Quick Take
- Narration: Mike Lenz brings a reliable, clear-voiced authority to this institutional history, technically strong and appropriate for the material without calling attention to itself.
- Themes: Regulatory history, pharmaceutical approval politics, patient advocacy and public health
- Mood: Authoritative and narrative-driven, the history of crises unfolds as genuine drama without sacrificing accuracy
- Verdict: A well-researched institutional history from someone who sat inside the FDA’s advisory process, essential context for anyone trying to understand how drug approval actually works.
I came to Drugs and the FDA with moderate skepticism. Books about regulatory agencies tend to fall into one of two traps: they either turn into advocacy pieces for less regulation or more, or they drown in procedural detail until the human stakes disappear. Mikkael Sekeres manages to avoid both. What he’s written is something rarer, a genuine institutional history that reads like narrative nonfiction because it treats regulatory failures as human stories before it treats them as policy problems.
Sekeres’s credentials are worth establishing at the outset because they matter to how the book works. He’s a leading oncologist and, crucially, a former chair of the FDA’s cancer drug advisory committee. This isn’t a journalist’s account of the FDA from outside the building; it’s a practitioner’s account from inside the deliberative process. When he describes the 2011 Avastin hearings, in which he participated as a panel member, he can tell you what the room felt like, what the arguments were before they became public record, and how the institutional pressures shaped outcomes in ways that the official documents don’t capture.
The Disasters That Built the System
The historical backbone of Drugs and the FDA is a sequence of regulatory failures that, taken together, explain why the FDA exists in its current form and why each expansion of its authority was hard-fought against significant industry and political resistance. Sekeres moves through contaminated vaccines that poisoned children, an early antibiotic containing antifreeze, thalidomide’s catastrophic effects on fetal development, and the AIDS crisis in which thousands died while effective treatments were locked in clinical trial protocols that controlled access to an unconscionable degree.
These stories work because Sekeres refuses to treat them as background context. The antifreeze antibiotic, elixir sulfanilamide, killed over a hundred people in 1937, and the legal structure at the time didn’t even classify it as adulteration because there was no efficacy standard. The tragedy predated the tools to prevent it. Walking through how each disaster created new legal authority, how patient advocacy changed what the FDA was culturally permitted to prioritize, and how commercial pressures continue to create friction at every stage of approval is the kind of institutional anthropology that makes a regulatory history feel like something worth listening to on a Sunday afternoon rather than an obligation.
The Avastin Case as Through-Line
The 2011 Avastin hearings function as the book’s organizing present-tense thread, and it’s a smart structural choice. Avastin, bevacizumab, was approved for breast cancer based on progression-free survival data that subsequent trials failed to confirm for overall survival. The question of whether to revoke that approval involved the FDA weighing patient advocacy groups, pharmaceutical interests, the statistical adequacy of the original trial, and what the agency’s mandate to ensure efficacy actually required in practice. Sekeres was there. His account of how those pressures were experienced and managed is the kind of inside narrative that no researcher working from documents alone could produce.
Reviewer R. B. Paul identifies the book correctly as being less about science than about authority, how and by whom regulatory power was delegated, built, and exercised. That framing is accurate and useful. Drugs and the FDA is not primarily a pharmacology text. It is an account of how a social institution accumulates legitimate authority through repeated crisis, and how that authority is perpetually contested by the commercial interests it regulates.
Mike Lenz and the Narration
Mike Lenz is a reliable narrator for this kind of nonfiction, technically precise, appropriately authoritative, and genuinely useful at keeping complex regulatory and clinical vocabulary intelligible without over-explaining. The Avastin deliberations involve nuanced statistical reasoning about trial design, and Lenz handles these passages without either glossing over the complexity or making them feel like a statistics seminar. At 8 hours and 40 minutes, the pacing is right for the material: enough time to develop the historical cases in real depth, not so much that the institutional framework becomes repetitive.
Who Should Listen and Who Should Skip
Listen if you want to understand why the COVID vaccine approval process generated so much public controversy, what the FDA’s actual mandate involves, or how the Alzheimer’s drug Aduhelm approval became a flashpoint for the ongoing tension between accelerated access and evidentiary rigor. This book gives you the institutional history needed to follow those debates with real comprehension.
Skip if you’re looking for a critique of the pharmaceutical industry’s role in influencing regulatory decisions, this is an account of how the FDA works and why it was built the way it was, not an exposé of industry capture. For the latter, there are other books better suited to that framing.
Frequently Asked Questions
Does the book cover the COVID-19 vaccine Emergency Use Authorization process specifically?
The COVID vaccine approval is mentioned as a contemporary reference point, but it’s not the book’s primary focus. Sekeres uses it as an example of how the FDA’s credibility becomes a political issue, but the historical backbone covers 20th-century regulatory crises more extensively than the pandemic period.
How does Sekeres handle the Aduhelm Alzheimer’s drug controversy at the FDA?
Aduhelm is addressed as a case study in the ongoing tension between accelerated approval processes and traditional evidentiary standards. Sekeres examines the advisory committee’s rejection of the drug and the subsequent approval as an example of the institutional pressures the FDA navigates, he doesn’t fully resolve the controversy but contextualizes it within the agency’s history.
Is this book accessible to someone with no background in clinical medicine or pharmacology?
Yes. Sekeres writes explicitly for a general educated audience. Clinical and regulatory terms are explained in context, and the narrative structure prioritizes human stakes over technical detail. The historical cases are accessible to any reader familiar with narrative nonfiction.
Does Sekeres advocate a particular position on how the FDA should reform its approval process?
He presents a measured, reformist perspective rather than a polemical one. His insider position means he takes institutional constraints seriously while still being clear about where the current process fails patients. It’s less a manifesto than an evidence-based assessment from someone who has worked within the system.
