Clinical trials lack serious oversight in the United States
The Food and Drug Administration does very little
to ensure the safety of the millions of people who participate in clinical
trials.
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.
The inspector general of the U.S. Department of Health and Human Services, Daniel 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.
“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur Caplan, chairman of the department of medical ethics at the University of Pennsylvania.
Do we need something like People for the Ethical Treatment of People?
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 report concluded that the FDA’s oversight of clinical trials is disorganized and underfinanced. Just like its oversight of imported food, foreign drug manufacturers, animal food, and the safety of over the counter medicines.
Posted: Sun - September 30, 2007 at 07:42 AM