Tag: FDA
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FDA Knew Its COVID Vaccine Safety Algorithm Could Hide Signals. It Used It Anyway.
Perhaps it’s time for IPAK to design The People’s Vaccine Safety Tracking System. Thoughts? by James Lyons-Weiler, PhD, Popular Rationalism, ©2026 (Sep. 17, 2026) — A new BMJ investigation documents a preventable pharmacovigilance failure: a known masking defect, an available statistical remedy, and public reassurance built partly on the absence of alerts that the surveillance…
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CNN Is Not Defending Science. It Is Defending a Technology From Scientific Scrutiny.
by James Lyons-Weiler, PhD, Popular Rationalism, ©2026 (Aug. 30, 2026) — CNN has published another article in which the label “misinformation” does the work that evidence should have done. The August 23 article, “mRNA Cancer Vaccines: Promising but Dogged by Misinformation”, celebrates Moderna and Merck’s personalized melanoma treatment while dismissing concern about cancer following COVID-19 vaccination.…
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FDA Commissioner Resigns
by Sharon Rondeau (May 12, 2026) — On Friday, The Wall Street Journal, as reported by Children’s Health Defense (CHD), said President Trump was displeased with FDA Commissioner Dr. Marty Makary and had “signed off on a plan to fire” him. As of this writing, FDA’s website boasts, “We’ve done a lot in the first…
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Vaccine Manufacturers Put on Dramatic Notice: FDA Rejects Moderna’s Flu Vaccine Application
by James Lyons-Weiler, PhD, Popular Rationalism, ©2026 (Feb. 12, 2026) — We suspect that Moderna’s refusal is an attempt to avoid giving FDA the data it needs for age-specific approval and recommendation by restricting its options to proceeding in a way that would force the FDA to lower its standards. FDA called Moderna’s $750M bluff.…
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Rational Discourse Is Hard at Work at the FDA
by James Lyons-Weiler, PhD, Popular Rationalism, ©2026 (Feb. 10, 2026) — In June 2025, the U.S. Food and Drug Administration instituted what is formally known as a class Safety Labeling Change to the prescribing information of mRNA COVID‑19 vaccines, requiring updated warnings about the risks of myocarditis and pericarditis following administration of these products. In conjunction with…
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Looking Back: The Best of Popular Rationalism, 2025
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Dec. 29, 2025) — Let’s Talk About What You Helped to Build in 2025 You’ve been with us this year — reading, sharing, questioning — and you weren’t just here for the ride. You were helping steer it. We published 295 articles; a mix of full-length feature articles,…
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The FDA Is (Finally) Applying Appropriate Standards of Evidence for COVID‑19 Vaccines in Children
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Dec. 1, 2025) — Key Takeaways The FDA now acknowledges that at least ten U.S. children died because of COVID-19 vaccination, admitting that regulators failed to identify these fatalities in real time. An internal memo by vaccine chief Vinay Prasad details years of methodological and cultural failure inside…
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Tylenol and Autism: More to the Story
by Joan Swirsky, ©2025 (Oct. 13, 2025) — In 2020, the Atlanta-based U.S. Centers for Disease Control and Prevention (CDC) said that one in 36 children (approximately four percent of boys and one percent of girls) was estimated to have autism-spectrum disorder, estimates that were significantly higher than those in all previous years. But just…
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BREAKING: FDA Rescinds Emergency Use Authorization for COVID-19 Vaccines
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Aug. 27, 2025) — The U.S. Food and Drug Administration (FDA) has rescinded the emergency use authorizations (EUAs) for COVID-19 vaccines, narrowing their availability to high-risk groups. Health and Human Services Secretary Robert F. Kennedy Jr. announced the change on Wednesday, describing it as a step to end…
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FDA Determines COVID-19 Vaccine of Limited Benefit to General Population
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Jul. 13, 2025) — Washington, D.C. — July 2025. According to CBS News, members of the US Health and Human Services administration “overrode career staff at the agency to limit the approvals of COVID-19 shots from Novavax and Moderna”. On May 16, 2025, the U.S. Food and Drug Administration…
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Elsa LLM at the FDA: A Responsible First Step Toward Efficient Government?
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Jun. 3, 2025) — The U.S. Food and Drug Administration (FDA) made a calculated move into the AI age this week with the official launch of Elsa, a generative AI tool built to assist—but not replace—its workforce. Developed in a secure GovCloud environment and isolated from industry-submitted data, Elsa…
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Moderna Withdraws Combo Vaccine Application: A Real-Time Validation of the FDA’s New Direction
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (May 22, 2025) — One day after the FDA unveiled its updated COVID-19 vaccine approval framework—and the NEJM article by Prasad and Makary detailed the reasoning—Moderna quietly withdrew its application for its mRNA-1083 combination flu/COVID-19 shot. The timing is not coincidental. It reflects exactly what the new policy is designed to…
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Explaining FDA’s Position: My Take on Prasad and Makary
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (May 21, 2025) — “The FDA is now saying: Here are restricted groups we will likely approve your products for, now show it is effective and safe in those groups.” When the FDA released its new framework for COVID-19 vaccine policy via a “Sounding Board” article in the New England…
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A Resilient Nation Tests Its Products — Not Its Citizens
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (May 18, 2025) — In today’s bureaucratic vernacular, resilience has become a euphemism for public tolerance of failure. Institutions now invoke the word to imply that a strong society absorbs harm, accepts uncertainty, and trusts authority—regardless of evidence. But this is not resilience. It’s submission. True resilience in a free…
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Film on Vaccine Injuries Now Available for Download, Distribution
by Sharon Rondeau (May 17, 2025) — As The Post & Email reported in mid-March, the world premiere of “Follow the Silenced,” a nearly-two-hour film produced by Mikki Willis and directed by Matthew Lynn Guthrie depicting the suffering of many Americans who received one of the COVID-19 “vaccines,” was premiered at the time at the…
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The Fluoride Reversal: FDA, RFK Jr., and the Reckoning with Chemical Childhood
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (May 14, 2025) — In a move that quietly signals the beginning of a major regulatory realignment, the U.S. Food and Drug Administration announced on May 13, 2025, its intent to remove concentrated ingestible fluoride prescription drugs for children from the market. The decision, initiated under the direction…
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Why Transparency in Government is Crucial for Your Safety and Wellness
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Apr. 24, 2025) — Fool me once, shame on me. Fool me twice, you just might kill me. This isn’t just a saying; it’s the brutal truth about the trust that has been shattered between the government and the public. Transparency is not a marketing strategy. It is…
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Eight Dyes, One Reckoning: RFK Jr.’s Food Color Ban Signals the End of a Toxic Era
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Apr. 23, 2025) — In a long-overdue but pivotal move, U.S. Health Secretary Robert F. Kennedy Jr. has announced that eight synthetic food dyes will be removed from the U.S. food and pharmaceutical supply by the end of 2026. Found in everything from candies and sodas to medications…
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A Postmortem on Peter Marks’ FDA Legacy: False Positives Killed Untold Numbers of People — and Marks Was Warned
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (Mar. 30, 2025) — Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research (CBER), resigned on March 28, 2025, with an overly dramatic letter (see below) citing conflicts with Health and Human Services Secretary Robert F. Kennedy Jr. over vaccine misinformation. His tenure was…
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An Important First Step Toward Cleaner Food: Food Manufacturers Meet Consumer Power in the New FDA’s Chemical Contaminants Transparency Tool
by Popular Rationalism Staff, ©2025 (Mar. 21, 2025) — In a move that could transform American food culture, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have launched the Chemical Contaminants Transparency Tool (CCT Tool)—a public, searchable database cataloging chemical contaminants found in foods across the U.S. market.…