Neuralink, led by Elon Musk, has achieved a significant milestone with the clearance from the U.S. Food and Drug Administration (FDA) for its inaugural human clinical trial. This clearance holds immense importance for the startup specializing in brain implants, particularly as it navigates ongoing investigations in the United States regarding its approach to animal experiments.
Neuralink, in a recent tweet, acknowledged the FDA approval as a significant initial stride towards leveraging their technology to benefit numerous individuals. While the specific study details were not disclosed, the company stated that it has not commenced recruitment for the trial but assured that further information would be forthcoming in the near future.
In an official statement, the FDA recognized that it has granted clearance to Neuralink for conducting trials on patients utilizing their brain implant and the associated surgical robot. However, the agency declined to furnish additional specifics regarding the clearance at this time.
Despite multiple requests for comment from Reuters, both Neuralink and Elon Musk have chosen not to respond.
As Neuralink achieves this significant milestone, it does so under the backdrop of federal scrutiny prompted by Reuters reports shedding light on the company's experiments on animals.
According to sources who spoke to Reuters in the previous year, Neuralink employees revealed that the company was conducting surgeries on sheep, monkeys, and pigs in a rushed and mishandled manner. These practices led to an excessive number of animal deaths, which could have been avoided. The sources claimed that Elon Musk exerted pressure on the staff to obtain FDA approval, and the experiments on animals were conducted to generate data supporting Neuralink's application for human trials.
Two years ago, the business inserted the incorrect-sized implants in 25 pigs out of the initial group of 60. Employees claimed that with better planning, the mistake might have been easily avoided before the pigs were all killed.
After Reuters published information about potential financial conflicts on the panel that oversaw Neuralink's animal testing, U.S. senators requested regulators to look into whether the composition of the panel played a role in the hurried and poorly executed studies.
Separate investigations are being conducted by the Department of Transportation to determine whether Neuralink transferred harmful germs on chips taken from monkey brains without the required containment procedures.
The Office of Inspector General for the U.S. Department of Agriculture is also looking into Neuralink for possible animal welfare breaches. This investigation focused on the USDA's control over Neuralink.
The investigation was started in response to growing staff anxiety that the corporation is hurriedly conducting trials that harm pigs, sheep, and monkeys.
Despite numerous requests for comment to the Reuters reports, neither Musk nor Neuralink ever did so.
According to FDA records and a Neuralink employee, as of a few weeks ago, the FDA has not checked Neuralink's laboratory.
Victor Krauthamer, an adjunct biomedical engineering professor with extensive experience at the FDA, including overseeing the office responsible for evaluating human-trial requests for brain implants, stated that the FDA typically does not conduct facility inspections as part of their review process for clinical trial applications. However, he expressed that considering the concerns surrounding Neuralink's animal experiments, such inspections would have been justified in this particular case.
Predictions
According to Reuters, Neuralink initially aimed to obtain approval for implanting its device in 10 patients. However, more recently, the company engaged in negotiations with the FDA to reduce the number of patients due to safety concerns raised by the agency. The exact number of patients approved by the FDA remains unknown at this time.
Musk thinks that brain implants might be used to treat conditions including obesity, autism, depression, and schizophrenia as well as telepathy and the capacity to explore the Internet. He rose to fame late last year when he said he had such high faith in the security of the devices that he would be willing to have his children implanted with them.
Starting from 2019, Elon Musk has made multiple predictions about the commencement of human trials for Neuralink. However, it was not until early 2022 that the company actually submitted an application for FDA permission. Unfortunately, as reported by Reuters in March, the government rejected the application.
Before approving human trials, the FDA had warned Neuralink about a number of safety issues that needed to be resolved, according to Reuters. Some of the problems included the implant's lithium battery, the potential for the wires to migrate inside the brain, and the difficulty of properly removing the device without injuring the brain.