News in brief - Feb. 7, 2000

FDA stops genetic trials after patient death - University's research is put on hold

FDA stops genetic trials after patient death

Philadelphia -- The Food and Drug Administration shut down all gene therapy trials at the University of Pennsylvania Institute for Human Gene Therapy last month. This action came after an investigation launched into the death of 18-year-old Jesse Gelsinger, the first to be attributed to a gene therapy trial, found "serious deficiencies in the procedures in place for oversight and monitoring of [the institute's] clinical trials."

The National Institutes of Health has launched its own investigation into whether the IHGT also violated government regulations on patient safety. If significant violations are found, the University of Pennsylvania institute could lose its federal funding. Genovo Corp., a major corporate sponsor of the institute, is considering alternative sites for its research.

In response to the suspension, University of Pennsylvania President Judith Rodin has called for the establishment of a committee of independent scientists to review IHGT's oversight and monitoring of clinical trials and to suggest remedial steps.

University's research is put on hold

Birmingham, Ala. -- The National Institutes of Health's Office for Protection from Research Risks ordered the University of Alabama at Birmingham to stop enrolling human subjects in about 25% of its federally funded research projects last month. Research with currently enrolled participants has not been interrupted.

The NIH office found flaws in the university's internal oversight of research projects involving human subjects, including failure to adequately review patient risks and insufficient tracking of research participants for follow-up information, said Associated Press reports. The university's Institutional Review Board has begun re-reviewing the affected projects.