July 9, 2015: Director Crookes tells two advocates JRC still shocks clients with FDA-uncleared devices
The Judge Rotenberg Center (JRC) uses painful electric skin shock devices to control the behaviors of its disabled clients. It is the only facility in the country where shocking of students is allowed (Gonnerman, 2007, p. 1). It "was established by Matthew Israel in 1971, as the Behavior Research Institute (BRI) (Davies, 2014)." It is located about fifteen miles south of Boston in Canton, Massachusetts, which is a New England state in the northeastern-most portion of the United States.
"In 2010, Disability Rights International submitted an urgent appeal to the United Nations, which presented evidence that the use of shock devices at JRC constitutes nothing less than torture. Two subsequent UN Special Rapporteurs on Torture agreed with us that the abuses rise to the level of torture under international law, and both have asked the United States State Department to investigate JRC. This request was forwarded to the Justice Department and an investigation is ongoing." Transcript of Proceedings, p. 166, Neurological Devices Panel (U. S. Food and Drug Administration, filed April 24, 2014), FDA.gov
"Paradoxically, the devices that are actually being used are ones that have not been cleared or approved" by the U.S. Food and Drug Administration (FDA). Transcript of Proceedings, p. 169 (2014)
If some of their "students" get out of their seats without raising their hands and asking for permission, the "educators" press the remote control buttons and deliver the jolt. Transcript of Proceedings, pp. 144-145, (2014)
Shocks have been used at JRC for an incredibly wide variety of behaviors. Although JRC claims that the intention is to stop self-harming or violent behaviors, it also has shocked students for many other things, including: involuntary body movements, waving hands, blocking out sound overstimulation by putting their fingers in their ears, wrapping their foot around the leg of their chair, tensing up their body or fingers, not answering staff quickly enough (xxx), screaming while being shocked, closing their eyes for more than 15 seconds, reacting in fear to other students being shocked, standing up, asking to use the bathroom, raising their hand (Miller), popping their own pimple, leaving a supervised area without asking, swearing, saying “no” (Ahern and Rosenthal 13), stopping work for more than 10 seconds, interrupting others, nagging, whispering, slouching, tearing up paper, and attempting to remove electrodes from their skin (Ahern and Rosenthal 20-21). Additionally, students are shocked for having 5 verbal behaviors in an hour. These behaviors can include talking to oneself, clearing one’s throat, crying, laughing, humming, repeating oneself, or “inappropriate tone of voice” (xxx). A former JRC teacher recalled how “one girl, who was blind, deaf, and non-verbal was moaning and rocking. Her moaning was like a cry. The staff shocked her for moaning. Turned out she had a broken tooth. Another child had an accident in the bathroom and was shocked” (Ahern and Rosenthal 3). The behaviors that JRC considers punishable by shocking are also discovered by surveillance footage, with shocks then administered after the fact. Shock has even been used as a threat to pressure students to say positive things about JRC in front of the state legislature (Berrington). Non-speaking students tend to be subjected to shock the most, and are the ones who often have a more difficult time speaking up about their abuse (xxx). (Davies, 2014)"Employees shocked him for aggressive behavior, he says, but also for minor misdeeds, like yelling or cursing. Each shock lasts two seconds. 'It hurts like hell,' Rob says. (The school's staff claim it is no more painful than a bee sting; when I tried the shock, it felt like a horde of wasps attacking me all at once. Two seconds never felt so long.) On several occasions, Rob was tied face-down to a four-point restraint board and shocked over and over again by a person he couldn't see. The constant threat of being zapped did persuade him to act less aggressively, but at a high cost. 'I thought of killing myself a few times,' he says." Gonnerman (2007. p. 1)
Lydia Brown (2014) said, "(GED-4 has) a shock more than fifteen times as powerful as the stun belts designed to incapacitate violent adult prisoners." See the math figures in Brown's Comments Submitted to the Neurological Devices Panel, p. 6, (Docket No. FDA-2014-N-0238 (2014), Regulations.gov
The JRC had substantially stepped up the old, FDA-cleared, GED-1 voltage level to the newer GED-4 intensity. GED stands for Graduated Electronic Decelerator: noxious, aversive skin shock devices that decelerate the frequency of occurrence rates of unwanted behaviors contingent upon the presentation of the electric stimuli. Two-second surges of electrons pass into the skin of autistics and others with disabilities through electrodes connected to their "legs, arms, soles of their feet, fingertips, and torsos." They wear the devices in packs on their backs. "Some students receive dozens of electric shocks per day." Transcript of Proceedings, pp. 14, 23-29, 96, 165, 166 (2014)
"The dog training collar: two to four for peak current.... Four milliamperes for the typical electric fence. The SIBIS would be peak current of 10 mA.... The GED is about three to four times the strength of SIBIS, and the GED-4 is about three times the strength of the GED-1.... The GED-3A, again, is 15 mA and the GED-4 is 41 mA 90 mA for peak current." Transcript of Proceedings, p. 114, 169-170 (2014)
The only ESD's in use at JRC are the GED-4 and the GED-3A. The previous device, GED-1, delivered less current than GED-4. JRC used Self-Injurious Behavior Inhibiting System (SIBIS), before they developed their own GEDs (Israel, von Heyn, Connolly, and Marsh, [ca. 1992]). SIBIS delivered less current than the GED-1. The SIBIS was a technological advance by Applied Behavior Analysts they modelled after a crude device developed the parents of a self-injurious autistic girl.
In reverse chronological order,
The Grant family's crude pre-SIBIS device.
The forerunner of SIBIS was conceived following futile attempts by Leslie and Moosa Grant to obtain effective treatment for their autistic daughter's severe self-injurious face and head hitting, which had produced lacerations to the bone and almost severed an ear. In medical parlance, the Grants went "shopping," requesting assistance from one professional after another, only to meet with eventual failure. After years of exposure to ineffective treatment, the Grants became well versed in behavior modification and learned that contingent electric shock was an effective means for eliminating otherwise untreatable self-injury. The Grants built a shock device, equipped with an accelerometer to activate the stimulus. The device was quite cumbersome, but it served its purpose by rapidly eliminating their daughter's self-injurious behavior. Justifiably, the Grants wondered why they had subjected their daughter to repeated failure using other approaches, and why devices such as the one they had built were not more readily available. Thus began their search for someone to build a better device for their daughter and for others similarly affected. Eventually they approached the Johns Hopkins Applied Physics Laboratory (APL). Designed as a research institution specializing in the transfer of space technology, APL inventors have produced devices such as the cardiac pacemaker and the implantable infusion pump. APL engineers were moved by the Grants' plight and agreed to build a prototype. In fact, they considered the problem only a minor technological challenge, which apparently it was, but they did not nor could they consider the behavioral side of the technology. Realizing in 1982 that the development of SIBIS posed a number of questions about apparatus-behavior interactions, APL asked Tom Linscheid, then on the medical faculty at Georgetown University, to serve as an unpaid consultant to advise on matters of behavioral technology. Tom had previously conducted clinical research on the use of contingent electrical stimulation as a treatment for life-threatening infant rumination. He subsequently invited my colleagues, Gary Pace and Michael Cataldo, and me to join him; and I eventually provided unpaid technical consultation from the Kennedy-Hopkins program. From the beginning we considered a number of questions about the ramifications of our involvement. Iwata (1988, p. 153)The SIBIS outside JRC. Brian Iwata (1988, p. 153) said, "(The) existence (of the SIBIS) was partially a product of my behavior. My association with the SIBIS project has been in the area of technology development."
He and other scientists reported that they employed SIBIS upon the Self-Injurious Behavior (SIB) of five females and males aged 11 to 24. They said, "In each case, the behavior was forceful contact with the head or face, and treatment consisted of mild and brief contingent electrical stimulation, delivered automatically or by a therapist via (SIBIS) (Linscheid et al., 1990, p. 53)." Within the report they concluded that SIBIS worked better than the hockey helmet which had been used unsuccessfully by other institutions hoping to protect the head and face of Johnny, an eleven year old autistic head-hitting boy, also diagnosed with an intellectual disability (1990, p. 63). Iwata also advocated an "apolitical" promotion of his shock device. Sometimes ABA practitioners treat SIB and exhaust all the alternatives to punishment they know how to use, he argued. The only options remaining, he said, were "restraint, sedating drugs, or aversive contingencies." Without explaining why, he ruled out restraint and sedation as too "devastating." However, as this blogger has reported from first-hand experience, major anti-psychotic tranquilizers aren't as bad as Iwata and JRC have made them out to be, especially compared to the nauseating shock he once felt as a young boy. Nevertheless, the professor from Florida continued, "The only remaining ethical action" was to punish SIB (Iwata, 1988, pp. 152, 53, 56), even with the SIBIS. So his response to children who hurt themselves was to continue hurting them until and unless they stopped doing it by themselves. He neglected to mention a much more humane solution, response blocking. A heavily padded, blow-blocking helmet and a soft pair of mittens would have solved the problem much more easily than SIBIS, but neither he nor his colleagues explored this common sense idea in Iwata (1988) or in Linscheid et al. (1990). What were they thinking when they invented their automatic head-blow-detecting, electroshock machine instead of designing a decent helmet? (Dave Jersey, 2015)JRC's punishments before shock. "Early on, punishments – known as aversives – were used to control the behavior of people who were called severely ―mentally retarded and children with autism. Punishments included pinching, spatula spankings, water sprays, muscle squeezes, forced inhalation of ammonia and helmets which battered the brain with inescapable white noise." Ahern and Rosenthal (2010, p. 8)
The SIBIS at JRC.
In the late 1980s, JRC began using SIBIS (Self-Injurious Behavior Inhibiting System) machines on students, as an alternative to spanking, squeezing and pinching. The machine, developed in 1985, produced a 0.2 second shock of 2.02 milliamps on the arms or legs of the recipient, with the intention of stopping self-injurious behaviors in children with autism and other developmental disabilities.... Over the years, JRC has found that an individual who responds to low levels of electricity may become ―adapted to pain and ―needs a stronger stimulation. The 12 year old nephew of Massachusetts State Representative Jeffrey Sanchez was diagnosed with autism and was a student at JRC in 1989 when JRC began using the SIBIS machine. As described in testimony before the Massachusetts legislature, 27 one day he received more than 5,000 shocks to stop his behaviors – to no avail. Ahern and Rosenthal (2010, p. 8)The JRC's GED's.
When the manufacturer of SIBIS refused JRC‘s request to provide them with a stronger and more painful shock machine, JRC developed its own mechanism for administering shock, the Graduated Electronic Decelerator (GED). The GED is a remotely controlled device that can be strapped to an individual‘s back or another part of the body with electrodes attached to the torso, arms, legs, hands and feet. The GED administers 15.5 milliamps of electricity. A stronger version, the GED-4, subjects an individual to a shock of 45.5 milliamps. Both may be used up to 2.0 seconds. The director of JRC, Matthew Israel, describes the shock as ―very painful. Sanchez‘s nephew is now 31 years old and remains at JRC. According to testimony before the Massachusetts Legislature in November 2009, he is still tethered to the GED shock machine. Ahern and Rosenthal (2010, p. 8)JRC's shock/restraint combination.
JRC also uses physical restraints as a form of aversive treatment, sometimes simultaneously with electric shock. The GED and restraints are sometimes combined because it is necessary to stop a person from ripping the GED pack off his or her body. Other times, physical restraints may be added to the use of the GED when the aversive power of electricity alone is not sufficient. As described on the JRC website, ―[T]he safest way to do this is to use mechanical restraint to contain the student, in a prone position, on a flexible plastic restraint platform that has been specially designed for the purpose. It is worth noting that, outside JRC, the use of any ―prone (face down) restraints are widely considered to be inherently dangerous, and many states have banned any form of prone restraints in the mental health context. Ahern and Rosenthal (2010, pp. 8-9)
The FDA has a substantial history with JRC. The U.S. Presidential agency is still deliberating on its potential Executive Branch ban on ESDs.
1994. "The GED device was cleared in 1994 (by the FDA) through a 510(k) clearance." Crookes, Transcript of Proceedings, p. 95 (2014)
2000. "In 2000, FDA showed up at JRC for an unannounced inspection and determined at that time, while the 3A device and the 4 device were in service and in use at the time, that it was no longer -- the 510(k) process no longer was required, that this device was under the exemption, the medical device exemption." Crookes, Transcript of Proceedings, p. 95 (2014)
May, 2011. FDA instructs JRC how to process GED 3A and 4 for FDA approval. "In 2011, however, FDA abruptly changed their position. They came to JRC again, 11 years later issued an untitled letter." Crookes, Transcript of Proceedings, p. 95 (2014) ... "In a letter dated May 23, 2011, FDA notified your facility that the changes and modifications to the originally-cleared (GED-1) require a new premarket notification under 21 CFR 807.81 (a)(3)." Warning Letter from New England FDA District Director Shamsi to JRC Director Crookes (December 6, 2012)
May, 2011-October, 2012. JRC does not comply with FDA directive regarding the required procedure to gain approval for the GED-3A and 4. See next two paragraphs.
October, 2012. FDA New England inspects JRC property, finds unapproved, improperly processed GED devices. "On October 3, 2012, through October 17, 2012, an investigator from the (FDA) inspected your (Canton) facility.... As a result of this inspection, we observed the Graduated Electronic Decelerator (GED-3A and GED-4) devices at your facility." Warning Letter from Shamsi to Crookes (December 6, 2012)
December, 2012. FDA warns Crookes of JRC violations. "...and in 2012 a warning letter stating that a new 510(k) notice for the GED devices was now required." Crookes, Transcript of Proceedings, p. 95-96 (2014) ... "As a result, the (3A and 4) violate the Federal Food, Drug, and Cosmetic Act because your facility has failed to obtain FDA clearance for approval.... Failure to promptly correct these violations may result in regulatory action being initiated by the FDA.... These actions include, but are not limited to, seizure, injunction, and civil money penalties." Warning Letter from Shamsi to Crookes (December 6, 2012)
December, 2012 - April, 2014. JRC cooperates with JRC. "We have been working with them since that time on submitting a new 510(k). However, upon their request, we submitted a pre-submission to the 510(k). A bit over a year ago we submitted the pre-submission. We scheduled a meeting with them to discuss the pre-submission and had not heard from them until two weeks ago regarding this meeting." Crookes, Transcript of Proceedings, pp. 95-96 (2014)
April, 2014. FDA announces its potential FDA ban. "Based on a comprehensive review of all available data and information, the FDA is concerned that ESDs...may present a substantial and unreasonable risk of illness or injury. Therefore, FDA is considering banning these devices under Section 516 of the Food, Drug and Cosmetic Act.... The ban that FDA is considering would apply to all ESDs for aversive conditioning, whether or not they are currently cleared by the FDA." Transcript of Proceedings, p. 19 (2014)
April, 2014. FDA convenes advisory panel on its potential GED ban. The investigation eventually led to an all-day, open-public, FDA advisory hearing in Gaithersburg, Maryland. The Neurological Devices Panel met to "discuss current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics." The purpose of the meeting was "to obtain scientific and clinical expert opinion on: the risks and benefits associated with other treatment options for this population; the risks and benefits of ESDs for aversive conditioning to modify undesirable behavioral characteristics in patients who exhibit SIB and aggressive behavior; whether ESDs for aversive conditioning present a substantial unreasonable risk of illness and injury; potential approaches to risk mitigation; the risks and benefits of applying the ban to devices currently in use by patients; and whether a clinical trial could be conducted to evaluate ESDs for aversive conditioning for the treatment of SIB and aggressive behavior." Transcript of Proceedings, p. 10, 19 (April 24, 2014)
April, 2014. FDA panel majority decides ESD's are potentially too harmful. The FDA had directed the panel to answer a set of questions. Question 3 was: "Considering the adequacy and availability of alternatives to treat patients exhibiting SIB and aggressive behavior, as well as the benefits ESDs may provide for these patients, please discuss whether ESDs intended to administer a noxious electrical stimulus for the treatment of SIB and aggressive behavior present a substantial and unreasonable risk of illness or injury.... So to restate, the question here is does the available evidence show that this presents a substantial and unreasonable risk of illness or injury?"... Transcript of Proceedings, pp. 313-314 (2014) ... Carlos Peña is the FDA Director, Division of Neurological and Physical Medicine Devices, Office of Device Evaluation. Officially, he was representing the FDA at the Devices Panel meeting. Toward the 6 p.m. closing time, Panel Chair Linda J. Yang concluded, "So, Dr. Peña, in answer to Question 3, 60% say yes, that there is an unreasonable and substantial risk of illness and injury, and 40% say no -- and I'm going to lump this in there together -- no or not enough data. It's hard to separate those apart." Transcript of Proceedings, pp. 2, 329 (2014)
April, 2014. Panelist Iwata, past president of the Association for Behavior Analysis International, votes against the majority of the panel on Question 3 and says the entire class of ESDs is not potentially too harmful.
My problem is separating the class from the device and the device from where it's being manufactured and used. My understanding is FDA is basically focusing on the class and not on a device or where it's being used. And if one examines electrical stimulation, I can imagine an electrical stimulus that is not painful; it might be annoying. So, for example, you walk across the carpet, you put your finger on the stereo, that is an electrical stimulation. That's annoying. It's annoying enough for me to not want to do that again. And that deters a lot of my behavior. On the other hand, we've got the GED-4, which I have not experienced and I hope I never do. If we were to look at other classes of devices such as, for example, visual stimulation, one would ask is it harmful to shine a laser in someone's eyes to deter them from engaging in behavior, and I'm sure everyone would agree, yes. But then what would happen if we ask, well, what if we shined a flashlight in their eye briefly? I'm not so sure about that. So I think it's entirely dependent upon the parameters of the class of devices, and I can envision parameters that really would not be viewed as noxious or painful by many people. So speaking about the class, I would have to say no. Transcript of Proceedings, pp. 327-328 (2014)June, 2015. Advocates continue lobbying the FDA in pursuit of the shock ban. Led by the Autistic Self-Advocacy Network, sixty-nine advocacy organizations sign onto a letter to FDA Commissioner Stephen Ostroff. They said, "We note that the FDA has refrained from making any final determination as to the status of these devices since last year’s hearing.... We remain concerned for the welfare of those currently receiving contingent electric shock while a ruling remains pending. These individuals spend every day wired to electric shock devices, unsure when they may next be shocked against their will." Letter from Advocacy Groups to FDA Commissioner, Dr. Stephen Ostroff, AutisticAdvocacy.org (June 6, 2015)
July 9, 2015. Jacob Persico, Disabled Peer Advocate from Rhode Island, and Jay M. Rosenthal, Advocate and Direct Care Staff member at Andrus Children's Center in New York, met with Glenda Crookes at the JRC school building in Massachusetts. She told them that they haven't stopped using the 3A and 4. (Personal communications by the two advocates to Dave Jersey, Reward and Consent blogger, soon after July 9, 2015)
July 14, 2015. Upon hearing the news from Persico and Rosenthal, Dave Jersey telephoned the FDA to tell them that JRC keeps using the latest-model GEDs. An FDA representative returned his call, and, also upon hearing the news, which JRC has nevertheless never denied, told him that the FDA would appreciate some more public input regarding JRC's continued use of the unapproved electroshock devices. The official provided Jersey with the New England District Complaint Line, (800) 891-8295, so that he may publish it on his blog, and then suggested to him that the advocates can tell the FDA Compliant Line operator how they feel about shock. Jersey asked, "If the New England District were to receive as many as a hundred phone calls, would that be too intrusive for the office?" The answer was negative. He was advised by the party on the line that the advocates may also state their views to Karen Archdeacon, a New England District Compliance Officer, whose name appeared within the body of the Warning Letter to Crookes (2012), by calling Archdeacon in New England at (781) 587-7491. Dave Jersey was also informed that the FDA's Center for Devices and Radiological Health, also known as the Medical Devices Center, will be making the ultimate ban-or-no-ban decision. Their contact information can be found here. Personal communication (July 14, 2015)