エピソード

  • Emergency Use & Fast-Tracking- How Safe Is It?

    Emergency Use & Fast-Tracking- How Safe Is It?
    2025/05/23
    hen normal rules get suspended in the name of urgency, what happens to safety? Dr. Ben Synth explores the controversial world of emergency use authorizations, fast-track designations, and accelerated approvals—pharmaceutical NASCAR where speed matters but crashes can be catastrophic. From COVID-19 vaccines authorized after two months of data to cancer drugs approved based on tumor shrinkage rather than survival, this episode reveals the high-stakes gambles regulatory agencies make during health crises. Discover the difference between emergency use authorization and regular approval, why Aducanumab for Alzheimer's became a lightning rod for criticism, and how HIV activists revolutionized drug development in the 1990s. Learn about breakthrough therapy designations, the weight loss injection phenomenon, and the fundamental tension between patients dying while waiting for perfect data versus accepting higher risks from incomplete evidence. It's the story of regulatory pathways that have saved countless lives while creating unprecedented controversies about the balance between innovation and safety.

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    45 分
  • How the FDA Works (and What It Can't Do)

    How the FDA Works (and What It Can't Do)
    2025/05/23
    Dr. Ben Synth breaks down the complex machinery of America's Food and Drug Administration, revealing how this massive bureaucratic network actually operates behind the scenes. From the Center for Drug Evaluation and Research to the Center for Veterinary Medicine, discover why your breakfast cereal gets more regulatory scrutiny than some face creams promising to reverse aging. This episode explores the decade-long drug approval process, the bizarre jurisdictional splits between agencies (FDA gets cheese pizza, USDA handles pepperoni), and the regulatory twilight zone where supplements make medical-sounding claims without medical-level proof. Learn about the FDA's enforcement limitations, international oversight challenges, and why some products that probably shouldn't exist continue to exist anyway. It's a deep dive into what the agency can and cannot control, revealing the philosophical tensions between innovation and safety that shape every regulatory decision.

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    34 分