Fresh off his trip to space, billionaire businessman Jeff Bezos on Monday offered to cover up to $2 billion in NASA costs if the US space agency awards his company Blue Origin a contract to make a spacecraft designed to land astronauts back on the moon.
NASA in April awarded rival billionaire entrepreneur Elon Musk’s SpaceX a $2.9 billion (roughly Rs. 21,595 crores) contract to build a spacecraft to bring astronauts to the lunar surface as early as 2024, rejecting bids from Blue Origin and defense contractor Dynetics. Blue Origin had partnered with Lockheed Martin, Northrop Grumman and Draper in the bid.
The space agency cited its own funding shortfalls, SpaceX’s proven record of orbital missions and other factors in a contract decision that senior NASA official Kathy Lueders called “what’s the best value to the government.”
In a letter to NASA Administrator Bill Nelson, Bezos said Blue Origin would waive payments in the government’s current fiscal year and the next ones after that up to $2 billion, and pay for an orbital mission to vet its technology. In exchange, Blue Origin would accept a firm, fixed-priced contract, and cover any system development cost overruns, Bezos said.
“NASA veered from its original dual-source acquisition strategy due to perceived near-term budgetary issues, and this offer removes that obstacle,” Bezos wrote.
“Without competition, NASA’s short-term and long-term lunar ambitions will be delayed, will ultimately cost more, and won’t serve the national interest,” Bezos added.
A NASA spokesperson said the agency was aware of Bezos’ letter but declined to comment further, citing the protest Blue Origin filed with the US Government Accountability Office accusing the agency of giving SpaceX an unfair advantage by allowing it to revise its pricing.
The GAO’s decision is expected by early August, though industry sources said Blue Origin views the possibility of a reversal as unlikely.
A SpaceX spokesperson did not respond to a request for comment.
Before choosing SpaceX, NASA had asked for proposals for a spacecraft that would carry astronauts to the lunar surface under its Artemis program to return humans to the moon for the first time since 1972. Blue Origin’s lunar lander is called “Blue Moon.” Bezos and Musk are the world’s richest and third-richest people respectively, according to Forbes.
Bezos’ offer came six days after he flew alongside three crewmates to the edge of space aboard Blue Origin’s rocket-and-capsule New Shepard, a milestone for the company’s bid to become a major player in an emerging space tourism market.
© Thomson Reuters 2021
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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