The brain implants that Elon Musk’s Neuralink are studying in humans have been controversial, and another voice is questioning whether there should be human trials happening at all.
Rep. Earl Blumenauer, of Oregon’s third congressional district, wrote a letter to the U.S. Food and Drug Administration (FDA) questioning why the numerous alleged Neuralink safety lapses called out in the press in elsewhere didn’t result in a delay of FDA approval. The trial, which Neuralink says it is undertaking (pdf) in the hopes of “enabling individuals with paralysis to control external devices,” has been open since 2023, and the first human implantation happened earlier this year.
“In an internal email from 2022, one Neuralink employee wrote that the company needed to work harder to prevent ‘hack jobs’ due to a rushed schedule that over-stressed staff and raised risks for animals,” Blumenauer wrote in the letter, first reported by Reuters and provided to Quartz, referencing a Reuters story from that year about Neuralink employee concerns.
Further, the letter questions why violations of so-called “Good Laboratory Practices” observed by the FDA itself during Neuralink’s animal-testing phase didn’t set off more alarm bells. “This failure has been criticized by a former high-ranking FDA official,” Blumenauer wrote. “While your agency’s eventual inspection ‘identified quality control lapses,’ it did not alter Neuralink’s approval to begin human trials.”
Neither Neuralink nor the FDA immediately responded to requests for comment.
Other agencies have raised questions about the Neuralink study. The U.S. Department of Agriculture looked into the animal testing procedures but found no violations. The Department of Transportation has fined Neuralink for transporting hazardous materials.
Musk said during a livestream on his website X last month that the first patient to get the Neuralink chip has been able to move a computer mouse with their mind, though this is not breaking ground in the world of brain computer implantation.