Recently, the FDA approved a new drug for Alzheimers amongst rabid controversy in the research world. The drug is designed to reduce the beta-amyloid plaques found in the brains of Alzheimer's patients. Unfortunately, removing amyloid plaques is NOT the same thing as slowing symtpoms of dementia.
The drug was fast-tracked in the FDA's "accelerated approval" program that per the FDA website "allows for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint."
The controversy surrounds the drugs efficacy and its VERY dangerous side effects. In fact, after the approval, 3 of the advisory board members resigned. The argument for not approving the drug lies in the drugs purported efficacy, shown not to be very efective. One of the Phase 3 trial showed LITTLE benefit, and one of the Phase 3 trial showed NO BENEFIT and in fact, the trials were stopped prematurely secondary the lack of positive evidence.