By Brenda Baletti, Ph.D.

The U.S. Food and Drug Administration (FDA) is proposing to ban the use of electric shock therapy to treat self-harm or aggressive behaviors, including in children with autism or Down syndrome.

Electrical stimulation devices are used for a specific type of aversive shock therapy that delivers an “often-painful electric shock” to people exhibiting self-injurious or aggressive behavior.

Proponents of the devices say they condition people to stop the behaviors, which are frequently associated with underlying intellectual or developmental disabilities.

Self-injurious behaviors can include head-banging, hand-biting or skin-picking. In severe cases, the behaviors may escalate to breaking bones, self-blinding or ingesting dangerous substances. Aggressive behaviors can involve assaulting other people, often seriously.

The therapy, which works by administering the shocks as punishment whenever such behaviors occur, often targets the highly vulnerable, including disabled children.

Regulators note that many patients in this group may have limited ability to communicate or provide informed consent.

According to the FDA, the devices pose significant physical and psychological risks. They’re known to cause pain, burns, tissue damage, anxiety, depression, and post-traumatic stress disorder.

The agency concluded that these risks cannot be mitigated through labeling or changes in how the devices are used, prompting the proposed rule change.

Massachusetts school with 50 locations defends electric shock therapy

Most practitioners largely abandoned the practice decades ago. The Judge Rotenberg Educational Center (JRC), based in Canton, Massachusetts, is the only known institution in the U.S. that uses the devices to control disabled youth. JRC operates about 50 residences throughout Massachusetts.

A 2007 Mother Jones investigation found that six children died at JRC in its 36-year history, prompting numerous lawsuits and government investigations into its use of the therapy.

Students at the school reported being shocked for minor infractions that didn’t qualify as aggressive behavior. For years, the facility has repeatedly thwarted the FDA’s attempts to ban the practice.

“This is the worst type of demeaning and deplorable aversive therapy imaginable,” said Brian Hooker, Ph.D., chief scientific officer at Children’s Health Defense.

Therapies that cause pain or harm to children to manage behavioral dysregulation “should be strictly outlawed and forbidden,” he said.

“We also now know directly from these patients the horrors that some of them faced when aversive therapies were used for behaviors they could not control,” Hooker said. “The psychological damage to these individuals is unimaginable and those responsible for this damage should be criminally liable.”

The FDA previously proposed a similar ban under the Biden administration, but the effort was halted under the Trump administration, which paused the process, Mother Jones reported.

Now the FDA indicates it will decide on the rule this month.

When the agency opened the proposal for comments in 2024, over 8,500 people commented. The comments were overwhelmingly critical of the therapy.

If finalized, the rule would make it illegal to market or use electric shock devices for treating aggressive or self-injurious behavior. The ban would apply to both new and existing devices, though the FDA has suggested a transition period to allow patients to move to alternative treatments under medical supervision.

The rule would not prohibit all types of shock therapy. Other forms of electroconvulsive therapy, sometimes used to treat conditions such as major depressive disorder and bipolar disorder, schizophrenia and catatonia, would still be allowed.

Psychiatrists prescribe this type of treatment for approximately 100,000 people in the U.S., but the treatment’s safety and effectiveness are contested.

FDA: no credible evidence shock therapy works

The FDA first banned involuntary shock treatment for self-injurious or aggressive behavior in 2020. The agency said the practice posed an “unreasonable and substantial risk of illness or injury” and that there was no evidence to support its use.

JRC sued the FDA, leading a federal court in July 2021 to overturn the ban. At the time, the law did not allow the FDA to ban a device for specific uses — such as for treating self-injurious or aggressive behavior — without banning the device altogether.

In 2022, Congress passed a new Food and Drug Omnibus Reform Act, in part to expressly grant the FDA the authority to ban a device for specific uses.

In September 2023, the Massachusetts Supreme Judicial Court ruled that JRC could continue shocking children.

Supporters of the practice say that it effectively treats the behaviors, but the FDA said there is no strong evidence to support that claim.

The agency said the current rule change proposal is based in part on the same evidence it relied on for its initial attempt to ban the practice in 2020. However, the FDA also analyzed all data produced since then.

The agency said that JRC produced most of the studies submitted to the agency in support of the treatment. Of the five studies submitted, four were authored by JRC staff. They were all based on the same information and patient data, and all share major limitations of design, methodology and generalizability.

The FDA said no new evidence has altered the agency’s assessment of the devices’ risks, and it noted the likely underreporting of adverse events.

Regulators also noted that the subjective experience of the shock therapy is unpredictable, and patients may experience trauma and suffering regardless of how intense the shock is.

Patients can experience fear, panic, pain or a sense of being “terrorized,” particularly when they are unable to communicate their distress.

Hooker said, “All individuals need to be treated with dignity and respect, and the best position for autistic individuals is to ‘presume competence’ and intelligence despite any outward appearance of the child.”

Related articles in The Defender

• ‘Profound Autism’: Will New Definition Lead to Better Care, Research?
• California Supreme Court Hands ‘Landmark’ Victory to Brain-Injured Patient
• Big Money for Pharma, Big Risk for Kids: When Doctors Prescribe Antipsychotics and SSRIs for Children With Autism

The post School With 50 Locations Uses Electric Shock Devices on Autistic Children — the FDA Wants to Ban the Devices appeared first on Children’s Health Defense.

 

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