United States – U.S. Food and Drug Administration inspectors unveiled problems with its record keeping and quality controls for animal trials that took place at Elon Musk’s Neuralink, less than a month after the startup said it got registration to start its trial to implant the brain with humans. Reuters reviewed the report.
Texas Plant Inspection
The inspection disclosed shortcomings in quality control at the Canadian biomedical company that operates an animal research facility in California. An inspection at the Neuralink Texas plant didn’t find any deficiencies consistent with the agency’s record.
In 2020, the period of time from June 12 to June 22 was when the only visits from the FDA to Neuralink facilities were conducted. The records of this visit are the sole records obtained from the FDA so far. Reuters published the company inspector reports, which were directly obtained by Redica Systems, a data analytics company that gets FDA compliance reports through the open records requests.
Implications for Human Studies
“These issues show a lack of attention to detail,” said Jerry L. Chapman, a senior quality expert with Redica Systems.
During the FDA inspection, the problems identified in the laboratory where such as missing calibration records for the pH meter which was used in the research carried out. One study involved seven items, including a “vital sign monitor” whose recalibration record could not be found. The number of animals the company experimented on with Neuralink reached hundreds of them, for example monkeys.
Yet other problems were the lack of quality assurance supervisors for finalizing the study conclusion report or justifying any deviations from the approved protocols or the standard operating procedure.
According to Chapman, “This is definitely a signal that the company needs to be vigilant about certain practices.” He also mentioned that the corporation would have to adhere to the same procedures for its human studies.
The brain implant is now being tested to let patients who cannot use their limbs due to spinal cord injury or ALS, also known as Lou Gehrig’s disease, merely think about moving a computer device or similar.
USDA Investigation and Animal Welfare Concerns
As reported by Reuters in mid-December 2022, the USDA investigators were reportedly looking into the possibility of animal welfare violations in Neuralink after internal staff had complained about excessive animal testing, which instead led to unnecessary suffering and deaths. The animal welfare NGO, Physicians Committee for Responsible Medicine, filed the form complaint denouncing breaches to both the FDA and USDA.
In early July, the USDA mentioned that there were no violations of animal research rules except for one incident in 2019 that had been reported by Neuralink and had been taken into consideration.
Specifically for animal research, the Food and Drug Administration has its own requirements, called Good Laboratory Practice, to provide a basis when any scientific data is being generated during medical device or drug development to be relied upon, three regulatory experts told Reuters.
FDA’s Data Integrity Assurance
Neuralink refers in its FDA request to the existence of animal data as evidence to test the implants in humans. Musk, the company’s wealthy CEO, had made a public announcement in May that his device was approved for human trials and claimed in the last month that the first patient had got the implant and was doing well.
Neuralink representatives did not provide any comment when asked about the inspection of the FDA.
Without the FDA declaring the problem as the most serious one based on the data entered into the FDA’s database, concerns might arise. But the issues profess to be pretty bad. They don’t look like a seed of taking the FDA’s harshest choices that would open the action mentioned by the experts.
Ongoing FDA Monitoring and Safety Assurance
According to the FDA spokesperson Carl Pflaum, Neuralink gave justified enough details about their trial on humans to grant it permission. The institution survives on regular audits, Pflaum said, from the commencement of a human trial to before the commercial launch to assure data integrity, reliability, and compliance with other FDA regulations.
“The FDA will always continue to monitor the safety of those enrolled in the study for Neuralink’s implant device through required, regular reports,” Pflaum said.
Concerns voiced by his organization months prior, Ryan Merkley, director of research advocacy at the animal rights nonprofit PCRM, said the FDA should have reviewed Neuralink before approving the human experiment.
Former long-time FDA official Victor Krauthamer stated that the agency had the authority and had previously carried out the examination prior to approving the company to proceed with its clinical research.
“It would have made sense for the FDA to have conducted the inspection before human trial approval,” said Krauthamer, who once reviewed human-trial requests for brain implants at the agency. “These are violations of fundamental requirements that you don’t want to worry about happening again in the human trial.”