FOIAengine REVEALS QUESTIONS ABOUT NEURALINK
Elon Musk, no stranger to controversy, took the stage a little over three months ago to double down on a big bet. In a livestream from California since viewed by millions, with fans in the room cheering him on, Musk talked up his brain-implant company, Neuralink, and made a boast that triggered a raft of FOIA requests.
It was a flashy show, pulled off with a Matrix theme – the interconnection of the body, the brain, and the mind. And, of course, Musk’s bankroll. As of last November 30, the day of the much-ballyhooed stream, the billionaire entrepreneur had already sunk at least $363 million into Neuralink, a brain implant start-up with no product and no public investors yet.
Musk is on a quest to make an implantable brain chip that could be used by quadriplegic patients to control a computer or other devices, and he has been pressuring employees at Neuralink to accelerate development. “We’re all already cyborgs, in a way” he told his audience. “Your phones and your computer are extensions of yourself.” Neuralink was just the logical next step.
Musk’s livestream was part publicity stunt and part recruitment effort, to get prospective engineers and others on board. And also, as it turned out, possibly a jab in the eye of the Food and Drug Administration. That’s what attracted our attention at FOIAengine.
In 2021, Neuralink posted a YouTube video of a macaque named Pager who, the company said, used a Neuralink implant to play the classic Atari video game Pong. That video has been viewed 6.4 million times. At his most recent show-and-tell, Musk played another video. This time, a macaque with a Neuralink chip in its skull appeared to be typing in response to telepathic commands. It was great theatre. The primate moved keys on a computer-screen keyboard – “with his mind,” Musk told the audience. “He can’t actually spell. I don’t want to oversell this thing.” Musk said Neuralink would be ready to test its devices, which use Bluetooth technology to send signals to chips implanted in the brain, on humans – within six months.
“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 we think probably in about six months we should be able to have our first Neuralink in a human,” Musk said.
But what he didn’t say was just as newsworthy: The FDA wasn’t ready to let Musk test his brain implants on human subjects.
The day after Musk’s presentation, the FDA received a FOIA request from someone whose affiliation wasn’t included in the FDA’s logs. The request was noteworthy because of its source and specificity – more about that later – but it wasn’t the first FOIA request about Neuralink. According to the FOIAengine database, there had been several earlier FOIA requests to the FDA and the Securities and Exchange Commission that mentioned Neuralink, but nowhere near the number of FOIA requests about Musk, Tesla, and Twitter. The latter two companies had shares that were constantly in play; they were the main focus of more than 50 recent FOIA requests about Musk. Neuralink had acquired a certain notoriety about its animal testing – some 1,500 animals, including over 280 sheep, pigs, and monkeys, have been killed in Neuralink experiments since 2018.
But Docket Alarm analytics show that Neuralink mostly avoided the lawsuits that dogged Musk and his public companies.
It wasn’t surprising that until recently Neuralink didn’t provoke many FOIA requests, either.
But there had been a few. A full 14 months before Musk’s big show-and-tell about Neuralink, a Bloomberg reporter on September 2, 2021 made a request to the FDA for “any correspondence” between that agency and Neuralink, “in particular . . . for waivers to [regulations governing medical device testing conducted outside of the U.S.].” The Bloomberg request was quite specific. It cited the applicable section of the FDA’s offshore testing regulations, and pointedly stated: “I am looking for waivers . . . requested by Neuralink.”
The Bloomberg requester might have been on to something, but there doesn’t appear to have been a resultant story. Still, FOIA requests to the federal government can be an important early warning of bad publicity or litigation to come. That is why PoliScio Analytics’ competitive-intelligence database FOIAengine tracks FOIA requests in as close to real-time as their availability allows. Of particular interest are requests that may significantly affect stocks and markets once the stories hit.
Then came Musk’s big reveal, featuring the typing monkey.
The next day, December 1, 2022, the FDA received a request from Yechiel Kops, a financial analyst and vice president at New York-based Jefferies. Jefferies is a top-tier investment bank and wealth manager, with $440 billion in assets under management.
According to FOIAengine, Kops’ was the first FOIA request to the FDA about the issue of animal testing and human trials. He sought “any emails, call logs or other communications between Neuralink, Elon Musk . . . or others representing Neuralink, specifically as it related to animal testing or human trials of their brain implantation device.” Kops hasn’t received a reply from the FDA. “I submitted the information request from my personal email account,” he stated. “Any attempt to draw a connection between my personal interests and my professional career is completely inaccurate.”
Kops had a two-month jump on journalists who began peppering the FDA with FOIA requests about Neuralink in late January of 2023. A Bloomberg reporter’s request on January 25 asked about Musk and Neuralink and stated, “I believe there is also communication outside of device approval that occurred with FDA leaders.” The FDA didn’t respond to our question about such communications.
On February 7, a Washington Post reporter made two FOIA requests for FDA inspection records from Neuralink’s laboratories in Texas and California, and for investigational device exemption submissions from Neuralink to the FDA’s Center for Devices and Radiological Health (CDRH).
On February 14, a Wall Street Journal reporter made a FOIA request for “emails dated between January 1, 2019 and present day, including attachments, between @neuralink.com addresses” and five top officials of the aforementioned CDRH, including its director, Dr. Jeffrey E. Shuren. We asked the FDA to comment, or to make Shuren available. An FDA spokesperson replied, in a brief statement, that “the FDA is in receipt of and processing the FOIA requests noted above. We have nothing further to share at this time.”
Earlier this month, the bad news for Neuralink finally broke. Investigative reporter Rachel Levy of Reuters was first to report that the FDA had rejected Neuralink’s application for human trials early in 2022, long before Musk made his “ready in six months” prediction. Her reporting came from sources within Neuralink, who revealed that their company had spent the prior year unsuccessfully trying to work through the agency’s concerns over the safety of the experimental implant. Other reporting indicated that the FDA reportedly has concerns about overheating of the device and toxic chemicals seeping into the brain from the implant. But the FDA hasn’t said anything publicly, and told us in a statement that it “cannot confirm or deny the possible existence of a pending product application.” That meant Musk was able to command the stage, and the attention, for a prediction that seemingly had no basis in fact.
“You could have a Neuralink device implanted right now, and you wouldn’t even know,” he teased at the show-and-tell event. “I mean, hypothetically. In one of these demos, in fact, I will.”
Coming next from FOIAengine: Short sellers.
John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. His most recent book is The Partisan: The Life of William Rehnquist. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at jaj@PoliScio.com.
