FDA faults gene-therapy researchers in teen's death

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DesertSun.Palmsprings.CA_12.9.99 - Health FDA faults gene-therapy gene-therapy...
Health FDA faults gene-therapy gene-therapy gene-therapy researchers in teen's death ByPaul Recer ; ' TMIi ASSOC.IATI!l I'UliSS BETHESDA, Md. An Arizona teenager teenager who died in a gene therapy experiment should never have been part of the study and researchers who conducted it violated at least two rules of the testing, federal officials said Wednesday. ' Food and Drug Administration officials officials said Jesse Gelsinger, 1 8, "did not meet the entry criterion" for participating in an experiment in which his liver was injected with a virus carrying a corrective gene. Researchers at the University of Pennsylvania, where the experiment was part of a series of gene therapy trials, denied the accusation and said they would defend their work at a hearing today at the National Institutes Institutes of Health. The allegations were announced Wednesday after a daylong hearing before an NIH advisory committee investigating the death and looking at safety issues in gene therapy experiments. experiments. The panel, called the Recombinant Recombinant DNA Advisory Commits tee, or RAC, also is considering new guidelines to sharpen federal control and force public disclosure of problems problems in gene therapy experiments. The RAC's hearing, before a packed auditorium, is to resume to day and is expected to continue : through Friday. . Gelsinger's death, the first directly blamed on a gene therapy experiment, experiment, prompted the review of the emerging medical treatment. The Tucspn teen-ager teen-ager teen-ager suffered from a genetic liver disorder and was enrolled in a University of Pennsylvania Pennsylvania trial designed to correct his condition by inserting normal genes into his liver. Gelsinger died within days of the experiment. Kathryn Zoon, chief of the FDA's Center for Biologies Evaluation, said preliminary findings show Gelsinger had elevated ammonia in his blood, an indication of a distressed liver, when he received the gene injection. She also said the Pennsylvania researchers researchers failed to notify the FDA of two other patients in the therapy experiments who suffered liver damage damage severe enough to halt the trial. Zoon said the researchers also failed to mention on patient consent forms that a monkey died after receiving experimental gene therapy. Dr. James Wilson, head of the University University of Pennsylvania team, said Gelsinger did meet the FDA requirements requirements when he enrolled in the trial, but his ammonia levels were "slightly elevated" just prior to the injection. BiiirtmiiiiiiinrT it m -. WW ... my- my- THK ASMICIATHO HUiSS Teen victim: Jesse Gelsinger, 18, poses near a statue at the University of Pennsylvania. The death of Gelsinger Gelsinger was the first caused directly by experimental gene therapy.

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  1. The Desert Sun,
  2. 09 Dec 1999, Thu,
  3. Page 34

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  • DesertSun.Palmsprings.CA_12.9.99 — FDA faults gene-therapy researchers in teen's death

    crawford_julie – 12 Oct 2017

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