[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Proposed Rules]
[Pages 24385-24418]
[FR Doc No: 2016-09433]

Vol. 81

Monday,

No. 79

April 25, 2016

Part VI

Department of Health and Human Services

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 Food and Drug Administration

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21 CFR Parts 882 and 895

Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To
Treat Self-Injurious or Aggressive Behavior; Proposed Rule

Federal Register / Vol. 81 , No. 79 / Monday, April 25, 2016 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 895

[Docket No. FDA-2016-N-1111]

Banned Devices; Proposal To Ban Electrical Stimulation Devices
Used To Treat Self-Injurious or Aggressive Behavior

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
ban electrical stimulation devices used to treat aggressive or self-
injurious behavior. FDA has determined that these devices present an
unreasonable and substantial risk of illness or injury that cannot be
corrected or eliminated by labeling. FDA is proposing to include in
this ban both new devices and devices already in distribution and use.

DATES: Submit either electronic or written comments on the proposed
rule by May 25, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-1111 for ``Proposal to Ban Electrical Stimulation Devices
Used To Treat Self-Injurious or Aggressive Behavior.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Proposed Rule

    FDA is proposing to ban electrical stimulation devices (ESDs) used
for self-injurious or aggressive behavior. ESDs are devices that apply
a noxious electrical stimulus to a person's skin upon the occurrence of
a target behavior in an attempt to condition the individual over time
to reduce or cease the behavior. Self-injurious behaviors (SIB) and
aggressive behaviors (AB) frequently manifest in the same individual,
and people with intellectual or developmental disabilities exhibit
these behaviors at disproportionately high rates. Notably, many such
people have difficulty communicating and cannot make their own
treatment decisions because of such disabilities, meaning many people
who exhibit SIB or AB are among a vulnerable population. SIB commonly
include: Head-banging, hand-biting, excessive scratching, and picking
of the skin. However, SIB can be more extreme and result in bleeding,
protruding, and broken bones; blindness from eye-gouging or poking;
other permanent tissue damage; or injuries from swallowing dangerous
objects or substances. AB involve repeated physical assaults and can be
a danger to the individual, others, or property. In our proposed rule,
like much of the scientific literature, we discuss SIB and AB in
tandem.
    ESDs are intended to reduce SIB and AB according to the principle
of aversive conditioning. Aversive conditioning pairs a noxious
stimulus with a target behavior such that the individual begins to
associate the noxious stimulus with the behavior, with the intended
result being that the individual ceases engaging in the behavior and,
over time, becomes conditioned not to manifest the target behavior. A
noxious stimulus is one that is uncomfortable or painful; the noxious
stimulus delivered by an ESD is an

electric shock to the skin. Some ESDs are intended for other purposes,
such as smoking cessation; however, the proposed ban includes only
those devices intended to reduce or eliminate SIB or AB. ESDs are not
used in electroconvulsive therapy, sometimes called electroshock
therapy or ECT, which is unrelated to this proposed rulemaking.
    The effects of the shock are both psychological (including
suffering) and physical (including pain), each having a complex
relationship with the electrical parameters of the shock. As a result,
the subjective experience of the person receiving the shock can be
difficult to predict. Physical reactions roughly correlate with the
peak current of the shock delivered by the ESD. However, various other
factors such as sweat, electrode placement, recent history of shocks,
and body chemistry can physically affect the sensation. As a result,
the intensity or pain of a particular set of shock parameters can vary
greatly from patient to patient and from shock to shock. Possible
adverse psychological reactions are even more loosely correlated with
shock intensity in that the shock need not exceed certain physical
thresholds. Rather, the shock need only be subjectively stressful
enough to cause trauma or suffering. Trauma becomes more likely, for
example, when the recipient does not have control over the shock or has
developed a fear of future shocks, neither of which is an electrical
parameter of the shock.
    Whenever FDA finds, on the basis of all available data and
information, that a device presents substantial deception or an
unreasonable and substantial risk of illness or injury, and that such
deception or risk cannot be, or has not been, corrected or eliminated
by labeling or by a change in labeling, FDA may initiate a proceeding
to ban the device. In making such a finding, FDA weighs the benefits
against the risks posed by the device and considers the risks relative
to the state of the art. With respect to ESDs for SIB and AB, FDA has
weighed these factors based on consideration of information from a
variety of sources, including the scientific literature, opinions from
experts (including an advisory panel meeting), information from and
actions of State agencies, information from the affected manufacturer,
information from patients and their family members, and information
from other stakeholders.
    FDA has determined that ESDs for SIB or AB present a number of
psychological and physical risks: Depression, fear, escape and
avoidance behaviors, panic, aggression, substitution of other behaviors
(e.g., freezing and catatonic sit-down), worsening of underlying
symptoms (e.g., increased frequency or bursts of self-injury), pain,
burns, tissue damage, and errant shocks from device misapplication or
failure. Based on literature for implantable cardioverter
defibrillators, FDA has determined that ESDs present the risks of
posttraumatic stress or acute stress disorders, shock stress reaction,
and learned helplessness. That literature provides additional support
for the risks of depression, anxiety, fear, and pain. Experts in the
field of behavioral science, State agencies that regulate the use of
ESDs, the sole current manufacturer and user of ESDs, and individuals
who were subject to ESDs corroborate most of these findings, and they
attest to additional risks.
    Our search of the scientific literature revealed a number of
studies showing that ESDs result in the immediate interruption of the
target behavior upon shock, and some of the literature also suggested
varying degrees of durable conditioning. However, the studies in the
literature suffer from serious limitations, including weak study
design, small size, and adherence to outdated standards for study
conduct and reporting. The conclusions of several of the studies are
undermined by study-specific methodological limitations, lack of peer
review, and author conflicts of interest. There is also evidence that
the shocks are completely ineffectual for certain individuals.
    FDA weighed the benefits against the risks. FDA recognizes that
ESDs can cause the immediate interruption of self-injurious or
aggressive behavior, but the evidence is otherwise inconclusive and
does not establish that ESDs improve the underlying disability or
successfully condition individuals to achieve durable long-term
reduction of SIB or AB. The short-term effect of behavior interruption
is outweighed by the numerous short- and long-term risks. For many
individuals who exhibit SIB or AB, these risks are magnified by their
inability to adequately communicate the harms they experience to their
health care providers. Even if immediate cessation is achieved, without
durable conditioning the target behavior will recur over time and
necessitate ongoing shocks to cause immediate cessation, magnifying the
risks. For some patients, the shocks are wholly ineffective and can
lead to progressively stronger shocks with the same result. Thus the
degree to which the risks outweigh the benefits increases over time.
    When considering the reasonableness of the risk of illness or
injury posed by a device in a banning proceeding, FDA also considers
the state of the art. Notably, the use of aversive conditioning in
general, and ESDs in particular, has been on the decline for decades;
only one facility in the United States still uses ESDs for SIB and AB.
This decline is due in part to scientific advances that have yielded
new insights into the organic causes and external (environmental or
social) triggers of SIB and AB, allowing the field to move beyond
intrusive punishment techniques such as aversive conditioning with
ESDs. Moreover, punishment techniques (which include the use of ESDs)
are highly context-sensitive, so the same technique may lose
effectiveness simply by changing rooms or providers. The evolution of
the state of the art responded to this limitation by emphasizing skills
acquisition and individual choice. The evolution is also due in part to
the ethical concerns tied to the risks posed by devices such as ESDs,
especially regarding the application of pain to a vulnerable patient
population.
    In light of scientific advances, out of concern for ethical
treatment, and in an attempt to create generalizable interventions that
work in community settings, behavioral scientists have developed safer,
successful treatments. The development of the functional behavioral
assessment, a formalized tool to analyze and determine triggering
conditions, has allowed providers to formulate and implement plans
based on positive techniques. As a result, multi-element positive
interventions (e.g., paradigms such as positive behavior support or
dialectical behavioral therapy) have become state-of-the-art treatments
for SIB and AB. Such interventions achieve success through
environmental modification and an emphasis on teaching appropriate
skills. Behavioral intervention providers may also recommend
pharmacotherapy (the use of medications) as an adjunct or supplemental
method of treatment. Positive-only approaches are generally successful
even for challenging SIB and AB, in both clinical and community
settings. The scientific community has long since recognized that
addressing the underlying causes of SIB or AB, rather than suppressing
it with painful shocks, not only avoids the risks posed by ESDs, but
can achieve durable, long-term benefits.
    Based on all available data and information, FDA has determined
that the risk of illness or injury posed by ESDs for SIB and AB is
substantial and

unreasonable and that labeling or a change in labeling cannot correct
or eliminate the unreasonable and substantial risk of illness or
injury. The purpose of this proposed rule is to seek comments on these
determinations as well as seek comments on FDA's proposal to ban ESDs
used for SIB or AB and comments on any other associated issues.

Legal Authority

    The FD&C Act authorizes FDA to ban a device intended for human use
by regulation if it finds, on the basis of all available data and
information, that such a device presents substantial deception or an
unreasonable and substantial risk of illness or injury. A banned device
is adulterated except to the extent it is being studied pursuant to an
investigational device exemption. This proposed rule is also issued
under the authority to issue regulations for the efficient enforcement
of the FD&C Act.
    In determining whether a deception or risk of illness or injury is
``substantial,'' FDA will consider whether the risk posed by the
continued marketing of the device, or continued marketing of the device
as presently labeled, is important, material, or significant in
relation to the benefit to the public health from its continued
marketing. Although FDA's device banning regulations do not define
``unreasonable risk,'' FDA previously explained that, with respect to
``unreasonable risk,'' we will conduct a careful analysis of risks
associated with the use of the device relative to the state of the art
and the potential hazard to patients and users. The state of the art
with respect to this proposed rule is the state of current technical
and scientific knowledge and medical practice with regard to the
treatment of patients exhibiting self-injurious and aggressive
behavior.
    Thus, in determining whether a device presents an ``unreasonable
and substantial risk of illness or injury,'' FDA analyzes the risks and
the benefits the device poses to individuals, comparing those risks and
benefits to the risks and benefits posed by alternative treatments
being used in current medical practice. Actual proof of illness or
injury is not required; FDA need only find that a device presents the
requisite degree of risk on the basis of all available data and
information.
    Whenever FDA finds, on the basis of all available data and
information, that the device presents substantial deception or an
unreasonable and substantial risk of illness or injury, and that such
deception or risk cannot be, or has not been, corrected or eliminated
by labeling or by a change in labeling, FDA may initiate a proceeding
to ban the device.

Summary of the Major Provisions of the Proposed Rule

    If this proposed rule is finalized as proposed, the ban would
include devices that apply a noxious electrical stimulus to a person's
skin to reduce or cease aggressive or self-injurious behavior. The
proposed ban would apply to devices already in commercial distribution
and devices already sold to the ultimate user, as well as devices sold
or commercially distributed in the future. A banned device is an
adulterated device, subject to enforcement action. The ban may not,
however, prevent further study of such devices pursuant to an
investigational device exemption.

Costs and Benefits of the Proposed Rule

    FDA is proposing to ban ESDs for the purpose of treating self-
injurious or aggressive behavior. Because we lack sufficient
information to quantify the benefits, we include a qualitative
description of some potential benefits of the proposed rule. We expect
that the rule would directly affect only one entity. In addition to the
incremental costs this entity would incur to comply with the
requirements of the proposed rule, there would be potential transfer
payments of between $11.5 million and $15 million annually either
within the affected entity or between entities. The present value of
total costs over 10 years ranges from $0 million to $60.1 million at a
3 percent discount rate, and ranges from $0 million to $51.4 million at
a 7 percent discount rate. Annualized costs range from $0 million to
$6.8 million at a 3 percent discount rate and range from $0 million to
$6.8 million at a 7 percent discount rate.

                   Table of Abbreviations and Acronyms
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      Abbreviation or acronym                   What it means
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AB................................  Aggressive Behavior.
ABA...............................  Applied Behavior Analysis.
AE................................  Adverse Event.
DBT...............................  Dialectical Behavioral Therapy.
DDS...............................  (Massachusetts) Department of
                                     Developmental Services.
DEEC..............................  (Massachusetts) Department of Early
                                     Education and Care.
EA................................  Environmental Assessment.
ESD...............................  Electrical Stimulation Device.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
FONSI.............................  Finding of No Significant Impact.
GED...............................  Graduated Electronic Decelerator.
ICD...............................  Implantable Cardioverter
                                     Defibrillator.
JRC...............................  Judge Rotenberg Educational Center,
                                     Inc.
NASDDDS...........................  National Association of State
                                     Directors of Developmental
                                     Disability Services.
NYSED.............................  New York State Education Department.
PBS...............................  Positive Behavioral Support.
PTSD..............................  Post-traumatic Stress Disorder.
SIB...............................  Self-Injurious Behavior.
SIBIS.............................  Self-Injurious Behavior Inhibiting
                                     System.
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Table of Contents

I. Background
    A. Introduction
    B. What are SIB and AB, and how do they affect patients?
    C. What are ESDs and how do they affect SIB and AB?
    D. How has FDA regulated ESDs in the past?
    E. Scope of the Ban
    F. Legal Authority
II. Evaluation of Data and Information Regarding ESDs
    A. Risks of Illness or Injury Posed by ESDs
    B. Effect on Targeted Behavior
    C. State of the Art

III. Determination That ESDs for SIB and AB Present an Unreasonable
and Substantial Risk of Illness or Injury
IV. Labeling
V. Application of Ban to Devices in Distribution and Use
VI. Proposed Effective Date
VII. Analysis of Environmental Impact
VIII. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
IX. Paperwork Reduction Act
X. Federalism
XI. References

I. Background

A. Introduction

    Electrical stimulation devices (ESDs) for self-injurious behavior
(SIB) or aggressive behavior (AB) are devices that apply a noxious
electrical stimulus (a shock) to a person's skin to reduce or cease
such behaviors. Although FDA cleared a few of these devices more than
20 years ago, due to scientific advances and ethical concerns tied to
the risks of ESDs, state-of-the-art medical practice has evolved away
from their use and toward various positive behavioral treatments,
sometimes combined with pharmacological treatments. Only one facility
in the United States has manufactured these devices or used them on
individuals in recent years. As a result of this evolution in treatment
over the past several decades, the available data and information on
the risks and benefits of ESDs are limited.
    Although the available data and information show that some
individuals subject to ESDs exhibit an immediate reduction or cessation
of the targeted behavior, the available evidence has not established a
durable long-term conditioning effect or an overall-favorable benefit-
risk profile for ESDs for SIB and AB. No randomized, controlled
clinical trials have been conducted, and the studies that have been
conducted are generally small and suffer from various limitations,
including the use of concomitant treatments over long periods that make
it difficult to determine the cause of any behavioral changes. The
medical literature shows that ESDs present risks of a number of
psychological harms including depression, posttraumatic stress disorder
(PTSD), anxiety, fear, panic, substitution of other negative behaviors,
worsening of underlying symptoms, and learned helplessness (becoming
unable or unwilling to respond in any way to the ESD); and the devices
present the physical risks of pain, skin burns, and tissue damage.
    Because the medical literature likely underreports adverse events
(AEs), risks identified through other sources, such as from experts in
the field, State agencies that regulate ESD use, and records from the
only firm that has recently manufactured and is currently using ESDs
for SIB and AB demand closer consideration. As discussed in section
II.A, these sources further support the risks reported in the
literature and indicate that ESDs have been associated with additional
risks such as suicidality, chronic stress, acute stress disorder,
neuropathy, withdrawal, nightmares, flashbacks of panic and rage,
hypervigilance, insensitivity to fatigue or pain, changes in sleep
patterns, loss of interest, difficulty concentrating, and injuries from
falling. In contrast to the state of the art for the treatment of SIB
and AB, the risks of ESDs are unreasonable.
    As discussed later in this document, FDA has determined that ESDs
present a substantial and unreasonable risk of illness or injury and
that the risks cannot be corrected or eliminated by labeling. Thus, FDA
has decided to ban these devices under section 516 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360f). The proposed
rule applies to devices already in distribution and use, as well as to
future sales of these devices.

B. What are SIB and AB, and how do they affect patients?

    SIB and AB are among the most striking and devastating conditions
associated with intellectual and developmental disabilities (Ref. 1).
Individuals with such disabilities may exhibit destructive behavior
that falls within two major categories, self-injury and aggression
toward others or property. The most common forms of self-injury include
head-banging, hand-biting, excessive scratching, and picking of the
skin. The most extreme cases of persons with serious self-injurious
behavior afflict an estimated 25,000 or more individuals in the United
States (Ref. 2). These more extreme behaviors usually involve repeated,
self-inflicted, non-accidental injuries producing, for example: (1)
Bleeding, protruding, and broken bones; (2) eye gouging or poking
leading to blindness; (3) other permanent tissue damage; and (4)
swallowing dangerous substances or objects. (For a more detailed
technical discussion, see Ref. 3.)
    Persons who exhibit SIB also frequently demonstrate aggression, the
other major category of destructive behavior. Aggressive behaviors
encompass a wide range of behaviors, which are generally defined by
conduct that, due to its intensity or frequency, presents an imminent
danger to the person who demonstrates it, to other people, or to
property (see, e.g., Ref. 4 for a discussion of aggression in autistic
children). Aggressive behaviors that involve repeated physical assaults
are dangerous particularly for caregivers and family. Beyond the
potential for obvious physical injury, SIB and AB can be very
distressing for parents and caregivers (Ref. 5), severely limit the
patient's participation in community activities, and lead to placement
of the patient in a more restrictive living environment (Ref. 6).
Accordingly, intervention is necessary for the safety of the individual
engaging in the aggressive behavior, for those against whom the
aggression is directed, and for the protection of property.
    The majority of published studies on SIB include aggression either
as part of the description of the clinical spectrum of the behavior or
as an inclusion criterion for the clinical study. Accordingly, this
proposed rule addresses self-injury and aggression in tandem as SIB and
AB. Destructive behavior in both major categories--aggression and self-
injury--are often present in individuals with intellectual or
developmental disabilities. Examples of those disabilities include, but
are not limited to: Autism spectrum disorder, Cornelia de Lange
syndrome, Down syndrome, Fragile X syndrome, hereditary sensory
neuropathy, Lesch-Nyhan syndrome, Rett syndrome, and Tourette syndrome.
Those disabilities may also include visual impairment, severe
intellectual impairment, and a variety of cognitive and psychiatric
disorders.
    Estimates of the prevalence of SIB in individuals with intellectual
or developmental disabilities range from 2.6 percent to 40 percent
(Ref. 7), or 2 to 23 percent in community samples (Ref. 8). More
recently, one analysis found a prevalence of SIB in a clinical
population of children with developmental disabilities at 32 percent,
suggesting that the actual prevalence may be at the high end of earlier
estimates (Ref. 9). Estimates of the prevalence of AB in individuals
with intellectual or developmental disabilities range as high as 52
percent, though 10 percent is more commonly reported (Ref. 8). Thus, by
conservative estimates, counting only individuals who have intellectual
or developmental disabilities (and not all people who manifest SIB or
AB), at least 330,000 people in the United States manifest SIB, AB, or
both; less conservative estimates are much higher (see Refs. 3 and
8).\1\
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    \1\ An estimated 1 to 3 percent of individuals in the United
States have an intellectual or developmental disability (Ref. 8).
Given a U.S. population of 330 million, at least 3.3 million people
would have such a disability; 10 percent of 3.3 million is 330,000,
and 2 percent of 3.3 million is 66,000. If there is no overlap, the
total would be 396,000 people. These numbers are based on the lowest
bounds reported in Ref. 8. Using the same source and method, the
highest bound would yield an estimate of about 7.4 million people.

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C. What are ESDs and how do they affect SIB and AB?

    As stated, ESDs apply a noxious electrical stimulus (a shock) to a
person's skin upon the occurrence of a target behavior in an attempt to
reduce or cease the behavior. As such, ESDs are a type of aversive
conditioning device (``aversive''). ESDs apply shocks to the skin. ESDs
are not used in ECT, sometimes called electroshock therapy, which is
unrelated to this rulemaking. The electrical shock from an ESD is
intended to interrupt the undesirable behavior and result in its quick
cessation. Repeatedly pairing the shock with the unwanted behavior is
intended to cause individuals to associate the two and thereby induce
them to decrease the frequency of the behavior or stop it altogether.
In order to achieve the intended results, the shock must be applied
during the behavior (for cessation and decrease) or immediately
afterward (for decrease). ESDs are intended to affect behavior in two
ways: By interrupting the target behavior as an immediate response to
the stimulus and, over time, through a conditioned reduction in the
target behavior.
    The main components of ESDs are an electrical stimulus generation
module, electrodes, and a trigger switch. Either a remote monitor
module or an automatic mechanism can trigger the electric shock to the
individual. Typically, the patient carries the stimulus generation
module, which applies an electrical current (the shock) to the
individual's skin via electrodes. When a remote monitor is used, an
observer determines when to apply an electrical shock to the patient
and triggers a shock from a specific stimulus generation module via a
radiofrequency signal. Alternatively, a sensor can detect certain
unwanted behaviors and automatically activate the generation module.
For example, an accelerometer attached to the head could detect head-
banging and, when the behavior is severe enough, trigger an electrical
shock.
    Although several factors specific to the patient affect shock
perception, the key device output characteristics that most affect
shock perception include: Electric current, voltage, skin resistance
(or load), pulse width, shock duration, output frequency and waveform,
electrode characteristics (e.g., size, location, design, or material),
and the number and frequency of shocks delivered. For the purposes of
this proposed rule, a stronger shock is one for which at least one of
those parameters is adjusted to increase the intensity or sensation.
    Electric current, measured in milliamperes (mA) for ESDs, is the
primary variable for determining the effects of an electric shock that
passes through the body. To determine the current output of a device
designed to deliver a constant voltage, the voltage is divided by the
electric resistance, measured in ohms ([Omega]), the relationship
described by Ohm's Law. A lower resistance for a given voltage results
in higher current; the skin's conducting resistance can vary between 1
k[Omega] and 100 k[Omega] (Refs. 10 and 11). Sweat and blood are
excellent conductors and therefore lower the conducting resistance,
which increases the current and the intensity of the stimulus.
    The sensory nerves respond to the current as a function of its
strength and duration. A stronger current will elicit a response with a
shorter pulse width, and a weaker current will need a longer pulse
width to elicit the same response. The pulse width (or pulse duration)
is the length of time a pulse of current is applied to the skin,
measured in milliseconds for ESDs. Longer pulse durations have been
shown to increase the intensity or unpleasantness of the sensation in
healthy subjects (Refs. 12-14).
    The characteristics of the electrodes that deliver the shock to the
skin also affect the perception of the shock. The amount of current
delivered per unit area of an electrode is referred to as the current
density. A higher current density has been found to correspond with a
more intense or unpleasant feeling (Refs. 15 and 16). One study has
shown that smaller electrodes deliver painful shocks that are described
as sharp, cutting, or lacerating. Larger electrodes for the same
current are associated with pain that was pinching, pressing, or
gnawing (Ref. 16). A related measure, power density, is found by
multiplying the current and the voltage and relating the product to
surface area; it is expressed as watts per unit area. Both current and
power densities correlate with the risk of burns; a higher current or
power density increases the risk. The risk of burns also increases when
the current itself is direct current; all FDA-cleared ESDs utilize
alternating current (AC) rather than direct current (DC).
    Electrodes additionally affect pain sensation in that placement on
locations with a higher density of sensory nerves will result in more
pain. For that reason, the hands, feet, genitals, underarms, torso,
neck, and face will be particularly sensitive to shocks. Repeated
shocks to the same location will also alter the perception, increasing
intensity or pain (Refs. 17-19). The exact mechanism behind this change
is unclear, but one hypothesis holds that the changing sensation may
result from changes in the skin's electrical resistance (Ref. 19).
Others have hypothesized that repeated stimulation depletes endorphins,
which are chemicals that affect pain sensation (Ref. 17).
    Finally, with regard to key device output parameters, some authors
have attempted to relate physiological responses, sensations and muscle
contraction for example, to electric current (e.g., Refs. 10, 11, and
20). The Judge Rotenberg Educational Center, Inc. (JRC), the only
entity of which FDA is aware that has recently manufactured ESDs and
that currently uses ESDs, has submitted a similar comparison (Ref. 21).
However, comparisons based solely upon the electric current
oversimplify the relationship because they do not account for other key
parameters, nor do they account for intersubject variability in
perception. (See, for example, Refs. 11, 17, 18, and 22-25). Such
comparisons also do not account for the recipient's psychological state
(Refs. 18, 22, and 23), which can affect the response to shocks.
Furthermore, the relationships between current and response as reported
by these authors (Refs. 10, 11, and 20) are more relevant in a setting
where a body part comes into direct contact with a 60-Hz AC electrical
source (e.g., a current from a wall outlet), with the current passing
through the chest. In contrast, ESDs provide localized stimulation to
the skin through an electrode interface. Thus, although the amount of
current may suggest a type of response (e.g., tingling, pain, or
involuntary muscle contraction), predictions based on such thresholds
are subject to considerable uncertainty.
    These key device output parameters affect the experience of the
shock primarily in terms of physiological responses (see Ref. 3 for a
more technical discussion). As explained in more detail in section
II.A.1, a stimulus need not be physically intense to trigger an adverse
psychological reaction. Thus, although lower peak current or shorter
pulse duration corresponds with lower physical intensity, neither
necessarily corresponds with a less-adverse psychological response.
Table 1 summarizes the device output characteristics of ESDs for SIB or
AB

that have been cleared by FDA or are currently in use. Note that FDA
has cleared 510(k)s for ESDs for SIB or AB from other manufacturers
besides JRC.

                                                         Table 1--Device Output Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Device name            Average current     Max current       Max voltage       Pulse width     Shock duration     Frequency      Power density
--------------------------------------------------------------------------------------------------------------------------------------------------------
Whistle Stop 1...............  ................  10 mA at 20       200 V...........  1-2 ms..........  0.5-12 s.......  10 Hz..........  0.02 W/cm. 2
                                                  k[Omega].
SIBIS........................  3.5 mA at 20      10 mA...........  200 V...........  6.2 ms..........  0.1-0.2 s......  80 Hz..........  0.16 W/cm. 2
                                k[Omega].
GED, GED-3A 2................  12 mA at 5        29.4 mA at 5      150 V...........  3.125 ms........  2 s............  80 Hz..........  1.01 W/cm. 2
                                k[Omega].         k[Omega].
GED-4 2......................  42 mA at 5        90 mA...........  ................  3.125 ms........  2 s............  80 Hz..........  ...............
                                k[Omega].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The 510(k) did not include enough information for FDA to determine the average current of the device (as indicated by blank field).
\2\ The GED-3A and GED-4 have not been cleared or approved by FDA, and we do not have information about all device characteristics (as indicated by
  blank fields).

    Again, individual patient variability makes comparison across
devices--and even individual shock applications--difficult. Some people
are generally highly sensitive to current, experiencing involuntary
muscle contraction from static electric shocks. On the other end of the
spectrum, some individuals can draw a large static electric spark and
hardly perceive it, much less experience a muscle spasm. Studies of
subjects without intellectual or developmental disabilities have
demonstrated a large range of intersubject variability for equally
applied shocks. For example, one study found that the range of pain
thresholds was 3.9 to 11.6 mA (Ref. 11), while another found the range
was 0.45 to 2.4 mA (Ref. 25). Such articles often did not include key
output characteristics, such as pulse width and frequency or electrode
size and placement, further confounding attempts to compare or apply
the findings. In light of variability and methodological limitations
underlying the reported current-response relationships, physiological
responses, including pain perception, are difficult to predict
accurately, especially based solely on the current.

D. How has FDA regulated ESDs in the past?

    In 1979, FDA classified aversive conditioning devices as class II
(see Sec.  882.5235 (21 CFR 882.5235)), which was consistent with the
recommendation of the Neurological Device Classification Panel of the
Medical Device Advisory Committee in 1978. Such devices may or may not
use electric shocks to administer a ``noxious stimulus to a patient to
modify undesirable behavioral characteristics'' (Sec.  882.5235). Thus,
ESDs intended to treat SIB and AB are within the aversive conditioning
device classification regulation. The proposed rule for classifying
aversives, including ESDs, focused on the risks of: (1) Worsened
psychological conditions, (2) errant electric shocks, and (3) the
harmful or lethal nature of excess electric current or its
inappropriate application (43 FR 55705, November 28, 1978). At the
time, FDA and the panelists believed that performance standards could
adequately assure the safety and effectiveness of aversives. We
received no comments from the public on the proposed rule, and we
issued the final rule classifying aversives as proposed at Sec.
882.5235 (44 FR 51726 at 51765, September 4, 1979).
    FDA has cleared four devices for the treatment of SIB as
substantially equivalent to the ones initially placed into class II,
510(k) notification numbers and clearance dates in parentheses:
     Stimulator Sonic Control, ``Whistle Stop'' (K760166; July
20, 1976);
     Self-Injurious Behavior Inhibiting System, ``SIBIS''
(K853178; February 28, 1986);
     SIBIS Remote Actuator (K871158; May 29, 1987); and
     Graduated Electronic Decelerator, ``GED'' (K911820;
December 5, 1994).
    A prescription is required for each, meaning that Federal law
restricts the sale of these aversives to professionals licensed
according to State requirements or those acting pursuant to a licensed
professionals orders (see 21 CFR 801.109).
    As part of the evaluation of the premarket notifications, i.e., the
510(k) submissions, FDA reviewed the average current (the amount of
electricity) and power density of the shocks (the wattage applied to a
given area of skin), among other things. Average current and power
density are important parameters in determining the likelihood and
severity of a potential physical injury from a shock. The cleared ESDs
include warnings never to place electrodes on the head or chest, or in
such a way that current would flow through the chest because this could
cause ventricular fibrillation (a dangerous irregularity in the
heartbeat).
    We are aware of only one manufacturer, JRC, that has recently
manufactured ESDs and that currently uses ESDs, including devices that
we have not previously cleared. JRC uses these devices because it is
also a residential facility, and its employees apply the devices to
individuals there. In 2000, FDA incorrectly notified JRC that it
qualified for exemption from registration and 510(k) requirements under
21 CFR 807.65(d). Once FDA recognized its error, FDA sent JRC an
Untitled Letter on May 23, 2011, and a Warning Letter on December 6,
2012, for violations related to the lack of FDA clearance or approval
for the modified GED devices.\2\
---------------------------------------------------------------------------

    \2\ The Warning Letter is available on the Internet at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331291.htm.
---------------------------------------------------------------------------

    FDA now has a better understanding of the risks and benefits
presented by these devices than it did 36 years ago when these devices
were classified, and, as discussed later in sections II.A and II.B, the
state of the art for the treatment of SIB and AB has progressed
significantly over that time period. As a result, FDA now believes that
the risk of illness or injury from the use of ESDs for the treatment of
SIB and AB is unreasonable and substantial.

E. Scope of the Ban

    The ban would apply to devices that apply a noxious electrical
stimulus to a person's skin to reduce or stop aggressive or self-
injurious behavior. (See section I.B for a discussion of the relevant
behaviors; see also Ref. 3 for a more technical discussion of the
scientific literature regarding these behaviors.) To FDA's knowledge,
the only such devices that are currently in use are two models of the
GED device (the GED-3A and GED-4), neither of which has been cleared or
approved by the Agency.
    The ban would not apply to ESDs used to create aversions to other
conditions or habits, such as smoking. Although other ESDs have
parallels in

treatment strategy and method, those devices address very different
conditions in very different patient populations. Smoking-cessation
devices differ with respect to whether patients have control over the
shocks--and what level of control they have--as well as how the
electric shock affects the target behavior and underlying conditions.
These differing types of ESDs thus present different benefit-risk
profiles.
    Importantly, individuals who manifest SIB or AB typically have
additional vulnerabilities that relate directly to the risks of the
treatment method. For example, individuals with intellectual or
developmental disabilities who manifest SIB or AB, and who have
difficulty communicating pain or other harms that may be caused by ESDs
would bear a higher risk of injury from the shock than smokers who
choose to use an ESD to help quit smoking. Those smokers, if without
intellectual or developmental disabilities, can immediately communicate
pain to the device's controller or remove the device themselves. They
can communicate symptoms of other harms that may be caused by ESDs,
such as PTSD, to their health care provider, which may lead to
discontinuation of the device's use. Communication challenges in
patients who suffer from SIB and AB are discussed in the literature,
were raised by the advisory panel, and are reviewed in more detail in
section II.A.

F. Legal Authority

    Section 516 of the FD&C Act authorizes FDA to ban a device intended
for human use by regulation if it finds, on the basis of all available
data and information, that such a device ``presents substantial
deception or an unreasonable and substantial risk of illness or
injury'' (21 U.S.C. 360f(a)(1)). A banned device is adulterated under
section 501(g) of the FD&C Act (21 U.S.C. 351(g)), except to the extent
it is being studied pursuant to an investigational device exemption
under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)). This proposed
rule is also issued under the authority of section 701(a) of the FD&C
Act (21 U.S.C. 371(a)), which provides authority to issue regulations
for the efficient enforcement of the FD&C Act.
    In determining whether a deception or risk of illness or injury is
``substantial,'' FDA will consider whether the risk posed by the
continued marketing of the device, or continued marketing of the device
as presently labeled, is important, material, or significant in
relation to the benefit to the public health from its continued
marketing (see Sec.  895.21(a)(1) (21 CFR 895.21(a)(1))). Although
FDA's device banning regulations do not define ``unreasonable risk,''
in the preamble to the final rule promulgating 21 CFR part 895, FDA
explained that, with respect to ``unreasonable risk,'' it ``will
conduct a careful analysis of risks associated with the use of the
device relative to the state of the art and the potential hazard to
patients and users'' (44 FR 29214 at 29215, May 18, 1979; Ref. 25a).
The state of the art with respect to this proposed rule is the state of
current technical and scientific knowledge and medical practice with
regard to the treatment of patients exhibiting self-injurious and
aggressive behavior.
    Thus, in determining whether a device presents an ``unreasonable
and substantial risk of illness or injury,'' FDA analyzes the risks and
the benefits the device poses to individuals, comparing those risks and
benefits to the risks and benefits posed by alternative treatments
being used in current medical practice. Actual proof of illness or
injury is not required; FDA need only find that a device presents the
requisite degree of risk on the basis of all available data and
information (H. Rep. 94-853 at 19; 44 FR 28214 at 29215).
    Whenever FDA finds, on the basis of all available data and
information, that the device presents substantial deception or an
unreasonable and substantial risk of illness or injury, and that such
deception or risk cannot be, or has not been, corrected or eliminated
by labeling or by a change in labeling, FDA may initiate a proceeding
to ban the device (see Sec.  895.20). If FDA determines that the risk
can be corrected through labeling, FDA will notify the responsible
person of the required labeling or change in labeling necessary to
eliminate or correct such risk (see Sec.  895.25).
    Section 895.21(d) requires this proposed rule to briefly summarize:
     The Agency's findings regarding substantial deception or
an unreasonable and substantial risk of illness or injury;
     the reasons why FDA initiated the proceeding;
     the evaluation of the data and information FDA obtained
under provisions (other than section 516) of the FD&C Act, as well as
information submitted by the device manufacturer, distributer, or
importer, or any other interested party;
     the consultation with the classification panel;
     the determination that labeling, or a change in labeling,
cannot correct or eliminate the deception or risk;
     the determination of whether, and the reasons why, the ban
should apply to devices already in commercial distribution, sold to
ultimate users, or both; and
     any other data and information that FDA believes are
pertinent to the proceeding.

We have grouped some of these together within broader categories and
addressed them in the following order:
     Evaluation of data and information regarding ESDs,
including data and information FDA obtained under provisions other than
section 516 of the FD&C Act, information submitted by the device
manufacturer and other interested parties, the consultation with the
classification panel, and other data and information that FDA believes
are pertinent to the proceeding, with respect to risks, benefits, and
the state of the art;
     the reasons FDA initiated the proceeding and FDA's
determination that ESDs for SIB and AB present an unreasonable and
substantial risk of illness or injury (FDA has not made a finding
regarding substantial deception);
     FDA's determination that labeling, or a change in
labeling, cannot correct or eliminate the risk; and
     FDA's determination that the ban applies to devices
already in commercial distribution and sold to ultimate users, and the
reasons for this determination.

II. Evaluation of Data and Information Regarding ESDs

    In considering whether to ban ESDs, FDA first conducted an
extensive, systematic literature review to assess the benefits and
risks associated with ESDs as well as the state of the art of treatment
of patients exhibiting SIB and AB. In the literature review, as
explained earlier, SIB and AB were considered in tandem, and these
conditions presented in individuals with intellectual and developmental
disabilities, such as autism spectrum disorder, Down syndrome, Tourette
syndrome, as well as other cognitive or psychiatric disorders and
severe intellectual impairment (including a broad range of intellectual
measures). The studies encompassed both children and adults. (For more
technical details, see Ref. 3.)
    FDA next convened a meeting of the Neurological Devices Panel of
the Medical Devices Advisory Committee (``the Panel'') on April 24,
2014 (``the Panel Meeting''), in an open public forum, to discuss
issues related to FDA's consideration of a ban on ESDs for SIB and AB
(see 79 FR 17155, March 27, 2014; Ref. 26). Although FDA is not

required to hold a panel meeting before banning a device, FDA decided
to do so in the interest of gathering as much data and information as
possible, from experts in relevant medical fields as well as all
interested stakeholders, before proposing this significant regulatory
action. Eighteen panelists with expertise in both pediatric and adult
patients represented the following biomedical specialties: Psychology,
psychiatry, neurology, neurosurgery, bioethics, and statistics, as well
as representatives for patients, industry, and consumers (Ref. 27). FDA
provided a presentation that described the banning standard, the
regulatory history of aversive conditioning devices, alternative
treatments, and a summary of the benefits and risks of ESDs, including
a comprehensive, systematic literature review based on the information
available at that time (Refs. 3 and 28). After the Panel Meeting, we
reviewed all 294 comments from 281 unique commenters submitted to the
public docket created for the Panel Meeting (Docket No. FDA-2014-N-
0238).
    FDA considered all available data and information from a wide
variety of sources, including from the categories listed in this
document. In weighing each piece of evidence, FDA took into account its
quality, such as the level of scientific rigor supporting it, the
objectivity of its source, its recency, and any limitations that might
weaken its value. Thus, for example, we generally gave much more weight
to the results of a study reported in a peer-reviewed journal than we
did to non-peer-reviewed papers.
     The scientific literature. FDA considered published
scientific sources to understand SIB and AB as well as the risks and
benefits of ESDs and the state of the art for the treatment of
challenging behaviors. However, several limitations influenced the
conclusions drawn from the literature, including the likely
underreporting of AEs, reporting biases, and various methodological
weaknesses.
     Information and opinions from experts, including those
expressed by the panelists at the Panel Meeting, as well as those
expressed in individual expert reports obtained by FDA from Drs.
Tristram Smith, Gary LaVigna, and Fredda Brown. Each of these experts
has experience in the field of behavioral psychology, particularly with
individuals who manifest SIB or AB. Drs. LaVigna and Brown have
expertise regarding the state of the art for treatment of SIB and AB
and the development of positive behavioral treatment plans for
patients, including for transition away from ESDs and other aversive
strategies. FDA obtained reports from these experts to supplement our
understanding of the risks and benefits of ESDs and the state of the
art for the treatment of SIB and AB.
     Information from State agencies and State actions on ESDs.
FDA has considered information regarding the use of ESDs for SIB and AB
from agencies in Massachusetts and New York. These agencies possess
substantial information on ESDs for SIB and AB because the overwhelming
majority of patients--nearly 75 percent--on whom ESDs are used are from
these two States. According to information provided by JRC in its
comments, 60 of the 82 individuals enrolled at JRC as of April 2014 on
whom GED devices were used are from these two States. FDA also
considered a comment from the Executive Director of the National
Association of State Directors of Developmental Disabilities Services
(NASDDDS), which was supportive of a ban, and various State legal
actions related to the use of ESDs for SIB and AB.
     Information from the affected manufacturer/residential
facility. In addition to presenting information at the Panel Meeting
and responding to questions from Panel members, JRC has made several
submissions to the Panel Meeting docket, as has a former JRC clinician.
     Information from patients and their family members. Three
individuals formerly on ESDs at JRC and family members of four such
individuals currently at JRC spoke against a ban at the Panel Meeting.
Two associations of family members of such individuals submitted
comments opposing a ban (one of the comments included 32 letters from
family members). Two individuals formerly on ESDs at JRC spoke in favor
of a ban at the Panel Meeting, and one other individual submitted a
comment in favor of a ban. In 2013 and 2014, FDA clinicians interviewed
three individuals formerly on ESDs at JRC by phone (one of whom spoke
in favor of a ban at the Panel Meeting).
     Information from other stakeholders, including other
government entities, disability rights groups, and members of the
public. In addition to NASDDDS and a JRC parents group, referenced
earlier, 15 other organizations concerned with the treatment and the
rights of individuals with disabilities spoke at the Panel Meeting, all
of which supported a ban. Twenty-two disability rights organizations
submitted written comments to the Panel Meeting docket, one of which
was signed by 23 disability rights groups. Nine of these organizations
were among the 15 represented at the Panel Meeting. All of these
comments support the ban. FDA also received a comment from the U.S.
Department of Justice Civil Rights Division supportive of a ban, and we
considered information from the National Council on Disability, the
National Institutes of Health, and the United Nations Special
Rapporteur on Torture.

A. Risks of Illness or Injury Posed by ESDs

1. Scientific Literature
    FDA conducted an extensive, systematic review of the medical
literature for harms, i.e., AEs, associated with ESDs to understand
specific risks and dangers that ESDs present to individuals' health. As
previously discussed, the focus of the analysis in considering a ban is
on risks and does not require proof of actual harm, but evidence of
actual harms helps inform the analysis. One prospective case-control
study and one retrospective chart review of 60 patients reported AEs
(Refs. 29 and 30, respectively). Additionally, 26 case reports or
series encompassing 66 subjects included an assessment of AE
occurrences. Ten other case reports or series did not assess AEs, and 6
articles, encompassing 11 subjects in total, noted that the researchers
did not observe AEs in their subject population. (See table 4 in Ref. 3
for a summary of articles reviewed for adverse events.) We identified
the following AEs in the literature.
    a. Psychological risks. The risks of psychological harm are less
tightly linked to the electrical parameters of an ESD shock than are
physical risks (section I.C discussed shock parameters and how they
relate to the physical response). For example, when the recipient does
not have control over the shocks and has previously received multiple
such shocks, psychological trauma such as an anxiety or panic reaction
can result even when the strength is relatively modest (Ref. 31). In
this example, the shock does not necessarily need to be stronger to
increase the risk of psychological trauma; it need only recur.
Similarly, the shock need not be painful; it need only be
psychologically stressful.
    Further, a series of less traumatic events can cause the
development of stress disorders such as PTSD. The underlying trauma
need not be a single, discrete event, although a single trauma can lead
to PTSD (Ref. 32; see also Ref.

31, discussing research on stressors prior to the 2013 update of the
Diagnostics and Statistical Manual of Mental Disorders). Shocks that
may be tolerable on their own could, in series, amount to a traumatic
experience leading to a stress disorder. (See Ref. 33 discussing
impaired cue-reversal independent of level of trauma.) In turn, such
disorders can leave an individual susceptible to future traumas such as
anxiety reactions that can be triggered by a relatively weak stimulus.
For example, a provider reaching for an ESD remote control can trigger
an anxiety response in individuals wearing ESDs, even without a shock.
Thus, although a shock may need to surpass a minimum subjective
threshold to be harmful (e.g., the shock needs to be sufficiently
stressful to the recipient), that subjective minimum (what is
sufficiently stressful) does not correspond with a particular objective
minimum (shock parameters).
    Several articles reported aversion, fear, and anxiety in response
to ESDs. One article states that ESDs may initially evoke fear, panic,
and even aggression responses (Ref. 34). For the most part, researchers
have interpreted these events as anticipatory responses prior to or
upon stimulus application. In addition to reports of panic and bouts of
aggression, others have reported events such as screaming, crying, or
shivering upon device application; grimacing; flinching; perspiring;
and escape behavior (Refs. 34-43). One article reported a temporary
aversion to the experimenter (Ref. 36). Such fear, anxiety, or panic
reactions are additionally concerning because when they cause the
individual to sweat, they would lead to electrical conductivity changes
across the skin that increase the intensity of the electric shock.
    Other articles report substitution of behaviors--negative or
collateral--that span a range of severity. One author speculated that,
in institutional settings, ``the probability that a replacement
behavior will be undesirable is quite high'' (Ref. 44). Some patients
``froze by refraining from showing any sort of behavior'' (Ref. 34).
Similarly, others reported a ``pseudocatatonic sit-down,'' i.e.,
muscular freezing or melting (Ref. 45). One study described temporary
tensing of the body and noted attempts to remove the device or grab the
transmitter during treatment (Ref. 30). Some patients resorted to
hostility and retaliation (Ref. 46), including surrogate retaliation,
threats, and warnings (Ref. 45). In some patients, another undesirable
behavior known as self-restraint, where patients attempt to physically
restrain themselves, for example, with their clothing, emerged or
intensified (Refs. 29 and 47). Others exhibited lesser self-injury and
aggression, non-injurious pinching, emotional behaviors, and napkin-
tearing. (See also Refs. 30 and 43.) In some cases, crying increased
(Ref. 48). One study reported that, as measured by rating scales of
dependency, affection-seeking increased repeatedly during treatment
(Ref. 42).
    Temporary or long-term increases in symptoms have also been
attributed to ESDs in the literature. One article reported increases in
emotionality and the frequency of self-injury, as well as post-
treatment incontinence (Ref. 49). Another observed increasing episodic
``bursts'' of self-injury, eventually reaching the point that extended
treatment with the ESD became impossible to maintain (Ref. 50).
    Some ESDs have been used for conditions other than SIB and AB,
e.g., obsessions or compulsions, according to the same principle of
aversive conditioning. FDA believes that reports of AEs from these
alternative uses are informative regarding the risks of ESDs for SIB
and AB because individuals with ESDs for other conditions generally do
not have the same patient vulnerabilities that often accompany SIB and
AB. As discussed in sections II.A.2 and A.3, these vulnerabilities
generally increase the risk of harm from ESDs for individuals who
manifest SIB or AB, so any harms from ESDs for other uses would be at
least as likely, if not more so, to cause harm to many patients
exhibiting SIB or AB.
    One article on the effects of shock on five subjects to reduce
obsessions and compulsions reported that one subject demonstrated
anxiety and psychotic delusions (Ref. 51). One case-control study on
ESDs used to treat alcohol dependence in 12 subjects found that
symptoms of experimental repression, such as headaches, restlessness,
and mild dysphoria, were common and appeared usually within 3 or 4 days
of the treatment (Ref. 52). Another researcher performed a prospective
study of ESDs used for smoking cessation in 14 subjects. The author
reported that seven subjects exhibited mild transient depression (Ref.
53). FDA acknowledges that confounding factors potentially contributed
to these AEs.
    Since ESDs are aversive conditioning devices, FDA also considered
AEs associated with aversive conditioning more generally. We identified
12 review articles examining AEs associated with punishment or aversive
conditioning. Many of the reviews acknowledge the possibility of
negative emotional reactions associated with punishment in general,
such as fear or avoidance (Refs. 54-59) and anxiety and depression
(Ref. 54). Some reviews, similar to the findings specific to ESDs,
noted AEs that include retaliation, increased aggression, or
substitution of one injurious behavior for another (Refs. 54 and 57-
60).
    FDA believes that the risks posed by another type of device that
delivers a shock to the patient are instructive. Specifically, a
comparison to implantable cardioverter defibrillator (ICD) devices
further supports the potential for certain psychological risks in
patients receiving shocks from ESDs for SIB and AB. While the strength
and purposes of the shock differ significantly between ICDs and ESDs,
the psychological risks posed by ESDs do not necessarily depend on the
strength of the shock, as discussed earlier, and FDA does not believe
the different purposes of the shocks undermine the comparison for the
following reasons. Treatment with either of these devices entails
several similar characteristics that support a comparison, including
the lack of patient control over the shocks, the application of
multiple shocks, and the startling or unpleasant nature of the shocks.
We found that fear of future shocks, in particular, is a trauma that is
shared for both the ICD and ESD populations, unlike other trauma
experiences in which subsequent trauma (repetition of the experience)
is unlikely, indicating that ongoing application worsens the harm (Ref.
61).
    The following risks have been reported in the literature for ICDs:
The development of PTSD, acute stress disorder, a shock stress reaction
(a temporary condition), learned helplessness, depression, and anxiety
(Refs. 61-63). A contributing factor in the development of these harms
in patients with an ICD may be that treatment with an ICD may act as a
constant reminder of the underlying life-threatening disease condition
(Ref. 64). A 2011 report observed that ``[t]he available research
literature can only provide a limited view of whether ICD shock or the
potentially life-threatening arrhythmic condition is the primary driver
of a PTSD presentation'' (Ref. 61). However, Sears and Conti report
that ``[s]hock is the major distinguishing factor between patients with
ICDs and general cardiac patient populations'' (Ref. 63), meaning that
the presence of an ICD, rather than the underlying cardiac condition,
increases the psychological risks. Other authors have reported that ICD
shocks may cause distress either from the associated pain, skeletal
muscle contraction, and nerve

stimulation or merely from fear of shocks (Ref. 62).
    Because of the similar characteristics of the shocks delivered by
ICDs and ESDs, and because the identified risks may be attributable to
the ICD shock itself, as opposed to the fear of a life-threatening
condition, the risks of development of PTSD or a shock stress reaction,
learned helplessness, depression, or anxiety may also exist when shocks
are applied by ESDs in patients with SIB or AB. FDA notes that due to
the drastically different intended uses, patient populations, benefit-
risk profiles, and state of the art for these devices, FDA is not
considering banning ICDs.
    b. Physical risks. Research shows that shock strength and other
device characteristics play a role in shaping the physical response to
ESDs, such as whether the patient receives burns or experiences pain
(see section I.C). We note that the lack of complete information
regarding shock characteristics in much of the literature can make it
difficult to determine to which ESDs these findings are applicable.
    The literature contains many reports of tissue damage or burns from
ESDs. Reports of skin damage ranged from burns to bruises to slightly
reddened or discolored areas. In all such reports, the effects were
temporary (Refs. 29, 30, 39, 41, 50, and 65).
    Given that ESDs achieve their intended effects by causing an
aversion with an electric shock, it is not surprising that researchers
have reported experiencing or observing pain upon ESD application to
themselves or their patients. For example, one experimenter stated that
he definitely felt pain when he applied the ESD to himself. He
described it like a dentist drilling on an un-anesthetized tooth, but
the pain terminated when the shock ended (Ref. 36). Another report
observed pain upon stimulation by the ESD (Ref. 35), and another
observed a tremor in the thigh (Ref. 36). Although ESDs are intended to
apply an aversive stimulus, and any pain that results from ESDs may
cause an aversive reaction, pain is nonetheless a harm that should be
considered in our analysis of risks posed by the device.
    Finally, two articles reported misapplication or device failure
(Refs. 39 and 65). In such cases, there is a risk that any of the harms
discussed in this section may occur but without any possibility of
benefit.
2. Likely Underreporting of AEs
    The Agency's analysis indicates that the medical literature suffers
from some significant limitations and has likely underreported AEs
associated with ESDs for a number of reasons. Perhaps most importantly,
the devices have been studied only on a very small number of subjects,
many of whom would have difficulty communicating or otherwise
demonstrating AEs and injuries. The bulk of the articles describe case
reports or series, employing only retrospective reviews of clinical
experience, not prospective studies. Further, most of the research
articles were published in the 1960s and 1970s, before significant
advances in the ability to diagnose and classify psychological AEs such
as PTSD. The dated nature of most of the research also means it did not
adhere to modern standards for AE monitoring. Simply put, researchers
likely did not report AEs because they had not planned to study them
separately. None of the articles on the application of ESDs described
an attempt to assess AEs systematically, and many articles did not
state whether the authors attempted to assess AEs at all. Finally,
researcher bias also may have contributed to underreporting of AEs.
    As noted, the literature review suggests some subjects' difficulty
with reporting AEs due to the subjects' disability likely hindered any
assessment of AEs, particularly psychological AEs. Since SIB and AB
often present in individuals with cognitive, intellectual, or
psychiatric conditions, SIB and AB affect many individuals with
diminished communication abilities. Patients who exhibit SIB or AB may
not offer--or providers may not recognize--feedback indicating injuries
from misfires or other erroneous applications of ESDs. For example,
conditions such as an autism spectrum disorder may impair expressions
of pain (see Ref. 66 for a discussion of pain sensitivity and
expression in autistic individuals). In such a case, an AE could go
unrecognized because the provider does not understand the individual's
response, if any.
    Worse, some individuals' impaired ability to communicate, express
themselves, or associate cause and effect, coupled with the difficulty
providers may have in distinguishing underlying symptoms from negative
effects of ESDs, compounds the dangers posed by these devices. This is
because individuals' impairments with communication or stimulus
association may prevent the individuals and their health care providers
from mitigating or avoiding both physical and especially psychological
harms. (See section II.C.1 for a discussion of interventions that do
not rely on stimulus association.) In such circumstances, ESDs are
riskier than for other patients on whom ESDs are used.
    For the reports of AEs that do exist, many of those researchers
published during the 1960s and 1970s, an era when conceptions of
disease and how a person's physiology may affect or cause disease,
i.e., pathophysiology, differed significantly from current medical
science, particularly psychiatric pathophysiology. As a result, those
researchers may have interpreted pathological processes differently.
For instance, they may not have recognized certain currently accepted
disease processes like acute and posttraumatic stress. Some researchers
did not report pain or discomfort as AEs since they were considered the
ESDs' intended result and indicators of effectiveness. (See, e.g.,
Refs. 44 and 57). In short, because science has advanced since much of
the AE reporting, FDA believes existing AE reports in the literature
are likely not comprehensive by current scientific and clinical
reporting standards.
    The Agency's analysis also suggests the possibility of bias against
reporting AEs. As previously noted, the majority of articles did not
define a systematic method for assessing AEs. In one review, the
authors concluded that there was no evidence associating AEs with ESDs
(Ref. 67). However, the authors went on to opine, ``in light of the
intrusive nature of shock treatment, it is puzzling that so few
negative side effects have been reported. In interpreting the existing
literature, we might be wise to consider the possibility that some
investigators have been predisposed to see only the positive side
effects.'' Similarly, the reports of treatment relapse in the
literature may not reflect the actual prevalence in clinical settings
because such cases are less likely to be submitted or accepted for
publication (Ref. 59).
    Potential bias against AE reporting might also have influenced the
authors of the article that included the largest group of individuals
(60) subject to ESD application in its retrospective review. The review
noted only one negative side effect, ``temporary discoloration of the
skin that cleared up in a few minutes or days'' (Ref. 30).
However,''temporary emotional behaviors, a temporary tensing of the
body, or attempts to remove the device or grab the transmitter noted
during treatment were classified as 'immediate collateral behavior' and
were not considered adverse events'' (Ref. 30). The lead author of this
article, Dr. Matthew Israel, may also have been biased in his roles as
founder of JRC and Chief Executive

Officer of JRC at the time he co-wrote the article.
    In light of the foregoing, FDA believes that researchers, by
current clinical and peer-review standards, likely underreported AEs.
Many patients on whom ESDs have been used have limited ability to
express themselves. Some earlier studies considered certain reactions
that we would now consider to be AEs as mere responses or even
treatment requirements. Even current researchers may classify AEs as
unwanted side effects that then go unreported. For example, of the 66
patient case histories spanning 1991 through 2014 that FDA received
from JRC, none reported any AEs, which is highly unusual for so many
patients over such a long time (though individual exposure periods
varied). Nor did any of these case histories include systematically
defined methods for short- or long-term AE monitoring. Thus, even the
more recent studies may still reflect outmoded standards.
Significantly, because much of the relevant literature was published
many years ago, it does not benefit from recent advancements in
psychiatric pathophysiology that have expanded researchers' ability to
identify and record AEs. In light of the foregoing, we conclude that
realized risks and dangers to individuals' health from ESDs are likely
greater than reported in the medical literature. As a result, the risks
posed by ESDs reported by other sources, discussed in the following
sections, warrant careful consideration.
3. Information and Opinions From Experts
    FDA presented the following dangers to individuals' health related
to the use of ESDs at the Panel Meeting: Negative emotional reactions
or behaviors, including aggression; burns and other tissue damage;
anxiety; acute stress, or PTSD; fear and aversion or avoidance; pain or
discomfort; depression and possible suicidality; psychosis; and
neurological symptoms and injury. The panelists generally opined that
the list was incomplete, and in some cases, too vague and in need of
clarification (see Ref. 68).\3\
---------------------------------------------------------------------------

    \3\ Unless otherwise noted, all references to statements and
opinions expressed at the Panel Meeting are taken from Ref. 68.
---------------------------------------------------------------------------

    One panelist noted peripheral nerve injury as a possible side
effect and was surprised JRC had not reported severe depression,
especially since ``producing pain in people who have no control over
the pain'' is ``a perfect paradigm for the learned helpless,'' and
learned helplessness is used in drug studies ``because it produces in
animals something analogous to depression and it can be used to test
antidepressants.''
    Another panelist stated that cardiac effects, renal effects, muscle
damage, and neurological symptoms, such as neuropathy, could be
happening at low levels but go unreported because there has not been a
systematic look at these types of potential injury over the last 40-50
years.
    Other panelists recommended specific additions and refinements to
the list of risks and dangers, including: Equipment malfunction; long-
term effects of pain; delineation of range of pain; trauma from falls;
mistrust of providers; learned helplessness; chronic stress;
generalized behavioral suppression; small, repetitive damage of other
tissues; cognitive impairment; neuropathy; ventricular fibrillation if
the electrodes are placed transthoracically; neuropsychiatric symptoms;
and emotional sequelae.
    Several Panel members echoed the concerns discussed earlier
regarding the likelihood of underreporting of AEs. For example, one
Panel member pointed out that the populations treated with ESDs are
very vulnerable and may not be able to self-report AEs. Panelists also
indicated that because clinicians have little understanding of the
breadth and the range of pain experienced by ESD patients, clinicians
may mistakenly attribute adverse effects to the patients' cognitive,
intellectual, or psychiatric conditions rather than to the device. Some
panelists observed that many of the risks and dangers of ESDs resemble
co-morbidities in the individuals subject to treatment; as a result,
adverse effects of the device would be difficult to distinguish from
symptoms of the disability. This could result in AEs being misperceived
as underlying symptoms, the likelihood of which is supported by the
lack of systematic evaluation of AEs in the literature discussed in
section II.A.2. Panel members similarly expressed concerns about
communication and diagnosis difficulties exacerbating the harms
experienced by patients on whom ESDs are used.
    In his expert report, Dr. Smith explains that ESDs for SIB or AB
``necessarily involve inflicting pain on a person with [an intellectual
or developmental disability],'' and notes the risks of fear and
agitation observed in one study. Dr. Smith details several limitations
to the studies on ESDs in the literature, including the failure of any
of the studies to have a prespecified, systematic plan for monitoring
AEs, which may have resulted in underreporting of AEs. He also
discusses the possibility that the publication process may also
introduce a bias against reporting AEs in the retrospective single-
patient studies relied on by many researchers of ESDs. This is because,
according to Dr. Smith, when studying only one patient, researchers
tend to emphasize data that epitomize experimental control rather than
an average response to the device (Ref. 8). Further, researchers
generally tend to publish clear-cut results rather than less-clear
outcomes (Ref. 8). Although he notes that the ``overall strength of
evidence is low'' with respect to both benefit and harm, Dr. Smith
concludes that ``existing evidence shows that aversive conditioning
with electric shock can be safe and effective in at least some cases,
but that it can also be misapplied, risking severe, negative
consequences'' (Ref. 8).
    A comment submitted by the Disability Law Center includes a 2014
expert affidavit from Dr. James Eason, a university instructor of
biomedical engineering with a Ph.D. in biomedical engineering and a
B.S. in electrical engineering who has particular expertise on ICDs
(Ref. 69, attachment 2). Dr. Eason opines on the potential hazards
posed by three ESDs: The SIBIS (cleared by FDA in 1986), the GED-1
(cleared by FDA in 1994), and the GED-4 (not FDA cleared or approved).
Focusing on peak current, based on his views on the relationship
between certain electrical stimulus parameters and pain, Dr. Easton
compares the SIBIS (4.1 mA), GED-1 (30 mA), and GED-4 (90 mA), with an
electrical fence (4 mA), a dog training collar (2-4 mA), and a cattle
prod (10 mA), respectively.
    Dr. Eason opines that, when applied to non-sensitive locations such
as the arm or leg, the SIBIS shock falls below the range usually
considered painful; the GED-1 shock falls within the range of pain
thresholds, meaning some would find it painful and some may not; and
the GED-4 shock would be painful or extremely painful to anyone.
According to Dr. Eason, when the electrodes are placed on sensitive
parts of the body, such as hands, feet, underarms, torso, or neck, all
three ESDs are capable of inflicting extreme pain on anyone. Dr. Eason
explains that sweating, which may be caused by stress or anxiety about
receiving a shock, lowers skin resistance, which in turn may lower
one's pain threshold, and that one's pain threshold may also be lowered
by repeated shocks. He further concludes all three devices are capable
of producing tissue damage due to strong muscle contractions, and all
are capable of causing superficial skin burns under certain
circumstances.

    Dr. Eason also concludes that the ESDs ``are likely to induce an
immediate increase in physiological stress ranging from mild to severe.
Further, the long-term effects of receiving numerous painful and
uncontrollable shocks will be an increased risk for developing ASD or
PTSD.'' His conclusion is based partly on observations of people who
have ICDs, which have been shown to induce psychological trauma,
including PTSD, as discussed in section II.A.1. Finally, Dr. Eason
believes the GED-4 presents a risk of heart palpitations, long-term
psychological disorders, and neurological effects.
    Dr. Eason's expert opinion is consistent with other available data
and information demonstrating that ESDs can be painful, particularly
when placed on sensitive areas, and that physiological and
psychological factors contribute to the experience of pain. However, as
explained in section I.C, because an individual's experience of pain
varies significantly based on many factors, pain predictions based on
peak current are subject to considerable uncertainty. As such, although
higher peak currents correspond to greater risks of physical illness or
injury, the peak current is but one factor in an individual's
experience. Similarly, pain is but one risk of physical harm that ESDs
pose. The devices pose serious risks of other short- and long-term
psychological and physical harms, as discussed in the literature and at
the Panel Meeting.
4. Information From State Agencies and State Actions on ESDs
    FDA reviewed complaints regarding ESD use made to the Massachusetts
Disabled Persons Protection Committee (DPPC) from August 30, 1993, to
July 28, 2013. Of 53 complaints, DPPC screened out 18 as not meeting
complaint criteria; DPPC found 22 more were unsubstantiated. The
remaining 13 complaints described the following AEs: Burns or tissue
injury (6 reports), inappropriate device use (3 reports), negative
emotional reactions (3 reports), and PTSD (1 report).
    In 2007, the Massachusetts Department of Early Education and Care
(DEEC) conducted an investigation of JRC's Stoughton Residence, where
GED devices were used on individuals living there (Ref. 70). According
to the Investigation Report, an individual reported waking up because
his roommate was screaming; his roommate had been asleep but was
shocked by a GED, waking him and causing him to scream. JRC staff
reported that ``the skin was off of the area'' of the leg where GED
shocks had been applied, that the GED was removed from the leg
``because the area on was too bad to keep the device,'' and either the
individual who received the shocks or the staff (it is not clear who)
believed a stage two ulcer was in the area where skin was missing (Ref.
70).
    In 2006, the New York State Education Department (NYSED) conducted
an onsite review of JRC's behavior intervention programs, with purposes
including identification of any health and safety issues relating to
JRC's use of aversive interventions (Ref. 71). The review was conducted
by NYSED staff and three behavioral psychologists serving as
independent consultants. It included a review of school policies,
student records, observations of school and education programs, and
interviews with staff and randomly selected individuals living at JRC.
The reviewers witnessed staff rotating GED electrodes on individuals'
bodies at regular intervals to ``prevent burns that may result from
repeated application of the shock to the same contact point'' (Ref.
71).
    During interviews, individuals reported ``pervasive fears and
anxieties related to the interventions used at JRC,'' which include
other interventions in addition to the GED devices. Although not
reported as relating specifically to GED use, one patient stated she
felt depressed and fearful, that her greatest fear was having to stay
at JRC past her 21st birthday, and that she thought about killing
herself every day. The review notes various other potential negative
effects that may result from aversive behavioral strategies, such as
depression, social withdrawal, aggression, and worsening of PTSD
symptoms in individuals diagnosed with PTSD, though it did not report
any specific instances of these adverse effects related to GED use.
    NYSED also submitted a comment to the 2014 Panel Meeting docket
stating that it has received reports of collateral effects from the use
of these devices, such as increases in aggression and increases in
escape behaviors or emotional reactions. NYSED states it has received
``numerous reports of students who have incurred physical injuries
(burns, reddened marks on their skin) as a result of being shocked and
for whom parents and students themselves have reported short-term and
long-term trauma effects as a result of use of such devices or watching
other students being shocked (e.g., loss of hair, loss of appetite,
suicidal ideation).'' NYSED believes it is well established that stress
and trauma impair brain functioning. According to NYSED, one student
explained, ``I am scared and sometimes I feel like my life is in
danger. There are days when I am scared to even say a word to anyone. I
am afraid to wake up because I never know what is going to happen to
me. I think I should not have to live in fear and be scared . . . I get
so depressed here I wish my life by fast'' (Ref. 72).
5. Information From the Affected Manufacturer/Residential Facility
    JRC acknowledges the risk of physical harms to the skin, that ``in
rare cases, mild erythema of the skin may result'' that disappears
within an hour to a few days, ``less than 1% of applications result in
<1 mm lesion,'' and ``it is possible that repeat exposure to the GED
skin-shock could result in blistering'' (Refs. 21 and 73). With respect
to psychological adverse effects, JRC states, ``there also may be
brief, temporary anxiety just prior to the delivery of the application
as well as occasional harmless avoidance responses (e.g., tensing of
the body, attempts to remove the electrode in some cases)'' (Ref. 21).
JRC also acknowledges that, ``in very rare circumstances, the GED may
errantly deliver an unintended skin-shock to a patient,'' either when
the shock is delivered to the wrong patient or due to spontaneous
activation (Ref. 73).
    In line with the decades-old research that considered pain or
discomfort to be merely an indicator of effective treatment (see
section II.A.2), JRC does not include pain in its discussion of AEs
caused by the device. Two tables provided by JRC in one of its
submissions suggest its GED devices may not cause pain based solely on
their peak current levels (Ref. 21). However, as discussed in section
I.C, conclusions regarding pain based on peak current alone are
difficult to draw, and the stimulus-pain matching tables in some of the
sources cited by JRC are not based on shock sources akin to ESDs. JRC
elsewhere acknowledges ``the stimulation may be considered painful by
some patients'' (Ref. 73), and when asked directly whether the stimulus
causes pain at the Panel Meeting, Dr. Nathan Blenkush, JRC's Director
of Research, answered ``yes.''
    Except for the harms described earlier, JRC maintains that it ``has
not found any side effects associated with aversive conditioning''
(Ref. 21) and ``there are no confirmed reports or confirmed medical
evidence that patients have any negative psychological side effects
related to any discomfort experienced due to therapy with the proper
use of the GED devices'' (Ref. 73). FDA's review of records collected
as part of a 2013 inspection of

JRC did not reveal any AEs reported by JRC for individuals with ESDs. A
former JRC clinician commented that he ``did not observe any permanent
negative side effects'' (Ref. 74). JRC concludes, ``the medical
literature cited by FDA [in the FDA Executive Summary for the Panel
Meeting] did not show any evidence of profound, sustained, or
significant harm or patient injuries resulting from use of ESDs'' (Ref.
21).
    However, with respect to psychological harms, JRC's records provide
compelling evidence of risks of such harms that may result from GED
use. For example, a JRC document entitled, ``Procedures to Facilitate
the Assessment of Possible Collateral Effects,'' dated June 14, 2012,
directs staff to note ``any sign of any adverse effect on the student
that may be resulting from the use of aversive interventions,'' and
``look for any collateral effects that may be related to the
administration of an aversive intervention.'' The collateral effects
listed in the JRC document include, but are not limited to: Nightmares,
intrusive thoughts, avoidance behaviors, marked startle responses,
mistrust, depressions, flashbacks of panic and rage, anger,
hypervigilance, and insensitivity to fatigue or pain. The corresponding
section of the training manual headed ``Responding to Collateral
Effects'' further directs staff to look for ``signs of any form of
distress or discomfort,'' including but not limited to: Changes in
sleep patterns, loss of appetite, confusion, irritability, lack of
energy, sadness, mood swings, significant weight loss, loss of
interest, fatigue and lack of energy, difficulty concentrating,
agitation, restlessness, or irritability, withdrawal from usual
activity, and feelings of helplessness. Another JRC document entitled
``Pre-Service Training Manual,'' dated September 11, 2012, contains the
same information.
    Although the patient records submitted by JRC do not indicate
occurrences of any of these harms, and JRC's comments claim they
adequately train their staff, monitor individuals on ESDs, and report
adverse events, FDA has reason to doubt that none of these harms
occurred. As discussed earlier, impairments with patient communication
and provider recognition pose difficulties in identifying harms caused
by the device, even for vigilant staff. State agencies in Massachusetts
and New York have reported problems with staff supervision of
individuals and monitoring of adverse events at JRC. For example, the
2006 NYSED review of JRC's program found that the collateral effects of
punishment ``are not adequately assessed, monitored, or addressed,''
and ``[t]here does not appear to be any measurement of, or treatment
for, the possible collateral effects of punishment such as depression,
anxiety, and/or social withdrawal.'' Further, ``[s]kin shock has the
potential to increase the symptoms associated with PTSD, yet there is
no evidence of data measuring these possible side effects or therapies
designed to treat these symptoms'' (Ref. 71). The 2007 Massachusetts
DEEC investigation resulted in several determinations of deficiencies
in patient oversight at one of JRC's residential facilities, including
lack of necessary training and experience among staff, problems
regarding communication of medical issues, monitoring staff neglect of
responsibilities that ``compromis[ed] the supervision and the safety of
residents,'' and staff failure ``to monitor the residents in a manner
that assured their health and safety'' (Ref. 70). Given these findings,
patient records may well fail to capture occurrences of harms.
6. Information From Patients and Their Family Members
    Although three individuals formerly at JRC who spoke at the Panel
Meeting either did not mention any harms or stated the GED did not harm
them, two other individuals formerly at JRC described a variety of
harms related to their experience with the GED, including panic and a
fear of authority and being controlled, severe muscle cramps that would
last 1 to 2 days, skin burn marks, terrible pain from the site of GED
application on the leg down to the foot, loss of sensation in the leg
and skin, frequent misfires, nightmares, freezing up upon hearing
certain sounds associated with GED application, and flashbacks.
    Three individuals formerly at JRC interviewed by FDA clinicians
asserted the following additional serious AEs resulting from GED use:
Heart palpitations, seizure, depression, and suicidality. These
individuals described the GED shock as ``a thousand bees stinging you
in the same place for a few seconds,'' a ``bad bee sting,'' and
``extremely painful,'' and gauged the pain level from 5 to 8, depending
on the GED model and the location of the shock on the body.
    Some of the relatives of individuals at JRC who spoke at the Panel
Meeting only spoke about the positive effects of the GED devices and
did not recount any adverse effects. Family members of individuals at
JRC and a JRC parent association also commented that individuals at JRC
have not suffered any side effects from the GED devices (see, e.g.,
Ref. 75). However, one parent of an individual formerly at JRC
described the following adverse effects from use of the GED: Burns,
fear, pain, PTSD, catatonia, and deep vein thrombosis caused by
catatonia.
7. Information From Other Stakeholders
    At the Panel Meeting, organizations concerned with the treatment
and rights of individuals with disabilities cited risks of the
following harms posed by ESDs based on first- or second-hand accounts:
Pain, fear, anxiety, panic, depression, attempts to avoid or escape,
nightmares, hyperarousal, flashbacks, burns, scars, loss of sensation,
muscle contractions, learned-helplessness responses, nerve damage,
muscle cramps, soreness, and neurological injuries such as seizures.
The presenters stated that, in some cases, ESDs hindered the
development of the very skills and behaviors necessary to control SIB
or AB.
    The written comments from disability rights organizations, as well
as health care professionals and other concerned citizens, identified
the following risks based on first- and second-hand accounts of the use
of ESDs: PTSD and other effects on brain function from stress,
including memory loss, loss of verbal communication, and sleep pattern
disturbances; severe psychological trauma; depression with possible
suicidal ideation; anxiety; increase in aggression; increase in escape
behaviors and emotional reactions; fear and aversion or avoidance;
seizures; migraine headaches; burns or red marks on the skin; loss of
hair; loss of appetite; pain; misuse of the device (misfires and
erroneous applications); persistent numbness and other neurological
injuries; and ear problems.
    One comment from a disability rights group cites a media report
quoting an expert in a lawsuit filed by a parent of an individual
formerly at JRC against JRC, describing the individual's state after he
was shocked repeatedly with a GED device: ``He was essentially in what
we would call a catatonic condition . . . That means a condition that
happens with people that are acutely psychotically disturbed'' (Ref.
76).
    Another comment from a psychologist, who has worked with patients
exhibiting SIB and AB, reports witnessing patients waking up screaming
from nightmares, which only happened after ESDs were used on them. The
psychologist reported that other patients have ``waking nightmares, in
which horrible memories of shock, pain, and restraint suddenly overcome

them, even during an otherwise happy event'' (Ref. 77).
8. Conclusion
    Based on the scientific literature regarding ESDs for SIB, AB, and
other unwanted behaviors, and regarding aversive conditioning
generally, FDA has determined that ESDs for SIB and AB present the
following risks: Depression; fear; escape and avoidance behaviors;
panic; aggression; substitution of other behaviors such as freezing and
catatonic sit-down; worsening of underlying symptoms, such as increased
frequency and bursts of self-injury; pain; burns; tissue damage; and
device misapplication or failure. Based on the scientific literature
regarding ICDs, FDA has determined that ESDs for SIB and AB also
present the risks of PTSD or acute stress disorder, shock stress
reaction, and learned helplessness. This literature also provides
support for the risks of depression, anxiety, fear, and pain.
    Experts in the field of behavioral science and State agencies that
regulate ESD use provide further support for the risks of depression,
PTSD, learned helplessness, fear, anxiety, substitution of collateral
behaviors, pain, burns, tissue damage, and inappropriate use. They
indicate ESDs have been associated with the additional risks of short-
and long-term trauma including suicidal ideation, chronic stress, acute
stress disorder, neuropathy, heart palpitations, and trauma from
falling. JRC's internal policies include long lists of risks for
aversives they use. Although these are not specific to ESDs, FDA finds
these lists further support that ESDs pose the risks of depression,
fear, anxiety, panic, learned helplessness, and substitution of
collateral behaviors, and they support that ESDs are associated with
the additional risks of nightmares, flashbacks, hypervigilance,
insensitivity to fatigue or pain, changes in sleep patterns, loss of
interest, difficulty concentrating, and withdrawal from usual activity.
Comments from individuals on whom ESDs have been used, their family
members, disability rights groups, and others, provide additional
support for the risks previously identified, and suggest ESDs may pose
the additional risks of severe psychological trauma, catatonia,
seizures, nerve damage, loss of sensation and numbness, migraine
headaches, impaired brain function due to stress, memory loss, and
muscle cramps.

B. Effect on Targeted Behavior

1. Scientific Literature
    FDA conducted an extensive, systematic review of the medical
literature for information assessing the clinical benefits of the use
of ESDs for SIB or AB. We identified a total of 45 studies, including
41 case reports or case series, a case-control study conducted outside
the United States (Ref. 29), a within-subjects comparison trial
conducted outside the United States (Ref. 78), a retrospective review
of 60 patient charts (Ref. 30), and a questionnaire followup study of
22 subjects on whom ESDs were used for aversive conditioning (Ref. 79).
(See table 3 of Ref. 3 for a summary of these 45 studies.) The 45
referenced studies showed that ESDs can have some immediate impact on
the targeted behaviors in some patients, i.e., they interrupted the
target behavior.
    We also evaluated 12 articles reviewing some of these 45 studies
that included specific clinical information on individual subjects and
examined the effectiveness of ESDs for various pathologies, e.g., AB,
SIB, or problematic behaviors more generally. (See Ref. 3 for
additional details.) These reviews generally support the conclusion
that ESDs used on patients exhibiting SIB or AB caused the immediate
cessation of the target behavior in some patients.
    One review article specifically examined reports of applying ESDs
to autistic children (Ref. 57). The authors noted that ``in all of
these studies, electric shock proved to be a highly effective
therapeutic agent with autistic children.'' They estimated that
positive effects compared to negative effects occurred at a ratio of 5
to 1. However, they also reported that setting-specificity (the
specific setting affects the results) may be an obstacle to an overall
satisfactory effect (see also Ref. 44). Similarly, a comparison of
different treatments for controlling behavior in individuals with
intellectual impairments or schizophrenia noted that, in terms of
immediate effects, ``punishment was the quickest means of suppressing
behavior'' (Ref. 80; see also Ref. 36). These studies show that ESDs
can interrupt SIB or AB, causing an immediate cessation of the
behavior.
    One study observed that a patient adapted to the stimulus intensity
(Ref. 29), and another study showed that the application of ESDs can
lead to adaptation (e.g., Ref. 36). Adaptation means that a patient no
longer responds at a particular level of stimulation--in the case of
ESDs, a particular shock strength--though the evidence is inconclusive
as to whether this occurs. Some, including JRC, believe that adaptation
occurs, and that when an individual adapts, the shock strength must be
increased in an attempt to achieve the same effects. However, experts
in the field, including at the Panel Meeting discussed in section
II.B.3, have explained that what has been characterized as adaptation
is really evidence of ineffectiveness, regardless of shock strength.
Thus, for some individuals, shocks are ineffective, including with
respect to immediate interruption or cessation of the target behavior.
    Twenty-two of the 45 literature studies reported on durability of
the effects of ESDs (Refs. 29, 30, 34, 36, 39, 40, 46, 50, 65, 79, and
81-92). A durable effect is one where an individual develops a
conditioned response, so the target behavior, along with the numbers of
shocks, is greatly reduced either while the individual continues to
wear the ESD or after the ESD is removed. Twenty of the studies
reported a durable effect that lasted from months to years. Two of the
22 studies reported no durability (Refs. 50 and 92). However, all 22
suffer from various flaws and limitations, as described in the next
section.
    Several of the literature reviews, which include reviews of many of
these 45 studies, made observations regarding durability. One review
opined that the use of ESDs might have long-term durability and
concluded that results of aversive conditioning studies ``suggest that
sufficiently intense punishers . . . may produce lasting reductions in
problem behavior'' (Ref. 59). However, this conclusion included the
qualifier, ``as long as the punishment contingency remains in effect,''
which implies that the authors were not discussing behavioral
conditioning durability after the removal of the punisher. The authors
also noted several limitations on the studies' findings. Importantly,
the available studies had methodological limitations that prevent
generalizing research findings to a treatment setting (Ref. 59). One
major limitation is that, because of the long duration of the studies,
unplanned changes or other uncontrolled conditions hinder attributing
observations to ESDs. The authors concluded that, ``[u]ntil additional
research on long-term maintenance is conducted, practitioners and
caregivers should not assume punishment will remain effective over the
long run'' (Ref. 59).
    Other reviews were much more doubtful regarding the durability of
ESD effects. One of the reviews discussed earlier in this subsection
reported that,

``[i]n marked contrast to [short-term effects], punishment and
extinction programs seemed to have the least durable success'' of any
of several behavioral treatments reviewed (Ref. 80). Another review
discussed earlier in this section reported that one author expressed
dissatisfaction with the lack of long-term durability (Ref. 57), and
another review similarly noted that the effect appeared to be short-
term only, i.e., symptoms are only ``momentarily suppressed'' (Ref.
55). A more recent review found that research into durability has
continued to lag (Ref. 93). See section II.C describing the state of
the art for a more comprehensive explanation of the reasons that the
research has lagged.
2. Literature Limitations
    The medical literature described in the previous section on the
effect of ESDs on SIB and AB suffers from a number of deficiencies that
limit confidence in the results. Most importantly, study design
deficiencies render these studies inadequate to draw any definitive
conclusions. As discussed in the previous section, 41 of the 45 studies
that the Agency's analysis identified were case reports or series,
which have limited evidentiary value in this patient population, as
discussed in the paragraphs that follow. Another study was a
retrospective analysis of patient charts (Ref. 30) that suffers from
various flaws, discussed later in this section. Another study reported
results from a questionnaire sent to 22 authors of case series
publications, of whom only 11 responded (Ref. 79), used an unscientific
sampling method (questionnaires were sent only to authors of published
articles, some published more than 5 years prior), and asked questions
that do not constitute validated measures of effects. The one
prospective case-control study examining ESDs for SIB and AB (Ref. 29)
only included 16 subjects (8 in the device group and 8 in the control
group) and did not use a direct measure of SIB or AB as the primary
outcome (instead, it measured a decrease in mechanical restraint).
Finally, the within-subjects comparison study looked at heart rate
changes as a measure of stress in five subjects, and it showed that
active treatment with ESDs correlated to a statistically lower mean
heart rate than when subjects were not wearing the ESD (Ref. 78). The
authors surmised that heart rate was an indicator of stress but this
correlation has not been demonstrated to be a valid marker of anxiety,
and direct measures of reduction in SIB and AB were not taken. No
randomized controlled trials directly examined ESDs for SIB or AB.
    Generally, a study's strength or weakness is related to design in a
number of ways, particularly through randomization, control, and the
number of study subjects. Randomization distributes characteristics
that could affect the results evenly across conditions. This equalizes
the influence of nonspecific processes not under study, e.g., the
effects of participating in a study, being assessed, receiving
attention, or self-monitoring. Control conditions attempt to subtract
other influences to ensure observations do not have alternative
explanations. They enable a comparison to a baseline in order to
distinguish effects, if any, of the device being studied. A larger
number of subjects provides greater confidence that the same results
can be expected for any given person under the same conditions.
Randomization and controls allow the researcher to determine cause-and-
effect, as opposed to mere coincidence, with greater confidence. As a
general rule, these study design features improve the strength of
conclusions, which is particularly useful in cases with potentially
significant confounding factors, subtle outcomes (including AEs), or
potential bias.
    In most cases, a study that is not randomized, controlled,
inclusive of a sufficient number of subjects, or that suffers from more
than one of these deficiencies, will yield weaker conclusions, and thus
more uncertain predictions. Studies that fail to account for AEs will
also yield weaker conclusions with respect to the benefit-risk profile,
because such a study would not fully account for the risks.
    In the case of ESDs used for SIB or AB, randomization, control,
large numbers of subjects, and AE reporting are critical to
understanding the benefit-risk profile. Many factors contribute to the
manifestation or reduction of target behaviors and therefore can be
significantly confounding. Those factors may include, but are not
limited to, the underlying condition, environmental cues, transient
psychological and physical states, and the treatment plan details. ESDs
used for SIB or AB may also produce subtle outcomes, especially when
the individual has intellectual or developmental disabilities that can
impair communication. Subtle outcomes may include, but are not limited
to, the development of stress disorders, fear and anxiety, pain and
suffering, or learned helplessness. In light of such circumstances,
drawing conclusions about the effectiveness of ESDs for SIB and AB,
especially with respect to durable conditioning, is difficult in the
absence of randomized controlled trials.
    In a randomized controlled trial, the researcher will randomly
assign each subject to one group, at least one of which is a control
group. A randomized controlled trial is prospective; the researcher
creates different conditions across groups at the outset and will
observe outcomes in the future. The researcher will eventually compare
the outcomes across groups, with the control group providing confidence
that the researcher-set conditions were responsible for any
differences. A randomized controlled trial is one of the best designs
for strong conclusions in most cases, including the use of ESDs for SIB
and AB. In reviewing all the evidence, FDA did not identify any
randomized controlled trials studying the effects of ESDs for SIB or
AB.
    Other designs are often considered to provide weaker evidence,
which is the case for ESDs used for SIB and AB. For example, a case-
control study is usually considered to be weaker because it does not
observe randomized subjects but, instead, retrospectively compares two
types of subjects (one acting as the control) by observing different
outcomes and working backwards to explain the cause of one set of
outcomes. Retrospective reviews are often considered weaker still
because they do not include a control group. Case reports or series are
even weaker because they report on, and attempt to explain, the
experiences of single individuals.
    Conclusions drawn from these other designs are generally considered
weaker because they do not rule out other causes for any differences in
results, including subject selection bias, as effectively. Designs that
take an outcome as given and then work backwards in an attempt to
explain it are more vulnerable to bias than prospective designs.
Single-subject designs such as case studies are less likely to yield
outcomes that would be typical for other such subjects. The conclusions
drawn from randomized controlled trials are therefore generally
considered much more reliable than these other designs. The general
rule applies to ESDs used for SIB or AB because of the known multiple
confounding factors, possible subtle outcomes (including unassessed
AEs), and because bias is of particular concern. Thus, the reliance on
weaker study designs for trials on ESDs limits the conclusions that may
be drawn regarding their effectiveness.
    Other weaknesses stem from the fact that the majority of research
articles

were published in the 1960s and 1970s. Specifically, researchers
published 26 articles before 1980, 12 from 1980 to 2000, and 7 since
2000. Consequently, most of the articles do not adhere to current, more
exacting peer-review standards for study conduct and reporting. This is
evident not only from the time of publication but from the information
provided regarding study design, conduct, and reporting. (See also
section II.A.2, discussing likely underreporting of AEs.)
    Some of the papers have significant methodological limitations in
addition to those already discussed. For example, the 2008 review by
Dr. Israel and colleagues (Ref. 30), which provides a retrospective
analysis of 60 subjects purporting to show all achieved successful
treatment (defined as at least a 90 percent reduction in the targeted
behavior), failed to explain, among other standard disclosures, data
collection procedures, whether it was retrospective or prospective, and
why and how staff made certain decisions that differed from patient to
patient (e.g., the number of GED electrode sets applied). In short,
that review did not take certain standard precautions that help to
identify and eliminate bias and variability in order to understand
results objectively.
    A 2010 review by Dr. Israel and colleagues is a series of case
reports on seven individuals at JRC (Ref. 94). The authors investigated
the addition of punishment-based techniques to behavioral modification
plans for people for whom positive-only techniques and pharmacotherapy
had been reported to have failed previously, and reported success from
skin-shock treatment at JRC. A review of case reports could be useful
to examine initial results for continued investigations of an
intervention; however, it was retrospective and covered few subjects.
The authors also failed to describe how they chose the specific case
reports, meaning that the authors may have overlooked or omitted
individuals for whom punishment-based techniques did not affect the
outcome. In contrast, studies that do not suffer from such
methodological limitations have found that the removal of punishment
techniques did not lead to an increase in problem behaviors (e.g., Ref.
95).
    A paper by Dr. van Oorsouw and Dr. Israel, et al. investigated the
effects of GEDs, but it too suffered from significant limitations (Ref.
96). The authors claim that contingent shock (another term for aversive
conditioning with ESDs) significantly improved some individuals'
behaviors; however, in each of the categories measured, no more than
four out of nine subjects demonstrated improvement. The other subjects
``did not show any change.'' Regarding measurements, the investigators
apparently included ``soft'' neurological signs and symptoms,
especially involuntary movements, which are common for individuals who
exhibit SIB or AB. They apparently applied shocks for such involuntary
movements even though the patients would not be able to consciously
control those behaviors. The investigators also appeared to consider
certain behaviors, such as refusing academic tasks, as target behaviors
even though such behaviors are not clinically considered aggressive or
self-injurious. Thus, the related results do not actually reflect the
use of the devices for SIB or AB. Additionally, the investigators
studied a small group with highly varied characteristics, e.g.,
intellectual capacity and primary diagnoses. Such high variability
among so few patients suggests that the investigators may not have
obtained results that could be generalized to other patients, even
without the aforementioned deficiencies.
    Further, the 2008 and 2010 reviews by Dr. Israel and colleagues
were published in The Journal of Behavioral Analysis of Offender and
Victim Treatment and Prevention (JOBA-OVTP). JOBA-OVTP no longer
appears to exist, and we determined that when it was active, it was not
a peer-reviewed source because the articles were only reviewed by the
journal's editorial board rather than an expert whose sole role was to
verify accuracy and validity. Failure to conduct peer review indicates
that the source is unreliable because its articles were not subjected
to independent expert critiques that help ensure unbiased, evidence-
based conclusions.
    FDA also identified conflicts of interest relevant to some of the
articles. While possible conflicts of interest do not on their own
discredit results, certain safeguards help maintain the credibility of
the authors. Authors commonly disclose possible conflicts in their
papers, allowing readers to consider the information accordingly, and
authors do not normally decide whether to accept their own papers for
publication. However, FDA has particular concern with the bias that may
have influenced many of the papers about the effects of ESDs on SIB or
AB. For example, Dr. Israel, the founder of JRC, was an author of
several of the 45 articles; Dr. Blenkush, the facility's Director of
Clinical Research, has co-authored several papers with him. At the time
some of those papers were published in JOBA-OVTP, Dr. Israel was on the
journal's editorial board and thus part of the reviewing and approving
body. Considering the lack of peer review of these papers, any
potential bias, intentional or not, in favor of the company or Dr.
Israel's personal interests apparently went unquestioned before
publication. In addition, without the expected conflict disclosures,
readers were not adequately notified of any potential bias, which could
affect their interpretation of the papers in consideration of the
source.
    The evidence in the scientific literature of the effects of ESDs on
individuals' SIB or AB is therefore generally weak, and it is
particularly weak with respect to the effectiveness of ESDs in
achieving durable, long-term conditioning. This is not only because
fewer studies considered long-term effectiveness, but more importantly,
these studies failed to control for other treatment interventions
applied over time, meaning that any effects observed may or may not
have been due, in whole or in part, to ESDs. Thus, although the
scientific literature indicates some individuals may stop engaging in
the target behavior as an immediate effect of ESD application, the
serious limitations discussed previously mean that durable long-term
conditioning has not been established.
3. Information and Opinions From Experts
    The Panel Meeting convened by FDA to consider the benefits and
risks of ESDs generally held opinions consistent with our review of the
literature. When asked whether the evidence presented at the Panel
Meeting demonstrates that ESDs provide a benefit, the Panel was
divided. However, approximately half the Panel agreed that there was a
benefit, but they qualified their answers by explaining that the
evidence showed a benefit from the interruption and immediate cessation
of the target behavior. They noted the weaknesses in the evidence,
including some of the limitations discussed previously. Three panelists
were undecided, with one indicating that anecdotal reports suggest
benefit for an ill-defined subpopulation. About one-third of the Panel
answered no, the evidence does not show that ESDs provide a benefit to
patients; they cited the poor quality of the evidence, the lack of
recent data, and the failure to examine long-term effects.
    At the Panel Meeting, one of the experts in the field observed that
intervention with an aversive stimulus should not entail increasing the
intensity, especially with ESDs, and that what might be characterized
as adaptation or habituation to a particular

shock level actually indicates that skin shock is ineffective for that
individual. As he explained, ``the way this whole process works is that
within a given range in terms of interventions that we use, some are
effective and some are not, and if they're not effective, you go on to
something else. . . . To use an analogy, a small amount of lemon juice
might be another aversive event, but if that doesn't work, we don't put
acid on the tongue.'' With respect to ESDs, because the shock is
designed to be effective very quickly, when it appears an individual
has habituated to the stimulus, ``it's not really habituation; that is,
they haven't adapted to it. It's simply ineffective, and you would move
on rather than to step up the voltage, so to speak.'' Thus, what may be
characterized as adaptation to a particular ESD shock level would be
evidence of ESD ineffectiveness regardless of shock level.
    Pointing to evidence FDA has considered, Dr. Tristram Smith's
expert opinion characterizes the results of the studies on aversive
conditioning with electric shock as ``highly favorable,'' indicating
that aversive conditioning reduces or eliminates severe SIB and
aggression. As discussed in section II.A.3, he concludes that ESDs can
be effective in at least some cases, but he is careful to note that the
overall strength of the evidence is low (Ref. 8). Dr. Smith highlights
many of the same evidentiary limitations discussed earlier, especially
that the results may not be generalizable because they are based on
small numbers of subjects and seldom provided information on key
parameters, including recruitment, retention, standardization of
measures, and participants' treatment history. Dr. Smith echoes the
concerns discussed earlier that the ability to reproduce the studies'
results in clinical practice is unclear because of differences between
medical research and treatment settings, and notes that publication
bias weighs in favor of reporting a clear effect on SIB and AB, since
reports of clear effect are more likely to be published (Ref. 8).
Finally, he observes that most of the few available studies have only
evaluated short-term effectiveness and not long-term outcomes.
4. Information From State Agencies and State Actions on ESDs
    According to NYSED, in 2006 it promulgated regulations to prohibit
future use of ESDs in public and private schools serving New York State
students, and require review of each student who continued to receive a
behavioral intervention with an aversive conditioning device by
independent panels of three behavior experts. NYSED reports that, ``in
almost every instance over a 6-year period of time, these panels have
determined after reviewing student-specific information that use of
such a device was not warranted.'' The panels ``consistently reported
that the data presented regarding the use of an aversive conditioning
device lacked evidence of effectiveness.'' NYSED also found that the
long-term use of ESDs further demonstrates the lack of efficacy.
Specifically, many students remain subject to ESDs for several years,
and many continue to receive shocks long into their adult lives. In
2006, NYSED documented that 17 New York citizens remained subject to
ESDs for 3 to 7 years (Ref. 72).
5. Information From the Affected Manufacturer/Residential Facility
    JRC asserts that its ESDs provide substantial benefits to
individuals by causing a meaningful decrease in the aggression, self-
injury, or other harmful behaviors they exhibit, and that the
literature evidences more positive side effects than negative ones. JRC
representatives have stated that they have observed multiple positive
side effects: The individuals ``are no longer a threat to themselves or
others. They are happy, they are healthy, they are medication and
restraint free, and for the first time in their lives they are
learning.'' In many individuals, JRC staff ``see a dramatic improvement
in the affect and the way that they present. Many of them are able to
receive medical treatment that they wouldn't otherwise have been able
to receive. They're able to enjoy time with their family.''
    Regarding the effectiveness of the devices in conditioning
patients' behavior, the JRC representatives stated at the Panel Meeting
that, of 83 individuals whose treatment plans included use of the GED
devices, 12 no longer wear the devices, 11 additional individuals have
stopped using ESDs altogether, and 6 have not received any applications
in the past 6 months. The representatives gave a detailed account of an
individual who they claim was successfully treated with a GED device.
In their view, banning ESDs would mean many individuals ``are going to
go back to the state of being restrained, of losing access to
education, and are going to lose access to the vocational progress they
have made, and they are going to return to a life of mechanical
restraint and high doses of drugs.''
    In its comments to the docket for the Panel Meeting, JRC submitted
patient data purporting to demonstrate the durability of the effects of
GED devices in reducing or eliminating SIB and AB. However, this
evidence lacks key information and provides only weak support for the
durable effectiveness of ESDs. Importantly, the ESDs were part of
multi-element interventions and thus were not solely responsible, if at
all, for any long-term changes in individuals' behavior. As section
II.C.1 explains, multi-element treatment plans that do not involve the
use of ESDs can be expected to result in durable effects (e.g., Ref.
97).
    Although JRC claims on its Web site that its devices are 100
percent effective (Ref. 98), at the Panel meeting JRC's Director of
Research acknowledged, ``The GED and skin shock is not 100% effective
for everybody . . . there are cases in the literature that show that
some people it doesn't work for.'' He acknowledged that sometimes
patients adapt to ESD shocks:

    [O]ne of the things that happens sometimes when you use these
types of devices is that there's a phenomenon of adaptation, which
means that the skin shock device no longer functions as a punisher
and the behaviors return. And that comes from using it over and over
again, and the frequency of the behaviors accelerates and it no
longer functions as a punisher, it no longer controls the behaviors.