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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: 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.

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