FDA panel considers ban on electric stimulation devices for aversion therapy

Today the FDA Neurological Devices Panel convened to consider a ban on electric stimulation devices for aversive conditioning in patients inflicting self-harm and displaying aggressive behavior. Though the panel made no decision today, it stated that its primary concern is the safety and wellbeing of patients receiving this therapy and recognized the need for clinical trials to examine the benefits and risks of electric stimulation devices in these patients.

Panel member Wayne K. Goodman, MD, chair of the department of psychiatry at Mount Sinai Hospital, stated that though many patients have seen benefits from this treatment he is “not ready to say we should disseminate this treatment to others.”

Other available treatments for self-injurious and aggressive behavior were discussed, including pharmacological, behavioral and other non-electrical therapies.

The panel consisted of 20 experts in clinical health, neurosurgery, therapeutics, research and additional backgrounds from the medical community.

The meeting, which was opened to the public, involved a Q&A for the FDA, clinical and scientific presentations and panel deliberations.

Also present at the meeting were representatives from the Judge Rotenberg Center (JRC), a private residential school in Canton, Mass. for children with developmental disabilities, emotional disturbances and multiple disabilities who exhibit behavior that interferes with learning. In 2006, a New York state report on electric stimulation was completed at the center. The New York State Education Department studied a sample of 12 of the 71 students undergoing aversive interventions, including electric skin shock, food contingent programs and/or manual or mechanical restraints. The report focused on the health and safety issues related to the use of electric shock devices (ESDs).

“Of the New York students at JRC, 53 were receiving stimulation with a graduated electronic decelerator (GED) and 24 were receiving stimulation from a ‘GED-4’ device which is not FDA approved or cleared but has been reported to have a peak output current that is three times that of the FDA–cleared ‘GED’. Specifically, the report concluded that the use of the electric skin shock conditioning devices at JRC raised health and safety concerns, and that the collateral effects (e.g., increased fear, anxiety or aggression) on students resulting from JRC’s punishment model were not adequately assessed, monitored or addressed,” the FDA wrote in its executive summary.

Many patients, family members and clinicians who addressed the panel were associated with JRC in some way, whether they were for or against the treatment.

The benefits and risks of ESD were outlined by practitioners, medical experts, former patients and family members. Benefits were defined as protecting the patient from self-injurious behavior and allowing them to interact in a safer way with peers and family.

The risks ranged from negative emotional reactions, skin burns and other tissue damage, pain/discomfort, learned helplessness, numbness, muscle cramps, psychosis, neurological symptoms, stress/PTSD, fear, hatred of practitioner and aversion/avoidance.