
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SATURDAY, May 14, 1994                   TAG: 9405160147
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-4   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium

NIH, DRUG MAKER BROKE FDA RULES

Government scientists and a prominent drug manufacturer violated federal regulations with an experimental hepatitis drug that killed five patients last summer, the Food and Drug Administration asserted Friday.

The agency stopped short of saying the problems led directly to the deaths. But it assailed drug maker Eli Lilly & Co., the National Institutes of Health and other researchers for such "serious violations" as not reporting side effects, not taking patients off the deadly drug soon enough and misleading volunteers about risks.

And the problems started long before the drug fialuridine, or FIAU, was ever tested in people for its ability to fight hepatitis B, agency documents indicated. In 1991, AIDS researchers began seeing toxic side effects from the drug. In one case, the FDA didn't learn of them until a year after a patient's death.

The FDA made the contentions in warning letters that threaten immediate "regulatory action" unless Lilly and the scientists tell the agency within 15 days how they will ensure such violations never again occur.

Agency officials wouldn't say what action they might take, but did say criminal charges are unlikely.

Dr. Sidney Wolfe of the watchdog Public Citizen Health Resources Group called the letters "an ineffectual slap on the wrist."

"These were people who, although they had hepatitis B, were not in the last stages, and they died, in my view, because of failure to report" problems with the drug, he said. "This is a signal FDA is really soft."

Lilly spokesman Ed West said the company believes it complied with all FDA regulations but would study the letter. At the time, the company believed problems in the AIDS and hepatitis trials were caused by the patients' diseases, not the drug, he said.

NIH officials didn't immediately comment.

The drug made headlines last June when the NIH abruptly canceled its testing in 15 patients with hepatitis B because many experienced severe side effects. Five have since died, and two survived only after liver transplants.

The drug had shown great promise for fighting the hepatitis B virus, which can cause deadly cirrhosis and liver cancer.

by CNB