Deaths and setbacks highlight gene therapy safety debate
Gene therapy shows life-changing promise but recent adverse cases have renewed safety debates. Science reported a six-year-old girl's death after an experimental gene-editing trial in China, and pharmaceutic firm HuidaGene disclosed a second likely gene-therapy-related death in a boy with Duchenne muscular dystrophy; both used China’s investigator-initiated trial (IIT) pathway. In the United States, doctors at CHOP reported a child developed a brain tumor probably driven by the AAV viral vector used four years earlier. Experts urge more transparency, risk-based development, independent oversight, and faster external review to balance safety with urgent patient needs.
Two deaths in China and a U.S. tumor have raised safety concerns
Context
Several children who received gene therapies recently had serious problems. Two deaths in China used the investigator-initiated trial pathway and a U.S. case involved a probable tumor after AAV delivery. Regulators may tighten rules and…
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