Researchers reported that the FDA authorized the $199 Q-Collar “brain protection” device despite internal reviewers warning that supporting studies were flawed, inconclusive, and altered without required oversight. The semi-rigid neck collar is intended to increase intracranial blood volume through jugular vein compression, but the FDA’s own documents state that evidence does not demonstrate concussion prevention, and agency statisticians had recommended against clearance after key trials failed to meet prespecified endpoints. Researchers reviewing the evidence base found unverified hypotheses, retroactively modified study endpoints, and duplicated or mathematically inconsistent data across Q30-funded studies, prompting expressions of concern for multiple publications. More than 46,000 units have been sold, including to adolescents and professional athletes, even though users reported no perceived protective effect.

Source: The BMJ