HUMAN TRIALS: Officials Call for Monitoring Changes
Based on more than a year's worth of hearings nationwide and the recent problems with gene therapy experiments, federal health officials and members of the National Bioethics Advisory Commission Wednesday called for changes in the monitoring of research trials using humans, the New York Times reports. Commission Chair Dr. Harold Shapiro of Princeton University said, "One problem we have heard again and again is that, once an experiment is approved, there is a failure to follow what's going on with the patients. I think there is a growing consensus that something must be done." On Wednesday, the commission heard testimony from NIH and FDA representatives, who discussed scientists' failure to inform federal agencies of "serious adverse effects" involving patients. The NIH revised an earlier figure of 691 serious adverse events for gene therapy trials involving adenovirus to 970 serious adverse events. The NIH also revealed there were 100 other serious adverse events in 100 different gene therapy experiments.
More Changes on the Horizon?
Dr. Lana Skirboll, director of the Office of Science Policy, said that the research institutes had begun to change procedures to address the problems and HHS soon will announce further changes. Skirboll added that "reporting is important both to understand which types of experiments might be more hazardous, and in building trust that scientists are carefully watching for problems." She said, "This research, we think, is very exciting and may produce huge benefits to human health ultimately. But to get there we have to go through the door of clinical trials with human patients. And we can't go through there if we don't have the patient's trust" (Hilts, 3/2).