Psychiatrists Urged to Support ECT Reclassification

Megan Brooks

February 09, 2016

The US Food and Drug Administration (FDA) is once again proposing to reclassify electroconvulsive therapy (ECT) from a high-risk to a low-risk intervention, and the American Psychiatric Association (APA) is encouraging its members to support this change.

"[I]t is so important for psychiatrists to take the lead in expressing their views in regard to the role that ECT plays in clinical practice and in the treatment of major depressive disorder," APA CEO and Medical Director Saul Levin, MD, MPA, and APA President Renée Binder, MD, write in a blog post. "For appropriate patients, ECT has been a lifesaver. It has given them an opportunity for a normal, functional life."

"Psychiatrists are in the position of knowing about ECT, and they should provide comments on this issue," Dr Binder noted in an interview with Medscape Medical News. The FDA's draft guidance on the proposed reclassification and a link for posting comments can be accessed online.

"Incredibly" Safe and Effective

This is not the first time the FDA has broached the topic of reclassifying ECT devices. The FDA Neurological Devices Panel took up the issue in 2011 but concluded that ECT devices should retain their class III classification. Those opposed to reclassification argued then that ECT causes memory problems, cognitive impairment, and other serious side effects.

"In 2011, there were some patients who spoke up and said that ECT has terrible side effects and it's a very dangerous treatment, but that is just not true," Dr Binder told Medscape Medical News. "ECT is a safe option that for appropriate patients is incredibly effective. ECT actually is a low-risk procedure the way that it is done in 2016, and classifying it as low-risk is certainly the appropriate classification rather than classifying it has high-risk. The facts and the science say that it is low-risk, and procedures should be classified appropriately," Dr Binder said.

The FDA proposes to reclassify ECT devices from class III to class II for the treatment of severe major depressive episode associated with major depressive disorder or bipolar disorder in patients aged 18 years or older who are treatment resistant or who require a rapid response because of the severity of their psychiatric or medical condition.

In a notice issued December 29, 2015, in the Federal Register, the FDA said it "believes that in the specified patient population, and with the application of general and special controls...the probable benefit to health from use of the device outweighs the probable injury or illness from such use."

"ECT is not done today the way it used to be done and the way it has been portrayed in the movies," Dr Binder said. "There is an anesthesiologist, the person gets a very mild anesthetic. You don't induce a big seizure; you can see a little twitch of the foot to know that it's been effective. It's very carefully calibrated, and in just a few treatments, people can feel so much better.

"Depression is treatable," Dr Binder added, "and there is no reason why anyone should remain depressed when there are so many good treatments. Medication can be effective, but medications have side effects, and medications take a long time to work. If there are no contraindications to it, ECT can be incredibly effective, and you can see it just with a few treatments."

Reclassification "Not Broad Enough"

Mark George, MD, distinguished professor of psychiatry, radiology, and neurosciences, Medical University of South Carolina, in Charleston, supports reclassifying ECT devices from class III to class II.

"Overall, it's a good thing and recognizes that ECT is a safe and effective treatment. My major concern is with the currently proposed FDA language, where they only propose the reclassification for patients with depression. My concern with the reclassification is that it is not broad enough. They do not propose to reclassify for other conditions where ECT is a lifesaver and where there are good data on efficacy. For example, in some conditions, like mania or catatonia, ECT is the only option. My worry is that if ECT is reclassified to II for only depression, this may lead to lack of reimbursement for using ECT in these other conditions," Dr George said.

"Thus, my recommendation is for the FDA to reclassify ECT to class II for depression, mania, catatonia, and some episodes of psychosis, like schizoaffective disorder. There are enough published data to support this," Dr George said.

"Historically," he added, "there have been people who are anti-ECT and, often, antipsychiatry and have opposed reclassification. My opinion is that these individuals are largely unfamiliar with all of the recent advances in ECT methodology, where we have greatly increased efficacy while also diminishing risks and side effects."

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