MONDAY, January 24 (Health.com) — Electroshock therapy today bears little resemblance to its lurid depictions in Hollywood dramas like One Flew Over the Cuckoo’s Nest.
For decades psychiatrists have used shock therapy to treat cases of depression that haven’t been helped by antidepressant medications, and in recent years the treatment—now known as electroconvulsive therapy (ECT)—has experienced something of a revival. Roughly 100,000 people in the U.S. now receive it each year.
The future of ECT is in doubt, however. On Thursday, a Food and Drug Administration (FDA) advisory panel will meet to consider whether the machines used in ECT should be more tightly regulated than they are now. If the advisory panel votes for more oversight—and if the FDA follows the panel’s advice, as it usually does—some experts fear that access to the treatment will be curtailed.
ECT machines are currently in a strictly controlled category of medical devices that includes pacemakers and prosthetic joints. As with prescription drugs, devices in this class must be approved by the FDA before they can be used on patients. But because ECT devices were already in use when the FDA put those rules in place about 35 years ago, they were exempted from the approval process.
The FDA is now revisiting the status of the devices. The agency can leave ECT devices in their current class and require manufacturers to provide evidence of safety and effectiveness, which may entail new clinical trials and could temporarily limit the devices’ use. Or it can rely on existing evidence and reclassify the devices to a less restrictive category that includes ultrasound machines, motorized wheelchairs, and contact-lens solution. That option would give ECT devices a pass and ensure that they remain available to doctors.
The impending FDA action has reawakened the debate surrounding this controversial treatment for depression and other mental disorders. More than 1,500 organizations and individuals have filed formal comments with the FDA.
The American Psychiatric Association (APA) and scores of individual psychiatrists have expressed support for permanently easing the restrictions on ECT devices, because they worry that manufacturers of ECT devices may lack the funds, time, or motivation to meet new FDA requirements (by conducting new research, for instance).
“It may be a major disaster,” says Max Fink, MD, a professor emeritus of psychiatry and neurology at Stony Brook University Medical Center, in New York, who researched and performed ECT for 45 years. “If they want an extensive review of safety and efficacy, that means somebody has to pay for it. It becomes a very expensive proposition and there is nobody to do it unless the government supports it. The manufacturers are all small companies in the U.S. There’s no General Electric for ECT devices.”
Next page: Patient advocates worry about side effects
