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Drug-trial deaths 'go unreported'
By Dan Vergano USA TODAY

Federallv sponsored researchers have widely shirked their responsibility to report injuries and deaths among study participants, a report suggests. "Thousands of deaths go unreported involving human, research subjects," says Adil Shamoo of the University of Maryland School of Medicine in Baltimore. He presented his study Saturday at an ethics conference sponsored by the Friends Research Institute. The National Institutes of health sponsors about 5,000 clinical human trials of medical treatments in about 47,000 locations. From agency reports, Shamoo estimates the number of current articipants at 7 million people. The agency could not,confirm that number, although an NIH report in 1997 pinned it at 6,078,099. Shamoo suggests that 12 million others participate in private clinical trials. The death of Jesse Gelsinger, 18, last year in a University of Pennsylvania clinical trial has galvanized public concern about the safety of human experiments and underreporting of study side effects. Using Freedom of Information Act requests, Shamoo collected the past 1O years of "institutional incident reports" ,submitted to the NIH by its sponsored researchers. The reports list injuries and deaths occurring among human research subjects. , In that tIme, the agency received only 878 reports, Shamoo says. He calls that rate "absurdly low," suggesting that normal death rates in a population of 7 million should have produced about 5,000 deaths, each of which should have triggered a report about whether the death was related to a drug under investigation. "These are provocative but unconfirmed numbers that suggest we really need better data collection." says medical ethicist Joseph FIllS of New York Presbyterian Hospital and Cornell University. .' After the uproar over Gelsinger's death, the NIH received 921 adverse-event reports from February to June, more in four months than the total for the previous decade, Shamoo says. 'We're seeing a massive failure of checks and balances on research." The 878 adverse-event reports generated only 41 investigations by the NIH's Office for Human Research Protections, according to the study. Of those investigations, 51 % resulted in the ension or termination of the research. ' Fins cautions that until the NIH gains a better idea of the true number of injuries and deaths in drug trials, hasty crackdowns could hinder drug development "I think proportionate regulation can protect human research subjects."

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