They also said none of the animal studies done before Gelsinger's treatment and none of the tests done on human volunteers predicted his crisis. Penn's preliminary, 337-page report was sent Wednesday to the federal Office of Recombinant DNA Activities, which will discuss the findings at its quarterly meeting next week. Penn's study has been halted and the Food and Drug Administration decided in October to halt two separate experiments by Schering-Plough trying gene therapy as a treatment for liver cancer and for colorectal cancer that spreads to the liver. Those studies also used relatively high doses of the adenovirus to carry new genes into the liver. Gelsinger had a relatively mild form of OTC deficiency.
Most babies born with the disease die within a few days of getting protein.
But the government has not approved testing in babies. Gelsinger had been through three comas with the disease, but it was under control with a restricted diet and drugs. After Penn reported Gelsinger's death, ORDA asked some 70 investigators doing human trials with adenoviruses to report any side effects. Practically all have responded, said ORDA director Amy Patterson, and the data are being reviewed by a panel of experts. Copyright 1999 The Associated Press.