UNITED STATES: Elon Musk's Neuralink, a medical device company, is under US federal investigation for potential animal-welfare violations amid staff complaints that its animal testing is being rushed, causing needless suffering and deaths.

Neuralink is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments.

The federal probe, which has 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 probe, one of the sources said, focuses on violations of the Animal Welfare Act, which governs how researchers treat and test some animals.

The investigation has come at a time of growing employee dissent about Neuralink's animal testing, including complaints that pressure from Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees.

Such failed tests have had to be repeated, increasing the number of animals being tested and killed, the employees said. 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 spokesperson for the USDA inspector general declined to comment. US regulations don't specify how many animals companies can use for research, and they give significant leeway to scientists to determine when and how to use animals in experiments. Neuralink has passed all USDA inspections of its facilities, regulatory filings show.

In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following 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 figure as a rough estimate because the company does not keep precise records on the number of animals tested and killed. Neuralink has also conducted research using 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 they face financial pressure to quickly bring products to market. The animals are typically killed when experiments are completed, often so they can be examined post-mortem for research purposes.

But current and former Neuralink employees said the number of animal deaths is higher than it needs to be for reasons related to Musk's demands to speed up research. Through company discussions and documents spanning several years, along with employee interviews, Reuters identified four experiments involving 86 pigs and two monkeys that were marred in recent years by human errors. The mistakes weakened the experiment's research value and required the tests to be repeated, leading to more animals being killed, three of the current and former staffers said. The three people attributed the mistakes to a lack of preparation by a testing staff 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 how the company organizes animal surgeries to prevent hack jobs. The rushed schedule, the employee wrote, resulted in under-prepared and over-stressed staffers scrambling to meet deadlines and making last-minute changes before surgeries, raising risks to the animals. 'It's driving me nuts' Musk has pushed hard to accelerate Neuralink's progress, which depends heavily on animal testing, current and former employees said.

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 he would trigger a "market failure" at Neuralink unless they made more progress, according to a former staffer who heard his comment.

Five people who've 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 more animal tests. Instead, these people said, Neuralink launches tests in quick succession before fixing issues in earlier tests or drawing complete conclusions. The result: more animals overall are tested and killed, in part because the approach leads to repeated tests.

The problems with Neuralink's testing have raised questions internally about the quality of the resulting data, three current or former employees said. Such problems could potentially delay the company's bid to start 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 of his management of Twitter, which he recently acquired for US $44 billion.

The US Food and Drug Administration is in charge of 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 didn't immediately comment.

Missed deadlines, botched experiments

Musk's impatience with Neuralink has grown as the company, which launched in 2016, has missed his deadlines on several occasions to win regulatory approval to start clinical trials in humans, according to company documents and interviews with eight current and former employees.

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 boasted internally of building a "Monkey Disneyland" in the company's Austin, Texas facility 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 heard the comment.

Another former employee recalled Musk saying he disliked using animals for research but wanted to make sure they were "the happiest animals" while alive. The animals have fared less well, however, when used in the company's research, current and former employees say.

The first complaints about the company's testing involved its initial partnership with 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 findings.

The group alleged that surgeons used the wrong surgical glue twice, which led to two monkeys suffering and ultimately dying, while other monkeys had different complications from the implants. The company has acknowledged it killed six monkeys, on the advice of USC Davis veterinary staff, because of health problems caused by experiments. It called the issue with the glue a "complication" from the use of an "FDA-approved product." In response to a Reuters inquiry, a USC Davis spokesperson shared a previous 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, which has since launched a formal probe, according to a source with direct knowledge of the investigation. USDA investigators then inquired about the allegations involving the UC Davis monkey research, according to two sources familiar with the matter and emails and messages reviewed by Reuters.

A spokesperson for the US attorney's office for the Northern District of California declined to comment.

^{SOURCE: Reuters}