In June 1993, researchers at America's National Institutes of Health abruptly halted trials of a new drug to combat hepatitis B virus, following deaths and serious complications among participants. Although the drug, fialuridine (FIAU), was intended to improve liver disease, many of the patients undergoing prolonged treatment were getting worse with several dying from liver failure.(1)
The liver toxicity surprised researchers, for the drug seemed safe and effective in animal experiments.(1) It reduced the amount of hepatitis virus in infected woodchucks, the "preferred" animal model, and was also tested for toxicity in mice, rats and rhesus monkeys. However, one of the trial's chief investigators later asked "...why didn't the animal toxicity studies show any abnormality at all due to the drug?"(2)
The metabolism of anti-viral drugs of this type is said to be very different in animals and people,(3) and the tragedy has prompted a closer look at related drugs to see if other patients are experiencing similar harmful effects.
1) N.Touchette, The Journal of NIH Research, 1993, 5, 33-35.
2) J.Hoofnagle, reported in ref. 1.
3) C.Macilwain, Nature, 1993, July 22, 275.
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