The US Food and Drug Administration can’t keep out of the limelight. It was heavily criticised for not providing adequate supervision of processed food and medicines imported from China, resulting in gigantic recalls and public health warnings. And now a report into its supervision of clinical trials suggests that it is disorganised, under-financed and often negligent. “In some ways, rats and mice get greater protection as research subjects in the United States than do humans,” Dr Arthur Caplan, of the University of Pennsylvania told the New York Times. Animal research centres have to register with the federal government, keep track of the number of subjects, are subject to unannounced spot inspections and dispatch problems quickly. None of this is true in human research.
A report from the Department of Health and Human Services says that the FDA is unable to identify all ongoing clinical trials or institutional review boards. It relies on voluntary compliance to correct violations. In addition, its guidance and regulations are behind the times.
The Times cited two disturbing examples of lack of oversight. In one, a woman checked into an Oklahoma clinic to participate in a drug trial for bipolar disorder. She was forced to stay against her will, even though her lawyer appeared at the doorstep with a writ of habeas corpus. The clinic had a number of other problems, but it took the FDA two years to send a warning letter. Last November the psychiatrist who owned the clinic was suspended for having sex with two patients. Apparently he continues to participate in drug trials and to do research.
The importance of government oversight is highlighted by a report in the Wall Street Journal about the growing use of dying hospice patients as participants in clinical trials. There is growing interest in these people because of their unique medical needs. However, clinical trials in this environment present serious ethical issues. “People are really vulnerable when they’re coming to the end of their life,” says Porter Storey, of the American Academy of Hospice and Palliative Medicine. “They’re willing to sign up for anything,” he says. They may put too much hope in an experimental cure or they may agree just to please their doctor.
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