Last week, a US Food and Drug Administration (FDA) advisory panel heard "horrendous" stories of the misuse of electrical stimulation devices (ESDs) that are currently approved to control unwanted behaviors in patients with developmental disorders and impassioned pleas from patient advocacy groups to have them banned.
As reported by Medscape Medical News, the majority of the members from the FDA's Neurological Devices Panel of the Medical Devices Advisory Committee agreed and voiced support for a complete ban on ESDs.
Although some former patients reported relief after undergoing treatment with ESDs, professional society representatives voiced outrage that the devices are still in use in any capacity.
"The use of noxious electrical stimulus is inhumane," said Jennifer Bellamy, legislative council for the American Civil Liberties Union (ACLU), during her testimony before the panel.
"The fact that we consider using it on people with disabilities and only people with disabilities is evidence of bias and discrimination. And we urge the ban of such devices," said Bellamy.
Torture, Not Treatment
ESDs are typically used to prevent repeated self-injurious behaviors (SIBs), such as head banging, hand biting, eye gouging, and other aggressive behaviors. But the devices have been identified with several potential serious adverse events (SAEs), including burns and tissue damage, depression and anxiety, pain and discomfort, post-traumatic stress disorder, and even suicidal behavior.
Part of the reason the meeting was called was to determine whether such devices should be banned or placed under specific restrictions.
Professional societies that made emotional presentations to the panel included the Disability Law Center of Boston, Massachusetts; the National Association of State Directors of Developmental Disabilities Services; the National Association of Councils on Developmental Disabilities, as well as the ACLU.
Nancy Weiss, codirector of the National Leadership Consortium on Developmental Disabilities, cited several examples of alleged misuse of ESDs that took place at the Judge Rotenberg Educational Center (JRC), which is a facility for developmentally disabled students in Massachusetts where unwanted behaviors such as asking to go to the bathroom or complaining of pain were treated with electrical shocks.
In 2010, Mental Disability Rights International issued a report entitled Torture Not Treatment that outlined in graphic detail the alleged abuses that took place at the JRC using ESDs.
"One girl who was blind, deaf and non-verbal was moaning and rocking. Her moaning was like a cry. The staff shocked her for moaning. Turned out she had broken a tooth. Another child had an accident in the bathroom and was shocked," according to the MDRI report.
There are currently 4 FDA-cleared ESDs "that are generally indicated to treat SIB in patients that are usually diagnosed as autistic or with intellectual and development disabilities," notes the FDA.
In addition, the JRC uses 2 devices that have been modified from the FDA's cleared list and have not been approved for use. One of these puts out an average current that is almost 3 times stronger than anything approved by the FDA.
"While the use of shock is court approved, it is a rubber stamp process. In years of tracking the probate court approval process, we have found not even 1 case in which the request to use shock was denied," said Weiss.
She concluded by urging the FDA to ban all ESDs, including those that have been modified.
"We do not advocate the use of punishment techniques to deter challenging behaviors. Our overarching goals are to ensure these people have the same rights as others in society, including the freedom from abuse," added Maureen Fitzgerald, director of disability rights at The Arc of the United States.
This device "is used in the guise of treatment, but it is actually punishment. Using aversive procedures to change behaviors of people with developmental disabilities is dangerous and dehumanizing, it results in the loss of dignity, and it's unacceptable in a civil society," said Fitzerald.
Room for Debate?
Although some clinicians on the panel reported successful outcomes after careful and judicious use of the devices in severe cases, the majority noted that there is currently insufficient evidence of efficacy.
The majority of panel members also noted that none of the currently approved treatment options are effective for individuals with SIB and aggressive behavior.
"But no psychiatric intervention is universally effective," said panel member Warren Bickel, PhD, from the Virginia Tech Carilion Research Institute in Roanoke.
"There are many therapies that have effect; we just don't know which works when for whom. I think the idea of defining refractory, serious self-injury and then saying that if 1 treatment works for 1 group or 1 person it should work for everybody is a mistake," added Scott Y. Kim, MD, PhD, from the Clinical Center at the National Institutes of Health.
The panel was also asked to consider whether device or labeling restrictions would address the risks for adverse events associated with ESDs. The majority of the members said that no strategy would be workable.
"I'm not sure that there's anything that could be changed related to labeling at this point to take care of the problems we've had," said Daniel Armstrong, PhD, professor of pediatrics at the University of Miami Miller School of Medicine in Florida.
"The one possible thing I see is that if individuals are engaging in behaviors that are life-threatening or involve significant potential loss or damage to an organ of themselves or another, perhaps the lowest level of the device could be used," he said.
"This is a nonvalidated technology; and I don't think mitigation can be discussed at this time," added Steven Miles, MD, from the Center for Bioethics at the University of Minnesota Medical School in Minneapolis.
The biggest debate, however, came during the discussion on whether there should be an official ban, and if so, how extensive it should be.
Full Ban Recommended
The FDA is authorized to ban a medical device that presents "an unreasonable and substantial risk of illness and injury" after all available data have been examined, according to Section 516 of the Federal Food, Drug, and Cosmetic Act.
The panel consensus was that these devices do present substantial and unnecessary risk and recommended a full ban, including for patients who are currently showing success with the treatment.
"If there is a ban, it should be applied to all of the devices in the distribution. The risk of the device is either unreasonable or it's not," said Erika Augustine, MD, a pediatric neurologist at the University of Rochester Medical Center in New York.
Although several other panel members want the ban to be prospective and not retrospective, the majority said that it should be the same rule across the board.
As for transitioning patients to new treatments, suggestions included doing so gradually during a period of 3 to 6 months, and if the behavior worsened during that period, a compassionate exemption should be placed on the device.
In other words, "the issue of individualization is very important," summarized panel chair Lynda J. Yang, MD, PhD, from the Department of Neurosurgery at the University of Michigan in Ann Arbor.
At the meeting's conclusion, a representative from the FDA noted that although the organization was pleased to hear the various recommendations, it has not yet made any final decisions.
Docket number FDA-2014-N-0238 has been opened for any individual to make public comments about a possible ban on ESDs until June 24. The FDA's 126-page Executive Summary, which was prepared before the meeting, can be downloaded from its Web site.
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Cite this: FDA Panel Hears Horror Stories of Shock Treatments - Medscape - May 01, 2014.