Debate over effectiveness of skin shocks continues

When the Food and Drug Administration will finally issue its final ban on electrical stimulation devices for treating self-injurious and aggressive behaviors is anyone’s guess.

But there is no doubt about how firmly a Massachusetts school embraces using a device to deliver either 15.25 or 44 millilamps of electric current to the arms or legs of individuals with intellectual disability and autism, many of whom also have psychiatric disorders.

Skin shocks — not to be confused with the voluntary depression treatment known as electroconvulsive therapy (ECT) — are designed to make a patient stop an undesirable behavior by causing them to associate it with pain.

Contingent skin shock delivered via a Graduated Electronic Decelerator (GED) “has changed the lives of those that have been approved for its use,” said Glenda P. Crookes, executive director of the Judge Rotenberg Educational Center in Canton in an email to New England Psychologist.

JRC contends that a 1987 consent decree gives it the permanent right to use GED shock treatment as an aversion therapy on patients so long as an individual’s treatment plan is reviewed by a probate court.

Before that court approval, JRC clients were restrained and overmedicated but now cases of extreme aggression and severe self-harming behaviors at the residential facility are rare, Crookes said.

“These clients are now free of medication and restraint and have access to things that they had not been possible previously,” Crookes wrote. “They are living in the community, getting an education, visiting with their families, working, volunteering, etc.”

Massachusetts Probate Court Katherine A. Field agrees with JRC, which appears to be the only facility in the country that uses GEDs for this population.

In a June 20 ruling, Field denied a 2013 petition by the Executive Office of Health and Human Services to terminate the consent decree and regulate JRC like any other provider DDS oversees in Massachusetts.

The case was argued over 44 days between October 2015 and October 2016 with 788 documents, photographs and videos and testimony from nearly 30 witnesses.

Massachusetts Attorney General Maura Healey’s office has appealed Field’s decision on behalf of the commissioners of DDS and the Department of Early Education and Care.

Even though the prevailing wisdom among those who work with clients with autism and intellectual disabilities has moved toward positive behavioral interventions and support, Field found that the state failed to show professional consensus that skin shocks breach the accepted standard of care.

In her 50-page decision reviewing findings of fact, Field cited JRC data that showed a reduction in the average monthly occurrence of aggressive behaviors from 457.52 pre-GED to 7.99 after.

Field also cited “credible testimony” from several former clients and parents who credited skin shocks with a significant improvement in their behavior.

The judge acknowledged expert testimony regarding the developments in psychotropic medications that were unavailable before the consent decree took effect. While Field said JRC might want to review whether such drugs should warrant a revision of its policies, she said there was no evidence at the hearing that they would be more effective than the current aversive treatment.

“In addition, psychotropic drugs have the potential for side effects, some of which can be quite serious,” Field wrote.

Field cited the American Psychological Association Division 33 guidelines allowing for the use of highly restrictive or aversive procedures “only in instances in which there is an immediate physical danger to self or others, or there may be permanent sensory of other physical impairment, or the client may be prevented from receiving necessary medical, surgical, or emergency medical services, or the frequency or intensity of the problematic behavior prevents adequate participation in normal activities appropriate for the individual’s circumstances and personal goals.”

Also cited was an Association for Behavior Analysis textbook that deemed mild electric shock as an effective and efficient means of reducing self-injurious behaviors.

There was conflicting testimony at the hearing over the degree of pain experienced by JRC clients who received a two-second skin shock from a GED.

Some experts described the shocks as extremely painful. The mother of one client and a physician who is the father of another client “both testified that the shock hurt but was brief,” according to Field’s decision.

Field’s decision makes no acknowledgement of a proposed ban by the FDA on electrical stimulation devices. The proposed ban published in April 2016 would apply to new devices and those already in use and indicates the federal agency “has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.”

The proposed ban indicates the FDA determined that individuals subjected to skin shocks experience varying degrees of pain and the potential for burns, ulcers, anxiety, panic, depression, and undesired self-restraint.

The FDA also found that assessing the psychological adverse effects of skin shocks on people with intellectual and developmental disabilities is difficult because of their diminished ability to communicate.

FDA Commissioner Scott Gottlieb acknowledged the proposed final ban was still a priority in an Oct. 17 post on the agency’s website. FDA bans devices only on rare occasions when deemed necessary to protect public health.

“We believe these products present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling,” Gottlieb stated.

But when will the final ban finally happen?

FDA spokeswoman Sandy Walsh said: “The FDA is still in the process of finalizing the rule and we cannot speculate on timing.”