The US National Institutes of Health (NIH) is telephoning every researcher who has ever registered a clinical gene therapy trial, in an effort to track down all previously unreported 'adverse events'. The move follows recent concern over hundreds of failed gene therapy experiments, including several deaths, which went unreported at the time. While most of these were reported to the Food and Drug Administration (FDA), which keeps such information confidential, few were submitted to the NIH, which makes it public. Many investigators have since said they thought they only had to notify the FDA.
The results of the current NIH investigation will be made available on the Internet by the end of the year, to try and win back public trust in gene therapy trials. Many researchers are calling for a properly designed database of adverse events, to allow comparison of different methods and gene delivery systems, says Professor Inder Verma, president of the American Society of Gene Therapy. Although the NIH has pledged its support for such a database, it remains unclear whether it will cover all adverse events or just those directly attributable to gene therapy. While many scientists are in favour of the former, biotech and pharmaceutical companies have repeatedly pushed for the latter.
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NIH tightens up monitoring of gene therapy mishaps