Data from 2015 show approximately half of US-born adults were exposed to harmful levels of lead as children; Florida’s Department of Health to advise against COVID-19 vaccination for "healthy" children; Black patients remain underrepresented in clinical trials for newly approved drugs despite FDA efforts.
Findings published yesterday in Proceedings of the National Academy of Sciences showed that over 170 million US-born individuals who were adults in 2015 were exposed to harmful levels of lead as children that may have significantly impacted their cognitive development. The Associated Press reports that exposure to leaded gasoline, which was banned in 1996, surpassed the CDC threshold in approximately half the US adult population in 2015—surpassing more than 5 mcg/dL. Harmful exposure in early childhood was associated with a 2.6-point drop in IQ.
The Hill is reporting that Florida’s Department of Health will contradict vaccine guidance from the CDC by advising against COVID-19 vaccination for “healthy children.” As the first state to recommend against coronavirus vaccination for children, details on who would qualify as a healthy child were not described by Florida’s Surgeon General Joseph Ladapo, MD, PhD, who made the announcement. Although typically more severe in older age groups, COVID-19–related hospitalizations and deaths were reported in 8300 and 100 children aged 5 to 11 years, respectively, as of mid-October 2021. The CDC currently recommends vaccination against COVID-19 for everyone 5 years and older.
Despite a 5-year action plan implemented in 2015 by the FDA to improve diversity in and transparency of pivotal clinical trials for newly approved drugs, a Health Affairs study published yesterday indicated that Black patients remain underrepresented in such trials. STAT reports that Black patients accounted for a median one-third the required enrollment for adequate representation within clinical trials, regardless of whether the trials occurred before, during, and after the FDA plan took effect. Findings also indicated that fewer than 20% of the 225 drugs approvals for which mortality and morbidity information was listed on the FDA plan website had data regarding treatment benefits or adverse effects for Black patients.