An independent review board has allegedly given Musk's company the green light to start its brain-computer interface testing on people suffering from paralysis due to cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS).
Musk has previously claimed that Neuralink's brain-computer interface (BCI) called the Link "will enable someone with paralysis to use a smartphone with their mind faster than someone using thumbs."
However, Neuralink isn't the first or only company working on brain interface devices. For decades, scientists in various countries have been studying the potential use of implants and devices to treat health issues like depression and paralysis. To date, thousands of people are already using neuroprosthetics like cochlear implants for hearing.
But the extensive scope of capabilities Musk is promising for the Neuralink device has caused concern and doubt among experts.
Neuralink entered the industry in 2016 and designed the Link, an electrode-laden computer chip that can be sewn into the surface of the brain. The Link can be connected to external electronics and a robotic device that implants the chip.
John Donoghue, a neuroscientist at Brown University, said the brain implant's design seems to use a novel kind of electrode. He led the research team that worked on the brain-computer interface "BrainGate" to help restore movement for individuals with paralysis.
According to Musk, Neuralink’s device could be used for various therapeutic uses, such as treating conditions like blindness, paralysis and depression. He added that the eventual goal is to create a "general population device" that could connect a user’s mind directly to supercomputers and help humans keep up with artificial intelligence (AI).
Additionally, Musk suggested that the brain implant could one day be used to extract and store thoughts, like a "backup drive for your non-physical being, your digital soul."
Neuralink trial to last six years
Musk revealed that Neuralink will soon initiate recruitment for the first human trial of its brain implant. However, he didn't share any details about the number of participants to be enrolled in the trial, which is slated to take an estimated six years.
During the study, a robot will implant the chip in the brain region that control's a person's intention to move. Musk's aim is for the person's thoughts to control a computer cursor or keyboard using the brain implant. (Related: UNESCO warns against BRAIN CHIPS being used as “personality-altering weapons.”)
In May, Neuralink revealed that the company had obtained Food and Drug Administration (FDA) clearance for its first-in-human clinical trial. Neuralink initially wanted to test on 10 human volunteers, but it then reported that the undisclosed final number was reevaluated due to FDA concerns.
Despite Musk's bold claims of the BCI functioning as a backup drive for the "digital soul," the company still has far to go.
As of writing, Neuralink has tested the brain implants on animals. One video released in 2021 shows a monkey using the device to play the video game Pong with his mind. Another video from 2022 allegedly shows a monkey typing on a computer telepathically.
While the FDA approval cleared the first hurdle on a human clinical trial, the scope, focus and design of the study are still unclear.
To add to the worry and concern of experts not involved in the upcoming Neuralink trial, FDA applications and approval processes are not available to the public. As a private company, Neuralink does not need to disclose such regulatory interactions to investors.
Reports revealed that the FDA's safety concerns were linked to the brain implant’s lithium battery potentially overheating. The agency also had questions about whether the machine’s small wires could migrate to other parts of the brain and whether the device could be removed without damaging brain tissue. No details have been released about how these concerns were resolved.
The FDA declined to comment specifically on Neuralink’s application process, but a spokesperson said that, generally, the agency has a "scientifically rigorous process to evaluate the safety and effectiveness of medical devices." The FDA spokesperson added that the FDA has "a deep commitment to ensure the responsible and humane care of animals" included in testing.
Meanwhile, Neuralink declined to comment on its plans for the human clinical trials.
Report reveals Neuralink has killed over 1,500 animals in experiments since 2018
The FDA approval also comes amid an ongoing investigation into Neuralink’s testing practices, along with shocking allegations of animal cruelty.
A report from Reuters revealed that Neuralink has killed more than 1,500 animals since it started experimenting on them in 2018.
The death of animal test subjects is not uncommon in labs, but employees have reported that the mortality rate of Neuralink is higher than necessary because of Musk’s "grueling development timeline," which they claim has resulted in more mistakes and failed operations.
Former employees also described some experiments as "hack jobs." In one failed experiment, the wrong size of devices was installed in 25 of 60 pigs used for testing.
In another experiment, the device was accidentally implanted into the wrong vertebra of two different pigs during two separate surgeries. The animals were euthanized to end their pain and suffering.
Neuralink did not respond to Reuters' request for comment.
The FDA also declined to comment, citing laws keeping commercial information private.
Several of Neuralink's company’s founders, which included well-known and respected researchers in the field, have left the company. Since July 2022, only two of the eight founding members remain at Neuralink.
L. Syd M. Johnson, a neuroethicist at the Center for Bioethics and Humanities at the State University of New York Upstate Medical University (SUNY Upstate Medical University), has stated that she wants to know exactly "what the FDA was thinking."
According to Johnson, one of the concerns about Musk's company is that "it’s not functioning in the way that many other research laboratories or organizations function."
"There are concerns about the potential that they are performing a kind of sloppy work and that their data may not be reliable," she concluded.
Amid the allegations and criticism about Neuralink's cruel animal studies, Musk has denied the tragic animal deaths.
Earlier in September, Musk replied to a meme of himself on X (formerly Twitter) where a user joked that he should take an ethics class after the death of the animal subjects involved in the company's experiments. In his reply, Musk insisted that "No monkey has died as a result of a Neuralink implant."
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Watch the video below to learn more about the hidden dangers of Neuralink.
This video is from the Kim Osbol - Copenhagen Denmark channel on Brighteon.com.
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WEF speaker touts technology allowing companies to monitor employees’ brains.
Ethical questions raised after Elon Musk’s Neuralink company implants chip in monkey’s brain.
UNESCO: Combination of neurotechnology and AI threatens mental privacy.
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