To: wvalx who wrote (22525 ) 9/30/1999 8:52:00 AM From: OmertaSoldier Respond to of 23519
It looks like Vivus may have done something right in dropping gene therapy tests? I found this rather interesting. DEATH DURING GENE TEST FUELS DEBATE ON ETHICS TEENAGE VOLUNTEER HADN'T BEEN ACUTELY ILL Associated Press September 30, 1999 PHILADELPHIA -- Gene therapy, a growing field of research that holds promise in curing ailments from heart disease to cancer, may come under closer scrutiny after the death of a teenager during an experiment at the University of Pennsylvania. "It certainly should cause us to pause and reflect," Jeffrey Kahn, director of the Center for Bioethics at the University of Minnesota, said Wednesday. "It's a very difficult thing for us to confront, especially when the death is attributed to the research." Doctors don't know why Jesse Gelsinger, 18, of Tucson, Ariz., died Sept. 17. He was four days into an experiment in which researchers placed healthy genes in his liver to combat a disease that inhibits the body's ability to rid itself of ammonia, which is produced when protein is processed. Most victims of the rare disorder, known as ornithine transcarbamylase deficiency, or OTC, die as infants. Gelsinger, diagnosed with OTC at age 2, had a mild form of the disease that he kept in check with medications and low-protein foods. He volunteered for the study to help others, said his father, Paul Gelsinger. Gene therapy studies usually involve people whose diseases are so advanced that traditional treatment doesn't work, but the Pennsylvania experiment included people with OTC who had with less severe symptoms. "There's a good reason, therapeutically, to do gene therapy before people are so sick it can't help them. But if the person is relatively healthy and the research poses a significant risk of harm or death, it poses a difficult dilemma," Kahn said. "When do you engage in what could be quite risky research when the individual could live a long time?" In gene therapy, working genes are inserted to compensate for genetic flaws, such as the ones that lead to OTC. "Research is a risky business," said John Lantos, associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago. "Often, experimental interventions are themselves dangerous. The hope is they're less dangerous than the disease." Pennsylvania's experiment involving 18 patients has been halted until researchers can determine why Gelsinger died. Officials at the university's Institute for Human Gene Therapy said his case will be closely reviewed and an autopsy will be conducted to determine the cause of death.