Version 1
: Received: 5 November 2024 / Approved: 6 November 2024 / Online: 6 November 2024 (11:01:07 CET)
How to cite:
Niazi, S. K. Rationality of Neurological Clinical Trials: A Challenge that the FDA must Resolve. Preprints2024, 2024110409. https://doi.org/10.20944/preprints202411.0409.v1
Niazi, S. K. Rationality of Neurological Clinical Trials: A Challenge that the FDA must Resolve. Preprints 2024, 2024110409. https://doi.org/10.20944/preprints202411.0409.v1
Niazi, S. K. Rationality of Neurological Clinical Trials: A Challenge that the FDA must Resolve. Preprints2024, 2024110409. https://doi.org/10.20944/preprints202411.0409.v1
APA Style
Niazi, S. K. (2024). Rationality of Neurological Clinical Trials: A Challenge that the FDA must Resolve. Preprints. https://doi.org/10.20944/preprints202411.0409.v1
Chicago/Turabian Style
Niazi, S. K. 2024 "Rationality of Neurological Clinical Trials: A Challenge that the FDA must Resolve" Preprints. https://doi.org/10.20944/preprints202411.0409.v1
Abstract
Antibodies approved by the FDA are failing to treat neurological disorders, and recently, it was reported that these trials may have violated patient’s rights and subjected them to high, likely lethal risk. The challenge with developing antibodies to treat neurological orders is their almost negligible bioavailability, requiring high dosing that can be toxic. The high potency of these drugs should also be viewed considering the placebo effects since all antibodies have shown severe side effects that are not prevented by the placebo responses. In this critical and urgent advice to the FDA, I am suggesting a guideline amendment to all clinical trials requiring proof of sufficient bioavailability at the site of action, where it is known. For antibodies to cross the blood-brain barrier, there are proven solutions such as conjugating with transferrin protein, making clinical trials in its absence more questionable and unethical.
Keywords
Alzheimer’s disease; FDA; lecanemab; donanemab; aducanumab; NY Times; clinical trials; bioavailability; human abuse
Subject
Medicine and Pharmacology, Neuroscience and Neurology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
