Year: 2024
Type: article
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.
Source: Biomedicines
Author: Sarfaraz K. Niazi
Institution: University of Illinois Chicago
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,955
OpenAlex ID: W4405700857