The head of the US agency responsible for animal welfare has told lawmakers that it did not find any violations of animal research rules at Elon Musk's Neuralink beyond a 2019 incident the brain implant company had already reported.
Officials with the Department of Agriculture (USDA) conducted a "focused" inspection in response to a complaint about the company's handling of animal experiments, but identified no compliance breaches, the agency's secretary Thomas Vilsack wrote to Congressman Earl Blumenauer in a July 14 letter reviewed by Reuters.
The inspection included visits at Neuralink's two facilities in January 2023, Vilsack wrote, adding that there would be more inspections.
Musk has expressed grand ambitions for his brain-implant startup, saying its chip would allow healthy and disabled people alike to pop into neighbourhood facilities for speedy surgical insertions of devices to treat obesity, autism, depression and schizophrenia. He even sees them being used for web-surfing and telepathy.
Neuralink is preparing to test its brain implant device on humans.
Vilsack said in his letter his agency did not include in its inspection citations an "adverse surgical event" at Neuralink that occurred in August 2019. The company proactively reported it and took corrective action, which complied with the policy at the time, Vilsack added. The USDA changed its rules in 2021 so that self-reporting a violation no longer avoids a citation.
In the 2019 incident, a Neuralink surgeon used a sealant to close holes drilled into a monkey's skull that had not been approved by the animal research oversight panel, according to emails and public records obtained by the Physicians Committee of Responsible Medicine (PCRM), an animal-welfare advocacy group.
The complaint that triggered the latest inspection was made in February 2022 by PCRM against Neuralink and the University of California, Davis, which was collaborating with the company at the time. It alleged the company carried out 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 the Inspector General (OIG), at the request of a federal prosecutor, has been investigating potential animal-welfare violations amid internal Neuralink employee complaints that its animal testing experiments were being rushed, causing needless suffering and deaths, Reuters has reported.
Through interviews and internal documents spanning several years, Reuters identified four experiments involving 86 pigs and two monkeys that were marred by human errors. The mistakes weakened the experiments' research value and required the tests to be repeated, leading to more animals being killed.
Vilsack offered no update on the progress of the OIG probe. "Should (the OIG) investigate the Neuralink facility and find that USDA should take additional actions, we will fully cooperate to take those actions," he wrote.
Neuralink and OIG representatives did not respond to requests for comment.
Blumenauer responded by calling for greater urgency in the probe. "I urge the Office of the Inspector General to quickly conclude their investigation and make public their findings," he said in a statement.
Ryan Merkley, PCRM's director of research advocacy, said the USDA was giving Neuralink "a free pass".
Oversight board
US lawmakers had also raised concerns to the USDA about potential conflicts of interest at an animal-research oversight board after Reuters reported it was filled with company insiders who may stand to benefit financially as the firm made progress with its goals.
Vilsack wrote that the law required the oversight board include an attending veterinarian and an individual unaffiliated with the research facility or its employees to provide an unbiased observer – a threshold that Neuralink formally meets. He said the agency's inspectors generally review such records and protocols, "which should surface any conflicts of interest."
The Food and Drug Administration (FDA) recently granted a company request 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 has reported.
Even after FDA clearance, the company faces other challenges. The Department of Transportation is probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment.
© Thomson Reuters 2023
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