FDA Wants to Rein in Shock Treatments

WASHINGTON (CN) — The Food and Drug Administration wants to ban electrical stimulation devices to treat aggressive or self-injurious behavior: new devices and those already in use.
     “The FDA 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 FDA regulation states.
     The devices apply a “noxious electrical stimulus” that delivers a painful electric shock to the skin when a person exhibits an unwanted behavior, similar to dog collars.
     The shocks are supposed to reduce or eliminate the behaviors in people with intellectual or developmental disabilities, according to the FDA.
     The draconian treatment is used particularly on people who exhibit head banging, hand biting, excessive scratching and picking of the skin, according to the proposed regulation.
     A disease characterized by all four behaviors is called Prader-Willi syndrome, a genetic disorder that is the most common known genetic cause of life-threatening obesity in children, according to the Prader-Willi syndrome U.S.A. website.
     The disease has been linked to an abnormality of the 15th chromosome, which causes hyperphagia, an uncontrollable desire to eat, and excessive weight gain on fewer calories.
     Prader-Willi syndrome causes its victims to constantly feel hungry, regardless of how much they eat. Commonly associated characteristics include obesity, mental retardation, short stature and a slew of others.
     Sufferers also commonly pick their skin until it bleeds, a behavior that is not well understood, and exhibit aggressive or self-injurious behavior, perhaps out of frustration caused by lack of satiation.
     But the FDA says the shock treatments make vulnerable people even more vulnerable because those with mental disabilities or impairments cannot make their own treatment decisions and often suffer significant adverse results.
     “FDA has determined that ESDs for self-injurious behavior or aggressive behavior present a number of psychological and physical risks: Depression, fear, escape and avoidance behaviors, panic, aggression, substitution of other behaviors (e.g., freezing and catatonic sit-down), worsening of underlying symptoms (e.g., increased frequency or bursts of self-injury), pain, burns, tissue damage, and errant shocks from device misapplication or failure,” the proposed regulation states.
     The ban would apply only to devices intended to reduce or eliminate self-injurious and aggressive behavior. The devices could still be used by people who voluntarily undergo the treatment for other purposes, such as quitting smoking.
     Comments can be submitted to the Federal eRulemaking Portal at www.regulations.gov or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     The deadline for comments is May 25.

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