On Point | Podcast A doctor's fix for America's ailing medication market
Apr 21, 2025
Dr. Jerry Avorn, a Harvard Medical School professor and author of 'Rethinking Medications', sheds light on the profit-driven compromises affecting prescription drugs. He discusses the evolution of FDA regulations and the troubling approval processes, like that of the Alzheimer's drug Aduhelm. Avorn emphasizes the tension between drug safety and escalating prices, critiquing the current system while advocating for reforms. He also addresses urgent issues like the fentanyl crisis and the unregulated supplement market, calling for better support for those struggling with substance abuse.
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Thalidomide Crisis & FDA Hero
- Thalidomide caused severe birth defects and was blocked by FDA's Frances Kelsey in the 1960s.
- Her refusal to approve it saved many American families from tragedies linked to the drug.
Problems With Accelerated Approval
- Accelerated approval lets drugs reach market faster based on surrogate markers.
- But companies often delay follow-up studies proving actual effectiveness, undermining this process.
Aduhelm's Controversial Approval
- Alzheimer's drug Aduhelm was approved despite failing trials and FDA advisory panel rejection.
- FDA leadership retroactively applied accelerated approval criteria, causing controversy and high drug cost.