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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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    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.

  • 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.”

    Quick! Someone send tell the AI that this is what you need to sequence to make medicine! 😏

  • 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.”

    Putting periods in acronyms is some 90s shit.

  • Discouraging use of artificial dye is a good idea. It interferes with people's ability to make health conscious choices. Requiring labeling would be a great start.

    Thing is they're not banning all dyes, they want “natural” dyes used instead. But “natural” does not necessarily mean better or safer.

    Food dye is used to cover up a lot of food crime.

    source? i did a brief search but didn’t see anything about it.

    Most of us wouldn't eat food that needs to be dyed to look safe to eat, if it weren't dyed, if we had a choice.

    You can look at it from a different angle. If there’s nothing actually wrong with the food other than appearance, then food dye prevents food waste.

    also:

    There is a deeper political issue here as well that I will not get into, but just point out. The recent Supreme Court decision ending Chevron Deference may have played a role here. The question is – who interprets federal regulations? The Chevron Deference standard says that the experts working in the relevant agency would be given deference when interpreting the law. For example, the FDA could determine how to apply the Delaney Clause based upon an expert level understanding of the complexities of toxicity research. The SC ended such deference, meaning that regulations can be interpreted by the courts without deference to experts. One has to wonder if this otherwise odd decision by the FDA was a response to this.

    setting the precedent to remove expert opinion of federal law and replace it with court opinion is not good.

    Except they want “natural” dyes used instead which do the same thing. but “natural” does not necessarily mean better or safer.

    Yeah. I mean, yes - there's a brain worm damaged person heading the FDA.

    Food dye is used to cover up a lot of food crime.

    source? i did a brief search but didn’t see anything about.

    I was specifically alluding to The Jungle by Upton Sinclair. More generally, modern food production is often still disgusting.

    Most of us wouldn't eat food that needs to be dyed to look safe to eat, if it weren't dyed, if we had a choice.

    so you could argue food dye prevents food waste. if there’s nothing actually wrong with the food other than appearance.

    Fair point, which is why I favor labeling. Let people make their own call, with clear labels providing enough information.

    setting the precedent to remove expert opinion of federal law and replace it with court opinion is not good.

    No disagreement from me.

    My point is that we might not be as quick to hand over control to bull-in-china-shop brain-worm victims if we actually regulated things. We missed that window a long time ago, but it needs to be part of the conversation if there's to be a recovery.

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

    (Just teasing for funsies)

    Haha. Fine by me, if it's clearly labeled.

    Edit: I'm not eating any bugs, if I know they're present...unless they're truly delicious...

  • Are we great yet?

    Wherever we're going, we're making great time!

  • 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 my God. The reasons why I am happy not to be an American are stacking thicker every week.

  • People will die.

    They're counting on it

  • People will die.

    It's not a conservative's problem until it effects them personally. By then it's usually too late, but at least they feel bad about that one issue for a while.

  • 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.”

    This could be a good use of AI. Since this regime is doing it, and since some of their claims are pretty unrealistic, it probably won't be. But, ML has been used for a while to help identify new drug compounds, find interactions, etc. It could be very useful in the FDA's work - I'm honestly surprised to hear that they're only just now considering using it.

    The Four Thieves Vinegar Collective uses some software from MIT ASKCOS that uses neural networks to help identify reactions and retrosynthesis chains to produce chemical compounds using cheap, homemade bioreactors. Famously, they are doing this to make mifepristone available for people in areas of the US without access to abortion care.

    You can check it out here. It's a good example of a very positive use-case for an AI/ML tool in medicine.

  • 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.”

    I hope by AI they don't mean LLMs because that is not the correct architecture for this job but definitely what every crook would go for to get funds.

  • Oh my God. The reasons why I am happy not to be an American are stacking thicker every week.

    Only weekly?

  • ......wait, this is a bad idea?

    Depends, did you take the drugs 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.”

    Can AI reliably tell if a cat is longer than a banana yet?

  • Depends, did you take the drugs yet?

    No. I was hoping they'd be blueberry flavored!

  • This could be a good use of AI. Since this regime is doing it, and since some of their claims are pretty unrealistic, it probably won't be. But, ML has been used for a while to help identify new drug compounds, find interactions, etc. It could be very useful in the FDA's work - I'm honestly surprised to hear that they're only just now considering using it.

    The Four Thieves Vinegar Collective uses some software from MIT ASKCOS that uses neural networks to help identify reactions and retrosynthesis chains to produce chemical compounds using cheap, homemade bioreactors. Famously, they are doing this to make mifepristone available for people in areas of the US without access to abortion care.

    You can check it out here. It's a good example of a very positive use-case for an AI/ML tool in medicine.

    Properly implemented machine learning, sure.

    These dimwits are genuinely just gonna feed everything to a second rate LLM and treat the output as the word of God.

  • 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.”

    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.

  • 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.”

    The guy on the photo has the bottom half of a huge head and the eyes up of a small head. Totally weird.

  • No. I was hoping they'd be blueberry flavored!

    That's on the way out

  • Can AI reliably tell if a cat is longer than a banana yet?

    An african cat or a european cat?

  • 34 Stimmen
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    P
    ::: spoiler Summary Part 3 21. In some cases, third-party YouTube creators upload “re-distributed” content, such as ESPN, CBS Sports, or Fox Sports college football game live streams or episodes of TV shows such as Family Guy. After ~12 hours, the creators edit the videos to cut out the “re-distributed” content and they edit the title, description, and meta-data of the videos to something unrelated. This appears to prevent brand advertisers from knowing against what sorts of content their ads were served on in their original form, and suggests that YouTube ad delivery placement reports may not accurately convey what sorts of content the ads were served against before the videos were retro-actively edited and re-named. 22. Disney, Lionsgate, Paramount, Universal/Focus Features, Bleecker Street, and streaming services like Disney+, Peacock, Sling TV, YouTube TV, and Hulu/FX, in their capacity as advertisers, have run ads against uploaded copies of their own intellectual property on third-party channels, thus potentially funding it. 23. The presidential election campaigns of Kamala Harris and Donald Trump, as well as major brands such Procter & Gamble, had ads served on videos that appear to belong to various professional film studios, such as “Deadpool & Wolverine”, whilst the film was being shown in movie cinemas in the summer of 2024. 24. The list of brands whose ads were served on third-party, “re-distributed” content YouTube channels which were later deleted by YouTube (and thus, likely retroactively redacted from their ad delivery placement reports), includes: a. the New York Times, the presidential election campaigns of Donald Trump and Kamala Harris, the House Majority PAC (a Democrat Super PAC), Procter & Gamble (P&G),Unilever, BMO Bank, Ben & Jerry’s, McDonald’s, US Bank, Crossmedia, Samsung, Disney+, FX networks, WarnerMedia (HBO Max), Mint Mobile, Focus Features (owned by NBCUniversal), Kellanova (Special K, Frosted Flakes), State Farm, Verizon, Visible (by Verizon), T-Mobile, Disney, Hulu, Mazda, the Wall Street Journal, Nissan, North Face, Paramount+, Health for California Insurance Center, A&E Television Networks (Lifetime), NBCUniversal Media (Peacock), Volvo cars, Lionsgate, Macy’s, Adobe, SlingTV, Hyundai, Genesis, AAA (American Automobile Association), Amazon, AMC Plus, Mindshare USA (part of GroupM/WPP), Peloton, Linkedin, TD Bank, Grammarly, General Mills, Ubisoft, Zaxby's, Dentsu X, Dentsu Carat, OMD (part of Omnicom), Publicis Media, Alfa Romeo (part of Stellantis), Starcom Worldwide, Horizon Media, Canvas Worldwide, Safelite, Ricolino (owned by Mondelez), Save The Children, Dick’s Sporting Goods, Hasbro, Kinder (Ferrero), TruGreen, California Teachers Association, Frontier Internet, Ticketmaster, Meta (Facebook), Ray Ban, JetBlue, Quest Nutrition, Shopify, General Motors, Ruiz Foods, JPMorgan Chase, Currax Pharmaceuticals, TikTok, B&H PHoto & Video, Invesco, VaynerMedia, Kingsford, St. George’s University, Empower insurance, Ezcater, Philo, GolfNow, World Vision Fund, Discover Puerto Rico, Dana-Farber Cancer Institute (Jimmy Fund), Novo Nordisk, Ooni, Aquasana, Panasonic, Atlassian, Caterpillar, Fandango, Harbor Freight Tools, Castlery Furniture, Blue Diamond Hotels, and others. b. Zefr, which is a Partner of the YouTube Measurement Program, appears to have been observed transacting ads for Dexcom on a “re-distributed” video of Netflix’s “Squid Game 3” which was later removed. Channel Factory, which declares itself to be a Google Premier Partner, part of the YouTube Measurement Program, and is TAG “Certified for Brand Safety”, was observed transacting ads on behalf of brands such as: General Mills on “re-distributed” YouTube videos of the movie “John Wick: Chapter 4” on a channel which was removed from YouTube, Sephora and Quest Nutrition on “re-distributed” YouTube videos of the movie “Spider Man: Homecoming” on a channel which was removed from YouTube, Tena (part of Essity) on “re-distributed” YouTube videos of the movie: “Deadpool & Wolverine” on a channel which was removed from YouTube “because it violated [YouTube’s] Community Guidelines” (archived here: https://www.loom.com/share/9fff55d650eb4fd68ae938fc19aa0299) :::
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    ulrich@feddit.orgU
    which one would sell more I mean they would charge a lot of money for the stripped down one because it doesn't allow them to monetize it on the back end, and the vast majority would continue using the resource-slurping ad-riddled one.
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    What new AI slop hell is this?
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    Niemand hat geantwortet
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    In fact Daggerfall was almost nothing but quests and other content like that.
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    Copyright law is messy. Thank you for the elaboration.
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    Isn't that arguably the nature of encryption, though? If you lose the key, you're SOL by design.
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    I really can't stand this guy. What a slag.