

Are Your Medications Safe And Effective?, with Jerry Avorn
13 snips Jun 26, 2025
In this insightful discussion, Jerry Avorn, a Harvard physician-researcher and author of 'Rethinking Medications,' uncovers the flaws in the FDA's drug approval processes, particularly the Accelerated Approval Program. He highlights how many medications are rushed to market without proven benefits, including ineffective cold and cancer treatments. Avorn critiques the reliance on surrogate measures for effectiveness, using the controversial Alzheimer’s drug Aduhelm as a key example. He also emphasizes the need for transparency in drug pricing and informed patient choices.
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FDA Accelerated Approval Origins and Issues
- The FDA's accelerated approval program started with good intentions during the AIDS crisis to provide early access to promising drugs.
- However, it later became a loophole allowing many drugs to be approved based only on surrogate markers without proven clinical benefits.
Sudafed Switch: Ineffective Medicine Sold
- Phenylephrine replaced pseudoephedrine in Sudafed to reduce meth production but doesn't relieve congestion.
- Americans spend millions on an ineffective cold remedy with the trusted Sudafed name.
Cancer Drug Approvals Rely on Surrogates
- Many cancer drugs are approved based on tumor shrinkage, a surrogate marker, without proving they extend patient survival.
- Progression-free survival often does not correlate with actual longer or better life for cancer patients.