Will human trials be scrapped? Musk's Neuralink faces federal investigation, experimental animals die frequently

Last week, Musk held Neuralink’s ​​ Show & Tell ​​​ The demonstration event showed the world the latest progress in brain-computer interfaces. At the meeting, Musk said that it is very difficult to go from prototype to production and faces many challenges. Neuralink has been working hard to initiate human trials and has submitted all the necessary documentation to the FDA to begin human trials. Musk estimates that the first Neuralink device could be in the human brain within 5-6 months.

At the meeting, Musk emphasized that Neuralink respects animal subjects and that brain-computer interface devices have undergone extensive benchmark testing before being implanted in animals. . Two monkeys, Pager and Sake, have both been successfully implanted with Neuralink upgrades.

The following is the sentence typed by Sake "can i please have snacks" (Can you give me some snacks?)

However, just a few days after the conference, according to Reuters information and relevant insiders, the medical device company founded by Elon Musk Neuralink is due to The company is under federal investigation for suspected animal rights violations, with employees believing the company's animal experiments were too hasty and caused unnecessary suffering and death.

Underprepared, overstressed, employees rush to meet deadlines

As we all know, Neuralink is developing brain implant technology designed to help Paralyzed people can walk again or be cured of other neurological conditions. The USDA's inspector general recently launched the federal investigation at the request of federal prosecutors, according to people familiar with the matter. One of the people said the investigation focused on whether the company violated the Animal Welfare Act, which oversees how researchers are treated Animals and animal experiments.

Neuralink Implant: N1. About the size of a quarter, it can be used to record and stimulate signals.

Reuters reviewed dozens of relevant company documents, including previously unreported information, recordings, emails, presentations and reports, and Interviews with more than 20 current and former employees revealed that the investigation comes at a time when employees are increasingly dissatisfied with Neuralink's animal experiments, and that the experiment failed because Musk demanded that the process be accelerated. caused by pressure.

The employees said the substandard testing had to be repeated, which undoubtedly increased the number of animals that were tested and died.

Musk and other Neuralink executives have not yet responded to requests for comment.

Because U.S. regulations do not specify the number of animals used in company research, and give scientists a lot of leeway on when and how to use animals in experiments room. Neuralink has passed all USDA inspections of its facilities, regulatory filings show.

According to information obtained by Reuters, about 1,500 animals have been killed since the company began its experiments in 2018, including more than 280 sheep, pigs and monkeys. That's a rough estimate because the company doesn't keep precise records of the number of animals it tests and kills, people familiar with the matter said. Neuralink has also been studied with rats and mice.

The total number of animal deaths does not necessarily indicate that Neuralink violated regulations or standards of research practice. Many companies, which often test on animals to advance human health care, face financial pressure to bring products to market quickly. Typically, after the experiments are completed, the animals are killed so that they can be examined for research after death.

However, current and former Neuralink employees say that more animals died than were necessary because of Musk's demands for faster research. Drawing on several years of company meetings and documents, as well as interviews with employees, Reuters confirmed that four experiments - involving 86 pigs and two monkeys - were marred by human error in recent years. These cognitive errors reduced the research value of the experiments, so they needed to be repeated, leading to more animals being killed, three current and former employees said. People familiar with the matter believe that the mistake was that the testers working in the high-pressure environment failed to make adequate preparations for the experiment.

In order to verify the effect of Neuralink, researchers implanted the above-mentioned device in pigs.

Earlier this year, one employee wrote angrily to colleagues that the company needed to overhaul the way animal surgeries were performed so that To avoid being criticized. The employee also wrote that the rushed schedule resulted in underprepared and overstressed staff scrambling to meet deadlines, with many adjustments being made at the last minute before surgery, threatening the animals' safety. Safety.

Both current and former employees said that Musk has been working hard to speed up the development of Neuralink, which relied in large part on animal experiments. Earlier this year, Musk sent employees a news article about an electronic implant developed by Swiss researchers that helped a paralyzed man walk again. He wrote to employees: "We can give people the use of their hands and feet again in their daily lives! Overall, we are not moving fast enough. It's driving me crazy!"

People familiar with the matter also said that over the years, Musk would ask employees to imagine that they had a bomb strapped to their heads to get them to move faster. A few years ago, Musk told employees that if they didn't make more progress, it would trigger a market failure for Neuralink.

Human trial plans may be scrapped within 6 months

Five employees involved in Neuralink’s animal experiments told Reuters that they had expressed this concern within the company. They say they prefer a more traditional testing method, in which researchers test one element at a time in animal studies and then conduct additional animal tests after drawing relevant conclusions. People familiar with the matter said Neuralink would conduct tests in rapid succession before fixing problems in early testing or drawing full conclusions. The result is that more animals often need to be tested and killed, in part because this approach leads to repeated testing.

A former employee asked management to be more cautious about experiments a few years ago, but was told by executives that was impossible given Musk's need for speed. of. The two told Reuters they left the company because of concerns about animal research.

Problems with Neuralink’s testing have raised questions within the company about the quality of the resulting data, three current and former employees said. The issues could delay the company's plans to begin human trials, which Musk has said it hopes to begin within the next six months. These incidents have also added to growing headaches for Musk, who recently acquired Twitter for $44 billion and has been criticized for his management of Twitter while also running electric car maker Tesla. and rocket company SpaceX.

The U.S. Food and Drug Administration (FDA) is responsible for reviewing the company's approval applications for medical devices and related experiments. However, the company has been criticized by the United States for the way the company treats animals during research. The FDA had no immediate comment on the Agriculture Department's Animal Welfare Act regulations.

Ideals are plump, reality is skinny

Neuralink employees said in interviews that compared with other research institutions, the company’s practices on experimental animals are quite good in some aspects. For example, company leaders announced internally that they would build a "Monkey Disneyland" at the factory in Austin, Texas. Musk has also told employees that he wants the company's monkeys in the Bay Area to live in a "monkey Taj Mahal."

Monkeys in Neuralink indoor entertainment facilities. Image source: Neuralink.

# However, the ideal is very full and the reality is very skinny. When the animals are used in research projects, Neuralink's practices are apparently less gentle than claimed.

Frequent experimental animal death accidents

According to a person familiar with the matter and relevant information reviewed by Reuters, Neuralink had an error in 2021. An accident resulted in unnecessary animal deaths when 25 of 60 pigs tested in a study had the wrong size device implanted in their heads.

With sufficient preparation, such mistakes could have been avoided. The incident was a wake-up call for Neuralink researchers. In May 2021, scientist Viktor Kharazia wrote to colleagues that FDA study reviewers may view the accident as a "red flag" since the company plans to submit the study as part of an application to begin human trials. .

Later, Neuralink repeated the experiment on 36 sheep. Finally, all experimental animals, including pigs and sheep, were killed after surgery.

Such accidents are not unique. According to two people familiar with the matter and information reviewed by Reuters, employees accidentally mixed up the spines of different pigs where the Neuralink device was supposed to be implanted during two separate surgeries. In fact, mistakes can easily be avoided by carefully checking the pig spine before inserting the device.

Ultimately, company veterinarian Sam Baker recommended that colleagues kill the pig immediately to end its suffering, saying, "Given the slim chance of a full recovery and the dire situation at the moment, Psychological condition, we believe euthanasia is the only option."

Charged for animal experimentation

The original charges against Neuralink involved its relationship with the University of California, Davis An experiment in branch-campus cooperation. In February, animal rights group Physicians Committee for Responsible Medicine filed a complaint with the USDA accusing Neuralink and UC Davis of botched surgeries that led to the deaths of monkeys, and publicly released its findings.

The organization claims that surgeons twice used the wrong surgical glue, causing two monkeys to suffer and eventually die, while others suffered different injuries from their implants. complication.

Neuralink admitted that it killed six monkeys on the advice of UC Davis veterinary staff because of health problems resulting from the experiments. However, Neuralink calls the problems caused by the surgical glue a "complication" caused by using an "FDA-approved product."

Meanwhile, in response to Reuters, a spokesperson for the University of California, Davis, shared a previous public statement defending its research with Neuralink and stating that they Did not violate any laws or regulations.

A federal prosecutor in the Northern District of California referred the animal rights group’s complaint to the U.S. Department of Agriculture’s inspector general, who has launched a formal investigation, according to people familiar with the matter. USDA investigators later asked about the allegations regarding monkey research at UC Davis.

One of the people also said the investigation involves the testing and treatment of animals at Neuralink’s internal facilities, without elaborating. In 2020, Neuralink introduced the project and built a large number of related facilities in California and Texas.

Neuralink employees are beginning to stand on the side of the animals

In fact, Musk is gradually losing patience with Neuralink. Since its founding in 2016, Neuralink has repeatedly missed deadlines that Musk had sought to win regulatory approval to conduct human clinical trials, according to company documents and interviews with eight current and former employees.

Also, Musk is clearly feeling pressure from Neuralink’s competitors, such as Synchron. Also founded in 2016, the company is developing a different implant that's less ambitious than Neuralink in pursuing medical advances but received FDA approval in 2021 for human trials. Synchron develops devices that allow paralyzed patients to text and type with just their thoughts. The company also conducted animal experiments, but only sacrificed about 80 sheep in its research.

Employees sometimes refuse Musk’s requests to make progress. During a company discussion a few months ago, a manager said Musk encouraged them to perform a complex surgery quickly on pigs, prompting protests from some employees at the company. Their objection was that the complexity of the surgery would prolong the time the pigs were under anesthesia and jeopardize their health and recovery.

Therefore, the staff believes that they should first find out how to shorten the operation time. Speaking of the long hours of anesthesia, one of the employees said, "It's too hard on those piglets." Concerns about the experiment, a town hall meeting was held and the procedure explained. Soon after, the company also opened the meeting to the federal licensing committee that reviews animal testing.

Neuralink executives have publicly stated that the company only conducts animal experiments when there are no other options. For example, at the previous Neuralink Show & Tell event, Musk said, “Surgery is done at a later stage. The purpose of this phase is to confirm the operation of the device, not to test preliminary hypotheses. We are careful to ensure that the test is confirmatory rather than exploratory, and only use animal experiments as a last resort after other methods have been tried. ”

A month before Musk’s remarks, Autumn Sorrells, the company’s head of animal care, instructed employees to remove the word “exploratory” from study titles and banned future studies. use.

But Neuralink records reviewed by Reuters contain numerous references to exploratory surgeries spanning several years. Three people familiar with the matter also strongly refuted claims that Neuralink avoided exploratory testing on animals.

Inside Neuralink, some employees expressed concern about Autumn Sorrells’ request to change the description of the exploratory study, saying it would be inaccurate and misleading. Some people even pointed out that this move seemed to be a "whitewashing" of Neuralink's animal experiments.

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