Dr. Richard Weiner 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.
Thank you for the opportunity to speak today. My name is Richard Weiner, and I’m here to speak for reclassification of ECT devices to Class II. I’m a board certified psychiatrist with undergraduate or graduate degrees in electrical engineering, systems engineering, and neurophysiology. I presently hold a position as Professor of Psychiatry at the Duke University School of Medicine. For the past three decades, I’ve undertaken a considerable amount of research dealing with various aspects of making ECT safer and more effective. Over this time period, I have also represented the American Psychiatric Association in regard to FDA classification of ECT devices on multiple occasions, including testimony at earlier public hearings on the topic.
Many in this room may not be aware that the most recent FDA proposed rule regarding ECT devices was actually a notice of intent published in 1990 in the Federal Register, stating FDA’s plan to reclassify ECT devices to Class II based on information provided by an earlier petition by APA, a subsequent Advisory Panel hearing, and a comprehensive FDA review at the time.
Today and tomorrow, this Advisory Panel has the task of deciding whether to recommend that FDA allow that intent to finally come to fruition. In this regard, it is worthwhile to focus upon whether the body of data over the intervening 20 years, in particular, what has been reported in the relevant peer-reviewed scientific literature, further supports such reclassification. Specifically, do such findings support the efficacy and safety of ECT itself, and are these findings applicable to contemporary U.S. ECT devices since FDA’s mandate is to regulate medical devices rather than medical practice?
Since 1990, there have been major advances in both ECT practice and ECT instrumentation, as has and will be pointed out by others of today’s speakers. These developments provide further compelling evidence that ECT can be delivered in a safe and effective fashion. 53
Specifically, for major depressive episodes, recent large NIMH- sponsored, multicenter trials, using contemporary U.S. ECT devices, have demonstrated that modern, evidence-based ECT technique is associated with response and remission rates that are substantially greater and more rapidly achieved than that reported elsewhere in the literature for any other form of antidepressant treatment, be it medications, psychotherapy, or more recently transcranial magnet stimulation. These studies have also provided the largest and most rigorously defined body of data concerning ECT side effects, most notably memory deficits, and have also elicited information on important functional indices such as quality of life, which not surprisingly improves following ECT.
With respect to memory deficits, such data are consistent with earlier findings that anterograde amnesia and retrograde amnesia, particularly for recent events, can be persistent. It should, however, be noted that the most recent APA recommendations on ECT practice clearly spell out the need to include the possibility of persistent retrograde amnesia in the informed consent process with ECT to ensure that all individuals for whom ECT is recommended receive this information.
I would also like to point out that recent multicenter trials have investigated the safety and efficacy of maintenance ECT, i.e., the use of single ECT treatments spread out over time to decrease the likelihood and severity of relapse. These data reveal that maintenance ECT is, indeed, effective and further that there is no evidence of memory impairment associated with such widely spaced out treatments.
One last point I would like to make is that the benefits and risks of any treatment are relative as opposed to absolute. By this I mean that the truly relevant consideration is whether providing a given treatment is more effective and safe than not using the treatment. For ECT, it is often the case that its more rapid and substantial benefit obviates the considerable morbidity and mortality of the underlying mental disorder remaining untreated. Individuals in the throes of a severe depressive episode are not just depressed. A compelling body of data indicate that they are also at significantly elevated risk not only of suicide, but medical debilitation and death from a wide variety of causes.
MS. WOOD: Thirty seconds.
DR. WEINER: This is particularly the case for the elderly where one study showed a significantly greater multiyear survival rate for individuals who received ECT for treatment of major depression than those who did not.
In closing, the evidence that present U.S. ECT devices are associated with a reasonable level of efficacy and safety is compelling, not on the basis of opinion or empirical observation but on the basis of hard scientific evidence. As such, present U.S. ECT devices meet established FDA criteria for Class II designation and I —