Abstract
Gene therapy researchers face a crackdown from regulatory authorities in the USA following the death of 18-year-old Jesse Gelsinger during a recent trial. The extent of American researchers’ non-compliance with regulatory guidelines – in one case condemned as ‘inexcusable incompetence’– has prompted calls for federal intervention.‘Gelsinger’s death doesn’t really have any impact on the concept of gene therapy, but it will make us more cautious,’ says Olivier Danos, President of the European Society of Gene Therapy and Scientific Director of Genethon (Evry, France), a non-profit-making research institute. ‘The death could have been avoided.’Professor Danos notes that the mistakes surrounding Gelsinger’s death were largely administrative and suggests that, under closer supervision by the Food and Drug Administration (FDA), it will become more difficult to initiate gene therapy trials. ‘This may be a good thing. In the beginning, everyone started gene therapy studies – the problem was that some of these might not have been scientifically meaningful’ says Danos. ‘Gene therapy research is competitive. It’s a high-pressure environment and mistakes will occur.’ he concludes.Despite the competition, American researchers are supposed to report all adverse events to both the FDA and National Institutes of Health (NIH). But, whereas the FDA respects confidentiality, the NIH makes adverse events public. This might be one reason why the FDA was aware of most adverse events but the NIH was not1xNIH tightens up monitoring of gene-therapy mishaps. Smaglik, P. Nature. 2000; 404: 5Crossref | PubMedSee all
Published Version
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