Reuters reported last month that FDA inspectors found
problems with record keeping and quality controls for animal experiments at
Neuralink last June, less than a month after the startup said it was cleared to
test its brain implants in humans.
Neuralink, which first tested its device in monkeys and
other animals, is now testing the device in humans. The company makes a
brain-chip which enables paralyzed patients to control a computer using only
their thoughts.
In a letter to the FDA on Monday, Democratic U.S.
Representative Earl Blumenauer said he was concerned the agency ignored
"troubling evidence" of animal testing violations that had been
raised dating back to at least 2019.
Blumenauer also cited reports by Reuters since late 2022
that described employees' complaints of "hack jobs" of animal
experiments due to a rushed schedule, causing needless suffering and deaths.
Employees also worried that data quality would be compromised, the media
organization reported at the time. He asked the FDA to explain how it
reconciled reports of such lapses with its decision to authorize Neuralink's
human trial.
"These alleged failures to follow standard operating
procedures potentially endangered animal welfare and compromised data
collection for human trials," wrote Blumenauer, who serves on the House
Ways and Means subcommittee on health.
In response to queries from Reuters about the letter, the
FDA said it would respond to the lawmaker directly. The agency also said it
routinely carries out inspections after a human trial is approved. When it
inspected Neuralink, the FDA said it did not find violations that would
undermine the safety of the trial.
Neuralink did not immediately respond to questions.
In recent years, a handful of device companies have begun
testing such brain implants in humans, including Synchron and Blackrock
Neurotech, who have both demonstrated the ability of patients to control
certain actions with their thoughts.
Last week, Neuralink presented a livestream on Musk's social
media platform X, showing how the first patient implanted with its brain device
was able to play online chess using his mind. Noland Arbaugh, a 29-year-old who
was paralyzed below the shoulders after a diving accident, also posted a
comment on X by relaying his thoughts.
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