Electroconvulsive therapy (ECT) devices are undergoing FDA scrutiny and could become subject to new requirements and restrictions that affect their use by psychiatrists. The FDA is considering whether to keep ECT devices in their current Class III category or drop them to Class II. If they remain in Class III, manufacturers (mostly small companies) would probably have to conduct clinical trials to prove safety and efficacy—trials that could be costly and cause some companies to have second thoughts about continuing to manufacture the devices. A drop to Class II might also result in a clinical trial requirement, although this would be a less likely outcome. The FDA would be more likely to implement special controls for use of ECT devices if they were lowered to Class II.
Sarah H. Lisanby, MD, director of the Division of Brain Stimulation & Therapeutic Modulation and professor of clinical psychiatry at Columbia University College of Physicians and Surgeons at the New York State Psychiatric Institute, said the FDA reevaluation of the classification of ECT devices is at a “critical juncture” for people who live with depression and their families. “Continued access to this lifesaving treatment depends on the decision taken by the FDA,” she stated.
Lisanby is heading up the current American Psychiatric Association (APA) effort to revise the ECT clinical guidelines published by the APA. The new guidelines will incorporate the results of recent studies done by NIMH that demonstrate the safety and efficacy of ECT.
“ECT is the most effective and most fast-acting treatment for depression we have,” added Lisanby. “ECT can work when medications fail, and medications fail more frequently than previously appreciated.” She pointed to the NIMH-sponsored STAR*D clinical trials as evidence.
The concern among psychiatrists about the future of ECT stems from an announcement in April 2009 that the agency was reviewing the status of 25 medical devices approved before 1976, and those grandfathered in after that date because they were deemed “equivalent.” ECT devices were included on that list. The FDA followed up its April announcement in a September 2009 notice that applied only to ECT devices. There the FDA acknowledged it had received “a significant number of inquiries from members of the public and the health care community in response to this order to ECT manufacturers.” As a result, it opened a separate docket—separating ECT devices from the other 24—to permit individuals other than manufacturers to submit information related to the safety and effectiveness of ECT.
The ECT regulatory proceeding slowed last fall and winter as the Obama administration looked for someone to head the FDA’s Center for Devices and Radiological Health (CDRH). The appointment of Jeffrey Shuren, MD, in late January allowed the CDRH to move ahead on the ECT matter with all due speed. Victor Krauthamer, the FDA official in charge of the rulemaking, explained that ECT devices have never been required to undergo clinical trials because they were on the market before 1976 when medical device amendments that required testing were passed by Congress. Pre-1976 devices were grandfathered in.
In the aftermath of the September request, 1395 comments have poured in—pro and con—many from groups with names such as the Committee for Truth in Psychiatry, the Antipsychiatry Coalition, and hundreds of their adherents. Individual psychiatrists and the APA defended ECT devices, which are generally prescribed for severely depressed patients when other forms of therapy (eg, medications or psychotherapy) have not been effective, cannot be tolerated, or (in life-threatening cases) will not help the patient quickly enough. Under the current FDA regulations, ECT is indicated for “severe psychiatric disturbances.” The APA argues that ECT is used very infrequently, and only after informed consent is obtained from the patient or his or her guardian.
Antipsychiatry groups contend that ECT devices have not gone through clinical trials—which is true—and have too many potential adverse consequences that outweigh any benefits. Linda Andre, director of the Committee for Truth in Psychiatry, said, “ECT is not infrequently administered under coercion or by outright force to patients who have explicitly refused it.” She also argues that ECT causes memory loss and therefore is not safe and that it is not effective except in some instances on a short-term (no more than 1 month) basis.
Despite these claims, however, documented evidence of widespread or systematic use of “force” or “coercion” in the provision of ECT is very difficult to obtain in the United States—notwithstanding isolated, anecdotal claims of such abuse. The most recent refinements in ECT techniques have markedly reduced risks of long-term cognitive impairment, and recent data show that “continuation” ECT results in no more cognitive impairment than does maintenance pharmacotherapy. There is also clear evidence of ECT’s ability to reduce suicidal ideation during acute treatment.1,2
Other groups have taken a middle road on the use of ECT. Harvey Rosenthal, executive director of the New York Association of Psychiatric Rehabilitation Services, agreed that some people have benefited from ECT, but that many have experi-enced severe memory loss, agitation, cognitive deterioration, and long-term brain damage and other injury, especially at the hands of equipment that was out of date and improperly inspected and maintained. “ECT should be delivered in an atmosphere of fully informed choice, with appropriate treatment protocols, appropriate timing, and appropriate government oversight,” he said.
Ken Duckworth, MD, medical director, the National Alliance on Mental Illness, said significant improvements have been made in this treatment and today there is strong evidence that ECT is both highly effective and relatively safe. “The most serious reported side effect of ECT is memory loss, which is relatively short-term and manageable in most cases, although more serious in a minority of cases,” he explained. “This is a significant side effect, but its impact should be considered relative to the pain and suffering of severe, intractable depression.”
1. Fink M, Taylor MA. Electroconvulsive therapy: evidence and challenges. JAMA. 2007;298:330-332.
2. Smith GE, Rasmussen KG, Cullum CM, et al; for the CORE Investigators. A randomized controlled trial comparing the memory effects of continuation electroconvulsive therapy versus continuation pharmacotherapy: results from the consortium for research in ECT (CORE) study. J Clin Psychiatry. 2010;71:185-193.