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See Inside October 2007

Experimental Drugs on Trial

A controversial lawsuit challenges the FDA's system of controlling access to experimental drugs and, some say, the scientific basis of drug approval

Abigail Burroughs was only 21 when she died. If her father and his supporters get their wish, however, she will attain a kind of immortality, joining Brown, Griswold, Roe and Miranda in the band of ordinary citizens whose personal travails have permanently changed the way Americans live.

A lawsuit, Abigail Alliance for Better Access to Developmental Drugs v. Andrew von Esch­en­bach, contends that government regulations kept Burroughs from obtaining potentially lifesaving experimental cancer medicines that her doctor recommended, violating her constitutional right to defend her life. The U.S. Court of Appeals in the District of Columbia ruled against this claim in August, and the plaintiffs plan to appeal to the U.S. Supreme Court. The ultimate outcome could become one of the most important court decisions ever to affect medical science, climaxing a conflict that has simmered since the early days of the AIDS epidemic. On the one hand are the heartrending emotional pleas of dying patients who are eager to try unproved experimental drugs. On the other are scientists determined to preserve the “gold standard” method that for decades has established which medications work—a series of clinical trials that in total can take 10 years to complete. Both sides want to protect patients’ lives, but they differ on the best strategies toward that noble end.

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