POLITICS
Health officials revise charter to refashion vaccine committee
Elijah Nouvelage/Getty Images
Federal officials have adopted a new charter for the committee that advises the Centers for Disease Control and Prevention on vaccine use. The move appears to be a bid to evade the type of legal challenge that has left the body in limbo and empower allies of health secretary Robert F. Kennedy Jr.
The revised charter, published Thursday, expands the list of qualifications for membership and puts greater emphasis on studying injuries possibly linked to vaccination, even though the committee has always paid close attention to any emerging evidence that called into question the safety of individual vaccines.
The committee has become a health policy battleground as the secretary has pushed to limit the number of vaccines recommended for all babies and children. Read more from STAT’s Helen Branswell and Anil Oza.
RESEARCH
As autoimmune disorders rise, CAR-T therapy is surprising researchers
Five years after CAR-T therapy helped put a deathly ill lupus patient into remission, researchers are seeing dramatic breakthroughs with the therapy for other hard-to-treat autoimmune disorders. The latest? A patient who made a rapid recovery after being extremely sick with a trio of autoimmune conditions.
Her remission, catalogued in a case study published Thursday in the journal Med, marked the first time that CAR-T therapy had successfully treated someone with those three diseases. The findings are somewhat counterintuitive, as researchers used to worry that this specific therapy could trigger or worsen autoimmune disease.
The promising results have come at a critical time. About 8% of people in the United States have an autoimmune condition, and rates of illness are thought to be increasing. Who are the pharma investors interested in this research? Read more from STAT’s Isabella Cueto.
FLIP-FLOP
GSK says goodbye to leucovorin (again)
The Food and Drug Administration is withdrawing approval of GSK’s leucovorin to treat cerebral folate deficiency, a rare brain disorder that shares symptoms with autism. The withdrawal announcement is the culmination of a bizarre episode that exemplified the ways political pressure began to shape the FDA’s work last year, as STAT previously reported.
In September, the agency asked GSK to revive leucovorin, which the company had discontinued in 1997 due to low sales. The inquiry appeared to stem from health secretary Robert F. Kennedy Jr. and President Trump’s long-standing interest in autism. Despite career staff successfully pushing to limit the approval to a rare disorder, which is what existing studies supported, FDA Commissioner Marty Makary publicly touted the drug as a cure for autism.
Withdrawing approval was always part of the plan, GSK told STAT, as the company never had any plans to market or manufacture the product. Rather, the agency asked GSK to submit the drug application so that generic drug companies could also update their labels to reflect the cerebral folate deficiency indication. If GSK held onto the approval, the company would be required to submit safety reports, which doesn’t make sense for a company not actively selling a drug.
Patients will still be able to access generic leucovorin, said health department spokesperson Andrew Nixon. — Lizzy Lawrence
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