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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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  • Don't lose too much sleep over it.

    This is likely going to be "Oops, all placebos!" in our future.

    Taking a drug that doesn't work is not necessarily the same as taking a placebo. I have suffered a lot from drug side effects, and some have hurt me long-term, years after I stopped taking the medicine. I am incredibly wary of taking anything new, even before all the horrors of 2025. With even worse approval processes, I expect that a lot of harmful and potentially debilitating or deadly stuff is going to end up on pharmacy shelves soon.

  • Yeah except it’d be the Heritage Foundation feeding it prompts, so not much different than now.

    Monkey paw finger curls inward

  • So we're going to depend on AI, which can't reliably remember how many fingers humans have, to take over medical science roles. Neat!

    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.

  • 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.”

    Things LLM can't do well without extensive checking on large corpus of data:

    • summarizing
    • providing informed opinions

    What is it they want to make "more efficient" again? Digesting thousands of documents, filter extremely specific subset of data, and shorten the output?

    Oh.

  • 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.

    when directed and used correctly by an expert

    They're also likely to fire the experts.

  • 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.”

    IF bribe_received: return ("Approved")

  • ai has a place in drug development, but this is not how it should be used at all

    there should always be a reliable human system to double check the results of the model

    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.

  • 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.”

  • 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.”

    People will die because of this.

  • Efficiency =/= Accuracy or safety

    I can efficiently put a screw in drywall with an electric drill, but it doesn’t mean it will hold it up or attach it to anything.

    Furthermore, something can be efficient in different ways depending on the criteria. Something can even be efficient in one context and inefficient in a different one. Efficiency as they use it is too vague.

  • I also prefer 100% natural ground insects in my food over artificial dyes.

    (Just teasing for funsies)

    Ricin is natural and one of the most potent plant-produced poisons.

  • 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.”

    My experiences with most AI is that you really, really need to double check EVERYTHING they do.

  • People will die because of this.

    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.

  • when directed and used correctly by an expert

    They're also likely to fire the experts.

    They already have.

  • 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.

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    (Premise - suppose I accept that there is such a definable thing as capitalism) I'm not sure why you feel the need to state this in a discussion that already assumes it as a necessary precondition of, but, uh, you do you. People blaming capitalism for everything then build a country that imports grain, while before them and after them it’s among the largest exporters on the planet (if we combine Russia and Ukraine for the “after” metric, no pun intended). ...what? What does this have to do with literally anything, much less my comment about innovation/competition? Even setting aside the wild-assed assumptions you're making about me criticizing capitalism means I 'blame [it] for everything', this tirade you've launched into, presumably about Ukraine and the USSR, has no bearing on anything even tangentially related to this conversation. People praising capitalism create conditions in which there’s no reason to praise it. Like, it’s competitive - they kill competitiveness with patents, IP, very complex legal systems. It’s self-regulating and self-optimizing - they make regulations and do bailouts preventing sick companies from dying, make laws after their interests, then reactively make regulations to make conditions with them existing bearable, which have a side effect of killing smaller companies. Please allow me to reiterate: ...what? Capitalists didn't build literally any of those things, governments did, and capitalists have been trying to escape, subvert, or dismantle those systems at every turn, so this... vain, confusing attempt to pin a medal on capitalism's chest for restraining itself is not only wrong, it fails to understand basic facts about history. It's the opposite of self-regulating because it actively seeks to dismantle regulations (environmental, labor, wage, etc), and the only thing it optimizes for is the wealth of oligarchs, and maybe if they're lucky, there will be a few crumbs left over for their simps. That’s the problem, both “socialist” and “capitalist” ideal systems ignore ape power dynamics. I'm going to go ahead an assume that 'the problem' has more to do with assuming that complex interacting systems can be simplified to 'ape (or any other animal's) power dynamics' than with failing to let the richest people just do whatever they want. Such systems should be designed on top of the fact that jungle law is always allowed So we should just be cool with everybody being poor so Jeff Bezos or whoever can upgrade his megayacht to a gigayacht or whatever? Let me say this in the politest way I know how: LOL no. Also, do you remember when I said this? ‘Won’t someone please think of the billionaires’ is wearing kinda thin You know, right before you went on this very long-winded, surreal, barely-coherent ramble? Did you imagine I would be convinced by literally any of it when all it amounts to is one giant, extraneous, tedious equivalent of 'Won't someone please think of the billionaires?' Simp harder and I bet maybe you can get a crumb or two yourself.