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March 2, 2000 NEWS BRIEFS Gene response The Institute for Human Gene Therapy (IHGT) has responded to the Food and Drug Administration’s investigation into the clinical trial in which patient Jesse Gelsinger died after receiving gene therapy. A document filed with the FDA Feb. 14 took issue with some of the FDA’s claims regarding informed consent, eligibility and reporting of adverse incidents. It stated that all trial participants gave informed consent and that their eligibility was documented. And while Penn agreed with the FDA’s finding that toxicity data for two participants should have been reported earlier, the report noted that the FDA did have the reports in hand well before it approved Gelsinger’s participation in the trial. And it noted that studies on primates that the FDA claimed had safety implications for the trial were conducted as part of an unrelated trial of a genetic treatment for a different disease. The report also said that the University would draft written standard operating procedures to prevent the communications problems between Penn and the FDA mentioned in the FDA’s investigation. Made-up truth Writer Grace Paley drew a crowd that overwhelmed the homey spaces of Kelly Writers House Feb. 14. The tiny Paley, her face and mop of white hair magnified on a television in the next room, captivated listeners up close and listeners three rooms back, listeners crushed into the foyer and pressed up the stairs. Paley’s New York voice penetrated even the farthest reaches of the house. In referring to one of her stories, she aptly described them all, using a typical Paley aphorism: “The story was made up, the way you make up the truth.” NEA visit National Endowment for the Arts Chair Bill Ivey spent the day at Penn Sept. 24. A reception at the Kelly Writers House followed a public interview and private lunch with undergraduates. The day ended in a town meeting at the Institute for Contemporary Art.