A leading medical ethics advocacy group asked federal regulators Tuesday to disqualify data collected by Elon Musk’s Neuralink medical device company during animal tests, potentially stymieing the tech mogul’s aspirations to develop brain implants.
Musk has said his company is months away from starting human trials and has begun submitting data to the FDA to gain regulatory approvals. Any sanctions from the agency could force Neuralink to begin the rigorous approval process anew.
“When you submit your paperwork to FDA, you can’t start following good laboratory practices at that time. You need to have been following them for quite a while,” said Ryan Merkley, the Physicians Committee’s director of research advocacy. “And clearly, from our perspective based on public records and news reports, it’s hard for us to believe that Neuralink had been following good laboratory practices.”
Representatives from Neuralink, which is developing a brain implant to treat neurological ailments, did not respond to a request for comment.
Musk said last month that the company would have its first experimental human implant “probably in about six months.” During the presentation, he showed video of a macaque named Pager playing the video game “Pong.” Musk said a brain implant allowed Pager to play without a controller.
Neuralink does “everything we possibly can” to test devices before implanting them in living creatures, Musk said at the time.
“We’re not cavalier in putting devices into animals,” he said. “We’re extremely careful. And we always want the device whenever we put the implant — whether it’s in a sheep or a pig or a monkey — to be confirmatory, not exploratory.”
The Physicians Committee obtained more than 700 pages of records from Neuralink’s tests on rhesus macaques, a frequently studied primate native to Asia, after a successful lawsuit against the federally funded California National Primate Research Center at the University of California-Davis, which conducted the experiments.
Those documents include surgical records for 22 monkeys. The Physicians Committee said two of those procedures represent severe violations of FDA regulations.
In 2018, a day after a Neuralink surgeon operated on a female macaque, according to public records, veterinary officials who observed the animal suffering recommended euthanasia in line with ethical standards for the treatment of research animals involved in tests.
The surgeon used a surgical glue that was known to cause catastrophic side effects, and the animal was likely experiencing fatal consequences, veterinary officials said.
But the study director kept the animal alive for another 24 hours to observe the aftereffects, the documents show. In that time, the monkey repeatedly collapsed after retching and gasping for breath, and staff euthanized her shortly thereafter.
In 2019, a year after that procedure, another Neuralink surgery repeated the mistake, records show. A surgeon implanted electrodes and temperature probes into a male macaque’s brain, but filled a void between the implants with the same unapproved glue that was found in the earlier surgery to be “toxic to the adjacent tissues.” The adhesive’s own product safety information indicates a risk of “‘acute nerve injury’ when directly applied to phrenic nerves.”
The 2019 surgery lasted 6½ hours, records show, and concluded when the monkey was euthanized. That represented a deviation from standard operating procedures in the tests, the Physicians Committee argues, putting animal test subjects at risk of undue suffering and tainting any data submitted as part of a regulatory filing.
“In light of the incidents documented above, we urge FDA to investigate [good laboratory practice] violations by Neuralink to determine if its facilities should be disqualified, which is within the agency’s power,” the Physicians Committee wrote to the FDA. “Disqualification would exclude Neuralink studies from consideration in support of applications for research or marketing permits for products regulated by the agency.”
The U.S. Department of Agriculture’s Office of Inspector General has reportedly launched an animal-cruelty investigation into Neuralink, stemming from employee accusations that pressure from Musk to hastily conduct experiments led to barbaric veterinary surgeries and the killing of roughly 1,500 animals involved in tests since 2018. Reuters first reported the existence of the investigation.
Deltrick Johnson, the deputy counsel to the Office of Inspector General, said in an email that the agency “neither confirms nor denies the existence of any such investigation.”
Reuters’s report cites internal Neuralink emails that described certain surgeries as rushed “hack jobs” that “resulted in underprepared and overstressed staffers scrambling to meet deadlines and making last-minute changes before surgeries, raising risks to the animals.”
It describes a 2021 incident in which researchers attached implants of the wrong size in the heads of 25 pigs. In a separate incident, Reuters reported, staff accidentally implanted a Neuralink device on the wrong vertebrae of a pig, then repeated the mistake in a second surgery.
Musk is already embroiled in controversies over his acquisition of Twitter and his recent use of the platform to attack former employees and government scientists.