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12 SAFETY

There is a great deal of controversy regarding the safety of ECT equipment, its use, and its long-term impacts, including permanent memory loss and death. The safety of ECT devices will remain a contentious issue until appropriate testing of all types of ECT devices is completed. The Committee received testimony and reviewed written materials regarding the efficacy of ECT and its safety.

ECT PROPONENTS AND OPPONENTS

Proponents assert that ECT is a relatively safe procedure with minimal long-term cognitive effects on memory and further cite a death rate of 1 in 10,000 to document safety.

Dr. Richard Weiner, Professor of the Department of Psychiatry at Duke University Medical Center, Chairperson of the APA's Task Force Committee on Electroconvulsive Therapy, and co-author of the Task Force report, appeared before the Committee at its May 18, 2001 public hearing on behalf of the APA. Dr. Weiner outlined that ECT is a highly effective and rapid treatment for individuals with certain defined severe mental illnesses.

At the same hearing, Dr. Sackeim. another APA representative and colleague on the Task Force. stated in his written testimony:

The efficacy of ECT in specific psychiatric conditions is amongst the most well established of any treatment in all of medicine ... The beneficial effects of ECT are not expected to last unless other biological treatments are used as maintenance treatments ... The medical morbidity and mortality rates with ECT are low. Despite some media statements to the contrary, a fair estimate is that death associated with ECT occurs in approximately 1 in 10,000 patients, approximately the same as receiving general anesthesia alone. This is particularly noteworthy since ECT is often used in patients with serious medical complications .... A limiting factor in the use of ECT is its cognitive effects ... the negative effects of ECT on cognition involve two types of deficits. During and following ECT, patients will show rapid forgetting of newly learned information. This is termed anterograde amnesia ... All available information, from scores of studies, indicates that this deficit disappears within days to a few weeks following the end of ECT. ECT also results in a loss of memory for events that occurred prior to the receipt of the treatment. This type of memory loss is termed retrograde amnesia ... All recent published surveys of patients who have received ECT have shown that the vast majority report that this form of memory loss is a small price to pay for the therapeutic effects of the treatment. As with all medical treatments, there are individual differences, and some very rare patients may manifest more extensive memory loss .... There is no firm estimate on this incidence ... but my estimate would be on the order of 1 in 500 patients. Careful scientific study has shown that ECT does not cause brain damage (cellular death) ... To the contrary, all antidepressant treatments promote the development of new neurons (brain cells), a recently discovered fact. ECT is the most effective in this regard.

The Committee also received testimony and letters from recipients of ECT. One representative letter stated, I suffer from chronic depressive disorder recurrent and received ECT two years ago... ECT has allowed me to function again. I will be eternally grateful that ECT was available to me and hope that it will continue to be available in the future" (undated letter received June 2001).

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Opponents, on the other hand, paint a very different picture. Dr. Peter Sterling, a neuroscientist at the University of Pennsylvania testified on July 18, 2001 regarding the effects of ECT on the brain. He stated:

ECT unquestionably damages the brain, and there are a variety of mechanisms that lead to this damage. In the first place, the electroshock delivered to the skull is basically similar to what you would get out of an electrical wall outlet, except that there is a transformer in the ECT machine that steps up the voltage ... when this is done two or three times a week for weeks, it's Just completely obvious that this is going to eventually cause some kind of brain damage...Now the second point, source of brain damage for ECT is that it causes... grand mal epileptic seizures ... and this causes an acute rise in blood pressure, well into the hypertensive range... And it frequently causes small ... hemorrhages in the brain. And wherever a hemorrhage occurs in the brain, nerve cells die, and they are not replaced. And so one can accumulate these hemorrhages over a period of treatments leading to brain damage. A third thing that ECT does is to rupture the blood brain barrier. This barrier normally protects the brain from potentially damaging substances in the blood .... breaching this barrier exposes nerve cells in the brain to chemical insults that can kill them ... also leads ... to swelling of the brain ... swelling leads to local arrest of blood supply. to loss of oxygen ... and to death of neurons. The fourth thing ... is that ECT ... causes neurons to release large quantities of ... glutamate. Glutamate excites further neuronal activity...and this becomes a vicious cycle ... Neurons literally... kill themselves from over activity .... the key manifestation of this brain damage is retrograde memory loss .... the tide seems to have turned. And one of the most important proponents of ECT, Dr. Harold Sackeim now acknowledges that memory and cognitive losses are real ... excerpt from Dr. Sackeim's recent editorial in the Journal of ECT ... Virtually all patients experience some degree of persistent and, likely, permanent retrograde amnesia. A series of recent studies demonstrates that the retrograde amnesia is persistent. and that this long-term memory loss is substantially greater with bilateral than right unilateral ECT.

ECT adversaries also state that the death rate is much higher than 1 in 10.000 and more likely is 1 in 200 for elderly persons undergoing ECT. Opponents cite data collected in Texas, the only state presently requiring reporting of the incidence of ECT. Mr. William Sullivan, Executive Director of the Mental Health Association of Essex County, testified that deaths do occur from the procedure, whether from the insult to the brain, a result of anesthesia, or muscle relaxants used. Mr. Sullivan called for objective research to determine the risks.

Again, the Committee received information and testimony from ECT recipients, as well as from family members regarding the adverse and/or permanent effects of ECT use on loved ones. The testimony of Linda Andre, Director of the Committee for Truth in Psychiatry, at the May 18th hearing, supplied the Committee with insight from a "survivor's" perspective:

I am a survivor of ECT. I had involuntary ECT, though not court-ordered ECT, and I had a fairly typical experience with it. By that I refer to the fact that I lost five years of my life, which were erased as if they had never happened ... I have documented brain damage, including 38 points off my I.Q. and I live with daily memory disability and cognitive disability that made it impossible for me to return to my career.

EQUIPMENT

The safety of the devices used to administer ECT has been an issue of longstanding contention among professionals and advocacy bodies. In 1976, Congress enacted legislation granting the federal Food and Drug Administration (FDA) authority to regulate certain medical devices, including machines used

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to administer ECT. However, the FDA was given only limited jurisdiction regarding ECT equipment due to a grandfather clause that allowed continued use absent FDA testing. Subsequently, in 1979, the FDA designated and classified ECT devices as Class III medical devices. A Class III designation is used for pre-market approval for devices that show an unreasonable risk of illness or injury. Yet, no formal tests were conducted by the FDA to determine the safety of such devices.

The APA, in its 2001 ECT Task Force report, identified certain devices that should no Ionizer be used, including sine wave, constant voltage and constant energy devices, due to their negative impacts on post ECT cognitive functioning of patients. The APA recommended the use of brief pulse devices that would be safer. However, the extent to which older ECT devices, no longer justified according to the APA, continue to be used is unknown. Though difficult to track, given existing oversight mechanisms, it appears likely that such devices will remain in the marketplace to some degree throughout the country and within New York State.

As an addendum to Ms. Andre's testimony was an article. "ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Misinformation," by Douglas Cameron, of the World Association of Electroshock Survivors:

It has now become fashionable to declare brain damage from ECT a thing of the past because of "new refinements" in the procedure and in the machines ... The implication that the sine wave device of old has been replaced by the brief pulse device of present lurks behind much of the continued use of ECT .... Modern day BP devices are not "lower current" machines, as most proponents claim. Through electrical compensation, they equal SW devices in every respect, and emit far greater energy .... Most experts agree that current, not convulsion ... is responsible for long term memory loss and severe cognitive dysfunction .... Manufacturers may have parted from the convulsion theory exemplified by just above seizure threshold devices of the past, to what might be just abovedamage threshold devices of the present, and if not forced to stop and prove the safety of their devices (allowing for even more powerful machines), might be embarking upon just above agnosognosic threshold appliances of the future.

In summary, modern electric shock machine companies are attempting to redefine safety from the original convulsion concept of "just above seizure threshold" to "safer wave form." The Food and Drug Administration must rescrutinize today's SW and BP devices, withdrawing their "grandfathered in" status under compulsive therapy devices. Because they utilize an entirely different principle,... all modern EST device manufacturers must be required to prove machine safety to the Food and Drug Administration, prior to further utilization of new machines.

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