Hype and Hope: Brain-chip Progress Evokes Investigations, Controversy

FOIAengine: Neuralink’s High Profile Makes It a Target

It was a Musk Moment unlike any other:  Two weeks ago, the first human participant in Neuralink’s brain-implant trials took the stage to show how he could play chess by imagining where he wanted the pieces to go.    

And how he could turn music on and off telepathically, simply by thinking about it.

This was no deepfake.  The moment was real, streamed live and watched by millions. 

“Hello, humans,” the 29-year-old quadriplegic said after he was introduced. “I wanted to start this out with a joke, but I didn’t think you lesser beings would understand.” 

His Neuralink audience reacted with chuckles, because they got the joke.  Neuralink’s founder, Elon Musk, envisions a cyborg reality in which body, brain, and mind can be interconnected via a computer chip robotically implanted in the brain. 

After delays, Neuralink’s human trial was approved by the Food and Drug Administration last May.  The company posted a call for clinical-trial volunteers in September.    Four months later, the man introduced as “Participant One” got the first implant.  He was later revealed to be Noland Arbaugh, paralyzed from the shoulders down after a diving accident at age 21.

Two months after receiving the brain implant – a chip with a thousand microscopic electrodes – Arbaugh was on stage, showing the world what was possible.  

“It’s pretty cool, huh?” Arbaugh said.  “It’s crazy.  It really is.  I’m so friggin’ lucky to be part of this.  Every day it seems like we’re learning new stuff, and I just can’t describe how cool it is to be able to do this.” 

“What does it feel like to move the cursor with your mind,” a questioner asked.

“Freakin’ wild,” Arbaugh replied.  “Like, right now, I can feel myself moving my index finger.  It’s not moving, but I can feel it. . . . And seeing that translate onto a screen, and being able to move a cursor, is such a wild, wild feeling.  . . I’m showing people how amazing this technology is, just by thinking.  That’s crazy.” 

A system that deciphers brain signals and translates them into commands holds promise for those suffering from paralysis or severe degenerative diseases.  The possibilities of this evolving technology are immense.  The best explainer we’ve seen is this one, published by the Wall Street Journal two days after Arbaugh’s livestream.    

Neuralink isn’t the only deep-pocketed start-up working on brain-computer interfaces – known in the med-tech world as BCIs.  But it’s certainly the most visible and, inevitably since it involves Musk, the most controversial. 

Neuralink was founded in 2016.  According to the Wall Street Journal (citing PitchBook), Neuralink has raised more than $687 million in funding.  Early investors included Google Ventures; the co-founders of PayPal and Coinbase; and Sam Altman, CEO of OpenAI.  Musk later fell out with Altman.  On February 29, Musk filed a sprawling lawsuit against Altman and others over the future direction of OpenAI. 

It’s been a year since we last wrote about Neuralink (see “Big Bet on Brain Implants:  Elon Musk, Cyborgs, and FOIA,” March 23, 2023).  Back then, Musk was touting a video of a monkey with a Neuralink implant.  The monkey appeared to be typing in response to telepathic commands.  A human trial hadn’t been approved. 

Last month’s livestream got our attention.  We dug into PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, to see who else is watching Neuralink. 

FOIAengine counts 45 FOIA requests about Neuralink since 2021, with almost all coming since the beginning of 2023 as Neuralink’s visibility increased and the race to develop and commercialize BCIs began to heat up. 

Although other companies like Paradromics, Synchron, Blackrock Neurotech and Precision Neuroscience are working on or have developed BCI systems similar to Neuralink’s – and, in some cases, have also implanted their devices in humans – those competitors have been ignored by FOIA requesters.  We counted only a single FOIA request about Synchron, and zero requests about the other companies. 

Neuralink’s notoriety has led to other problems, not only for Neuralink but for the FDA as well.

Last week, Rep. Earl Blumenauer (D-Ore.) sent a letter to FDA Commissioner Robert Califf criticizing the agency for approving Neuralink’s human trials “despite serious concerns about the company’s research protocols” dating to 2022.  Blumenauer cited prior warnings raised to the FDA by the Physicians Committee for Responsible Medicine about Neuralink’s “likely” safety violations.  An FDA spokesperson acknowledged the letter and told us the agency would respond to Blumenauer. 

Last May, Blumenauer and Rep. Adam Schiff (D-Cal.), along with six other lawmakers, filed a similar complaint with Agriculture Secretary Tom Vilsak, whose department oversees clinical testing on animals. 

In November, Blumenauer and three other congressional Democrats asked the Securities and Exchange Commission to investigate to Neuralink for securities fraud.  One month earlier, the Physicians Committee made a similar demand to the agency’s Enforcement Division.  The group sought a fraud investigation of Neuralink and Musk after Musk posted on X that “no monkey has died as a result of a Neuralink implant” – a statement the group asserted Musk knew was a falsehood. 

FOIA requests to the federal government can be an important early warning signals of bad publicity, litigation to come, or uncertainties to be hedged and gamed out.  In Neuralink’s case, it’s probably all of the above.  FOIA requests targeting Neuralink are coming from a mélange of news organizations, plaintiffs lawyers, and public interest organizations.

Since the beginning of 2023, when FOIA requests about Neuralink accelerated, questions about Neuralink and its trials have come in to the FDA, SEC, and the Agriculture Department’s Animal and Plant Health Inspection Service from these media companies:  Reuters (8 requests), the Washington Post (4),  Bloomberg (3), the New York Times (2), CNBC (2),  the Wall Street Journal, Fortune, Business Insider, and Capitol Forum.     

Plaintiffs law firm Siri & Glimstad, a frequent FOIA requester that vacuums up records on many topics, weighed in with two requests to the FDA in February, the most recent month for which logs are available.  The law firm sought “all records concerning the approval for Neuralink to conduct its first human clinical trial” and “all communications (including but not limited to emails, text messages, direct messages, Teams chats, etc.) sent or received by” various FDA officials involved in approving the Neuralink human trial.    

The Physicians Committee for Responsible Medicine made a sweeping request for Neuralink’s clinical-trial-related premarket approval applications and nonclinical records; “all communications between Neuralink and FDA regarding its application; and all photographs related to Neuralink’s application.”

The documents being sought could be significant, because Neuralink thus far has released little information on its own.  As of this writing, Neuralink’s human trial is not listed on the website ClinicalTrials.gov, which is where most device companies post information about their trials and research. 

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Next:  A defective heart pump caused at least 49 deaths.  Did FOIA requests send a signal?

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.