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Elon Musk’s Neuralink ought to be disqualified from FDA approval, advocacy groups says

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An advocacy group of greater than 17,000 doctors has petitioned the Food and Drug Administration (FDA) to disqualify Elon Musk’s Neuralink from receiving approval for its brain implant.

The Physicians Committee for Responsible Medicine (PCRM) claims Neuralink has violated the ‘good laboratory practices’ (GLP) regulations, which ensures the standard and integrity of non-clinical laboratory studies, with its ‘hack job’ surgeries and staff ‘manipulating data.’

Among the animal’s deaths were by the hands of Matthew McDougall, the pinnacle neurosurgeon, who administered nearly six times the quantity of an unapproved ‘toxic’ substance that led to a monkey’s death, a former Neuralink worker told DailyMail.com. 

Ryan Merkley, PCRM’s director of research advocacy, told Dailymail.com that McDougall, who can also be a neurosurgeon for Sutter Health in San Francisco, didn’t follow protocol on several occasions.

This was stated in messages written by John Morrison, the study director on the University of California, Davis (UC Davis), Merkley added.

The group of doctors claims the company and its neurosurgeon, Matthew MacDougall (pictured), violated FDA's good laboratory practices' (GLP) regulations

Elon Musk said his Neuralink is searching for FDA approval to begin human trials, but a bunch is attempting to block these efforts. The group of doctors claims the corporate and its neurosurgeon, Matthew MacDougall (right), violated FDA’s good laboratory practices’ (GLP) regulations

DailyMail.com has contacted Neuralink and McDougall. 

Musk announced earlier this month that Neuralink had submitted ‘most of its’ paperwork with the FDA and expected to begin human trials in six months.

‘There are whistleblower reports of animals receiving the fallacious size device and implantation sites, all of which might have been fixed if the corporate slowed down,’ Merkley said.

‘But there was pressure to maneuver fast and so they deviated from protocol.’ 

These reports have led the US Department of Agriculture (USDA) to open a federal investigation into Neuralink for animal-welfare violations, but PCRM is hoping the FDA will follow suit. 

PCRM filed a lawsuit against UC Davis in February to realize access to 700 pages of lab notes from Neuralink staff that detail experiments. DailyMail.com has obtained copies of the notes.

If the FDA disqualifies Neuralink, the primate facility at UC Davis may very well be disqualified from conducting its experiments since testing was presupposed to be overseen by Morrison, who works for the university.

Nevertheless, Morrison’s role was to make sure Neuralink followed the GPL and, based on PCRM, he didn’t achieve this.

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

In accordance with the FDA, GPL is ‘a high quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.’ 

PCRM told DailyMail.com that McDougall is liable for administering BioGlue to 2 monkeys, each of whom died resulting from complications.

He instructed staff in 2018 to manage 15 to twenty milliliters when it must have been three to 5, the person accustomed to the matter said. 

‘There was no reason to make use of it,’ the previous Neuralink worker told DailyMail.com.

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

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

McDougall also kept the animal alive for an additional 24 hours to watch the aftereffects, lab notes show, which also state the monkey suffered brain swelling, partial paralysis, bleeding in her lungs and ulcers in her esophagus resulting from excessive vomiting

Reuters reported on a 2019 document labeled ‘Neuralink Company Confidential Do Not Distribute’ that describes a second incident with the BioGlue.

The document states that ‘a Neuralink surgeon deviated from approved protocol in a scheduled terminal surgery through the use of material (‘BioGlue’) [sic] which was not approved to be used in our study.’

Each monkeys were euthanized.

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

DailyMail.com obtained lab notes from experiments conducted at the California National Primate Research Center. Neuralink's head neurosurgeon Matthew MacDougall's name is shown. This note reads: 'Dr. MacDougall says edges smooth (not sharp)

DailyMail.com obtained lab notes from experiments conducted on the California National Primate Research Center. Neuralink’s head neurosurgeon Matthew MacDougall’s name is shown. 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  'cranial sealant' was administered on a monkey's skull that, led to its death

PCRM is attempting to dam Neurlink’s FDA approval resulting from an incident in 2018, when  ‘cranial sealant’ was administered on a monkey’s skull that, led to its death

In accordance with CryoLife, the firm that developed the sealant: ‘When used improperly, or applied incorrectly, serious adversarial events have been reported regarding compression of adjoining anatomic structures.

And the outcomes seen in Neuralink’s experiments suggest it was misapplied.

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

‘The explanation we’re filing a request with FDA is since it oversees other regulations, quality and rigor of non-clinical and clinical testing,’ Merkley told DailyMail.com.

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

UC Davis staff wrote that the monkey should only be kept for an additional 24 hours resulting from its declining condition after which euthanized

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

The notes (pictured) state Bioglue was the reason behind death.  Neuralink has admitted in a blog post that one in all the monkeys died due to adhesive

‘The actual fact [Neuralink] is making mistakes and altering records is a significant issue, and the FDA must trust paperwork.

‘It is tough to trust Neuralink’s paperwork.’ 

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

‘As a part of this work, two animals were euthanized at planned end dates to collect necessary histological data, and 6 animals were euthanized on the medical advice of the veterinary staff at UC Davis,’ reads a Neuralink blog post. 

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

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