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Want to send this story to another AOL member? Click on the heart at the top of this window. FDA: Gene Therapy Rules Violated By PAUL RECER .c The Associated Press WASHINGTON (AP) - The Food and Drug Administration says in a letter that a University of Pennsylvania researcher violated safety regulations in a gene therapy experiment in which a patient died. In the stern warning letter, the FDA said that Dr. James M. Wilson of the University of Pennsylvania ``violated regulations governing the proper conduct of clinical studies'' in a series of gene therapy experiments designed to correct a liver disease. Wilson headed a gene therapy experimental study that was halted after the death of 18-year-old Jesse Gelsinger of Tucson, Ariz. The teen-ager is the first patient known to have died as a direct result of a gene therapy experiment. The teen-ager died last September just four days after he was injected with the gene therapy drug. An autopsy report blamed his death on the effects of the experiment. In its letter on Friday, the FDA ordered Wilson and the University of Pennsylvania's Institute for Human Gene Therapy to continue cessation of all current human experimental drug trials and not to apply for new studies until ``corrective actions have been implemented.'' A warning letter is an FDA procedure that notifies a researcher or institution of what the agency considers to be violations of federal law. It means that unless the offending actions are corrected, the agency can take some enforcement action without further notice. The warning letter said the university had 15 days to report on steps it plans to correct the violations. The University of Pennsylvania said in a statement that it takes the FDA letter ``extremely seriously.'' The statement said the university had already answered many of the allegations contained in the letter and was ``disappointed'' that the FDA discounted or rejected those earlier responses. Gelsinger was enrolled in an experiment designed to test whether new genes could correct an inherited liver condition caused by a genetic flaw. In the experiment, a virus modified to carry the corrective gene was infused directly into the liver. The 20-page letter sent to Wilson said than an inspection showed that the University of Pennsylvania researchers failed to properly report serious reactions experienced by patients who had the gene therapy before Gelsinger. The letter also said the university failed to make a timely report about the death of at least two lab monkeys in similar gene therapy experiments. The warning letter accused the university of: Failure to properly report changes in the experimental protocol. Among the changes was elimination of a provision to stop the experiment if two patients experienced serious liver toxicity. ``These protocol revisions reflect significant changes that affect the safety of study subjects,'' the letter said. Failure to immediately notify or properly report serious adverse reactions in four patients. An annual report by the university, the letter said, ``misrepresented the true nature of the toxicities experienced by these four subjects.'' Enrollment of new patients in the experiments using higher doses despite adverse reactions experienced by earlier patients at lower doses. ``Your actions demonstrate a disregard for the protocol stopping rules you had agreed to follow that were designed to protect the safety of study subjects,'' the letter said. Failure to properly report liver damage found in a laboratory monkey even though the results suggested ``a significant risk for human subjects.'' Failure to revise informed consent documents for new patients after some earlier patients had serious side effects. This meant, the letter said, that some patients were not told ``new information about the possible risks of participation.'' Failure to properly conduct the required laboratory tests on patients either before or after the experiment. ``We conclude that the (institute) did not exert due diligence to ensure that the follow-up tests were performed according to the protocol,'' the letter said. AP-NY-03-04-00 0348EST Copyright 2000 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL