Elon Musk’s Neuralink should be barred from FDA approval, stakeholders say

An advocacy group of more than 17,000 doctors has petitioned the Food and Drug Administration (FDA) to bar Elon Musk’s Neuralink from being approved for his brain implant.

The Physicians Committee for Responsible Medicine (PCRM) alleges that Neuralink’s “hack job” operations and staff “data manipulation” violated Good Laboratory Practices (GLP) regulations that protect the quality and integrity of nonclinical laboratory studies guarantee. ‘

Some of the animal’s deaths were attributed to Matthew McDougall, the lead neurosurgeon, who administered nearly six times the amount of an unapproved “toxic” substance that resulted in a monkey’s death, a former Neuralink employee told DailyMail.com.

Ryan Merkley, director of research advocacy at PCRM, told Dailymail.com that McDougall, who is also a neurosurgeon for Sutter Health in San Francisco, failed to follow the protocol on several occasions.

This was stated in communications from John Morrison, the study leader at the University of California, Davis (UC Davis), Merkley added.

Elon Musk said his Neuralink is seeking FDA approval to start human trials, but a group is trying to block those efforts. The group of doctors allege the company and its neurosurgeon Matthew MacDougall (right) violated FDA good laboratory practice (GLP) regulations

DailyMail.com has contacted Neuralink and McDougall.

Musk announced earlier this month that Neuralink has filed “most of its” filings with the FDA and is expected to begin human trials in six months.

“There are whistleblower reports of animals being given the wrong size devices and implant sites, all of which could have been fixed if the company had slowed down,” Merkley said.

“But there was pressure to act quickly and they deviated from protocol.”

These reports have prompted the US Department of Agriculture (USDA) to launch a federal investigation into Neuralink for animal welfare violations, but PCRM hopes the FDA will follow suit.

PCRM filed a lawsuit against UC Davis in February to gain access to 700 pages of lab notes from Neuralink employees detailing experiments. DailyMail.com received copies of the notes.

If the FDA disqualifies Neuralink, the primate facility at UC Davis could be disqualified from conducting its experiments because the tests should be overseen by Morrison, who works for the university.

However, Morrison’s role was to ensure that Neuralink followed the GPL, and according to the PCRM he did not.

DailyMail.com spoke to Morrison about the allegations and Neuralink experiments, but he declined to comment.

According to the FDA, GPL is “a quality system that addresses the organizational process and conditions under which nonclinical health and environmental safety studies are planned, conducted, monitored, recorded, archived, and reported.”

PCRM told DailyMail.com that McDougall was responsible for administering BioGlue to two monkeys, both of which died from complications.

He instructed staff to give 15 to 20 milliliters in 2018 when it should have been three to five, the person familiar with the matter said.

“There was no reason to use it,” the former Neuralink employee told DailyMail.com.

Elon Musk’s Neuralink has come under fire over animal cruelty allegations during experiments at the University of California, Davis, where implants were placed in the monkey’s brain (pictured is a scan from the university showing the implant in an animal’s brain).

McDougall also left the animal alive for an additional 24 hours to observe the after-effects, according to lab notes that also state the monkey suffered from brain swelling, partial paralysis, bleeding in the lungs and ulcers in the esophagus due to excessive vomiting

Reuters reported a 2019 document entitled Neuralink Company Confidential Do Not Distribute describing a second incident involving the BioGlue.

The document states that “a Neuralink surgeon deviated from the approved protocol in a planned final surgical procedure by using material (“BioGlue”). [sic] which was not approved for use in our study.’

Both monkeys were euthanized.

BioGlue is a protein hydrogel that bonds to tissue and mechanically bonds to synthetic materials.

DailyMail.com obtained lab notes from experiments conducted at the California National Primate Research Center. The name of Neuralink’s lead neurosurgeon, Matthew MacDougall, is displayed. This note reads: “Dr. MacDougall says edges smooth (not sharp)

PCRM is attempting to block Neurlink’s FDA approval due to an incident in 2018 when “skull sealant” was applied to a monkey’s skull, resulting in its death

According to CryoLife, the company that developed the sealant, “Serious adverse events associated with compression of adjacent anatomical structures have been reported when misused or misapplied.

And the results of Neuralink’s experiments suggest it was misapplied.

MacDougall was involved in a 2016 study that experimented on two monkeys, where he drilled holes in the monkeys’ skulls and attached a steel head post to the animals’ skulls.

“The reason we are submitting an application to the FDA is that they oversee other regulations, the quality and rigor of non-clinical and clinical testing,” Merkley told DailyMail.com.

UC Davis staff wrote that due to its deteriorating condition, the monkey should only be kept for another 24 hours and then euthanized

The notes (pictured) state that Bioglue was the cause of death. Neuralink admitted in a blog post that one of the monkeys died from the glue

‘The fact [Neuralink] makes mistakes and changing records is a serious problem and the FDA needs to trust the paperwork.

“It’s hard to trust Neuralink’s records.”

Neuralink has confirmed that it conducted tests at the university and previously noted that several animals were euthanized during the experiments.

“As part of this work, two animals were euthanized on planned end dates to collect important histological data, and six animals were euthanized on the medical advice of UC Davis veterinary staff,” reads a Neuralink blog post.

PCRM suggests that advances in brain-machine interfaces can be made using human-relevant methods, including non-invasive methods and data collected from patients during medically necessary neurosurgery.