New rules for US gene therapy researchers

The USA's Food and Drug Administration (FDA) has proposed new regulations for gene therapy researchers, aimed at addressing public concern over the safety of patient trials. Sparked by the outrage that followed the death of teenager Jesse Gelsinger during a gene therapy trial in 1999, the new rules say that scientists running a gene therapy experiment would have to post details of any potential risks on the FDA's website.

In addition to gene therapy trials, the proposals also cover xenotransplantation - the use of animal organs and tissues to treat human disease. 'Both of these technologies hold great promise, but they may also pose a remote but unique risk to the individuals who have volunteered to participate in these kinds of studies' said FDA Commissioner Jane Henney.

Delegates attending the recent Gene Therapy 2001 conference in Utah heard how Gelsinger died following an immune reaction to the virus used to deliver a therapeutic gene to his liver. James Wilson of the University of Pennsylvania, leader of the team that conducted the trial, has since carried out experiments on mice and monkeys to find out what went wrong. Wilson and his colleagues found that the virus did not stay in the liver, but spread to other organs, which triggered unexpected inflammation. 'We all need to learn a lot of science from this patient' said Savio Woo of the Mount Sinai School of Medicine after Wilson's presentation.