Report assails FDA oversight of clinical trials

The Baltimore Sun

WASHINGTON -- The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.

In a report due to be released today, the Department of Health and Human Services' inspector general, Daniel R. Levinson, said federal health officials do not know how many clinical trials are being conducted, audit less than 1 percent of the nation's testing sites and, on the rare occasions when inspectors do appear, generally show up long after the tests are completed.

The FDA has only 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with an inspection to determine if the corrective action that the agency demanded had actually taken place, the report found.

"In many ways, rats and mice get greater protection as research subjects in the United States than do humans," said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

Animal research facilities must register with the federal government, keep track of subject numbers, get unannounced spot inspections and address problems speedily or risk closure, none of which is true in human research, Caplan said.

The FDA only oversees the safety of trials done by companies seeking approval to sell drugs or devices. Using an entirely different set of rules, the Office for Human Research Protections oversees trials financed by the federal government.

Privately financed noncommercial trials have no federal oversight.

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