- Musk's lithium batteries, which are also used in his 'brain chip' are
toxic and explosive
- Musk screwed, and got pregnant, his Neuralink staff
- Musk tortured a vast number of animals
- Musk has no scientific experience in biology science
Reuters
Rachael Levy and Marisa Taylor
On at least four occasions since 2019, Elon Musk has predicted that his
medical device company, Neuralink, would soon start human trials of a
revolutionary brain implant to treat intractable conditions such as
paralysis and blindness.
Yet the company, founded in 2016, didn’t seek permission from the U.S.
Food and Drug Administration (FDA) until early 2022 – and the agency
rejected the application, seven current and former employees told Reuters.
The rejection has not been previously reported. In explaining the decision
to Neuralink, the agency outlined dozens of issues the company must
address before human testing, a critical milestone on the path to final
product approval, the staffers said. The agency’s major safety concerns
involved the device’s lithium battery; the potential for the implant’s
tiny wires to migrate to other areas of the brain; and questions over
whether and how the device can be removed without damaging brain tissue,
the employees said.
A year after the rejection, Neuralink is still working through the
agency’s concerns. Three staffers said they were skeptical the company
could quickly resolve the issues – despite Musk’s latest prediction at a
Nov. 30 presentation that the company would secure FDA human-trial
approval this spring.
Neuralink has not disclosed details of its trial application, the FDA’s
rejection or the extent of the agency’s concerns. As a private company, it
is not required to disclose such regulatory interactions to investors.
During the hours-long November presentation, Musk said the company had
submitted “most of our paperwork” to the agency, without specifying any
formal application, and Neuralink officials acknowledged the FDA had asked
safety questions in what they characterized as an ongoing conversation.
Musk and other Neuralink officials did not respond to requests for comment
on the company’s device or its dealings with the FDA. The agency declined
to comment on Neuralink, citing laws keeping commercial information
private.
The Neuralink sources declined to provide Reuters with the agency’s
written rejection, a legally confidential document. The staffers,
including four who had read the FDA document and others aware of the
agency’s concerns, described the safety issues in interviews, speaking on
condition of anonymity.
Such FDA rejections do not mean a company will ultimately fail to gain the
agency’s human-testing approval. But the agency’s pushback signals
substantial concerns, according to more than a dozen experts in FDA
device-approval processes.
“Neuralink doesn’t appear to have the mindset and experience that’s needed
to get this to market anytime soon.”
Kip Ludwig
FORMER PROGRAM DIRECTOR FOR NEURAL ENGINEERING AT THE U.S. NATIONAL
INSTITUTES OF HEALTH (NIH)
The rejection also raises the stakes and the difficulty of the company’s
subsequent requests for trial approval, the experts said. The FDA says it
has approved about two-thirds of all human-trial applications for devices
on the first attempt over the past three years. That total rose to 85% of
all requests after a second review. But firms often give up after three
attempts to resolve FDA concerns rather than invest more time and money in
expensive research, several of the experts said.
Companies that do secure human-testing approval typically conduct at least
two rounds of trials before applying for FDA approval to commercially
market a device.
Neuralink’s regulatory struggles stem largely from its culture of setting
goals for breakthroughs on extremely ambitious timelines and viewing
regulators as obstacles to innovation, according to more than a dozen
current and former company employees. That leadership style, mirroring how
Musk runs electric-car pioneer Tesla, can create vulnerabilities when
applied to developing a medical device that must be tested on human
subjects before final approval, the staffers say.
Still, Musk retains the full confidence of many loyal Neuralink staffers
and some industry investors, who point to his past successes in taking on
extreme challenges as the founder of Tesla and rocket-builder SpaceX.
“I definitely would never bet against him,” said Bob Nelsen, co-founder of
venture capital firm ARCH Venture Partners, who said he invested personal
money into Neuralink. “If he has some bumps in the road with Neuralink, or
any other thing, he’ll regroup and figure it out … Just think about it:
Those are hard industries with huge safety barriers – cars and rockets.”
In public comments over the years, Musk has detailed a bold vision for
Neuralink: Both disabled and healthy people will pop into neighborhood
facilities for speedy surgical insertions of devices with functions
ranging from curing obesity, autism, depression or schizophrenia to
web-surfing and telepathy. Eventually, Musk has said, such chips will turn
humans into cyborgs who can fend off the threat from sentient machines
powered by artificial intelligence.
“I could have a Neuralink device implanted right now, and you wouldn’t
even know,” Musk said at the Nov. 30 presentation, a livestreamed “show
and tell” event, drawing laughs from the crowd. At another public company
event in 2020, he said: “You’ll be able to save and replay memories…. The
future is going to be weird.”
Such high-flying ambition has contributed to Neuralink’s estimated worth
of more than $1 billion, far higher than its competitors, according to
four people familiar with the private valuation.
Neuralink officials have publicly vowed to address any FDA concerns. Musk
made headlines late last year when he said he was already so confident in
the devices’ safety that he would be willing to implant them in his own
children.
Musk also has said Neuralink would restore full mobility to paralyzed
patients. In February, however, Dongjin “D.J.” Seo, Neuralink’s vice
president of engineering, said at a conference that the “primary
short-term goal” was more modest: to help paralyzed patients communicate
through computerized text without typing. Seo said full mobility, along
with restoring sight to the blind, were “long-term” goals.
Musk’s public claims and well-known impatience pose a critical test for
the FDA in balancing demands for speedy review with the diligence required
to ensure safety and efficacy, said Kip Ludwig, former program director
for neural engineering at the U.S. National Institutes of Health (NIH), a
federal agency. The FDA in recent years has faced pressure from Congress
to accelerate reviews but also criticism over controversial approvals,
such as its 2021 authorization of an Alzheimer’s treatment without
conclusive proof of efficacy.
Industry players closely watching Neuralink’s development have long
expected a collision between Musk and the FDA, Ludwig said, as the
billionaire pushes Neuralink to quickly navigate regulatory reviews.
“Everybody in the industry was saying: ‘Oh my God, they’re going to run
straight into a brick wall,’” Ludwig said of Musk’s bid for FDA approval.
“Neuralink doesn’t appear to have the mindset and experience that’s needed
to get this to market anytime soon.”
Without commenting on Neuralink, the FDA said it upholds high standards in
vetting all brain implants even as it aims to speed reviews. “Innovation
and safety are not an either-or scenario,” said Owen Faris, who helps
oversee the FDA’s Office of Product Evaluation and Quality.
A company document from last fall said Neuralink expected the FDA to
authorize human trials for its brain implant by March 7, 2023. But three
Neuralink sources with knowledge of the company’s FDA interactions said
they are not confident of any imminent regulatory approvals and that any
prediction on the timing is a “gamble,” as one of the sources put it.
Neuralink’s focus on speed has contributed to other problems. Reuters
exclusively reported late last year that the federal government was
investigating the company’s treatment of its research animals. The probe
was launched amid growing employee concern that the company is rushing
experiments, causing additional suffering and deaths of pigs, sheep and
monkeys. Three Neuralink staffers now tell Reuters that company leaders
wanted animal experiments accelerated to gather data to address FDA
concerns over the human-trial application.
Reuters also broke the news that the Department of Transportation is
separately investigating whether Neuralink illegally transported dangerous
pathogens, on chips removed from monkey brains, without proper containment
measures.
The Department of Transportation said its investigation is ongoing. The
U.S. Department of Agriculture’s Office of Inspector General, which is
conducting the animal-treatment probe, declined to comment.
Turning down government money, advice
While Neuralink garners outsized attention because of its famous founder,
more than a dozen companies are developing or manufacturing devices in the
wider $6 billion field of so-called neuromodulation devices, which record
or stimulate neural activity.
Researchers have experimented with such devices for more than four
decades. The FDA has approved a significant number of them, including
those treating Parkinson’s disease, epilepsy and obsessive-compulsive
disorder. Development typically takes many years. For example, NeuroPace,
which makes the brain implant to treat epilepsy, received final FDA
approval in 2013 – 16 years after the company’s launch.
Neuralink competes in a niche of so-called brain computer interface (BCI)
devices. Such devices use electrodes that penetrate the brain or sit on
its surface to provide direct communication to computers. No company has
received final FDA approval to market a BCI brain implant, the agency
said, although the exact definition of the category is debated in the
industry.
Neuralink officials touted plans to eventually produce a device with
16,000 electrodes, far more than other currently proposed devices. But
that may not break any new ground. Neuralink plans only 1,024 electrodes
in its first implant. That’s similar to devices from other firms, which
also plan to add thousands more electrodes later, according to Ludwig, the
former NIH official. Further, he said, the question of whether more
electrodes will significantly help patients remains hotly debated among
brain-implant experts.
Neuralink’s electrodes are attached to wires thinner than a human hair,
which are implanted in the brain, the company has said. It also aims to
revolutionize surgeries with a robot to sew its microscopic wires into
brain tissue, while avoiding blood vessels, in minutes.
Musk’s company, however, trails at least one direct rival in the race for
FDA approval. Synchron, a competitor making a BCI implant, has won the
agency’s blessing for human trials. Like Neuralink, Synchron aims to help
paralyzed people type with their minds. With Neuralink playing catch-up,
Musk approached Synchron last summer about making an investment, Reuters
reported in August.
The NIH, which supports and finances medical innovation, seeks to help
brain-implant companies with public-private partnerships as part of its
BRAIN initiative (Brain Research through Advancing Innovative
Neurotechnologies). The agency finances half a dozen firms including
Blackrock Neurotech, a start-up, and medical device giant Medtronic.
Launched in 2014, the effort will receive about $680 million this year.
Beyond grants, it provides access to government experts who advise on how
to gain FDA approval and commercialize a device.
BRAIN initiative team leader Nick Langhals said the agency reached out to
Neuralink to offer help but was declined. “We wouldn’t leave a company
like Neuralink off the list, but they were not interested,” Langhals said,
adding that the company didn’t explain its reasons.
Musk has told senior Neuralink managers that NIH funding would bring
unwanted public oversight and bureaucratic hurdles, according to one
person who heard such comments from Musk and a second source with
knowledge of Musk’s views about the NIH.
The episode reflects a wider view at Neuralink that the government
generally moves slowly and stifles innovation, five current and former
employees said. In a presentation to staff last fall, the company set a
goal of making the FDA “our #1 Fans by showing that we go above and
beyond,” according to a document reviewed by Reuters. The presenter at the
internal company meeting, however, also referred to a veteran surgeon and
FDA reviewer as a “curmudgeon,” according to two people who heard the
comment.
Neuralink could be helped by federal laws passed in recent years aiming to
accelerate FDA reviews. Among a host of policy changes, Congress
instituted the “breakthrough” designation for novel devices targeting
serious conditions. The label gives companies faster agency feedback
during the development process.
The breakthrough-device program, among other changes, has helped the FDA
substantially reduce the total time companies spend seeking agency
approvals, the FDA says. The agency also must respond to human-trial
applications within 30 days.
Of 750 devices currently labeled breakthrough, more than 100 are
neurological, the FDA says. Neuralink secured the label for its brain
implant in July 2020, according to the company. In an undated company
document, Neuralink said it hoped that, by December 2021, the FDA would
approve testing 10 people, giving “the first humans a mind blowing
experience.”
‘This is not a toy’
As Neuralink races to deliver a marketable implant, more than a dozen
current and former Neuralink staffers describe a working environment that,
while demanding and ambitious, is also loose and disorganized.
Musk has been one of the few constants in leadership: Nearly all eight
company founders, which included acclaimed scientists, have departed. Musk
himself often pays more attention to his higher profile ventures – Tesla,
SpaceX and Twitter – than to Neuralink, three company sources said. Musk’s
emails to Neuralink staffers often come from his SpaceX address, said two
people who reviewed them.
Hiring and promoting young employees has been a Neuralink hallmark since
its founding, the current and former employees said. The company brims
with recent college graduates and interns. One team had no members over 30
years old, a Neuralink source recalled. The strategy saves money and
aligns with Musk’s view that younger workers often innovate better than
older ones, the employees said.
The company’s former president, Max Hodak, had not turned 30 when he
joined Neuralink at its founding. Before Neuralink, Hodak worked in a
neural engineering lab while in college at Duke University and launched a
cloud-computing startup afterward. Currently, one key company liaison to
the FDA is a software engineer in his mid-20s, four current and former
employees said.
That lack of experience in medical regulation has contributed to tensions
inside Neuralink over development pace, the staffers said. In the
company’s early years, executives discussed real estate for outpatient
centers nationwide before the company had finalized a device, one former
employee recalled. The plans sparked a debate among more experienced top
scientists, who chafed at the development speed envisioned by generally
younger staffers, the employee said.
A different Neuralink source recalled a meeting in late 2020 or early 2021
in which an angry Musk shouted until about 2 a.m. about what he called the
company’s slow regulatory progress. When executives called his expected
timeline unrealistic, Musk replied that he would make the FDA understand
the need for fast approvals. Musk has participated in some phone calls
between Neuralink and the agency, often seeking to expedite human trials,
according to two people with knowledge of the calls.
“He can’t appreciate that this is not a car. This is a person’s brain.
This is not a toy.”
Former Neuralink employee on Musk’s approach to Neuralink
The source who described the late-night meeting said Musk expects
Neuralink to operate like Tesla, which brought several ground-breaking
electric vehicles to market relatively quickly. “He can’t appreciate that
this is not a car,” this source said. “This is a person’s brain. This is
not a toy.”
At the meeting, Musk said he would make major changes at Neuralink without
faster progress, this source recalled. Several weeks later, in March 2021,
Musk fired company president and de facto leader Hodak, according to
several current and former employees. Three years later, the company
remains without a president.
Musk and Neuralink did not respond to inquiries about why Hodak was fired.
Hodak declined to comment.
Since Musk ousted Hodak, a coalition of executives has filled the gap,
though employees often disagree on who is truly in charge.
The leadership includes Shivon Zilis, a long-time Musk confidante who
formerly worked at a venture capital firm. Zilis recently gave birth to
two children fathered by Musk, in a relationship she calls non-romantic.
Her LinkedIn page identifies her as Director of Operations and Special
Projects. Another key executive is Seo, the engineering chief and only
remaining founder besides Musk. In mid-February, Ian O’Hara, an executive
who oversaw the robot program, announced his departure, according to four
sources familiar with the matter.
Seo declined to comment. Zilis and O’Hara did not respond to inquiries.
Safety concerns
The FDA’s rejection listed dozens of what the agency calls “deficiencies”
that the company must address before human trials, five Neuralink sources
said. They called some issues relatively minor.
One serious FDA concern involved the possibility that the device’s tiny
threads, which carry electrodes, could migrate to other areas of the
brain, according to six current and former employees. The company has
sought to address the issue through animal tests on dozens more pigs,
three Neuralink sources said.
Migrating wires can induce inflammation, impair function in critical areas
of the brain and rupture blood vessels, said Victor Krauthamer, a former
FDA official for three decades, including a stint as acting director of
the office that reviews human-trial requests for brain implants. A
migration problem can also erode the device’s effectiveness, leading to
the risk of surgical removal, he and other experts said.
“The threads can cause damage because brains are very, very soft and very
delicate,” Krauthamer said.
The FDA’s concerns about the battery are also potentially serious, experts
in brain devices said. Neuralink proposed making its device with a novel
charging system involving lithium batteries that could be recharged
remotely. The agency found the company needed to show in animal studies
that the battery was very unlikely to fail, six current and former
Neuralink employees said. If any component of the device that is connected
to the battery current fails, the current could potentially damage brain
tissue, three brain-implant experts said.
The FDA also raised questions about whether the device could be removed
without damaging brain tissue. In Neuralink’s November presentation,
officials acknowledged the FDA concern but downplayed it.
Engineer Alex Wood-Thomas was asked about the potential danger of removing
the device in order to implant an upgraded one in the future. He responded
that, because of the threads’ small size, scarring “within the brain is so
minimal that they’re actually removed quite easily.”
Several employees disputed his characterization as misleading and
unsupported by animal studies, according to two Neuralink sources and
internal discussions seen by Reuters.
Wood-Thomas declined to comment.
The FDA also flagged concerns that the device could overheat, also
potentially damaging tissue.
Neuralink may be able to address all of the FDA’s concerns, industry and
regulatory experts said.
If the FDA has lingering minor issues with a company’s device, it might
let the firm move forward with a slower, staged trial, the experts said.
The agency has suggested such a path might work for Neuralink, with fewer
subjects implanted at first, and more tested months later, according to
two people familiar with the discussions. Still, that proposal
disappointed Neuralink because it could delay progress toward final FDA
approval, one of the sources said.
Neuralink is hardly alone among brain-implant pioneers in slogging through
difficult research and regulatory challenges that can drag on for years,
said Gene Civillico, a neurophysiologist who formerly worked for both the
FDA and the NIH on neural-implant research.
“The reason we don’t have a (BCI) device yet like Neuralink’s is not
because no one has spent any money on it,” Civillico said. “It’s not
because Elon Musk hasn’t thought about it enough. It’s because it’s a hard
problem.”