1 in 10 Newly Approved Drugs Don’t Work

Nearly 1 in every 10 newly approved drugs by the U.S. Food and Drug Administration (FDA) don’t work, according to a research letter published online in JAMA Internal Medicine. Of the 210 new drugs approved between 2018 and 2021 to treat conditions such as lung disease, cancer, and Alzheimer’s disease, 21 drugs were approved based on trials whose results did not meet one or more goals to show that the drugs worked. The FDA recently approved the drug aducanumab despite two clinical trials being stopped because the drug did not meet the goal of improving dementia. More transparency from the FDA is needed to reassure doctors and patients alike that their approval procedures ensure public safety.