FDA Advisory Panel Favors ECT in High-Risk Category

The FDA panel heard comments at the hearing from both supporters and opponents of ECT reclassification.

"It is important that the FDA is considering the reclassification to Class II," said Sarah Lisanby, M.D., the chair of APA's Task Force on ECT and professor and chair of the Department of Psychiatry and Behavioral Sciences at Duke University. "It is also important that [the FDA has] called on experts and allowed members of the public to raise the questions that concern them."

Opponents of reclassification, some of whom had received ECT, also opposed ECT in general, pointing to adverse events like memory problems, cognitive impairment, or brain damage. Some said ECT amounted to "torture."

Supporters, including both psychiatrists who administer ECT and patients who had received the treatment, spoke of its value for severely ill patients.

Among the witnesses favoring ECT and reclassification was Kitty Dukakis, wife of former Massachusetts governor and 1988 presidential candidate Michael Dukakis. She told the panel about her long-term major depression.

"I would not be alive today without ECT," she said. "I ask the panel to place ECT devices into Class II and make it possible for thousands to benefit from a form of treatment that has transformed our lives."

Many of those who spoke in opposition had undergone treatments decades ago, before advances that today produce fewer side effects, noted Richard Weiner, M.D., Ph.D., a professor of psychiatry at Duke University School of Medicine.

"Modern evidence-based techniques have increased remission rates more than any other modality, with fewer memory deficits and improved quality of life," Weiner told the panel. "There are benefits and risks of any treatment. For ECT, the more rapid and substantive benefit is greater than the long-term morbidity of mental illness."

Risks for cognitive side effects of the procedure have declined over the last 10 or 15 years with use of unilateral placement of electrodes, ultrabrief pulse waves, individualized seizure titration, and other developments, said Lisanby in an interview with Psychiatric News.

Claims of brain damage after ECT were not borne out by Lisanby's NIMH-funded studies of nonhuman primates or by postmortem studies of brains from people who had undergone numerous ECT treatments, she said.

"There is a failure to differentiate brain change from brain damage," she said. "Changes in the brain are a desired effect of both antidepressant medications and ECT."

The lack of unanimity in the panel's views may be due to differences in familiarity with ECT, Lisanby suggested. Many of the panelists, including the chair, neurologist Thomas Brott, M.D., of the Mayo Clinic, were not psychiatrists.

"I don't know if the rest of the medical community is as familiar as psychiatrists are with ECT as it is currently used," said Lisanby. "There is clearly an information gap."

The FDA's scientific team tried to fill that gap by presenting data based on placebo-controlled studies using sham ECT. Those indicated little evidence of benefit beyond 30 days, FDA scientists told the panel.

However, much of the data comparing ECT with sham treatment came from research decades ago, before the use of modern ECT equipment and techniques, said panel member William McDonald, M.D., a professor of psychiatry and behavioral sciences and chief of geriatric psychiatry services at Emory University.

"Recent developments in ECT have confirmed the high remission rate and significantly decreased the side-effect burden, including cognitive side effects, of ECT," he said in an interview.

Furthermore, design flaws in the older trials may have confounded results. Patients in the trials, for all of whom ECT was indicated and who had consented to its use, could not be ethically denied the treatment, said another panel member, Scott Kim, M.D., Ph.D., an associate professor of psychiatry and co-director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.

"Typically, the sham studies were concerned about the ethics of continuing to restrict patients in the sham arm from getting real ECT," he told Psychiatric News. "So after the intervention phase of, say, four weeks, patients received the best option according to their doctor's recommendations. In one of the largest and best sham trials where there was a four-week ECT effect but not a two- or six-month effect, the authors specifically noted that most of the sham-arm patients received ECT and in fact received more ECT during the follow-up period than the real ECT group."

Designing new time-limited, sham-controlled ECT studies still might be possible despite the ethical issues, said Kim.

"But the scientific question involving some novel technique or technology would have to be unique and compelling to justify it,"—given the agreed-upon efficacy of the treatment, he said.

"The existing body of data is enough to allow us to develop specific controls for the use of ECT," said McDonald. "We might do more research on potential cognitive side effects, but currently we have to accept them as a part of the treatment and include that information in the informed-consent process."

The hearings were the first part of the FDA's review process, during which it collects and evaluates evidence. Eventually it will propose a classification rule, permit further public comments, review those comments, and then propose a final rule. That process may take a year or more, especially if new research is required.