News

"I'm shocked!" said no one.

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

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

Was it the heaps of dead monkeys?

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.

“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!

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!

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).

You'd literally need to be crazy to want a human chip.