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

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http://www.washingtonpost.com/wp-dyn/content/article/2011/01/28/AR2011012806328_pf.html

FDA panel advises more testing of

'shock-therapy' devices

By Brown

Washington Post Staff Writer

Friday, January 28, 2011; 10:10 PM

An expert panel advising the Food and Drug Administration decided

Friday that electroconvulsive therapy (ECT) machines should

undergo the same rigorous testing as new medical devices coming

onto the market - a decision that could drastically affect the

future of psychiatry's most controversial treatment.

The majority of the 18-member committee said not enough is known

about ECT, also known as "electroshock" or simply "shock" therapy,

to allow the devices to be used without more research into its

usefulness and hazards.

If the agency follows the panel's advice, which it usually does,

the two companies whose machines are used in the United States

will have to provide evidence of the therapy's safety and

effectiveness either from existing research or new studies. If the

FDA isn't convinced, the devices could be removed from use.

The panel's opinion is the latest chapter in ECT's seven-decade

history, during which the treatment has been lauded as a

lifesaver, villified as a form of legally sanctioned torture, and

has seen its popularity rise in recent years after a long decline.

ECT machines deliver an electrical current to the brain, inducing

a generalized seizure in which the patient briefly loses

consciousness. How that may be therapeutic or cause permanent

memory loss - the side effect most frequently mentioned by

patients - isn't known.

About 100,000 Americans undergo ECT each year, usually getting

about a dozen treatments over several weeks. Some then get

"maintenance" ECT every few weeks, as the therapeutic effect, when

it occurs, often doesn't last. The treatment is most often used

for depression and has also been prescribed to patients with

schizophrenia, catatonia, and more recently, to some violent

children with autism.

"It was the best possible outcome we could have gotten," said

Breeding, 58, a clinical psychologist from Austin who says

the procedure should be banned. He testified before the panel at a

two-day meeting in Gaithersburg.

For some patients, ECT epitomizes what they view as the coercion

and lack of respect for the patient's point of view that is unique

to psychiatry. That's also largely how it's been depicted in

popular culture, most famously in the book and film "One Flew Over the Cuckoo's Nest," where it was a

tool of punishment and social control of mental patients.

"I lost not only my memories of the time I was subjected to this

torture but I was robbed of almost all memories from about 2003,

two years before treatment, to 2008, three years after treatment

stopped," testified Scogin, a special-ed teacher who got

ECT after a suicide attempt. Her statement was read by a friend

because Thursday's snowstorm stranded her in the Charlotte

airport.

Other patients described ECT as a lifesaving, if mysterious,

treatment worthy of wider use.

Among them was Kitty Dukakis, the 74-year-old wife of 1988

Democratic presidential nominee and former Massachusetts governor

Dukakis. She first got ECT at age 63, and continues to get

it once a month.

"It is not an exaggeration to say that I don't think I would be

alive without ECT. It has been a miracle in my life," she said.

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 A. Ross, a psychiatrist and

neuroscientist at s 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

G. Como, a neuropsychologist at the FDA.

Panel Chairman G. Brott, a neurologist at the Mayo

Clinic's campus in ville, 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.