According to corporate records and interviews with six current and former employees, Elon Musk’s brain-implant startup has staffed an animal-research review board with insiders who may stand to profit financially as the company achieves its goals.
According to federal law, institutions that conduct certain kinds of animal experiments must have such oversight boards. The panels’ duties include assuring ethical treatment of animals, rigorous research standards, and the accuracy of data that regulators use to determine whether a medicine or medical device is safe for testing on humans.
Twelve animal-research and bioethics specialists told Reuters that the composition of the panel at Musk’s business, Neuralink, raises concerns about possible violations of conflict-of-interest laws intended to safeguard study integrity. While pursuing regulatory approval for human trials of a brain chip meant to enable paralyzed individuals type with their minds, among other ambitious ambitions, Neuralink is undertaking animal tests.
According to a company document examined by Reuters, as of late 2022, 19 of the board’s 22 members were Neuralink workers. The CEO who oversaw Neuralink’s program for caring for animals served as the oversight board’s chair, and at least 11 other members were also employed by the firm in some capacity.
There haven’t been any prior reports describing the panel’s composition or any potential conflicts of interest. A better understanding of its composition is provided in the wake of two federal investigations into possible animal welfare breaches by Neuralink and claims that the company unlawfully transferred harmful infections on implants taken from monkey brains, as first reported by Reuters. According to a December Reuters report, several workers had grown concerned that animal studies were being hurried under Musk’s drive to advance development, resulting in unnecessary suffering and deaths of pigs, lambs, and monkeys.
The composition of the board may have altered since late last year. Requests for comment on this story and earlier Reuters reporting about the inquiries into its animal experiments by Musk and Neuralink went unanswered.
“Institutional animal care and use committees,” or IACUCs, are the names of the review panels. It’s unusual for IACUCs to include personnel with such direct financial stakes in the research outcome, according to the experts in animal research and bioethics. Employee participation on these panels is particularly problematic for companies like Neuralink, which frequently compensate staff with volatile company stock and tend to concentrate on a single ground-breaking product.
According to five current and former workers of Neuralink and Neuralink job adverts seen by Reuters, employees of Neuralink are routinely compensated with salaries and stock-based incentives. According to two employees, certain senior-level workers might earn millions of dollars if the business succeeds in obtaining crucial regulatory permits. The salary packages of the Neuralink IACUC members, who are also employed by the company, were not known to Reuters.
If the private company’s valuation, which is currently more than $1 billion, keeps rising, Neuralink stockholders might make significant gains. For the business to obtain federal approval for human trials and, ultimately, brain-implant commercialization, successful animal trials are essential. According to a March article from Reuters, Neuralink’s first application for a human trial was denied by the U.S. Food and Drug Administration in part because the business had not demonstrated the device’s safety in animal studies.
At Duke University, Dr. Miguel Nicolelis, a neuroscientist and physician, has studied brain implants for almost three decades. He claimed that the IACUC members in charge of monitoring his animal tests never took part in the research, which included animal tests similar to the ones Neuralink is currently carrying out. According to Nicolelis, the independence of such boards is essential for preserving the integrity of animal studies that may have an influence on people in the future through clinical trials.
He referred to the composition of the Neuralink board as “an obvious conflict of interest.”
The animal-research and bioethics specialists added that many businesses contract out animal testing and oversight to institutions of higher learning or scientific research that have stringent regulations to avoid such conflicts of interest. These organizations often forbid members of IACUCs and electors who vote on animal experimentation from having direct financial interests.
For the initial phase of its animal testing, Neuralink collaborated with the University of California, Davis. But after a disagreement, the company left the university because it found the administrative procedures to be too cumbersome and lengthy, according to two current and two former Neuralink employees. After then, Neuralink internalized the oversight and research processes.
In a response, UC Davis noted that while it would not comment on Neuralink’s new oversight board, its conflict-of-interest policies forbade “interested” parties from voting or “influencing decisions” on such panels.
The greatest public funder of biomedical research in the world is the National Institutes of Health in the United States. According to Dr. Patricia Brown, head of the NIH’s Office of Laboratory Animal Welfare, the agency prohibits any IACUC member receiving money or stock from a research sponsor from reviewing or voting on that sponsor’s animal research on programs it supports.
Regarding Neuralink’s board, the NIH declined to comment. According to Reuters, the organization once contacted Neuralink to offer funds and advice as part of a program designed to advance brain-implant research. Because Musk sought to avoid public scrutiny and what he saw as bureaucratic obstacles, Neuralink was not interested in receiving money from the NIH.
The main organization in charge of enforcing laws governing animal welfare is the U.S. Department of Agriculture (USDA). Two former senior USDA officials were among the animal-research professionals Reuters spoke with who assessed the agency’s general enforcement of conflict-of-interest regulations as lackluster.
Members of the IACUC are prohibited by USDA regulations from “reviewing or approving an activity in which that member has a conflict of interest.” But the definition of a conflict in that rule is ambiguous. However, it does provide an instance of a circumstance when a board member is “personally involved in the activity.”
The experts and former agency employees claimed that the USDA had construed the rule narrowly. They claimed that until an IACUC member votes to authorize a specific experiment that member is also directly executing as an employee of the corporation, the agency infrequently indicates a conflict. Beyond that, the experts said, the USDA permits a variety of possible conflicts that are never allowed in human studies, which are managed by other federal agencies that have comparable conflict-of-interest rules. Universities, research institutions, and a lot of businesses often forbid or try to minimize conflicts like those on Neuralink’s IACUC in animal testing.
In response to a query from Reuters, the USDA stated that during 10 inspections of Neuralink’s animal-research facilities since 2020, the department had not discovered any conflicts of interest on the company’s board of directors. According to public documents and a person with knowledge of the examinations, the company has passed all inspections without receiving any citations.
The organization refuses to respond to specific queries regarding how it interprets the law or implements the conflict-of-interest guidelines for animal research and oversight.
The combined investigation is focusing on the agency’s control over Neuralink as well as overall animal welfare. The probe comes after a lengthy line of USDA OIG investigations, three of which have been published since 2014 and have criticized the agency’s animal welfare enforcement as being ineffectual. A stretched staff is one problem: Inspecting 11,785 sites, including labs, zoos, and breeders, the USDA employs 122 inspectors, according to a Congressional Research Service report from last July.
The USDA rarely enforces its conflict-of-interest policies. Delcianna Winders, who is in charge of the Animal Law and Policy Institute at the Vermont Law and Graduate School, reviewed the records and found that in the more than 11,000 USDA inspections conducted over the past ten years, the agency issued eight citations for conflicts at research labs, none of which resulted in a fine. According to her, there is a significant risk that conflicted IACUC members may put their own interests ahead of that of the animals because there is no enforcement.
She claimed that “the USDA is really only looking at paperwork and not looking under the hood.” She claimed that the situation involving the board of Neuralink serves as an example of the issue with “the too narrow meaning the USDA is giving to “conflicting interest.”
Neuralink collaborated with the University of California, Davis between September 2017 and December 2020, utilizing the institution’s federally sponsored primate research facility and its established IACUC. Before the cooperation ended, Neuralink gave UC Davis more than $1.9 million for research, according to the institution. In collaboration with the university, Neuralink surgeons and other staff members continued to directly work on the tests.
According to a UC Davis spokesman who spoke to Reuters, the university’s IACUC ordered improvements to Neuralink’s research protocols and training after its oversight of Neuralink’s trials revealed an animal welfare event in 2019. The representative said that no UC Davis employees were involved in the incident, but she would not elaborate.
In the midst of conflict, Neuralink ended its collaboration with UC Davis in 2020, erected its own facilities for animal experimentation, and established its own IACUC.
The IACUC at Neuralink is in charge of keeping animal testing to the bare minimum needed for research. After studies, tested animals are usually slaughtered so that researchers can examine them after death.
According to Neuralink employees and corporate records viewed by Reuters, the company has rushed and occasionally mishandled tests, particularly when it fully internalized animal experiments. In accordance with Musk’s demands, the company’s IACUC permitted Neuralink to expedite animal tests, according to three persons familiar with the panel’s rulings, who spoke to Reuters.
According to corporate records, the company murdered 250 or so sheep, pigs, and primates in 2021 and 2022. According to Reuters, the business implanted the incorrect-sized devices in 25 out of 60 pigs in one incident in 2021. Employees at Neuralink claimed that with proper planning, the error might have been prevented.
A number of animal-research professionals referred to Autumn Sorrells’ dual position as board chair and executive in charge of Neuralink’s animal-care program as a particularly unsettling conflict.
Requests for comment from Sorrells were not returned.
According to internal records and two Neuralink insiders with knowledge of the committee’s procedures, several of the 22 IACUC members also report to Sorrells in their Neuralink roles, which are independent from the board. According to one of the sources, this dynamic deters those members from disagreeing with the board on issues.
According to a federal official with knowledge of the agency’s interactions with Neuralink, during a USDA inspection in January that was prompted by the December Reuters report and related scrutiny from U.S. Congress members, Neuralink never disclosed to USDA inspectors other IACUC members’ close connections to Sorrells. If such links had been made public, inspectors would have probably looked more closely at the potential conflicts, the official added.