FDA Panel Recommends Testing of Electroshock
SATURDAY, Jan. 29 (HealthDay News) -- An advisory panel to the
U.S. Food and Drug Administration decided on Friday that
electroconvulsive (also known as "electroshock") devices should be
subject to the same tough testing as other medical devices entering
The much-awaited decision is the latest chapter in the
decades-old controversy surrounding the psychiatric treatment,
which some patients see as doing great harm, even as others hail it
as a valuable treatment.
The FDA doesn't have to follow its advisory committees'
recommendations but usually does.
The panel's decision was endorsed by those worried about the
potential harms of electroconvulsive therapy (ECT).
"It was the best possible outcome we could have gotten," Austin, Texas-based clinical psychologist John Breeding told the Washington Post. Breeding, a longtime opponent of the procedure, testified before the panel at a two-day meeting that began Thursday in Gaithersburg, Md.
The panel heard testimony from both ECT patients and FDA
researchers who pored over hundreds of studies into the therapy.
According to the
Post, the FDA staffers said that current research suggests ECT does outperform placebo or "sham" ECT and after a month it may also outperform antidepressants.
But on the other hand, the FDA review of data also found that
the treatment was tied to "impairment in orientation, memory and
global cognitive function immediately after ECT and up to six
Post reported, although many aspects of memory do seem to
return to normal after another six months.
Supporters of electroshock had lobbied for the devices to be
downgraded to a medium-risk classification, which would put the
devices in the same category as syringes and allow them to be sold
without new testing.
The advisory panel did not support such a move, and their
recommendation might push the FDA to require manufacturers to
demonstrate that the devices are safe and effective, something 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 has supported a downgrading
in classification, while opponents argue that electroshock therapy
can cause long-term brain damage, including memory loss, according
The New York Times.
"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,"
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 patients' 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.
However, 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.
And Evelyn Scogin, a teacher whose statement was read at the
panel meeting, said she regrets the ECT treatment she received
after a suicide attempt. "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," the
Prior to this week'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.
A final decision could come later this year, the
The American Academy of Family Physicians has more about
depression and electroshock therapy.
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