ASHINGTON — The Food and Drug Administration on Friday proposed banning the use of electric shocks that have been employed to treat children who are aggressive or prone to harming themselves, moving to end a long-running controversy over the devices.
The target of the proposed ban is just one facility: the Judge Rotenberg Educational Center, a school for students with psychiatric problems, developmental delays, and autism in Canton, Mass., south of Boston. Other states that previously permitted use of the devices, including New York, have banned them, citing the potential for injury and a lack of evidence that they work.
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” said Dr. William Maisel, acting director of FDA’s Office of Device Evaluation. “These devices are dangerous and a risk to public health. We believe they should not be used.”
The devices work by delivering shocks via electrodes attached to the skin. Critics have argued that treatment is painful and unnecessary, and have previously disseminated a graphic video showing the devices being used at the Rotenberg Educational Center.
Proponents of the shock devices argue that they have proven to be an effective means of changing destructive behavior by children and others with developmental disabilities.
In a statement, the Rotenberg Educational Center said that there are “hundreds of peer-reviewed articles on the safe and effective use” of the electric shocks and that they are “only administered when other therapy options have been exhausted and parents and doctors” approve their use.
Staff members, the center said, are “committed to serving these students, when no other facility can or will, and to finding the best ways to manage their behaviors to a level where they are no longer causing severe injury and pain to themselves, they can learn, and they can spend quality time with their family and friends.”
At an FDA advisory committee session on the issue in 2014, the center’s executive director at the time, Glenda Crookes, defended the devices as safe and effective. She said that 60 of the school’s 241 students — all age 18 or older — were using the device as part of their behavior therapy, after other treatments failed.
Some of the students, Crookes said, come in “bloodied, they’ve harmed themselves to the point where parents don’t know what to do, and we know we have a potential solution. The positive behavior support techniques at JRC hadn’t worked, [and] at all other institutions have not worked.”
Critics have argued that the aversion therapy treatment was also used for minor behavioral infractions. Students who have undergone the shock treatments have complained of burns, post-traumatic stress disorder, and more serious physical reactions, in addition to psychological trauma. Several lawsuits have been filed against the school.
The FDA began looking into the use of electrical stimulation devices after officials from the Massachusetts Department of Developmental Services and the state of New York raised concerns about them. In April 2014, after the advisory meeting, the FDA panel concluded, by a slight majority, that the device for the treatment used at Rotenberg “presented a substantial and unreasonable risk of illness or injury.”
In its statement Friday, the FDA said it believes “state-of-the-art behavioral treatments, such as positive behavioral support and medications, can enable health care providers to find alternative approaches for curbing self-injurious or aggressive behaviors in their patients.”
The FDA said the devices can cause depression, anxiety, fear, and panic, and worsen underlying symptoms. The agency was particularly concerned about disabled patients, who might not be able to convey their pain or give informed consent.
The proposal is now subject to a 30-day public comment period before it goes to the White House for final approval. The Rotenberg Educational Center said it had not been notified by the FDA about the proposed ban but hoped families directly affected by the decision would have an opportunity to “have a voice before any final decision is made.”
This story has been updated with a statement from the Judge Rotenberg Educational Center.