Neuralink, Elon Musk's company that makes chips to be implanted in the brain, is under federal investigation in the United States for possible animal welfare violations, amid internal complaints from staff that its tests on animals are being accelerated, causing suffering and needless deaths, according to documents reviewed by Reuters and sources familiar with the investigation and company operations.
Neuralink Corp is developing a brain implant that it hopes will help paralyzed people walk again and cure other neurological ailments.
The federal investigation was opened in recent months by the Inspector General of the US Department of Agriculture (USDA), at the request of a federal prosecutor, according to two sources.
The investigation, according to one of the sources, focuses on violations of the Animal Welfare Act, which controls how researchers treat and examine some animals.
This development comes at a time of increasing employee dissent over Neuralink's animal testing, including complaints that Musk's pressure to speed up development has resulted in failed experiments,
Such failed tests have had to be repeated, increasing the number of animals being tested and euthanized, employees say.
Company documents include messages, audio recordings, emails, presentations, and reports.
Musk and other Neuralink executives did not respond to requests for comment.
Reuters was unable to determine the full scope of the federal investigation or whether it involved the same alleged problems with animal testing identified by employees in interviews.
A spokesman for the USDA inspector general declined to comment.
US regulations do not specify how many animals companies can use for research, and give scientists significant leeway in determining when and how to use animals in experiments.
Neuralink has passed all USDA inspections of its facilities, regulatory documents show.
In all, the company has euthanized around 1,500 animals, including more than 280 sheep, pigs and monkeys, after experiments since 2018,
Sources characterized that figure as a rough estimate because the company does not keep accurate records on the number of animals culled.
Neuralink has also done research on rats and mice.
The total number of animal deaths does not necessarily indicate that Neuralink is violating standards or standard research practices;
many companies often use animals in experiments to improve human health care and face financial pressures to bring products to market quickly.
Animals are generally killed when the experiments are complete, often so that they can be examined post-mortem for research purposes.
Human errors in animal tests
Through documents spanning several years and interviews with employees, Reuters identified four experiments involving 86 pigs and two monkeys that were marred in recent years by human error.
The errors weakened the investigative value of the experiments and required the tests to be repeated, leading to the deaths of more animals, three of the current and former employees said.
All three people attributed the errors to the lack of preparation of test personnel working in a "pressure cooker" environment.
One employee, in a message seen by Reuters, wrote an angry letter earlier this year to colleagues about the need to review the way the company organizes animal surgeries to prevent "hacking jobs."
The rushed schedule, the clerk wrote,
Musk has worked hard to speed progress at Neuralink, which relies heavily on animal testing, current and former employees said.
“We could allow people to use their hands and walk again in daily life!”
he wrote to staff at 6:37 am Pacific Time on February 8. Ten minutes later, he continued: “Overall, we're not moving fast enough.
It's driving me crazy!"
On several occasions over the years, Musk has told employees to imagine they have a bomb strapped to their heads in an effort to make them move faster, according to three sources who repeatedly heard the comment.
On one occasion a few years ago, Musk told employees he would cause "market failure" at Neuralink unless they made more progress,
Five people who worked on Neuralink's animal experiments told Reuters they had raised concerns internally.
They said they had advocated for a more traditional testing approach, in which researchers would test one item at a time in an animal study and draw relevant conclusions before moving on to more animal testing.
Instead, these people said, Neuralink launches tests in rapid succession before fixing problems in previous tests or drawing full conclusions.
The result: more animals are used and euthanized overall, in part because the approach leads to repeat testing.
A former employee who asked management several years ago to slow down the tests says a senior executive told him it wasn't possible given Musk's demands for speed.
Two people told Reuters they left the company over concerns about animal research.
Problems with Neuralink's tests have raised questions internally about the quality of the resulting data, three current or former employees said.
Such issues could potentially delay the company's bid to begin human trials, which Musk has said the company wants to do within the next six months.
They also add to a growing list of headaches for Musk, who is facing criticism over his management of Twitter, which he recently acquired for $44 billion.
The US Food and Drug Administration (FDA) is in charge of reviewing the company's applications for approval of its medical device and associated trials.
However, the company's treatment of animals during research is regulated by the USDA, under the Animal Welfare Act.
The FDA had no comment.
Missed deadlines, failed experiments
Musk's impatience with Neuralink has grown as the company, which launched in 2016, repeatedly missed deadlines to gain regulatory approval to begin human clinical trials, according to company documents and interviews with eight employees. current and previous
Some Neuralink rivals are having more success.
Synchron, which launched in 2016 and is developing a different implant with less ambitious goals for medical advances, has received FDA approval to begin human trials in 2021. The company's device has allowed paralyzed people to send messages text and write just by thinking.
Synchron has also carried out tests on animals, but has only euthanized about 80 sheep as part of its research,
Musk has approached Synchron about a possible investment, Reuters reported in August.
Synchron declined to comment.
In some ways, Neuralink treats animals quite well compared to other research facilities, employees said in interviews, echoing public statements by Musk and other executives.
Company leaders have bragged internally about building a "monkey Disneyland" at the company's Austin, Texas, facility where laboratory animals can roam, a former employee said.
In the company's early years, Musk told employees that he wanted the monkeys at his San Francisco Bay Area operation to live in a "monkey Taj Mahal," according to a former employee who heard the story. comment.
However, the animals have fared less well when used in company research, current and former employees say.
The first complaints about the company's tests affected its initial partnership with the University of California, Davis, to perform the experiments.
In February, an animal rights group, the Physicians Committee for Responsible Medicine, filed a complaint with the USDA accusing the Neuralink-UC Davis project of performing surgeries improperly and publicly released their findings.
The group alleged that the surgeons used the wrong surgical glue twice, causing two monkeys to suffer and eventually die, while other monkeys had different complications from the implants.
The company has acknowledged that it slaughtered six monkeys,
following the advice of UC Davis veterinary staff, due to health problems caused by the experiments.
He called the glue problem a "complication" from using an "FDA-approved product."
In response to a query from Reuters, a UCDavis spokesperson shared an earlier public statement defending his investigation with Neuralink and saying he complied with all laws and regulations.
Two researchers in a screenshot from a Neuralink promotional video, while they implant one of the chips.
A federal prosecutor in the Northern District of California referred the animal rights group's complaint to the USDA inspector general, who has since launched a formal investigation, according to a source with direct knowledge of the investigation.
USDA researchers then inquired about the allegations related to the UC Davis monkey research, according to two sources familiar with the matter and emails and messages reviewed by Reuters.
The investigation concerns the testing and treatment of animals at Neuralink's own facility, one of the sources said, without elaborating.
In 2020, Neuralink decided to run its program in-house and has since built its extensive facilities in California and Texas.
Delcianna Winders, director of the Institute for Animal Law and Policy at the Vermont Graduate and Law School, said it is “highly unusual” for the USDA inspector general to investigate animal research facilities.
Her work, she says, has focused mainly in recent years on dogfighting and cockfighting actions in applying the Animal Welfare Law.
"It's hard for little pigs"
Mistakes that led to unnecessary animal deaths include a case in 2021, when 25 of 60 pigs had the wrong size devices implanted in their heads, a mistake that could have been prevented with more preparation, according to a person with knowledge of the situation. and company documents and communications reviewed by Reuters.
The error raised alarms among the Neuralink researchers.
In May 2021, scientist Viktor Kharazia wrote to colleagues that the error could be a "red flag" for reviewers of the FDA study, which the company planned to submit as part of its application to begin human trials.
His colleagues agreed, and the experiment was repeated with 36 sheep, according to the person with knowledge of the situation.
All the animals, both pigs and sheep, were euthanized after the procedures, the source said.
Kharazia had no comment in response to the requests.
On another occasion, staff accidentally implanted the Neuralink device into the wrong vertebrae of two different pigs during two separate surgeries, according to two sources with knowledge of the matter and documents reviewed by Reuters.
The incident frustrated several employees who said the errors, on two separate occasions, could have been easily avoided by carefully counting the vertebrae before inserting the device.
Company veterinarian Sam Baker advised his colleagues to immediately euthanize one of the pigs to end its suffering.
"Based on the low probability of a full recovery and his current poor psychological well-being, it was decided that euthanasia was the only appropriate course of action."
Baker declined to comment on the incident.
Employees have at times pushed back on Musk's demands to move faster.
In a company discussion several months ago, some Neuralink employees protested after a manager said Musk had encouraged them to perform complex surgery on pigs too soon.
The employees resisted, claiming that the complexity of the surgery would prolong the amount of time the pigs would be under anesthesia, putting their health and recovery at risk.
They argued that they should first figure out how to reduce the time it would take to do the surgery.
“It's hard on the little pigs,” said one of the employees, referring to the long period under anesthesia.
In September, the company responded to employee concerns about its animal testing by hosting a town hall to explain its processes.
Neuralink executives have said publicly that the company tests animals only when it has exhausted other research options, but company documents and messages suggest otherwise.
During a Nov. 30 presentation the company streamed on YouTube, for example, Musk said surgeries were used later in the process to confirm the device works rather than test initial hypotheses.
“We are extremely careful,” he said, to make sure testing is “confirmatory, not exploratory,” using animal testing as a last resort after trying other methods.
In October, a month before Musk's comments, Autumn Sorrells, the head of animal care,
ordered employees to retroactively remove the word “scan” from study titles and stop using it in the future.
Sorrells had no comment in response to the requests.
Neuralink records reviewed by Reuters contained numerous references over several years to exploratory surgeries, and three people with knowledge of the company's research strongly rejected the claim that Neuralink avoids exploratory animal testing.
Company discussions reviewed by Reuters showed that several employees raised concerns about Sorrells' request to change the descriptions of the exploratory studies, saying it would be inaccurate and misleading.
One noted that the request seemed designed to provide “better optics” for Neuralink.
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