Gold standard? 10% of new drugs cleared by FDA fall short of the study's goals.
One in 10 new drugs were cleared by federal drug regulators in recent years based on studies that didn't achieve their main goals, a new study shows.found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or end points, that weren't achieved. Those 21 drugs were approved to treat cancer, Alzheimer's and other diseases.
Researchers said the findings raise questions about whether the federal agency's drug approvals lack transparency about the some products' safety and effectiveness. Dr. Reshma Ramachandran, an assistant professor at Yale School of Medicine who co-authored the study, said doctors, patients and health insurers depend on the FDA to rigorously vet new drugs.
The federal agency needs to reassure the public"the rubber stamp that they gave — considered the gold standard around the world — really means the drug has been proven to have safety and efficacy that outweighs any risks," she said. What types of drugs did not meet study goals? The researchers reviewed FDA documents to evaluate whether the clinical trials met their main"end points," or goals that measure whether a drug works. Three targeted influenza and other infectious diseasesOthers targeted blood cancers and Alzheimer's, and lung, digestive and genetic diseasesprompted researchers to find how often the agency approved drugs despite clinical trials with failed or mixed results.
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