Wired News Report
3:00 a.m. 3.Feb.2000 PST
The father of a teenager who died during a gene therapy experiment testified that he was not properly informed of potential dangers to his son's health, at a Congressional hearing Wednesday.
Paul Gelsinger told Congress that University of Pennsylvania scientists had wrongly led him to believe that their treatment for a rare liver disorder had produced some improvement in one patient. At a public meeting in December, however, the scientists said they had not seen any benefits, Gelsinger said.
"Some of the information I was given was not true," he told members of a Senate subcommittee reviewing the government's oversight of gene therapy trials.
The hearing was held after the U.S. Food and Drug Administration found that a University of Pennsylvania lab did not follow proper protocol for the experiment.
Eighteen-year-old Jesse Gelsinger, who died in September, was the first reported death as a result of a gene therapy experiment. Gelsinger was undergoing gene therapy as part of clinical trial for a rare liver disease.
Tennessee Republican Bill Frist, chairman of the Senate Subcommittee on Public Health, heard testimony from the victim's father, Paul Gelsinger, several genetics experts, and representatives from the FDA and the National Institutes of Health.
Following Wednesday's testimony, Frist said more hearings were in order and that he plans to consider writing legislation that would protect patients in more than 300 ongoing gene therapy trials.
"I'm concerned that there are significant gaps in the oversight and monitoring of gene therapy trials," Frist said in a statement.
Since Gelsinger's death, the NIH has urged researchers to come forward with any adverse events involving gene therapy that had not yet been reported. The NIH received 652 previously unreported serious adverse events, which Frist called "unexcusable."
Although gene therapy research offers hope for patients who suffer from diseases like cystic fibrosis, AIDS, and cancer, there's no room for mistakes that compromise patient safety, Frist said.
Experts estimate that hundreds of patients in gene-therapy trials have died, but the deaths have mostly been blamed on the patients' underlying conditions rather than the therapy itself.
The Wall Street Journal reported that the NIH said it would redouble its efforts to monitor gene therapy experiments, focusing specifically on potential conflicts of interest among researchers.
The University of Pennsylvania lab's main investor is Genovo, a company founded and partly owned by the lab's director, Dr. James Wilson.
Reuters contributed to this report.
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