April 23 (Bloomberg) -- U.S. regulators are weighing whether to ban a device used for decades to shock children and adults with disabilities in an effort to stop dangerous or unwanted behavior.
Only one institution in the U.S., the Judge Rotenberg Educational Center in Canton, Massachusetts, is known to use an electrical stimulation device to administer shocks, according to a report released yesterday by the Food and Drug Administration in advance of tomorrow’s advisory meeting on the device. The center is using modified versions of an approved product in violation of U.S. law, the agency said.
The FDA can ban devices with an unreasonable and substantial risk of illness or injury, after taking into account their benefits and available alternatives. A 122-page review of the electrical stimulation devices outlined risks including burns and psychological harm, the lack of long-term benefit and research that suggests positive reinforcement is best to treat behavioral issues.
“Serious concerns have been raised about the use of aversive conditioning electrical stimulation devices on children and adults with developmental disabilities,” FDA staff members wrote in the report prepared for the Neurological Devices Panel. “The agency is reviewing the available evidence regarding the risk and potential benefits of, and alternatives to, aversive conditioning electrical stimulation devices for self-injurious and aggressive behavior.”
Officials at the Judge Rotenberg Educational Center said the approach is a critical component of therapy for children who have exhausted other treatment options. It is used only with the consent of parents and authorization from a Massachusetts court where students are assigned an attorney. The intensive behavioral program is an option of last resort for patients with life-threatening disorders, the school said in a statement.
A “record of successfully treating hundreds of patients with the most severe forms of behavior disorders in the nation stands as irrefutable evidence that intensive behavioral treatment supplemented with the use of a GED device is safe and critically necessary for some people to survive and have an opportunity to live a healthy and productive life,” the school said yesterday in its statement. “Without the treatment program at JRC, these children and adults would be condemned to lives of pain by self-inflicted mutilation, psychotropic drugs, isolation, restraint and institutionalization – or even death.”
The facility offers a program for people with special needs and touts its “near zero” rejection policy, rarely rejecting or expelling students based on the severity of their behavior.
“Our specific goal is to provide each individual with the least intrusive, most-effective form of treatment to insure his/her safety, the safety of others, and promote healthy growth and development,” the special-needs school said on its website.
The device made and used at the center is known as a graduated electronic decelerator, with electrodes that can be placed on the bottom of the feet, palms of the hands, lower back or the inner arms or legs. The devices used at the Judge Rotenberg Center have an average output current almost three times as high as the approved level, the FDA said in its report.
It was unclear from the report how often the devices were used. Behaviors the school said it was targeting included self- harm, aggressive or destructive actions and physical and sexual assaults. The students had a range of ailments, including mental retardation, severe behavior disorders, autism and seizure disorders, attention deficit hyperactivity and other medical problems.
Twenty-one states currently ban the use of electrical stimulation devices and other approaches that use such interventions to help modify difficult or dangerous behavior.
The school has been the subject of controversy in the past.
Matthew Israel, the school’s former executive director, was indicted as an accessory after the fact and for misleading investigators in 2011 after two students received inappropriate shocks. He entered into a deferred prosecution agreement with the Massachusetts Attorney General that required the appointment of an independent monitor.
A former student called the school and, posing as a member of the quality control department, instructed staff members to administer 77 shocks to one student and 29 to another. The independent monitor’s report found the event was the result of a hoax and not a standard practice at the school.
The United Nations Special Rapporteur on Torture conducted two investigations of the school, calling for a ban on all coercive measures including electroshock procedures and saying the rights of the students had been violated.
In February 2013, 86 students ages 14 through 50 had court- approved treatment that included electrical stimulation devices, according to documents the school provided to the agency as part of a continuing compliance investigation.
Studies show body chemistry affects how an electric current is experienced by a person and their perception of pain. While there is a widely held belief that people with autism have a high pain threshold, a 2013 medical journal analysis laid out the possibility that they simply don’t respond with the same cues, not that they don’t suffer.
A literature review conducted by the FDA concluded that electrical stimulation devices can help reduce self-inflicted injuries and aggressive behavior over a short period of time, though the long-term benefits are less clear. The shocks, occasionally administered with a prod, reduced self-harm such as head banging, assaults on others and the need for restraints.
The studies, generally conducted in the 1960s and 1970s, weren’t comprehensive investigations of the procedures and didn’t meet contemporary standards, the agency said. They also didn’t provide information on the simultaneous use of other treatments.
--With assistance from Anna Edney in Washington.