Left Brain Right Brain

The Judge Rotenberg Center (JRC) is known for its use of strong aversives in the educational programs of many of the students resident there. These aversives are delivered via electric shocks from “GED” devices many of the students wear. The GED devices have undergone some revisions over time and the current versions have not been approved for use on humans. Thus, the NY State Department of Education has notified JRC that they must cease using the unapproved devices. Apparently, JRC no longer manufactures nor has on hand the older, FDA approved devices. Thus, this letter in effect ends the use of electric shocks on New York students.

Below is a letter sent to JRC’s executive director, Glenda Crookes on March 12th, 2013 (the pdf is here, and I apologize for any mistakes in the OCR of that document).

Upon review of the “Warning Letter” CMS #367480 issued by the Department of Health and Human Services, Food and Drug Administration (FDA) on December 6, 2012 to the Judge Rotenberg Educational Center (JRC), and your responses thereto, the New York State Education Department (NYSED) finds JRC in violation of 8 NYCRR §200.22(f)(2)(viii) which states:

The use of any aversive conditioning device used to administer an electrical shock or other noxious stimuli to a student to modify undesirable behavioral characteristics shall be limited to devices tested for safety and efficacy and approved for such use by the United States Food and Drug Administration where such approval is required by Federal regulation.

In the above-referenced warning letter, the FDA states:

“In a letter dated May 23, 2011, FDA notified your facility that the changes and modifications to the originally-cleared GED device require a new premarket notification under 21 CFR 807. 81 (a)(3). As a result, the GED3A and GED4 devices violate the Federal Food, Drug, and Cosmetic Act (Act) because your facility has failed to obtain FDA clearance or approval. Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act, 21 US.C. § 351(f)(1)(B), because your facility does not have an approved application for premarket approval in effect, pursuant to
section 515(a) of the Act, 21 US.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 US. C. § 360j(g). In a letter dated June 29, 2012, FDA again notified, your facility that the GED3A and GED4 devices are adulterated and require the submission of a premarket notification. In responses to the letters dated May 23, 2011, and June 29, 2012, your facility stated that it is planning to make a submission under section 510(k) of the Act, 21 US.C. § 360(k), for changes and modifications to the GE03A and GED4 devices by December 2012. We still have not received any submission from your facility. “

Therefore, consistent with the March 5, 2013 order by the Honorable Gary L. Sharpe, Chief Judge of the U.S. District Court, Northern District of New York, NYSED requires JRC to cease use of the GED-3A and GED-4 devices with NYS stUdents with disabilities not later than 30 days of receipt of this letter. All parties affected by this corrective action have been notified. This notification, which provides 30 days’ notice to JRC, replaces the corrective action letter issued to you on January 15, 2013.

As noted on the FDA website “Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.” (emphasis added) 8 NYCRR §200.22(f)(2)(viii) specifically requires that devices used for aversive interventions be “limited to devices tested for safety and efficacy and approved for such use by the FDA where such approval is required by federal regulation.” Without premarket approval, the devices have not been ‘tested’ and determined to be safe and effective for their intended use or uses. The use of the word “approval” for purposes of the above-referenced regulation was intended to encompass all requirements by FDA regarding such devices, including premarket approvals.

JRC was first notified by the FDA that the above-referenced devices did not have FDA clearance or approval as early as May 2011, yet you chose not to disclose this information to the New York State Education Department (NYSED), despite your direct knowledge since 2006 of New York State (NYS) regulations that specifically require FDA approval or clearance of devices used for aversive conditioning. It is JRC’s responsibility to ensure compliance with applicable NYS laws and regulations relating to the education of NYS’ students with disabilities.

In a letter dated January 18, 2013, Mr. Flammia raises the claim that “treatment with the GED devices is federally mandated by the students’ IEPs.” While the IEPs of the NYS students may indicate use of Level III aversives or a GED device, only one specifies the use of the GED 4 device. Further, while IDEA guarantees a free appropriate public education (FAPE), 34 CFR §300.18 specifically states that FAPE means special education and related services that meet the standards of the State Educational Agency. The standards of this State include the requirement for a prohibition on the use of aversive interventions, except as provided in 8 NYCRR §200.22(e) and that the use of any aversive conditioning device used to administer an electrical shock or other noxious stimuli to a student to modify undesirable behavioral characteristics shall be limited to devices tested for safety and efficacy and approved for use by the FDA. The FDA has publicly posted that the GED3A and 4 do not meet their standards for a determination that they are “safe and effective for its intended use or uses.”

Nothing in Mr. Flammia’s response to the New York State Education Department (NYSED) provides any documentation that the FDA now finds these devices safe for use, even during a transition period. Further, Mr. Flammia states “JRC is currently assessing 2 the time that it would take to revert back to use of the original version of the GED device” … and that the “time that it will take to revert back to the original version of the GED device is being reviewed and is unknown at this time.” Even if a transition period were appropriate, it would be irresponsible and inappropriate for NYSED to authorize JRC to continue to use devices not tested and determined to be safe with NYS students. As I stated in my letter of January 15, 2013 if you have a letter or other documentation indicating that the FDA finds it safe to continue the use of such devices during a transition period or that it has issued premarket approval of such devices, determining them to be “safe and effective for its intended use or uses,” then you should immediately fax that information to me.

In Mr. Flammia’s January 18, 2013 letter, he notifies NYSED that JRC no longer manufactures the FDA-approved GED devices or has such devices in your inventory. (This is information that was not previously disclosed by JRC to NYSED.) Therefore, you must take immediate steps to provide an approved device to implement the students’ IEPs or, until such time as the FDA notifies JRC that such devices have been determined safe for continued use, you must implement an interim alternative behavioral intervention plan with these students that does not include the use of GED 3A or GED 4. We are notifying each of the school districts that their Committees on Special Education must take immediate action to address this issue in the students’ IEPs.

In summary, effective 30 days from receipt of this letter, unless otherwise directed by the court, JRC must cease the use of the GED 3A and GED 4 devices with NYS students until such time as the FDA notifies you that the use of such devices have the required FDA approvals. If you have additional information from the FDA that it has determined that it is safe to use such devices during a transition period, and you would like to discuss this transition plan, please contact my office to arrange a meeting.

The letter was dated March 12, so the 30 day time limit is approaching fast.

I think the New York Department of Education could do much more to support these students through this transition than merely inform their school districts that their IEP’s need to be updated. This is a major change for students with quite extraordinary needs.

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By Matt Carey

Recently I wrote about a letter from a survivor of the Judge Rotenberg Center (JRC). At the time I did not know if I needed permission to publish the letter in full so I linked to the post I found it at, from Autistic Hoya: Judge Rotenberg Center Survivor’s Letter. I’ve since contacted Nancy Weiss and confirmed that the author gave permission for people to post. Below is that letter. It is very difficult to read and could be a trigger.

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The following letter was sent to Nancy Weiss, Director of the National Leadership Consortium on Developmental Disabilities at the University of Delaware on January 11, 2013. Ms. Weiss assured the author that she would protect the writer’s anonymity. Ms. Weiss can pass messages to the author. Ms Weiss can be contacted as below:
Home Office: 443-318-4879
Cell: 410-241-7257
email: nancy-weiss@comcast.net

Dear Ms. Weiss

Hello my name is xxx. I was told you are someone I can talk to in confidence and be safe. I would like to share with you my letter that I wrote to the FDA about life inside JRC and on the GEDs. It was torture being there. And I suffered so much. I am still tormented. Here is my letter of testimony:

My name is xxx and I attended the Judge Rotenberg Center. I am writing to ask you to please reconsider your approval of the GED for use on ANY human being. I was placed on the GED about 2 months after arriving. I started out on the GED-1, and during my last few years I was placed on the GED-4. There are so many of us that were tortured with these devices, this “treatment”. I believe the reason why more ex-students haven’t spoken out is because they are either non-verbal, afraid, or believe that no one cares about us or it will not make a difference. Parents and families that speak and rally in favor of the GED, are not the ones who have to experience it, the pain and anxiety, day after day for years on end.

The GED IS harmful. Even the GED-1. I was burned many times, and I still have scars on my stomach from being repeatedly shocked there, by the FDA approved GED-1. The electrodes had actually burned into my skin. I experienced long term loss of sensation and numbness in my lower left leg, after getting a shock there. I felt searing pain all the way down to the bottom of my foot, and was left with no feeling in my skin from the knee down for about a year. Again, this was with the GED-1. After complaining to JRC nursing about my leg, they told me to tell the Neurologist about it during a follow up visit for a suspected seizure. He asked the staff what that device was on my leg, and they explained to him it was an electrode. After their explanation, the Neurologist said, “Well, I don’t know what that thing is, but it needs to come off.” JRC left the device off my leg for about a year, then decided on their own, without sending me back to a Neurologist, it was ok to put it back. I have seen students with torso electrodes accidentally placed on their spine area, get a shock there and be violently bent backwards.

Also, I would like you to know that the devices have a tendency to malfunction and go off all by themselves. JRC refers to this as a “misapplication”. It happened to me and other students so many times I cannot count. Sometimes the GED’s will just start to go off and shock you by themselves. Other times the staff shock one student but the remote can also set off someone else’s device at the same time. I have also gotten accidentally shocked from staff mixing up my device with another student’s device, shocking me instead. Then there are the times when staff intentionally misuse the GED. I have had a staff who became angry with me and started pushing more than one remote at a time, shocking me several places on my body at once. I have had staff intentionally give me shocks for things I didn’t do in places like the bus where there was no camera to prove it. I have had numerous staff over my years there threaten me with a GED, antagonize me to try and get me to have a behavior they can then shock me for, merely for the sport of it. Staff can and DO use the GED to scare non-verbal students into doing what they want them to by pretending they are about to shock them. Some even laugh when they do this.

Many of the things I and others get shocked for at JRC were very small things. They would often shock us for things simply because staff found them annoying and they would keep writing therapy notes until our psychologist added it to our program. I got shocked for tic like body movements, for which I have no control over, and which don’t hurt me or anybody else. I would be shocked for waving my hand in front of my face for more than 5 seconds, for closing my ears with my fingers, which I do when things get too loud, because I cannot tolerate too much noise. I would be shocked for wrapping my foot around the leg of my chair, for tensing up my body or my fingers, and the list goes on and on. There was a period of time where I and many of the other students were getting shocked for having 5 verbal behaviors in an hour. A verbal behavior is a minor behavior like talking to yourself, noises (such as clearing your throat), or talking without permission. Every hour would start a new block. And if you were pinpointed more than 4 times in that hour, on the 5th you would get a shock, and then for EVERY minor verbal behavior after that you would be shocked. If you talked out a 6th time, shock. If you had to go to the bathroom, and you had to go really bad, but you asked more then once, that would be nagging, which is a verbal behavior. And these were the things we were getting shocked for. My program was this way for a while. Some of my verbal behaviors I got pinpointed for were crying, talking to myself (even quietly), noises, laughing, humming, repeating myself and inappropriate tone of voice (which was based on staff’s opinion of how my voice should sound). Almost every time I spoke or answered a question, I was pinpointed with these behaviors. My reaction was to stop speaking, but they also made part of my program that if I didn’t answer staff in 5 seconds, I would automatically be shocked. I was paralyzed with fear every day. No matter what I did I was doomed. I ask those who read my letter to think to themselves about how often they do some of these things while they are working. Twirl their pens, talk to yourself or think out loud, ask a question to someone nearby, hum a song that’s in your head, laugh at something funny in the room. These are things humans do. And they are not harmful. Yet we were being subjected to terrible pain and fear for doing these simple things. One day, out of the blue, the case managers went through the building and scratched off this punishment from all their students recording sheets. They didn’t say anything to us about it, just made it like it never happened. Although I can’t say for sure, I overheard talk that one of the male students had told his lawyer and family they were shocking him for talking, and that JRC was never supposed to be allowed to do that to us. Whatever the reason, they covered it up fast. And even though they stopped, they still need to be held accountable for all of it. Because it went on for a very long time, and I suffered greatly because of it. People NEED to know these things happened.

There was a time when I was there that I was on the portion program. This is where JRC starves you as a punishment for having a behavior. For example, my first plan was that for every time I had a minor behavior, such as talking to myself, rocking, wiggling my fingers, I would lose a part of my next meal. My meals came to the classroom cut into tiny pieces and divided into portions inside of a little plastic cup. Every time I had one of these little behaviors, I was forced to stand up and throw one cup away. There were many days I would lose most of my meals. And the hungrier I got, the more frantic and restless my body became. This caused me to have more behaviors like tics and rocking, and in turn I would lose more food. My mind clouded and I could no longer concentrate. I would often become so frustrated from this I would end up hurting myself. At the end of the day, at 7pm, I was offered “LOP” (loss of privilege) food. This was made intentionally to be completely unappetizing. It was ice cold, and it was made up of chicken chunks, mash potato, spinach, and then doused with liver powder, then set to sit in the refrigerator for days. The smell alone made me sick. And I never once was able to eat it, no matter how hungry I got.

It was very difficult to sleep at JRC. There are several alarms in the room and over the bed. Every time someone moved in bed it would set a loud alarm off that could be heard throughout the house. Most of us on GED’s had to sleep with the devices on. That means locks and straps that get all tangled around you and make it very hard to lay down in a comfortable way. I was very anxious to close my eyes, always fearing a shock for something I might not have even known I did. My fears came true one day, and I was given a GED-4 shock while I was asleep. It was not explained to me why I got this shock. I was terrified and angry. I was crying. I kept asking why? And they kept telling me “No talking out”. After a few minutes Monitoring called, and told the staff to shock me again for “Loud, repetitive, disruptive talking out.” The next day I asked the supervisor why I had gotten that GED. And she explained that staff had found a small piece of plastic in my self-care box, which contained my shampoo bottles etc, and that they considered this a hidden weapon. I could not believe it. I did not hide anything in my self-care box. I had not done anything wrong. Yet I was shocked for it, and worse off in my sleep. That piece of plastic, of which I was never shown, had probably broken off of one of the plastic containers inside the box. And I was severely punished for this. After this incident I really stopped sleeping. Every time I closed my eyes they would jump open, anticipating that jolt somewhere in my body.

I truly believe that the judges that approve us for the GED have no idea what it really is like. All they have to go on is what JRC claims. The GED does not feel like a “hard pinch” or a “bee sting.” It is a horrible pain that causes your muscles to contract very hard, leaving you sore afterward. I would often have a limp for one or two days after receiving a GED. The devices JRC puts on us are not the same ones they show to the outside world when they let outsiders try the GED. Students wear a different electrode, a long one with 2 metal electrodes that radiate the electricity across a large area.

Besides the physical pain, life with GEDs is a life of constant anxiety. I experienced heart palpitations daily, had a very hard time sleeping and eating, and became rather paranoid, always wondering if I was about to get shocked and constantly alert in all directions. I eventually became very depressed there and contemplated suicide every night. Now, after having been gone almost 4 years, I am still having nightmares and flashbacks during the day, especially when I hear certain noises that remind me of GEDs and JRC.

I want to mention, similar to many other students, I was also tied to the 4-point restraint board and given multiple shocks for a single behavior. And if I screamed out in fear while on the board, I would be shocked for that as well. I was shocked for behaviors I had no control over, such as tensing up and tic-like body movements. We were always having to watch others getting shocked in the room. Hearing others scream, cry, beg to not be shocked. Students would scream “I’m sorry, No, Please!!” all day. I, like other students, would cringe and feel sick and helpless while watching others getting shocked. I was so anxious about getting shocked that I would many times bang my head just to get it over with. The GED often was the cause of my behavior problems. The students that get shocked the most at JRC are non-verbal. So they cannot speak up. I feel that just because we were born different, we are not given the same rights to be protected from tortures like the GED.

We are at the mercy of guardians and judges. When I was brought to court to be approved for the GED, I was not told where we were going or why. I was brought into the courtroom wearing a helmet and restraints on my wrists and ankles. I was not questioned by the judge. All he had to go on was my appearance in those restraints, testimony from JRC officials, and charts of provoked behaviors. These behaviors came from being forced to sit in isolation with a straight upright posture, in the center of a hard restraint board, day after day, week after week, for two months. I received no real help and no socialization. For those two months I was not allowed to sit in a chair, at the classroom or residence. I was to sit on the board. Also, JRC provoked me by not allowing me to shower during those two months. Instead of showers, I was bathed tied to a restraint board, naked, while staff washed me, putting their hands all over me. All in front of cameras, where Monitoring watched, including men. Being tied on a restraint board, naked, with my private areas exposed to the staff in the bathroom and the cameras was the most horrible, vulnerable, frightening experience for me. I would scream out “rape, rape!” And these were recorded as major behaviors for me. When I first arrived at JRC, I was immediately subjected to humiliation and provocation by them forcing me to wear a diaper. I in NO WAY needed or have ever needed a diaper as an adult. I am completely independent in all toilet and hygiene skills. And they knew that. I had NEVER worn a diaper up until that day, except of course when I was a little baby. And that is exactly how they made me feel, like a little baby. I was embarrassed and confused and angry. I took that diaper off constantly. When I would take the diaper off they would mark that down on my chart that they would later show the judge as destructive behavior. I would often get restrained on the 4 point board for taking off the diaper and fighting staff not to make me put it back on. In these ways and more, JRC provoked many behaviors in me that were shown on a chart to the judge. There is no way the judge could know what was provoking my behaviors. JRC told the judges that their program was the only thing that could help me. That theirs is the only last resort treatment.

I was considered a difficult case. I would like you to know that I am doing very well in a new program that is nothing like JRC. I don’t get shocked or put in restraints, and I am given help by staff and doctors that I can talk to. I am not drugged up as JRC claims I would be if I left. JRC made no attempt to understand me. Feelings do not matter to JRC and we were specifically not allowed to express them. I felt like an animal test subject there. My new program does not punish me for my problems, that are the result of having Aspergers Syndrome. I have gotten so much better from getting real help instead of constant punishment and pain.

I ask you to please investigate carefully into the GED. The ones that are actually being used on the students, not the samples JRC provides, as I have experienced them to be extremely manipulative in all things. There are no doctors overseeing us with the GED. Every few years they would drive me to a doctors office near Framingham, Ma, and not tell me why. In his office he would literally walk in, say hi how are you, and before you can answer he has signed their papers and you are shown the door.

I have attached with this email a document I wrote called “The Board” which is about one of JRC’s worst tortures that they used on me and others. I wrote it so that outsiders can feel what we feel, and hopefully to help others understand the agony of GED treatment. I invite you to read it, and I hope it will share a new perspective for you, the perspective of the ones that should matter the most, the human beings on which these devices are being used.

Sincerely,
xxx
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The Board
By: xxx
December 2012

The most sickening, horrifying experience of my life was being shocked on the restraint board. What is the board? It is a large, door sized contraption made out of hard plastic, with locking restraint cuffs on each corner where your wrists and ankles get locked in. Your body becomes stretched spread eagle style, pinned tight, rendering you completely helpless, combined with an overwhelming feeling of vulnerability. It is a torture that you would expect to see in a horror movie. The kind that makes you cringe and scream while you watch. The kind you cant get out of your head even a after it’s over. Only this was happening for real, to me.

They added the restraint board, which for me was 5 shocks over 10 minutes to my program after a few months, which means getting shocked 5 different times, over a period of 10 minutes for having just one single behavior. If you have just one of those behaviors on your sheet, which can be getting out of your seat without permission (even without doing anything violent), tensing your body, anything they decide to put in your program. A behavior is anything you do that JRC considers a problem. Anything from hitting your head, to talking to yourself, saying a swear word, rocking, even screaming from fear and pain of the shocks, is a “behavior”. The staff grab you, put you in restraints, walk or drag you to where the board is kept (usually right in the middle of the classroom with all the other students watching and stepping around you), and thanrestrain you to the board. Arms and legs locked in. Then the terror starts. You have to wait for it. You never know when it’s coming. The staff shocking you usually hides behind a door or desk so you can not see them. JRC lavishes in the element of surprise when shocking us. Then all of a sudden the searing pain and jolt in your arm or leg or stomach, or sometimes even the fingertips or thigh or even bottom of your feet. Whichever part of the body gets shocked, it will travel throughout. If you get shocked in your arm, for example, it is not a “hard pinch” it is a radiating electricity that will travel from your bicep through to your fingertips. Your whole arm jerks against the restraints, causing added pain from your muscles being forced to contract against being tied up. The loud screech of the device goes off with it, and they say, “(name) there is no tensing up”. One down, 4 to go. Your heart races immediately, and you sweat profusely. All you want to do is throw up. That ten minutes feels like hours. You try to prepare yourself for the next shock. I keep saying in my head, 4 more, 4 more. Please just finish please. Trying not to scream in fear because i will be shocked for that as well. It comes again without warning, next time maybe in your stomach, the stabbing pain runs from left to right, right to left, across your belly button area. Your stomach heaves in and you lose your breath. More sweat now. Your heart beats faster now than you can feel possible. I start to hope my heart stops. Anything to let me away from this.3 more. But now it’s even harder, I don’t feel I can take any more of this torture. Besides the pain, it’s the panic and fear in your mind. There were times when I peed on myself. One particular time I was put on the board for hitting my head the night before. They said because the staff did not “follow my program”. They put me on the board. They shocked me repeatedly in the stomach. And when they finally got to 5, I thought “it’s over”. But then they didn’t take me off the board. They gave me a 6th, than 7th, than 8th. They kept going. I was so filled with fear, not knowing what was happening or when they would ever stop. I went away in my head. I started floating. I had no more tears left. When they finally stopped after 10, they sent other staff in to “change my batteries”. When they lifted the electrodes off of my stomach, it was stuck. They had to pull because it had burned into my skin. I still have those scars on my stomach. When they took the devices off of me to test them, I was still strapped to the board. Every time I heard the noise from the test, I cried and panicked. The staff attempted to comfort me, she whispered to me so they wouldn’t hear her, because any kind of comforting is never allowed. I was shocked on the board on many separate occasions. One time for something I never even did.

I lived this. These things happened. These things were done to me and I witnessed them done to many others.

Bullying is a major issue. This is especially true among the disabled. A recent study focused on bullying within the school aged autistic population, and I discussed that at the Autism Science Foundation blog. Another study has just come out recently in School Psychology Quarterly, National prevalence rates of bully victimization among students with disabilities in the United States. I hope to obtain the full paper and review the methods, but for now here is the abstract:

This study examined the prevalence rates of bully victimization and risk for repeated victimization among students with disabilities using the Special Education Elementary Longitudinal Study and the National Longitudinal Transition Study-2 longitudinal datasets. Results revealed that a prevalence rate ranging from 24.5% in elementary school to 34.1% in middle school. This is one to one and a half times the national average for students without disabilities. The rate of bully victimization was highest for students with emotional disturbance across school levels. Findings from this study also indicated that students with disabilities who were bullied once were at high risk of being bullied repeatedly. Elementary and middle school students with autism and high school students with orthopedic impairments were at the greatest risk of experiencing repeated victimization. Implications of the findings are discussed. (PsycINFO Database Record (c) 2013 APA, all rights reserved)

Students with disabilities are victims of bullying as much as 1.5 times more often than their non-disabled peers. The authors also found Elementary and middle school students with autism and high school students with orthopedic impairments were at the greatest risk of experiencing repeated victimization.

The fact that the disabled are victims of bullying at a high rate is not surprising. The fact that this includes autistics is not surprising. It is valuable, though, to get this documented. It does beg the question of what will happen to change this?

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By Matt Carey