A proposal to require new clinical data on the efficacy and safety of electroconvulsive therapy may be the death knell for the controversial treatment of psychiatric disorders.
Ernest Hemingway famously underwent 20 rounds of ECT at Mayo Clinic to treat him for depression in 1961. He is reported to have lost some of his memory as a result and wrote “It was a brilliant cure but we lost the patient,” shortly before committing suicide.
When Hemingway died, ECT devices had already been on the market for decades, largely unregulated. The Food and Drug Administration only took up oversight of medical devices in 1976. The agency then classified ECT as Class III, the highest risk level. ECTs, however, were never subject to the mandatory premarket approval application (PMA) process that shows Class III products are safe and effective.
Late last year, the FDA suggested dropping the devices to Class II if they were used on patients with severe depression or bipolar disorder who did not respond to antidepressants. In that class, the devices would be considered safe and effective and not require a PMA. However, if ECTs were used for any other psychiatric condition, they would remain Class III and now require a PMA.
If the FDA sticks to that proposal, the manufacturers of the device, which are only a handful and not huge companies, might not be able to afford such research. That would eliminate a tool clinicians have long praised.
Manufacturers for the device did not immediately respond to requests for comments.
But for years, the American Psychiatric Association has lobbied to drop the device into a lower risk category and celebrated its efficacy. And for decades, the FDA wavered on its decision.
In 2009, a full 30 years after the FDA deemed ECTs dangerous, the Government Accounting Office gave the agency a deadline to demand that devicemakers provide evidence of safety and information about any adverse effects.
The FDA came to its recent proposal after an independent advisory committee on neurological devices reached consensus that the agency should use Class III for schizophrenia, bipolar manic states and schizoaffective and schizophreniform disorders. It did not, however, reach consensus on the classification of ECT for depression.
The FDA received over 3,000 comments on the proposal by the due date of March 28. Some were pleased with the reclassification but were alarmed at how restrictive the proposal was.
“It ignores the substantial evidence for the safety and effectiveness of ECT in schizophrenia, schizoaffective disorder, mania and catatonia,” Dr. Charles Kellner, a professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City and chief of the ECT service at Mount Sinai Hospital wrote in a comment letter.
If the FDA finalizes its decision and clinicians continue to provide ECT, its use might be considered off label and payers don't reimburse for that type of use, Kellner said.
Also, malpractice insurance companies and hospitals could refuse to cover doctors who provide ECT for the non-cleared uses.
As many as 40% of the 100,000 Americans who get ECT every year could lose access to the devices, Kellner estimated.
The APA supports a Class II designation for schizophrenia, schizoaffective disorder, mania and catatonia. The group insists that clinical evidence shows these patients benefit from ECT.
Opponents wrote in comments to the FDA that a Class III designation and PMA should be required for any use of ECT.
“ECT is very harmful to the brain and mind…the FDA should demand the usual testing, starting with animals, that is required before psychiatric treatments,” said Dr. Peter Breggin, a psychiatrist in Ithaca, New York.
Patients also spoke out against ECT getting a Class II designation. "As a former recipient of electric shock therapy (ECT), I find it barbaric and would rather die than ever submit to these treatments again,” Roberta Ruggiero wrote in a comment.
It is unclear to when the FDA will finalize its decision on whether or not to reclassify the devices. An agency spokeswoman said there is no regulatory deadline, but it's a high priority for the agency.