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Health updates: Italian pharmaceutical reforms and US vaccine monitoring investigation
In Italy, the Istituto Superiore di Sanità (ISS) has released a video addressing factors that influence dietary choices and the prevention of non-communicable chronic diseases, emphasizing the role of food environments over purely individual responsibility.
Additionally, the Italian Medicines Agency (AIFA) is engaging with manufacturers of lecanemab and donanemab to discuss monitoring protocols and patient selection for these monoclonal antibody treatments for early-stage Alzheimer's. AIFA is also proceeding with a strategic revision of the national pharmaceutical formulary, which may impact reimbursement criteria and access to medicines within the National Health Service.
In the United States, a journalistic investigation by the British Medical Journal (BMJ) has examined flaws in the Vaccine Adverse Event Reporting System (Vaers). The report, based on government emails and interviews, suggests that the decision by the CDC and FDA to rely solely on a Bayesian statistical method—rather than using both Bayesian and proportional reporting ratios (PRR)—may have reduced the sensitivity of the system in detecting safety signals regarding COVID-19 vaccines.
Entities
Agenzia Italiana del Farmaco · British Medical Journal · Centers for Disease Control and Prevention · Food and Drug Administration · Istituto Superiore di Sanità