US IoM Views FIAU Deaths, ADRs

The US Institute of Medicine says it is opposed to US Food and Drug Administration plans to require six-monthly reporting of serious adverse reactions and deaths during clinical trials.

In a report on five deaths in the summer of 1993 associated with hepatic toxicity in trials of fialuridine (FIAU), an experimental hepatitis drug developed by Eli Lilly and Oclassen Pharmaceuticals, the IoM says the agency's proposed requirement for "a cumulative and all-encompassing report" biannually "will prove to be a substantial impediment to development of drugs to combat life-threatening diseases in which adverse events are frequent because of the often progressive nature of the underlying disease."

The FDA proposed amending adverse drug reaction reporting requirements following the FIAU deaths. It accused National Institutes of Health, Lilly and other scientists of serious violations of federal regulations, including not reporting side effects, not taking patients off the drug quickly enough, not following the written plans for the experiment and not keeping proper records of treatment.