Stories
Slash Boxes
Comments

SoylentNews is people

posted by Fnord666 on Wednesday February 07 2018, @10:28AM   Printer-friendly
from the how-do-you-test-its-effectiveness? dept.

"Biohackers" are growing bolder with their self-experimentation:

Aaron Traywick, 28, who leads biotech firm Ascendance Biomedical, used an experimental herpes treatment that did not go through the typical route of clinical trials to test its safety. Instead of being developed by research scientists in laboratories, it was created by a biohacker named Andreas Stuermer, who "holds a masters degree and is a bioentrepreneur and science lover," according to a conference bio. This is typical of the Ascendance approach. The company believes that FDA regulations for developing treatments are too slow and that having biohackers do the research and experiment on themselves can speed up the process to everyone's benefit. In the past, the company's plans have included trying to reverse menopause, a method that is now actually in clinical trials.

"We prefer to do everything before a live audience so you can hold us accountable in the days to come as we collect the data to prove whether or not this works," Traywick said before last night's spectacle. And, he added, "if we succeed with herpes in even the most minor ways, we can move forward immediately with cancer."

Despite specifying that he wanted "technical questions," someone in the audience asked whether Ascendance had received ethical permission for the experiment. Traywick said he didn't. Technically, everything has been officially labeled "not for human consumption," he said.

Also at The Scientist.

Related: Gene Therapy to Kill Cancer Moves a Step Closer to Market
Biohackers Disregard FDA Warning on DIY Gene Therapy


Original Submission

Related Stories

Gene Therapy to Kill Cancer Moves a Step Closer to Market 6 comments

Arthur T Knackerbracket has found the following story:

A new era of treating disease has moved a step closer to reality in the United States.

A Food and Drug Administration panel gave a thumbs-up Wednesday to a gene therapy that involves genetically engineering a patient's T-cells to fight a particular type of leukemia, The New York Times reports.

If the FDA agrees with the panel's recommendation and moves to approve the treatment for commercial use, it would be the first such gene-altering treatment to make it to market.

[...] Once the stuff of science fiction, altering human genes has been creeping into reality of late. Also on Wednesday, researchers at Harvard announced they'd managed to encode video files into the genetic material of living cells, demonstrating the viability of a "molecular recorder" that could lead to more disease treatments in the future.

-- submitted from IRC


Original Submission

Biohackers Disregard FDA Warning on DIY Gene Therapy 45 comments

"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?


Original Submission

Biohacker Regrets Injecting Himself With Gene Therapy in Front of a Live Audience 20 comments

A Biohacker Regrets Publicly Injecting Himself With CRISPR

When Josiah Zayner watched a biotech CEO drop his pants at a biohacking conference and inject himself with an untested herpes treatment, he realized things had gone off the rails.

Zayner is no stranger to stunts in biohacking—loosely defined as experiments, often on the self, that take place outside of traditional lab spaces. You might say he invented their latest incarnation: He's sterilized his body to "transplant" his entire microbiome in front of a reporter. He's squabbled with the FDA about selling a kit to make glow-in-the-dark beer. He's extensively documented attempts to genetically engineer the color of his skin. And most notoriously, he injected his arm with DNA encoding for CRISPR that could theoretically enhance his muscles—in between taking swigs of Scotch at a live-streamed event during an October conference. (Experts say—and even Zayner himself in the live-stream conceded—it's unlikely to work.)

So when Zayner saw Ascendance Biomedical's CEO injecting himself on a live-stream earlier this month, you might say there was an uneasy flicker of recognition.

Man Who Attempted DIY Gene Therapy Found Dead 42 comments

Aaron Traywick, a biohacker who once injected himself with an untested herpes therapy on a crusade to expand access to medications, was found dead on Sunday morning in Washington, DC, police confirmed to BuzzFeed News.

Traywick, 28, was found in a spa in Northwest DC, according to police. Staff discovered him in a sensory deprivation flotation tank, according to his colleague Tristan Roberts.

His body was taken for an autopsy, and his cause of death was not immediately known. Their investigation is still ongoing, but the police say they don't suspect foul play.

https://www.buzzfeed.com/stephaniemlee/aaron-traywick-biohacker-died

Also at Newsweek and the BBC.

Previously: "Biohacker" Injects DIY Herpes Vaccine in Front of Audience and Facebook Live (Aaron Traywick)
Biohacker Regrets Injecting Himself With Gene Therapy in Front of a Live Audience (Josiah Zayner reacting to Aaron Traywick)


Original Submission

This discussion has been archived. No new comments can be posted.
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
(1)
  • (Score: 5, Insightful) by stormwyrm on Wednesday February 07 2018, @10:41AM (14 children)

    by stormwyrm (717) on Wednesday February 07 2018, @10:41AM (#634358) Journal

    Good grief, if you were a real lover of science then you would be doing science the right way, instead of grandstanding while playing at science. Perform a proper experiment with controls and all that and publishing your results in a reputable peer-reviewed journal for other experts to examine would be much more convincing. What these asshats are doing reflects the worst sort of science by press conference [embopress.org]. Performing such uncontrolled "trials" of their snake oil in front of a live audience doesn't hold them accountable, especially when all they've done is essentially make a spectacle worthy of an old-time medicine show.

    --
    Numquam ponenda est pluralitas sine necessitate.
    • (Score: 3, Interesting) by Anonymous Coward on Wednesday February 07 2018, @11:20AM

      by Anonymous Coward on Wednesday February 07 2018, @11:20AM (#634370)

      Good grief, if you were a real lover of science then you would be doing science the right way, instead of grandstanding while playing at science.

      But this is who we have become as a culture. Everyone must have their spotlight and live their lives publicly. A missed opportunity for public exposure is a missed opportunity for fame and fortune. As ridiculous as it sounds these types of people may be vying for a reality show to track their lives as "human guinea pigs trying to help mankind". We are a "look at me!!" nation competing for eyes in a "look at me!" world.

    • (Score: 5, Insightful) by aristarchus on Wednesday February 07 2018, @11:21AM (10 children)

      by aristarchus (2645) on Wednesday February 07 2018, @11:21AM (#634371) Journal

      Not only that, but I hear that this

      someone in the audience asked whether Ascendance had received ethical permission for the experiment.

      is really hard to get. Ethical permission. Hmm, I wonder what that even is? Were they referring to getting permission from "ethical"? Or getting permission "ethically"? I assume they meant getting permission from an ethical review board, or Institutional Review Board (IRB), as required, kinda, after WWII by the Declaration of Helsinki, amoung other treaties, standards, and such. But since they are Hackers, and Bio-hacks at that, they probably have no medical background, no understanding of the scientific method, and no historical memory of why ethical standards for experimentation on humans were put in place. Kind of like the Uber Doctor service, that makes house calls, but it is just some guy who happens to drive a BMW. Cheaper than traditional doctors! Disruptive, man! Latest thing.

      • (Score: 3, Interesting) by Immerman on Wednesday February 07 2018, @04:23PM (9 children)

        by Immerman (3985) on Wednesday February 07 2018, @04:23PM (#634423)

        Enlighten me - what exactly are the ethical concerns of experimenting on *yourself*?

        Now, if you've actually been duped/manipulated into performing someone else's experiment on yourself, then that's a rather different scenario. Hmm, it would also be consistent with a live broadcast of the critical moment - plenty of witnesses to help absolve the actual experimenter of responsibility.

        • (Score: 4, Insightful) by DeathMonkey on Wednesday February 07 2018, @05:38PM (3 children)

          by DeathMonkey (1380) on Wednesday February 07 2018, @05:38PM (#634448) Journal

          From a regulatory perspective so long as they're only experimenting on themselves I think the FDA should leave them alone.

          From a science perspective, though, how useful is an experiment performed on a sample of one?

          • (Score: 0) by Anonymous Coward on Wednesday February 07 2018, @07:25PM (1 child)

            by Anonymous Coward on Wednesday February 07 2018, @07:25PM (#634506)

            Instead of experimenting on themselves, the researchers should grow human children in artificial wombs and experiment on them.

            I Am Absolutely Serious

            • (Score: 0) by Anonymous Coward on Thursday February 08 2018, @10:53AM

              by Anonymous Coward on Thursday February 08 2018, @10:53AM (#634816)

              Even if you managed to make clones of yourself, they'd have their rights like any other human and they would be protected from you exerting your experiments on them.
              However, if you made clones of yourself as a backup and then experimented on yourself, that would be ethically OK! But, you don't really know if your clones would volunteer to continue your work once they grow up and emancipate, and I am pretty sure that they would be prevented from being persuaded by your notes to do so.

          • (Score: 2) by Immerman on Wednesday February 07 2018, @07:26PM

            by Immerman (3985) on Wednesday February 07 2018, @07:26PM (#634507)

            Exploratory experiments can actually be quite useful - you're unlikely to learn anything concrete from one such an experiment unless the results are very dramatic, but a large number of diverse experiments can serve to highlight avenues worthy of more in-depth research. Sure, there'll be plenty of false positives and negatives, but it's a huge improvement over blindy jumping directly into investing the resources for a statistically significant experiment size.

            It's also quite useful for initial safety studies - you don't have to kill 100 mice to know there's a problem with your serum, you can be reasonably certain after the first one or two keel over after the injection. Especially if dissection reveals your serum as a likely culprit.

        • (Score: 2) by Freeman on Wednesday February 07 2018, @06:04PM

          by Freeman (732) on Wednesday February 07 2018, @06:04PM (#634467) Journal

          No ethics issues with experimenting on yourself. Maybe some few screws loose, if they aren't doing best practices. Other than that, all we've got here is the next YouTube video of people doing dumb things. Medical research is expensive, because we don't play with people's lives. Theoretically anyway, big Pharma seems to be rather corrupt though, so who knows.

          --
          Joshua 1:9 "Be strong and of a good courage; be not afraid, neither be thou dismayed: for the Lord thy God is with thee"
        • (Score: 4, Insightful) by aristarchus on Wednesday February 07 2018, @06:31PM

          by aristarchus (2645) on Wednesday February 07 2018, @06:31PM (#634484) Journal

          If you are willing to experiment on yourself, you are a bit too invested emotionally in your research. Confirmation bias? Hard to do a double-blind trial with just me, myself, and I. Even moreso in front of cameras. So it is bad science, very bad. And if the "researcher" in question is subjecting him or her self to dangers that no rational person would consent to risk, we might invite this very smart science lover to a select research institute where the greatest minds in the world are free to pursue their ground-breaking research free of government interference (but bound by "I love me" jackets, padded cells, and liberal non-therapuetic drugs).

        • (Score: 0) by Anonymous Coward on Wednesday February 07 2018, @06:34PM (1 child)

          by Anonymous Coward on Wednesday February 07 2018, @06:34PM (#634486)

          It's a problem if it costs a lot of other people's money and time to save you. Or somehow you screwed up and made a worse contagious disease. By the way some "live" vaccines can in theory spread disease to immune compromised people.

          So I think it's ethical if:
          a) it works with no issues
          b) nothing really happens
          c) it kills you quickly
          And it can't really hurt other people.

          • (Score: 0) by Anonymous Coward on Wednesday February 07 2018, @07:21PM

            by Anonymous Coward on Wednesday February 07 2018, @07:21PM (#634503)

            a), b), c), and d) "it can't really hurt other people" can't be known before the experiment.

            In other words, you're saying the ends justify the means. Except we don't know where it ends.

        • (Score: 2) by Mykl on Thursday February 08 2018, @01:53AM

          by Mykl (1112) on Thursday February 08 2018, @01:53AM (#634622)

          I can think of several examples where experimenting on yourself can have disastrous consequences, ethically, for others:

          - Dr Jeckyll
          - Dr Octopus
          - Dr Polaris
          - The Fly

    • (Score: 5, Insightful) by tangomargarine on Wednesday February 07 2018, @03:53PM (1 child)

      by tangomargarine (667) on Wednesday February 07 2018, @03:53PM (#634416)

      I really don't follow how doing this nonsense in front of a live audience "holds them accountable." So you're supposed to keep informed about what happens after the show? They release all the data on their website or something?

      Not to mention, you have fuck-all assurance of what the guy actually injected himself with. For all you know it was saline solution and the company is making up all their followup data for shits and giggles.

      --
      "Is that really true?" "I just spent the last hour telling you to think for yourself! Didn't you hear anything I said?"
      • (Score: 0) by Anonymous Coward on Wednesday February 07 2018, @06:32PM

        by Anonymous Coward on Wednesday February 07 2018, @06:32PM (#634485)

        I really don't follow how doing this nonsense in front of a live audience "holds them accountable."

        We get to watch him die in agony? Will this be Pay-per-view, or basic cable?

  • (Score: 5, Funny) by GreatAuntAnesthesia on Wednesday February 07 2018, @11:16AM

    by GreatAuntAnesthesia (3275) on Wednesday February 07 2018, @11:16AM (#634366) Journal

    "We prefer to do everything before a live audience so you can hold us accountable in the days to come as we collect the data to prove whether or not this works," that if we inadvertently create an incurable airborne zombie apocolypse virus, we will be sure to infect as many people as possible at ground zero."

  • (Score: 5, Insightful) by ledow on Wednesday February 07 2018, @11:33AM (2 children)

    by ledow (5567) on Wednesday February 07 2018, @11:33AM (#634373) Homepage

    Self-experimentation has been done before. There are very famous examples of respected scientists doing exactly that (is it stomach ulcers that springs to mind? Someone gave themselves ulcers deliberately and then showed what caused them and thereby "cured" them?).

    Guess what? You still can't give it to patients other than yourself without going through all the hoops that you're trying to avoid. And all you've done is prove that it didn't kill YOU and worked in YOU. Which is bog-useless to anyone hoping for it as a treatment. It's no better than anecdotal "Oh, well, honey and lemon REALLY cleared up my cold" kind of 'evidence'.

    Rather than grandstand about something that experimenters have done before, and which is kind of useless in terms of medicine, get your stuff through the FDA approvals process which is how it is for a reason (the same as any other country's process): What doesn't kill you might well kill the next person taking it, even if you had no ill-effects. How many drug trials, even under the most controlled of circumstances, still come out as either "no medical benefit" or literally putting people into serious life-threatening conditions (people have had their kidneys destroyed by participating in late-stage drug trials, after the drugs passed all kinds of tests beforehand in other humans).

    This achieves nothing, but marketing. And I don't use medicine from people who are more interested in marketing than patient safety.

    • (Score: 2) by HiThere on Wednesday February 07 2018, @05:33PM

      by HiThere (866) Subscriber Badge on Wednesday February 07 2018, @05:33PM (#634446) Journal

      The one that occurred to me was Yellow Fever, but, yeah, there's a long history. Many people ended up dead, but it was in a good cause. And this particular guy sounds as if he's well informed of the risks.

      --
      Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
    • (Score: 3, Insightful) by edIII on Wednesday February 07 2018, @08:07PM

      by edIII (791) on Wednesday February 07 2018, @08:07PM (#634536)

      This is because we've long ago moved away from evidence and fact-based truth to the full post-truth world. In that world, evidence is what a PR campaign says it is. Evidence is what the loudness of your Twitter followers contains, and remember, in the event of a dispute, liberally spread fake-news rebuttals across the Internet. It's Wild West old-timey medicine shows with the truth distribution system known as the Internet </sarcasm>.

      To be fair, the FDA long ago lost any moral or scientific authority it had. So I can understand why these disruptive bio-hackers are giving the finger to the system. They know it's deeply flawed and corrupt, and unless you have billions and the right connections, you never get anywhere in that morass of an industry.

      You're exactly correct. It doesn't matter if they live, if they're cured, what they find, etc. Whatever findings they produce must be replicated and understood using proper and unbiased science to give us the legal indemnities they would need to operate. Not to mention, it would be nice to know if it didn't kill us.

      What I lament though is that truly proper and unbiased science doesn't exist. So I either get innovation in health care from the corrupt greedy fuckers that see deaths as percentages, or Wild West dreamers enjoying their bio-hacking civil disobedience. Either way, the medical system is poorer for it.

      --
      Technically, lunchtime is at any moment. It's just a wave function.
  • (Score: 2) by The Archon V2.0 on Wednesday February 07 2018, @07:24PM

    by The Archon V2.0 (3887) on Wednesday February 07 2018, @07:24PM (#634505)

    ... and I can give you a "live demonstration" of how drinking bleach cures children with autism.

    (I have been told that this idea is actually a thing some idiots tried. Assuming the reports are true it sounds more like someone trying to get away with child murder.)

  • (Score: 2) by MichaelDavidCrawford on Thursday February 08 2018, @01:43AM (1 child)

    by MichaelDavidCrawford (2339) Subscriber Badge <mdcrawford@gmail.com> on Thursday February 08 2018, @01:43AM (#634612) Homepage Journal

    The guy who first proposed that Yellow Fever was spread by mosquitos met with skepticism.

    So he trapped a mosquito between a water glass and his arm until it bit him.

    Hilarity ensued.

    --
    Yes I Have No Bananas. [gofundme.com]
    • (Score: 1, Informative) by Anonymous Coward on Thursday February 08 2018, @05:26AM

      by Anonymous Coward on Thursday February 08 2018, @05:26AM (#634695)
      That guy's name was Jesse William Lazear [wikipedia.org], a doctor from Johns Hopkins hospital who worked closely with Walter Reed in Cuba, studying yellow fever. He died of yellow fever in 1900, seventeen days after deliberately letting a mosquito bite him. They initially covered up the fact that he had done this intentionally, and it wasn't until 1947 that the truth came out from Lazear's own notebooks.
(1)