Over the next few weeks, a company called Kernel will begin sending dozens of customers across the US a $50,000 (roughly Rs. 37 lakhs) helmet that can, crudely speaking, read their mind. Weighing a couple of pounds each, the helmets contain nests of sensors and other electronics that measure and analyse a brain’s electrical impulses and blood flow at the speed of thought, providing a window into how the organ responds to the world. The basic technology has been around for years, but it’s usually found in room-size machines that can cost millions of dollars and require patients to sit still in a clinical setting.
The promise of a leagues-more-affordable technology that anyone can wear and walk around with is, well, mind-bending. Excited researchers anticipate using the helmets to gain insight into brain aging, mental disorders, concussions, strokes, and the mechanics behind previously metaphysical experiences such as meditation and psychedelic trips. “To make progress on all the fronts that we need to as a society, we have to bring the brain online,” says Bryan Johnson, who’s spent more than five years and raised about $110 million (roughly Rs. 815 crores) —half of it his own money—to develop the helmets.
Johnson is the chief executive officer of Kernel, a startup that’s trying to build and sell thousands, or even millions, of lightweight, relatively inexpensive helmets that have the oomph and precision needed for what neuroscientists, computer scientists, and electrical engineers have been trying to do for years: peer through the human skull outside of university or government labs. In what must be some kind of record for rejection, 228 investors passed on Johnson’s sales pitch, and the CEO, who made a fortune from his previous company in the payments industry, almost zeroed out his bank account last year to keep Kernel running. “We were two weeks away from missing payroll,” he says. Although Kernel’s tech still has much to prove, successful demonstrations, conducted shortly before COVID-19 spilled across the globe, convinced some of Johnson’s doubters that he has a shot at fulfilling his ambitions.
A core element of Johnson’s pitch is “Know thyself,” a phrase that harks back to ancient Greece, underscoring how little we’ve learned about our head since Plato. Scientists have built all manner of tests and machines to measure our heart, blood, and even DNA, but brain tests remain rare and expensive, sharply limiting our data on the organ that most defines us. “If you went to a cardiologist and they asked you how your heart feels, you would think they are crazy,” Johnson says. “You would ask them to measure your blood pressure and your cholesterol and all of that.”
The first Kernel helmets are headed to brain research institutions and, perhaps less nobly, companies that want to harness insights about how people think to shape their products. By 2030, Johnson says, he wants to bring down the price to the smartphone range and put a helmet in every American household—which starts to sound as if he’s pitching a panacea. The helmets, he says, will allow people to finally take their mental health seriously, to get along better, to examine the mental effects of the pandemic and even the root causes of American political polarisation. If the Biden administration wanted to fund such research, Johnson says, he’d be more than happy to sell the feds a million helmets and get started: “Let’s do the largest brain study in history and try to unify ourselves and get back to a steady state.”
Johnson is something of a measurement obsessive. He’s at the forefront of what’s known as the quantified-self movement. Just about every cell in his body has been repeatedly analysed and attended to by a team of doctors, and their tests now cast him as a full decade younger than his 43 years. Along those lines, he wants to let everyone else analyse, modify, and perfect their minds. No one knows what the results will be, or even if this is a good idea, but Johnson has taken it upon himself to find out.
Unlike many of his tech-millionaire peers, Johnson grew up relatively poor. Born in 1977, he was raised in Springville, Utah, the third of five children. “We had very little and lived a very simple life,” says his mother, Ellen Huff. A devout Mormon, she stayed home with the kids as much as possible and earned a modest income from a rental unit on the other side of the family’s duplex.
Johnson remembers his mother knitting his clothes and grinding wholesale batches of wheat to make bread. “We were not like my friends,” he says. “They would buy things from stores, and we just did not do that.” His dad, a trash collector turned lawyer, had a drug problem and an affair, which led to his divorce from Huff. Later, delinquent child support payments, missed pickups on the weekends, and legal troubles contributed to his disbarment. “After some time of challenge, my father successfully overhauled his life 20 years ago,” Johnson says. “Throughout his struggles, we remained close and without conflict. He has been a unique source of wisdom, counsel, and stability in my life.”
Johnson had little idea what to do with his life until he served a two-year church mission in Ecuador, where he interacted with people living in huts with dirt floors and walls made of mud and hay. “When I came back, the only thing I cared about was how to do the most good for the most people,” he says. “Since I didn’t have any skills, I decided to become an entrepreneur.”
While at Brigham Young University, he started his own business selling cellphones and service plans, making enough money to hire a team of salespeople. After that, he invested in a real estate development company that collapsed and left him $250,000 (roughly Rs. 1.8 crores) in debt. To get out of the hole, he took a job selling credit card processing services to small businesses door to door. Soon he was the company’s top salesman.
This was the mid-2000s, and Johnson’s customers kept complaining about the hassle of setting up and maintaining credit card payment systems on their websites. In 2007 he started Braintree, a software company focused on easing the process with slick interfaces. It succeeded—and had good timing. After signing up a slew of restaurants, retailers, and other small businesses, Braintree became the middleman of choice for a profusion of startups premised on ordering services online, including Airbnb, OpenTable, and Uber. The company also made a great bet on mobile payments, acquiring Venmo for only $26 million (roughly Rs. 190 crores) in 2012. The next year, eBay bought Braintree for $800 million in cash, a little less than half of which went to Johnson.
Despite his newfound fortune, Johnson felt miserable. He was stressed out and overweight. He’d gotten married and had kids at a young age, but his marriage was falling apart, and he was questioning his life, religion, and identity. He says he entered a deep depressive spiral that included suicidal thoughts.
The decision to sell Braintree well before it peaked in value had been motivated in part by Johnson’s need to change those patterns. “Once I had money, it was the first time in my life that I could eliminate all permission structures,” he says. “I could do whatever I wanted.” He broke with the Mormon church, got divorced, and moved from Chicago, where Braintree was headquartered, to Los Angeles to start over.
Arriving in California, Johnson consulted with all manner of doctors and mental health specialists. His bodily health improved with huge changes to his diet, exercise, and sleep routines. His mind proved a tougher puzzle. He meditated and studied cognitive science, particularly the ways people develop biases, in an effort to train himself to think more rationally. By late 2014 he was convinced his wealth would be best spent advancing humanity’s understanding of the brain. He took a large portion of his windfall and started OS Fund, a venture firm that has invested in several artificial intelligence and biotech companies. These include Ginkgo Bioworks, Pivot Bio, Synthego, and Vicarious, some of the most promising startups trying to manipulate DNA and other molecules.
Mostly, though, Johnson staked his fortune on Kernel. When he founded the company, in 2015, his plan was to develop surgical implants that could send information back and forth between humans and computers, the way Keanu Reeves downloads kung fu into his brain in The Matrix. (In the early days, Johnson discussed a potential partnership with Elon Musk, whose company Neuralink. has put implants in pigs and monkeys, but nothing came of it.) The idea was, in part, to transfer thoughts and feelings directly from one consciousness to another, to convey emotions and ideas to other people more richly than human language allows.
Perhaps more important, Johnson reckoned, AI technology was getting so powerful that for human intelligence to remain relevant, the brain’s processing power would need to keep pace.
Johnson and I began discussing brains in mid-2018, when I was working on a story about the overlap between neuroscience and AI software. During an initial interview at his company’s headquarters in LA’s Venice neighborhood, Johnson was cordial but somewhat vague about his aims. But at the end of the visit, I happened to mention the time I underwent a mental healing ritual that involved a Chilean shaman burning holes in my arm and pouring poisonous frog secretions into the wounds. (I do mention this a lot.) Excited, Johnson replied that he had a personal shaman in Mexico and doctors in California who guided him on drug-induced mind journeys. Based on this common ground, he decided to tell me more about Kernel’s work and his own adventurous health practices.
By then, Johnson had abandoned neural implants in favour of helmets. The technology needed to make implants work is difficult to perfect—among other things, the human body tends to muddy the devices’ signals over time, or to reject them outright—and the surgery seemed unlikely to go mainstream. With the helmets, the basic principle remained the same: put tiny electrodes and sensors as close as possible to someone’s neurons, then use the electrodes to detect when neurons fire and relay that information to a computer. Watch enough of these neurons fire in enough people, and we may well begin to solve the mysteries of the brain’s fine mechanics and how ideas and memories form.
On and off for almost three years, I’ve watched as Kernel has brought its helmets into reality. During an early visit to the company’s two-story headquarters in a residential part of Venice, I saw that Johnson’s team had converted the garage into an optics lab full of mirrors and high-end lasers. Near the entryway sat a shed-size metallic cube designed to shield its contents from electromagnetic interference. On the second floor, dozens of the world’s top neuroscientists, computer scientists, and materials experts were tinkering with early versions of the helmets alongside piles of other electrical instruments. At that point the helmets looked less like 21st century gadgets and more like something a medieval knight might wear into battle, if he had access to wires and duct tape.
Despite the caliber of his team, Johnson and his odd devices were considered toys by outsiders. “The usual Silicon Valley people and investors would not even talk to us or poke around at all,” he says. “It became clear that we would have to spend the time, and I would have to spend the money, to show people something and demonstrate it working.”
A hospital or research center will typically employ a range of instruments to analyse brains. The list is a smorgasbord of acronyms: fMRI (functional magnetic resonance imaging), fNIRS (functional near-infrared spectroscopy), EEG (electroencephalography), MEG (magnetoencephalography), PET (positron emission tomography), etc. (et cetera). These machines measure a variety of things, from electrical activity to blood flow, and they do their jobs quite well. They’re also enormous, expensive, and not easily condensed into helmet form.
In some cases the machines’ size owes in part to components that shield the patient’s head from the cacophony of electrical interference present in the world. This allows the sensors to avoid distracting signals and capture only what’s happening in the brain. Conversely, signals from the machines need to penetrate the human skull, which happens to be well-evolved to prevent penetration. That’s part of the argument for implants: They nestle sensors right up against our neurons, where the signals come in loud and clear.
It’s unlikely a helmet will ever gain the level of information an implant can, but Kernel has striven to close the gap by shrinking its sensors and finding artful ways to block electromagnetic interference. Among its breakthroughs, Johnson’s team designed lasers and computer chips that were able to see and record more brain activity than any previous technology. Month after month, the helmet became more refined, polished, and lightweight as the team made and remade dozens of prototypes. The only trick was that, to suit the different applications Johnson envisioned for the helmet, Kernel wound up needing to develop two separate devices to mimic all the key functions of more traditional machines.
A look inside the Flow. Photographer: Damien Maloney for Bloomberg Businessweek
One of the devices, called Flow, looks like a high-tech bike helmet, with several brushed aluminum panels that wrap around the head and have small gaps between them. Flip it over, and you’ll see a ring of sensors inside. A wire at the back can be connected to a computer system.
This helmet measures changes in blood oxygenation levels. As parts of the brain activate and neurons fire, blood rushes in to provide oxygen. The blood also carries proteins in the form of hemoglobin, which absorbs infrared light differently when transporting oxygen. (This is why veins are blue, but we bleed red.) Flow takes advantage of this phenomenon by firing laser pulses into the brain and measuring the reflected photons to identify where a change in blood oxygenation has occurred. Critically, the device also measures how long the pulse takes to come back. The longer the trip, the deeper the photons have gone into the brain. “It’s a really nice way to distill out the photons that have gone into the brain vs. ones that only hit the skull or scalp and bounced away,” says David Boas, a professor of biomechanical engineering and director of the Neurophotonics Center at Boston University.
The other Kernel helmet, Flux, measures electromagnetic activity. As neurons fire and alter their electrical potential, ions flow in and out of the cells. This process produces a magnetic field, if one that’s very weak and changes its behavior in milliseconds, making it extremely difficult to detect. Kernel’s technology can discover these fields all across the brain via tiny magnetometers, which gives it another way to see what parts of the organ light up during different activities.
The helmets are not only smaller than the devices they seek to replace, but they also have better bandwidth, meaning researchers will receive more data about the brain’s functions. According to the best current research, the Flow device should help quantify tasks related to attention, problem-solving, and emotional states, while Flux should be better suited to evaluating brain performance, learning, and information flow. Perhaps the No. 1 thing that has scientists gushing about Kernel’s machines is their mobility—patients’ ability to move around wearing them in day-to-day settings. “This unlocks a whole new universe of research,” Boas says. “What makes us human is how we interact with the world around us.” The helmets also give a picture of the whole brain, as opposed to implants, which look solely at particular areas to answer more specific questions, according to Boas.
Once their Kernel helmets arrive, Boas and his colleagues plan to observe the brains of people who’ve had strokes or suffer from diseases such as Parkinson’s. They want to watch what the brain does as individuals try to relearn how to walk and speak and cope with their conditions. The hope is that this type of research could improve therapy techniques. Instead of performing one brain scan before the therapy sessions start and another only after months of work, as is the practice today, researchers could scan the brain each day and see which exercises make the most difference.
Devices are also going out to Harvard Medical School, the University of Texas, and the Institute for Advanced Consciousness Studies (a California lab focused on researching altered states) to study such things as Alzheimer’s and the effect of obesity on brain aging, and to refine meditation techniques. Cybin, a startup aiming to develop therapeutic mental health treatments based on psychedelics, will use the helmets to measure what happens when people trip.
All of this thrills Johnson, who continues to harbor the grandest of ambitions for Kernel. He may have given up on computer-interfacing implants, but he still wants his company to help people become something more than human.
A couple years ago, Johnson and I boarded his private jet and flew from California to Golden, Colo. Johnson, who has a pilot’s license, handled the takeoffs and landings but left the rest to a pro. We were in Colorado to visit a health and wellness clinic run by physician-guru Terry Grossman and have a few procedures done to improve our bodies and minds.
The Grossman Wellness Center looked like a cross between a medical clinic and the set of Cocoon. Most of the other guests were elderly. In a large central room, about 10 black leather chairs and matching footrests were arranged in a loose circle. Each chair held a couple of fluffy white pillows, with a metal pole on the side for our IV drips. A few of the ceiling tiles had been replaced and fitted with pictures of clouds and palm trees. In rooms off to the side, medical personnel performed consultations and procedures.
Our morning began with an IV infusion of two anti-aging fluids: Myers’ Cocktail—a blend of magnesium, calcium, B vitamins, vitamin C, and other good stuff—followed by a helping of nicotinamide adenine dinucleotide. Some of the IV fluids can trigger nausea, but Johnson set the drip to maximum and complemented the IV by having a fiber-optic cable fed into his veins to pepper his blood with red, green, blue, and yellow wavelengths of light for added rejuvenation. “I have to experience pain when I exercise or work,” he said, adding that the suffering makes him feel alive.
A few hours later, Johnson went into one of the treatment rooms with Grossman to get a stem cell injection straight into his brain. Earlier he’d provided 5 ounces of his blood, which had then been spun in a centrifuge so Grossman could separate out the plasma and put it through a secret process to “activate the stem cells.” Now, Johnson hopped onto a reclined exam table, lying on his back with his head angled toward the floor. Grossman pulled out a liquid-filled syringe. Instead of a needle at the end, it had a 4‑inch‑long, curved plastic tube, which the doctor coated with some lubricating jelly. He pushed the tube into one of Johnson’s nostrils, told the patient to take a big sniff, then pinched Johnson’s nose shut. They repeated the process for the other nostril. The procedure looked incredibly uncomfortable, but again, Johnson was unfazed, pulling in the stem cells with determination and excitement.
This snorting procedure—designed to improve mood, energy, and memory—was just a small part of Johnson’s overall health regimen. Each morning the CEO took 40 pills to boost his glands, cell membranes, and microbiome. He also used protein patches and nasal sprays for other jobs. After all this, he did 30 minutes of cardio and 15 minutes of weights. At lunch he’d have some bone broth and vegetables foraged by his chef from the yards of houses in Venice. He might have a light dinner later, but he never consumed anything after 5 p.m. He went to bed early and measured his sleep performance overnight. Every now and then, a shaman or doctor would juice him up with some drugs such as ketamine or psilocybin. He’d taken strongly enough to these practices to tattoo his arm with “5-MeO-DMT,” the molecular formula for the psychoactive compound famously secreted by the Sonoran Desert toad.
To make sure all his efforts were doing some good, Johnson had a lab measure his telomeres. These are the protective bits at the end of DNA strands, which some Nobel Prize-winning science has shown can be good indicators of how your body is aging. The longer the telomeres, the better you’re doing. Johnson used to register as 0.4 years older internally than his chronological age, but a couple of years into his regimen under Grossman, when he was in his early 40s, his doctors were telling him he was testing like a man in his late 30s.
During one of our most recent conversations, Johnson tells me he’s stopped snorting stem cells and experimenting with hallucinogens. “I got what I wanted from that and don’t need to mess with it right now,” he says. After many tests and much analysis, he’s discovered he operates best if he wakes up at 4am, consumes 2,250 calories of carefully selected food over the course of 90 minutes, and then doesn’t eat again for the rest of the day. Every 90 days he goes through another battery of tests and adjusts his diet to counteract any signs of inflammation in his body. He goes to bed each night between 8 and 8:30pm and continues to measure his sleep metrics. “I have done tremendous amounts of trial and error to figure out what works best for my health,” he says. “I have worked very hard to figure these algorithms out.”
In terms of what our birth certificates say, Johnson and I are the same age. He’ll turn 44 in August, a month before I do. To someone like me, who prizes late nights with friends, food, and drink, Johnson’s rigid lifestyle doesn’t exactly sound romantic. But it does seem to be paying off: When he last got tested, he had the exercise capacity of someone in his late teens or early 20s, and a set of DNA and other health markers pegged his age at somewhere around 30. As for me, I lack the courage to ask science what it makes of my innards and will go on celebrating my dad bod.
As Johnson sees it, had he not changed his lifestyle, he’d have remained depressed and possibly died far too young. Now he does what the data say and nothing else. “I did a lot of damage to myself working 18-hour days and sleeping under a desk,” he says. “You might earn the praise of your peers, but I think that sort of lifestyle will very quickly be viewed as primitive.” He says he’s at war with his brain and its tendencies to lead him astray. “I used to binge-eat at night and could not stop myself,” he says. “It filled me with shame and guilt and wrecked my sleep, which crushed my willpower. My mind was a terrible actor for all those years. I wanted to remove my mind from the decision-making process.”
The nuance in his perspective can be tricky to navigate. Johnson wants to both master the mind and push it to the side. He maintains, however, that our brain is flawed only because we don’t understand how it works. Put enough Kernel devices on enough people, and we’ll find out why our brain allows us to pursue addictive, debilitating behaviors—to make reckless decisions and to deceive ourselves. “When you start quantifying the mind, you make thought and emotion an engineering discipline,” he says. “These abstract thoughts can be reduced to numbers. As you measure, you move forward in a positive way, and the quantification leads to interventions.”
Of course, not everyone will want to make decisions based on what a helmet says their brain activity means. Taking the decisions out of thought patterns—or analysing them for the purposes of market research and product design—poses its own, perhaps scarier, questions about the future of human agency. And that’s if the Kernel devices can fulfill the company’s broader ambitions. While the big, expensive machines in hospitals have been teaching us about the brain for decades, our understanding of our most prized organ has remained, in many ways, pretty basic. It’s possible Kernel’s mountain of fresh data won’t be of the kind that translates into major breakthroughs. The brain researchers who are more skeptical of efforts such as Johnson’s generally argue that novel insights about how the brain works—and, eventually, major leaps in brain-machine interfaces—will require implants.
Yet scientists who have watched Kernel’s journey remark on how the company has evolved alongside Johnson, a complete outsider to the field. “Everybody he’s recruited to Kernel is amazing, and he’s been able to listen to them and motivate them,” says MIT neuroscientist Edward Boyden. “He didn’t have scientific training, but he asked really good questions.” The test now will be to see how the company’s devices perform in the field and if they really can create a whole new market where consumers buy Flow and Flux helmets alongside their Fitbits and Oura rings. “There’s a lot of opportunity here,” Boyden says. “It’s a high-risk, high-payoff situation.”
If Johnson’s theories are correct and the Kernel devices prove to be as powerful as he hopes, he’ll be, in a sense, the first person to spark a broader sort of enlightened data awakening. He recently started a program meant to quantify the performance of his organs to an unprecedented degree. Meanwhile, he’s taking part in several experiments with the Kernel helmets and is still looking for ways to merge AI with flesh. “We are the first generation in the history of Homo sapiens who could look out over our lifetimes and imagine evolving into an entirely novel form of conscious existence,” Johnson says. “The things I am doing can create a bridge for humans to use where our technology will become part of our self.”
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Neuralink Faces US Federal Probe, Staff Complaints Over Animal Tests
Elon Musk’s Neuralink, a medical device company, is under federal investigation for potential animal-welfare violations amid internal staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to documents reviewed by Reuters and sources familiar with the investigation and company operations.
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.
© Thomson Reuters 2022
Neuralink Expected to Begin Human Trials in Six Months, Elon Musk Says
Elon Musk said on Wednesday a wireless device developed by his brain chip company Neuralink is expected to begin human clinical trials in six months.
The company is developing brain chip interfaces that it says could enable disabled patients to move and communicate again. Based in the San Francisco Bay Area and Austin, Texas, Neuralink has in recent years been conducting tests on animals as it seeks US regulatory approval to begin clinical trials in people.
“We want to be extremely careful and certain that it will work well before putting a device into a human but we’ve submitted I think most of our paperwork to the FDA and probably in about six months we should be able to upload Neuralink in a human,” Musk said during a much-awaited public update on the device.
The event was originally planned for October 31 but Musk postponed it just days before without giving a reason.
Neuralink’s last public presentation, more than a year ago, involved a monkey with a brain chip that played a computer game by thinking alone.
Musk is known for lofty goals such as colonizing Mars and saving humanity. His ambitions for Neuralink, which he launched in 2016, are of the same grand scale. He wants to develop a chip that would allow the brain to control complex electronic devices and eventually allow people with paralysis to regain motor function and treat brain diseases such as Parkinson’s, dementia and Alzheimer’s. He also talks about melding the brain with artificial intelligence.
Neuralink, however, is running behind schedule. Musk said in a 2019 presentation he was aiming to receive regulatory approval by the end of 2020. He then said at a conference in late 2021 that he hoped to start human trials this year.
Neuralink has repeatedly missed internal deadlines to gain US Food and Drug Administration (FDA) approval to start human trials, current and former employees have said. Musk approached competitor Synchron earlier this year about a potential investment after he expressed frustration to Neuralink employees about their slow progress, Reuters reported in August.
Synchron crossed a major milestone in July by implanting its device in a patient in the United States for the first time. It received US regulatory clearance for human trials in 2021 and has completed studies in four people in Australia.
© Thomson Reuters 2022
NASA’s Orion Spacecraft Enters Lunar Orbit a Week After Artemis I Launch
NASA’s Orion spacecraft was placed in lunar orbit Friday, officials said, as the much-delayed Moon mission proceeded successfully.
A little over a week after the spacecraft blasted off from Florida bound for the Moon, flight controllers “successfully performed a burn to insert Orion into a distant retrograde orbit,” the US space agency said on its website.
The spacecraft is to take astronauts to the Moon in the coming years — the first to set foot on its surface since the last Apollo mission in 1972.
This first test flight, without a crew on board, aims to ensure that the vehicle is safe.
“The orbit is distant in that Orion will fly about 40,000 miles above the Moon,” NASA said.
While in lunar orbit, flight controllers will monitor key systems and perform checkouts while in the environment of deep space, the agency said.
It will take Orion about a week to complete half an orbit around the Moon. It will then exit the orbit for the return journey home, according to NASA.
On Saturday, the ship is expected to go up to 40,000 miles beyond the Moon, a record for a habitable capsule. The current record is held by the Apollo 13 spacecraft at 248,655 miles (400,171 km) from Earth.
It will then begin the journey back to Earth, with a landing in the Pacific Ocean scheduled for December 11, after just over 25 days of flight.
The success of this mission will determine the future of the Artemis 2 mission, which will take astronauts around the Moon without landing, then Artemis 3, which will finally mark the return of humans to the lunar surface.
Those missions are scheduled to take place in 2024 and 2025, respectively.
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