Dr. Pamela Sullivan 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 her remarks as published in the public record of the meeting.
Good morning. My name is Dr. Pamela Sullivan. I am a practicing psychiatrist and an officer of the International Society for ECT and Neurostimulation. ISEN is a professional society of over 200 ECT practitioners dedicated to promoting best practices in ECT. Our members have a vast amount of clinical experience in providing ECT. We have also contributed much of the research evidence base demonstrating the efficacy and safety of ECT. As a professional organization, representing psychiatric physicians, nurses, and other ECT clinicians, we urge the FDA to reclassify ECT devices as Class II devices.
ECT is an important lifesaving treatment that is a standard part of contemporary medical practice. When the clinical and scientific evidence is fairly considered, ECT is shown to be remarkably safe and effective.
Modern ECT is a highly developed procedure carried out by a team of medical practitioners with specialty training. ECT physicians must be credentialed by their institutions to perform the procedure. Anesthesiologists who are part of the ECT team must also be credentialed to provide the anesthesia. Modern standards for anesthesia delivery apply to ECT just as they do for any other medical or surgical procedure.
ECT is typically prescribed for severely, psychiatrically ill patients for whom other forms of treatment, such as antidepressants and antipsychotic medications and psychotherapy, have not been effective or are poorly tolerated. It is also prescribed when a patient is so ill that rapid definitive treatment is urgently needed. Because of this, it is often lifesaving in patients who are suicidal or physically debilitated because of depression. ECT is an important treatment option for elderly patients. Depression in the elderly may be particularly severe and may not respond as well to medications. While ECT is very effective across all age groups, recent research shows especially favorable response in the elderly.
The medical risks of ECT have been carefully studied. These risks include the effects on memory, which are generally modest and acceptable, particularly when one considers how sick ECT patients typically are and how helpful the treatment is. The risks of severe, untreated depression including suicide are significantly greater than the risks of ECT. In other words, the risk/benefit ratio, a way of considering the advisability of any medical procedure, is overwhelmingly in favor of ECT in the severely ill patients for whom ECT is an option.
Modern ECT techniques, including the use of right unilateral, non-dominant hemispheric electrode placement and brief and ultrabrief pulse stimuli, have substantially reduced the cognitive side effects of ECT. After extensive study, researchers have found no evidence that ECT causes any damage to the brain. The memory effects of ECT are explained in detail to all patients in the informed consent process before the treatment is initiated and mostly limited to patchy gaps in memory for some events in the weeks to months before the treatment course and during the treatment series.
ECT has been subject to more scrutiny than almost any other procedure in medicine. Referral for ECT is already very restricted largely because of the inaccurate negative image of the treatment promulgated in the media, which is disturbing to patients and even some medical practitioners. To further inappropriately limit the availability of ECT as a treatment option would have devastating effects on thousands of our most ill psychiatric patients.
We believe access to ECT should be greater, not less, for appropriately selected patients. ECT relieves suffering and prevents loss of life by suicide and medical complications of untreated depression. Like many medical procedures for severe illness, it does have its side effects and risks. When the evidence is examined thoroughly and objectively, as the FDA is now doing, it becomes clear that ECT as practiced in the United States today is a safe and vital treatment option for severely ill psychiatric patients.
The ISEN expresses its strong support for the reclassification of ECT devices to Class II. Thank you.