The FDA, Surrogate Endpoints, And Blood Pressure Drugs

(Updated) In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels-- the surrogate endpoint-- serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a specific endpoint-- including cholesterol and other lipids, blood glucose, weight loss, and blood pressure.
Source: Forbes.com Healthcare News - Category: Pharmaceuticals Authors: Source Type: news