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U.S. Food and Drug Administration inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.
The inspectors identified quality control lapses at the company’s California animal research facility. A similar inspection at Neuralink’s Texas facility did not find problems, according to agency records.
Those visits took place last year from June 12-22, and represent the FDA’s sole inspections of Neuralink facilities on record. The inspector reports were shared with Reuters by Redica Systems, a data analytics company that obtains FDA compliance reports through open records requests.
“These issues show a lack of attention to detail,” said Jerry L. Chapman, a senior quality expert with Redica Systems.
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“I’m shocked!” said no one.
I would be shocked if this wasn’t the case.
I’m pretty sure a couple of the monkeys said it.
And yet they approved human trials…
The FDA is ridiculously underfunded because the American healthcare system is a giant grift and medical companies donate a shit ton of many to politicians from both parties.
Just like with the IRS and EPA, it’s underfunded and understaffed on purpose
A large chunk of their funding comes from the very companies that are going through the approval process.
Little did we know that Elon Musk would be strangled to death by the cold hands of a pair of disembodied robotic arms being remote controlled by an enraged capuchin with an Nvidia GPU embedded in its skull
Don’t give me poetic hope.
Was it the heaps of dead monkeys?
Science can’t move forward without heaps!
I mean, is the idea of experimenting on grafting PCBs to monkeys’ brains even remotely ethically sound? Then again, injecting cleaning products and makeup into animals bloodstreams, or exposing their eyes to caustic chemicals, never struck me as terribly ethical either.
I mean, all of the initial monkeys had to be euthanized because of how fucked up they were. Constantly digging at the implant, constantly screaming in pain, etc. Going to say there may have been some horrific problems there.
I believe they were biting their own fingers off as well. They stopped publishing research when they took the study out of the college and finished it independently. Probably unrelated to all the mutilated monkeys though.
“These issues show a lack of attention to detail,” said Jerry L. Chapman, a senior quality expert with Redica Systems.
All right! Sign me up for one of their brain chips!
Frankly I’d be much more shocked to find a regulatory agency show up at a Musk company and find “everything here is being performed with integrity and following the regulations to the letter”.
I’m skeptical of the FDA’s capabilities in blood red states like Texas. (Or any federal regulatory agencies, frankly.) The states do everything in their power to show contempt, weaken, undermine, infiltrate and obstruct them (and feds are slow at best to react).
The FDA is a joke. I repeatedly got food poisoning from a bag of hard boiled eggs before I figured it out. I reported it to the FDA/USDA to try and get the batch tested to keep anyone else from getting sick, and they just had me call someone that ended up being a lawyer for the store that sold the eggs, whose sole interest was to tell me I couldn’t prove anything so I shouldn’t sue.
In July, the USDA said it did not find any violations of its animal research rules beyond a 2019 incident that Neuralink had already reported. ‘VIOLATIONS OF FUNDAMENTAL REQUIREMENTS’
The FDA has its own requirements for animal research, known as Good Laboratory Practice, to demonstrate that any scientific data being collected in the development of a drug or medical device is reliable, three regulatory experts told Reuters.
Neuralink cited its animal research data in its FDA request to test the implants in humans. Musk, the company’s billionaire founder, announced in May that his device was cleared for human trials, and said last month the first patient had received an implant and was recovering well.
So, the USDA inspection is entirely irrelevant wrt to research integrity. USDA is about animal welfare, the FDA is about whether health-related claims made by commercial companies are based on reliable evidence rather than cherry-picking and/or hand-waving.
I do not understand how the FDA managed to approve human trials before it inspected the facilities. That might be reasonable with a company that had gone through this process before but it is a horrible decision for a company which has never done anything like this before.
IIRC FDA approval was initially denied and I haven’t seen anything that explains what changed in between denial and approval. But it is worth noting that the FDA is not well-equipped to resist commercial pressure.
Definitely one to watch.
Musk lied to further his own goals? No way!
You’d literally need to be crazy to want a human chip.
Not crazy. Just very stupid
I mean, I want a brain-computer interface, just not the hot garbage Musk is producing. We’re most likely at least a decade away from something that should actually be used in humans. There are a ton of problems that still need to be solved for, including very fundamental ones like standardized protocols and how to go about managing firmware updates.
Nothing is hack proof. I’ll pass on an interface with computer interface with my brain. It can be useful for some disabled people but I can’t see it being overly positive for the public at large.
As much as I want it il also wait until it’s been out for at least 30 years. I might be dead by then. I’ll settle for some actual working smart glasses.
