The medical device company Neuralinkof Elon Muskis being investigated at the federal level for possible animal welfare violationsamid internal complaints from staff that their animal testing is being precipitatingcausing suffering Y deaths unnecessary, according to documents reviewed by the agency Reuters and sources familiar with the company’s investigation and operations.
Neuralink Corp is developing a brain implant with which he hopes to help paralyzed people walk again and cure other neurological ailments. The previously unreported federal investigation was opened in recent months by the US Department of Agriculture’s Inspector General at the request of a federal prosecutor, according to two sources familiar with the investigation. According to one of the sources, the investigation focuses on violations of the Animal Welfare Law, which regulates the treatment and testing of animals by researchers.
The investigation has come at a time of growing discontent among employees about Neuralink’s animal testing, including complaints that pressure from CEO Musk to speed up development has led to failed experimentsaccording to a review of Reuters from dozens of Neuralink documents and interviews with more than 20 current and former employees. These failed tests have had to be repeated, increasing the number of animals tested and euthanized, employees say. Company documents include previously undisclosed messages, audio recordings, emails, presentations and reports.
Musk and other Neuralink executives did not respond to requests for comment.
Reuters could not determine the full scope of the federal investigation or whether it involved the same alleged problems with animal testing identified by employees in interviews with Reuters. A spokesman for the USDA inspector general declined to comment. US regulations do not specify many animals companies can use for research and leaves a wide leeway scientists to determine when and how to use animals in experiments. Neuralink has passed all US Department of Agriculture inspections of its facilities, as stated in regulatory documents.
In all, the company has killed about 1,500 animalsincluding more than 280 sheep, pigs Y monkeysfollowing experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company’s animal testing operations. Sources characterized that figure as a estimate approximate because the company does not keep accurate records on the number of animals tested and euthanized. Neuralink has also conducted research with rats Y mice.
The total number of animals killed does not necessarily indicate that Neuralink is in violation of regulations or current research practices. Many companies routinely use animals in experiments to improve healthcare, and face financial pressure to bring products to market quickly. Animals are usually sacrificed after the experiments are complete, often so that they can be examined post mortem for research purposes.
But current and former Neuralink employees say the number of animal deaths is greater than necessary for reasons related to Musk’s demands for expedite investigation. Through company discussions and documents spanning several years, along with employee interviews, Reuters identified four experiments involving 86 pigs and two monkeys that have been marred in recent years by human error. The errors weakened the investigative value of the experiments and forced retesting, 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 a test staff working in a pressure cooker environment.
One of the employees, in a message seen by Reuters, wrote an angry letter to his colleagues earlier this year about the need to review the way the company organizes animal surgeries to avoid “hacked jobs.” The rushed schedule, the employee wrote, caused underprepared and stressed staff to rush to meet deadlines already make last-minute changes before surgeries, which increased the risks to the animals.
Musk has pushed hard to speed progress at Neuralink, which relies heavily on animal testing, according to current and former employees. Earlier this year, the CEO sent his employees an article about Swiss researchers who had developed an electrical implant that helped a paralyzed man walk again. “On February 8, at 6:37 am (Pacific Time), he wrote to his employees: “We can get people back to using their hands and walking in their daily lives! Ten minutes later, he continued: “In general, we are not moving fast enough. It’s driving me crazy.”
On several occasions over the years, Musk has told employees to imagine they had a bomb strapped to their heads in an effort to get them to move faster, according to three sources who repeatedly heard the comment. On one occasion a few years ago, Musk told employees that he would cause a “market failure” at Neuralink unless they made more progress, a comment perceived by some employees as an threat closing operations, according to a former employee who overheard his comment.
Five people who have worked on Neuralink’s animal experiments told Reuters who had raised their concerns internally. They said they had advocated for a more traditional testing approach, in which researchers tested one item at a time in an animal study and drew relevant conclusions before moving on to further animal testing. Instead, Neuralink launches tests in rapid succession before either fixing the problems in previous ones or drawing full conclusions. The result: in general, more animals are experimented on and killed, partly because the tests are repeated.
A former employee who asked management several years ago for more deliberate testing was told by a senior executive that it was not possible given Musk’s demands for speed, the employee said. Two people told Reuters who left the company because of their concern for animal research.
Problems with the Neuralink tests have raised Doubts internally about the quality of the resulting data, said three current or former employees. These problems could delay the start of the human trials, something Musk has said the company wants to do in the next six months. They also add to a growing list of headaches for Musk, who is facing criticism for his handling of Twitter, which it recently acquired for $44 billion. Musk also continues to run electric car maker Tesla Inc and rocket company SpaceX.
The US Food and Drug Administration is in charge of reviewing company 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 immediate comment.
Musk’s impatience with Neuralink has grown as the company, which launched in 2016, has missed their deadlines on several occasions to get regulatory approval to start human clinical trials, according to company documents and interviews with eight current and former employees.
Some Neuralink rivals are having more success. Synchronouswhich launched in 2016 and is developing a different implant with less ambitious goals for medical breakthroughs, has received FDA approval to start human trials in 2021. The company’s device has allowed paralyzed people to send texting and typing just by thinking. Synchron has also conducted tests on animals, but has only killed about 80 sheep as part of its research, according to peer-reviewed studies of the Synchron implant. Reuters. Musk has contacted Synchron about a possible investment, as reported Reuters in August.
Synchron declined to comment.
In some aspects, Neuralink treats the animals quite well compared to other research facilitiesthe employees said in interviews, echoing public statements by Musk and other executives. Company officials 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 monkeys from his San Francisco Bay Area operation to live in a “monkey Taj Mahal,” said a former employee who heard the complaint. comment. Another former employee remembers that Musk said he didn’t like using animals for researchbut that he wanted to make sure they were “the happiest animals” while they lived.
However, the animals have not fared as well when used in company research, current and former employees say.
The first complaints about the company’s tests concerned 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 botched the surgeries in which the monkeys were killed and made the results public. The group claimed that surgeons used the wrong surgical glue twice, causing two monkeys to suffer and eventually die, while other monkeys suffered different complications from the implants.
The company has acknowledged that it euthanized six monkeys, on the advice of USC Davis veterinary staff, due to health problems caused by the experiments. He called the problem with the glue a “complication” stemming from the use of an “FDA-approved product.” In response to a query from Reutersa spokesperson for USC Davis shared an earlier public statement defending its research with Neuralink and stating that it had followed all laws and regulations.
A federal prosecutor for the Northern District of California referred the animal rights group’s complaint to the USDA Inspector General, who has launched a formal investigation, according to a source with direct knowledge of the investigation. USDA researchers then inquired into the allegations relating 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 introduced the program to its own facilitiesand has since built his own in California and Texas.
A spokesman for the Northern California District Attorney’s Office declined to comment.
Delciana windersdirector of the Institute for Animal Law and Policy at the Vermont Graduate and Law School, said it is “very unusual” have the USDA inspector general investigate animal research facilities. Winders, an opponent of animal testing who has criticized Neuralink, said the inspector general has mainly focused in recent years on animal fights. dogs Y roosters when applying the Animal Welfare Law.
“It’s hard on the piggies”
Among the errors that caused unnecessary deaths of animals is one that occurred in 2021, when 25 of the 60 pigs of one study had devices of the wrong size implanted in their heads, an error 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 set off alarm bells among Neuralink researchers. In May 2021, Viktor Kharazia, a scientist, wrote to colleagues that the error could be a “red flag” for FDA reviewers of the 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 familiar with the situation. All the animals, both pigs and sheep, were slaughtered after the procedures, the person said.
Kharazia had no comment in response to the requests.
On another occasion, staff accidentally implanted the Neuralink device into the vertebra wrong of two different pigs during two different surgeries, according to two sources with knowledge of the matter and documents reviewed by Reuters. The incident frustrated several employees who claimed that the errors – on two separate occasions – could have been easily avoided by carefully counting the vertebrae before inserting the device.
The company vet sam baker he advised his colleagues to immediately kill one of the pigs to end its suffering.
“Taking into account the unlikely chances of her full recovery and her poor psychological state, it was decided that the euthanasia it was the only appropriate measure,” Baker wrote to colleagues about one of the sows a day after the operation, adding a heartbroken smiley.
Baker did not comment on the incident.
Sometimes, employees have resisted Musk’s demands to move quickly. In a discussion at the company several months ago, some Neuralink employees protested after a manager said Musk had encouraged them to perform complex surgery on pigs soon. The employees objected, arguing that the complexity of the operation would lengthen the time that the pigs would be under anesthesia, putting their health and recovery at risk. They argued that they must first find a way to reduce the time required for the operation.
“It’s hard on the piggies”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 holding a town hall to explain its processes. Soon after, he opened the meetings to staff on the federal board of directors who review animal experiments.
Neuralink executives have said publicly that the company only tests on animals when it has exhausted other research options, but company documents and messages suggest otherwise. During a Nov. 30 presentation the company aired on YouTube, for example, Musk said the surgeries were used later in the process to confirm that the device worked, not to test early hypotheses. “we are extremely careful”, he said, to ensure that the evidence is “confirmatory, not exploratory”, using animal tests as last resource after trying other methods.
In October, a month before Musk’s comments, Autumn sorrellsresponsible for the care of the animals, ordered the employees to delete “exploration” of the study titles retroactively and will 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 expressed their concern by Sorrells’ request to change the descriptions of the exploratory studies, saying it would be inaccurate and misleading.
One of them noted that the petition seemed designed to provide a “best optics” to Neuralink.
(With information from Reuters)
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