Federal regulators are poised to enact new restrictions on psychiatry’s most controversial treatment, electroconvulsive therapy, which treats people with acute mental illnesses by sending a seizure-inducing jolt of electricity through their brains.

A draft rule under consideration at the Food and Drug Administration would reclassify ECT as safe and effective — and only moderately risky — for adults with severe depression who haven’t responded to medication or other therapies.

But it would also impose new requirements: Physicians would have to warn patients that the side effects of ECT, also called electroshock therapy, can include confusion and memory loss and that its long-term safety is unproven. They’d have to monitor patients’ memory and cognitive skills before and during treatment with sensitive neuropsychological tests.

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And the FDA would also classify ECT as high risk for psychiatric conditions other than depression and for children and adolescents.

A high risk designation isn’t just a symbolic gesture: Psychiatrists warn, with alarm, that it could prompt insurers to stop covering and doctors to stop recommending ECT for younger patients and for those with conditions such as schizophrenia, mania associated with bipolar disorder, and the stupor-like state known as catatonia.

“Its use for these indications is widespread, even ubiquitous, and to deny the extensive evidence in support of that is indefensible,” said 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.

Many patients, however, take the opposite view: They say after decades of letting ECT proceed without rigorous evaluation, the FDA should take a much tougher stance. They blame the shock therapy for causing severe cognitive and emotional damage and call for tight restrictions or an outright ban.

Deborah Schwartzkopff, for instance, had 66 ECT treatments between 1996 and 2010 to treat depression. Schwartzkopff, 55, a registered nurse from McMinnville, Ore., said the therapy left such gaping holes in her memory that she couldn’t recall her wedding or the birth of her children. Her marriage of 28 years ended “because I couldn’t remember that relationship, and without those memories, I had no emotional connection,” she said.

“Personally, I think ECT should be banned, but at a minimum, we should be testing these devices for their safety and effectiveness,” Schwartzkopff said.

The FDA received 2,040 comments on its draft rule before the public comment period closed in late March. The agency has not given a timetable for issuing a final rule.

Shock therapy
A detail of an electroconvulsive therapy machine. Kayana Szymczak for STAT

A long way from ‘Cuckoo’s Nest’

About 100,000 patients, most of them with intractable depression, receive ECT in the US each year.

The treatment has come a long way since it was depicted as a barbaric and terrifying tool for subduing patients in “One Flew Over the Cuckoo’s Nest.” Patients get anesthesia to minimize pain and muscle sedatives so they’re less likely to hurt themselves during the seizure. Ultra-brief pulse therapy delivers a fraction of the electricity used in the past. And the electrodes are positioned to minimize side effects.

ECT benefits nearly 80 percent of patients who try it, mostly for the short-term, according to a research summary prepared by the FDA.

Among the many patients who have hailed it as a lifesaver is Kitty Dukakis, the wife of former Massachusetts Governor Michael Dukakis. She has said ECT helped her overcome decades of disabling depression and alcohol and drug addiction.

Precisely why electroshock therapy works is a mystery. Some studies suggest the procedure can stimulate the growth of brain cells and the release of neurotransmitters, activating the brain’s electrical networks. Yet other studies raise the potential for harm, noting for instance that ECT can cause tiny hemorrhages or interfere with connections that underlie the brain’s complex circuitry.

The most common complication is memory loss, for both events around the time of the shocks and for past events in the patient’s life. A 2003 review of multiple studies, published in the BMJ, found that a third of patients who had received ECT reported memory loss that lasted six months or more.

For many patients, however, cognitive issues resolve in a few weeks or months. That’s what happened to Natasha Tracey, who turned to ECT in 2009 after she lost her job at a Seattle software company and became suicidal.

At first, her memory loss was so severe, she said, that she couldn’t even remember how to get to the grocery store. “The street I lived on looked foreign. Things in my apartment — I couldn’t remember how they got there,” said Tracey, 38. “Fortunately, that cleared up and I don’t feel any lasting impact.”

Although ECT didn’t help Tracey, she believes the therapy is an important option for patients who have tried other therapies that haven’t alleviated their suffering.

Shock therapy
A detail of an electroconvulsive therapy machine. Kayana Szymczak for STAT

A chilling effect

The FDA’s move has been a long time coming.

The agency has had the authority to regulate medical devices since 1976, but for decades let ECT machines alone because they’d been in widespread use since the 1950s. In 2009, however, the US Government Accountability Office, a watchdog, said it was time for regulators to evaluate all potentially dangerous medical devices, even those that had been around for years.

That meant the FDA had to make a choice: Regulators could classify ECT as high risk and require ECT manufacturers to conduct clinical trials proving that their machines were safe and effective. (Trials are required for all medical devices newly designated high risk.) Or they could deem the machines only moderate risky, based on the weight of existing evidence from scientific studies.

After contentious hearings, a FDA advisory panel in 2011 recommended that ECT devices be designated high risk for all patients.

That recommendation touched off a storm of controversy. And the FDA effectively tabled the issue, declining to move on it — until now.

In its new draft rule, the agency says it accepts existing evidence of ECT’s efficacy for adults with severe depression and proposes that devices be put in the “moderate risk” category for this group of patients.

“All of us sighed a big sigh of relief,” said Dr. Stephen Seiner, director of the psychiatric neurotherapeutics program at McLean Hospital in Belmont, Mass., which performed 10,000 ECT treatments last year — the most in the US. “It’s an important message to the medical community that ECT is safe.”

But the FDA notes it isn’t similarly convinced by the evidence of ECT’s value for patients under 18 and for those with other psychiatric illnesses. If its proposed rule stands, the agency will require manufacturers of ECT machines to launch clinical trials for these indications. It’s widely expected they will decline to do so because of the cost.

In that event, physicians would still be able to provide ECT “off label” to patients with mania, schizophrenia, catatonia, or other conditions. But insurance companies may refuse to pay. And physicians may worry about the potential for malpractice lawsuits if anything goes wrong.

Labeling ECT “high risk” for conditions other than depression will have a “chilling effect” on the therapy for thousands of terribly ill patients, most of whom have exhausted all other options, said Dr. William McDonald, a professor of psychiatry at Emory University.

Both the American Psychiatric Association and the National Alliance of Mental Illness, a leading consumer group, take issue with the FDA and say the agency should classify ECT as moderately risky for all conditions for which it is commonly used.

Shock therapy
A treatment room in the Electroconvulsive Therapy Clinic at McLean Hospital in Belmont, Mass. Kayana Szymczak for STAT

Preventing relapse

Relapse is common with ECT, and many psychiatrists recommend monthly “maintenance” sessions after an initial round of therapy — usually nine to 12 treatments over the course of three to four weeks.

But the FDA’s proposed rule doesn’t recognize maintenance ECT as of proven value or designate it moderate risk. Psychiatrists also want to change that.

Kate MacDonald, 70, of Cambridge, Mass., had maintenance therapy for over a year after she received ECT treatment for severe depression at McLean in September of 2010. Before the treatment, she had lost 40 pounds in five months and was becoming unresponsive and paranoid, she said.

After only a few treatments, she began to respond: “I could carry on a conversation again. I had some light in my eyes.”

She’s convinced ECT saved her life.

“The memories I’ve lost are almost all related to the time I was sick,” said MacDonald, who volunteers for three organizations and says she’s as happy as she’s ever been. “If someone said to me, ‘Kate, you’re [either] going to lose a whole bunch of memories or be depressed the way I was,’” she said, “I would say, ‘Take the memories.’”

Correction: A previous version of this story misspelled Kate MacDonald’s name.

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  • Dear HJ,
    Actually I am not repeating myself, I am repeating the science. I have given you my sources, please given me yours. The 70-90% `success rate is the spin given by ECT psychiatrists. It has never been supported by statistics. Yes, Mayo & Johns Hopkins and more enthusiastically, Duke, recommend it. Many of their psychiatric staff have financial interests in continuing it as it is a good solid cash cow for the clinics they run.
    Yes, HJ, the higher echelons of the APA are quite happy to cause brain injury as `treatment’ for MONEY. And a lot of it. For instance a small hospital in Portland, Oregon creams at least $20 million a year from ECT. BUT, many hospitals don’t use ECT at all. Their patients do just as well if not better than ECT patients do, so clearly it’s not necessary to use brain damage as treatment.
    How long this will last now that a major class action in the US has won a significant case against the ECT machine manufacturers is a big question. The action claimed that these companies failed to warn patients that their machines caused permanent brain damage. That means that first, they have proved to the court that the plaintiffs, i.e. the ECT recipients DO have brain damage, and second, that the ECT machines caused it.
    How long will it be now before there will be cases against the psychiatrists who used these machines knowing that they cause permanent brain damage? Wanna guess? That is the next step. The one after that is that the insurance rates the ECT docs (no more than 20% of psychiatrists already) will have to pay, will skyrocket in the face of litigation.
    ECT is on the way out, HJ, but feel free to follow the spin, believe what you want even in the face of real evidence. Some people still believe the earth is flat, others believe that the earth came into existence 6000 years ago, and hang the evidence to the contrary. You can believe whatever you like but by encouraging ECT, you are encouraging people to risk permanent brain damage. THAT is what I object to, and I will continue to do so until the thing is outlawed.

    • What is not being told to patients is the cumulative effects of receiving general anesthetic weekly or bi-weekly for a prolonged period of time. Once the patient has managed to escape the grasp of the medical community they discover that they still have the same crushing depression, enhanced by major memory problems, and are now in the midst of a battle to withdraw from the effects of the anesthetic.

    • My experience may be anecdotal, but I had maintenance ECT for three years and do not have brain damage. As a matter of fact post ECT I was able to go to college and earn a Bachelor’s Degree. I also am within five classes of having a Master’s Degree. I graduated Suma when I earned my Bachelor’s Degree. ECT may not be a “cure” but it helped me SURVIVE so that I could accomplish these things in my life. I may be wrong but a lot of this seems like soar grapes because it wasn’t a cure. Sorry, but there is no cure.

  • Deidre Oliver, please stop posting and droning on and on, continuously repeating yourself. Statistics show that the success rate of ECT is 70-90%. Both the Mayo Clinic and Johns Hopkins recommend it.

  • No treatment is without possible complication. I had short term memory loss, too. My goal for ECT treatments was to elevate my depression so that I could have the chance to make new memories. I was able to achieve that goal. It seems to me people want a “cure” for depression, or bipolar, and other conditions. Sorry folks there is no cure. I also don’t think you are necessarily being fair when you blame everything you will ever come down with on ECT. My veins are shot to, but I think it has more to do with taking Tegretol for years and having to get medication levels drawn every six weeks. Maybe blood draws should be more scrutinized. Perhaps you were fated to develop an autoimmune disease even if you hadn’t had ECT. I have two autoimmune conditions, but there’s no way I am going to blame that on ECT.

  • Yes. My long term memory has huge gaps. And although my short term memory is slowly getting better, I have to write everything down and post notes to myself all over the house. My goal with ECT was to lift my depression so I could go back to work. (I am an RN.) But with such impaired memory, how can I practice nursing again??? My previously great veins are also shot; 3 sticks to draw my blood yesterday. I cracked and chipped an onlay on a front tooth. My sleep is shot. I have very diminished senses of taste and smell. And I’ve developed some strange rheumatic auto-immune symptoms that are stumping my Drs. So don’t tell me that ECT is safe!

  • For several years I suffered Major Depression that was medication resistant, so my Psychiatrist recommended ECT. The doctors assured me that it was relatively safe and any memory loss issues would be temporary. They performed several series of them over the next 10 years, because the positive results were temporary and fairly short lived. Anyway, the total number of ECT’s I received grew to be in the hundreds. I stopped them 12 years ago, but unfortunately in my case the ECT’s permanently wiped the majority of my “Long Term Memory”, and I am still badly affected by “Short Term Memory” loss.
    What has this meant in real life terms? Without my long term memory’s, family and friends are strangers to me. With my persistant short term memory damage it makes living independently impossible. Besides brain damage most of my teeth are cracked, my veins were so badly scarred from anesthesia that I had to get a Portacath, and I developed Glaucoma. Do I believe ECT should be limited or regulated? Absolutely.
    (This commentary took me over 4 hours to write)

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