In the aftermath of 18-year-old Jesse Gelsinger's death last September during a University of Pennsylvania gene therapy trial, intensified regulation of such studies will be a major topic at the American Society of Gene Therapy (ASGT) annual meeting, May 31-June 4 in Denver.
"I think the important thing is to really keep focus," says society president Savio L. Woo, director of the Institute for Gene Therapy at Mount Sinai School of Medicine. "Medical research is a risky business, and we can't say there will be no risk involved .... Tragic incidents will occur, and when they do occur, we must learn from them and move onward."
In February, President Bill Clinton asked Health and Human Services (HHS) Secretary Donna E. Shalala to instruct two of her department's agencies, the Food and Drug Administration (FDA) and the National Institutes of Health, to accelerate their review of gene therapy guidelines and recommendations. ...
