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General interest items edited by Janice Flahiff

Hastings Center Fellow Joseph Fins Urges Caution for Psychosurgery in Health Affairs Article

Hastings Center Fellow Joseph Fins Urges Caution for Psychosurgery in Health Affairs Article

From the Hastings Center Spotlight

Misuse of an FDA Law allowing humanitarian exemptions may harm vulnerable psychiatric patients, according to an article in Health Affairsby 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.’”

The authors argue that the FDA’s Humanitarian Device Exemption regulation, through which the surgery was approved, should be revised so that use of such devices in neuropsychiatric patients meets the highest standards of clinical research, patient safety and research integrity. They write that the humanitarian approval allows device manufacturers to seek a “simpler, cheaper and faster approval process” while depriving patients of “the rigorous trial that the severity and complexity of their condition warrants, as well as hampering scientific discovery.”

“We believe there needs to be more careful regulation of the use of the Humanitarian Device Exemption in psychiatric patients,” says 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.”

Congress established the humanitarian device exemption in the Safe Medical Devices Act of 1990 to help bring novel devices to the market to treat uncommon conditions that otherwise might not attract the attention of device manufacturers. The act required that in order to receive such an exemption, the device must be intended to diagnose or treat conditions that affect 4,000 or fewer people in the U.S. annually. The authors argue that OCD is not rare.

Other Hastings Center work in neuropsychiatry include research on thediagnosis and treatment of psychiatric disorders in children, funded by the National Institute for Mental Health, and another on the uses and misuses of neuroimaging, funded by the DANA Foundation.

From the Hastings Center About Page

The Hastings Center is an independent, nonpartisan, and nonprofit bioethics research institute founded in 1969. The Center’s mission is to address fundamental ethical issues in the areas of health, medicine, and the environment as they affect individuals, communities, and societies.

To achieve this mission, the Center has established four goals:

  • To pursue interdisciplinary research and education that includes both theory and practice.
  • To engage a broad audience of thoughtful people in the work of the Center.
  • To collaborate with policy makers, in the private as well as the public sphere, to identify and analyze the ethical dimensions of their work.
  • To strengthen the international dimensions of the Center’s work.






February 24, 2011 - Posted by | Medical and Health Research News | , , , , , , , ,

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