Several of the psychiatrists on the panel who supported a switch to class II for ECT when used to treat the bipolar indication cited the need for alternative treatments and the few treatment options available for severely ill treatment resistant patients with bipolar disorder – and the difficulty in conducting clinical trials in such patients.
The panel unanimously recommended that ECT devices remain in class III for schizophreniform disorder. Some panelists also thought that the devices should remain in class III when used to treat catatonia. Others pointed out, however, that this is a relatively rare condition and that ECT could be inappropriately restricted and might not be available for these patients if categorized as class III.
Availability Issues
In an interview after the meeting, Dr. Richard D. Weiner, professor of psychiatry and behavioral sciences at Duke University, Durham, N.C., said he did not expect that a change in classification would result in the unavailability of ECT. In addition, the result of the hearing will not have an effect on the practice of ECT for at least several years, predicted Dr. Weiner, who also spoke during the open comment session of the meeting. An FDA spokesperson said once the agency makes a decision on the classification, it will have to go through the public notice and comment process, which can take at least 1 year.
The FDA received about 3,000 responses about this classification issue in a public docket, between September 2009 and January 2010, from medical and mental health providers, current and former ECT providers, recipients of ECT and their relatives and friends, as well as other groups. Most – 79% – of the responses opposed reclassification to class II; 14% supported reclassification. The most common adverse events reported were related to memory, followed by cognitive decline and brain damage, according to the FDA. Some people also reported that did not think they had been adequately informed about the risks of ECT before they were treated, FDA officials said at the meeting.
Currently, there are two manufacturers of ECT devices in the United States: Mecta Corp. and Somatics.
The FDA usually follows the recommendations of its advisory panels, which are not binding. Members of FDA panels are cleared of potential conflicts related to the topic under review.
After a decline that began in the 1960s, the use of ECT increased in the 1990s, and each year more than 100,000 patients in the United States are treated with ECT, according to the FDA.