In a recent development that has stirred the tech and health communities, US Representative Earl Blumenauer has raised serious concerns regarding the Food and Drug Administration's (FDA) oversight of Elon Musk's Neuralink. The Oregon Democrat is questioning why the FDA seemingly turned a blind eye to "troubling evidence" of animal testing violations by Neuralink, especially before the company was greenlit to implant its first brain chip into a human patient in May 2023.
Blumenauer's inquiries stem from a letter he dispatched to the FDA, seeking clarity on why the agency allowed Neuralink to proceed with human trials despite alleged lapses in standard operating procedures during its animal experiments. These lapses, according to Blumenauer, not only jeopardized animal welfare but also risked the integrity of data crucial for human trials. The FDA, in response, has assured that it found no evidence suggesting Neuralink's human trials would be unsafe, emphasizing its routine inspections of human trials post-approval.
However, the backdrop to this controversy includes a series of unsettling findings. Last year, the FDA identified issues in Neuralink's animal experiments in California, highlighting concerns over quality control, inadequate record-keeping, and uncalibrated medical instruments. A Reuters investigation further revealed that seven Neuralink instruments, including vital signs monitors, had not been calibrated during animal tests.
Adding to the company's woes, in 2022, the US Department of Agriculture initiated an investigation into Neuralink following employee complaints about rushed animal testing leading to unnecessary suffering and deaths. The investigation uncovered that Neuralink's "botched" experiments had resulted in the deaths of over 1,500 animals, including monkeys, sheep, and pigs, by December 2022.
This controversy has not only cast a shadow over Neuralink's pioneering efforts in brain-computer interfaces but also raised questions about the FDA's regulatory vigilance. As the debate unfolds, the tech and medical communities are keenly awaiting further developments and the FDA's comprehensive response to the concerns raised by Blumenauer and his congressional colleagues[1].
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