CANTON, Mass. - Some cut themselves. Others slam their heads against walls or desks - so hard that one girl detached both retinas and a young man triggered a stroke. Another pulled out all his teeth.
Self-injury is one of the most difficult behaviors associated with autism and other developmental or intellectual disabilities, and a private facility outside Boston that takes on some of the hardest-to-treat cases is embroiled in a major debate: Should it use electrical skin shocks to try to keep patients from harming themselves or others?
The Food and Drug Administration is considering whether to ban devices used by the Judge Rotenberg Educational Center in Canton, Massachusetts, the only place in the country known to use skin shocks as aversive conditioning for aggressive patients.
It's a rare move by the FDA, following years of complaints from disability rights' groups and even a UN report that the shocks are tantamount to torture.
FDA Commissioner Margaret Hamburg says the shock therapy has raised a lot of questions.
"We really wanted to take a much more focused and rigorous look at it," Hamburg said in an interview with The Associated Press. "There's a lot of concern about the downside of this approach and the harm and the risk to the patients receiving it."
Rotenberg must get a court's approval to begin administering skin shocks to a student. The centre uses a graduated electronic decelerator, or GED, that is attached to the arms or legs. If the student acts aggressively - head-banging, throwing furniture, attacking someone - then a centre worker can press a button to activate the electrode, delivering a two-second shock to the skin.
Some patients compared the shocks to a hard pinch or bee sting. Others say it's far more painful; one said it was like being stung by a thousand bees.
At an FDA advisory committee hearing this year, most of the neurology and ethics experts concluded the device poses an unreasonable and substantial risk, while acknowledging that other therapies don't work for everyone.
"I think that what has happened is that this has gone on for this long because this is a population who cannot adequately speak for themselves," Dr. Karen Weigle, a clinical psychologist affiliated with the University of New Hampshire's Institute on Disability, told fellow committee members.
Dr. Steven Miles, a bioethicist at the University of Minnesota, was one of several advisers concerned about the lack of scientific studies showing the shock therapy works. That only one treatment facility uses them, he said, makes it "unreasonable to conclude that these devices are part of the standard of care for this class of patients."
But Louisa Goldberg of Newton, Massachusetts, says the skin shocks are the only treatment that has worked for her son, Andrew, who suffered brain damage at birth and became dangerously aggressive as he got older.
Andrew Goldberg spent years at a New Hampshire facility, where his mother says he bit, hit and kicked staff members. When restraints did not work, workers tried medications to calm him. "He was a zombie," Louisa Goldberg said.
He was kicked out at age 19 and taken to Rotenberg, which weaned him from some medications and began the skin shocks. Now, at 33, Goldberg still gets a shock or two every month, but his mom says his life is better.
"Andrew is awake. He's alert. He's happy and he's functioning to the best of his abilities," Louisa Goldberg said in an interview. "We have our son back."
Rotenberg's executive director, Glenda Crookes, calls the shocks a last resort coupled with positive behavior programs, such as rewarding students with time at JRC's Internet cafe or the teen lounge with its arcade games. The idea is that the two-second shock is quick but painful enough to jar the patient out of the harmful episode.
Of the 235 patients at the centre, 55 are being treated with skin shocks. Most are in their 30s; five are between age 17 and 21.
The FDA first cleared the GED device for use in 1994. But Rotenberg started using a more powerful version, about 2.5 times stronger, that was developed after one student built up a tolerance to the shocks. In 2000, the FDA said the newer device didn't need approval, but the agency changed its position in 2011 and said approval was required, eventually leading to April's hearing on whether to ban it altogether.
The centre insists it is safe.
Some former students say otherwise.
"It's not safe. It doesn't feel safe. I ended up having nightmares," Jennifer Msumba testified via video at the FDA's hearing. The 38-year-old said the GED left burn marks and was prone to misfires, unintended shocks.
Msumba's mother is suing JRC. Her attorney says Jennifer Msumba, who has autism, was given more than 230 electrical shock treatments since 2002 and not permitted to take psychiatric medications. Msumba said she is less anxious at a new treatment facility in Florida.
"They help figure out what makes me want to do things that could be harmful so I can learn how I feel before it happens," Msumba told the AP.
Rotenberg representatives says the suit has no merit and that "Jennifer made incredible progress" at the centre.
About 10 percent of people with intellectual disabilities or autism display self-injurious behavior. Severity varies widely and treatment should be individualized, said Dr. Louis Hagopian, program director of the neurobehavioral unit at Baltimore's Kennedy Krieger Institute. Hagopian was not part of the FDA panel reviewing skin shocks.
The most studied approach - behavioural treatment - involves identifying what social or environmental factors trigger a patient's behavior, and then teaching the person coping skills plus altering their environment to decrease those problematic situations. Hagopian said medications that address mood, impulsiveness and other conditions also frequently are used.
Jennifer Msumba's suit is not the first.
Cheryl McCollins sued the centre for malpractice after her autistic son, Andre, was shocked more than 30 times over approximately seven hours in 2002. In a surveillance video played in court, Andre is seen lying face down with his arms and legs tied to a restraining board. He can be heard screaming, "Help me. No." The centre settled the suit.
The centre says that "is not the same treatment approach JRC would take today." Crookes, the centre's executive director, said skin shocks would be suspended earlier and the centre would take a closer look at potential triggers of aggression.
Sharon Wood of Charlottesville, Virginia, fears a ban on skin shocks would return her 21-year-old son, Joshua, to the violent behavior that used to force her to lock herself in a room with her young daughter. Joshua Wood is profoundly autistic. His parents say they tried everything but the only thing that worked was the shocks.
"Do not take away what is saving his life," Sharon Wood said in an interview as the FDA considers the ban. "Don't take this away until you are convinced there are better alternatives."
Facts and figures about the school and facility at the centre of the controversy:
The Judge Rotenberg Educational Center outside Boston is the only place in the country known to use electrical skin shocks as aversive conditioning for patients with severe developmental and behavior disorders who harm themselves or others. The Food and Drug Administration is considering whether to ban the skin shock devices used by the center.
- The centre was founded in 1971. It has been using skin shocks on patients since the early 1990s.
- It costs $245,000 a year for a patient at the center, usually paid by states, including Medicaid, or local school districts. One student is a private pay.
- The centre treats about 230 children and adults.
- About 50 patients are being treated with GED skin shocks. Five are between the ages of 17 and 21. Most are in their 30s.
