Dr. Daniel Fisher presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are his remarks as published in the public record of the meeting.
I represent a national mental health consumer organization, to answer an earlier question, the National Coalition for Mental Health Recovery, which represents millions of mental health consumers. I do not have any financial relationship with the manufacturers of ECT devices.
I base my testimony on my practice as a board certified psychiatrist, my neurochemical research at National Institute of Mental Health, and my 19 years of directing a federally funded technical assistance center, the National Empowerment Center.
I’m appalled that the FDA is considering downgrading ECT devices from Class III to Class II, the same classification as a wheelchair. In my expert opinion, and that of a recent review of ECT literature by Drs. Reed and Mentel (ph.), any short-term gain of ECT is offset by its risks. I recommend, one, ECT devices continue to be designated as Class III; two, that their use be suspended until meaningful long-term efficacy and minimal risk of memory loss, cognitive deficits, brain damage, and mortality are independently demonstrated by premarket approval.
Two of my cases illustrate some of the negative aspects of ECT.
I saw a 19-year-old young man in an outpatient clinic. He suffered from major depression, was slow to respond to Prozac. He was admitted to an inpatient facility where the psychiatrist immediately started a series of eight ECT treatments. Upon discharge, his depression had slightly lifted, but he could no longer recognize his friends. He was so distraught over the side effects of ECT that he hung himself.
This case points out that ECT not only does not decrease suicidality but can actually increase it, and there are, by the way, much more extensive validation of this in my testimony that I submitted.
Case B, in my capacity as a consultant, I learned that a 51-year- old woman was experiencing memory loss and confusion which intensified once a month. Belatedly, she acknowledged that she was given monthly outpatient ECT. She had been threatened with rehospitalization by her doctor if she disclosed. She wanted to stop the ECT and, in my presence, was able to tell her doctor that she wanted to leave his care. She did so, was successfully switched to an antidepressant with fewer side effects. The case illustrates that ECT causes cognitive defects and memory loss.
The most detailed studies of memory were carried out by Dr. Irving Janis, who found gross gaps and subtle losses of memory and a general slowness and great effort in recalling details. These side effects were also validated by a proponent of ECT, Dr. Harold Sackeim. In 2007, he reported that there are memory deficits and said, “This study provides the first evidence in a large prospective sample that adverse cognitive effects can exist for an extended period and that they characterize routine treatment by ECT in community settings.”
The APA guidelines for ECT inaccurately contend that the memory loss with ECT is minimal. Furthermore, the APA consent form drastically underestimates mortality associated with ECT by stating a risk of 1 in 10,000, whereas the average of numerous studies indicated a tenfold higher rate of death than suggested by the APA. The APA also suggests that “Brain damage should not be included in the informed consent process as a risk of treatment.”
It appears the APA Task Force on ECT overlooked considerable evidence that ECT does produce brain damage as summarized by neuroscientist Dr. Peter Sterling. One, ECT is designed to evoke grand mal seizures posing an acute rise in blood pressure well into the hypertensive range and is frequently the cause of small hemorrhages in the brain. Two, ECT ruptures the blood-brain barrier. This barrier normally prevents many substances in the blood from reaching the brain. Where the barrier is breached, nerve cells are exposed to the insult. Brain edema, anoxia, and neuronal death occur. Three, ECT causes neurons to release large quantities of the neurotransmitter glutamate which releases more glutamate leading to excited toxicity and neuronal death.
According to Dr. Peter Breggin, the brain disabling hypothesis states that the more potent the somatic therapies in psychiatry, such as ECT and cingulotomy, they produce brain damage and dysfunction, and this damage and dysfunction is the primary —
DR. BROTT: You have 30 seconds.
DR. FISHER: — beneficial effect.
I conclude by saying how is it possible that in a democracy with the most advanced constitution of any country, a whole class of people can be subjected to brain-disabling procedures without regulation by the Government. I can only conclude that being labeled mentally ill means you lose your rights and protection under the constitution. I entreat you to protect this labeled class of people by regulating these devices as they should be under Class III and that all conflicts of interest —