Neuralink, Elon Musk’s biotechnology startup, announced its opening for human clinical trials on Tuesday. What would it take for you to be willing to sign up for Neuralink recruitment?
The brain implant startup received FDA approval for human trials after five years in the making. The research on humans with paralysis will be a part of the Precise Robotically Implanted Brain-Computer Interface, or the "PRIME" study for short. The study will look at the safety and functionality of the brain implant.
But how safe is the implant, and how much do we really know about it?
Those with paralysis brought on by amyotrophic lateral sclerosis (ALS) or cervical spinal cord damage may be eligible for the study. Still, Neuralink did not specify how many people would be able to sign up for the trial, which would last for around six years.
The study's primary objective, according to Neuralink, is to make it possible for individuals to operate a computer cursor or keyboard just with their thoughts. To do this, a brain-computer interface (BCI) implant will be surgically implanted by a robot in a part of the brain that governs the desire to move.
Andrew Jackson, Ph.D., a professor of Neural Interfaces at Newcastle University, said, "The Neuralink technology has made some advances, mainly a wireless subcutaneous device, increased channel count and the robotic assistance for implantation. It is one of a number of new technologies that are at the stage of early trials with small numbers of people (see also Synchron) with the potential in the future to offer improved assistive technologies for people with paralysis."
Musk claims that Neuralink would enable quick surgical insertions of its chip devices to cure obesity, autism, depression, and schizophrenia.
Experts predict that it might take the firm more than 10 years to obtain commercial use permission for the BCI device, even if it is safe for human usage.
Musk's company isn't the only one experimenting with brain implants, either. L. Syd M Johnson, Ph.D., associate professor and ethics consultant at the Center of Bioethics and Humanities at Upstate Medical University told Healthnews, "Several companies are currently experimenting with humans using brain-computer interfaces, and this research has been ongoing for several years." She said, "Neuralink is the least likely to advance science in this area."
Controversy with Neuralink
"It's clear Neuralink's device poses huge safety risks to patients," said Ryan Merkley, Director of Research Advocacy at the Physicians Committee for Responsible Medicine (PCRM) to Healthnews.
PCRM is a nonprofit that advocates against using live animals for testing. Neuralink recently fell under fire when WIRED published a piece on animal abuse and the death of a monkey in 2022 based on published documents from PCRM asking that the University of California, Davis, where the animal studies were conducted, and Neuralink be investigated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service in violation of the Animal Welfare Act.
"Monkey experiments conducted by the company resulted in chronic infections, seizures, paralysis, and parts of the device breaking off in the brain. Last year, the FDA raised serious safety concerns when it initially rejected Neuralink's application for human trials," explained Merkley. "The company should invest in a noninvasive device, which wouldn't come with the same risks."
"The company’s record with preclinical animal trials is abysmal, and they’re under investigation by several federal agencies for activities related to their botched research with nonhuman primates."- Johnson
The company’s record with preclinical animal trials is abysmal, and they’re under investigation by several federal agencies for activities related to their botched research with nonhuman primates. They have no proven record of being able to safely conduct animal trials, let alone trials with human subjects. It’s a mystery to me why the FDA has approved them for human clinical trials. It’s unconscionable. If they ever find people gullible enough to sign up, it’s likely there will be severe adverse events, and possibly deaths.
Moreover, former employees told Reuters in December that the startup is rushing to market and could possibly put human lives at risk. According to current and former workers, the business negotiated fewer patients with the U.S. Food and Drug Administration (FDA) after the agency expressed safety concerns.
Johnson said, "It’s a mystery to me why the FDA has approved them for human clinical trials. It’s unconscionable. If they ever find people gullible enough to sign up, it’s likely there will be severe adverse events, and possibly deaths."
The company had previously intended to gain clearance to implant its device in 10 people. How many patients the FDA finally authorized is unknown.
"Hundreds of pages of public records and reports from company whistleblowers have revealed sloppy, rushed experiments on animals," said Merkley. "Neuralink appears to be operating with the Silicon Valley mindset of 'move fast and break things.' That's a dangerous plan for a medical device company."