FDA panel advises more testing of 'shock-therapy' devices

One proponent, a nurse from Baltimore, drove through the snow on her day off to read a grateful Christmas card from a patient, choking up as she did.

"I actually think it's more controversial than abortion," Amy Lutz, a 40-year-old mother of five from Villanova, Pa., said of ECT, which her 12-year-old autistic and manic-depressive son gets regularly.

She brought with her two poster-size photographs of the boy, his face and hands bloodied from self-inflicted blows. She told the committee that ECT, tried after a half-dozen other therapies, stopped the violent behavior and increased her son's achievement in school.

A 1976 law requiring safety and effectiveness of all new medical devices permitted ones in longstanding use, including ECT machines, to stay on the market. Later, however, Congress told the FDA that those grandfathered-in devices either had to undergo rigorous testing or be officially "reclassified" as already-proven to be safe and effective (although, in some cases with special warnings about their use).

In addition to patient testimony, the advisory panel heard FDA staffers describe their analysis of hundreds of ECT studies.

As a group, the studies tended to be poorly designed and with too few patients to allow the drawing of firm conclusions. Many failed to follow patients long enough to discover the duration of ill effects. Ones done decades ago studied techniques and electricity dosages different from current practice.

The FDA staff reported the existing research suggests that for depression, ECT is more effective than placebo or "sham" shocks and after a month more effective than antidepressants.

In terms of hazards, the FDA staff's review found the treatment is associated with "impairment in orientation, memory and global cognitive function immediately after ECT and up to 6 months." Certain aspects of memory may return to baseline after six months. "Autobiographical memory" - recollection of events in one's life - appears to be at greatest risk. High-dose electric current and current applied to both sides of the brain are associated with more thinking and memory problems.

Panel member Christopher A. Ross, a psychiatrist and neuroscientist at Johns Hopkins University, asked if the published studies identified any risk factors that predisposed patients to memory loss and thinking impairment.

"Evidence-based data for that issue just doesn't exist," said Peter G. Como, a neuropsychologist at the FDA.

Panel Chairman Thomas G. Brott, a neurologist at the Mayo Clinic's campus in Jacksonville, Fla., said he was amazed that essentially no research had been done on ECT's effects using functional MRI imaging, repeated brain wave (EEG) studies, or autopsy examinations of patients.

"I tried to look and saw very little. I concluded that the evidence is not there to decide either way," he said.