Misuse of an FDA Law allowing humanitarian exemptions may harm vulnerable psychiatric patients, according to an article in Health Affairs by an interdisciplinary group of multinational investigators led by Weill Cornell Medical College ethicist Dr. Joseph J. Fins, a Hastings Center Fellow and Board member. The article calls on the U.S. Congress and federal regulators to tighten a law that permits use of brain devices to treat rare neuropsychiatric disorders without sufficient clinical trials and patient oversight. A New York Times report on the article noted that while hundreds of people have had psychosurgery to treat obsessive compulsive disorder, “some of the field’s most prominent scientists are saying, ‘Not so fast.’”
“We believe there needs to be more careful regulation of the use of the FDA's Humanitarian Device Exemption in psychiatric patients,” said Dr. Fins. “We want to ensure that only orphan diseases are included in this exemption and that safety information is collected from every patient treated with these devices.” The authors argue that OCD is not rare.
Other Hastings Center work in neuropsychiatry include research on the diagnosis and treatment of psychiatric disorders in children and on the uses and misuses of neuroimaging.
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Hastings Center Fellow Joseph Fins Urges Caution for Psychosurgery in Health Affairs Article - The Hastings Center
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