FDA panel seeks more testing of 'shock-therapy' devices
Saturday, January 29, 2011
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 John 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 Evelyn 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 Michael 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.