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Last week, Musk also said confidently that Neuralink is expected to conduct human tests within 6 months, and this time it is probably going to be ruined.
Last week, Musk held a Neuralink Show & Tell demonstration event to show the world the latest progress of brain-computer interface . At the meeting, Musk said that it was very difficult to go from prototype to production and faced many challenges. Neuralink has been working hard to initiate human trials and has submitted all the documents required to start the human trials to FDA. Musk estimates that the first Neuralink device could enter the human brain within 5-6 months. Musk emphasized at the meeting that Neuralink respects animal subjects and that brain-computer interface devices have been extensively benchmarked before they are implanted into animals. Both Monkey Pager and Sake have successfully implanted Neuralink’s upgraded devices.
The following sentence "can i please have snacks" is written by Sake (Can you give me some snacks?)
However, a few days after the conference was completed, according to the information of Reuters and relevant people familiar with the matter, The medical equipment company Neuralink, created by Elon Musk , is undergoing a federal investigation in the United States for suspected infringement of animal rights. Employees believe that the company's animal experiments have caused unnecessary pain and death because they were too hasty.
Inadequate preparation and excessive pressure, employees are rushing to complete the task before the deadline
As we all know, Neuralink is developing brain implant technology to help paralyzed people walk again or cure other neurological diseases. According to people familiar with the matter, the USDA inspector general recently conducted the federal investigation at the request of federal prosecutors. One of the people familiar with the matter said that the focus of the investigation is whether the company violates the Animal Welfare Act , which mainly supervises researchers how to treat animals and experiment with animals
Neuralink Implant: N1. About the size of a quarter of a coin, it can be used to record and stimulate signals.
Reuters looked up dozens of related documents from the company (including previously unreported information, recordings, emails, presentations and reports), and interviewed more than 20 current and former employees and found that the investigation was underway, employees were increasingly quarreling against Neuralink’s animal experiments, and the failure of the experiment was caused by pressure from Musk to speed up the process. These employees said that the unqualified test had to be repeated, which undoubtedly increased the number of animals tested and dead.
Musk and other Neuralink executives have not responded to requests for comment.
Because the US regulatory regulations do not specify the number of animals used by company research institutes, and give scientists a lot of room for maneuver when and how to use animals in experiments. Regulatory filings show that Neuralink has passed all USDA inspections of its facilities.
According to information obtained by Reuters, since the company launched its experiments in 2018, it has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys. This is just a rough estimate because the company has not kept an accurate record of the number of animals tested and killed, people familiar with the matter said. Neuralink also conducted studies with rats and mice.
The total number of animal deaths does not necessarily indicate that Neuralink violates regulations or research practice standards. Many companies often use animals to experiment to promote the development of human health care, and they face economic pressure to quickly bring their products to the market. Usually, after the experiment is completed, these animals are killed so that research examinations can be performed after they die.
However, Neuralink's on-the-job and former employees said that the number of animals died higher than they actually needed as Musk asked to speed up the research.Through years of company meetings and documents, as well as interviews with employees, Reuters confirmed that in recent years, four experiments (including 86 pigs and two monkeys) have been affected by human error. These cognitive errors reduce the research value of the experiments, so repeated trials are needed, which leads to more animals being killed, three on-the-job and former employees. People familiar with the matter believe that the mistake is that testers working in high-pressure environments have failed to make sufficient experimental preparations.
In order to verify the effect of Neuralink, the researchers implanted the above-mentioned device in the pig's body.
Earlier this year, an employee in a letter to his colleagues, said indignantly that the company needs to completely reform the way animal surgery is carried out so that it can prevent criticism. The employee also wrote that the hasty schedule has led to underprepared and overpressed employees rushing to complete the task before the deadline, and many adjustments were made at the last minute before the operation, which threatened the safety of the animals.
Both on-the-job and former employees said that Musk has been working hard to speed up the development of Neuralink, which largely relies on animal experiments. Earlier this year, Musk sent employees a news article about an electronic implant device developed by researchers in Switzerland, helping a paralyzed man walk back. He wrote to employees and said, "We can let people reuse their hands and feet in their daily lives! Overall, our movements are not fast enough. This is driving me crazy!"
people familiar with the matter also said that over the years, Musk always made employees imagine that they had an bomb tied to their heads, so that they could move faster. A few years ago, Musk told employees that if they can’t make greater progress, this would cause Neuralink’s market to fail .
6 months human trial plan may be ruined
Five employees involved in Neuralink animal experiments told Reuters that they have expressed this concern within the company. They said they advocated a more traditional test method, that is, researchers first tested one element at a time in animal studies, and then conducted other animal tests after drawing relevant conclusions. Neuralink will conduct tests in rapid succession before fixing problems in early testing or reaching complete conclusions, people familiar with the matter said. The result is that more animals often need to be tested and killed, partly because this approach leads to repeated tests.
A former employee asked management to be more cautious about experiments a few years ago, but an executive told him that this was impossible given Musk's speed requirements. The two told Reuters that they left the company because of concerns about animal research.
Three in-service and former employees said that Neuralink's testing issues raised questions about the quality of the result data within the company. These issues may delay the company's plan to start human trials, and Musk has said the company hopes to start human trials within the next six months. These incidents have also made Musk more and more troublesome. He recently acquired Twitter for $44 billion. Many people are currently criticizing him for his management capabilities, and he also runs electric car maker Tesla and rocket company SpaceX.
The U.S. Food and Drug Administration (FDA) is responsible for reviewing the company's application for approval for medical devices and related experiments. However, the FDA did not immediately comment on the way the company treats animals during the research process under the USDA Animal Welfare Act.
Ideal is full, reality is skinny
Neuralink Employees said in an interview that compared with other research institutions, the company has done quite well with experimental animals in some aspects. For example, the company's leaders internally claimed that they would build a "monkey Disneyland" at their factory in Austin, Texas.Musk also told employees that he wanted the monkeys who were experimenting in the San Francisco Bay Area to live in the "Monkey Taj Mahal".
Neuralink Monkey in indoor entertainment facilities. Source: Neuralink.
However, ideals are full and reality is skinny. When these animals were used in research projects, Neuralink’s approach was obviously not as mild as claimed.
Frequent deaths of experimental animals
According to a person familiar with the matter and relevant information reviewed by Reuters, Neuralink had an accident that caused unnecessary animal deaths due to mistakes in 2021. At that time, 25 of the 60 pigs tested in a study had their heads implanted with incorrect equipment.
If fully prepared, such errors could have been avoided. The accident sounded a wake-up call for Neuralink researchers. In May 2021, scientist Viktor Kharazia said in a letter to colleagues that FDA research examiners may view the accident as a "red flag" and the company plans to submit the study as part of an application to start a human trial. After
, Neuralink repeated the experiment on 36 sheep. Finally, all experimental animals, including pigs and sheep, were killed after the operation. An accident like
is not an isolated case. According to two people familiar with the matter and relevant information reviewed by Reuters, an employee accidentally confused the spine of different pigs that the Neuralink device should have been implanted in two different surgeries. In fact, just carefully check the pig's spine before inserting the device to easily avoid errors.
Finally, company veterinarian Sam Baker advised colleagues to kill the pig immediately to end its pain, saying, "Given the small chance of it recovering completely and its current poor mental state, we think euthanasia is the only desirable approach."
was charged for animal experiments
The initial allegations against Neuralink involved its experiments in collaboration with UC Davis . In February, the U.S. Committee of Responsible Medical Physicians, an animal rights group, filed a complaint with the U.S. Department of Agriculture alleging that the monkey died in a failed surgery program at Neuralink and the University of California, Davis, and publicly released its findings.
tissue claimed that the surgeon used the wrong surgical glue twice, causing the two monkeys to suffer and eventually die, while the others experienced different complications due to the implant.
Neuralink admitted that they killed 6 monkeys at the advice of UC Davis veterinarians due to health problems caused by the experiment. However, Neuralink calls the problem caused by surgical glue "complications" caused by using "FDA-approved products."
At the same time, a UC Davis spokesperson shared a previous public statement in response to Reuters, defending his research with Neuralink and saying they did not violate any laws and regulations.
According to relevant people familiar with the matter, a federal prosecutor in the Northern District of California submitted a complaint from the animal rights organization to the US Department of Agriculture Inspector General, who has initiated a formal investigation. USDA investigators then asked about allegations about the UC Davis monkey study.
One of the people familiar with the matter also said the investigation involved testing and treatment of animals in an internal Neuralink facility, but was not specified in detail. In 2020, Neuralink introduced the project and built a large number of related facilities in , California, and Texas.
Neuralink Employees began to stand on the side of animals
In fact, Musk is gradually losing patience with Neuralink. Since its inception in 2016, Neuralink has repeatedly missed the deadline Musk has won for regulatory approval for human clinical trials, according to the company’s documents and interviews with eight in-service and former employees.
In addition, Musk obviously felt pressure from Neuralink competitors, such as Synchron.Also founded in 2016, the company is developing a different implant that is not as ambitious as Neuralink in chasing medical progress, but received FDA approval in 2021 to conduct human trials. Synchron developed devices allow paralyzed patients to send and receive text messages and type through thoughts. The company also conducted animal experiments, but only about 80 sheep were sacrificed in the study.
Employees sometimes refuse Musk's request to catch up with the progress. During a company discussion a few months ago, a manager said Musk encouraged them to quickly complete a complex surgery on pigs, which was subsequently protested by some of the company’s employees. Their objection is that the complexity of the surgery can prolong the anesthesia of pigs and endanger their health and recovery.
Therefore, employees believe that we should first find out how to shorten the operation time. Speaking of prolonged anesthesia, one of the employees said, "This is too difficult for those pigs."
In September, Neuralink held a town hall meeting in response to employees' concerns about their animal experiments and explained the experiment process. Soon after, the company also opened the meeting to the federal authorized committee responsible for reviewing animal tests.
Neuralink executives have publicly stated that the company only conducts animal experiments when there is no other option. For example, at the previous Neuralink Show & Tell event, Musk said, "The surgery is used in the later stages, with the purpose of confirming the operation of the equipment, rather than testing the pre-examination. We are cautious. To ensure that the test is confirmatory, not exploratory, animal experiments will be used as a last resort after trying other methods."
A month before Musk made the above remarks, the head of the company's animal care department Autumn Sorrells instructed employees to remove the term "exploratory" from the study title and prohibit future use.
However, the Neuralink record reviewed by Reuters contains a large number of references on exploratory surgery over the past few years. Three people familiar with the matter also strongly refuted Neuralink’s claim to avoid exploratory trials on animals.
Inside Neuralink, some employees expressed concern about the requirements for Autumn Sorrells to change the Exploring Research Description, saying it would be inaccurate and misleading. Some people even pointed out that this move seems to be a "whitewash" in Neuralink animal experiments.
Original link: https://www.reuters.com/technology/musks-neuralink-faces-federal-probe-employee-backlash-over-animal-tests-2022-12-05/
