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  I am including the Comments form The National Disability Rights Network on the safety and effectiveness of electroshock devices as a supposed "treatment" for autism and other developmental disabilities.  Please submit a comment if you have experience with this awful practice.

April 14, 2014  


Avena Russell
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Rm. 1535
Silver Spring MD 20993-0002

Re: Written Testimony for Neurological Devices Panel of the FDA Medical Devices Advisory Committee, Docket No. FDA-2014-N-0238, Schedule for public meeting on April 24, 2014 

Dear Ms. Russell,

The National Disability Rights Network (NDRN) appreciates having the opportunity to comment in advance of the Neurological Devices Panel of the Medical Devices Advisory Committee meeting later this month to examine the safety and effectiveness of aversive conditioning devices that use a noxious electrical stimulus.  

NDRN is the national membership association for the Protection & Advocacy (P&A) agencies / Client Assistance Programs (CAP) that provide legally-based advocacy services to persons with disabilities in every state, the District of Columbia, and U.S. territories. NDRN promotes a society where people with disabilities have equality of opportunity and are able to participate fully in community life by exercising informed choice and self-determination. For over 30 years, the P&A / CAP Network has been mandated by Congress, to protect the civil rights of individuals with disabilities of any age and in any setting including schools and other types of programs providing education services and supports.  

In January 2009, NDRN documented the horrific abuses of students in our report "School is Not Supposed to Hurt: Investigative Report on Abusive Restraint and Seclusion in Schools”  (http://ndrn.org/sr/SR-Report.pdf). In two subsequent reports, and through the Protection and Advocacy agencies, NDRN continues to hear of stories across the country where children have been injured and in some cases killed as a result of restraint, seclusion and aversive interventions. 

NDRN believes the FDA should ban the use of aversive conditioning devices that are intended to administer noxious electrical stimuli to the body to modify behavior.  

Based on the available research, and the work of the P&A / CAP Network with individuals with all types of disabilities, NDRN believes that the devices are both unsafe and ineffective in meeting their intended purpose. NDRN’s position is supported by the federal government, and other non-governmental organizations, as well as the professional academic literature. From a national perspective, it is important to note the substantial evidence, that is available that shows that evidence-based positive alternatives to behavior modification, such as the use of positive behavioral interventions and supports are safe, and effective for use with students with the most significant behavioral needs.

 Furthermore, NDRN fully supports the testimony submitted by the designated Protection and Advocacy agency in the state of Massachusetts, Disability Law Center, Inc. (DLC). DLC has directly worked with individuals who have been exposed to aversive behavioral interventions, such as the aversive conditioning device used by the Judge Rotenberg Center (JRC) in Massachusetts. DLC’s testimony submitted in response to the same federal register notice clearly articulates the safety issues based on the pain inflicted by the device, the misfirings of the device, and the long-term traumatic effects.  

The only school known to use an aversive conditioning device that delivers a noxious electrical stimulus, is the device called the Graduated Electronic Decelerator (GED) used with students at the Judge Rotenberg Center (JRC) in Massachusetts. While NDRN recognizes that the focus of the FDA is on all devices, it is important to note that JRC is the only known entity known to use such a device. As stated in DLC’s testimony, the device was both developed by and is manufactured by JRC.[1] As discussed in the written testimony of DLC, at any given time, residents may be wearing up to five GEDs simultaneously, so JRC residents are unaware of when, where, why and how many times they will be shocked. Furthermore, the GED has undergone many changes, and the current device used at JRC is unapproved despite JRC representing the GED was approved and warnings from the FDA to seek either clearance or approval of the devices. 

As a national organization whose members provide legally-based advocacy services to persons with disabilities across the United States, NDRN believes it is critical that the Panel both review the expertise of medical and industry professionals on safety and effectiveness but also take into account the lived experience of students who have been subjected to the use of aversive conditioning devices, such as the GED, and the experience of former teachers who have administered the electric stimuli. DLC’s testimony chronicles the physical harm to one student:

 

…the burns and scars from being repeatedly shocked on her stomach. Electrodes had actually burned into her skin, and she experienced long-term loss of sensation, and numbness in the lower left leg after being shocked there. She describes feeling “searing pain all the way down to the bottom of her foot” and how she was “left with no feeling in her skin from the knee down for a year.” When electrodes were accidentally placed on students’ spines, she witnessed others being violently bent backwards.”

 

Also, the Panel should take into serious account the video shown in the courtroom of Andre McCollins, a JRC resident from New York who was shocked 31 times, using the weaker GED, for failure to take off his coat. The video is available at http://www.myfoxboston.com/story/17409093/graphic-video-of-teen-being-restrained-shocked-played-in-court. As the video clearly demonstrates, the use of restraints and the aversive


[1] BRI News, Winter 1991, Behavioral Research Institute, RI. (Note: The Behavioral Research Institute (BRI) changed its name to the Judge Rotenberg Center (“JRC”) in 1994.  JRC is designated by the FDA as the manufacturer of the GED.  See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=147131&lpcd=HCB.  JRC/BRI refers to itself as the manufacturer of the GED. See “A Comparison of Long Term Decelerative Effects”, JRC Pub. No. 93-2, available at http://www.effectivetreatment.org/comp.html, noting (at p. 3) that it manufactured 100 GED units from 12/90 and 3/93.  DLC maintains that JRC engages in interstate commerce through the manufacturing process, and through the movement of students across interstate lines to attend JRC, and the use of the GED across state lines, when students are off-site.  See Barnes v. U.S., 142 F. 2d 648, 651 (9th Cir. 1944) (“Commerce so used in the statute is not confined in meaning to the actual transportation of articles across state lines, but includes the whole transaction of which such transporting is a part.”) (citations omitted).  JRC previously maintained that it was exempt from FDA jurisdiction as engaging in the “practice of medicine,” it is no longer asserting this argument or contesting FDA jurisdiction.

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