, you dolts.
    That only mostly kills people that arguably volunteer for it.

    • Considering the small but non-zero chance that one of these morons initiates something contagious and harmful, yes, I'm fine with the Feds cracking down on "basement biolabs".

      But then again, it's even easier for this scenario to occur with normal hybridization in places where pigs and ducks are raised on farms.

      Biohacking to produce lethal epidemics is more likely to be intentional and by terrorists. We will keep on watching for this using existing antiterror strategies.

    • so are the people with deadly diseases being test subjects for a big pharmy clinical trial in any different situation? Half being a control group that gets a placebo, half getting something that probably won't work?

      or it's okay with you because a multi-billion dollar corporation is doing it?

  • Isn't this issue self-correcting though? I mean gene-therapies are taking their sweet ass time through approval because most of them wind up causing cancer, and they killed the first experimental human subject.

    So like, if all the people who want to inject themselves with experimental treatments that're most likely just going to give them run-away cancer are allowed to do so; doesn't the whole issue go away after they all die?

  • ...Isn't some asshole 'practicing medicine without a license' or some high school kid raising up a batch of anthrax. It's individuals producing deadly medicine-resistant viruses genetically engineered to attack a specific individual. A DNA sample of the target is all that's necessary. Make it airborne and delivery can use multiple indirect routes extremely difficult to prevent for even the most large, sophisticated, and well-funded state security apparatus. No person of power would be safe from retribution.

  • Because that's how you start the Eugenics Wars.

  • The general public is starting to be anti-science, the USA is the land of the ignorant where being smart is shunned upon.

    In the meantime, Germany and Russia will make super-soldiers while Japan makes cute sexy catgirls.

  • by tgibson ( 131396 ) on Wednesday November 22, 2017 @02:27PM (#55605247) Homepage

    Here's an article [bbc.com] that has a few paragraphs of his followup tests in the weeks following the injection.

    He opened the documents sent from the lab and frowned slightly as he read. Then he laughed.
    "Alright, so - yeah, this was not what we were hoping for."

    According to the test results, Roberts' viral load rose from 28,800 on week two to 36,401 on week three - still low levels, but not the desired results. His count of CD4 helper T-cells - the immune system cell that HIV attacks - was higher than he'd ever seen it, but there was no way to know what that meant.

    "More data is necessary," Traywick chimed in from off-camera. Then he sat down next to Roberts, joking: "We didn't kill you."

  • As to the actual story not sure how much they can as the FDA regulates licensed individuals doing business. Further in the US all "drugs" are defecto legal until they are specifically banned.

    And when it comes to a therapy all one has to do is go to a country that doesn't care and or by extension just hop on a boat with a flag of said country and go into international waters.

    But onto my topic.... There is absolutely going to be an underground movement both against government drug regulation and corporate dr

    • by EvilSS ( 557649 )
      That's going to be cool but I can't wait until someone cultures their fecal bacteria, coaxes some of the strains to take up that glowing jellyfish plasmid, and re-introduces into themselves, giving them glow in the dark poop.

      You can literally buy everything you need for under $200 right now including the plasmid.
      • Neat, so why hasn't anyone tried this yet?

        • by EvilSS ( 557649 )
          Critical lack of imagination?
          • I've got about 20 tabs open reading about this stuff now. I'm guessing you were talking about taking a sample of your own e.coli, doing the popular glowing e.coli lab and then ingesting the modified result so it reproduces?
            I had no idea this kind of stuff was within reach of the common person. Really fucking neato'

    • The development of microreactors could revolutionize the production of pharmaceuticals in small quantities.
      https://en.wikipedia.org/wiki/... [wikipedia.org]
      "The microreactor is usually a continuous flow reactor (contrast with/to a batch reactor). Microreactors offer many advantages over conventional scale reactors, including vast improvements in energy efficiency, reaction speed and yield, safety, reliability, scalability, on-site/on-demand production, and a much finer degree of process control." It's almost like a 3d p
  • Excellent, anyone but a doctor injecting ink under your skin or a metal implant but a Doctor should be severely punished!

  • "You can't stop it, you can't regulate these things," patient zero, Tristan Roberts

    We don't have to. The people involved will soon die off from ineffective treatment at best, or die from being treated with untested, dangerous drugs.

    • Or, hopefully, some/many will get cured. This is unregulated human experimentation, it can go horribly wrong... or not.

      • or not.

        Hundreds of billions of dollars and tens of thousands of researchers over decades has gone into solving things like HIV and cancer.

        What do you think the chances are that some 20-somethings in their basement are going to figure it out?

        But anyway, we agree. Let them do it.

    • Or cure themselves without the 500k+ of medical debt, and change the way society looks at healthcare.

      Seriously, the risk assessment goes something like this=

      I can't afford experimental treatment. If I try it myself I might live, I might find a better cheaper way to administer/manufacture a drug, and I will maybe face fines. If I do nothing...... I die anyway.

      Kind of a no brainier.... but I suppose they may need a...... bladerunner.

      • Or cure themselves without the 500k+ of medical debt

        Yes, because the chances that some "biohackers" in their basement are going to come up with the cure to HIV is very likely. Hundreds of billions of dollars and universities and medical organizations around the world have been "hacking" it for 40 (?) years now.

        Anyway, we agree. Let them do it. Just get contracts in place so nobody can sue when the inevitable happens.

    • and that's totally different from clinical trials of new medicines for deadly diseases...how exactly? almost all of those fail too, the control and test subjects all get the usual mortality rate. you have no point.

      • and that's totally different from clinical trials of new medicines for deadly diseases...how exactly?

        Because they take place under the supervision of real doctors?
        Because they are based on trials in non-human test subjects?
        Because they are based on years or decades of research?

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