Such oversight boards are required by federal law for
organizations experimenting on certain types of animals. The panels are charged
with ensuring proper animal care, high research standards, and the reliability
of data that helps regulators decide whether drugs or medical devices are safe
for human testing.
The membership of the panel at Musk's company, Neuralink,
raises questions about potential violations of conflict-of-interest reguwlations
aimed at protecting research integrity, a dozen animal-research and bioethics
experts told Reuters. Neuralink is conducting animal experiments as it seeks
regulatory approval for human trials of a brain chip intended to help paralyzed
people type with their minds, among other ambitious goals.
Nineteen of the board's 22 members were Neuralink employees
as of late 2022, according to a company document reviewed by Reuters. The
oversight board's chair was the Neuralink executive who led the company's
animal-care program, and at least 11 other members were employees directly
involved with animal care or research.
Details of the panel's membership and its potential
conflicts have not been previously reported. Insight into its makeup comes in
the wake of two federal investigations, first reported by Reuters, into
potential animal-welfare violations by Neuralink and allegations that it
improperly transported dangerous pathogens on implants removed from monkey
brains. Reuters reported in December that some employees had grown concerned
about the animal experiments being rushed under pressure from Musk to speed
development, causing needless suffering and deaths of pigs, sheep and monkeys.
It's possible the board's membership has changed since late
last year. Musk and Neuralink didn't respond to requests for comment for this
story or previous Reuters articles about the investigations into its animal
testing.
The review boards are known as “institutional animal care
and use committees,” or IACUCs. The animal-research and bioethics experts said
it's rare for IACUCs to include employees with such direct financial stakes in
the research outcome. Putting employees on such panels poses a particular
problem at startups such as Neuralink because they tend to focus on a single
breakthrough product and commonly reward employees with volatile company
shares.
Neuralink staffers typically are compensated with salary and
stock-based incentives, according to five current and former employees and
Neuralink job advertisements reviewed by Reuters. Two of the staffers said some
senior-level employees stand to make millions of dollars if the company secures
critical regulatory approvals. Reuters couldn't determine the compensation
terms of the Neuralink IACUC members who are also company employees.
Neuralink shareholders could see big gains if the private
company's valuation, currently more than $1 billion, continues to soar.
Successful animal trials are critical for the company to gain federal approval
for human trials and, ultimately, brain-implant commercialization. Reuters reported
in March that the U.S. Food and Drug Administration rejected Neuralink's first
human-trial application, in part because the company had not proven the
device's safety in animal tests.
Dr. Miguel Nicolelis, a neuroscientist and physician, has
conducted brain-implant research at Duke University for nearly three decades.
He said the IACUC members overseeing his animal experiments never had any role
in the research, including animal tests of the same type Neuralink is
conducting now. The independence of such boards, Nicolelis said, is critical to
protecting the integrity of animal research that could impact humans in future
clinical trials.
“It's an obvious conflict of interest,” he said of the
Neuralink board's composition.
Rocky Partnership
Many companies outsource animal testing and oversight to
universities or research institutes with strict rules to prevent such conflicts
of interest, the animal-research and bioethics experts said. These institutions
generally prohibit people with direct financial interests from serving on
IACUCs or voting on animal experiments.
Neuralink originally partnered with the University of
California, Davis, to help conduct and oversee its animal tests. But the
company later ditched the university after a dispute, viewing the school's
processes as too slow and bureaucratic, one current and one former Neuralink
staffer said. Neuralink then brought the research and oversight in-house.
UC Davis declined to comment on Neuralink's new oversight
board but said in a statement that its conflict-of-interest rules prohibit
“interested” parties from voting or “influencing decisions” on such panels.
The US National Institutes of Health is the world's largest
public funder of biomedical research. On projects it backs, the agency bars any
IACUC member deriving income or stock from a research sponsor from reviewing or
voting on that sponsor's animal research, said Dr. Patricia Brown, the director
of the NIH's Office of Laboratory Animal Welfare.
The NIH declined to comment on Neuralink's board. The agency
once reached out to Neuralink to offer funding and guidance under a program
intended to boost brain-implant research, Reuters previously reported.
Neuralink wasn't interested in NIH funding because Musk wanted to avoid public
oversight and perceived bureaucratic hurdles.
The US Department of Agriculture (USDA) is the lead agency
enforcing animal-welfare regulations. The animal-research experts interviewed
by Reuters, including two former top USDA officials, described the agency's
overall enforcement of conflict-of-interest rules as lax.
USDA regulations forbid IACUC members from participating in
the “review or approval of an activity in which that member has a conflicting
interest.” But that rule doesn't clearly define a conflict. It does offer, as
one example, a situation in which a board member is “personally involved in the
activity.”
The USDA has interpreted the rule narrowly, the experts and
former agency officials said. The agency, they said, rarely flags a conflict
unless an IACUC member votes to approve a particular experiment the member is
also directly running as a company employee. Beyond that, the USDA allows a
range of potential conflicts that would never be permitted in human trials,
which are overseen by other federal agencies that have similar
conflict-of-interest regulations, the experts said. Conflicts such as the ones
on Neuralink's IACUC also are typically prohibited or avoided in animal trials
by universities, research institutes and many companies.
In response to an inquiry from Reuters, the USDA said it had
found no conflicts of interest on Neuralink's board when the department
inspected its animal-research operations during 10 inspections since 2020. The
company has passed all inspections with no citations, according to public records
and a person with knowledge of the examinations.
The agency declined to answer detailed questions about its
legal interpretation or enforcement of conflict-of-interest rules for animal
research and oversight.
The USDA's Office of Inspector General, the agency now
probing potential animal-welfare violations by Neuralink, is also investigating
allegedly slipshod Animal Welfare Act enforcement by the USDA itself, in a
joint probe with the U.S. Department of Justice, Reuters has reported.
The USDA and Justice Department declined to comment on the
investigation. The USDA inspector general didn't respond to requests for
comment.
The joint probe is examining the agency's oversight of
Neuralink and of animal welfare more broadly. The investigation follows a long
history of USDA OIG reports, including three since 2014, blasting the agency's
animal-welfare enforcement as ineffective. One issue is a stretched staff: The
USDA employs 122 inspectors to inspect 11,785 facilities, ranging from zoos and
breeders to labs, according to a Congressional Research Service report last
July.
USDA enforcement of conflict-of-interest rules is rare. In
more than 11,000 USDA inspections over the past decade, the agency issued eight
citations for conflicts at research labs, none of which resulted in a penalty,
according to a review of the records by Delcianna Winders, who oversees the
Animal Law and Policy Institute at the Vermont Law and Graduate School. The
lack of enforcement, she said, poses a serious risk that conflicted IACUC
members will put their own interests before those of the animals.
“The USDA is really only inspecting paperwork and not
looking under the hood,” she said. The case of Neuralink's board, she said,
illustrates the problem with “the overly narrow interpretation the USDA is
giving to ‘conflicting interest.'”
Animal Welfare 'Incident'
Between September 2017 and December 2020, Neuralink
partnered with the University of California, Davis, relying on the school's
federally funded primate-research lab and its established IACUC. UC Davis
received more than $1.9 million from Neuralink for experiments before the
partnership ended, the university said. Neuralink surgeons and other staffers
continued to work directly on the experiments, in consultation with the
university.
A UC Davis spokesperson told Reuters the university's
monitoring of Neuralink's experiments detected an animal-welfare incident in
2019, prompting the university's IACUC to mandate changes in Neuralink's
research protocols and training. The spokesperson said the incident didn't
involve UC Davis staff but declined to comment further.
Amid tensions, Neuralink canceled its partnership with UC
Davis in 2020, then built its own animal-testing facilities and created its own
IACUC.
Neuralink's IACUC is charged with limiting the number of
animals tested to the minimum required for research. Tested animals are
typically killed after experiments so researchers can examine them post-mortem.
The company has rushed and at times botched experiments,
especially after it brought animal experiments fully in-house, according to
Neuralink staffers and company records seen by Reuters. The company's IACUC
allowed Neuralink to accelerate animal experiments, in line with Musk's
demands, three sources familiar with the panel's decisions told Reuters.
In 2021 and 2022, the company killed about 250 sheep, pigs
and primates, the company records show. In one instance in 2021, the company
implanted 25 out of 60 pigs with the wrong-sized devices, Reuters previously
reported. Neuralink employees said the error could have been avoided with
better preparation.
Several animal-research experts called the role of board
chair Autumn Sorrells — also the executive heading Neuralink's animal-care
program — a particularly troubling conflict.
Sorrells didn't respond to requests for comment.
Several of the 22 IACUC members also report to Sorrells in
their Neuralink jobs, separate from the board, according to internal documents
and two Neuralink sources with knowledge of the committee's operations. This
dynamic discourages those members from dissenting in board matters, one of the
sources said.
Neuralink never disclosed other IACUC members' close
connections to Sorrells to USDA inspectors during an inspection in January that
was prompted by the December Reuters report and related scrutiny from US
Congress members, according to a federal official with knowledge of the
agency's dealings with Neuralink. Inspectors likely would have examined the potential
conflicts more closely if those connections were disclosed, the official said.
© Reuters
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