Why approval for Elon Musk’s Neuralink for humans is a bad idea

However, the implantation of BCIs in monkeys enabling them to control a cursor via their brain is not novel and has been done in 2014 by Dr Miguel Necolelis’s lab at Duke University. Neuroscientists have been routinely hearing neurons fire since the early 1960s in their laboratories.

Most of the work that Neuralink does is, like most other research, cumulative. The only real upgrade it offers is the bandwidth of data collection, by implanting 3,000+ electrodes in comparison with 256 electrodes that have been done previously. This, according to the company’s claims, will provide the desired increase in speed and accuracy comparable to real-time movement. In the case of an invasive surgical implant, questions immediately arise about how safe the materials used in the fabrication of the implants are — how truly inert they are — and despite the coatings on the surface, how stable is the material. Before this is anywhere near implantation in humans, it has to be ascertained that there is no leaching of any harmful chemical in the brain over time and the impact of small everyday actions, like bumping into something, has to be studied. The second concern is the thin wires, which will arguably build more resistance and be susceptible to heat generation.

When 3000 such wires as hypothetical implants are sending and receiving signals, how would the heat generation be mitigated, to protect the brain tissue? Given the wires are so thin, how would they stay in place in a freely moving human? What does the movement do to the surrounding brain tissue? What kind of injury does the gel-like brain tissue sustain? Neural injury happens at a microscopic level, which scans can’t detect, but these tend to build up over the years, ultimately leading to permanent complications and disability. Then there is an issue of immune reaction and scar tissue formation around the brain. Neurosurgeons and prosthetic experts have always known that the brain is adept at sequestering any injury with scar tissue, which can itself become extremely seizure prone. Questions like these are usually answered by preclinical data in animal studies.

In the case of Neuralink, except for showing individual animals, and images from a brain (without even disclosing if that brain in question is a rodent, a pig or a monkey) there is no released imaging or quantitative data from their so-called histology unit. There is no data published about the per cent mortality in experimental animals or the success rate of the surgery. There is pretty much no quantitative data available to the public about the safety of the procedure, or the efficacy of the implant — except what the Neuralink team chooses to display in a purely qualitative fashion.

To make matters worse, a lawsuit by an animal ethics group has revealed several violations of animal welfare by Neuralink with monkeys being used for invasive implant surgeries, and high mortality among animals from surgery-related infections or other complications. The company is also being investigated for the same by federal agencies. Collectively, these events point to a general culture of secrecy about data regarding the safety of the device and its efficacy against non-invasive BCIs, which are also in development. In addition, there is a conscious effort to mitigate the critical eye by dialling up the coolness factor for the general public.

In the US, in line with their capitalist ideology, private companies are given every possible latitude to protect proprietary and patented technologies. Private companies are not required to divulge or publish any of the data that they submit to the FDA. Consequently, all evidence that Neuralink will have submitted to the FDA for approval will be protected from public scrutiny. It is, however, known that Neuralink filed for this approval in 2022 and the FDA rejected the application, citing safety issues with the lithium batteries in the implanted chip and other concerns.

It is unclear on what basis the FDA revised their decision. In an ideal world, companies would be ethical and the FDA would also be exacting and relentless in their scrutiny before approving a device. However, in reality, neither really applies when it comes to companies with deep pockets that routinely lobby legislators and regulatory authorities to review their products favourably for approvals.

There are several red flags with Neuralink already. There is reportage around Musk building a pressure cooker work environment by creating unrealistic timelines. There has also been an exodus of several initial founders including Dr Max Hodak, whose brain-child Neuralink was. Neuralink walked away from NIH funding when members from the BRAIN initiative approached them, purportedly because government funding would mean more federal oversight as well as requirements of making the data available. A competitor company, InBrain has already pointed out that the material used to build the implant wires (PEDOT) may not be as stable and inert in the long term as the company claims.

In theory, if this interface is able to do what it claims to do, there will still be many steps ahead before it can truly start being beneficial for patients in need. The scientific and medical communities need to keep their eyes peeled, despite cautious optimism, because medical history in the US is full of instances when companies prioritise profit over patient safety, and regulatory oversight fails to curb such practices. Before the ethics of creating cyborgs can be debated at length, we need to ensure whether the Neuralink device is safe and offers any actual benefit over non-invasive counterparts.

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The writer is Head of the Department, Psychology at Ashoka University