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posted by CoolHand on Monday November 09 2015, @11:08PM   Printer-friendly
from the self-study dept.

Last year, Kennedy, a 67-year-old neurologist and inventor, did something unprecedented in the annals of self-experimentation. He paid a surgeon in Central America $25,000 to implant electrodes into his brain in order to establish a connection between his motor cortex and a computer.

Along with a small group of pioneers, Kennedy, who was born in Ireland, had in the late 1980s developed "invasive" human brain-computer interfaces—literally wires inside the brain attached to a computer, and he is widely credited as the first to allow a severely paralyzed "locked-in" patient to move a computer cursor using her brain. "The father of cyborgs," one magazine called him.

Kennedy's scientific aim has been to build a speech decoder—software that can translate the neuronal signals produced by imagined speech into words coming out of a speech synthesizer. But this work, carried out by his small Georgia company Neural Signals, had stalled, Kennedy says. He could no longer find research subjects, had little funding, and had lost the support of the U.S. Food and Drug Administration.


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  • (Score: 4, Insightful) by Gravis on Tuesday November 10 2015, @12:16AM

    by Gravis (4596) on Tuesday November 10 2015, @12:16AM (#260989)

    Kennedy says the agency began asking him for more safety data, including on the neurotrophic factors he was using to induce neuronal growth. When Kennedy couldn’t provide the data, the FDA refused to approve any more implants.

    so the bottom line is that he needs to collect "safety data" whatever that means. the question is how can he obtain this information and why hasn't he done so?

    while the FDA may seem like the bad guy here, their stringent requirements prevent people from being used like disposable lab rats. these rules exist to protect us from monstrous people and corporations.

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  • (Score: 0) by Anonymous Coward on Tuesday November 10 2015, @12:42AM

    by Anonymous Coward on Tuesday November 10 2015, @12:42AM (#261001)

    protect us from monstrous people

    Yeah, horrible people like the guy who wants to help paralyzed people be able to talk again. Thanks, Daddy Gov't, for keeping us safe!

    • (Score: 4, Insightful) by anubi on Tuesday November 10 2015, @03:37AM

      by anubi (2828) on Tuesday November 10 2015, @03:37AM (#261053) Journal

      I think the OP was referring to those corporate leeches who use financial coercion to force the sale of whatever it is they want... in this case - they may want a YOU as a lab rat.

      Financial and debt pressure being what it is, if it were made legal, there are those who would not think twice about conscripting you for "payment of debt".

      Can you see the financial pressure to sell a kidney should that be made legal?

      It would make yet another "rush to the bottom" as the elite classes who are chartered by our government to print money choose from those without that charter - just as it is for a person's time. Some of us must earn our money, while others pay for what they want by "extending the debt ceiling" - with all the work of a pen and a handshake.

      --
      "Prove all things; hold fast that which is good." [KJV: I Thessalonians 5:21]
  • (Score: 2) by RamiK on Tuesday November 10 2015, @02:34AM

    by RamiK (1813) on Tuesday November 10 2015, @02:34AM (#261037)

    "these rules exist to protect us from monstrous people and corporations."
    Nonsense. Those rules are bought and paid for by those same "monstrous people and corporations". Here, specifically, if you'd just read the rest of the full article you'd be able to see that such regulation can only hope at exporting the research abroad. Which is, of course, it's true intention: to keep original research and innovation outside the US market place.

      - Warning: Somewhat off-topic, though not the conventional Milton Friedman rant -

    When a market is diverse with many medium players, regulation can be effective. However, when you have only 5-15 players and they're all so rich they can - and do - individually push candidates through elections, you can never hope regulation will be effective at doing good.

    At that point you might as well start considering either aggressive deregulation or nationalization depending on the market; Where by, food, drugs, weapons and critical infrastructure should usually get nationalized while commerce, public consumerism, entertainment and luxuries should usually get deregulated or dealt with using anti-monopoly and anti-cartel laws.

    Unfortunately, in the US, the same people who own drugs and weapons also have stocks in public consumerism and entertainment resulting in a government that can't really do anything except rapidly deteriorate into a police state as it's rich desperately cling to their ill-serving power by buying off all the politicians...

    --
    compiling...
    • (Score: 2) by Zz9zZ on Tuesday November 10 2015, @05:20AM

      by Zz9zZ (1348) on Tuesday November 10 2015, @05:20AM (#261094)

      I'm not sure how to mod you. It'd be great if we had "insightful troll".

      Obviously many rules are in place to protect the people. I'm not sure I can fathom how you can throw out the effort of generations for the sake of an online discussion...

      Those rules are under constant attack by the aforementioned corporations et. al. Doesn't mean all protections have gone away, and there are limits to what money can buy. We shall see how the politicians hold out in the future, or if every shred of morality can be stripped away to leave naked little goblins shrieking at each other and combing their greasy hair in front of cameras in the hopes that people will see them as less evil than their competition.

      --
      ~Tilting at windmills~
      • (Score: 2) by RamiK on Tuesday November 10 2015, @02:41PM

        by RamiK (1813) on Tuesday November 10 2015, @02:41PM (#261259)

        I started off by saying "When a market is diverse with many medium players, regulation can be effective" since I believe that. But, "there are limits to what money can buy" is just factually false. Even when it comes to criminal laws, when there's enough money involved, elected officials, cops and judges will be bribed for decades on end unless deregulation (decriminalization) puts a stop to the incentives as in the case of drugs and alcohol.

        We're living at an age where large corporation avoid paying taxes while being awarded governmental and municipal contracts. You can't fight them in courts since the law is owned by the highest bidder and they likely signed individuals on EULAs forbidding class actions when there's old laws that actually afford protections. You can't even vote for a candidate that prioritized the issue since they'll just either bribe him, his opponents, or everyone else in the comities through campaign contributions.

        But, this is all a case by case matter. In most matters criminal laws and governmental and municipal regulations are effective. The issue is that the exceptions are starting to outweigh the majority in impact as technology evolves. The most extreme case has been nuclear power. Where, regardless of how you structure the market, from privately own for-profits to government owned non-profits, there are regulation violations that threaten large chunks of the country. In those cases, it's actually right to consider closing down all reactors and putting some money into research in hopes a safer alternative can be developed.

        In the case of the FDA, many of the regulations that deal with the transport and selling of toxic materials are quite effective at keeping those materials from entering the consumer market. However, all their dealings with pharmaceuticals have been nothing but a hindrance to drug development. Companies are conducting the same experiments at 10-15 labs worldwide, sign the researchers NDAs, and then selectively release the papers showing drugs that have no positive impact to be effective as supporting collaborating evidence.
        The problem can be approached in two ways, nationalization or deregulation:

        Nationalization: The proposed solution is that the FDA will be the one to conduct trials. Companies interested in entering the market, will need to pay for the required trials to the FDA. With enough blinds it's possible to remove 80% of the required trials and phases since you're now working with researchers that are equally rewarded for presenting a failed experiment as well as a successful one. There are no NDAs or selective publishing.

        Deregulation: The alternative solution is to eliminate all but the basic requirements for entering drugs to the market: Pharmaceuticals will have to provide the full papers and research materials and will be forbidden from signing NDAs but won't be required to follow any specific procedures or trial phases. Insurance companies and medical practitioners will be forbidden under due-diligence from treating using drugs and procedures that didn't stand up to this standards. Finally, patients will be monitored more regularly and metrics will be collected anonymously in open databases. The end-result will be similar to FOSS beta testing: Like programmers, individual researchers will be pressured to produce good results under public scrutiny. Again, there are no NDAs or selective publishing.

        Of the two approaches, I suspect deregulation is the least susceptible to tampering while promoting more research and development. Simply because, it's conducted in the open and under public scrutiny and not in some government owned and operated lab.

        However, there are merits to both approaches and there's room to compromise: Late human trials could be repeated as a for-cost paid-service by FDA operated labs as recommended quality assurance. Pharmas need to excuse not using such services even if they're not required. And only the most established companies and researches will be awarded the trust to skip such measures by the market.

        --
        compiling...
  • (Score: 2) by darkfeline on Tuesday November 10 2015, @12:27PM

    by darkfeline (1030) on Tuesday November 10 2015, @12:27PM (#261205) Homepage

    I think it's a chicken and egg problem. In order to understand more about the brain, we need to do experiments. In order to do experiments (safely, humanely), we need to understand more about the brain. Someone has to take the first bold step into the darkness.

    Much like the Nazis and their inhumane human experiments. Yes, Nazis, blah blah, but the data that they have obtained on, e.g., humans freezing to death continues to be invaluable to this day saving human lives. Ironic, and I'm not advocating doing groundbreaking, inhumane experiments, but that's reality.

    You *might* be able to advance science slowly and humanely, but I wouldn't count on it; sometimes, a key paradigm shift breakthrough is needed.

    --
    Join the SDF Public Access UNIX System today!
    • (Score: 2) by Gravis on Tuesday November 10 2015, @02:03PM

      by Gravis (4596) on Tuesday November 10 2015, @02:03PM (#261238)

      I think it's a chicken and egg problem. In order to understand more about the brain, we need to do experiments. In order to do experiments (safely, humanely), we need to understand more about the brain.

      this is why we have lab animals. not to spoil the surprise but we are closely related to a lot of different animals.