The head of the US agency responsible for animal welfare told lawmakers he found no violation of animal research rules in Elon Musk’s Neuralink beyond a 2019 incident that the brain-implant company had previously reported.
Department of Agriculture (USDA) officials conducted a “focused” inspection in response to a complaint about the company’s handling of animal experiments, but did not identify any compliance violations, agency secretary Thomas Vilsack wrote to Congressman Earl Blumenauer in a July 14 letter reviewed by Reuters.
The inspection included visits to Neuralink’s two facilities in January 2023, Vilsack wrote, adding that there would be more inspections.
Musk has expressed high ambitions for his brain implant startup, saying his chip would allow healthy and disabled people to show up at neighborhood facilities for quick surgical insertions of devices to treat obesity, autism, depression and schizophrenia. He even sees them being used for web browsing and telepathy.
Neuralink is preparing to test its brain implant device in humans.
Vilsack said in his letter that his agency did not include in its inspection citations an “adverse surgical event” at Neuralink that occurred in August 2019. The company proactively reported and took corrective action, which was in line with policy at the time, added Vilsack . The USDA changed its rules in 2021 so that self-reporting a violation no longer prevents a citation.
In the 2019 incident, a Neuralink surgeon used a sealant to close holes made in a monkey’s skull that had not been approved by the animal research oversight panel, according to emails and public records obtained by the Responsible Physicians Committee. (PCRM), an animal welfare advocacy group.
The complaint that triggered the last inspection was made in February 2022 by the PCRM against Neuralink and the University of California, Davis, which at the time was a collaborator of the company. He claimed that the company performed deadly experiments on 23 monkeys between 2017 and 2020. Neuralink ended its collaboration with UC Davis in 2020.
Since then, the USDA’s Office of Inspector General (OIG), at the request of a federal prosecutor, has been investigating possible animal welfare violations amid internal complaints from Neuralink employees that their animal experiments were being rushed, causing needless suffering and death, Reuters reported.
Through interviews and internal documents over several years, Reuters identified four experiments involving 86 pigs and two monkeys that were harmed by human error. The errors weakened the research value of the experiments and required the tests to be repeated, leading to the death of more animals.
Vilsack offered no update on the progress of the OIG investigation. “Should (the OIG) investigate the Neuralink facility and find that the USDA must take additional action, we will fully cooperate to take those action,” he wrote.
Representatives for Neuralink and OIG did not respond to requests for comment.
Blumenauer responded by asking for greater urgency in the investigation. “I call on the Office of the Inspector General to quickly complete its investigation and make its findings public,” he said in a statement.
Ryan Merkley, PCRM’s director of research advocacy, said the USDA was giving Neuralink “a free pass.”
supervisory board
US lawmakers also raised concerns to the USDA about potential conflicts of interest on an animal research oversight board after Reuters reported it was full of company insiders who could benefit financially as the company moves forward on its goals.
Vilsack wrote that the law required the supervisory board to include an attending veterinarian and an individual unaffiliated with the research center or its employees to provide an impartial observer — a threshold that Neuralink formally meets. He said agency inspectors often review these records and protocols, “which should bring to light any conflicts of interest.”
The Food and Drug Administration (FDA) recently granted an application for the company to begin testing its brain implant device in humans. It initially rejected Neuralink’s request for a human trial last year, citing safety reasons, Reuters reported.
Even after FDA clearance, the company faces other challenges. The Department of Transportation is investigating whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment.
© Thomson Reuters 2023