Drug test deaths called 'accident'

June 03, 1994|By Los Angeles Times

WASHINGTON -- Disagreeing with the findings of an earlier federal investigation, an advisory panel of private physicians appointed by the National Institutes of Health has labeled the deaths of five hepatitis patients using an experimental drug "an unavoidable accident."

The controversy, which has shaken the world of biomedical research, involved people with chronic hepatitis who had been taking a drug known as fialuridine, or FIAU, in a clinical research project sponsored by NIH. The deaths of one-third of the 15 patients who were on the drug in 1992 and 1993 occurred weeks after their last dosages, authorities said.

Last month the U.S. Food and Drug Administration, concluding a study of the tragedy, said that those involved in the FIAU research -- scientists, physicians and drug maker Eli Lilly & Co. -- had failed to fully disclose the drug's potential risks or take note of its ominous side effects.

But the new study released yesterday by an NIH panel of outside experts found no fault with those who developed the drug or administered it to chronically ill patients who had volunteered for the project.

David R. Challoner and David M. Kipnis, who headed a panel of seven physicians to determine what went wrong, said in a report to NIH director Harold E. Varmus that the deaths resulted from "delayed drug toxicity" and could not have been foreseen.

The panel did say that scientists must do a better job checking for drug toxicity by testing patients for six to nine months after they have taken certain drugs. But it said that should not be done for all drug trials because of the expense.

Dr. Challoner said his panel's study has been forwarded to the FDA. Because that agency and NIH are both divisions of the Department of Health and Human Services, the department's assistant secretary for health will be asked ultimately to develop a federal position on the controversy. The drug in question no longer is being used, although research on it is continuing.

One reason for the conflicting conclusions, Dr. Challoner said, was a difference in approaches by FDA investigators and NIH panelists. He said his panel focused on the quality of the clinical research project while the FDA found faults based on records kept by those who conducted the research.

Dr. Kipnis said the recent FDA report, for example, criticized some physicians for failing to report abdominal pains experienced by some people taking the new drug. But he said interviews by panel members found the doctors felt "abdominal discomfort did not reach the degree of severity to be reported."

Dr. Jay Hoofnagle, the NIH's lead investigator of FIAU, was criticized by the FDA for alleged "significant violations" of federal regulations. But the panel's report defended him.

"Dr. Hoofnagle was enthusiastic about the possibility of developing an efficacious treatment for hepatitis B. However, his approach was careful," the panel said.

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