On Saturday, January 29, 2011, David Brown, published an article for The Washington Post the results of which we are still awaiting more than a decade later. This article is partially reproduced under "fair use" for educational purposes to assist the public in understanding ECT's history of safety testing and regulation.
Article begins here:
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 it's usefulness and hazard.
If the agency follow 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 should 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, vilified 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.
...
In addition to patient testimony, the advisory panel heard FDA staffers describe their analysis of the 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.
...
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 Christopher A. Ross, a psychiatrist and neuroscientist at Johns 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 Peter G. Como, a neuropsychologist at the FDA.
Panel Chairman Thomas G. Brott, a neurologist at the Mayo Clinic's campus in Jacksonville, 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."
*** end of article.
It is baffling to consider how the FDA reclassified this device in 2018, making yet another request for premarket approval safety studies and product development protocols (i.e. electrical dosing limits based on safety testing). I am still awaiting their response to my FOIA inquiry requesting all PMA and PDP submitted by their deadline March 26, 2019.
You can read the full article at the link http://www.washingtonpost.com/wp-dyn/content/article/2011/01/28/AR2011012806328.html?noredirect=on&sid=ST2011012902836