The FDA’s own parent department, the Department of Health and Human Services, just issued a report that says the FDA “does very little to ensure the safety of the millions of people who participate in clinical trials,” according to the New York Times. The FDA has 200 inspectors, some of whom are part-time, to monitor 350,000 testing sites—and even when they reported “serious problems,” their findings were downgraded 68% of the time by higher-ups in Washington.
The chairman of the department of medical ethics at the University of Pennsylvania says, “In many ways, rats and mice get greater protection as research subjects in the United States than do humans.”
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, Mr. Caplan said. Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been.
The Times article offers a quick, horrible illustration of where the lack of oversight can lead. A woman who agreed to an experimental drug treatment for bipolar disorder signed an agreement that said she could leave the study at any time, then was held against her will when, three days before the drug was to be administered, she tried to drop out. Her lawyer had to go to court, obtain a writ of habeas corpus, and then track down the doctor at another location because the staff wouldn’t let him serve the writ at the hospital. In the meantime, the woman was given the experimental drug anyway. Incidentally, this same doctor gave genital herpes infections to two other patients.
“Report Assails F.D.A. Oversight of Clinical Trials” [New York Times]