On January 29, 2024, Elon Musk posted a claim on X.com1 that in a clinical trial run by Neuralink, one of its devices was successfully implanted into a human participant.2 Aside from a two-page study brochure published on the Neuralink Patient Registry website,3 this is the only source of information that we have on the clinical trial, and the only indication that the study has started recruiting participants.
The trial has not been registered on ClinicalTrials.gov or any other clinical trial registry, the study protocol is not available, and there is no published statistical analysis plan. Registration of a clinical trial is a legal requirement under FDAAA4, however phase 1 and device feasibility studies are exempt from this requirement, and presumably this study falls under this category.
While prospective registration may not be legally required, it is still an ethical requirement of the Declaration of Helsinki5 that every clinical trial be registered prospectively. The rationale for this is to prevent certain kinds of scientific bias, such as the non-publication of non-positive results, as well as outright scientific fraud, such as changing a trial’s primary outcome after the results are known. The Declaration of Helsinki also requires that all clinical trial results be made publicly available, regardless of the outcome. Prospective registration is also a condition for publication according to the policy of the International Committee of Medical Journal Editors (ICMJE),6 which makes the Neuralink trial unpublishable in any journal that holds to this standard. (Whether an ICMJE journal will apply this standard rigorously is another question.)
While Elon Musk may be content to conduct a programme of secret clinical research outside the scrutiny of peer review, we have already seen what happens when a charismatic leader with a cult following does so. Years before the downfall of the blood testing company Theranos, warnings were raised about the clandestine nature of their “stealth research” programme.7 These warnings were largely unheeded and in the end, the blood testing methods they touted were exposed as a fake and its founder was convicted of fraud and sent to prison.8 Theranos provided inaccurate results for an estimated one out of ten tests, placing at risk the proper care of thousands of patients.9
The ethical standards of prospective registration and publication of results that are enshrined in the Declaration of Helsinki are not meaningless red tape intended to slow down the march of progress. They are meant to reduce biases, prevent fraud and help ensure that the risks and burdens that patient participants take on are redeemed by as much socially valuable knowledge as possible. Despite the “Silicon Valley” thinking that difficult and long-standing problems in biomedicine can be solved by the sheer cleverness and work ethic of those who have success writing an app or shipping a piece of computer hardware,10 the biology of human disease is fundamentally different, more difficult to understand, and requires risk on the part of human subjects to progress, which comes with certain moral obligations. While it is not literally illegal for Elon Musk’s Neuralink to conduct an unpublishable device feasibility trial without prospective registration, this is a poor justification for doing so.
References
1. Musk E: X.com. 2024. Available from: https://twitter.com/elonmusk/status/1752098683024220632
2. Drew L: Elon Musk’s Neuralink brain chip: what scientists think of first human trial. Nature. 2024. DOI: 10.1038/d41586-024-00304-4
3. Neuralink Corp.: Neuralink PRIME Study Brochure. 2023. Available from: https://neuralink.com/pdfs/PRIME-Study-Brochure.pdf
4. United States Congress: Food and Drug Administration Amendments Act of 2007. Public Law. 2007;110-85:121. Available from: https://www.congress.gov/110/plaws/publ85/PLAW-110publ85.pdf
5. World Medical Association: Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 2013. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
6. International Committee of Medical Journal Editors: ICMJE Clinical Trial Registration Statement. 2019. Available from: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
7. Ioannidis JPA: Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?. JAMA. 2015;313:663. DOI: 10.1001/jama.2014.17662
8. Lowe D: Thoughts on the Elizabeth Holmes Verdict. 2022. Available from: https://www.science.org/content/blog-post/thoughts-elizabeth-holmes-verdict
9. Das RK and Drolet BC: Lessons from Theranos – Restructuring Biomedical Innovation. Journal of Medical Systems. 2022;46. DOI: 10.1007/s10916-022-01813-3
10. Lowe D: Silicon Valley Sunglasses. 2022. Available from: https://www.science.org/content/blog-post/silicon-valley-sunglasses
