Elon Musk, the man whose cars are currently under recall because they keep crashing into things, was told by the FDA he cannot put chips in our brains. Hallelujah. Thank you, FDA! See, Musk founded a company called Neuralink in 2016 (and yes, it appears, based on the Wiki, that he actually did found this one, and didn’t buy his way into an already existing company, like he did with Tesla.)
He’s been promising all sorts of wild, Elizabeth Holmes-ian sh*t about Neuralink’s brain implants, like helping paralyzed people walk again, blind people see, or that they “will turn humans into cyborgs who can fend off the threat from sentient machines powered by artificial intelligence.” You know, normal stuff—only, well, Neuralink didn’t apply for clinical trials until 2022, and the FDA said not no, but hell no to the request. Per Reuters:
The rejection has not been previously reported. In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path to final product approval, the staffers said. 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.
These are all things you should probably solve before you put a lithium battery into someone’s brain, no? The good news is, because Neuralink is a private company, it doesn’t really have to disclose its interactions with the FDA to its investors! That always instills confidence. Per the above article:
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
So here’s where it gets genuinely unhinged. Neuralink’s internal culture is, according to Reuters, to treat the FDA as if it’s the enemy. Take that in for a second. A company that wants to implant chips in your brain thinks the government agency that wants to keep its citizens safe is the enemy, here. Something is very wrong!
As a reminder: Tesla allowed its drivers (and everyone else on the road) to be guinea pigs for its self-driving feature. The same feature is now under recall because it is not safe! We are talking about chips in brains, here—much harder to recall because removing something from your brain is a big deal!
As if this isn’t horrifying enough, Neuralink is also under investigation by the Department of Transportation on “whether Neuralink illegally transported dangerous pathogens, on chips removed from monkey brains, without proper containment measures.” So basically, these geniuses are playing fast and loose everywhere and, I cannot stress this enough, want permission to implant things in our brains. They can’t even clean their chips properly! Didn’t they see the 1995 classic Outbreak?! You don’t mess with monkey pathogens.
Musk wants to do this all on his own, his way, and is refusing any assistance from the government, boing so far as to reject funding from the NIH—you know, the government organization that has led to countless medical breakthroughs. Per Reuters:
Musk has told senior Neuralink managers that NIH funding would bring unwanted public oversight and bureaucratic hurdles, according to one person who heard such comments from Musk and a second source with knowledge of Musk’s views about the NIH.
The episode reflects a wider view at Neuralink that the government generally moves slowly and stifles innovation, five current and former employees said.
What innovation? You can’t start human trials because you have no viable product or plan, just a silly idea on a whiteboard and a bunch of sycophants who tell you it’s a great idea. Surely, if you had partnered with a government agency, you would be farther down the path by now—or, perhaps, this is all a big F-ing grift and unserious by nature?
As the article points out, brain implant devices aren’t new. I know someone who got one to treat a neurological disorder well over a decade ago. The issue is that Neuralink wants to implant devices into people’s brains and wants as little government oversight as possible. Who does that benefit, exactly? No one but a private company and a founder who, through his other companies, has demonstrated he does not give a f*ck about anyone but himself and his delusions of grandeur.
The source who described the late-night meeting said Musk expects Neuralink to operate like Tesla, which brought several ground-breaking electric vehicles to market relatively quickly. “He can’t appreciate that this is not a car,” this source said. “This is a person’s brain. This is not a toy.”
Reuters
I will keep beating this drum. Tesla rushed out its self-driving feature, put everyone on the road in danger as a result, and now it’s under recall. You do not want anything this man is a part of near your brain.
The FDA, according to the article, has raised valid safety concerns about the device, primarily that its threads could migrate in your brain and that the device could damage the brain when it is removed. Additionally, the FDA raised concerns that the device could overheat, damaging your brain tissue. Cool. Just normal brain implant stuff, then?
There still might be a path forward for a trial if Neuralink can get its act together. Per Reuters:
If the FDA has lingering minor issues with a company’s device, it might let the firm move forward with a slower, staged trial, the experts said. The agency has suggested such a path might work for Neuralink, with fewer subjects implanted at first, and more tested months later, according to two people familiar with the discussions. Still, that proposal disappointed Neuralink because it could delay progress toward final FDA approval, one of the sources said.
All I can say is that this is the human brain we’re talking about. You don’t get a second one. I won’t let Elon Musk near mine, no matter how much he screams about “innovation.”
(featured image: Taylor Hill/Getty Images)
