US Regulators Rejected Neuralink's Bid To Test Brain Chips In Humans, Citing Safety Risks (reuters.com) 68
According to Reuters, Elon Musk's medical device company, Neuralink, was denied permission last year to begin human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness. The U.S. Food and Drug Administration (FDA) outlined dozens of issues the company must address before human testing can begin, according to seven current and former employees. From the report: The agency's major safety concerns involved the device's lithium battery; the potential for the implant's tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said. A year after the rejection, Neuralink is still working through the agency's concerns. Three staffers said they were skeptical the company could quickly resolve the issues -- despite Musk's latest prediction at a Nov. 30 presentation that the company would secure FDA human-trial approval this spring.
Neuralink has not disclosed details of its trial application, the FDA's rejection or the extent of the agency's concerns. As a private company, it is not required to disclose such regulatory interactions to investors. During the hours-long November presentation, Musk said the company had submitted "most of our paperwork" to the agency, without specifying any formal application, and Neuralink officials acknowledged the FDA had asked safety questions in what they characterized as an ongoing conversation. Such FDA rejections do not mean a company will ultimately fail to gain the agency's human-testing approval. But the agency's pushback signals substantial concerns, according to more than a dozen experts in FDA device-approval processes.
The rejection also raises the stakes and the difficulty of the company's subsequent requests for trial approval, the experts said. The FDA says it has approved about two-thirds of all human-trial applications for devices on the first attempt over the past three years. That total rose to 85% of all requests after a second review. But firms often give up after three attempts to resolve FDA concerns rather than invest more time and money in expensive research, several of the experts said. Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device.
Neuralink has not disclosed details of its trial application, the FDA's rejection or the extent of the agency's concerns. As a private company, it is not required to disclose such regulatory interactions to investors. During the hours-long November presentation, Musk said the company had submitted "most of our paperwork" to the agency, without specifying any formal application, and Neuralink officials acknowledged the FDA had asked safety questions in what they characterized as an ongoing conversation. Such FDA rejections do not mean a company will ultimately fail to gain the agency's human-testing approval. But the agency's pushback signals substantial concerns, according to more than a dozen experts in FDA device-approval processes.
The rejection also raises the stakes and the difficulty of the company's subsequent requests for trial approval, the experts said. The FDA says it has approved about two-thirds of all human-trial applications for devices on the first attempt over the past three years. That total rose to 85% of all requests after a second review. But firms often give up after three attempts to resolve FDA concerns rather than invest more time and money in expensive research, several of the experts said. Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device.
The news isn't that it was rejected (Score:5, Informative)
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You must be the the most epic no life having sack of shit on the planet. Truly impressive how each day, each HOUR, you are here, losering up the place like someone will actual care and acknowledge your pathetic existence.
You make MTG sound like Stephen Hawking. Kys.
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Re:The news isn't that it was rejected (Score:4)
Uh, "a few human error mistakes such as using the wrong glue" is super sloppy in the medical device world. (Where'd you get that info? Did I miss it in the article?)
Generally, that level of sloppy can be solved with funding, so...
Those thousands of people suffering worse can... use another company's product? I don't know. I'm new to this. Maybe one of those that have FDA clearance already?
Synchron
Medtronic
NeuroPace
You ever have an implant turn into a mass of shouldn't-be-there biologic material and have it removed to prevent, say, sepsis? Not pretty.
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None of the devices caused deaths when they were properly installed. They did make a few human error mistakes ....
They caused deaths when they were not properly installed. I'm sure that's all been sorted out now, so where can I join the queue? I need the implants that will make me love Musk.
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Say *what*? A "fetus" doesn't have any desires. They're part of the mother, and the mother has desires... and rights.
And now they're looking to ban birth control. Now, who has rights?
Meanwhile, are you volunteering to get the implants?
This is dumb. (Score:1)
Oh, so 2/3 of the applications are approved on the first try? Are these for brain implants? Do they involve novel surgical techniques? Probably not.
Most firms give up after 3 tries? Are they firms with a single product and a specific goal of bringing that product to market. Do they have essentially unlimited funding from the wealthiest person in the world? No? So that's not really relevant either, is it? This is just more FUD from the usual suspects.
Re:This is dumb. (Score:4, Insightful)
Despite what Musk's reality distortion field would have you believe, Neuralink's isn't the first BCI system. FDA actually has guidelines for this type of project, Musk/Neuralink felt that they were "special" and the guidance just doesn't apply to them, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations [fda.gov]
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I designed some of the highest frequency neural stimulators in the 1990's. To get good connections, you have to transect nerves and let them regrow through the electrode array, which was how David Edell did some tests with lab animals. Still works aobut as reliably as cold fusion, lots of theories, no usable results.
Resistance is futile (Score:2)
I understand that there are some legitimate medical conditions for which a chip implanted in the brain might have some therapeutic benefits (epilepsy and similar mental illnesses). However, it also opens up the possibility for ethical dilemmas, should this technology be used for things like behavior modification.
Suppose it could help you lose weight or quit smoking? That's not so bad.
Cure your kid of ADHD? We’re getting into a gray area now.
Turn gay people straight/trans people cisgender? Now we'r
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Cure your kid of ADHD? We’re getting into a gray area now. Turn gay people straight/trans people cisgender? Now we're firmly in ethical dilemma land.
They would never be used for anything so morally grey as that. I mean, where even would the profit be in that? No, they just want to pipe commercials directly into your brain so you can’t ignore them. Forever.
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That said this company is nowhere near ready to do anything. Besides mangling a few poor monkeys they haven't accomplished anything whatsoever
Re: Resistance is futile (Score:2)
Imagine if you was an employer could implant a chip into somebody's head that made them perfectly loyal to your company and willing to accept substandard living conditions and long work hours in exchange for low pay all without ever discussing unions or turning to a violent revolution.
Why would they need to imagine it when they already have plenty of people like you who are living proof that none of those things are mutually exclusive?
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Imagine if you was an employer could implant a chip into somebody's head that made them perfectly loyal to your company and willing to accept substandard living conditions and long work hours in exchange for low pay all without ever discussing unions or turning to a violent revolution.
That was basically the plot of Star Trek Voyager's Workforce [imdb.com] episode, except accomplished in the story by means of "brainwashing". More recently, the Halo TV series on Paramount+ depicted the SPARTAN soldiers as having implanted devices to suppress emotions and increase loyalty.
I would like to think that dystopian elements of sci-fi serve as a warning, but I guess there are those who see it as a goal.
That said this company is nowhere near ready to do anything.
It's only sci-fi until it's not. My damn cell phone can search photos I've taken for specific content usin
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I think the profit from that would be turning people into perfect worker bees. Imagine if you was an employer could implant a chip into somebody's head that made them perfectly loyal to your company and willing to accept substandard living conditions and long work hours in exchange for low pay all without ever discussing unions or turning to a violent revolution.
Wow - that idea would make a great TV series! In Holmdel NJ, there's his abandoned AT & T office building where we could film it...
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No, they just want to pipe commercials directly into your brain so you can’t ignore them. Forever.
You don't have ads in your dreams? [youtube.com]
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Back in the 90s when some scientists mistakenly thought they had discovered the "gay gene", there were various scams offering to genetically modify your child to be straight. Apparently there is a market for it.
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There are several workin gbrain implants in medical use, such as brain stem implants for the deaf. Do we call cochlear implants brain implants, tied to the auditory nerve as they are? I've not heard of those _reading_ anything from their electrodes: are there any medical experts on this channel?
Re: Resistance is futile (Score:3)
Mostly playing devil's advocate here but what if it's someone who wants their ADHD cured or for a gay person who wants to be straight or for a trans person who would rather treat their mind to eliminate the dysphoria instead of undergoing hormone replacement and affirming surgeries? Is that morally gray? Are they not allowed the agency to decide for themselves what treatments would best fit their own plans in life?
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I believe it is morally gray because you have no way to tell if there is any coercion involved. Its not like there is a history of making people who are different conform or be ostracized and/or killed.
Teenagers as a general term tend to want to conform to those around them or those they want to be in with. For instance, there is a high school near here where the students are saying they aren't "straight" because straight is boring or everybody has ADHD and wants special help. This could be good, this
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The ethical dilemma has actually become something of a common trope in sci-fi. An entire X-Men movie was based on a similar premise. Do you sacrifice some of your individuality to better fit in with the collective? What if the "treatment" isn't voluntary? Is society ultimately the better for it?
If someone wants to have a chip implanted in their head on a consentual basis, they certainly should have the right. The grander societal implications of that though, are something I'll leave for sci-fi authors
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The only reason for a gay person to want to be straight is because some outside force is making being gay a problem for them. Family, society, even the law in some countries. The only morally right thing to do is fix the homophobia.
The example of a trans person is more compelling because transitioning does often involve medical intervention. Depending on the individual, they might want various hormone therapies, and/or surgery. Treating the dysphoria might be a useful alternative, especially if there are me
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The only reason for a gay person to want to be straight is because some outside force is making being gay a problem for them. Family, society, even the law in some countries. The only morally right thing to do is fix the homophobia.
As well, what I have seen in life is that something, somewhere, somehow, with one exception, the gay people that I know are smart and often very talented. Obviously not all, but the early AIDs epidemic took out a lot of awesome folk.
The example of a trans person is more compelling because transitioning does often involve medical intervention. Depending on the individual, they might want various hormone therapies, and/or surgery. Treating the dysphoria might be a useful alternative, especially if there are medical complications that prevent them using the other options. It would have to be a free choice though, and where family/society/law and medical bills are involved, it never is.
This is true. Before using the more invasive procedures, the potential "complete" trans person should spend a lot of time dressing and acting like the other gender/sex. I watched a documentary focussing on two men who fully transitioned, and then changed their mind and transiti
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Mostly playing devil's advocate here but what if it's someone who wants their ADHD cured
I'll probably be skewered, but ADHD is not a disease. The so called symptoms of ADHD mainly came about because teachers wanted young males to be complaint, and back in the mid 90's, they just put 'em on Ritalin, and all is good. Teacher makes the diagnosis, Doctor Rubber stamps it, and little Johnny is put in his chemical straitjacket.
I would have been diagnosed because I'm not good at sitting still, even though I have laser focus. I fidget, I get bored easily. I'm annoying as all hell. These kids are ju
Re: Resistance is futile (Score:2)
Hello,
Lifetime member of Club ADHD here, on Ritalin in the 80's. Max dosage allowable for almost 2 years, then cold turkey and don't bother to explain to the kids what is going to happen. Let them figure it out all on their own years later. Ah the good old days, huh?
More to my point. It's actually a thing, not made up! Well, at least I can say that in my case. I work as a trainer in a technical field, so my work requires a lot of attention AND attention to detail. After my experience with Ritalin, I patent
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Will it be this way for everyone? Highly unlikely. But if your point is "it didn't work for Billy, so nobody can use it", I'm afraid you may not understand how medicine and biology work.
Almost every male in my sons classes were on Ritalin. Now I'm not an expert, but if everyone of a particular sex is ADHD, perhaps there could be an issue in the diagnosis?
What's truly the most harming? Listening to a bunch of ignorant ass people tell you that you're just doing it for attention...for most of your life.
It certainly wasn't me saying anything like that. Did you think I was? I consider the overuse of Ritalin and other drugs more a victimization of young people.
Actual ADHD is a real problem. There was an intern working with me for a while, Our group all loved the guy. Personable outgoing plus enthusiastic. But he really couldn't focus on
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Mostly playing devil's advocate here .... for a gay person who wants to be straight or for a trans person who would rather treat their mind to eliminate the dysphoria....
I think we're putting the cart way before the horse on this one. I don't think any of these medical devices are able to alter human behavior or change human thoughts. Generally speaking brain implants fall into two categories: (1) a brain-computer interface to control a computer with your brain, i.e. to enable a paralyzed person to control a wheel chair, a computer, or or some other device, (2) have some kind of therapeutic value in cases of epilepsy, deafness, or blindness. They provide targeted neural st
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The Borg reference is valid. Once you open a channel of communication between a brain and a computing device, there is no limit to the ways in which corporations will use it. We've seen that with Twitter, Facebook, and Google who control certain types of communication. With a direct connection to the brain, the control is far more intimate. Here we talk of temporary use to deal with mental aberrations, but when it becomes practical to add permanent cellular connections, it becomes a much bigger problem.
Ther
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Turn gay people straight/trans people cisgender? Now we're firmly in ethical dilemma land.
No we are not at all. The ethics on this are absolutely clear!
If you are forcing persons to get a chip in their head so you can modify their behavior - BAD
If after you have determined and accurately portrayed the risks and likely complications someone chooses to have your chip implanted and to have you modify their behavior in a specific way to correct an illness and that is ALL you do - GOOD
And this isnt people asking to have an perfectly good limb amputated etc. Being a homosexual or being 'trans' is a i
Re: Resistance is futile (Score:2)
"Being a homosexual or being 'trans' is a illness. It prevents you from engaging in a lot normal human activity and is a barrier to happiness. The great shame of modern median and psychology will be embracing and affirming these diseases"
Man, weird how that "illness" is all over the animal kingdom, isn't it? Must be a lot of "unhappy" monkeys that won't be able to "engage in normal [monkey] behavior". (Clue: 'normal' refers to "average" in psychology. It's not a default selection on a keyboard in your brai
Makes sense. Hippocratic logic etc. (Score:4, Insightful)
What the shit, Elno? (Score:2)
He can't even not kill a rat with his electrodes, let them make it safe for a fucking rodent before they try it on a human
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That guy has an endless line of followers with their lips on his sack.
No thanks (Score:1)
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> unlike a sex-change, which is something impossible for a Mammal...
Well yes, if you use the expression to mean that. I think that's why there's a tendency towards describing it as "Gender affirming surgery".
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I think that's why there's a tendency towards describing it as "Gender affirming surgery".
Ultimately though, the disparity between body and mind exists in the brain. It just happens to be preferable to modify the non-brain-parts because historically speaking, medical science has a terrible track record when it comes to treatments intended to alter the functioning of the brain. If you're not already familiar with the subject, read up on frontal lobotomies, if your stomach is up to it.
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There are tonnes of different mental illnesses.
But no one suggests, we treat, for example, bulimia, by agreeing with the patient that, yeah, they should lose a few pounds...
A human "identifying" as a cat cannot get a tail attached — not yet [iheart.com], anyway. A White woman identifying as Black is fired for lying about her race [cnn.com] — and races are a lot closer to each other, than sexes...
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I tend to avoid using them interchangeably.
I tend to use the word sex more in the context of biological types, like male and female. Gender I tend to use it more to refer to clusters of learned behaviours, like wearing skirts and ties.
I think there is crossover too, but when it gets to what specifics fall where, that's an area that's often about opinion more than fact.
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This is not about you — words (including pronouns, by the way) have known meaning shared by all users of a language.
The point stands: if you seek to "reaffirm" it by changing the sexual organs of a human being, it is the sex you're trying to change, even if you'd rather use a different synonym to describe it.
And changing sex is impossible for Mammals, despite the immense diversity of our circa 6400 species...
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> This is not about you
Not really sure why your saying that.
> words (including pronouns, by the way) have known meaning shared by all users of a language.
In a general sense, and there's a lot of variability, but that is far from implying your usage of the words sex and gender is the correct one.
> The point stands: if you seek to "reaffirm" it by changing the sexual organs of a human being, it is the sex you're trying to change, even if you'd rather use a different synonym to describe it.
I'm not goi
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Because you referred to yourself — and your own word-usage — earlier.
And this is why, when there is doubt, we use dictionaries — preferably, not of the "living and breathing" kind...
I meant no such implication in the most recent post. In the first one, however, I did link to the dictionary-entry for "gender" [princeton.edu], which I'm going to quote now:
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Here's another definition - https://www.merriam-webster.co... [merriam-webster.com]
Gender meaning behavioral, cultural, or psychological traits typically associated with sexual traits is more or less 75 years old, and it's grown over time and both usages are common today. That's why I specified I tend to use sex for biological traits, and gender for socio-cultural practices, rather than use them both to refer to biological sex. I think the difference is important.
> So, back to the original point
On your link on 'trans kid trea
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> unlike a sex-change, which is something impossible for a Mammal...
Well yes, if you use the expression to mean that. I think that's why there's a tendency towards describing it as "Gender affirming surgery".
Performed by the famous Russian, Rabbi Cutchyacockoff!
Oh, I'm going to hell now!
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Nobody is doing anything close to brain surgery to children!
You have lost the ability to think reasonably; retarded by your outrage porn which isn't even real news.
They are not offering children plastic surgery anyway (which IS what it is but don't mess with the industry! it's ok for 16 year olds to get plastic surgery...why?) They are however messing with hormones which isn't far from the unregulated chemical pollution that has gone on for a century experimenting on all of us--- some chemicals which mess
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This is irrelevant — mutilations like removal of breasts [nytimes.com] or castration (excuse me, "vaginoplasty") are invasive enough for my argument. The procedures are truly life-altering [reuters.com], and yet the question of informed consent — by the under-age patients — is pooh-poohed away.
So, if we're Libertarian enough to accept a 17 year-old boy's "consent" to the irreversible [thebostonpilot.com]:
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Elon has had more gender affirming surgery than most trans youth. He has a full head if hair and masculine jawline. Quite a turnaround from the 1999 Musk. https://www.marca.com/en/lifes... [marca.com]
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He was born male and never attempted to change that — which change is impossible for a Mammal, unlike the empty promises of today's quacks.
The direct brain-to-computer interface is possible — in theory. Whether or not it satisfies the FDA's requirements for substantial efficacy, it is theoretically achievable. Unlike a sex-change.
Now, this Libertarian would rather abolish FDA completely, but we don't need to argue that now. I don't need to prove myself r
Please pay you monthy eyesight subscription (Score:3, Insightful)
Looking forward to a world where you can lose your ability to see if you cannot afford your monthly eyesight subscription.
Insightful (Score:2)
I'm dying here. All the way down. Proof word: oversee
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I meant the above as just a joke but, as I typed it out it does sound like something The Zuck and others are likely drooling over. Just think what the SillyCon Valley sociopaths could do when they have chips planted directly in your brain. It's chilling.
Call it a covid vaccine (Score:1, Funny)
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and it will sail through the approval process no questions asked.
But does it actually prevent...oh...nevermind, carry on.
Musk's Agendas (Score:2)
His sinister projects tend to have apparently altruistic fronts, and this is one of them. Another is SpaceX, which while providing routine services like launching satellites, financing his program, its origin and continuing underlying purpose is Musk's fantasy of a Mars colony, where he can do his