This letter, by Health Research Group Deputy Director Peter Lurie, M.D., MPH, appeared in the Washington Post on February 14, 2000.
The death of Jesse Gelsinger in the University of Pennsylvania gene therapy study raises the issue of reporting adverse events in clinical trials. Researchers are required to report adverse events in all clinical trials for experimental drugs to the Food and Drug Administration (FDA). Debate rages over whether gene therapy investigators should be required to report such events to the National Institutes of Health, which can disclose these events to the public, in addition to reporting them to the FDA, which cannot. This question evades the real issue: the failure of the FDA to disclose adverse events in all clinical trials. The FDA is charged with preserving the public health, not with protecting drug companies from investors who might desert them if they learned that an experimental drug “has some toxicity. One cannot conduct quality or ethical research in an environment in which other scientists’ experiences are hidden. Denying information can be hazardous; this may be the real lesson of the Gelsinger episode.