Should regulatory authorities approve drugs based on surrogate endpoints?

Abstract: When the FDA approved new Alzheimer's drug Aduhelm based on little clinical evidence, experts protested. Yet the Aduhelm controversy is just the latest in a pattern of regulators approving new drugs based on surrogate endpoints rather than clinical outcomes that matter to patients. In The BMJ, Jeanne Lenzer and Shannon Brownlee argue that surrogate endpoints provide no guarantee of clinical benefit and should be used only as a last resort in drug trials.