Neuralink's Animal Experiments Under FDA Fire

Neuralink’s alleged animal mistreatment skeletons may be coming back to haunt the company after FDA recently cited problems with record keeping and quality controls for animal experiments at its California research facility.

The company is developing a brain implant to help patients paralyzed by spinal cord injury or Lou Gehrig’s disease communicate using thoughts to control a computer device. Facilities in California and Texas were used for animal testing on monkeys, along with other animals, to progress Neuralink’s technology. The issues documented by FDA include findings from the California facility, noting that no such issues were seen at its Texas facility.

FDA reportedly visited the facility last year from June 12 to 22 – representing the agency’s sole inspections of the company’s facilities on record. Inspectors identified a litany of problems at the site, including missing calibration records for instruments such as a pH meter used in one of the studies and, for another study, seven instruments including a vital signs monitor which had no record of having been calibrated. Additional issues at the facility included quality assurance officials not signing off on the final study report or documenting any deviations from approval protocols or standard operating procedures.

Currently, FDA has not issued a designation detailing the severity of problems found at the inspection, according to the agency database. Reuters, who first broke the news of the report, wrote that according to experts, “While the problems identified are serious, they do not appear to be significant enough to justify the FDA's worst inspection designation, which would prompt action.”

The agency routinely conducts inspections after human trial approval and before commercial approval to “assure data integrity and reliability”, along with compliance with accompanying FDA regulations, Carly Pflaum, an FDA spokesperson, told Reuters.

Neuralink, which obtained FDA approval in May 2023 to start human trials for its implantable, cited its animal research data in the application to the agency. Just last month, the company reported that its first human patient had been implanted with the brain chip and appears to have fully recovered. The patient, according to Elon Musk, CEO of Neuralink, in a Spaces event on social media platform X, previously known as Twitter, is able to control a computer mouse using their thoughts.

Experts have questioned why FDA had not inspected Neuralink before giving approval for its in-human trails since concerns about its animal subjects have been reported since 2022. The agency has jurisdiction to conduct such an inspection before permitting a company to begin its clinical trial and has done so before in other cases.

Victor Krauthamer, a former long-time FDA official, told Reuters, “It would have made sense for the FDA to have conducted the inspection before human trial approval. These are violations of fundamental requirements that you don’t want to worry about happening again in the human trial."

Previous allegations

This, however, isn’t the first time Neuralink has been on the wrong side of animal-welfare violation allegations. MD+DI reported in December 2023 that the company was being accused of animal suffering and death during its research into the brain implant. An exclusive Reuters report revealed multiple internal staff complaints that animal testing was being rushed, resulting in needless suffering and death of its testing animals.

“Some complaints stated that Elon Musk, the CEO of Neuralink, was pressuring employees to accelerate development despite resulting botched experiments,” according to previous MD+DI reporting. “These failed tests would have had to be repeated, 20 current and former employees told Reuters, increasing the testing and subsequent killing of more animals.”

Additionally, the Physicians Committee for Responsible Medicine, an advocacy group, filed a complaint with the US Department of Agriculture (USDA) in early 2022, alleging that the company was mistreating its animal subjects and causing unnecessary animal deaths. Neuralink denied these allegations.

The USDA did, however, opt to open a probe into Neuralink’s treatment of animals at the end of 2022.

In an email to MD+DI at the time, USDA Office of the Inspector General wrote, "USDA OIG neither confirms nor denies the existence of any such investigation. We have no comment."

In summer 2023, an update from Secretary Thomas Vilsack in a letter to Oregon Congressman Earl Blumenauer stated that the agency had not found violations at the facilities apart from a company reported incident in 2019. It was further noted that more inspections were planned.

Industry reaction

The FDA report detailing the problems at Neuralink’s California facility has sparked renewed concern over company transparency.

In an article by Forbes, industry experts raised questions about Neuralink’s blasé approach to communicating scientific news, and the ethicality of not registering its implant trial on ClinicalTrials.gov — a public database in which most clinical trials are registered for transparency and accountability.

Neuralink’s dissemination of important information usually comes from social media posts on Musk’s X platform rather than traditional peer reviewed publications, or repositories, which Marcello Ienca, a professor of ethics of AI and neuroscience at Technical University of Munich, told Forbes, “Seems to sidestep the established protocols that underpin scientific integrity,” and prevents experts from evaluating the full scope and impact of claimed advances.

Additionally, while not illegal for the company to not have registered its clinical trial on ClinicalTrial.gov, Ienca said not doing so “violates fundamental ethical guidelines for biomedical research.” Specifically, she cited the Declaration of Helsinki, a cornerstone statement of ethical principles for medial research involving humans. Neuralink has not communicated to the public that it has set up any internal ethics board or code of ethics and has not engaged in any major activities from policy organizations like OECD, according to Forbes.

Neuralink did not respond to MD+DI’s request for comment.