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With a Trump-driven reduction of nearly 2,000 employees, F.D.A. will Use A.I. in Drug Approvals to ‘Radically Increase Efficiency’

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  • People will die because of this.

    Yeah I'm going to make sure I don't take any new drugs for a few years. As it is I'm probably going to have to forgo vaccinations for a while because dipshit Kennedy has fucked with the vaccination board.

  • I'll try arguing in the opposite direction for the sake of it:

    An "AI", if not specifically tweaked, is just a bullshit machine approximating reality same way human-produced bullshit does.

    A human is a bullshit machine with an agenda.

    Depending on the cost of decisions made, an "AI", if it's trained on properly vetted data and not tweaked for an agenda, may be better than a human.

    If that cost is high enough, and so is the conflict of interest, a dice set might be better than a human.

    There are positions where any decision except a few is acceptable, yet malicious humans regularly pick one of those few.

    Your argument becomes idiotic once you understand the actual technology. The AI bullshit machine's agenda is "give nice answer" ("factual" is not an idea that has neural center in the AI brain), and "make reader happy". The human "bullshit" machine, has many agendas, but it would have not got so far if it was spouting just happy bullshit (but I guess America is a becoming a very special case).

  • People will die because of this.

    pretty sure that's the basis of it's appeal for them

  • Yeah I'm going to make sure I don't take any new drugs for a few years. As it is I'm probably going to have to forgo vaccinations for a while because dipshit Kennedy has fucked with the vaccination board.

    Just check if the drug is approved in a proper country of your choice.

  • Yeah I'm going to make sure I don't take any new drugs for a few years. As it is I'm probably going to have to forgo vaccinations for a while because dipshit Kennedy has fucked with the vaccination board.

    If you can afford it, there is always the vaccines from other countries. It's fucked up that it's come to this and there's even more of a price tag on health.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Oh good, a 60% chance you’ll get an ineffective or killer drug because they’ll use AI to analyze the usage and AI to report on it.

  • I have to quibble with you, because you used the term "AI" instead of actually specifying what technology would make sense.

    As we have seen in the last 2 years, people who speak in general terms on this topic are almost always selling us snake oil. If they had a specific model or computer program that they thought was going to be useful because it fit a specific need in a certain way, they would have said that, but they didn't.

    ik what you mean, there's a difference between LLMs and other systems but its just generally easier to put it all under the umbrella of 'AI'

  • Or maybe that is part of the allure of automation: the eschewing of human responsibility, such that any bias in decision making appears benign (the computer deemed it so, no one’s at fault) and any errors - if at all recognized as such - become simply a matter of bug-fixing or model fine-tuning. The more inscrutable the model the better in that sense. The computer becomes an oracle and no one’s to blame for its divinations.

  • Or maybe that is part of the allure of automation: the eschewing of human responsibility, such that any bias in decision making appears benign (the computer deemed it so, no one’s at fault) and any errors - if at all recognized as such - become simply a matter of bug-fixing or model fine-tuning. The more inscrutable the model the better in that sense. The computer becomes an oracle and no one’s to blame for its divinations.

    I am convinced that law enforcement wants intentionally biased AI decision makers so that they can justify doing what they’ve always done with the cover of “it’s not racist because a computer said so!”

    The scary part is most people are ignorant enough to buy it.

  • Your argument becomes idiotic once you understand the actual technology. The AI bullshit machine's agenda is "give nice answer" ("factual" is not an idea that has neural center in the AI brain), and "make reader happy". The human "bullshit" machine, has many agendas, but it would have not got so far if it was spouting just happy bullshit (but I guess America is a becoming a very special case).

    It doesn't. I understand the actual technology. There are applications of human decision making where it's possibly better.

  • Text to avoid paywall

    The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA.

    Another initiative involves a review of chemicals and other “concerning ingredients” that appear in U.S. food but not in the food of other developed nations. And officials want to speed up the final stages of making a drug or medical device approval decision to mere weeks, citing the success of Operation Warp Speed during the Covid pandemic when workers raced to curb a spiraling death count.

    “The F.D.A. will be focused on delivering faster cures and meaningful treatments for patients, especially those with neglected and rare diseases, healthier food for children and common-sense approaches to rebuild the public trust,” Dr. Marty Makary, the agency commissioner, and Dr. Vinay Prasad, who leads the division that oversees vaccines and gene therapy, wrote in the JAMA article.

    The agency plays a central role in pursuing the agenda of the U.S. health secretary, Robert F. Kennedy Jr., and it has already begun to press food makers to eliminate artificial food dyes. The new road map also underscores the Trump administration’s efforts to smooth the way for major industries with an array of efforts aimed at getting products to pharmacies and store shelves quickly.

    Some aspects of the proposals outlined in JAMA were met with skepticism, particularly the idea that artificial intelligence is up to the task of shearing months or years from the painstaking work of examining applications that companies submit when seeking approval for a drug or high-risk medical device.

    “I don’t want to be dismissive of speeding reviews at the F.D.A.,” said Stephen Holland, a lawyer who formerly advised the House Committee on Energy and Commerce on health care. “I think that there is great potential here, but I’m not seeing the beef yet.”

    Final stage capitalism: Purging all the experts (at catching bullshit from appllicants) before the agencies train the AI with newb level inputs.

  • It doesn't. I understand the actual technology. There are applications of human decision making where it's possibly better.

    LLM does no decision making. At all. It spouts (as you say) bullshit. If there is enough training data for "Trump is divine", the LLM will predict that Trump is divine, with no second thought (no first thought either). And it's not even great to use as a language-based database.

    Please don't even consider LLMs as "AI".

  • Or maybe that is part of the allure of automation: the eschewing of human responsibility, such that any bias in decision making appears benign (the computer deemed it so, no one’s at fault) and any errors - if at all recognized as such - become simply a matter of bug-fixing or model fine-tuning. The more inscrutable the model the better in that sense. The computer becomes an oracle and no one’s to blame for its divinations.

    I saw a paper a while back that argued that AI is being used as "moral crumple zones". For example, an AI used for health insurance acts allows for the company to reject medically necessary procedures without employees incurring as much moral injury as part of that (even low level customer service reps are likely to find comfort in being able to defer to the system.). It's an interesting concept that I've thought about a lot since I found it.

  • LLM does no decision making. At all. It spouts (as you say) bullshit. If there is enough training data for "Trump is divine", the LLM will predict that Trump is divine, with no second thought (no first thought either). And it's not even great to use as a language-based database.

    Please don't even consider LLMs as "AI".

    Even an RNG does decision-making.

    I know what LLMs are, thank you very much!

    If you wanted to even understand my initial point, you already would have.

    Things have become really grim if people who can't read a small message are trying to teach me on fundamentals of LLMs.

  • Oh good, a 60% chance you’ll get an ineffective or killer drug because they’ll use AI to analyze the usage and AI to report on it.

    If it actually ends up being an AI and not just some Trump cuck stooge masquerading as AI picking the drug by the company that gave the largest bribe to Trump, I 100% guarantee this AI is trained only on papers written by non-peer reviewed drug company paid "scientists" containing made up narratives.

    Those of us prescribed the drugs will be the guinea pigs because R&D costs money and hits the bottom line. The many deaths will be conveniently scape-goated on "the AI" the morons in charge promised is smarter and more efficient than a person.

    Fuck this shit.

  • Even an RNG does decision-making.

    I know what LLMs are, thank you very much!

    If you wanted to even understand my initial point, you already would have.

    Things have become really grim if people who can't read a small message are trying to teach me on fundamentals of LLMs.

    I wouldn't define flipping coins as decision making. Especially when it comes to blanket governmental policy that has the potential to kill (or severely disable) millions of people.

    You seem to not want any people to teach you anything. And are somehow completely dejected at such perceived actions.

  • Different types of AI, different training data, different expectations and outcomes. Generative AI is but one use case.

    It's already been proven a useful tool in research, when directed and used correctly by an expert. It's a tool, to give to scientists to assist them, not replace them.

    If you're goal to use AI to replace people, you've got a bad surprise coming.

    If you're not equipping your people with the skills and tools of AI, your people will become obsolete in short time.

    Learn AI and how to utilize it as a tool, you can train your own model on your own private data and locally interrogate the model to do unique analysis typically not possible in realtime. Learn the goods and bads of technology and let your ethics guide how you use it, but stop dismissing revolutionary technology because the earlier generative models weren't reinforced enough get fingers right.

    I'm not dismissing its use. It is a useful tool, but it cannot replace experts at this point, or maybe ever (and I'm gathering you agree on this).

    If it ever does get to that point, we need to also remedy the massive social consequences of revoking those same experts' ability to have sufficient income to have a reasonable living.

    I was being a little silly for effect.

  • I saw a paper a while back that argued that AI is being used as "moral crumple zones". For example, an AI used for health insurance acts allows for the company to reject medically necessary procedures without employees incurring as much moral injury as part of that (even low level customer service reps are likely to find comfort in being able to defer to the system.). It's an interesting concept that I've thought about a lot since I found it.

    I can absolutely see that. And I don’t think it’s AI-specific, it’s got to do with relegating responsibility to a machine. Of course AI in the guise of LLMs can make things worse with its low interpretability, where it might be even harder to trace anything back to an executive or clerical decision.

  • I wouldn't define flipping coins as decision making. Especially when it comes to blanket governmental policy that has the potential to kill (or severely disable) millions of people.

    You seem to not want any people to teach you anything. And are somehow completely dejected at such perceived actions.

    You seem to not want any people to teach you anything.

    No, I don't seem that. I don't like being ascribed opinions I haven't expressed.

    I wouldn’t define flipping coins as decision making. Especially when it comes to blanket governmental policy that has the potential to kill (or severely disable) millions of people.

    When your goal is to avoid a certain most harmful subset of such decisions, and living humans always being pressured by power and corrupt profit to pick that subset, flipping coins is preferable, if that's the two variants between which we are choosing.

  • Oh good, a 60% chance you’ll get an ineffective or killer drug because they’ll use AI to analyze the usage and AI to report on it.

    That is an underestimate, since it doesn't factor in the knockdown effect of the more lax regulations having, so people will try to sell all kinds of crap as "medicine".

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    Why lie? There's absolutely no reason to lie here. Nevermind. Vibe coded cyberjunk.
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    Because the trillions is the point.. Not security.
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    You don’t understand. The tracking and spying is the entire point of the maneuver. The ‘children are accessing porn’ thing is just a Trojan horse to justify the spying. I understand what are you saying, I simply don't consider to check if a law is applied as a Trojan horse in itself. I would agree if the EU had said to these sites "give us all the the access log, a list of your subscriber, every data you gather and a list of every IP it ever connected to your site", and even this way does not imply that with only the IP you could know who the user is without even asking the telecom company for help. So, is it a Trojan horse ? Maybe, it heavily depend on how the EU want to do it. If they just ask "show me how you try to avoid that a minor access your material", which normally is the fist step, I don't see how it could be a Trojan horse. It could become, I agree on that. As you pointed out, it’s already illegal for them to access it, and parents are legally required to prevent their children from accessing it. No, parents are not legally required to prevent it. The seller (or provider) is legally required. It is a subtle but important difference. But you don’t lock down the entire population, or institute pre-crime surveillance policies, just because some parents are not going to follow the law. True. You simply impose laws that make mandatories for the provider to check if he can sell/serve something to someone. I mean asking that the cashier of mall check if I am an adult when I buy a bottle of wine is no different than asking to Pornhub to check if the viewer is an adult. I agree that in one case is really simple and in the other is really hard (and it is becoming harder by the day). You then charge the guilty parents after the offense. Ok, it would work, but then how do you caught the offendind parents if not checking what everyone do ? Is it not simpler to try to prevent it instead ?
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    "Extra Verification steps" I know how large social media companies operate. This is all about increasing the value of Reddit users to advertisers. The goal is to have a more accurate user database to sell them. Zuckerberg literally brags to corporations about how good their data is on users: https://www.facebook.com/business/ads/performance-marketing Here, Zuckerberg tells corporations that Instagram can easily manipulate users into purchasing shit: https://www.facebook.com/business/instagram/instagram-reels Always be wary of anything available for free. There are some quality exceptions (CBC, VLC, The Guardian, Linux, PBS, Wikipedia, Lemmy, ProPublica) but, by and large, "free" means they don't care about you. You are just a commodity that they sell. Facebook, Google, X, Reddit, Instagram... Their goal is keep people hooked to their smartphone by giving them regular small dopamine hits (likes, upvotes) followed by a small breaks with outrageous content/emotional content. Keep them hooked, gather their data, and sell them ads. The people who know that best are former top executives : https://www.theguardian.com/technology/2017/oct/05/smartphone-addiction-silicon-valley-dystopia https://www.nytimes.com/2019/03/01/business/addictive-technology.html https://www.today.com/parents/teens/facebook-whistleblower-frances-haugen-rcna15256