July 25, 2016
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.
Comments of members of the Patient, Consumer, and Public Health Coalition on
Proposed Rule To Ban Electrical Stimulation Devices Used To
Treat Self-Injurious or Aggressive Behavior
[Docket No. FDA-2016-N-1111]
Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to ban electrical stimulation devices (ESDs)* used to treat self-injurious behavior (SIB) or aggressive behavior (AB). ESD treatments are ineffective and have serious side effects, and there are alternative, less stressful treatments available.
The goal of ESDs is to reduce self-injurious or aggressive behavior by punishing it with shocks. However, the strategy of preventing violent behavior in any situation by using a painful punishment is rejected by most experts. That is why the overwhelming majority of SIB and AB patients are not treated with ESDs. Only one facility in the U.S. manufactures and uses ESDs, the Judge Rotenberg Educational Center, Inc. (JRC). Even if ESDs were a safe, effective, and humane treatment, those used by JRC as recently as 2012 had not been cleared by the FDA. FDA has sent warning letters to the Center at least three times stating that the devices are in violation of FDA regulations because they have been modified to increase the voltage they provide but a new application has not been filed with the FDA.[i], [ii]
Because of advances in human rights and behavioral therapy, nearly half of the States prohibit the use of ESDs.[iii] The United Nations has said use of ESDs, such as those used by the Rotenberg Center, constitutes a violation of the UN Convention Against Torture, and would not be legal if used even against convicted terrorists.[iv], [v]
ESDs have a long list of harms including “depression, PTSD, anxiety, fear, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness, as well as the physical risks of pain, and skin burns.”3 The devices are associated with an increased risk of “suicidality, chronic stress, neuropathy, and injuries from falling.”3 They are associated with “nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and withdrawal from usual activity.”3
We agree with the FDA that adverse events are likely to be under-reported because the children and adults subjected to ESD often have problems that make it difficult to persuasively communicate to anyone who would be likely to report adverse events to the FDA. In addition, the individuals administering ESDs are unlikely to be taught or encouraged by their employer (who requires them to administer ESDs) to report adverse events resulting from ESD “treatment.”
Although the scientific literature reports that ESD shocks can immediately interrupt SIB or AB, these studies have been criticized for “weak study design, failure to control for concomitant treatments, small size, lack of peer review, and conflicts of interest.”3 We agree with the FDA that “the evidence is inadequate to establish that ESDs improve individuals’ underlying conditions or…reduce or cease the target behavior to achieve durable long-term reduction of the target behavior.” The established risks are even more unacceptable given the lack of evidence of benefits.
There is clear research evidence that positive reinforcement is more effective and longer-lasting than negative reinforcement (punishment). We agree with the FDA that positive-based behavioral approaches are effective at reducing self-injurious and aggressive behavior, providing greater benefits and less risk than ESDs. We also agree with the FDA that “addressing the underlying causes of SIB and AB…rather than suppressing behaviors with shocks not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits.”
ESDs are not established to be effective for most self-injurious or aggressive behaviors and represent a substantial and unreasonable risk of injury. They are also inhumane. For the above reasons, we strongly support the ban on electrical stimulation devices.
American Medical Women’s Association
MRSA Survivors Network
National Center for Health Research
National Physicians Alliance
Washington Advocates for Patient Safety
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or email@example.com
*We are aware that ESDs are not used in electroconvulsive therapy (ECT or electroshock therapy) and that this proposed rule does not apply to ECT devices.
[i] Willingham E (April 22, 2016). FDA Proposes Ban On Electric Shock Devices Used On Autistic Children. Forbes. http://www.forbes.com/sites/emilywillingham/2016/04/22/fda-seeks-to-ban-electric-shock-devices/#7e7c39e87ead
[ii] Food and Drug Administration (December 6, 2012). Inspections, Compliance, Enforcement, and Criminal Investigations: Warning Letter CMS#367480, the Judge Rotenberg Educational Center. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331291.htm
[iii] Federal Register (April 25, 2016). Food and Drug Administration: Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule. [Docket No. FDA-2016-N-1111] https://www.federalregister.gov/articles/2016/04/25/2016-09433/banned-devices-proposal-to-ban-electrical-stimulation-devices-used-to-treat-self-injurious-or
[iv] Ahem, L (October 2, 2010). Disabled children at Mass. School are tortured, not treated. The Washington Post. http://www.washingtonpost.com/wp-dyn/content/article/2010/09/17/AR2010091705376.html
[v] Burkholder A (August 5, 2014). Controversy over shocking people with autism, behavioral disorders. CBS News. http://www.cbsnews.com/news/controversy-over-shocking-people-with-autism-behavioral-disorders/