US lawmaker seeks answers on FDA inspection of Musk's Neuralink
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[March 26, 2024]
By Marisa Taylor
WASHINGTON (Reuters) - A U.S. lawmaker involved in health policy has
asked the Food and Drug Administration why it did not inspect Elon
Musk's Neuralink before allowing the brain implant company to test its
device in humans.
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.
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![](../images/032624PIX/health73.jpg)
Neuralink logo and Elon Musk silhouette are seen in this
illustration taken, December 19, 2022. REUTERS/Dado Ruvic/Illustration/File
Photo
![](http://archives.lincolndailynews.com/2024/Mar/26/images/ads/current/debbiesfloral_lda_030724.png) 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.
(Reporting by Marisa Taylor; Editing by Rosalba O'Brien)
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