# Anish Koka - Why Vinay Prasad Didn’t Last at the FDA

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Text version: https://stenobird.com/podcast/science-from-the-fringe-7022876/anish-koka-why-vinay-prasad-didn-t-last-at-the-fda.md
Podcast: [Science From the Fringe](https://stenobird.com/podcast/science-from-the-fringe-7022876)
Published: 2026-03-12T16:26:02+00:00
Episode link: https://sciencefromthefringe.substack.com/p/anish-koka-why-vinay-prasad-didnt
Audio file: https://api.substack.com/feed/podcast/190698039/fb777ef1c7cb959e8763dc54c3ae5402.mp3
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Duration seconds: 3505

## Resource

In this episode of Science from the Fringe , host Bryce Nickels speaks with cardiologist and medical commentator Dr. Anish Koka about his recent article examining the forces that led to physician-scientist Vinay Prasad’s departure from the U.S. Food and Drug Administration (FDA). They discuss how Prasad’s efforts to strengthen evidentiary standards for drug approvals quickly ran up against powerful political, financial, and institutional interests. The conversation explores how his brief tenure became a case study in the difficulty of reforming institutions where scientific standards, patient desperation, political pressure, and financial incentives collide. As Anish explains, Vinay Prasad is an unusually independent thinker within academic medicine who built a reputation challenging weak evidentiary standards for drug approvals long before entering government. Once at the FDA, he attempted to raise those standards—particularly for vaccines and costly therapies approved on limited or indirect evidence. Those efforts quickly triggered backlash from pharmaceutical companies, investors, patient advocacy groups, biotech media, and political actors with stakes in the approval pipeline. Anish walks through a detailed timeline of the flashpoints that defined Prasad’s short tenure: disputes over gene therapies for rare diseases, conflicts with companies such as Sarepta, Moderna, and UniQure, and broader debates about how regulators should weigh desperate patient demand against uncertain clinical evidence. He explains how controversial trial designs—such as reliance on historical controls or small datasets—can allow extremely expensive treatments to reach the market without clear proof they improve patient outcomes. In his view, Prasad’s push to tighten evidentiary standards ex…

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