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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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.
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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.”
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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.
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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.
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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.
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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.
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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.
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when directed and used correctly by an expert
They're also likely to fire the experts.
They already have.
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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.
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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).
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People will die because of this.
pretty sure that's the basis of it's appeal for them
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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.
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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.
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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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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'
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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.
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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.
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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.
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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.
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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".
