Effect of Gelsinger's death reaches far and wide

A year ago yesterday, only a prophet could have predicted the consequences of the death of a single young man on an entire field of medical research. But today, the aftershocks of the death of 18-year-old Jesse Gelsinger, who died while participating in a study at Penn's Institute for Human Gene Therapy -- the first reported fatality in the experimental field -- are clearly evident. Despite the promising advances that came this summer with the mapping of the entire human genome, the tragedy at Penn slowed a huge portion of the country's genetic research. And after a year of governmental inquiry into the actions of the researchers at the IHGT and an official suspension of human trials there, gene therapy researchers, bioethicists and lawmakers across the country have had to readjust and reconsider the ramifications of gene therapy and other evolving fields like it. Larry Kedes, a researcher with the Institute for Genetic Medicine at the University of Southern California, said that since Gelsinger's death, he has noticed "a great deal of more clinical oversight... on any clinical gene therapy trials being proposed or underway." "Because of what happened to [Gelsinger] it became very clear that there needed to be reform of the patient protection system," said Abbey Meyers, president of the National Organization for Rare Disorders and a former National Institutes of Health gene therapy advisor on the Recombinant DNA Advisory Committee. According to Meyers, the idea that patients must be protected in research became a law after the Nazi war crimes trials at Nuremberg, more than 50 years ago -- and the common law had not been changed since. "Gelsinger's death showed that the system must change," Meyers said. "It was the fault of the system and there was no way for the government to enforce the rules." Said Stephen Eck, co-director of the cancer gene therapy programs at the IHGT: "What the Gelsinger death did was it brought into sharper focus what people had already been concerned about." He added that the tragedy simply shed light on an already wide-spread problem. After the death, critics began to snipe that institutional review boards -- internal committees set up to oversee experimental processes at each research program -- are not enough protection for patients undergoing experimental treatments. The U.S. Food and Drug Administration and the NIH announced in March two initiatives to protect patients in these trials. The first program is the FDA's Gene Therapy Clinical Monitoring Plan, requiring that sponsors of gene therapy trials routinely submit their third-party monitoring plans to the FDA and also be subjected to routine surveillance and inspection. Second is the Gene Transfer Safety Symposia in which the NIH and the FDA will establish quarterly forums for the sharing and analysis of medical and scientific data from gene transfer research. But some researchers are skeptical about the changes, saying that they make scientific innovation much more difficult. At the time bone marrow therapies were being researched, "if these regulations had been in place, it would have been terminated," said Dusty Miller, a gene therapy researcher at the Fred Hutchinson Cancer Center. Many people died for what "ultimately resulted as a very useful tool," he said. "The same can be said for gene therapy technology." Miller warned that excessive regulations may cause potential researchers to shy away from becoming involved in the research area and sponsors to be fearful of investing, which will lead to a significantly slowed process for developing therapies. Julie Neusch, director of corporate communications at ValiGen, a genomics company, said that "a lot of money has dried up" already in the gene therapy field. Meyers also pointed out the threat to patient safety when researchers have stock in a company and stand to financially benefit from the success of their research. Media have been quick to speculate about possible conflicts-of-interest from IHGT Director James M. Wilson's involvement with an outside company, Genovo, Inc. "There is a presumption that researchers are in it for financial gain," Miller said. "But we are not in it for ourselves. Why do it? Clinical research is tough."

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