FDA panel advises more testing of ‘shock-therapy’ devices
by David Brown/Washington Post/1.28.2011
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. Read More