Slashdot Mirror

← Back to Stories (view on slashdot.org)

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

Posted by msmash on from the steering-clear dept.

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.

28 of 220 comments (clear)

  1. They can't stop it by hawguy · · Score: 5, Insightful

    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.

    1. Re:They can't stop it by Penguinisto · · Score: 2

      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...

      --
      Quo usque tandem abutere, Nimbus, patientia nostra?
    2. Re: They can't stop it by saloomy · · Score: 2, Insightful

      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.

    3. Re:They can't stop it by Wycliffe · · Score: 2

      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.

    4. Re:They can't stop it by hawguy · · Score: 2

      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 a risky experimental treatment. Slowly dying in a hospital bed isn't really appealing.

    5. Re:They can't stop it by nospam007 · · Score: 2

      "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.

    6. Re: They can't stop it by Anonymous Coward · · Score: 2

      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.

    7. Re: They can't stop it by arth1 · · Score: 2

      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.

    8. Re: They can't stop it by Altrag · · Score: 2

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

    9. Re: They can't stop it by Anonymous+Cow+Ward · · Score: 2

      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.

      --
      Examine even your most deeply held beliefs. Nobody is always right.
  2. Actually... by Penguinisto · · Score: 2

    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?

    --
    Quo usque tandem abutere, Nimbus, patientia nostra?
    1. Re:Actually... by Anonymous Coward · · Score: 2, Funny

      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!

  3. Alternative Medicine by Osgeld · · Score: 4, Funny

    Worked for Steve Jobs!

    1. Re:Alternative Medicine by Opportunist · · Score: 4, Funny

      Well, is he still sick? Is he?

      --
      We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
    2. Re:Alternative Medicine by Mal-2 · · Score: 5, Funny

      He'll be back in a few years. He's spending a decade dead for tax purposes.

      --
      How is the Riemann zeta function like Trump rallies? Both have an endless number of trivial zeros.
    3. Re:Alternative Medicine by outlander · · Score: 2

      +1

      Nice to see you, Mr. Desiato.
      Your bodyguard's a bit rude, innit?

      --
      "Truth is what works" -- William James "It works!!" -- o-dark-AM comment
  4. Only we're allowed to experiment on you! by Anonymous Coward · · Score: 4, Insightful

    There is no freedom without self ownership.

  5. Save a life, or comply with rules and regulations? by Anonymous Coward · · Score: 5, Insightful

    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.

  6. You know who else was a DIY biohacker? by idontgno · · Score: 3, Insightful

    No, not Hitler. But he did have a German name.

    --
    Welcome to the Panopticon. Used to be a prison, now it's your home.
  7. Circumstances by sjbe · · Score: 5, Insightful

    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.

    1. Re:Circumstances by gnick · · Score: 3, Informative

      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.

      --
      He's getting rather old, but he's a good mouse.
    2. Re:Circumstances by NicknameUnavailable · · Score: 2

      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 because he happens to have a lab and he's your buddy.

      Just like most regulations, this has nothing whatsoever to do with public safety and everything to do with taxation. If biohackers and individual treatments become as common as the local barber (hint: they could be, there are plenty of biotech majors and they nearly all have their own labs, all of them can follow a protocol,) then it cuts out the trillions of dollars in getting FDA approval, going through trials, cuts out pharma monopolies, healthcare device manufacturer contracts paying out 10,000x or more the cost of the hardware to the manufacturer, all of which gets taxed, etc.

      I'm not saying biotech isn't hard, or that it can't be fucked up - but if you fuck it up the potential for harming another person is astronomically low, you'd be more likely to die from the aforementioned barber choking on saliva, twitching, and slicing your throat with the scissors then having a panick attack and drowning you in barbasol to try to cover up the crime before you bled out. When you fuck up biotech it just dies before you can do anything with it, it's working with living things and those die when they stray outside of the parameters designed for.

      Worst case scenario you get some charlatans who pop up and take advantage of people, just like we already have with holistic and faith healers.

    3. Re:Circumstances by hawguy · · Score: 2

      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 backyard chemist could do the same treatment for $1K (because he doesn't have all of the regulatory hurdles (and yes, safety standards) to follow, then it opens the treatment to many more people.

      Is the risk better than the reward? I dunno, ask someone who's dying and can't afford the treatment if he'd be willing to use an experimental treatment by a backyard biochemist that has only a 25% chance of success.

  8. Re:Save a life, or comply with rules and regulatio by Opportunist · · Score: 4, Insightful

    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.

    --
    We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
  9. Re:Viral by DontBeAMoran · · Score: 2

    So now we need to wear condoms when browsing Facebook or Gizmodo? Fucking morans!

    --
    #DeleteFacebook
  10. Tristan Roberts' post-injection test results by tgibson · · Score: 4, Informative

    Here's an article 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."

  11. Re:Save a life, or comply with rules and regulatio by 93+Escort+Wagon · · Score: 2

    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.

    --
    #DeleteChrome
  12. Re:If you think Government is the solution by JoeDuncan · · Score: 3, Insightful

    Not all "freedom" is desirable.

    For instance the "freedom" to abuse others without consequence; is generally NOT considered a "freedom" we should have.