Millions at Risk in Clinical Drug Trials According to Report

On September 27, 2007 the New York Times published an article that questioned the risk to millions who participate in drug trials. The article was based on a report released by the US Department of Health and Human Services Office of Inspector General on September 28, 2007.

The report noted that the federal health officials with the FDA (US Food and Drug Administration) did not know how many clinical trials were being conducted, and actually audited fewer than 1 percent of the testing sites. The Office of Inspector General report also noted that in the few cases when inspectors did appear at the trial site they generally showed up long after the tests had been completed.

The report noted that there were approximately 350,000 testing sites ongoing and that the FDA only had 200 inspectors to review these sites. As a result the report noted that only about 1% of all test sites were audited by the FDA. It was also reported that when inspectors found serious problems in human trials, in 68% of those instances top drug officials in Washington downgraded those report findings. The report also noted that in the remaining cases, the FDA almost never followed up with inspection findings to determine whether the corrective actions that the agency demanded had occurred.

Responding to the report Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania commented in the Times article, "In many ways, rats and mice get greater protection as research subjects in the United States than do humans". Caplan also noted, "Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research".