Marcus Chen
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Ionis Priced the First Alexander Disease Drug at $1.14 Million a Year, and Got a Federal Voucher It Can Resell for More Than $100 Million
Zilganersen is the first drug for Alexander disease, an antisense therapy designed to lower the toxic protein that drives a fatal brain disease. It also carries a $1.14 million annual price and a pediatric voucher Ionis can resell for more than $100 million.
InvestigationsAn AI Read 4.4 Million Mother-and-Baby Records and Says It Can Predict Illness. It Has Yet to Meet a Living Patient.
MoChiAgent forecasts maternal and infant disease from hospital records at a scale no clinician could read. A cautionary predecessor, Epic's sepsis tool, caught only a third of the cases it promised to catch.
InvestigationsPennsylvania Announced Two Measles Deaths Its County Coroner Never Recorded
Pennsylvania classified two Lancaster County fatalities as measles-associated, including a newborn the county coroner says he certified as dying from a ruptured spleen and blood loss. The CDC won't add either to the national count until the record shows measles caused or contributed to the deaths.
Infectious DiseaseForty Years of Calling ME/CFS Psychosomatic Taught the Institutions How to Dismiss the Vaccine-Injured
Immune exhaustion ties ME/CFS to long COVID. A Yale preprint finds the same signatures in the vaccine-injured, plus spike protein still circulating 709 days after a COVID shot. The institutions that spent decades dismissing the first are dismissing the rest.
InvestigationsKennedy Reopens the Federal Vaccine Rulebook, Starting With the Words That Decide Which Shots Your Child Gets
HHS is asking whether the three labels that decide which shots your child gets still work, and putting the COVID-era override of its own vaccine advisers on the record as the reason public trust cracked.
Infectious DiseaseFor Sixty Years the Screwworm Was Gone. It's Back in Texas, and the FDA Reached for Its COVID-Era Emergency Powers.
The flesh-eating fly the US wiped out in 1966 has crossed the southern border into Texas, and Washington's answer leans on the same emergency law it used for COVID drugs, this time to slap an emergency label on Zoetis's best-selling dog pill.
Drugs & FDAThe FDA Is Building an On-Ramp for Medical AI That Can Hallucinate
The FDA has cleared more than 1,000 AI medical devices and not one large language model. Its new discussion paper starts building the pathway for the ones that can make things up, with faster delivery to market named as an agency priority.
Infectious DiseaseKindergarten Vaccine Exemptions Doubled in Five Years. The Number Is a Verdict on the Agencies, Not the Parents.
Exemptions climbed to a record 4.2 percent of kindergartners while medical exemptions never budged from 0.2 percent. The rise is not a medical event. It is five years of institutional credibility spent, showing up in the one column parents control.
Infectious DiseaseThe Neuroscientist Who Mapped Fear in the Brain Says a Face Can't Reliably Reveal It
People scowl only about a third of the time they are angry. A multibillion-dollar industry sells software that assumes the other two-thirds are legible.
Drugs & FDAThe Screwworm America Eradicated With Sterile Flies Is Back, and This Time Washington Also Reached for an Emergency-Authorized Chemical
Dicyclanil, an Australian sheep-blowfly chemical with mouse liver tumors in its toxicology file, is now cleared for cattle, swine, goats and wildlife under section 564, the same emergency-use power heavily used for pandemic countermeasures.
Infectious DiseaseThe FDA Put an Emergency Label on a Zoetis Dog Pill for a Screwworm America Erased in 1966 Without a Single Drug
The sterile-fly barrier that kept the flesh-eating screwworm out of America for sixty years gave way, and Washington's answer has been a run of emergency drug authorizations, the newest for a Zoetis dog pill whose maker's own release cites no efficacy data against the parasite.
Drugs & FDAThe FDA Approved Moderna's mRNA Flu Shot for Seniors Without Proving It Works in Them
In February the FDA's own vaccine chief refused to even review it. One week later the agency reversed course, and the trial data never changed.
Infectious DiseaseSeven Weeks, 345 People Sick, and Not One Recall Notice With a Lot Code
The FDA said the outbreak jalapeños did not reach grocery stores directly. Two days later the USDA named eighteen grocery products made with them, sold in 23 states. Seven weeks in, not one recall notice carries a lot code.
InvestigationsMonths Before Officials Told Pregnant Women the COVID Shot Was Safe, Fauci Privately Flagged a Theoretical First-Trimester Miscarriage Risk
Senators Ron Johnson and Rand Paul pulled the first messages off Fauci's government iPhone: a January 2021 chain in which he privately flagged a theoretical first-trimester miscarriage risk, months before official guidance told pregnant women the shot carried no such concern.
Infectious DiseaseBritain, France, and Germany Don't Put COVID Shots on the Childhood Schedule. A US Order to Match Them Got Called 'Anti-Science.'
Britain, France, and Germany already keep routine COVID shots off the schedule for healthy children. When a US executive order moved the same way, the AMA, Paul Offit, and the press answered with 'zero data' instead of a debate.
Infectious DiseaseThe Screwworm America Eradicated Is Back, and the FDA's First Move Was an Unapproved Spray
The fly the US drove off the continent in 1966 has crossed the border again, and the FDA's emergency answer is a wound spray that never cleared its own approval process. The method that actually won the war is the sterile fly, and Texas is racing to rebuild the factory it let die.
Drugs & FDAThe FDA Said No to Moderna's mRNA Flu Shot in February. By August, the Two Men Who Said No Were Gone.
The FDA refused to even review Moderna's mRNA flu shot in February because it was never tested against the enhanced vaccines seniors are steered toward. The two officials who objected are gone, and the agency approved it anyway, for the oldest patients, on a promise to prove it works later.
Drugs & FDAThe FDA Approved Narcolepsy's First Orexin Agonist. Takeda's Last One Was Pulled for Liver Injury.
Takeda's oveporexton switches on the orexin receptor that narcolepsy type 1 patients can no longer signal. The company's last orexin drug was halted in 2021 after patients crossed serious liver-injury thresholds.
Infectious DiseaseMexican Jalapeños Sickened 1,400 Americans in 2008. Eighteen Years Later, a Different Farm and the Same Import Gap Did It Again.
Salmonella Javiana in jalapeños from Sinaloa has sickened 345 people across 27 states. It is the second time in eighteen years that imported Mexican peppers have done this, and the FDA still physically inspects only about 1 to 2 percent of the food crossing the border.
InvestigationsArkansas Cut 18,000 Eligible People From Medicaid Over Paperwork, and the 2027 Fix Is AI Its Own Authors Say Will Reproduce the Bias
A federal work requirement hits ACA Medicaid on January 1, 2027. Health-policy academics propose using AI to verify, screen, and manage the rollout, and the paper's lead author admits the system will "100% reproduce" the biases baked into the data.
Infectious DiseaseThe Licensed Ebola Vaccine Was Never Proven to Stop the Strain Now Killing Congo
Bundibugyo virus has driven the fastest-growing Ebola outbreak on record, with 1,707 deaths across eastern Congo and nearly 90 percent of cases in Ituri, and the WHO's own experts say the one licensed Ebola vaccine should not be used against it.
InvestigationsTwo Vaccine Injury Programs, One Country: COVID Claims Landed in the One That Almost Never Pays
The federal fund for routine vaccine injuries has paid $5.2 billion to nearly 10,000 people. The program COVID shots were routed into has compensated 34 claims, and RFK Jr. wants to change the math.
Autoimmune & InflammationRare but Real: The Autoimmune Hepatitis After mRNA That VAERS Was Built to Miss
Twenty-seven biopsy-confirmed cases of autoimmune hepatitis after an mRNA dose, jaundice and an ALT of 1,092 that resolved on steroids. The disproportionality math found 'no safety signal.' It was measuring a reporting system, not the liver.
Infectious DiseaseA Toxicologist Mapped 800 Shared Causes Across 4,000 Diseases. His Protocol Treats Them by Subtraction, Not Prescription.
Ronald Kostoff argues chronic and infectious disease grow from the same toxic soil, a damaged immune system, and that removing the cause has to come before any drug can work.