In ECT, two electrodes are placed on a patient’s scalp, which deliver an electrical current that induces a short seizure in the brain. Researchers aren’t sure exactly how it lifts depression, but possible explanations include release of critical neurotransmitters and alterations in brain metabolism and excitability, according to W. Vaughn McCall, MD, MS, professor and chair of the Department of Psychiatry and Behavioral Medicine at Wake Forest University Health Sciences and editor-in-chief of The Journal of ECT.

ECT usually works quickly in most people who try it, which is especially critical for people with acute suicidal thoughts and behaviors.

Numerous studies have demonstrated ECT’s effectiveness, yet it’s still viewed as a murky treatment, often misunderstood and mired in controversy. Mention the letters “ECT,” and you’ll likely get a variety of negative reactions.

But today’s ECT is radically different from the unregulated treatment of the 1940s and ‘50s. Below, Dr. McCall shares five of the most common myths about ECT.

1. ECT is excruciating.

According to Dr. McCall, ECT is commonly misconstrued as “a painful, bone-breaking experience, associated with violent body movements.” But patients don’t feel anything during the procedure. Before ECT is performed, patients are given a muscle relaxant to prevent significant movement. They also receive general anesthesia so they’re asleep for the entire ECT session. Immediately following ECT, patients may be confused and disoriented and have a headache for a short period of time.

2. ECT damages the brain.

Studies that have used magnetic resonance imaging (MRI) to look at the brain haven’t found any evidence that ECT changes brain anatomy, McCall said. (1-3) Animal studies have found that ECT may even promote growth of brain cells. (This 2007 study found that the animal model of ECT encouraged cell growth in an area of the brain responsible for processing emotions.)

3. ECT makes people feel worse.

The research on ECT is extensive and demonstrates that ECT is safe and effective for severe depression. For instance, a 2008 meta-analysis found ECT was superior to sham ECT, placebo and antidepressants.

In McCall’s own research, about 80 percent of people who have ECT report improvements at six-month follow-up. “On the average, the 20 percent who do not respond or stay well after ECT have a quality of life that is unchanged from their pre-ECT condition,” he said. (4-6)

4. ECT erases memory.

“ECT has always been associated with some degree of memory loss,” according to McCall. But “Progressive improvement in technology has led to a progressive decrease in memory loss as a [significant] problem.” Most patients experience short-term memory loss. Some patients experience memory loss of events that happened weeks or months before ECT.

But it’s rare for people to have decades of memories wiped out, he said. More common are difficulties with short-term memory, and the ability to concentrate and pay attention after ECT treatment.

Still, some patients report extensive memory loss. When McCall consults with patients, he explains that while research hasn’t substantiated dramatic memory loss, a small number of individuals do claim considerable loss. It’s unclear how this occurs. Improperly administered ECT may be one reason. “The likelihood of significant memory loss is highly dependent upon ECT technique,” McCall said. (7-8) So it’s important to see a physician who specializes in ECT.

5. ECT is curative.

On the one hand, ECT is viewed as ruining people’s lives, but on the other, it’s seen as a cure-all for depression. But while ECT is effective, its benefits are short-lived, McCall said. In fact, one of the greatest challenges is identifying how to prolong ECT’s gains, he said.

“It’s rare for someone to be well in fewer than four sessions.” Often one course of ECT is around six to eight sessions. Some patients may be given 12 to 15 sessions, but beyond 15 is unusual, he said. While patients undergo treatment, it’s critical for the administering physician to continually assess their progress, he said.

Multiple courses also might be necessary. These additional courses might increase the risk for memory loss and other side effects. McCall treated a 92-year-old woman with late-onset depression who received 91 sessions in the last 22 years of her life. Before she passed away, she donated her brain for research. McCall and his colleagues examined her brain and found no microscopic changes that would suggest damage from ECT. (9)

The need for more ECT courses speaks less about the treatment’s success, McCall said, and more about depression’s high relapse rate.

“Overall, we have to remember that whatever warts ECT has, it’s a treatment for a serious illness,” he said. ECT isn’t indicated for mild depression, as McCall stressed; instead it’s used to treat a severe depression that destroys lives. Opposition to ECT may, in part, stem from people’s misunderstanding of acute depression, McCall said.

Severe depression is disabling and potentially deadly, he said. People become so despondent they can’t get out of bed let alone go about their day. They can lose their appetite and drop weight dramatically. Marriages fall apart. Older people lose their independence and are unable to take care of themselves. Others contemplate or try to commit suicide. For these individuals, ECT provides the necessary relief. For these individuals, the benefits outweigh the risks, McCall said.

Further Reading

1. Coffey CE, Weiner RD, Djang WT, et al. Brain anatomic effects of electroconvulsive therapy. A prospective magnetic resonance imaging study. Arch Gen Psychiatry 1991;48: 1013-1021.

2. Devanand DP, Dwork AJ, Hutchinson ER, et al. Does ECT alter brain structure? Am J Psychiatry 1994;151: 957-970.

3. Wager T, Atlas L, Leotti L, et al. Predicting individual differences in placebo analgesia: contributions of brain activity during anticipation and pain experience. J Neurosci 2011;31: 439-452.

4. McCall WV, Rosenquist PB, Kimball J, et al. Health-related quality of life in a clinical trial of ECT followed by continuation pharmacotherapy: effects immediately after ECT and at 24 weeks. J ECT 2011;27: 97-102.

5. McCall WV, Reboussin BA, Cohen W, et al. Electroconvulsive therapy is associated with superior symptomatic and functional change in depressed patients after psychiatric hospitalization. J Affect Disord 2001;63: 17-25.

6. McCall WV, Prudic J, Olfson M, et al. Health-related quality of life following ECT in a large community sample. Journal of Affective Disorders 2006;90: 269-274.

7. Sackeim HA, Prudic J, Nobler MS, et al. Ultra-Brief Pulse ECT and the Affective and Cognitive Consequences of ECT. Journal of ECT 17:77, 2001.

8. Sackeim HA, Dillingham E, Prudic J, et al. Effect of concomitant pharmacotherapy on electroconvulsive therapy outcomes. Archives of General Psychiatry 2009;66: 729-737.

9. Scalia J, Lisanby Dwork A, Johnson J, et al. Neuropathological examination after 91 ECT treatments in a 92 year old woman with late-onset depression. Journal of ECT 2007;23: 96-98.

These individuals may have treatment-resistant depression or refractory depression. While there’s some debate over the precise definition, treatment-resistant depression is typically thought of as failing to achieve remission after two treatments or two antidepressants, according to George Papakostas, M.D., director of Treatment-Resistant Depression Studies in the Department of Psychiatry at Massachusetts General Hospital.

Why Some People Have Treatment-Resistant Depression

People develop treatment-resistant depression for many reasons. Some struggle with severe depression, which is difficult to treat. Medical illness and comorbid psychological disorders — such as drug or alcohol abuse or eating disorders — also complicate treatment response, according to Dr. Papakostas and Yvette Sheline, M.D., professor of psychiatry and the director for the Center for Depression Stress & Neuroimaging
 at the Washington University in St. Louis. Severe stress also can impact improvement, Dr. Sheline said.

A variety of genetic, neuroimaging and electrophysiological studies have investigated the underlying causes of treatment-resistant depression. And researchers know one thing for sure: Refractory depression is not the result of one brain region or neurotransmitter system.

Preliminary research suggests that individuals with depression may have abnormalities in the frontal and temporal regions in the brain and dysfunction in serotonin modulation. Also, the subgenual cingulate (Cg25), which is located under the cortex along the midline of the brain, may play a role. Cg25 is activated when an individual experiences sadness. It also connects to other regions involved in mood, motivation and sleep. When antidepressants are effective, this area is less active. Some researchers have hypothesized that in refractory depression, Cg25 doesn’t turn off. In general, according to Papakostas, there isn’t enough evidence to show a consistent or unifying theory.

Other individuals may not have refractory depression after all. For instance, according to Sheline, a thyroid problem may mimic depression. Individuals may have bipolar disorder — though there’s recent evidence that bipolar disorder may be overdiagnosed in patients who appear to have treatment-resistant depression — or a long-term low-grade depression called dysthymia. If a treatment isn’t working, it’s critical that your physician re-evaluate your diagnosis.

Treatment Options for Refractory Depression

According to Sheline, there’s disagreement about the number of medication trials a person needs to try before moving onto more invasive interventions. While physicians determine this on an individual basis, it’s important for patients to have an adequate dose of medication for an adequate amount of time, Sheline said. “Each antidepressant has different therapeutic dose ranges, and these also vary according to individual factors, such as age,” she said. An adequate duration of treatment is usually six weeks. If there’s partial improvement, doctors may recommend patients stay on the medication for six to 12 weeks, Papakostas said.

This is why it’s especially important to take medication as prescribed. Many patients stop taking their medication after a week if they don’t get better, Sheline said. But this isn’t enough time to see improvement. Skipping or forgetting a dose can decrease a medication’s efficacy and make it look like it’s not the right medication for you. Also critical is practicing healthy habits, such as engaging in physical activities and getting enough sleep, and managing stress. Exercise boosts mood, while stress and lack of sleep exacerbate depression.

If one antidepressant truly doesn’t work, physicians will typically prescribe an antidepressant from a different drug class. Or they’ll prescribe an augmenting agent, such as lithium or an atypical antipsychotic medication to boost the effectiveness of the antidepressant.

If medication and psychotherapy are unsuccessful, these are other options:

Electroconvulsive therapy (ECT). ECT involves placing electrodes on a patient’s scalp, which sends a specific current that induces a short seizure in the brain. In the 1950s, ECT developed a bad reputation because it was administered without anesthesia and with a high voltage, Sheline said. But today, it’s a completely different treatment, she said.

ECT is administered with general anesthesia and the voltage is carefully controlled. In fact, Sheline noted that there is ongoing work to decrease the pulses to minimize side effects. There’s also been concern that ECT is involuntary, Papakostas said. He clarified that ECT is voluntary and requires a patient’s informed consent.

ECT does have various bothersome side effects, including memory loss and headaches. It’s understandable why patients would hesitate to try it, Papakostas said. However, both Papakostas and Sheline agree that a large body of research substantiates ECT’s efficacy. When compared with medication and psychotherapy, ECT appears to work faster and has a higher chance of success, according to Papakostas. It also has the most efficacy data of all the more invasive interventions.

Transcranial magnetic stimulation (rTMS). According to Papakostas, this treatment is second to ECT in quality of data. Transcranial magnetic stimulation doesn’t require anesthesia or induce a seizure like ECT. Instead it creates a magnetic field that produces an electric current in a specific area of the brain. It’s typically used for mild to moderate depression. The Food and Drug Administration has approved one device called the NeuroStar TMS to treat depression, which may be used after one antidepressant has failed.

Vagus nerve stimulation (VNS). In 2005, the FDA approved vagus nerve stimulation for treating treatment-resistant depression. The device is surgically implanted onto the vagus nerve on the left side of the neck and delivers mild electrical impulses. Think of it as a cardiac pacemaker. According to the University of Maryland Medical Center, it sends 30-second impulses to the vagus nerve every five minutes.

For over a decade, VNS has been used to treat patients with epilepsy. Researchers began studying VNS for refractory depression when they noticed that some patients’ moods improved. Whether VNS is an effective treatment for refractory depression is unclear. It appears to help some people tremendously but not others. To date, “the data [on VNS] just isn’t on par with ECT or rTMS,” Papakostas said.

Not finding a treatment that lifts your depression can be utterly frustrating and make you feel hopeless. But while it may take more time and effort, together with your physician, you can find a treatment that works for you. Remaining optimistic is important. “Being able to maintain a positive, hopeful attitude is as critical as [getting the right treatment], Papakostas said.

Key risks are defined as substantial risks of device use that could significantly influence the risk/benefit profile of the device. Mitigating factors may potentially serve as regulatory controls to adequately reduce the risk of device use such that a reasonable assurance of safety and effectiveness can be demonstrated for the device.

Like the determination of potentially significant adverse events discussed in the safety review, the identification of key risks is based on similar criteria, that is, they are substantiated by a comprehensive review of all sources of data, there is sufficient evidence of significant frequency and severity, and there’s evidence of being associated with ECT device use. [...]

The key risks of ECT are presented in this slide and reorganized into three different main categories.

The first category, medical and physical risks includes adverse reaction to anesthetic agents and neuromuscular blocking agents, alterations in blood pressure, cardiovascular complications, death, dental and oral trauma, pain and discomfort, physical trauma, prolonged seizures, pulmonary complications, skin burns, and stroke. The other two main categories include cognitive and memory dysfunction, and device malfunction. [...]

Again, here’s the list of proposed key risks. The Panel will be asked if this is a complete and accurate list of the key risks presented by ECT and asked to comment on whether you disagree with the inclusion of any of these risks or whether you believe any other risks are among the key risks presented by ECT.

Key Risks and Mitigating Factors of ECT

I’ll now present an examination of each key risk and potential mitigating factors by reviewing this table which goes over the next three slides.

Adverse reactions to anesthesia are rare but potentially severe complications associated with ECT. These reactions are related to the use of anesthetic agents and neuromuscular blocking agents to which patients may have rare but potentially severe reactions. Potential mitigating factors may consist of pre-ECT assessment, including pertinent medical and surgical history, family history of reaction to anesthetic agents, physical exam, as well as appropriate procedure monitoring and clinical management to any reaction that may arise.

Alterations in blood pressure are common but typically benign complications associated ECT. Hypertension as well as hypotension may be associated with ECT treatment. Potential mitigating factors include pre-ECT assessment of medical, particularly cardiovascular status, appropriate procedure monitoring, and clinical management.

Cardiovascular complications are uncommon but potentially severe complications of ECT treatment. They most commonly include arrhythmias and/or ischemia. Cardiovascular complications are one of the most frequent causes of morbidity and mortality associated with ECT. Potential mitigating factors for cardiovascular complications include pre-ECT assessment which may include blood pressure assessment, pre-ECT electrocardiogram, echocardiogram or Holter monitoring, appropriate procedure monitoring, and clinical management.

Death is a rare but severe outcome of ECT treatment. It is a result of various complications of ECT such as reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke. Potential mitigating factors include those proposed for each of these key risks.

Dental and oral trauma including dental fractures, dislocations, lacerations, and prosthetic damage are uncommon complications of ECT and are generally of mild to moderate severity. Potential mitigating factors may include pre-ECT dental assessment, removal of prostheses, as well as the use of mouth protection or bite blocks during the procedure.

Pain and discomfort are common but generally mild to moderate complications of ECT. They are typically treated with the use of as-needed analgesic medication.

Physical trauma associated with ECT, they include fractures and soft tissue injury. Physical trauma usually occurs as a consequence of significant muscle contraction during the treatment. Though more prevalent in previous years of ECT use, in current practice, this key risk is uncommon. Potential mitigating factors to prevent or reduce the severity of physical trauma include the use of general anesthetic agents and neuromuscular blocking agents. 189

Prolonged seizures are an uncommon and moderate to severe complication of ECT. Status epilepticus may ensue if prolonged seizures are not properly treated. Potential mitigating factors include an appropriate pre-ECT neurological assessment as well as EEG monitoring during the procedure and the availability of rapid treatment of prolonged seizures should they occur.

Pulmonary complications, such as prolonged apnea or aspiration, are rare but potentially severe complications of ECT. With cardiovascular complications, they represent one of the most common causes of morbidity and mortality associated with ECT. Potential mitigating factors include appropriate pre-ECT assessment of pulmonary function, pre- ECT tests such as chest x-ray and pulmonary function test, and appropriate monitoring and clinical management before, during, and after the procedure.

Skin burns are uncommon and typically mild complications of ECT. They most commonly occur when there’s poor contact of the electrode with the skin surface resulting in high impedance in the electrical circuit. Skin burns may be mitigated by proper skin preparation, electrode contact, including the use of conductivity gel.

Stroke is a rare and potentially severe complication that may be associated with ECT. Potential mitigating factors include pre-ECT assessment of risk factors for stroke, including possible neuroimaging or cardiovascular and neurovascular assessment when appropriate, appropriate procedure monitoring, and clinical management during the treatment.

The issue of inadequate informed consent processes and/or forced treatment has been raised in the public docket, in the MAUDE database, and in the published literature. Critics of the informed consent process claim that if individuals are inadequately or inaccurately informed of the risks of ECT, the risk/benefit assessment is altered.

One potential mitigating factor for inadequate consent is the requirement of a more rigorous informed consent process. Such a process would help to ensure that the patient is making a fully informed decision about receiving treatment. The process would consist of outlining a more rigorous consent process in the user labeling of the device that would require the use of an additional checklist in addition to standard written informed consent procedure. This checklist would contain all known risks of device usage, the likelihood of occurrence, and the potential severity.

During the process, the treating physician and patient would be required to review each item with both parties signing off to acknowledge discussion of the item. This checklist could then be kept with the standard written informed consent documentation, and the criteria for patient capacity to consent to treatment and perform the acceptance of risk through this process would remain unchanged. Acceptance of risk checklist may be a useful special control for addressing the risks of ECT device use. Within FDA, there’s precedence for requiring such additional informed consent requirements.

Please keep this discussion of key risks and potential mitigating factors in mind in your deliberations of the following question regarding whether the medical and physical risks of ECT can be adequately mitigated. [...]

My name is Katherine Kitty Dukakis, and I live in Brookline, Massachusetts, except during the months of January, February, and March when my husband and I live in the westward section of Los Angeles, and he teaches at the winter quarter at UCLA.

Nearly 30 years ago, in the early 1980s, I began experiencing recurring cycles of depression for no apparent reason. They would hit me every eight or nine months and last for some three or four months, and I could only describe them as being some of the most painful experiences I’ve ever had. I was treated with therapy, and it would seem to be one unending series of antidepressants after another. Nothing seemed to help, and each cycle produced a depression deeper and more painful than the last.

Finally, after some 17 years of this, Dr. John Matthews of the Massachusetts General Hospital suggested that my husband and I talk with the hospital’s ECT specialist, Dr. Charles Welch, about the advisability of undergoing a series of ECT treatments when I was next hit with another of these depressions.

My ECT treatments started 11 years ago, and I would usually have 5 or 6 treatments each time my depression returned. I am now and have for the past 11 months been on ECT maintenance and receive a treatment once a month under Dr. Welch’s supervision in Boston and Dr. Ruben Espinoza’s in Los Angeles.

It is not an exaggeration to say that I doubt very much that I would not be alive today without ECT. The treatment has been a miracle in my life and for my husband, our three children and their spouses, and our eight grandchildren. In fact, I feel so strongly about the importance of ECT as a treatment for severe depression and other mental and emotional illnesses that I have spoken to grand round meetings in hospitals in close to 30 states and coauthored with Larry Tye a book on the subject entitled Shock: The Healing Power of Electroconvulsive Therapy. It is a book that many doctors recommend that their patients read if they are considering ECT.

I have often been asked by physicians to speak individually to patients who are suffering from serious depression but are frightened by the prospect of the treatment. In fact, Larry and I wrote at the end of our preface in our book, “ECT is the only remedy in mainstream medicine that is expanding in use, receiving increased attention and research, and offering lifesaving hope to tens of thousands of people even as some of the public believe it is extinct.”

I have a real fear, as have so many of us who have been helped by ECT, that changes some groups are advocating will affect the very positive strides that many of us have made. What is really troubling for the thousands of us, who thanks to ECT are leading healthy and happy lives, is the possibility that ECT will not continue to be made readily available to us and to so many others who could be helped by it.

As both a patient and an advocate, I want to urge you, the Panel, in the strongest possible terms, to reclassify ECT devices into Class II and make it possible for thousands more to benefit from a form of treatment that has transformed our lives. Thank you.

The FDA systematic review of the literature of cognitive adverse events [of ECT] included only randomized controlled trials as I mentioned. However, we did examine data from crossover designs if analyzable pre-crossover data were available. In addition, studies had to use standard psychometrically validated neuropsychologic tests.

The statistical comparisons that were examined included comparisons among various ECT treatment conditions, such as electrode placement, energy dose, frequency of treatment, waveform, and pulse. The comparisons also included ECT versus sham, ECT versus other treatments such as drug and medication placebo, and comparison of pre- and post-ECT changes in baseline cognitive test performance, although the pre- to post- ECT comparisons in themselves were non-randomized.

From this literature search, a total of 68 studies were identified which met these criteria.

This slide summarizes the findings of the published systematic reviews, meta-analyses, and practice guidelines. Overall, these sources indicate that there is evidence for impairment in orientation, anterograde and retrograde memory, and global cognitive function immediately after ECT that may last up to six months. Autobiographical memory is the most commonly reported memory impairment in these reviews. There is limited evidence to suggest that the effects of ECT on memory and cognitive function may not last more than six months.

A greater risk of memory or cognitive impairment is associated with sine wave compared to brief pulse ECT, bilateral and dominant hemisphere electrode placement, and the use of high energy dose ECT. This literature also suggests that raising the electrical stimulus above the individual seizure threshold increases the efficacy of ECT but at the expense of greater memory and cognitive impairment.

To continue, these summaries report that patient self- reported memory loss tends to be more persistent than the deficits that can be measured on formal neuropsychological testing. However, for those patients who do experience memory or cognitive impairment, they consider this to be a considerable source of distress for themselves and their families. The effects of ECT on cognitive function do not appear to differ among various psychiatric diagnoses such as schizophrenia and mania.

These summaries also suggest that factors other than the ECT treatment may impact cognitive function. These include individual variability, degree of improvement in depression, and the use of psychotropic medications at the same time as ECT.

I will not present the findings from the FDA systematic review of the cognitive adverse events literature. As noted earlier, FDA identified 68 studies which met the search criteria.

Cognitive Abilities Impacted by ECT

The specific cognitive domains for which data was available are listed on the next two slides. Bear in mind that the classification of cognitive domains is not mutually exclusive as there is considerable overlap among various cognitive functions.

Orientation includes person, place, and time, is most often measured by the number of seconds to minutes needed for a patient to become reoriented following ECT. Executive function includes aspects of attention, mental tracking and planning, problem solving, response inhibition, set-shifting, and working memory. Global cognitive function is typically a composite score on tasks of multiple cognitive domains. In the ECT literature, the most commonly used measure is the Mini Mental State Examination. Global memory typically is a composite score on a standardized memory battery. The most commonly used measure in the ECT literature is the Wechsler Memory Scale, although there are numerous other batteries that have been studied.

Anterograde memory, also commonly referred to as short- term memory, is the capacity to encode, store, and retrieve novel verbal and non-verbal information. Retrograde memory, also commonly referred to as long-term memory, is the capacity to retrieve information encoded prior to the initiation of ECT and is typically reported in the literature as personal or autobiographical memory, which is the ability to recall past personal information and events, such as birthdays, anniversaries, et cetera. Impersonal retrograde memory is the ability to recall historical or factual information such as the colors of the American flag or past presidents. Subjective memory is typically a patient’s self-report scale of perceived memory problems.

Other cognitive abilities, including language, visual, spatial, and motor function, among others, are typically part of a formal neuropsychological test battery. However, there are relatively few studies in the ECT literature examining these cognitive functions and therefore are not included in this presentation.

In reviewing the cognitive adverse events literature, there is a lack of consistent methodology regarding the time points of when cognitive assessment takes place. In reviewing the literature, the cognitive assessment time points generally fell into these categories. Acute effects are those occurring within the first 24 hours of ECT seizure termination. Subacute effects are those occurring from 24 hours to less than 2 weeks. Medium-term effects are those occurring from 2 weeks to less than 3 months. Longer-term effects are those occurring from 3 months to less than 6 months, and long-term effects are those occurring at 6 or more months.

There’s also some lack of consistency in the literature with respect to energy dose utilized. The FDA review of the cognitive adverse events literature generally categorized energy dose as follows. Low dose is considered to be 1 to 1.5 times the seizure threshold, moderate dose is 1.5 to 3 times the seizure threshold, and high dose is defined as more than 3 times the seizure threshold.

The cognitive and memory adverse events literature also looked at the effects of electrode placement. Electrode placement is generally categorized in the literature as bilateral, which for many studies consists of bitemporal placement, bifrontal placement, unilateral which consists of unilateral nondominant hemisphere and/or right unilateral hemisphere, and finally left unilateral or unilateral dominant hemisphere. All of these terms are in the literature.

MS. CARRAS: I have a question for Dr. Weiner. Dr. Weiner, I did a lot of outside reading to prepare for this appointment, and I was wondering if you could answer Linda Andre’s assertion that you have worked for companies that make electroconvulsive shock machines.

DR. WEINER: Yeah, I’d be glad to answer that. Earlier in my career, I did a small amount of consulting with the device companies. As I said, I was trained in electrical engineering and systems engineering. So I was familiar with more than most psychiatrists are with the electrical properties and gave them advice. It was never more than a miniscule part of any income I had.

DR. BROTT: When was the latest date of that activity?

DR. WEINER: The latest date of that activity, I don’t recall, but I don’t believe any of it was within the past 10 years, but let me add that some of the research that I did in conjunction with a colleague, Dr. Krystal, resulted in a patent by Duke University which is licensed to one of the companies, MECTA, and to avoid conflict of interest, I do not personally receive royalties from that.

DR. BROTT: While you’re up there, do you practice, do you administer ECT?

DR. WEINER: Yes, I do. Yes, I do.

DR. BROTT: And, you know, I noticed you mentioned you have this engineering background. What machine or what device or devices do you use?

DR. WEINER: Well, I’ve used both the presently marketed ECT devices.

DR. BROTT: And you currently use both of them?

DR. WEINER: Yes, I use one more than the other just because that happened to be the one that we had.

DR. BROTT: And how do you, you know, how old are they, and how do you maintain them, and do they ever develop problems? How do you detect problems? What can you tell us about these devices in everyday use?

DR. WEINER: Well, they’re pretty robust. They tend not to break down, and if there’s anything we think wrong with it, then we have it either fixed locally — there are service manuals that come with the machines — or we send it back to the factory to work on, but that’s been very rare that something like that has happened.

DR. BROTT: Could you give us any recent examples with the date? Like the last time it broke down was 1950 or, you know, 19-whatever and what it was.

DR. WEINER: Oh, I think, you know, two, three years ago, one of the knobs that control the chart drive got loose and wasn’t functioning. We had that fixed.

DR. BROTT: Is there any standard maintenance or, you know, in the manual that comes with it or who’s responsible for the machine just to see that it’s doing what it’s supposed to do? I presume this is in a medical center, hospital setting?

DR. WEINER: Right, right. It’s subject to the same medical equipment testing practices that any medical equipment is within a medical center that the medical center tends to have policies and procedures for. They’re not specific to ECT but to all medical devices.

DR. BROTT: What does that mean in terms of this device? Do they come in and look at it or do anything with it?

DR. WEINER: They generally look at it and make sure that there’s no problems with leakage current. There’s not specific tests that they generally carry out. There have been some places that have done those. The service manual includes instructions on how some of those things could be carried out, but there’s not specifics, and that’s true for most medical devices that are used in hospitals.

DR. BROTT: Other questions of the Panel members? Dr. Ellenberg.

DR. ELLENBERG: If you wouldn’t mind staying up. This is Jonas Ellenberg. Is there a fail-safe mechanism on the ECT machines that would not allow a certain current level with a certain level without an override by a senior official at the hospital or are they —

DR. WEINER: Yeah, there are constraints on the maximum output charge that actually come actually through the FDA. The FDA has maintained a limit which goes back a number of years so that there’s been no increase allowed in quite a number of years.

DR. ELLENBERG: That’s not my question. Does the machine regulate that? Does it stop?

DR. WEINER: Oh, you cannot —

DR. ELLENBERG: You cannot do it.

DR. WEINER: — set it to go higher than that. Plus, there’s voltage limiting built into the machine. So if the impedance was apparent, the machine would shut off.

So my name is Dr. Sarah Lisanby. I’m happy to answer your question about the informed consent process for electroconvulsive therapy, which is a very detailed and important process, and guidance is given to practitioners in the APA Task Force guidelines on ECT, and it includes a sample of the informed consent document.

The informed consent process is more than simply having the patient sign a form. The form itself documents a process that occurs between the clinician and the patient, and usually also family members are involved in this, where all of the risks and benefits are carefully detailed, the alternatives to treatments are discussed. Alternative treatments besides ECT include medications or psychotherapy, and these risks and benefits of the alternatives are weighed relative to the risks and benefits of ECT.

This process is quite extensive, and we do carefully go through each of the major and most common side effects of ECT. In particular, the different aspects of the effects of ECT on memory are very thoroughly covered. Also the risk of the anesthesia itself, how long these risks are expected to last, how long their therapeutic benefit is expected to last, all of this is discussed.

I typically perform the informed consent process days to weeks prior to the first treatment when the patient comes for a consultation to discuss whether ECT or other treatments may be appropriate for them. So it’s not typically done, in my practice, on the day of the treatment, but rather in the days to weeks prior to the first treatment. Usually this is, in my own practice, in collaboration and in the presences of the family members of the patient’s choosing. Often it could be the spouse or other family members who are present, and how long the process takes is variable. I would say at minimum we spend at least, in my practice, 90 minutes in my initial consultation, but the duration of time is variable. The informed consent process could last beyond that initial visit. It could be on follow-up visits.

DR. BROTT: How long does the consent process take? I’m sure you don’t take 90 minutes with the form. How long is the consent process itself with the form?

DR. LISANBY: Well, I would say once I’ve presented the form and we’re at that stage — and the typical informed consent forms are several pages long. Our sample APA ECT consent form, I don’t have a copy with me, but it is several pages long. The one that we used at our hospital was multiple pages, and it does take time for the patient to read through this, for the family to read through it. Oftentimes they take it home and come back at the next visit and discuss it and answer their questions. So to answer your question, how many minutes this takes, it is variable. I would say, you know, minimum in my own personal practice, at least 30 minutes face-to-face giving them the form initially and then oftentimes they come back for another visit and we continue the discussion, which is why when I did say 90 minutes, I wasn’t exaggerating. It is a process that —

Persistent Memory Loss with ECT

The rate of persistent memory loss. So in discussing the risks of memory loss with patients who are contemplating ECT, I explain the different types of memory that could be affected by the treatment. One distinction is memory for the ability to learn new events, which is anterograde amnesia. The other form is memory for past events, which is retrograde amnesia.

The evidence shows, and I explain this to patients, that anterograde memory, which is the ability to form new memories, that is typically a transient problem that is not, according to the published literature, anterograde memory loss has not been shown to be persistent over the long term. 106

So when you talk about risk of persistent memory loss, what we’re referring to is the retrograde amnesia, and there are different types of retrograde amnesia depending on how long in the past the memories were formed, and so that can be broken up into recent events and remote events. Recent events could be events that happened in the days or even hours prior to the treatment, and remote events could be the weeks to months prior to the treatment. And I explain to patients what the published evidence suggests about the differential vulnerability of recent and remote memories to memory loss and persistent memory loss, and this has been thoroughly studied.

To summarize that, the events from earlier in life, from the months to years prior to the first treatment, the effects of ECT are less on those more remote memories, whereas the effects of ECT have been more seen in the recent memory, a closer time to the treatment, and so even though there may be cases where there is some memory loss for the near term or remote events, over time, these memories begin to come back. Evidence suggests that there is some recovery of some of that memory, but in terms of persistent retrograde memory loss, that has been, according to the evidence, found to be most marked for the events that occurred close in time to the treatment.

Another View of Informed Consent in ECT

From Lauren Tenney, M.Phil., M.A., M.P.A.

MS. TENNEY: Besides being in special education when I was 15 years old, I’m a Ph.D. candidate, and I’ve spent a lot of time working on issues of informed consent. There’s an article by Michael Cummings and his colleagues called “How Informed Is Informed Consent?” where they looked specifically at mental health treatment and found that well over half of the people that were saying to be giving informed consent weren’t. Informed consent is actually two different processes that need to be held out. The first is informing, which contains four different things of giving information, giving options, giving time, and then reassuring that the person understands what you’re talking about, and the consent, which is a three-step phase process which includes reviewing all the information that they have, making of the options of what they’re taking or doing, and having the amount of time for somebody to then be able to withdraw that consent. One of the most important things about informed consents is that it is an ongoing and continuing process. Once the form is signed, it is not over. At any given point, somebody can revoke their consent. What’s happening in many states, and in New York State specifically, is that people aren’t even being given — well, first, if you don’t have all the information, you can’t really give informed consent. So the idea of down-classifying the shock machine without doing any kind of safety and efficacy testing further removes the opportunity to give real informed consent.

In New York, they don’t require informed consent. They take you to court, and they court-ordered 200 rounds of electroshock to somebody who they later found out was linguistically isolated and spoke Spanish, and that was why they couldn’t communicate with the woman, and the state, they knew the injunction came down, and the state shocked her that day even though they knew that they were supposed to stop doing it.

And so when you’re looking at forced treatment, which the Federal Government has said is a failure of the system, and that that alternative needs to be —

DR. BROTT: I have to ask you to wrap up your answer.

MS. TENNEY: Yeah, absolutely. But I mean to understand, the most essential part of the informed consent is that it is ongoing and that it is hierarchical, and you can’t get to one step without the other. So to say something happens, that somebody gives informed consent in 15 minutes, by the definition of informed consent, it’s impossible because you’re supposed to have a very good amount of time to be able to consider your options and weigh them out before you decide to enter into this.

I thank you for this opportunity. Forgive me my emotion. I was here at the FDA in 1985 and testified, and later on that year, the National Institutes of Health, the National Institute of Mental Health, had a two-day consensus conference on electroconvulsive therapy.

I don’t have a memory. I don’t know if it’s because I argued with a psychiatrist and he dumped me in the locked ward and shocked me five times. I became violent. I tore my nails off grabbing onto the door, and he said after five times, he says, sometimes they don’t help people.

The way I got in there was arguing with him. I had trouble with headaches. I’ve learned since then it’s because I was deprived of coffee. I had a drunken acting first sergeant that had confined me to quarters, and he got away with it, and I had headaches and I complained. So I’m psychiatrically labeled. But I became a physics teacher, and I have degrees in mathematics and physics for Carver Arnum Research (ph.) and I decided to go teaching physics.

I would ask any of these professionals here for the physics. You know, they say physics is an example. A little physics to see if there’s any — this is high school physics. High school physics. If I had a 15-pound baby, talking about 200 joules, and when they talk about low treatments, every one of you that’s involved in ECT knows that if they don’t make a grand mal seizure, it doesn’t count. Give it again. Turn up the voltage. All right. 200 joules. How high would I have to drop a 15-pound baby to have the equivalent of one shock treatment? All you professionals here. How high would I have to drop a 15-pound baby to have the same energy or how many pistol slugs would I have to shoot into its brain? This is just mechanical equivalence, high school physics. Anybody?

A joule is the energy of one kilogram being lifted a tenth of a meter. It’s equivalent to dropping a baby from a 10-foot high building.

At the 1985 National Institutes of Health conference, I gave them the Winchester ballistics sheet from Winchester and a Thymatron electroconvulsive device showing the energy equivalent to three pistol slugs to the head.

Now, they use autism to justify it and use depression. Did anybody watch the BBC with the G-20 last month? Obama was in South Korea, and BBC had a little spot on it, “The Devastated Seoul,” now one of the most thriving affluent societies, and they said how much appreciation. They went back and said, “But there’s a problem.” They’ve got the highest suicide rate in the world. Between the ages of 10 and 40, the major cause of death now is suicide in Korea. Is it because they need a shock treatment? It wasn’t like that before the war? Affluence.

My mother had to help a baby that was dying from diarrhea and vomiting from the woman next door. She was a good woman, but she had been raised in daycare and she couldn’t bond to her baby. My mother was a teacher. So she cared for the baby during the summer, and it recovered and thrived.

We’re talking about depriving children and then punishing them for the effects, whether it’s autism or depression. Look into it. The breakdown of the home is what destroyed Korea. Yes, it’s an affluent society, the highest suicide rate in the world. You want to electroshock all of them? They pay now $1,000 a treatment.

They pay $1,000 a treatment. Somebody just said, professional testimony, we need a million people treated. $1,000 million we’re going to pay a year for this. Thank you.

My name is Mary Rosedale. I’m a board certified psychiatric nurse practitioner and an Assistant Professor of Nursing, and I’m here as a representative of the American Psychiatric Nurses Association which has prepared a position statement on this issue.

The American Psychiatric Nurses Association, APNA, was founded in 1986 and is the largest professional association of psychiatric nurses representing both psychiatric nurses at the basic level of practice, RNs, and psychiatric nurse practitioners and psychiatric clinical nurse specialists. APNA is the only psychiatric organization that is inclusive of all RNs in the United States as well as having international members and represents over 7,000 members. It also has a panel of mental health consumers that offer advice to the governing board in formulating policy statements.

We are pleased to offer comments in support of the use of electroconvulsive therapy in the treatment of severe depression that has been shown to be refractory to medication.

For more than seven decades, psychiatric mental health nurses have provided customized treatment to patients receiving ECT. In addition to advancing evidence-based treatment modifications and developing advanced practice nursing roles, psychiatric nurses have been vital patient advocates, assuring that patients receiving accurate information about ECT, educating the public and influencing public policy.

ECT is an effective treatment for severe depression. The literature on the efficacy of ECT for treatment of depression is as extensive as for almost any other medical treatment. Moreover, ECT is a rapidly acting treatment. Multiple trials of adequately administered ECT have demonstrated a speed of antidepressant response for patients experiencing severe major depressive episodes. For patients who urgently need relief of depressive symptoms, such as those who pose a danger to themselves or to others, ECT can be the treatment of choice. For patients who have not responded to or cannot tolerate medications, ECT may be the safest alternative.

Modern techniques and brief pulse devices have increased the safety of ECT. Morbidity and mortality are less than that of childbirth, with 1 to 2 deaths per 10,000 patients treated with ECT. Advances in anesthetic and ECT administrative techniques have greatly mitigated side effects.

The most significant concerns about ECT are the treatment-related cognitive impairment, but even this symptom has been markedly reduced with advances in ECT administration. ECT remains the treatment of choice for severely depressed patients with other concurrent health risks.

And so in conclusion, it is the position of the American Psychiatric Nurses Association that ECT is a proven therapy and that future and further clinical trials are not necessary to establish its safety and efficacy. APNA encourages the FDA to classify these devices in an appropriate manner to assure that patients have access to ECT while at the same time assuring that ECT devices function safely and in the manner intended. APNA believes that ECT operated by properly trained professionals and in circumstances of medical necessity offer patients with severe depression an option that would otherwise be unavailable. APNA stands ready to assist in the development of additional standards of practice in the application of ECT.

Thank you for your attention, and we urge you to reclassify these devices in a manner that provides the proper balance between access to evidence-based treatment and patient safety. Thank you.

Good afternoon. My name is Dr. David Boger. I’m a board certified adult psychiatrist in private practice in New York City.

I come to you today both as a physician who supports the use of ECT in carefully selected patient populations and as a patient myself who has undergone extensive electroconvulsive therapy. I refer you to my personal article I wrote entitled, “Shocking the Shrink: A Psychiatrist Undergoes ECT.” I’ve experienced episodic depressions characterized by sleep and appetite disturbance, impaired concentration, complete loss of interest in usual activities, hopelessness, debilitating fatigue, and prominent suicidal ideations since the age of 10. My father, incidentally, was unofficially diagnosed with depression which eventually led to his tragic suicide.

I saw a plethora of psychiatrists who eventually made the diagnosis of bipolar II disorder, a variant of manic depressive illness. I was introduced to lithium by a prominent psychiatrist at NIMH and in combination with antidepressants, first the tricyclics and then the newer SSRIs like Prozac, was able to maintain a high function for several years at a time.

Despite all the interventions, I still experienced recurrent depressions and hypomanic episodes every few years that sidelined me often for months at a time. It was not until 2003, when I had another rapid-onset severe bout of bipolar depression that my New York psychiatrist recommended, of course, ECT. At that time, I was dangerously depressed and actively suicidal, unable to make a commitment to refrain from self-harm and was so admitted to New York University Hospital. I stayed there almost a month receiving three ECT treatments a week. At that time, the protocols and equipment left me dazed for at least 24 hours with significant amnesia for events occurring around the time of treatments. I enjoyed a brisk but incomplete recovery. The suicidal feelings were quickly extinguished but a persistent sleep disturbance and low self-esteem persisted. I was discharged alert and fully oriented on a combination of antidepressants, antipsychotics, and mood stabilizers.

I suffered through manageable symptoms until December 2008, when the walls came crashing down. My mother’s Alzheimer’s disease took a major turn for the worse, and the responsibilities and challenges of resuming a medical practice seemed to overwhelm me. In January 2009, I was readmitted to NYU, imminently suicidal. I had made arrangements to buy lethal rat poison and ingest it.

By that time, the science of ECT, thank God, had evolved, and under general anesthesia, I received ultrabrief right unilateral pulse electric current administered to the right temple area only. The electrical current elicits a generalized motor seizure blocked from motoric expression by the inhibitory drug succinylcholine. I slept pain free during the process which lasted only minutes. In less than three weeks of three times a week treatment, I experienced a full recovery this time marked by absence of suicidal feelings, improved self-esteem, and the resumption of hope for the future.

In contrast to the treatments of 2003, the side effects were minimal. I was alert, clear-headed, and completely functional within an hour of treatment and experienced no lingering cognitive effects. It was decided with informed consent that I would receive monthly maintenance ECT treatments on an outpatient basis to reinforce the remission and to prevent relapse. I’ve continued these sessions for nearly two years. I’ve experienced no discrete depressive episodes and have had no problems with memory, concentration, or abstractive reasoning. On the days of treatment, usually scheduled early in the morning, I set aside the rest of the morning to sleep off the effect of the general anesthesia. By afternoon, I’m ready to go and, in fact, once taught a seminar for medical students at Mount Sinai in which I demonstrated the absence of side effects from my own ECT treatments.

While other pharmacological treatments had been useful in achieving partial remission of depressive symptoms, only ECT has eradicated entrenched suicidal ideation and allowed me to function at my highest capacity. Thanks to the improvement in the medical devices and more sophistication in the anesthesia techniques, I feel now as well as I have in my entire life. I don’t know how long treatments will continue, but to date I’m very satisfied with the results. I’m convinced that I would be dead if ECT were not available to me.

Thank you for the opportunity to speak here. Thanks.

Hi, thanks. My name is Lauren Tenney. I’m a survivor of psychiatry. I was never given electroshock, but it’s much because of the work of advocates and activists in the 1960s and 1970s and 1980s that prevented me from being exposed to the treatment which is known to cause brain damage, including memory loss, damage to the body, and destruction of life.

I consider myself very lucky. At 15 I was institutionalized at a state facility in New York, and in recent meetings, as recent as the end of last year, the New York State Office of Mental Health justifies the young person that can be shocked in a situation that is identical to what would have been seen as my situation at 15. And so I feel, on top of everything else, the idea of young people being shocked is a human rights violation and needs to be looked at, and as a matter of fact, the United Nations Special Repertoire on the Convention Against Torture has cited that electroshock along with several other psychiatries, several other practices such as forced drugging, may constitute torture or ill treatment.

Theopalproject.org collected over 80 comments and sent them onto the FDA when you were doing the initial commenting January 4th and 5th, I’m not sure of the date, but when you were doing it. We sent out over 80 comments and, you know, many of the people who are currently being shocked may have no idea that there is an opportunity to comment on the potential down-classification of the shock machine without a safety investigation.

Many of these people, including children and senior citizens, may be involuntarily committed, barred access to the outside world and the Internet, leaving options for their voice to be heard discounted. Various reasons such as poverty, illiteracy, fear of retaliation, lack of access to the Internet, fear of coming out, and saddest for those whose death was caused by ECT, which itself is a crime against humanity, will prevent some people’s voices from being heard.

So while in numbers we may not be able to rise against the strength of the industries that will undoubtedly prosper from a down- classification of the shock machine, please bear in mind what it means for someone to speak up and voice their opinion and share their personal experiences.

This is the reason that we sent this letter out to you. I think you all should have gotten this.

I’m appealing to your humanity here and I’m asking you to seriously consider what it is that people say. In 74 of the comments, about 12 or 13 people used the word “please.” Please stop the use of ECT. Please do not cave into the industry on this issue. Please do not reclassify unless you undertake investigation. Please don’t destroy any more brilliant minds like this. Please consider carefully the approval process and reclassification of ECT. Please do not reclassify the ECT device to Class II without further requiring premarket approval applications. Please stop this process until you have had ample time to hear from those of us who have had firsthand experience with ECT. Do not allow these companies to get away with this please. Please be sure to do safety exploration and testing before moving forward. Please stop them now. Please do not allow ECT machines to be used as safe without proper investigation. It seems to me that even if one was destroyed, that is one too many. Please stop this treatment.

You know, for centuries, we have been going through periods of time when psychiatric industry comes under investigation because of the way it acts, and we have this opportunity right now again to try to make some change and to try to make it stick.

The door has been open on a very important conversation that is silently brewed amongst people who are survivors of shock treatment and their allies for decades with little effect. Our battle is now, as it always has been, Will the people who have power to end psychiatric abuse and torture and require full and informed consent based on actual safety investigations do so?

Hundreds of attempts of thousands of people over the decades have left many of us unhopeful that —

DR. BROTT: You have 30 seconds left.

MS. TENNEY: Well, shock is a social justice issue. FDA, we want you to ban the use of all shock devices on minors, ban the use of shock devices for all forced, coerced, and uninformed shock procedures which routinely happen across this country, and institute a moratorium on all use of shock devices until proven safe. Thank you.

Thank you for permitting me as well as other members of the public to provide comments at this important meeting. I would first like to applaud this Panel for coming together on a matter of critical importance to people with disabilities. I’m here in my capacity as a board member of the National Council on Disability, an independent federal agency which advises the President and Congress on all issues affecting people with disabilities.

I also want to let you know that I’m a psychiatric survivor myself and therefore can speak as a person with a disability who has been impacted in a profound way by the subject at hand. I have been in recovery from my bipolar disorder, alcoholism, substance abuse for 25 years. I’ve had the privilege of having had excellent medical care when I was sick, something that many of my brothers and sisters have not had access to. At the same time, I would like to thank the FDA for approving medications Lamictal and Seroquel. These medications have helped me.

Medical devices have profound impact on the lives of people with disabilities. While many devices hold great promise for increased participation of persons with disabilities in the community, their safety and effectiveness needs to be carefully studied to ensure the potential negative impacts are eliminated or mitigated.

The NCD wishes to specifically highlight its views regarding ECT and the classification of devices for ECT. I’ve drawn heavily from our groundbreaking report, “From Privileges to Rights: People Labeled with Psychiatric Disabilities Speak for Themselves,” in preparing commentary. As noted in this NCD report, ECT is of great concern to the disability community. The advisory committee considers the FDA’s role in regulating the device used to conduct ECT. NCD wants to help inform the committee about the role these particular devices have on lives of people who often don’t have a voice. People with psychiatric disabilities are routinely deprived of their rights in a way no other disability group has been.

While I know this committee is focusing on how to classify ECT, NCD believes that ECT devices are inherently inhumane, unsafe, and ineffective and should not be classified as a therapeutic device. Public policy needs to move in the direction of a totally voluntary community-based mental health system that safeguards human dignity and respects individual autonomy. People labeled with psychiatric disabilities should have a major role in the direction and control of programs and services designed for their benefit, and most importantly, germane to this committee meeting, public policy should move towards the elimination of ECT and psychosurgery as unproven and inherently inhumane procedures.

Effective humane alternatives to these techniques exist now and should be promoted. I’ve concluded from my own personal experience and from NCD’s policy development research that one of the reasons public policy concerning psychiatric disability is so different from that concerning other disabilities is the systematic exclusion of people with psychiatric disabilities from policy making. It is rare that people with psychiatric disabilities are heard in public policy forums, and thus I want to take full advantage as a member of the psychiatric disability community as a presidentially appointed member of the Council to urge you to carefully consider classifying ECT devices as any type of therapeutic device.

Again, I thank you for allowing me to comment.

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 —

My name is Dorothy Dundas, and I am 69 years old from Newton, Massachusetts, and I’ve been waiting 50 years to come before this Panel, those of you who have a power to make a humane decision.

When I was 19 years old, I became sad and lonely, and I tried to kill myself. I took a half a bottle of aspirin, my parents took me to the Massachusetts General Hospital, and thus began my three-year hellish odyssey as a prisoner in the horrors of the mental health system. I was diagnosed with schizophrenia and given 50 shock treatments against my will, 40 insulin comas and 10 superimposed electroshocks.

Very early on the dark winter mornings of 1961, three other teenage girls and I were awakened, dressed in johnnies, and told to lie flat on our beds, which we were lined up right next to each other. We were then injected with insulin, and on 10 of those mornings, a dark-suited man would walk through the door. He carried all his equipment in a small black suitcase, this man of death and destruction. He set up his machine behind our heads, one by one. We were curled up beneath our sheets. When they peeled the sheets off of us, forcing us onto our backs, bare and open and vulnerable, I was second in the lineup. Before being turned, I would often peek out from a small secret opening in my sheet to see what they were doing to Susan, the first to receive the treatment. I would make myself watch as if it might prepare me in some way, and then she would shake violently all over. I could no longer watch. I would shiver beneath my sheet, and then they would come to me. I can still feel the sticky cold jelly they put on my temples. My arms and legs were held down, and just before he pushed the shock button, he would ask, is everybody ready? Of course, he was not speaking to me, petrified and stone silent. Each time, I expected I would die. I would wake up with a violent headache and nausea. My mind was blurred. I permanently lost eight months of my memory for events preceding the shock. I also lost my self-esteem. I had been crushed as flat as a pancake. But I was very, very lucky because on one of those cold winter mornings, exactly 50 years ago, my friend Susan never woke up from the shock. She had just turned 17, and when she died, she became a part of me.

The ECT was a violent and damaging assault on my brain and my very soul. It made me emotionally worse, not better. I became catatonic and desperately in fear for my life. To this day, I have great trouble staying focused in a conversation, keeping my train of thought. I forever lost the ability to do math in my head, and before this time, I had been a very good student. When I was given an IQ test a few months after the ECT and asked the population of the United States, I answered 1,000. When he asked me to guess again, I answered 2,000. I remember having no idea where to find the answer in my head.

For me, in addition to losing my train of thought, the most troubling residual effect has been the memories of those traumatic mornings, the violent and abusive assaults on my brain. For far too long, there has been a collusion between the FDA, the APA, the AMA, and the companies which make the shock machine. This is big business, and a lot of money is being made by many at the shameful expense of those who have been harmed over the years.

To me, informed consent is meaningless. Those of us who have already experienced ECT are only the truly informed. Right now this is a human rights issue, and this is a torture issue.

In the end, after three years of hell, it was a kind young doctor who spoke to me in a gentle voice who gave me hope. He took me off all medication, expressed horror when hearing of my experience with ECT —

DR. BROTT: You have 20 seconds.

MS. DUNDAS: — and recognized — I urge you to ban the use of this dangerous and barbaric machine and, by doing so, finally to show the courage and understanding to support the many more humane and holistic approaches to healing emotional pain. Thank you.

My name is Evelyn Scogin. I’m here to tell you my story of assault from ECT so that you will understand the harm this machine does every time it is used. I came to psychiatry in 2004 at the age of 47. I was experiencing severe stressors at the time. So I naturally turned to a mental health professional for assistance and advice. I entered the psychiatric system at the time, trusting the psychiatrist as the health professional that would care for me in my time of need and perhaps help me solve my emotional issues. That is what I was led to believe.

I entered the hospital taking one psychiatric drug and left taking seven. My psychiatrist diagnosed me with bipolar disorder. At the urging of the psychiatrist, I gave up my hard-won career of teaching special needs deaf students. One month later, in January of 2005, I was in the hospital again because I was depressed.

My sister has informed me that the psychiatrist described ECT treatment as safe with only a loss of memory of the day of the treatment which would return shortly thereafter. I say my sister told me that because I have no recollection of any conversation with the psychiatrist concerning ECT. Never did it occur to me that anything that a so-called professional recommended would be harmful to me. I have no memory of the meeting or any events thereafter.

I was subjected to six months of numerous treatments. During my course of treatment, my emotional, physical, and cognitive health severely declined.

My family has informed me, because I have no recollection, that when I was released from the hospital after treatment, I could not be left alone as I would wander off somewhere and become lost. I often could not tell you my name and the names of any of my children. I lost not only my memories of the time I was subjected to this torture, but I was robbed of almost all memories from 2003, two years before the treatment, to 2008, three years after the treatment stopped. I was unable to converse or write coherently because my word recall was so limited, just like someone who had had a stroke. Taking care of many of my everyday needs was beyond me. In fact, one of my sisters had to take charge of my bank account. I could no longer drive or go to the mailbox alone.

I’ve fought long and hard over the last several years to recover from the effects of this abuse and rebuild my life. However, I will never recover the part of myself that was stolen from me which consisted of my memories. Because of these lasting effects, I have, as of yet, been unable to return to my chosen profession of teaching. I’m training for a new job, but it remains a struggle for me each and every day to learn new tasks.

The persons that believe ECT helps are psychiatrists. If you ask the patients, with some rare exception, they don’t feel that it helped them. ECT destroyed my life. You, this Panel, should not be a party to destroying minds with this dangerous device when there’s no evidence that it has any benefit. You should not permit these machines to create chaos in person’s memories without first demanding proof that it can truly help humans. It has never been proven to be effective at curing anything, never.

Some think approval from the FDA means a product is effective and that it is safe. These people have been betrayed. By limiting the evidence, by limiting the issues they want you to address, by excluding all questions of efficacy, the FDA is using this Panel as a instrument of that betrayal. By agreeing to membership in this Panel, it is your solemn duty to protect others. Downgrading these devices to Class II would be unforgivably irresponsible.