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Gene therapy safety issues come to fore

Nature Biotechnology volume 17, page 1153 (1999)Cite this article

Gene therapy is once again in the spotlight—brought there by news reports of "adverse events," including half a dozen deaths, involving participants in several separate clinical trials. Although none of these deaths has yet been attributed directly to the gene transfer procedures being evaluated, the mere possibility of such a connection is stirring intense interest, and highlights some of the complications that arise from dual oversight of the field.

Concerns over the unexplained deaths—the first for gene therapy—have officials at both the US Food and Drug Administration (FDA; Rockville, MD) and US National Institutes of Health (NIH; Bethesda, MD), who for nearly a decade have shared oversight responsibilities for gene therapy research, scrambling to make sense of those reports while also dealing with the clamor that they are causing.

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  1. Jeffrey Fox

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Fox, J. Gene therapy safety issues come to fore. Nat Biotechnol 17, 1153 (1999). https://doi.org/10.1038/70689

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