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ISSUING its report on the deaths of five patients treated with fialuradine (FIAU), an experimental drug, in a study aimed at eliminating the carrier state of hepatitis B, the Institute of Medicine (IOM) has exonerated the scientists involved. There was no "evidence of negligence or carelessness," the fatalities could not have been foreseen, the report concludes.
This conclusion was similar to an earlier report prepared at the request of the director of the National Institutes of Health. But it is at some variance with a probe of the incident by the Food and Drug Administration (FDA), which concluded in its report that the investigators had failed to analyze the data regarding adverse events in a way that might have tipped them off to the toxicity of FIAU (JAMA. 1994;272:9-11).
The latest report was prepared by an eight-member committee chaired by Morton Swartz, MD, professor of medicine, Harvard Medical School, Boston,
Marwick C. IOM Panel Exonerates Researchers in FIAU Deaths. JAMA. 1995;273(15):1165. doi:10.1001/jama.1995.03520390017006