Can AI and Robots do your job?

[Irace86.2.0]

Originally Posted by ZDan

https://www.wired.com/story/elon-mus...monkey-deaths/

Musk is *the worst*.

As someone who has a plant-based diet, who has discussed the problems with our meat industry and with animal testing, I can say I'm not surprised that animals felt pain or discomfort in the process of doing these studies. l don't know what you would expect, and I'm not surprised that animal rights watch groups would protest such studies like they do for all studies including testing makeup and lotions on animals for reactions. We wouldn't have any medical devices, pharmaceutical products, knowledge of disease process and so on if we never studied or performed studies on animals, and we brutally kill animals every day for food, so the hypocrisy when a few animals suffer in such a study is astounding. There are videos of fowl hanging by their necks, surviving being slaughtered to be dipped in burning hot steam before going through plucking machines while completely lucid or cows being lifted into the air by their feet before being cut open at the neck to bleed out, squirming in the air through the process trying to flee. Farmers regularly cull millions of animals...silence from the masses. Three monkeys die in experiments that could help paraplegics walk again...headline news.

So despite the claims, they have approved human trials??? Maybe the complaints weren't as bad as the article is suggesting.

[ZDan]

Originally Posted by Irace86.2.0

l don't know what you would expect,

I would expect that whatever regulations prevent corporations from torturing animals in research and development, that Elon Musk would ignore every single one of them...

[Spuds]

All kinds of animals are bred as test subjects, and that's just how testing works.

That being said, Musk making false statements to hide his company's shortcomings such that the investment stream continues to flow is not surprising at all. This is a common theme and why I personally want nothing to do with him or any companies he runs.

[Irace86.2.0]

Originally Posted by ZDan

I would expect that whatever regulations prevent corporations from torturing animals in research and development, that Elon Musk would ignore every single one of them...

Originally Posted by Spuds

All kinds of animals are bred as test subjects, and that's just how testing works.

That being said, Musk making false statements to hide his company's shortcomings such that the investment stream continues to flow is not surprising at all. This is a common theme and why I personally want nothing to do with him or any companies he runs.

The letters to the SEC come from the Physicians Committee for Responsible Medicine, a nonprofit striving to abolish live animal testing. The group claims that Musk’s comments about the primate deaths were misleading, that he knew them “to be false,” and that investors deserve to hear the truth about the safety, “and thus the marketability,” of Neuralink’s speculative product.

“They are claiming they are going to put a safe device on the market, and that’s why you should invest,” Ryan Merkley, who leads the Physicians Committee’s research into animal-testing alternatives, tells WIRED. “And we see his lie as a way to whitewash what happened in these exploratory studies.”

I'm against animal suffering and am for a plant-based diet, but I don't jump on board everything PETA says, nor groups like this. I'm a little more pragmatic. By the numbers, millions of animals go to slaughter in horrific ways to support a diet preference, so I'm far less concerned about a dozen monkeys needing to be euthanized and going through a crappy experience in the process of medical research where the benefits are profound.

Yes, Musk is going to conceal and placate. That is what all CEOs do. This isn't a surprise to me, but some of these charges seem hilarious: “They are claiming they are going to put a safe device on the market, and that’s why you should invest." Well duh! That is the plan. It isn't to put an unsafe device on the market, so people should invest.

It wasn't just animal testing. It was development of a product and procedure for implanting the device. Human trials will probably require further development, but that will be more like testing and fine tuning. The candidates are willful participants who are going to be dead in years or are quads. Investors don't care about ten monkeys, even if that was half of the subjects. They care about whether Musk has the ability to form a team capable of making the product reality. The fact that this is at human trials from animal trials suggests the claims made in the article weren't significant enough. 90% of pharmaceutics fail during the drug development process (Source), and this is true for medical devices too (Source), so moving a product to human trials in spite of these claims makes me skeptical of the claims of gross negligence.

[Spuds]

Originally Posted by Irace86.2.0

I'm against animal suffering and am for a plant-based diet, but I don't jump on board everything PETA says, nor groups like this. I'm a little more pragmatic. By the numbers, millions of animals go to slaughter in horrific ways to support a diet preference, so I'm far less concerned about a dozen monkeys needing to be euthanized and going through a crappy experience in the process of medical research where the benefits are profound.

Yes, Musk is going to conceal and placate. That is what all CEOs do. This isn't a surprise to me, but some of these charges seem hilarious: “They are claiming they are going to put a safe device on the market, and that’s why you should invest." Well duh! That is the plan. It isn't to put an unsafe device on the market, so people should invest.

It wasn't just animal testing. It was development of a product and procedure for implanting the device. Human trials will probably require further development, but that will be more like testing and fine tuning. The candidates are willful participants who are going to be dead in years or are quads. Investors don't care about ten monkeys, even if that was half of the subjects. They care about whether Musk has the ability to form a team capable of making the product reality. The fact that this is at human trials from animal trials suggests the claims made in the article weren't significant enough. 90% of pharmaceutics fail during the drug development process (Source), and this is true for medical devices too (Source), so moving a product to human trials in spite of these claims makes me skeptical of the claims of gross negligence.

The teams Musk has assembled are often lacking in the quality assurance department. His leadership emphasizes the appearance of success over solid engineering and independent criticism. If QA is not competent or empowered to critique evaluations, you wind up with people who have a personal stake making the go nogo decisions in an echo chamber. Hence why we were told we would definitely have FSD cars in 2017, then 2018, then 2019. It's why the Starship launches keep getting scrutinized and postponed by the FAA.

Who do you suppose makes the decision to move a product to human trials?

[Irace86.2.0]

Originally Posted by Spuds

The teams Musk has assembled are often lacking in the quality assurance department. His leadership emphasizes the appearance of success over solid engineering and independent criticism. If QA is not competent or empowered to critique evaluations, you wind up with people who have a personal stake making the go nogo decisions in an echo chamber. Hence why we were told we would definitely have FSD cars in 2017, then 2018, then 2019. It's why the Starship launches keep getting scrutinized and postponed by the FAA.

Who do you suppose makes the decision to move a product to human trials?

This is true. He does push for faster innovation. I don't think his teams or products lack solid engineering; it is often some of the best people and best engineering. It is the final quality control that needs more refining. He's not one for waisting time refining and perfecting something that they will likely improve and update shortly down the road with something else. He definitely cuts corners. No doubt. It keeps costs down and speeds innovation and development. SpaceX recent launchpad failure is another example of moving and innovating fast and under-calculating the likelihood of failure. That is the price of keeping costs down often in the private/corporate sector that we see time and time again. It can be worse in Musk's companies, for sure.

Looks like here is another timeline for FSD release for FSD 12.0 supposedly released this year. Maybe this one will be it:

https://www.carexpert.com.au/car-new...ting-from-beta

Like the FAA has just finished their investigation with SpaceX and is demanding actions before being cleared for another launch, the FDA does the approvals for trials, and they denied Neuralink's initial application, citing the need for changes before Neuralink would be cleared for human trials. Apparently that happened.

https://www.reuters.com/investigates...link-musk-fda/

[Spuds]

Originally Posted by Irace86.2.0

This is true. He does push for faster innovation. I don't think his teams or products lack solid engineering; it is often some of the best people and best engineering. It is the final quality control that needs more refining. He's not one for waisting time refining and perfecting something that they will likely improve and update shortly down the road with something else. He definitely cuts corners. No doubt. It keeps costs down and speeds innovation and development. SpaceX recent launchpad failure is another example of moving and innovating fast and under-calculating the likelihood of failure. That is the price of keeping costs down often in the private/corporate sector that we see time and time again. It can be worse in Musk's companies, for sure.

Looks like here is another timeline for FSD release for FSD 12.0 supposedly released this year. Maybe this one will be it:

https://www.carexpert.com.au/car-new...ting-from-beta

Like the FAA has just finished their investigation with SpaceX and is demanding actions before being cleared for another launch, the FDA does the approvals for trials, and they denied Neuralink's initial application, citing the need for changes before Neuralink would be cleared for human trials. Apparently that happened.

https://www.reuters.com/investigates...link-musk-fda/

So that's one article indicating that the FDA can reject a request to move to human clinical trials, but I have not yet found anything official that says they have that authority. I have found that the FDA can make recommendations such that they would later be more likely to approve the premarket application, but my understanding is that occurs after clinical trials. Likewise all the official documentation on animal studies is best practice recommendations, and does not require review by an external agency.

https://www.fda.gov/regulatory-infor...edical-devices

https://www.fda.gov/patients/learn-a...opment-process

Edit, I must have missed the IND section of clinical trials. Still, they note that an actual hold is rare and more often there are recommendations made to improve safety.

Approval

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

Approval to begin clinical trials.

Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:
-Participants are exposed to unreasonable or significant risk.
-Investigators are not qualified.
-Materials for the volunteer participants are misleading.
-The IND application does not include enough information about the trial’s risks.

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.

The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.

This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

[Irace86.2.0]

Originally Posted by Spuds

So that's one article indicating that the FDA can reject a request to move to human clinical trials, but I have not yet found anything official that says they have that authority. I have found that the FDA can make recommendations such that they would later be more likely to approve the premarket application, but my understanding is that occurs after clinical trials. Likewise all the official documentation on animal studies is best practice recommendations, and does not require review by an external agency.

https://www.fda.gov/regulatory-infor...edical-devices

https://www.fda.gov/patients/learn-a...opment-process

Edit, I must have missed the IND section of clinical trials. Still, they note that an actual hold is rare and more often there are recommendations made to improve safety.

Check my sources linked in post 130. The FDA rejects a lot.

[Spuds]

Originally Posted by Irace86.2.0

Check my sources linked in post 130. The FDA rejects a lot.

I believe that was referring to premarket approvals after clinical trials, not the investigational new drug approval before clinical trials. I'm referring to the latter.

[Irace86.2.0]

Originally Posted by Spuds

I believe that was referring to premarket approvals after clinical trials, not the investigational new drug approval before clinical trials. I'm referring to the latter.

The FDA is involved in every aspect of the process. For medical devices, the FDA is expecting at least a 95% reliability of the devices at a 95% confidence interval. With that said, they are allowing a certain number of failures, so if we had a 100 monkeys, five monkeys would have device failures, and because the devices are Class III medical devices (only 10% of medical devices are), failure typically leads to significant harm or death, whether that is infections, repeat procedures to remove a failed device, harmful symptoms or death. Think of a pacemaker failing or an insulin pump failing (dumping insulin). Working for a decade in the ED, I've seen plenty, even if it is a small percentage of the total.

The FDA is involved in every stage from preclinical (animal) studies to the final approval to post-clinical studies to pull something off the market. You mention that holds and denials are rare, but I hope you aren't suggesting that the FDA is soft with allowing products to move through the stages. Holds and denials are rare because companies invest millions and do everything they can to be in compliance and to make a product that will be successful through the whole process.

Tying this back to Neuralink, and in light of them being denied once by the FDA, the fact that they are cleared for Phase I (human) trials with a Class III device suggests they have done their due diligence with pretrials and showed enough efficacy and safety to move forward, given the rigorous demands of the FDA.

https://www.fda.gov/media/124862/download
https://www.fda.gov/drugs/informatio...cess-continued

[Spuds]

Originally Posted by Irace86.2.0

The FDA is involved in every aspect of the process. For medical devices, the FDA is expecting at least a 95% reliability of the devices at a 95% confidence interval. With that said, they are allowing a certain number of failures, so if we had a 100 monkeys, five monkeys would have device failures, and because the devices are Class III medical devices (only 10% of medical devices are), failure typically leads to significant harm or death, whether that is infections, repeat procedures to remove a failed device, harmful symptoms or death. Think of a pacemaker failing or an insulin pump failing (dumping insulin). Working for a decade in the ED, I've seen plenty, even if it is a small percentage of the total.

The FDA is involved in every stage from preclinical (animal) studies to the final approval to post-clinical studies to pull something off the market. You mention that holds and denials are rare, but I hope you aren't suggesting that the FDA is soft with allowing products to move through the stages. Holds and denials are rare because companies invest millions and do everything they can to be in compliance and to make a product that will be successful through the whole process.

Tying this back to Neuralink, and in light of them being denied once by the FDA, the fact that they are cleared for Phase I (human) trials with a Class III device suggests they have done their due diligence with pretrials and showed enough efficacy and safety to move forward, given the rigorous demands of the FDA.

https://www.fda.gov/media/124862/download
https://www.fda.gov/drugs/informatio...cess-continued

I think you are misunderstanding these sources. For the first pink, that is the inspection procedure that applies to "Animal Rule" applications. The "Animal Rule" is a means of seeking approval when testing on human subjects would be unethical due to having to expose them to lethal or debilitating substances. You aren't going to inject a nerve agent into a person to test whether your anti-nerve agent chemical works. In that case, you need to have special scrutiny on the animal testing.

The second link notes the IND existence, but is more focused on the NDA, which occurs after clinical trials. I still haven't seen any indication that the FDA is involved prior to the IND. The source I provided from the FDA itself described the IND process and specifically said holds are rare, usually because biotech firms do their due diligence. The fact that there was already a hold on Neuralink's IND (or device equivalent) is a pretty big red flag in that context, indicating that the testing and process was not up to the FDA standard the first time around.

None of the charts you provided indicate the FDA actually has any involvement in preclinical trials. My point is that it is up to the company to QA their own process, and for the most part self regulate. The first time the FDA has to be involved is at the IND, and what they are looking for is whether the company's report indicates that the risks are understood, and that appropriate measures have been taken in the process of understanding those risks. It's self-reported. That's why empowered QA is important. Again, Musk has shown multiple times he is willing to omit pertinent information, or even outright lie, to make some product appear more successful than it really is. I would guess that means he is also willing to pressure his employees to do so.

[Irace86.2.0]

Originally Posted by Spuds

I think you are misunderstanding these sources. For the first pink, that is the inspection procedure that applies to "Animal Rule" applications. The "Animal Rule" is a means of seeking approval when testing on human subjects would be unethical due to having to expose them to lethal or debilitating substances. You aren't going to inject a nerve agent into a person to test whether your anti-nerve agent chemical works. In that case, you need to have special scrutiny on the animal testing.

The second link notes the IND existence, but is more focused on the NDA, which occurs after clinical trials. I still haven't seen any indication that the FDA is involved prior to the IND. The source I provided from the FDA itself described the IND process and specifically said holds are rare, usually because biotech firms do their due diligence. The fact that there was already a hold on Neuralink's IND (or device equivalent) is a pretty big red flag in that context, indicating that the testing and process was not up to the FDA standard the first time around.

None of the charts you provided indicate the FDA actually has any involvement in preclinical trials. My point is that it is up to the company to QA their own process, and for the most part self regulate. The first time the FDA has to be involved is at the IND, and what they are looking for is whether the company's report indicates that the risks are understood, and that appropriate measures have been taken in the process of understanding those risks. It's self-reported. That's why empowered QA is important. Again, Musk has shown multiple times he is willing to omit pertinent information, or even outright lie, to make some product appear more successful than it really is. I would guess that means he is also willing to pressure his employees to do so.

The Animal Rule was an example. FDA works with USDA and other agencies around the Animal Welfare ACT. It is all interlaced.

https://www.fda.gov/cosmetics/produc...tory%20Animals.
https://www.nal.usda.gov/animal-heal...0Animal%20Care.

Part of pretrial animal studies is to find a therapeutic range and then to find a toxic range. Sometimes studies don't go further to human trials because the animals develop tumors or die, even if it is at super therapeutic doses, sometimes thousands of times higher. Everything that happens in pretrials is reportable on applications for human trials. Failing to do efficacy studies can be grounds for a denial to move to human trials, so compliance and due diligence is a must. If there are reports of negligence, safety concerns, rights violations, etc, you bet the government will show up like they will for a restaurant, and you bet the results of pretrials and adherence to guidelines play in their decision to approve or deny applications, but this tends to not be an issue, as companies invest in products and want to be compliant in order to get approved.

https://www.fda.gov/media/93963/download

Musk and company could lie, but this would be bad--very bad. There is a reason they were denied the IND, and it was because they likely WERE transparent and didn't lie. Being denied is less important than the fact that they were approved, which means they made the necessary changes or provided the necessary data to meet safety and efficacy guidelines. Also, what do you think will happen in Phase I human trials if Neuralink is as cavalier as you suggest? They will get shut down hard and fast. Lots of money down the tube. Loss of confidence with investors. They are going to do everything they can to succeed.

https://www.fda.gov/medical-devices/...ory-misconduct

[ZDan]

Originally Posted by Irace86.2.0

Yes, Musk is going to conceal and placate. That is what all CEOs do.

Not all corporations resort to cheating. Remember when Mazda was going to bring a turbodiesel to the U.S. market? They couldn't meet customer expectations for performance like VW did so they just didn't bring it. Contrast with what VW did...

I'm not against capitalism, but *unregulated* capitalism is actively eating itself. It rewards psychopaths like Musk who have zero qualms about exploiting their employees and their customers as much as possible while neglecting regulations. F that guy, he's the worst...

[Irace86.2.0]

Originally Posted by ZDan

Not all corporations resort to cheating. Remember when Mazda was going to bring a turbodiesel to the U.S. market? They couldn't meet customer expectations for performance like VW did so they just didn't bring it. Contrast with what VW did...

I'm not against capitalism, but *unregulated* capitalism is actively eating itself. It rewards psychopaths like Musk who have zero qualms about exploiting their employees and their customers as much as possible while neglecting regulations. F that guy, he's the worst...

I don't disagree about unregulated capitalism. I voted for Bernie.

I don't think Neuralink is cheating in any way similar to what VW did, nor has Musk, for the most part. He definitely is guilty of union busting. He was guilty of trying to manipulate the stock market to screw over short sellers. I think he placates and smoothes, as any CEO/politician would. He minimizes the problems and embellishes the successes, although he is also fine talking about the problems and hell, trials and tribulations that his companies or himself has gone through, whether we are talking about Tesla, SpaceX, SolarCity, X, etc.

Remember, there are hundreds of thousands of people begging for this technology. I could list all the conditions, but I don't know if that is necessary to drive home the point that this type of technology is profound. Musk will have no problem finding volunteers. They already are reaching out to him on X. I don't believe he will be taking short cuts with people's lives during clinical trials. He will get shut down hard. Check it out.