Association for Behavior Analysis International

The Association for Behavior Analysis International® (ABAI) is a nonprofit membership organization with the mission to contribute to the well-being of society by developing, enhancing, and supporting the growth and vitality of the science of behavior analysis through research, education, and practice.

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47th Annual Convention; Online; 2021

All times listed are Eastern time (GMT-4 at the time of the convention in May).

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Symposium #272
CE Offered: BACB — 
Ethics
Challenging the FDA Ban on Electrical Stimulation Devices
Sunday, May 30, 2021
3:00 PM–3:50 PM
Online
Area: PCH/DDA; Domain: Service Delivery
Chair: Nicholas Lowther (Judge Rotenberg Educational Center)
Discussant: R. Nicolle Nicolle Carr (University of Oklahoma)
CE Instructor: Nathan Blenkush, Ph.D.
Abstract: Aversive conditioning devices have been utilized for treatment refractory self-injury, aggression, and other problem behaviors for over 50 years. In March of 2020, 6 years after disclosing consideration of a ban, the Food and Drug Administration (FDA) banned Electrical Stimulation Devices (ESDs) including the Graduated Electronic Decelerator (GED) for the treatment of self-injurious (SIB) and aggressive behavior (AB). The Judge Rotenberg Center (JRC) and the JRC Parents Association petitioned the FDA for a stay of action in relation to the ban and have filed an appeal of the ban with the United States Court of Appeals for the District of Columbia. The FDA issued a partial stay allowing patients already using ESDs to continue such use. Here we review the regulatory history of ESDs, the attack on ESD research methodology, internal FDA documents obtained through the Freedom of Information Act, and provide a status update on the challenge to the FDA ban. Taken together, we argue the FDA ban places political considerations before the individual needs of clients. Ethical considerations for behavior analysts with treatment refractory clients are discussed.
Instruction Level: Intermediate
Keyword(s): electrical stimulation, treatment refractory
Target Audience: The audience should have a working understanding of various experimental design methodologies and the treatments typically used for severe behaviors.
Learning Objectives: At the conclusion fo the presentation, participants will be able to: (1) describe the benefits and critiques of single-subject research and randomized controlled trials; (2) state the regulator factors associated with medical devices; (3) understand the status of a lawsuit to stop the ban.
 

Regulatory History and Mirroring Criticisms of Research Methodology for Electrical Stimulation Devices and Small N Designs

DAWN O'NEILL (Judge Rotenberg Center; Contextual Behavioral Science Institute)
Abstract:

Aversive conditioning devices have been utilized for treatment refractory self-injury, aggression, and other problem behaviors for over 50 years. Early devices were not regulated or classified by the FDA. In 1979, ESDs were classified as Class II medical devices. All medical devices must go through an FDA approval process. There have only been two medical devices banned by the FDA (powdered medical gloves and implantable prosthetic hair fibers). In 2020, the FDA presented a final ruling to ban the use of the devices for the treatment of self-injury and aggression, but not the device itself. An overview of the regulatory history of electrical stimulation devices (ESD) with emphasis on the Graduated Electronic Decelerator (GED) is provided. Additionally, the methodological attacks on the ESD research which mirror common objections to single-subject research methodology in behavior analysis are discussed. For example, the use of small samples, demonstration of cause and effect without a randomized control trial, limits of generalization, and prosthetic versus curative independent variables. The strengths and limitations of ESD research and treatment applications are discussed in relation to the code of ethics. Ethical codes pertain to reliance on scientific knowledge, treatment efficacy, and punishment procedures.

 
Challenging the FDA Ban on Electrical Stimulation Devices
NATHAN BLENKUSH (Judge Rotenberg Educational Center)
Abstract: In March of 2020, 6 years after disclosing consideration of a ban, the FDA banned Electrical Stimulation Devices (ESDs) including the Graduated Electronic Decelerator (GED) for the treatment of self-injurious (SIB) and aggressive behavior (AB). The JRC Parents Association and The Judge Rotenberg Center petitioned the FDA for a stay of action in relation to the ban and have filed an appeal of the ban with the United States Court of Appeals for the District of Columbia. The FDA issued a partial stay allowing patients already using ESDs to continue such use. Here the current status and rationale for challenging the ban is presented. The FDA acknowledged the existence of treatment refractory patients. However, the FDA claims the literature shows ESD’s cause harm and do not cause a long-term conditioning effect. Further, Positive Behavior Support (not applied behavior analysis) is offered as state-of-the-art treatment for SIB/AB. These claims are critically analyzed and discussed. Through documents obtained through the Freedom of Information Act, we show the FDA failed to disclose expert opinions indicating ESD efficacy. The FDA also failed to disclose opinions from sixteen of its own scientists suggesting ESDs presented only a remote probability of serious adverse health consequences.
 

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