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GAITHERSBURG, Md. -- Members of an FDA advisory panel said Thursday that the agency should ban the use of electrical stimulation devices for aversive conditioning in patients with self-injurious or aggressive behavior.

The majority of the advisers on the agency's Neurological Devices Panel said the device class poses "an unreasonable and substantial risk of illness or injury" to patients based on all available data and information. Panelists also felt that a clinical study of the device in adults and children would be unethical.

The panel was not asked by the agency to vote on any issue regarding the device, only to discuss a series of questions.

The devices deliver electric shocks and are typically used on severely autistic or developmentally disabled individuals who have repeatedly injured themselves or others through behaviors such as eye gouging, skin pinching, hair pulling, or striking their heads against hard surfaces.

At least some of the FDA's concerns appear to have been prompted by allegations of abuses involving such devices at the controversial Judge Rotenberg Center in Canton, Mass. The center is currently the only entity in the U.S. that manufactures and uses electrical stimulation devices (ESDs) for aversive conditioning, specifically its Graduated Electronic Decelerator (GED 3A and GED 4).

Four ESDs are technically cleared for marketing in the U.S., including one developed by the Judge Rotenberg Center. The center's device was cleared in 1994, but it modified the device without FDA's approval, and is therefore currently in violation of federal law. The center is in talks with FDA on a new premarket notification for the product. The other three devices were cleared from 1976 to 1987, but FDA believes they are no longer manufactured or distributed.

While the majority of the panel supported a ban of all currently marketed and prospective electrical stimulation devices, some panelists did note that the treatment is helpful in refractory cases where current treatment options, such as pharmacological, behavioral, alternative, and experimental therapies, are not effective.

The panel was more split about whether the devices provided a benefit for patients. Several panelists felt strongly that the devices did not provide benefit, while others saw benefits when the therapy was used as a last resort in certain subpopulations.

, a professor of medicine and bioethics at the University of Minnesota Medical School in Minneapolis, commented on the dearth of published clinical evidence on the benefits of the device, beyond anecdotal and case reports.

"The data is more than 50 to 55 years old. I can't think of any other comparable risk therapy that is allowed to persist on such old data," Miles said. "The plural of anecdotes is not data, especially when it comes from a single treatment center with a conflict of interest ... There are no subpopulations within the treatment facility for which selective efficacy exists."

The public commenters were also split on the risks and benefits of the device. There were emotional testimonies from former patients and parents of patients at the Judge Rotenberg Center calling the device a "godsend" as a last treatment for patients who were nonresponsive to other therapies.

On the other hand, nearly 20 disability advocacy and patient representative groups testified that the products were "unsafe," "inhumane," and a form of torture, calling for their outright ban from the market.

"The use of noxious electrical stimulants is inhumane," said , legislative counsel for the American Civil Liberties Union in Washington. "The fact that we consider using it on people with disabilities, and only people with disabilities, is evidence of significant bias and discrimination. We urge you to ban the use of these devices."

All four models of the devices currently in use comprise a battery, an electric pulse generator, electrodes that are attached to the skin on the trunk or extremities, and either a built-in accelerometer or a radio-controlled actuator to deliver the pulse. Approved voltages range from 150 to 200 volts with shock durations of 0.5 seconds to as long as 12 seconds. Frequencies may range from 10 Hz to 80 Hz, and maximum currents from 10 mA to 29.4 mA.

One of the Rotenberg devices now in use, however, delivers nearly three times the maximum approved current, FDA says. The Rotenberg center has been investigated by state authorities in New York and Massachusetts and by the United Nations (twice), but it remains open and continues to use what's known as shock-based aversive conditioning.

The agency is not required to follow its advisory committees' recommendations but it usually does.

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