In a 9 minutes long live-stream, Noland Arbaugh, the first recipient of the neural implant made by the Brain-Computer interface company Neuralink was seen playing chess online by being able to control the cursor with the help of the implant and his thoughts. Arbaugh, a 29-year-old who was rendered quadriplegic after a freak diving accident 8 years back received the implant in January. Despite the initial lack of transparency and public scepticism surrounding the trial in January, Arbaugh’s recovery seems to have been fairly normal and he says that he has not suffered any cognitive impairments following the procedure. In a recent Neuralink company meeting, Arbaugh was invited to discuss the implant and how he uses it and proceeded to display his skills by playing Mario Kart. He also claims that one of the first things he did after receiving the implant was to play Civilisation VI overnight. While the implant has allowed him to carry out activities such as play video games and learn new languages, in the live-stream, Arbaugh emphasised on the fact that there is still a long way to go in-terms of perfecting the implant considering it is still very much in its early days. The former program director for neural engineering in the U.S. National Institutes of Health, Kip Allan Ludwig, said that “while the feats shown by Neuralink are not a breakthrough, it is a good starting point and considering that it’s still early days post-implantation, there is still a lot that needs to be learned on both the company and the subject’s side to maximise the amount of information control”.
Following the live-stream, Democrat representative Earl Blumenauer, raised concerns regarding the troubling evidence of potential animal testing protocol violations surrounding the company and its approval for human trials. Citing the Reuters report from late 2022, Blumenauer asked the FDA as to how it had reconciled reports of such lapses with the decision to authorise Neuralink’s human trials. The report published by Reuters in December 2022, discusses the federal investigation carried out by the U.S department of Agriculture (USDA) and staff reports surrounding rushed experiments leading to increased animal deaths. The report mentions the death of 1500 animals, including more than 280 sheep, pigs, and monkeys since 2018. While the alarming death toll of animals is no indication for potential animal welfare protocol violations, according to the staff, most of the deaths were the result of increased human error due to pressure for speeding the research leading to fairly avoidable deaths.
After being rejected for approval by the U.S. Food and Drug administration (FDA) on four different occasions, the company was finally able to win approval in May of 2023, despite the lack of laboratory inspection carried out by the FDA as a result of the concerns surrounding the aforementioned protocol violations. Neuralink started recruiting potential subjects for its human trials in September 2023.
This news was followed by a letter by the Physicians Committee for responsible medicine, (PCRM) a non-profit organisation working towards abolishment of animal testing, requesting the U.S. Securities and Exchange commission (SEC) to carry out an investigation into Neuralink on accounts of Securities Fraud. The letter states that the implant resulted in “debilitating health effects in the monkeys”, including chronic infections, swelling in brain, tattered cerebral cortex and so on. It details cases of 4 Rhesus Macaques since late 2017 and their reaction to the implant with the latest report being regarding Animal 22, a 6-year-old male rhesus macaque who was subjected to a 7-hour surgery in January of 2020. A week after the procedure, the staff observed “crepitus-like sensation near the implanted port”, which essentially means crackling sound produced as a result of the tissues rubbing abnormally. Two months after the surgery staff noted that the implant was loose leading to the subsequent euthanization of the monkey. The necropsy report noted that the “screws attached to the implant were loose and could be easily lifted”. The letter also points out that the health records of the monkeys show that the animals suffered physical trauma and despite the average lifespan of Rhesus macaques being about 25 years in captivity, the monkeys used for the experiments lived to the average age of 7.25 years.
In response to the Musk’s initial claims on Jan 2, 2024, regarding the recovery of the first patient to receive the implant (now known to be Noland Arbaugh), PCRM, released a statement pointing towards the company’s history of botched animal experimentation and the alleged violation of multiple laws over multiple of U.S. government departments. The organisation has continuously focused on a shift towards non-invasive brain implants due to the several dangers that invasive implants pose to the human nervous system and their need for continual animal experimentation.
A recent Reuters report from March 1st states that the FDA found problems with record keeping and quality control for animal experiments shortly after the company was cleared for human trials. While the visits took place in June of last year, the reports were shared recently by Redica Systems – a data analytics company that obtained FDA compliance reports through open records requests. The reports discuss missing calibration records for instruments such as vital signs monitors and a lack of signatures on final study reports by quality assurance officers. Despite all of this, in July the USDA stated it did not find any violations of its animal research protocols aside from an isolated incident from 2019 which was reported by the company. Despite the severity of the problems in relation to the FDA’s Good Laboratory Practice, Cary Pflaum, an FDA spokesperson, said that “Neuralink has provided them with sufficient information in support of the approval.”
In his statement to Reuters, Victor Krauthamer, a former long-time FDA official stated that “It would have made sense for the FDA to have conducted the inspection before human trial approval. These are violations of fundamental requirements that you don’t want to worry about happening again in the human trial.”
In light of the recent trial conducted, these prior allegations regarding safety and future of human subjects who take part in the trials. Although as previously stated Arbaugh has not seen any serious complications, what really needs to be observed here is the longevity of the device considering the difficulty in replacing neural implants. This mainly involves assimilating the implant into the cortex and evading any potential damage caused by the polymer threads in the structure and their long-term biocompatibility. Given the allegations and reports put forth by PCRM, it is important for the company to recognise any potential harm that can be caused to the patients in the long term. While the clinical brochure for the clinical study trial gives a basic outline of the device, it does not give any further information about the aforementioned concerns. Additionally, despite there being an active patient registry on the Neuralink website for both the U.S. and Canada the studies are not listed on ClinicalTrials.gov (a US government web-based resource maintained by the U.S. National Library of Medicine and National Institutes of Health in-order to protect potential volunteers signing up for clinical trials in the country. While it is not illegal for Neuralink to not register its trials on the website considering its not funded by NIH and is a privately run organisation, it violates the ethical guidelines of biomedical research involving humans.
The rapidly growing field of Neurotechnology hints at a promising future for providing medical aid to people with a variety of neurological conditions. However, given its sensitive nature, it is also marred with several concerns with respect to patient safety and protection, areas which need to be prioritised by companies like Neuralink aiming to develop cortical implants. Thus, despite the future promise shown by the Neuralink implant and Arbaugh’s recovery, the lack of both transparency and peer-reviewed studies in respect to both present and past trials raises concerns for the long-term safety of the implant.
