Dr. William Narrow presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are his remarks as published in the public record of the meeting.
My name is William Narrow. I’ve been a board certified psychiatrist for 20 years and currently serve as the Associate Director for the Division of Research at the American Psychiatric Association. Thank you all for the opportunity to speak on behalf of the APA regarding the safety and efficacy of electroconvulsive therapy and to address FDA’s classification of medical devices used for ECT.
Before I begin my remarks, let me say that neither I nor the American Psychiatric Association is involved in the manufacture or sale of ECT devices.
ECT is an important treatment option for psychiatrists. It is most often used to treat psychiatric illness in three situations: when rapid, definitive treatment is needed to prevent harm to the patient, when other treatment options present unacceptable risks, or when a patient has a previous history of poor medication response or a good response to ECT.
ECT is most often used to treat severe symptoms of three mental disorders, major depressive disorder, schizophrenia, and bipolar disorder. All of these disorders can be manifested in life-threatening ways, including profound and intractable suicidal intent, catatonia that can lead to complications such as dehydration, starvation, and venous thrombosis, and manic episodes that can lead to lack of self care, destructive behavior, and physical exhaustion.
The availability of ECT assures rapid, safe, and effective treatment for the manifestations of severe mental disorders. In many cases, it is lifesaving. A large body of evidence published in peer-reviewed medical journals has documented the safety and efficacy of ECT.
Much of the public stigma attached to ECT is based on lurid media depictions of early treatments in which high doses of electricity were administered without anesthesia for any number of psychiatric problems or simply for punishment. Modern ECT is nothing like these portrayals.
The American Psychiatric Association has developed recommendations for ECT treatments, training, and privileging. These recommendations state that ECT should be administered by a team of trained health professionals with experience in ECT administration, including a trained ECT psychiatrist, an anesthesia provider, and one or more nurses. The electrical stimulus is given while the patient is under light general anesthesia with muscle relaxation. The seizure, initiated by the electrical stimulus, is monitored by EEG. After the procedure, the patient is monitored by a registered nurse as is done for any procedure involving general anesthesia. Although ECT causes side effects, it uses electrical currents given in a controlled setting to achieve the most benefit with the fewest possible risks.
ECT is not a treatment that should be lightly considered, and the patient and physician must discuss all options available before deciding on any treatment. The APA recommends a rigorous informed consent procedure for ECT. The patient and his or her family are informed about the procedure through in-person discussions, written material, and any supplementary means available before giving consent. Risks, benefits, and the voluntary nature of treatment are explained. If the patient is unable to give informed consent, state and local laws governing consent to treatment are followed. Detailed sample patient information and consent forms have been developed by the APA.
As noted in our written comments submitted to the FDA in 2010, the APA strongly supports the reclassification of ECT devices to Class II with special controls. Should the ECT move forward with such a reclassification, manufacturers should be asked to disseminate science- based guidelines similar to those developed by the APA. If the FDA does decide to promulgate controls involving postmarket surveillance, the controls should only be those to ensure the safety of the device. The APA has particular concerns regarding patient registries based on the potential for re-identification and breaches of privacy by third parties.
Thank you for allowing me to speak to the FDA Panel today. I’m happy to answer any questions you may have. As a psychiatrist and a researcher, I consider ECT an important treatment option for patients who are not responding to other therapies or whose lives are at risk. Thank you.