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ederal 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.

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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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  • Without memory you have no quality of life. Imagine if you no longer recognise your children, your lover, your friends, and therefore have no memory of the times you spent together, the life you shared. Imagine if you no longer remember your skills, a musician who said “I’ve lost music”, an artist who doesn’t recognise her own work or know how she made it (me). Can you not see that our memories ARE our lives, they are who we are, they define us. If the absence of torment is all you require, without the richness of your past, or the ability to manage your present and future, then maybe ECT IS for you – it isn’t for most, especially the 60-80% who don’t even gain a short term benefit from that torment, but lose anyway. If you haven’t had it, do you know you are not one of them, if you have and plan to have more, are you sure it will always `help’?

  • We are seeking electroshock survivors that have had electroshock in past two years and are US residents. If you feel you have suffered an acquired traumatic brain injury secondary to the above procedure and are interested in participating in a class action in a product device suit please go to ectjustice.com.

    • Had ect both in-patient & out-patient March ’15 – May 2015. Never told true facts re: % who respond is NOT 80-85% as told, and cognitive function & loss of memory never mentioned would even happen, aside from confusion day if procedure. Not given brochures/video/resources to research. Awoken by pDOC hr after RN gave nite sleep meds, to get me to sign consent. No idea what he sd or what I signed that nite 11p or so.

  • There are always a group of claims made that resurface in almost every article on ECT – that Modern ECT is a lot different from One Flew over the Cuckoo’s Nest. I.E. that:
    1. It now has anaesthesia and paralysing drugs to prevent harm form the massive convulsion.
    2. It uses far less electricity
    3. It is ultra brief
    4. The electrodes are placed to avoid damage.
    5. That 80% of people benefit from it.
    6. Its method of operation is not really known.

    BUT:
    Anaesthesia and paralysing drugs were introduced 60 years ago, in the early 1950s to prevent fractures. It was NOT to reduce brain damage which was at the time the aim of ECT.
    Electricity: Until approximately 1990, 24 years ago, ECT used 100-150 volts for 1 second- it now uses up to 450 volts for 8 seconds.
    Brief Pulse ECT was first used 70 years ago in 1946. Ultra brief Pulse ECT was used in the 1960s – 50 years ago. It does NOT refer to the ECT treatment, it is the width of the Square Wave Pulse of which there are 140 per second for an average 8 seconds = well over 1000 ultra brief electrical pulses firing through the brain per single treatment.
    Electrodes: The first manipulation of electrode placement was 74 years ago in 1942. One sided electrodes were in common use in 1970, 46 years ago. Today most ECT use remains bilateral exactly as seen in the movie.
    80% success rate: There is no reliable evidence that more than 40% of ECT recipients, and often far less that that, get any positive effects at all and these effects are not likely to extend beyond a few weeks. There is also NO evidence that real ECT has any benefit over placebo ECT beyond the acute injury phase.
    Unknown action: Saying this confers an almost miraculous effect, (not unintentionally either.) The truth is far more mundane. The `improvements’ seen in under 50% of people are the symptoms of a Traumatic Brain Injury. The acute symptoms of concussion can include a mild euphoria (also a short-lived side effect of seizures), known in neurology as “concussion euphoria” (also short-lived), apathy, memory loss, vagueness and confusion and a lack of initiative where the person agrees with whatever is suggested to them. They may also suffer from anosognosia as a result of injury to the brain where the person is unaware of their deficits.
    No matter how often these issues are glossed over by the PR handouts that psychiatrists commonly distribute there are some FACTS that cannot be disguised.
    First: The neurological definition of a Traumatic Brain Injury is:
    1. A TBI occurs when a force is applied to the head that causes a disruption in normal brain function –
    2. ECT applies an electrical force to the head that causes a grandma seizure and a coma, both serious disruptions to normal brain function –
    3. Therefore, ECT causes a TBI.
    The second major factor is how lucrative ECT is. A Psychiatrist performing ECT can make $30,000 a week, and hospitals regularly make over $20 million a year from the treatment.
    I suggest the readers of this article check out some of the over 2000 reports from people whose lives have been destroyed by ECT. For every Kitty Dukakis and Carrie Fisher there are 10 who didn’t come out well:
    “ECT benefits nearly 80 percent of patients who try it, mostly for the short-term, according to a research summary prepared by the FDA.”

    I use to LOVE, and can, no longer. Love anything or anybody.

    I don’t feel depressed anymore, I don’t feel anything. I do feel as if a part of me is missing.
    I use to own a home, had a daughter, cooked, played piano, garden, sewing, and lost the love of my life. I used to go to mass, and enjoy life, like, biking, jogging, people, a few very dear friendships. I lost all of them.

    I’ve got 13 GCEs, 4 top grade, since ECT I’ve sat only 1 exam…I struggled to just pass, well bottom of the class – my memory and impaired concentration can’t cope.
    I can spend all afternoon in deep, personal conversation with one other person, then, the very next day in the street cut her or him dead, walk away from the smile of, to me, a total stranger, which has lost me untold friends
    I’m told ECT is given to cure suicidal tendencies, which I find very peculiar, because before ECT I was never suicidal,

    JUDY GARLAND, 2000.I couldn’t learn anything. I couldn’t retain anything;
    I would much rather have lost a limb or 2 than to have lost my memory — my “self.”,
    I try but I just can’t recreate who I am.
    The memories of our past give us an understanding of where we fit in the world. I have experienced more than a “cognitive deficit.
    It isn’t fun to sit and listen while my children reminisce about their growing up years, while I am unable to participate in the conversation.
    I was not relieved of depression. I was not told that memory loss would be permanant. It has disabled my life

    Damage is unquestionable…Degrading, hostile and barbaric.

    It ruined my marriage, my life…The effects of the “treatment” made me suicidal

    When I awoke after each “treatment” I felt completely broken, like a walking zombie.If you think you’re losing your mind – have ECT, and for certain you will.

    his memory loss occurred as a result of brain damage purposely done by doctors in the name of helping me.
    I didn’t experience even a tiny bit of improvement in my depression from ECT– not even for one day.

    ECT didn’t work for the depression, and although it was the modern version- unilateral, from right side, am now disabled with profound memory loss.

    They shut down the ECT program at a hospital in my state because the sudden surge in the 65 year old age group once they qualified for Medicare and ECT was covered.
    Some patients had had obscene numbers of ECTs. It was probably just a coincidence that each treatment earned the hospital a lot of money and that the psychiatrists who brought in the most money gained significant perk.
    I hope the doctor that performed my ECT enjoys his McMansion, while I scrape by on disability.

    ….. but of course, the nurses exclude descriptions of the burn marks on ECT victims in the daily notes in the Australian ‘Mental Health’ System….. I am told.

    347 patients received the currently available methods of electro shock, including the supposedly most benign forms and confirmed that electro shock causes permanent brain damage and dysfunction. 2007 “Modern ECT”
    Then Let’s look at WHY Drs Kellner and Seiner are fighting so hard to continue the to date untested ECT machines EXACTLY AS IS:
    At Dr Seiner’s hospital he boasts 10,000 ECT treatments in a year – at (conservatively) $1000 per treatment = $10 million dollars – That works out, again conservatively, at 12 treatments each person = 833 patients whose hospital stay will be about $75,000 each = $62.5 MILLION per year so, for ECT treatments alone we’re looking at about $72.5 MILLION. Quite a nice little earner, don’t you think? Oh, and individually docs who perform ECT will get about $30,000 a week and the anaesthetists a bit more than that – so we have a lovely gravy train here, all dedicated to causing serious injury to around 800 people (there’ll be some repeat customers because we know it doesn’t last). Then maybe the rest Plus a few who haven’t read this who’ll be ECT virgins. WOW!

  • “ECT” = ELECTRO-CUTION TORTURE.
    Yes, a very, very small percentage of it’s victims claim that it’s helped. OK, fine. BUT, MOST victims of ECT either can’t, or won’t say it’s helped. The numbers of those who claim ECT has caused harm, far outweighs the few who claim it’s helped. ECT is NEITHER “safe”, nor “effective”. Those quacks who still push ECT are the ideological descendants of Dr. Josef Mengele.
    ECT = ELECTRO-CUTION TORTURE
    (Note: In the article above, it’s admitted the shrinks have NO IDEA how it works. Think about that. No idea….

  • I had ECT on an outpatent basis in 2003. It was a disaster. I ended up in jail on false charges, I thought I knew everyone saw, I believed my children had wrecked my house and other things that turned my life into a horror move. That movie is still running 13 years later. I have not had a relationship with a woman that lasted long in fact I haven’t had any relationships in years, I still have memory problems and my judgement and decision making so skewed I am constantly in trouble and it never gets better. I know doctors and scientist say it is relatively safe but there is a percentage of us who are damaged permanently! No body listens and nobody follows up on ECT. You ruined my life with that damn machine and nobody cares or understands. I used to be a proud and respected Senior Non`Commissioned Officer in the Air Force. Never before 2003 did I see the inside of a jail. Since then I’ve been jailed half a dozen times. Before 2003 I never had to be hospitalized for anything. But I have been hospitalized for all kinds of reasons since. The list goes on and on. An endless series of serious problems that continues to this day and threatens to end my life.
    Eric Thomsen
    Land O Lakes, FL

    • Thank you for your service Eric. I can’t believe that we treat our Veterans this way by shocking their brains. We did this to hundreds of WWII veterans and many of them were never the same and had to be institutionalized. To add insult to injury, I feel compelled to point out that some people, most of them non-Veterans, are COURT ORDERED to receive this barbaric ‘treatment’ even individuals who are living peaceably in their own homes. If you do not believe me, I will cite examples. I also feel compelled to point out, that two causes of debilitating depression are grief and trauma. The latestDSM has created new guidelines for individuals who are mourning the death of a loved one. This exclusion or waiver allows a prescriber to label a person with clinical depression, if after two weeks of mourning, they are unable to take care of themselves. How fallen is the state of our families and our communities, if we cannot stop our busy busy lives for two weeks to nurture and support a loved one who is mourning! Shame on us for outsourcing the care of our grieving loved ones to psychiatric institutions, nursing homes, and foster homes! My mom ran interference for my service disabled WWII Veteran dad for forty years. God bless her and every caregiver who nurtures and supports those with PTSD. For some, depression can cause a catatonic like state because an individual in mourning may appear not to care about his/her appearance or self care. Other cultures respect this state and do not label, medicate, or shock a person undergoing profound grief. In our culture however, there are little to no supports for people in altered states of consciousness; every person must fit in a Wonder bread assembly line and produce, produce, produce. No wonder, we are on the verge of self annihiliation as a culture. We have lost our way. We no longer care for people and offer bedside care in our houses. We outsource our loved ones to Western style ‘medicine’

    • Please look up the lists of neurological results of Traumatic Brain Injury and see if you can get some help from a neurologist . You’ll need to get a GP To refer you for an MRI brain scan though this might not show much (sometimes even quite severe damage can’t be seen on scans). Then try to get the GP to refer you for neuropsychological tests. As a vet you might be able to get this on some kind of benefit as they can be expensive . If you can get junto neuro rehab you might be able to learn to manage your disability because that’s what you have, an iatrogenic disability caused by doctors.

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