Elon Musk’s brain-transplant venture has filled an animal-research oversight board with company insiders who could stand to benefit financially, according to company documents and interviews with six current and former employees. Are.
Such oversight boards are required by federal law for organizations conducting experiments 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.
on membership of the panel muskcompany of neuralink, a dozen animal-research and bioethics experts told Reuters, raise questions about possible violations of conflict-of-interest rules aimed at protecting research integrity. Neuralink is conducting animal experiments as it seeks regulatory approval for human trials of a brain chip aimed at helping paralyzed people type with their brains, among other ambitious goals.
Nineteen of the 22 board members were Neuralink employees through the end of 2022, according to a company document reviewed by Reuters. The chairman of the oversight board was a 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. The insight into its makeup comes in the wake of two federal investigations, first reported by Reuters, into possible animal-welfare violations by Neuralink and allegations that it improperly carried dangerous pathogens on implants removed from monkey brains . Reuters reported in December that some employees had become concerned about animal experiments under pressure from Musk to speed up development, causing unnecessary suffering and death to pigs, sheep and monkeys.
It is possible that the membership of the board has changed since the end of last year. Musk and Neuralink did not respond to requests for comment for this story or previous Reuters articles about its animal testing investigation.
Review boards are known as “Institutional Animal Care and Use Committees” or IACUCs. Animal-research and bioethics experts said it is rare for IACUCs to involve staff with such direct financial stakes in research results. Placing employees on such panels poses a particular problem at startups like Neuralink because they tend to focus on a single successful product and reward employees with typically volatile company shares.
Neuralink employees are typically compensated with a salary and stock-based incentives, according to five current and former employees and Neuralink job advertisements reviewed by Reuters. Two of the employees said some senior-level employees could earn millions of dollars if the company wins key regulatory approvals. Reuters could not determine the terms of compensation for Neuralink IACUC members, who are also company employees.
If the private company’s valuation, currently at more than $1 billion, could turn out to be big for Neuralink’s shareholders. Successful animal tests are critical for the company to obtain federal approval for human trials and eventually brain-implant commercialization. Reuters reported in March that the US Food and Drug Administration rejected Neuralink’s first human-trial application because the company had not proven the device’s safety in animal tests.
Dr. Miguel Nicolelis, a neuroscientist and physician, has conducted brain-transplant research at Duke University for nearly three decades. He said the IACUC members overseeing his animal experiments never had any role in the research, which includes the same type of animal testing Neuralink is now doing. Nicolais said the independence of such boards is critical to protecting the integrity of animal research that could affect humans in future clinical trials.
“It’s clearly a conflict of interest,” he said of the composition of the Neuralink board.
Rocky Partnership
Animal-research and bioethics experts said many companies outsource animal testing and oversight to universities or research institutes with strict rules to prevent such conflicts of interest. These institutions typically bar 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 monitor its animal trials. But the company later dropped the university after a dispute, viewing the school’s processes as too slow and bureaucratic, said a current and a former Neuralink employee. Neuralink then conducted in-house research and oversight.
UC Davis declined to comment on Neuralink’s new oversight board, but said in a statement that its conflict of interest rules prevent “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. Dr. Patricia Brown, director of NIH’s Office of Laboratory Animal Welfare, said the agency bars any IACUC member receiving income or stock from reviewing or voting on animal research that it sponsors.
NIH declined to comment on Neuralink’s board. Reuters previously reported that the agency had once reached out to Neuralink to offer funding and guidance as part of a program aimed at promoting brain-implant research. Neuralink was not interested in NIH funding because Musk wanted to avoid public oversight and perceived bureaucratic hurdles.
The US Department of Agriculture (USDA) is the principal agency enforcing animal-welfare regulations. Animal-research experts interviewed by Reuters, including two former top USDA officials, described lax overall enforcement of the agency’s conflict of interest rules.
USDA rules prohibit IACUC members from participating in “the review or approval of an activity in which that member has a conflict of interest”. But that rule doesn’t clearly define conflict. It provides as an example a situation in which a board member is “personally involved in the activity.”
Experts and former agency officials said the USDA interpreted the rule too narrowly. The agency, he said, rarely flags a conflict unless an IACUC member votes to approve a particular experiment, with the member also acting directly as an employee of the company. In addition, the USDA allows for a range of potential conflicts that would never be allowed in human trials, which are overseen by other federal agencies that have similar best-of-interest regulations, experts said. Conflicts such as Neuralink’s IACUC also commonly ban or avoid animal trials by universities, research institutes, and many companies.
In response to a Reuters inquiry, the USDA said it found no conflicts of interest on Neuralink’s board when the department inspected its animal-research operations during 10 inspections since 2020. According to public records, the company passed all inspections without a citation. And a person having knowledge of examinations.
The agency declined to answer detailed questions about its legal interpretation or application of conflict of interest rules to animal research and oversight.
The USDA’s Office of the Inspector General, the agency now investigating possible animal-welfare violations by Neuralink, is also probing the USDA’s alleged lax enforcement of the Animal Welfare Act, in a joint investigation with the US Department of Justice. Has been, Reuters has reported.
The USDA and the Justice Department declined to comment on the investigation. The USDA inspector general did not respond to requests for comment.
The joint investigation is probing the agency’s oversight of Neuralink and Animal Welfare more broadly. The investigation follows a long history of USDA OIG reports, including three from 2014, characterizing the agency’s animal-welfare enforcement as ineffective. One issue is an increased staff: The USDA has hired 11,785 inspectors to inspect 11,785 facilities, from zoos and breeders to laboratories, 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 in research labs, none of which resulted in fines, according to a review of records by Deliciana Winders, who oversees the Institute for Animal Law and Policy. Are. Vermont Law & Graduate School. This lack of enforcement, she said, creates a serious risk that conflicted IACUC members will put their own interests before those of animals.
“The USDA is really just inspecting the paperwork and not looking under the hood,” she said. The case to Neuralink’s board, she said, illustrates the problem with “the overly narrow interpretation the USDA is giving to ‘conflicting interest.'”
animal welfare ‘event’
Between September 2017 and December 2020, Neuralink partnered with the University of California, Davis, to rely on the school’s federally funded primate-research lab and its established IACUC. UC Davis received more than $1.9 million (about Rs 15 crore) from Neuralink for the experiments before the partnership ended, the university said. Neuralink surgeons and other staff continued to work directly on the experiments in consultation with the university.
A spokesperson for UC Davis told Reuters that the university’s oversight of Neuralink’s experiments detected an animal-welfare incident in 2019, prompting the university’s IACUC to mandate changes to Neuralink’s research protocols and training. The spokesperson said that UC Davis employees were not involved in the incident, 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 has been accused of limiting the number of animals tested to the minimum required for research. Test animals are usually killed after experiments so that researchers can perform post-mortems.
The company has rushed and at times conducted unsuccessful experiments, especially after bringing animal experiments completely in-house, according to company records seen by Neuralink employees and Reuters. The company’s IACUC allowed Neuralink to expedite animal experiments in line with Musk’s demands, three sources familiar with the panel’s decisions told Reuters.
Company records show that in 2021 and 2022, the company killed approximately 250 sheep, pigs and primates. In one instance in 2021, the company implanted 25 out of 60 pigs with the wrong-sized devices, Reuters previously reported. Neuralink staff said the mistake could have been avoided with better preparation.
Many animal-research experts cited the role of board chair Autumn Sorrels — the executive head of Neuralink’s animal-care program — as a particularly troubling conflict.
Sorrels did not respond to requests for comment.
Many of the 22 IACUC members report to Sorrels in their Neuralink jobs, separate from the board, according to internal documents and two Neuralink sources with knowledge of the committee’s operations. One of the sources said this dynamic discourages those members from disagreeing on board matters.
Neuralink did not disclose the close ties of other IACUC members to Sorrels to USDA inspectors during an inspection in January, according to a federal official with knowledge of the agency’s dealings with Neuralink, a December Reuters report and members of the US Congress. Was inspired by the investigation related to. The official said that if those connections were disclosed, inspectors would have looked more closely into possible conflicts.
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