Dr. Sarah Lisanby 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, and thank you for this opportunity to give testimony on this important topic. My name is Sarah Lisanby. I’m a medical doctor, a board certified psychiatrist and ECT practitioner and researcher, the Chair of the Department of Psychiatry at Duke University and the Chair of the American Psychiatric Association Task Force on ECT.
The APA reimbursed my travel to come to this meeting.
I’m here to deliver one critical point. Depression kills while ECT saves lives. ECT is the most effective and rapidly acting treatment for severe depression available today. Scientific evidence and peer-reviewed medical literature supports the safety and efficacy of ECT. The number of publications on ECT exceeds 10,000 in the U.S. National Library of Medicine. The consistent finding is that ECT is unparalleled in efficacy in a range of serious conditions including major depressive disorder, bipolar disorder, catatonia, psychotic depression, medication resistant schizophrenia, and other severely disabling conditions, many of which are unresponsive to all other treatments.
ECT works even when psychotherapy or medications fail, and studies report that up 80 to 90 percent of people experience a complete recovery. ECT is an indispensable part of mainstream medicine. Training and the indications and uses of ECT is a required part of psychiatry residency. ECT is an essential part of the APA practice guidelines on the treatment of depression.
We still use ECT today because no approved treatment has yet been able to replace it. I also do research on new forms of brain stimulation, and while promising, none has yet replaced ECT.
The APA Task Force on ECT supports reclassification because large-scale controlled clinical trials in hundreds of patients, sponsored by the National Institutes of Health, have repeatedly demonstrated the efficacy of ECT. ECT has evolved dramatically over the years. In stark contrast to portrayals in the movies, ECT is performed under general anesthesia in a medical environment by physicians and nurses. Informed consent is an important part of the process. The electrical parameters have been refined through decades of careful study, and the dosage is individually tailored to improve safety.
The enhanced safety profile merits Class II designation. It is my position and the official position of the APA that ECT is a safe and effective evidence-based medical treatment. ECT is endorsed by the APA when administered by properly qualified psychiatrists for appropriately selected patients.
Medication resistance is a serious problem. The National Institute of Mental Health funded STAR*D trial, noted that approximately 60 percent of the patients failed to respond after 2 treatments, and about 1/3 failed to respond even after 4 medications. If we assume that a third of the estimated 14 million Americans diagnosed with depression per year are treatment resistant, that yields an estimated 4.6 million Americans with treatment-resistant depression. The most effective approved treatment for these people is ECT.
When ECT goes untreated or when it is ineffectively treated, it can cause extreme suffering and even death by suicide. Suicide is a leading public health problem which accounted for nearly 35,000 deaths in the U.S. in 2007. ECT is rapidly effective against suicidal impulses. Without ECT, suicidal patients would have few effective options left.
Let’s not lose sight here of the key stakeholders in this discussion. If ECT were to disappear tomorrow, it’s not the medical establishment that would suffer. Indeed, a comparatively small number of psychiatrists administer ECT. If ECT were to disappear, it’s not the economy that would suffer. The two companies that make ECT devices are small and not publicly traded.
If ECT were to disappear tomorrow, those who are suffering already and who have no effective alternatives are precisely the ones who would suffer the most. Their families, their children, their loved ones, their friends, and their communities would suffer. Given the prevalence of depression, it is likely that everyone in this room knows someone who has been affected.
Aside from my professional roles, I’m also the family member of a person whose life was saved by ECT. This dual perspective puts me in an excellent position to speak to the gravity of the discussion that faces you today.
People whose lives have been affected by severe treatment- resistant depression deserve the best that medical science has to offer, and today that is ECT. Until a safe alternative that matches or exceeds the therapeutic spectrum of ECT comes along, threatening or restricting its availability would only serve to take away the last hope from those who are already suffering from hopelessness. Without this safety net of ECT, we as physicians will only be able to stand by helplessly in the face of suffering, knowing that an effective treatment was removed from the medical toolbox.
Thank you for your attention, and the references to my comments are found in your packet.