FEDERAL SCIENTISTS CLEARED BY NIH

A US National Institutes of Health panel has found that federal scientists who conducted a study into fialuridine last summer, during which five people died, were not guilty of wrongdoing and recommended changes in liver toxicity testing during drug trials.

Several weeks ago, the US Food and Drug Administration sent a letter to four researchers and two executives at Eli Lilly, Oclassen Pharmaceuticals and the NIH (Marketletter May 23) saying that they had repeatedly violated scientific procedure and federal regulations in conducting the studies.

The NIH panel also said that the FDA did not respond to several requests for its audit which led to the warning letters. The FDA responded that the panel had access to the same documents the agency used but the two groups addressed different questions. In addition, the panel disagreed with the FDA's recommendation that all patients should be monitored during Phase I and II for six to nine months after a trial as such a procedure would be too costly. It said that monitoring should be carried out when there are scientific reasons for suspecting long-term or delayed toxicity. However, the panel did not specify how officials could identify such drugs before the initiation of human trials and agreed that even in retrospect it was not possible to detect that the fialuridine problems would have occurred.