FDA May Ease Up on Electroshock Devices
THURSDAY Jan. 27, 2011 -- Electroshock devices, currently classified by the U.S. Food and Drug Administration as high risk for the treatment of severe depression, could be downgraded to medium risk this year.
An FDA advisory panel is scheduled to meet Thursday to discuss reclassifying the devices, which would pave the way for wider use among people with depression and other mental illnesses.
A medium-risk classification would put the devices in the same category as syringes and allow them to be sold without new testing, The New York Times reported.
If the current classification continues, the FDA could require manufacturers to demonstrate that the devices are safe and effective, which it has not previously done. Some say the tests that such proof would require would be prohibitively expensive for the device makers.
The American Psychiatric Association supports the classification change, while opponents argue that electroshock therapy can cause long-term brain damage, including memory loss, the newspaper said.
"It's a treatment for the most severe form of depression," Dr. Charles Kellner, chief of geriatric psychiatry at Mount Sinai School of Medicine in New York City, told the Times. "It can really be lifesaving."
Dr. Edmi Y. Cortes, director of psychiatric services at the University of Miami Hospital, said that today's electroconvulsive therapy (ECT) devices are both safe and effective. "It's beneficial that some of the leading experts in psychiatry and ECT are getting together with the FDA to finalize a consensus," she said.
"The devices are effective when used appropriately," Cortes said. "For the most part, they are used to treat severe cases of depression, depression that has not been responsive to medication or depression that presents with symptoms like severe agitation or suicidal thoughts."
This type of depression is fairly uncommon, Cortes said. "For the most part, ETC is used as a second or last resort treatment," she said.
Cortes noted that the treatment can result in some memory loss. "Some people experience spotty memory, some may be transient, some may be longer- lasting. Another common side effect is confusion right after coming out of the anesthetic, which usually resolves before the patient goes home," she said.
The treatment can be given in both in-hospital and as an outpatient therapy, Cortes said. On average, most patients undergo six to 12 sessions, she added.
Some patient's symptoms are completely resolved after treatment. These patients are encouraged to take antidepressants and also to participate in psychotherapy, Cortes added.
"Some don't require ECT again during their life and some require what we call maintenance ECT, which can be done every so often to avoid any recurrence of symptoms," she explained.
How ECT works isn't known. "The most widely accepted theory is that ECT releases large amounts of serotonin in the brain and that's what improves the depressive symptoms," Cortes said. Increasing the amount of serotonin in the brain is how most antidepressant drugs work, she noted.
Electroshock therapy is usually performed under general anesthesia. The procedure lasts about 40 seconds and involves the delivery of a small amount of electric current to the head, which causes seizure activity in the brain. The amount of electricity used has decreased since electroshock therapy was introduced in the 1930s, which has helped reduced the side effects, according to the U.S. National Institutes of Health (NIH).
According to the NIH, electroshock can be helpful for severely depressed patients who don't respond to depression medication or whose depression is accompanied by delusions or other psychotic symptoms. Severely depressed patients who are suicidal or pregnant also may be candidates for electroshock therapy.
Treatments cost $1,000 to $2,500 a session, which includes anesthesiology, Kellner told the Times. Usually six to 12 treatments are needed, the NIH said.
Critics of electroshock therapy, including the New York-based advocacy group Alliance for Human Research Protection, argue that it's unsafe. "It's all trial and error -- it's all experimental," Vera Hassner Sharav, alliance president, told the Times. Sharav questioned why, after years of controversy, there have not been clinical trials.
Prior to Thursday's meeting, the FDA requested information on safety and effectiveness from the two U.S. manufacturers of electroshock devices, Somatics LLC of Lake Bluff, Ill., and the Mecta Corp. of Lake Oswego, Ore.
The FDA doesn't have to follow its advisory committee's recommendation but usually does.
A final decision could come later this year, the Times said.
Posted: January 2011