Tag: FDA and ECT

08/11/20

Throwing Down the Gauntlet for ECT, Part 1

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Effective on December 26, 2018, the FDA issued a final order that required a premarket approval application for most uses of electroconvulsive therapy (ECT) devices. It also reclassified using ECT devices to treat catatonia or a severe major depression episode or bipolar disorder from Class III (higher risk) to Class II (moderate risk) with special conditions. This meant ECT manufacturers would have to submit information to the FDA demonstrating their ECT device complied with special controls that diminish known risks and provided an assurance of safety. These special controls were requirements about the technical limitations of the ECT device, about the labeling of potential adverse effects, about necessary practitioner training and a few aspects of clinical practice with the device. Carlos Pena, director of the Division of Neurological and Physical Medicine Devices for the FDA, said: “We remain committed to ensuring patients have access to reasonably safe and effective medical devices using the most current and scientifically robust information available.”

The reclassified uses for ECT devices into Class II are limited to the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients age 13 years and older who are treatment-resistant or who require a rapid response treatment due to the severity of their psychiatric or medical condition. The safe use of ECT for treatment of these conditions has been well studied and is better understood than other uses. Therefore, sufficient information exists to establish special controls that mitigate known risks and provide a reasonable assurance of safety and effectiveness for these two uses of ECT devices. Manufacturers of ECT devices for the indications above will now need to submit information to the agency to demonstrate their devices are in compliance with these special controls.

A Premarket Approval (PMA) application is the scientific and regulatory review process the FDA uses to evaluate the safety and effectiveness of Class III medical devices. Class III devices support or sustain life, are of significant importance in preventing the impairment of human health, or they “present a potential, unreasonable risk of illness or injury.” PMA is based on the FDA determining there is sufficient, valid scientific evidence in the PMA application to assure the device is safe and effective for its intended use(s). The FDA determined that general and special controls alone were not sufficient to assure the safety and effectiveness of Class III devices.

For that reason, they required a PMA application from manufacturers to obtain marketing approval for their devices. A PMA application is required for all uses of an ECT device not specified as Class II, including disorders like schizoaffective disorder and bipolar manic states. This is because the FDA said it does not have sufficient information to establish special controls to provide a reasonable assurance of the safety and effectiveness of ECT devices for these indications.

In Psychiatric Times, Doctor Charles Kellner, who is the Chief of ECT Therapy ay New York Community Hospital, said the FDA’s final order was very good news in that it allowed for the ongoing availability of ECT devices in the US, but had “slightly less good news” in that what he referred to as “on label” indications was shorter than it had been in the past. With regard to the implications of the FDA order, he said most importantly moving depression into Class II ensures the majority of ECT patients will not have any change in their care. The way the order is written closely mirrors existing clinical practice. He estimated that major depression and catatonia account for 60% to 70% of current American ECT practice.

He emphasized that the FDA order does not regulate medical, clinical practice, meaning “practitioners are free to continue to prescribe ECT for any patient, regardless of diagnosis, whom they feel would benefit from the treatment.” Choosing to leave schizophrenia, schizoaffective disorder and mania in Class III was perplexing and disappointing to him, as he said schizophrenia was the leading indication globally for ECT and “the clinical and research evidence base support ECT as safe and effective for this illness.” He believed ECT devices will continue to be a small, but important part of psychiatric tools. From his contacts with other ECT practitioners around the country, he believed ECT use was increasing.

Dr. Kellner has spent most of his professional career in the study of ECT, especially with geriatric patients and can be understood as having a more positive view on the practice and future of ECT. But is his assessment accurate? Is the use of ECT increasing? Is the FDA final report good news and slightly less good news with regard to ECT or is it an overly optimistic view of both ECT and the FDA final rule?

Psychologist Phillip Hickey pointed out some inconsistencies in previous statements made by Dr. Kellner with regard to ECT that suggests his apparent optimism was at least partly playing to his perceived audience, other psychiatrists and medical doctors. In an editorial which he co-authored for the Journal of ECT, he said: “Despite its widespread acceptance in the medical community, ECT remains surrounded by ‘controversy.’” Yet in an earlier article for New Scientist, Kellner was quoted as saying “ECT ‘remains in the shadows’”, and described it as the second most controversial medical procedure after abortion. In the US and UK, only a tiny fraction of people whose depression doesn’t respond to medication are offered ECT.

Philip Hickey asked if only a tiny fraction of eligible patients were referred, “doesn’t this suggest that they [psychiatrists and other medical specialists] are, as a group less supportive of electric shocks” then Kellner claimed? He then cited a supporter of electric shock, George Kirov, a professor at Cardiff University who supervises ECT treatment in the city of Cardiff, Wales. Kirov acknowledged there are mixed feelings about ECT, even among psychiatrists. “If I speak to medical professionals outside of psychiatry, there is almost disbelief that we are using such an archaic practice.”

Joanna Moncrieff is a psychiatrist with reservations about the use of ECT in psychiatry. In her 2008 book, The Myth of the Chemical Cure, she acknowledged that ECT is still an accepted part of psychiatric clinical practice, but she thought its use was waning. She said it was the most controversial of current psychiatric treatments. The efficacy of ECT for depression in the short-term was still regarded as well-established, but she said it had no long-term effect. “In other words, a few weeks after the ECT has taken place, people are no better than they would have been if they had never had it.” She added:

The state produced by ECT offers several explanations for the apparent therapeutic effects of ECT. Firstly, the acute cognitive effects may temporarily override underlying emotional states and reduce people’s ability to express their emotions. The fact that the beneficial effects of ECT do not persist beyond the period of treatment would support this idea (Ross 2006).

Ross said the burden of proof is on ECT advocates to show that ECT can be prescribed ethically and rationally. He suggested a research study be conducted involving a randomized, prospective, double-blind, placebo-controlled design be done in which the placebo was sham ECT. But he wondered whether a true double blind was even possible in sham ECT research. “In the absence of such a study, whatever its outcome, the sham ECT literature supports the conclusions that: real ECT is no more effective than placebo, except during the period of time ECT is being administered; even that difference is modest.” He noted how the effectiveness of ECT was over-endorsed repeatedly in the psychiatric literature.

Moncrieff said other possible explanations for the apparent therapeutic benefit of ECT include the sedative and calming effects of ECT may produce improvement, particularly in people with agitated depression. The organic behavioral cycle produced by ECT, with its euphoria and disinhibition, can be mistaken as improvement. This is often misdiagnosed as mania, even in people with no history of manic depression. Lastly, ECT may work psychologically. In other words, patients may be able to break the double-blind methodology of the ECT control trials since the sham procedure cannot replicate the acute cognitive effects of ECT. Particularly if they have previously had ECT and believed ECT worked for them, they could be disappointed if they determined they had received the sham procedure. Conversely, they may do better if they received the real ECT treatment and were able to perceive it.

These explanations offered a more compelling explanation of the effects of ECT than the idea it was a specific treatment for major depression, according to Moncrieff. In addition, there is no currently accepted coherent theory of the efficacy of ECT or what it does to the brain that might help in depression:

(The jury is still out on ECT. Its use has survived much longer, despite widespread opposition from some psychiatric survivors and the fact that it is widely acknowledged that its effects are not persistent. Its effects can be explained by the acute cognitive impairment it causes, sometime amounting to a brain injury-like state that can be mistaken for recovery from depression.

Dr. Kellner may have an overly optimistic view for the future of ECT in the wake of the FDA final rule. I’d like to have some clear evidence one way or the other about whether ECT use is actually increasing. And I am not sure if the FDA final report is the “good news” he thinks it is. It appears to me the FDA has thrown down a gauntlet for medical device companies. They are to demonstrate their ECT devices are in compliance with special controls that diminish the known risks of ECT for Class II conditions.

And the companies are required to meet more stringent expectations, with sufficient and valid scientific evidence, that an ECT device does not “present a potential, unreasonable risk of illness or injury” if they want to claim their device as a treatment for Class III conditions. I hope the FDA remains committed to the stated standard of science described in their final rule on ECT. It will be interesting to see what the agency does with a recent publication in the Journal of Ethical and Human Psychology, “Electroconvulsive Therapy for Depression,” that raises the possibility that past support for ECT may be based on poor quality research. We will look at the claims of that study in Part 2 of this article.

09/20/16

Appalling Silence on ECT

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Kenny was put on antidepressants at the age of 14 because he was struggling in a difficult family situation. His symptoms became worse. The psychiatrist added another drug with again worsening symptoms. At one point, he was taking six different psychiatric drugs. Kenny was eventually told his depression was “treatment resistant” and needed electroshock therapy.  “The risks were downplayed.” He was given 30 rounds of ECT and went from a high school honor student to having to be retaught how to tie his shoes. Wait, there’s more!

Kenny lost all memories of childhood and all memories of high school. He says it’s an identity crisis. He suffered severe headaches for a year and a half after the shocks and had to see a cardiologist because ECT left him with heart arrhythmia. Testing by a neurologist, done six months after the shocks, showed a loss of 50 IQ points compared to his high school IQ. Kenny still suffers from night terrors about the shocks.

Dr. Langemann’s article on “Shock Therapy” for the Huffington Post also referred to a biomedical engineer who said the “brief pulse” of ECT is actually a series of several hundred pulses, and not a single pulse. These pulses overstimulate brain cells, causing rapid random firing, intentionally causing a Grand Mal seizure. “The current causes overheating inside the brain and the electric field can tear holes in the cells (which causes the cells to die).” She noted that a conservative estimate is that 100,000 patients per year receive ECT.

Incredibly, ECT has never been through the standard clinical trial process to prove its safety or efficacy. Although the FDA has had the authority to regulate medical devices since 1976, it disregarded ECT machines because they’ve been in widespread use since the 1950s, according to STAT News in “Psychiatric Shock Therapy.” The FDA placed ECT machines in the class III (high risk) category where they have remained since that time. But in December of 2015, the FDA made public a draft document proposing to reclassify ECT machines as a class II (low risk) device. Before the public comment period ended in late March of 2016, the FDA had received 2,040 comments on its draft rule. The agency has not set a timetable for issuing its final ruling.

While the proposed regulations would indicate that ECT was “safe and effective” and only moderately risky for adults, it would only be approved for adults with severe depression who haven’t responded to medication or other therapies. It would remain classified as a high risk  (class III) for psychiatric conditions other than major depression and for children and adolescents. There would be new requirements as well. Doctors would have to warn patients of the side effects of ECT, which include confusion and memory loss; and that long-term safety for ECT is not proven.

Psychiatrists warn that that these new regulations could lead to insurers not covering ECT and doctors not recommending it for younger patients and those with conditions like schizophrenia, bipolar disorder and catatonia. (They say it like that’s a bad thing) Charles Kellner, a professor of psychiatry at the Icahn School of Medicine said, “Its use for these indications is widespread, even ubiquitous, and to deny the extensive evidence in support of that is indefensible.” Supporters say ECT has come a long way since it was portrayed in “One Flew Over the Cuckoo’s Nest.” Patients get anesthesia and sedatives to minimize pain and muscle spasms, so they are less likely to hurt themselves during the ECT seizure. “Ultra-brief pulse therapy delivers a fraction of the electricity used in the past.” However, as noted above, this claim is disputed. See “The Frankenstein Monster of ECT” and “Is ECT Brain Disabling?” on this website.

Writing for GlobalResearch, Dr. Gary Kohls described ECT “therapy” sessions as: “sub-lethal electrocutions of the brain that reliably produces seizures and coma.” He noted that the perceived improvement with ECT is often because of the frequent short-term and long-term memory loss that occurs with shock treatment. “The patient may no longer remember the traumatizing interpersonal/sexual/social/ psychological/spiritual conflicts that previously made them feel sad, nervous, depressed, anxious or hopeless.” He lamented that studies show physicians reach for their prescription pad within minutes of most clinic encounters. “Time is money.”

Dr. Kohls then quoted excerpts from the testimony of Leonard Roy Frank before the Mental Health Committee of the New York State Assembly in 2001. Mr. Frank was a psychiatric survivor and activist who personally experienced 35 ECT procedures and 50 insulin coma treatments. The transcript of his testimony can be read here in its entirety. He said:

This was the most painful and humiliating experience of my life. My memory for the three preceding years was gone. The wipeout in my mind was like a path cut across a heavily chalked blackboard with a wet eraser. Afterwards I didn’t know that John F. Kennedy was president although he had been elected three years earlier. There were also big chunks of memory loss for events and periods spanning my entire life; my high school and college education was effectively destroyed. I felt that every part of me was less than what it had been.

Frank then elaborated on some of the adverse effects from ECT. With regard to memory loss, he indicated that the APA downplays memory loss, saying most patients actually report improved memory; and only a minority of patients report problems with memory loss. He said the vast majority of individuals he has talked to reported moderate-to-severe amnesia going back two years and more from the time they received ECT.  His own experience was noted above.

Quoting the 2001 APA Task Report on ECT, Frank noted where a reasonable ECT-related mortality rate was suggested to be 1 per 10,000 patients. However, some studies show the ECT death rate is about one in 200. This rate may not still be accurate, as an increasing number of the elderly are being electro shocked. “Statistics based on California’s mandated ECT reporting system indicate that upwards of 50 percent of all ECT patients are 60 years of age and older.”

Frank described what he referred to as “the myth of informed consent.” While outright force is seldom used, “genuine informed consent is never obtained” because ECT specialists minimize the procedure’s nature and effects to candidates and their families; and because of the implicit coercion that can be brought to play. There is a lack of accountability with psychiatry. It was a “Teflon” profession, meaning what little criticism there is doesn’t stick. “Psychiatrists routinely carry out brutal acts of inhumanity and no one calls them on it — not the courts, not the government, not the people.”

Electroshock could never have become a major psychiatric procedure without the active collusion and silent acquiescence of tens of thousands of psychiatrists. Many of them know better; all of them should know better. The active and passive cooperation of the media has also played an essential role in expanding the use of electroshock. Amidst a barrage of propaganda from the psychiatric profession, the media passes on the claims of ECT proponents almost without challenge. The occasional critical articles are one-shot affairs, with no follow-up, which the public quickly forgets. With so much controversy surrounding this procedure, one would think that some investigative reporters would key on to the story. But it’s happened only rarely up to now. And the silence continues to drown out the voices of those who need to be heard. I’m reminded of Martin Luther King’s 1963 “Letter from Birmingham City Jail,” in which he wrote: “We shall have to repent in this generation not merely for the vitriolic words and actions of the bad people, but for the appalling silence of the good people.”

Psychiatrist Peter Breggin has advocated against ECT for decades. You can watch an 11-minute video he did called, “Electroshock is Brain Trauma.” He indicated the 100,000 per year estimate for ECT was based on data he gathered in 1979 for his book critical of shock treatment. He said today every large city has several places that do shock treatment. “It’s extremely remunerative.”

Dr. Lagemann indicated that standard treatment is 9 to 12 shocks, at a cost of $2,000 to $2,500 each. When you do the math, you come up with a minimum income of $1.8 billion (9 x 100,000 x $2,000 = $1.8 billion). About half the cost is covered by Medicare. Mr. Frank indicated that in 2001, psychiatrists specializing in shock treatment earned $300,000-$500,000 a year compared to other psychiatrists whose mean annual income was $150,000.

What’s wrong with shock treatment? How does it work? It’s not as mysterious as the advocates make out. Shock works by passing an electric current through one or both frontal lobes of the brain, producing an electrical lobotomy.  The electricity also passes through the memory centers of the temporal lobe, causing additional devastation. Finally, the current passes throughout the brain and that, along with the severe seizures that result, causes widespread brain dysfunction and damage. Some patients initially become euphoric from the damage, whereupon the shock doctor notes approvingly, “mood elevated.” All patients eventually become apathetic and indifferent, and unable to resist, whereupon the doctor notes with finality about the outcome, “no longer complaining.”

Dr. Breggin said the only reason that modern shock doctors don’t talk about ECT as damaging the brain is because he publicized and documented how it was in his book, Electroshock: Its Brain-Disabling Effects. He noted that when ECT treatment is done, it results in a period of coma. “How could a blow to the brain with electricity so severe it causes a coma, and you’re not harmed by it?” Very often the EEG brain waves flat line—that’s temporary brain death. The person wakes up completely disoriented. The longer the treatment continues, the more past memory the person loses.

The STAT News article noted where a woman who had 66 ECT treatments between 1996 and 2010 to treat depression left such holes in her memory that she couldn’t recall her wedding day or the birth of her children. Her 28-year marriage ended, ““because I couldn’t remember that relationship, and without those memories, I had no emotional connection.”

Dr. Breggin created a free website about shock treatment: ECT Resources Center.  Among its documents is a simple introductory statement and brochure for widespread distribution. There are also PDFs of more than 100 scientific articles on issues with ECT. He urged people to do everything they can to stop someone they know getting ECT, because they will never be the same afterward.

As of September 1st, there has not been an announcement of what the FDA plans to do with ECT. But when the FDA announced it was soliciting comments of the proposed regulatory changes, the American Psychiatric Association created a form letter for psychiatrists to “take the lead in expressing their views” regarding the role of ECT in clinical practice and treating major depressive disorder. See “Time is Now to Support the ECT Reclassification Effort.” The letter asserted that ECT was an important treatment option for some people with severe mental health conditions. “Your proposed reclassification will greatly improve access to safe, effective treatment for individuals with serious and persistent psychiatric disorders.” You can download and read a copy of the form letter in the above link. I wonder how many of the 2,040 comments were APA form letters from psychiatrists?