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Did Elon Musk Get a Pass from FDA For His High-Risk Device Trial?
(Thursday, October 12, 2023) Animal studies are critical for demonstrating the safety of a product prior to the initiation of human clinical trials. Clinical trials will not be allowed to proceed by the FDA if any major product-related safety issues are observed in animal studies. But did Elon Musk’s company get a break from this policy or lie to the FDA? Based on independent reports, it seems the FDA has allowed a clinical trial with a brain implant, called N1 implant developed by Neuralink, a company owned by the billionaire Elon Musk, despite serious safety concerns about the device observed in the animal trials. But there is likely more to the story. Neuralink has developed a fully implantable brain-computer interface designed to let the patient control physical functions using thoughts. The device is implanted surgically into the cortex of the brain using a specially designed sewing machine robot. So, in effect, the device has two parts: the N1 implant, and the R1 robot. The implant is powered by a rechargeable lithium battery which is charged wirelessly. The implant seems to be designed for permanent implantation as the robotic process for placing/sewing it on the brain seems complicated enough to make it almost impossible to reverse without damaging the brain. Presumably, the implant seems to be remotely programmable as well so additional functionalities may be added later. Reminds you of the Matrix movies. In the first trial, the device will be tested for its ability to control simple actions on a computer or mobile device. If successful, future trials will evaluate the control of complex functions. Brain-computer implants have been developed for decades. The biggest differentiator for N1 Implant is its small size and sophisticated circuitry. There is not much information available about the device other than some videos on YouTube. The company primarily communicates via carefully curated YouTube videos and X (formerly known as Twitter) about its work. There are no peer-reviewed publications about the development of the device or any of the experiments conducted with the device that we could find. The YouTube videos paint a very positive picture of the device and the experiments but are clearly highly edited and over-simplified. All this creates a cloud of mystique about the device which is why there is so much speculation about the merits of Neuralink’s technology. Based on the company’s YouTube videos, N1 implant and the R1 robot were used in studies in monkeys and pigs where it was reported to be safe and worked as designed. But that claim has been challenged by independent non-FDA groups. An animal rights nonprofit group against live animal testing, Physicians Committee for Responsible Medicine (PCRM), has challenged Neuralink’s claims for the safety of the N1 implant. Specifically, PCRM conducted an undercover investigation of the animal facilities and interviewed numerous researchers involved in the monkey studies to find various serious safety concerns in the animals used in Neuralink’s experiments. According to PCRM, there were several cases of chronic infections, swelling in the brain, “remnant electrode threads” from the device found in the brain, “tattered” cerebral cortex, paralysis, seizures, loss of coordination and balance, and depression in monkeys, that were so severe that 12 of the animals had to be euthanized. This is a very serious allegation as in all public announcements by the company and specifically by its owner, Mr. Musk, it has claimed that no animals died due to the implanted device. There is no evidence that the animal facility where Neuralink conducted its animal studies or Neuralink facilities itself have ever been audited by the FDA based on the review of the FDA’s inspection database. The animal study reports were obviously included in its Investigational Device Exemption (IDE) application with the FDA for the first clinical trial. The FDA approved the IDE for the N1 Implant in May 2023, so the FDA’s concerns, if any, were satisfied by the company. The company, the FDA, and Mr. Musk have not commented on PCRM’s findings. The discussions between Neuralink and the FDA, the contents of the IDE application, and any documents submitted by Neuralink to the FDA in support of the FDA’s queries about its IDE application, are all protected by Federal confidentiality laws. Neuralink has not disclosed the first clinical protocol publicly which could shed some light on any specific measures to address the safety concern with the implant. All we have are speculations and conjectures about whether the company lied about or omitted the safety data about its animal experiments to the FDA. Animal safety data is critical. Almost 25 years ago, in one of the first gene therapy trials, an 18-year-old teenager died because the researchers chose to hide safety concerns observed in monkey experiments. That trial was also approved by the FDA. The N1 Implant is a glitzy entry in the brain-computer interface science, supported by a company with seemingly unlimited resources and a powerful benefactor. It would be devastating to this science if the FDA was lied to or misled about the safety of this device, not to mention the criminal offenses that may have been committed, if true. It would also be terrible if the FDA allowed the study to proceed despite safety issues because of external pressure. It is also hard to imagine someone dumb enough to lie like this for a medical device of this stature where any accident or mishap would be enormously visible and easily caught. So, we need to give the company the benefit of our doubt at this moment and wait for more information about this device. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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