Dec 5 (Reuters) – Elon Musk’s Neuralink, a medical device company, is under federal investigation for possible animal welfare violations amid complaints from internal staff that its animal tests are being rushed, causing unnecessary suffering and dead, according to documents reviewed by Reuters and Reuters. sources familiar with the company’s research and operations.
Neuralink Corp is developing a brain implant that it hopes will help paralyzed people walk again and cure other neurological diseases. The federal investigation, which had not been previously reported, 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 with knowledge of the investigation. The investigation, one of the sources said, is focused on violations of the Animal Welfare Act, which regulates how researchers treat and test some animals.
The investigation comes at a time of growing employee dissent over Neuralink’s animal testing, including complaints that CEO Musk’s pressure to speed up development has led to botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and current people. former employees Those failed tests have had to be repeated, increasing the number of animals tested and killed, employees say. Company documents include previously unreported 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 Reuters 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 filings show.
In total, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, after experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company’s animal testing operations. The sources characterized that number as a rough estimate because the company does not keep accurate records of the number of animals tested and killed. Neuralink has also conducted research with rats and mice.
The total number of animal deaths does not necessarily indicate that Neuralink is violating regulations or standard research practices. Many companies routinely use animals in experiments to advance human health care and face financial pressure to bring products to market quickly. Animals are usually killed when experiments are completed, often so that they can be examined postmortem for research purposes.
But current and former Neuralink employees say the number of animal deaths is higher than it should be for reasons related to Musk’s demands to speed up research. Through discussions and company documents spanning several years, along with interviews with employees, Reuters identified four experiments involving 86 pigs and two monkeys that were affected in recent years by human error. The mistakes weakened the research value of the experiments and required the tests to be repeated, leading to more animals being killed, three of the current and former employees said. All three people attributed the failures to a lack of preparation of testing personnel working in a pressure cooker environment.
One employee, in a message seen by Reuters, wrote an angry missive earlier this year to colleagues about the need to overhaul the way the company organizes animal surgeries to prevent “hack jobs.” The rushed schedule, the employee wrote, resulted in underprepared and stressed staff scrambling to meet deadlines and making last-minute changes before surgeries, increasing the risks to the animals.
Musk has pushed hard to speed up Neuralink’s progress, which relies heavily on animal testing, current and former employees said. Earlier this year, the CEO sent employees a news article about Swiss researchers who developed an electrical implant that helped a paralyzed man walk again. “We could enable people to use their hands and walk again in daily life!” wrote to staff at 6:37 am Pacific Time on February 8th. Ten minutes later, he continued, “In general, we just don’t move 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 to try 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 he would trigger a “market failure” at Neuralink unless they made more progress, a comment perceived by some employees as a threat to shut down operations, according to a former employee who overheard the your comment .
Five people who have 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 element at a time in an animal study and draw relevant conclusions before moving on to further animal testing. Instead, these people said, Neuralink launches tests quickly before fixing problems in previous tests or drawing full conclusions. The result: More animals overall are tested and killed, in part because the approach leads to repeated testing.
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 speed demands, the employee said. 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. Those issues could 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 faces criticism over his management of Twitter, which he 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 responsible for reviewing the company’s applications for approval of its medical device and associated trials. The company’s treatment of animals during research, however, is regulated by the USDA under the Animal Welfare Act. The FDA did not immediately comment.
MISSING TERMS, FAILED EXPERIMENTS
Musk’s impatience with Neuralink has grown as the company, which launched in 2016, has repeatedly missed its deadlines for getting regulatory approval to begin human clinical trials, according to company filings and interviews with eight current and former employees.
Some Neuralink rivals are more successful. Synchron, which launched in 2016 and is developing a different implant with less ambitious goals for medical advances, received FDA approval to begin human trials in 2021. The company’s device has enabled paralyzed people to write and write thinking alone. Synchron has also conducted animal tests, but only killed about 80 sheep as part of its research, according to studies of the Synchron implant reviewed by Reuters. Musk approached Synchron about a potential investment, Reuters reported in August.
Synchron declined to comment.
In some ways, Neuralink treats animals pretty well compared to other research facilities, employees said in interviews, echoing public statements by Musk and other executives. Company leaders have boasted internally of building a “Monkey Disneyland” at the company’s facility in Austin, Texas, where lab animals can roam, a former employee said. In the company’s early years, Musk told employees he wanted the monkeys at his San Francisco Bay Area operation to live in a “monkey Taj Mahal,” said a former employee who overheard the comment. Another former employee recalled Musk saying he didn’t like using animals for research, but wanted to make sure they were “the happiest animals” while they were alive.
However, animals have fared less well when used in company research, current and former employees say.
The first complaints about the company’s tests involved its initial partnership with the University of California, Davis, to conduct 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 botching surgeries that killed monkeys and publicly released its conclusions. The group alleged that surgeons used the wrong surgical glue twice, causing two monkeys to suffer and eventually die, while other monkeys had complications other than the implants.
Elon Musk arrives at the In America: An Anthology of Fashion themed Met Gala at the Metropolitan Museum of Art in New York City, New York, U.S., May 2, 2022. REUTERS/Andrew Kelly
The company has acknowledged that it killed six monkeys, on the advice of UC Davis veterinary staff, because of health problems caused by the experiments. He called the problem with the glue a “complication” of using an “FDA-approved product.” In response to a Reuters query, a UC Davis spokesperson shared an earlier public statement defending its research with Neuralink and saying it followed all laws and regulations.
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 investigators then asked about the allegations involving UC Davis…