Legislation to tighten up the regulation of federally funded human gene therapy trials was introduced into the US house of representatives last week. The move follows concerns that deaths and serious deterioration of patients involved in gene therapy experiments are not being reported adequately.
Researchers are supposed to report any adverse effects to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC). But the RAC's powers were reduced in 1997, which former RAC chair LeRoy Walters says may have sent 'mixed messages' to scientists about what they should report. Both NIH and FDA (Food and Drug Administration) officials are now planning a computerised database to monitor any problems, and site visits to investigate ongoing clinical trials.
In Britain, the RAC's equivalent, the Gene Therapy Advisory Committee (GTAC) has absolute power - it approves all trials and protocols and must be told of any side effects. Says Dr Alan Kingsman of UK gene therapy firm Oxford Biomedica 'The important thing to get out of what's happened in the US is that the bad things which have happened there are much more to do with bad procedure than with the technology. What we really must not do is sacrifice the field because of bad procedures in the US'.