Neuralink is developing a brain implant it
hopes will help paralysed people walk again and cure other neurological
ailments. The federal probe, which has not been previously reported, was opened
in recent months by the US Department of Agriculture's Inspector General at the
request of a federal prosecutor, according to two sources with knowledge of the
investigation. The probe, one of the sources said, focuses on violations of the
Animal Welfare Act, which governs how researchers treat and test some animals.
The investigation has come at a time of
growing employee dissent about Neuralink's animal testing, including complaints
that pressure from CEO Musk to accelerate development has resulted in botched
experiments, according to a Reuters review of dozens of Neuralink documents and
interviews with more than 20 current and former employees. Such failed tests
have had to be repeated, increasing the number of animals being tested and
killed, the employees say. The company documents include previously unreported messages,
audio recordings, emails, presentations and reports.
Musk and other Neuralink executives did not
respond to requests for comment.
Reuters could not determine the full scope
of the federal investigation or whether it involved the same alleged problems
with animal testing identified by employees in Reuters interviews. A
spokesperson for the USDA inspector general declined to comment. US regulations
don't specify how many animals companies can use for research, and they give
significant leeway to scientists to determine when and how to use animals in
experiments. Neuralink has passed all USDA inspections of its facilities,
regulatory filings show.
In all, the company has killed about 1,500
animals, including more than 280 sheep, pigs and monkeys, following experiments
since 2018, according to records reviewed by Reuters and sources with direct
knowledge of the company's animal-testing operations. The sources characterised
that figure as a rough estimate because the company does not keep precise
records on the number of animals tested and killed. Neuralink has also
conducted research using rats and mice.
The total number of animal deaths does not
necessarily indicate that Neuralink is violating regulations or standard
research practices. Many companies routinely use animals in experiments to
advance human health care, and they face financial pressure to quickly bring
products to market. The animals are typically killed when experiments are
completed, often so they can be examined post-mortem for research purposes.
But current and former Neuralink employees
say the number of animal deaths is higher than it needs to be for reasons
related to Musk's demands to speed research. Through company discussions and
documents spanning several years, along with employee interviews, Reuters
identified four experiments involving 86 pigs and two monkeys that were marred
in recent years by human errors. The mistakes weakened the experiments'
research value and required the tests to be repeated, leading to more animals
being killed, three of the current and former staffers said. The three people
attributed the mistakes to a lack of preparation by a testing staff working in
a pressure-cooker environment.
One employee, in a message seen by Reuters,
wrote an angry missive earlier this year to colleagues about the need to
overhaul how the company organises animal surgeries to prevent “hack jobs.” The
rushed schedule, the employee wrote, resulted in under-prepared and
over-stressed staffers scrambling to meet deadlines and making last-minute
changes before surgeries, raising risks to the animals.
Musk has pushed hard to accelerate
Neuralink's progress, which depends heavily on animal testing, current and
former employees said. Earlier this year, the chief executive sent staffers a
news article about Swiss researchers who developed an electrical implant that
helped a paralyzed man to walk again. “We could enable people to use their
hands and walk again in daily life!” he wrote to staff at 6:37 a.m. Pacific
Time on Feb. 8. Ten minutes later, he followed up: “In general, we are simply
not moving fast enough. It is driving me nuts!”
On several occasions over the years, Musk
has told employees to imagine they had a bomb strapped to their heads in an
effort to get them to move faster, according to three sources who repeatedly
heard the comment. On one occasion a few years ago, Musk told employees he
would trigger a “market failure” at Neuralink unless they made more progress, a
comment perceived by some employees as a threat to shut down operations,
according to a former staffer who heard his comment.
Five people who've worked on Neuralink's
animal experiments told Reuters they had raised concerns internally. They said
they had advocated for a more traditional testing approach, in which researchers
would test one element at a time in an animal study and draw relevant
conclusions before moving on to more animal tests. Instead, these people said,
Neuralink launches tests in quick succession before fixing issues in earlier
tests or drawing complete conclusions. The result: More animals overall are
tested and killed, in part because the approach leads to repeated tests.
One former employee who asked management
several years ago for more deliberate testing was told by a senior executive it
wasn't possible given Musk's demands for speed, the employee said. Two people
told Reuters they left the company over concerns about animal research.
The problems with Neuralink's testing have
raised questions internally about the quality of the resulting data, three current
or former employees said. Such problems could potentially delay the company's
bid to start human trials, which Musk has said the company wants to do within
the next six months. They also add to a growing list of headaches for Musk, who
is facing criticism of his management of Twitter, which he recently acquired
for $44 billion. Musk also continues to run electric carmaker Tesla Inc and
rocket company SpaceX.
The US Food and Drug Administration is in
charge of reviewing the company's applications for approval of its medical
device and associated trials. The company's treatment of animals during
research, however, is regulated by the USDA under the Animal Welfare Act. The
FDA didn't immediately comment.
Missed deadlines, botched experiments
Musk's impatience with Neuralink has grown
as the company, which launched in 2016, has missed his deadlines on several
occasions to win regulatory approval to start clinical trials in humans,
according to company documents and interviews with eight current and former
employees.
Some Neuralink rivals are having more
success. Synchron, which was launched in 2016 and is developing a different
implant with less ambitious goals for medical advances, received FDA approval
to start human trials in 2021. The company's device has allowed paralyzed
people to text and type by thinking alone. Synchron has also conducted tests on
animals, but it has killed only about 80 sheep as part of its research,
according to studies of the Synchron implant reviewed by Reuters. Musk approached
Synchron about a potential investment, Reuters reported in August.
Synchron declined to comment.
In some ways, Neuralink treats animals
quite well compared to other research facilities, employees said in interviews,
echoing public statements by Musk and other executives. Company leaders have
boasted internally of building a “Monkey Disneyland” in the company's Austin,
Texas facility where lab animals can roam, a former employee said. In the
company's early years, Musk told employees he wanted the monkeys at his San
Francisco Bay Area operation to live in a “monkey Taj Mahal,” said a former
employee who heard the comment. Another former employee recalled Musk saying he
disliked using animals for research but wanted to make sure they were "the
happiest animals” while alive.
The animals have fared less well, however,
when used in the company's research, current and former employees say.
The first complaints about the company's
testing involved its initial partnership with University of California, Davis,
to conduct the experiments. In February, an animal rights group, the Physicians
Committee for Responsible Medicine, filed a complaint with the USDA accusing
the Neuralink-UC Davis project of botching surgeries that killed monkeys and
publicly released its findings. The group alleged that surgeons used the wrong
surgical glue twice, which led to two monkeys suffering and ultimately dying,
while other monkeys had different complications from the implants.
The company has acknowledged it killed six
monkeys, on the advice of USC Davis veterinary staff, because of health
problems caused by experiments. It called the issue with the glue a
“complication” from the use of an “FDA-approved product.” In response to a
Reuters inquiry, a USC Davis spokesperson shared a previous public statement
defending its research with Neuralink and saying it followed all laws and
regulations.
A federal prosecutor in the Northern
District of California referred the animal rights group's complaint to the USDA
Inspector General, which has since launched a formal probe, according to a
source with direct knowledge of the investigation. USDA investigators then
inquired about the allegations involving the UC Davis monkey research,
according to two sources familiar with the matter and emails and messages
reviewed by Reuters.
The probe is concerned with the testing and
treatment of animals in Neuralink's own facilities, one of the sources said,
without elaborating. In 2020, Neuralink brought the program in-house, and has
since built its extensive facilities in California and Texas.
A spokesperson for the US attorney's office
for the Northern District of California declined to comment.
Delcianna Winders, director of the Animal
Law and Policy Institute at the Vermont Law and Graduate School, said it is
“very unusual” for the USDA inspector general to investigate animal research
facilities. Winders, an animal-testing opponent who has criticised Neuralink,
said the inspector general has primarily focused in recent years on dog
fighting and cockfighting actions when applying the Animal Welfare Act.
It's hard on the little piggies
The mistakes leading to unnecessary animal
deaths included one instance in 2021, when 25 out of 60 pigs in a study had
devices that were the wrong size implanted in their heads, an error that could
have been avoided with more preparation, according to a person with knowledge
of the situation and company documents and communications reviewed by Reuters.
The mistake raised alarms among Neuralink's
researchers. In May 2021, Viktor Kharazia, a scientist, wrote to colleagues
that the mistake could be a “red flag” to FDA reviewers of the study, which the
company planned to submit as part of its application to begin human trials. His
colleagues agreed, and the experiment was repeated with 36 sheep, according to
the person with knowledge of the situation. All the animals, both the pigs and
the sheep, were killed after the procedures, the person said.
Kharazia did not comment in response to
requests.
On another occasion, staff accidentally
implanted Neuralink's device on the wrong vertebra of two different pigs during
two separate surgeries, according to two sources with knowledge of the matter
and documents reviewed by Reuters. The incident frustrated several employees
who said the mistakes – on two separate occasions – could have easily been
avoided by carefully counting the vertebrae before inserting the device.
Company veterinarian Sam Baker advised his
colleagues to immediately kill one of the pigs to end her suffering.
“Based on low chance of full recovery … and
her current poor psychological well-being, it was decided that euthanasia was
the only appropriate course of action,” Baker wrote colleagues about one of the
pigs a day after the surgery, adding a broken heart emoji.
Baker did not comment on the incident.
Employees have sometimes pushed back on
Musk's demands to move fast. In a company discussion several months ago, some
Neuralink employees protested after a manager said that Musk had encouraged
them to do a complex surgery on pigs soon. The employees resisted on the
grounds that the surgery's complexity would lengthen the amount of time the
pigs would be under anesthesia, risking their health and recovery. They argued
they should first figure out how to cut down the time it would take to do the
surgery.
“It's hard on the little piggies,” one of
the employees said, referring to the lengthy period under anesthesia.
In September, the company responded to
employee concerns about its animal testing by holding a town hall to explain
its processes. It soon after opened up the meetings to staff of its
federally-mandated board that reviews the animal experiments.
Neuralink executives have said publicly
that the company tests animals only when it has exhausted other research
options, but documents and company messages suggest otherwise. During a
November 30 presentation the company broadcast on YouTube, for example, Musk
said surgeries were used at a later stage of the process to confirm that the
device works rather than to test early hypotheses. “We're extremely careful,”
he said, to make sure that testing is “confirmatory, not exploratory,” using
animal testing as a last resort after trying other methods.
In October, a month before Musk's comments,
Autumn Sorrells, the head of animal care, ordered employees to scrub
"exploration" from study titles retroactively and stop using it in
the future.
Sorrells did not comment in response to
requests.
Neuralink records reviewed by Reuters
contained numerous references over several years to exploratory surgeries, and
three people with knowledge of the company's research strongly rejected the
assertion that Neuralink avoids exploratory tests on animals. Company
discussions reviewed by Reuters showed several employees expressing concerns
about Sorrells' request to change exploratory study descriptions, saying it
would be inaccurate and misleading.
One noted that the request seemed designed
to provide “better optics” for Neuralink. © Reuters