Report by IG of Department of Health and Huma Services Indicates "rats and mice get greater protection as research subjects ... than do humans"

Excerpt NY Times report "Report Assails F.D.A. Oversight of Clinical Trials ":

In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

The F.D.A. has 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 inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

...

While some of the report’s findings surprised ethicists, its conclusion that the agency’s oversight of clinical trials is disorganized and underfinanced has long been known and is, in many ways, identical to criticisms leveled at other agency functions, including its oversight of imported food, foreign drug manufacturers, animal food and the safety of older medicines.

In each case, the size and complexity of the tasks facing the agency have grown enormously as the number of inspectors for those tasks has generally declined.

See source to read rest including recommendations of the panel, details of one doctor's abuse of test subjects, author of quote in title above, etc.

tags: fda  food safety  medicine safety  clinical trials  

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