Gene therapy under the gun

Washington -- The death in September 1999 of a patient as a result of experimental gene therapy and the widespread failure of investigators to report adverse events to the NIH, indicate that federal oversight of gene therapy "is failing," Sen. Bill Frist (R-Tenn.), chairman of the Senate Committee on Health, Education, Labor and Pension's subcommittee on public health, said Wednesday.

Senior FDA and NIH officials told Frist and other members of the subcommittee that they have initiated a number of steps to tighten the regulation of gene therapy trials. ...