Carlton Lee probably contracted hepatitis B when he was a Peace Corps forestry management volunteer in Sierra Leone in the 1980s. His young, vigorous immune system suppressed the initial assault, but the virus hung on tenaciously, a cranky, chronic nuisance living and breeding in his liver, a bomb that could go off at any time, that could cause fatal liver disease. In 1989, despite his own viral death threat--or perhaps because of it--Lee joined the National Commission on AIDS as its chief congressional liaison, the person responsible for representing the commission and its aims up on the Hill. He was so impressed by the activism of people with AIDS, by their aggressive pursuit of experimental treatments, that he decided to take a more vigorous role in the search for a cure for his own illness. Early in 1992 he was accepted into a clinical trial at the National Institutes of Health to test a drug against the hepatitis B virus. Last summer a toxic reaction to that drug killed him.
Four other volunteers in the same drug trial died in the space of less than three months; two more survived only after liver transplants. That casualty count makes this NIH trial the worst clinical disaster in recent memory. But it doesn't stop there: an investigation into earlier trials has revealed at least five other deaths and five hospitalizations that might have been caused by the same drug.
The trials and their fatal results have raised serious questions about how well scientists and government regulators minimize research risks for human volunteers who offer their bodies to advance medical science. Everyone wants to know the same thing: why this happened, and how to make sure it never happens again. To that end the NIH is reviewing the procedures used by its researchers during the trials; the Food and Drug Administration has assigned two task forces to study the matter; and the Institute of Medicine is embarking on an independent review of both institutions to ensure objectivity.
It was a medical nightmare to begin with, says Jay Hoofnagle, who as the leader of the NIH study has become the target of most of this scrutiny. Then it was an emotional and personal nightmare. Now it’s becoming an administrative, legal type of nightmare. It’s been very tough.
It may get even tougher. The drug in question--fialuridine, or FIAU--is a chemical cousin to several of the most prominent AIDS drugs today, including AZT and ddI, as well as several being tested in clinical trials right now. The FIAU fiasco has already irrevocably changed the way we think about clinical trials in this country; it may also irrevocably change the way we conduct them.
