08/18/20

Throwing Down the Gauntlet for ECT, Part 2

Electroconvulsive therapy (ECT) has been used as a treatment for mental health disorders for almost ninety years. It is acknowledged as a controversial psychiatric treatment by advocates and opponents alike. Centers that promote its use say it has become safer and more tolerable and claim it to be one of the most effective treatments in the history of psychiatry. Others see it as a cruel and barbaric therapy with risk factors that include permanent memory loss and even a small danger of death. A review by John Read, Irving Kirsch and Laura McGrath, “Electroconvulsive Therapy for Depression,” may have begun to shift that debate towards concluding the known risks outweigh the supposed benefits.

Over the past thirty years there has been a global movement towards evidence-based medicine, requiring the systematic collection and analysis of data about the effectiveness of treatments. According to John Read and Richard Bentall in “The effectiveness of electroconvulsive therapy,” this approach assumes that clinical decision-making should be informed by a hierarchy of information in which data from placebo-controlled randomized trials stands at the apex. The randomized controlled trial (RCT) is where participants are randomly assigned to the treatment group or to a control group, in order to help ensure there is no bias when assigning participants to the two conditions. With the realization that the research results were biased when the researcher or participant was aware of the participant’s presence in the treatment or the control group, the gold standard methodology became the double-blind RCT, where neither researcher nor participant was aware of which group participants were in.

The ideal control treatment in a double-blind RCT is a placebo—something that looks and feels like the treatment but is inert. In other words, it does not have the experimental influence the treatment group has. For ECT, this entails a simulation or “sham,” where the participant received the general anesthetic, but not the electricity (SECT). And in the entire history of ECT use, there have only been eleven such studies.

John Read has done several past reviews of the ECT literature (See the above link for “The effectiveness of electroconvulsive therapy” and “Is Electroconvulsive Therapy for Depression more Effective Than Placebo?”), finding that there is no evidence of a lasting effect. But there have been several metanalyses which have shown the opposite. So, he thought it would be useful to not only look again at the studies, but to also look at the quality of these metanalyses. In a podcast for Mad in America, Read said: “We wanted to try and understand how these metanalyses kept concluding that ECT works, when the studies they were using were such poor quality, in our view, that you really couldn’t reach any conclusions.”

He wanted to assess whether the studies were of good enough quality to merit having been included in the metanalyses. And to also see whether or not the metanalyses had shown any interest in the quality of the studies they reviewed. Read and his coauthors developed a rating scale for assessing the quality of the trials, which included the five basic Cochrane collaboration criteria to evaluate a metanalysis. Tellingly, there has not been a single robust study into whether ECT works since 1985. The size of the placebo ECT/SECT studies was also small, averaging 37 people; the largest size was only 77 individuals. In a review of the Read, Kirsch, McGrath study for the Council for Evidence-Based Psychiatry, John Bentall said it seemed unlikely to him that any safe conclusions could be drawn from studies with such small numbers.

None of the placebo ECT/SECT studies were double blind. Some studies blinded the researcher; some did not. In order to blind the participants, you would have to use only individuals who had never had ECT previously. The reason for this is that if you had previously had ECT, you would know that you always wake up with a headache and confusion for few hours. “So, you know what group you’re in,” making it impossible to properly design a double-blind ECT study, unless you only include participants who have never had ECT before.

There was also a lot of selective reporting in the studies. Read discussed how one study asked the psychiatrist, nurses and patients to rate the effectiveness of the study, but only reported data on the psychiatrists. Another study reported both psychiatrist and patient ratings, where the psychiatrist found ECT to be better than placebo, but the patient did not. “The studies were in an appalling quality, and how any of them got included in serious metanalysis is a wonder.” Additionally, the metanalyses were arbitrary in which of the existing eleven placebo ECT/SECT studies were included. They included between one and seven of the eleven studies.

Read, Kirsch and McGrath concluded the data used in these metanalyses was not good enough to answer the question of whether or not ECT actually worked. They could not say ECT does not work; just that the data does not indicate that it works. “There isn’t any evidence that it does work. But the point is the studies were so poor, that we don’t know.” Added to that is the lack of research into adverse effects, such as brain damage and memory loss. Read said the ECT research is so poor, they don’t know how many people actually get permanent or persistent memory loss. Estimates range from 12.5% to 55%, with studies asking patients reporting the higher percentages. They concluded in the study:

Given the high risk of permanent memory loss and the small mortality risk, this longstanding failure to determine whether or not ECT works means that its use should be immediately suspended until a series of well designed, randomized, placebo-controlled studies have investigated whether there really are any significant benefits against which the proven significant risks can be weighed.

Read said the Royal College of Psychiatrists stated they plan to update its statement on ECT and will do so in light of their review. And the UK’s National Institute for Health and Clinical Excellence (NICE) has said they will consider the implications of the review in the current update of depression guidelines. On the podcast, James Moore asked John Read if the UK would go ahead and make changes in its regulation of ECT, could that have any influence on what occurs in the US? He said he hoped they would consider it and planned to send copies to the FDA and the American Psychiatric Association.

In the Mad in America podcast, Irving Kirsch acknowledged that in the placebo literature, placebo also effects the doctors administering the ECT treatment. “If you change the expectations of the doctors who are administering the treatment, you can increase the placebo effect.” He said the exact mechanism by which this expectation is communicated is unknown. However, different placebos have different effects and the effect increases as you raise the bar on the complexity of the procedure. Capsule placebos are more effective than pills; placebo injections are more effective than either capsules or pills; and placebo surgery is the most effective placebo of all. “The more invasive the procedure, the great the placebo effect.” Nevertheless, he was surprised by the magnitude of placebo effect with ECT.

The stronger the expectation, the stronger the placebo effect. . . You get responses from both the sham and the genuine treatment. And with ECT when you are looking at the long-range effects, the sustained effects, there seems to be not differences at all.

He said particularly with depression, you can anticipate a large placebo effect. One of the characteristics of depression is a sense of hopelessness. When you are then given a new treatment, whether it be a drug or something else, you can have the thought that maybe this will work. “It instills a sense of hope that counters the hopelessness that is a core feature of depression.” His sense is that ECT should be prohibited and gave the following reasons.

First, the negative effects are so strong.

Second, there is no good evidence that ECT has any effect at all, especially in the long-term.

Third there are other means of treatment.

The authors estimated that about 1 million people receive ECT annually; 250,000 in the UK.

08/11/20

Throwing Down the Gauntlet for ECT, Part 1

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.

06/18/19

Better Living Through Brain Stimulation

Electrical stimulation to treat medical conditions is not the new, cutting edge research and treatment one would expect. Besides electroconvulsive therapy (ECT), which originated in the 1930s, there is evidence the ancient Egyptians knew about the electrical properties of Nile catfish. However, it’s not clear if they used them for medical purposes. The first evidence for electrical “treatment” dates from Plato and Aristotle who described the ability of the torpedo fish to generate so-called “curative effects.” Scribonius Largus (1-50 AD) and Galen (130-201 AD) said the torpedo fish could be used to treat headache, gout, and epilepsy.

Today, not only is there ECT, but Transcranial Magnetic Stimulation (TMS), Repetitive Transcranial Magnetic Stimulation (rTMS), Transcranial Direct Current Stimulation (tDCS), Deep Brain Stimulation (DBS) and more. There are two, perhaps three needed distinctions. First, every type of brain stimulation except DBS is noninvasive—meaning they do not require surgery. DBS surgically implants parts of the stimulation device into the patient’s brain. The second distinction is that tDCS is the only brain stimulation that does not require a physician’s prescription. It is also more affordable and “safer.”

Thirdly, ECT uses very high current levels, around 800 milliamps, to induce an intentional, controlled seizure. For a comparison, tDCS uses a maximum of 2 milliamps. “Due to the severity of the effects produced by Electroconvulsive Therapy, the patient is almost always sedated during stimulation, which lasts for an average of 1 to 6 seconds. The required use of sedation greatly increases the potential, and severity of any negative side effects.” Sedation during ECT is to prevent fractures from severe muscle spasms, according to Peter Breggin in Brain Disabling Treatment in Psychiatry, (p. 242):

For the past 40 and more years, a modified form of ECT had been standard, involving sedation with a short-acting barbiturate, muscle paralysis with a curare derivative or similar drugs that prevent activation of the muscles of the body and artificial respiration with oxygen. The purpose of these modifications was not, as some advocates claim, to reduce memory loss and brain damage. Muscle paralysis was intended to prevent fractures from severe muscle spasms, while the artificial respiration kept the paralyzed patient breathing.

TMS and rTMS are electromagnetic therapies typically used for treatment-resistant depression. Patients sit in a specially designed chair with positioning frames used to hold their head in place during treatment. “Positioning frames are required for TMS therapy because the stimulation apparatus does not touch the individual’s head, but instead hovers just a few centimeters above the scalp.” The key difference with rTMS is the repetitive nature of the magnetic pulses, which is rapidly increased, switching between positive and negative polarities in milliseconds. The increased strength of electromagnetic induction in rTMS may potentially “solidify longer lasting changes in the brain, whereby TMS may only induce short-term changes.” Yet a recent study found no difference in remission rates between rTMS and sham rTMS.

TMS devices can only penetrate a few centimeters into the outer cortex of the brain. Because of the way electromagnetic fields operate, the strength of TMS devices declines rapidly the farther away the machine is positioned from the scalp. So, if targeting deeper regions of the brain is what you want, a more direct stimulation method like tDCS is needed. tDCS devices are available for home use. However, because of the complex nature of the technology and the need for precise positioning of the electrodes, it is recommended they only be used within clinical settings. Another consideration is that you are sending an electric current, albeit a low one, to modulate neuronal excitability in a specific area of your brain.

An article in Psychological Medicine gave a brief history of tDCS, and noted the 20^th century discovery in Iraq of the “Baghdad battery,” a DC generator dated from the ancient Persian civilization (490 BC). It was possibly used for medical purposes. It wasn’t until the 1800s that a DC battery was invented by Luigi Galvani. His nephew, Giovanni Aldini, was the first person to use DC for clinical purposes. A 27-year old farmer was treated for melancholy madness (major depression). “The patient’s mood progressively improved so that Lazarini [the patient] was apparently completely cured several weeks after the beginning of the treatment.”

It wasn’t until 1998 that modern tDCS was developed. Technological innovation has enabled electronic and biomedical engineers to build “precise tDCS devices with better control of stimulation parameters” than older devices—and do so at reduced costs. This led some people to experiment with self-administering tDCS and sometimes having tDCS touted as a ‘miracle device.’ However, even the receptive authors of the article on tDCS cautioned against such media attention. They urged careful, neutral presentation of data to the public. “Sensationalistic news about the benefits of tDCS leads people to self-administer stimulation, as we can see in some Internet do-it-yourself tDCS forums.”

tDCS devices are inexpensive and easy to use. There are even YouTube videos of individuals experimenting on themselves. Dan Hurley published an article for The New York Times, describing the history and science of tDCS as well as his personal experience with it. He described the work of Dr. Felipe Fregni, an Associate Professor at Harvard. He has written extensively about the potential benefits of tDCS, including its effects on “migraine, chronic pain, post-stroke paralysis, Parkinson’s disease, depression, tinnitus, fibromyalgia, marijuana craving and, strangely enough, the tendency to lie.” Dr. Fregni said the main safety concern is that individuals have begun treat themselves: “What they fail to realize is that applying too much current, for too long, or to the wrong spot on the skull, could be extremely dangerous.” See “Jump Starting Your Brain” for more information and concerns with tDCS.

While not technically tDCS, the FDA recently approved a new cranial electrotherapy stimulator (CES) for the treatment of anxiety, depression and insomnia. The Cervella Cranial Electrotherapy Stimulator uses a Bluetooth-enabled set of headphones and an app to deliver a low-level, constant current to the individual’s cranium. According to the parent company, Cervella allows for automated recoding of treatment data, reminders and analytics aimed at improving patient outcomes. You also need a prescription in order to purchase one for the cost of $695.

Another form of electrostimulation called transcranial alternating-current stimulation (tACS) recently demonstrated the possibility of reversing the decline of working memory that comes with the aging brain. After 25 minutes of stimulation, the researchers found a rapid improvement in working memory for adults aged 60 to 76 years-old. The effects outlasted a 50-minute post-stimulation period. “The results provide insight into the physiological foundations of age-related cognitive impairment and contribute to groundwork for future non-pharmacological interventions targeting aspects of cognitive decline.”

Working memory is responsible for decision-making and allowing us to retain and access information such as names, phone numbers, and where we’ve put things. Age and cognitive deterioration in disorders like dementia contribute to the decline of working memory. The hypothesis tested by this study is that working memory operates by slow, low-frequency theta rhythms synchronizing with faster, gamma rhythms between the prefrontal and temporal areas in the brain. When these two areas are on the same wave length, “communication is tight, and working memory functions seamlessly.” As we age, these brain areas lose their synchronicity.

Interestingly, when a targeted form of tACS stimulation (HD-tACS) was used on participants, the age-related synchronization discrepancies disappeared. “HD-tACS appeared to eliminate age-related impairment in working-memory accuracy.” In a related test, young adults with poor working memory received the HD-tACS stimulation and also improved their results. “We could boost their working memory even though they weren’t in their 60s or 70s.”

Neuroscientists, including the lead author of the study, cautioned that more work needed to be done with HD-tACS. The boost in performance may be statistically significant, but not clinically significant. This is also only one study so far. “I’d like to see this replicated by other labs, and extended to test other aspects of working memory.” STAT News said for HD-tACS stimulation to become a treatment for working memory deficits, “it would have to overcome a long list of hurdles, starting with proof that it’s safe.” Regardless of whether this experiment results in practical applications, it does provide evidence of the differences in working memory with older adults: “Brain circuits become functionally disconnected and fall out of synchrony.”

Deep Brain Stimulation (DBS) is an entirely different animal. A preliminary surgical procedure implants part of the device into a patient’s brain. Wires connecting the electrodes to the device, and sometimes the device itself, are implanted underneath the skin’s surface. DBS is a relatively new technique and considered to be a last resort treatment method, as are TMS and ECT. There are immense risks to DBS and currently it is only used to treat severe neurological conditions like Essential Tremor, Parkinson’s Disease, Tourettes Syndrome, and Dystonia. Long-term studies of Parkinson’s patients treated with DBS have shown they have DBS-related scar tissue in their brains. There have also been serious mood, behavior and personality changes documented.

These include suicide, depression, apathy, fatigue, mania and serious impulse control issues, such as hypomania, aggression, addiction (to gambling, shopping, drugs, alcohol) and hypersexuality, sometimes resulting in criminal behaviour, including pedophilia.

And by the way, they aren’t quite sure how it works. See, “Deep Brain Jolts” and “Deep Brain Problems” for more information on DBS.

None of the above-described methods of brain stimulation should be used at home without a prescription or the supervision of a doctor, including tDCS and tACS. There are potential serious adverse effects for some procedures like ECT and DBS. Better memory and living through brain stimulation is still a future hope and may just be a pipe dream. For more on issues with electrical brain stimulation, also see “Electrical Psychiatry.”

05/22/18

To Shock or Not to Shock

To shock or not to shock; that is the question. Is electroconvulsive therapy (ECT) an effective and safe treatment for severe cases of mood disorders such as depression? Or is it something that “permanently impairs memory and causes other long term signs of mental dysfunction such as difficulties with concentration and new learning?” It continues to be one of the most controversial treatments used in medicine because “precisely why electroshock works is a mystery.” And it’s also because it has a history of being used as a form of torture and euthanasia by at least one Nazi doctor.

In October of 1939, shortly after the invention of ECT by two Italian researchers, Adolf Hitler signed a decree that authorized German doctors to euthanize any psychiatric patient who was deemed incurable. “Between 1939 and 1941, tens of thousands of patients were killed at psychiatric hospitals.” While the program officially ended in 1941, the practice continued until the defeat of Germany in 1945 particularly with Dr. Emil Gelny. After just three months of clinical training, Gelny was granted a specialist qualification in psychiatry in 1943 and placed in charge of two psychiatric hospitals in Austria. At first, he used lethal doses of drugs like morphine and barbiturates to kill ‘incurable’ patients, but when the drugs became scarce, he modified existing ECT machines.

After the initial shock rendered the patient unconscious, he added four extra electrodes and attached them to the person’s wrists and ankles to deliver the lethal shocks. In “Mass killing under the guise of ECT,” the authors wrote: “Besides its easy availability and cost-effectiveness, a further important factor was that ECT could be camouflaged as a medical procedure to reduce patients’ suspicion, at a time when many correctly feared that drugs were used to kill them.” The author of “How Electroconvulsive Therapy Became a Nazi Weapon” said it was not clear how many individuals Gelny murdered with ECT. The combined death toll at the two hospitals was 4,800, but most patients likely died from drug overdoses or malnutrition. For more information on the Nazi use of psychiatry in euthanasia, see “Psychiatry’s role in the holocaust.”

Supporters of ECT like Dr. Jeffrey Lieberman say that modern ECT technologies allow for individualized treatment for each patient so the minimum amount of electricity needed to induce a seizure is used. Allen Frances, the chair for the DSM-IV, said on Twitter that if he had severe depression, “ECT would definitely be my 1^st choice.” The use of anesthetics combined with muscle relaxants and oxygenation “render ECT an extremely safe procedure,” according to Dr. Lieberman. He thought it was extremely ironic that the inventors of ECT failed to even be nominated for a Nobel Prize, “despite the fact that their invention was the only early somatic treatment to become a therapeutic mainstay of psychiatry.” He noted where the APA, NIH and FDA all approve the use of ECT “as a safe and effective treatment for patients with severe cases of depression, mania, or schizophrenia, and for patients who cannot take or do not respond to medications.”

On the other side of the ECT debate is Dr. Peter Breggin, who has been personally and professionally fighting against the use of ECT for over thirty years. You can review a wealth of information, including over 150 scientific studies by him and others, on his website: ECT Resources Center. One of his ‘key articles,’ “The FDA should test the safety of ECT machines” was written in 2010 to inform the FDA about the damaging effects of ECT as it was considering a reclassification of ECT treatment as safe for depressed patients. Breggin’s opening comment was: “Since its inception in the late 1930s, electroconvulsive therapy (ECT) has never been subjected to testing for Food and Drug Administration (FDA) approval in regard to safety and effectiveness.”

He said ECT is acknowledged, even among staunch advocates of the procedure, as the most controversial treatment in psychiatry. The Consensus Development Conference on ECT, conducted by NIH, was cited as affirming that assertion. “Given this extraordinary degree of controversy, there can be no justification for not subjecting ECT to the same scrutiny that is given to devices and treatments that are far less controversial, including at the least new animals studies.” Since it causes an acute delirium, there is no scientific doubt ECT harms the brain and mental function.

ECT produces sufficient trauma to the brain to cause a severe grand mal convulsion. All ECT treatments result in a period of coma lasting several minutes or more, sometimes including a flat line EEG. In routine application, the patient awakens in a delirium that is virtually indistinguishable from any other closed head injury. Typical symptoms include severe headache, memory dysfunction, disorientation, confusion, lack of judgment and unstable mood. The treatment always results in apathy, and sometimes in euphoria, which are typical reactions to traumatic brain injury. Consent forms routinely warn patients not to make decisions during or shortly after the completion of any series of ECT treatments.It is acknowledged in neurology that repeated head injuries that produce concussive symptoms are likely to cause persistent harm. ECT treatments are far more traumatic than most concussions, and include prolonged coma after each treatment, sometimes accompanied by EEG flat lining, and severe delirium after a few treatments or less. The number of traumatic ECT treatments usually far exceeds the number of concussions that produce lasting harm.In the rational practice of regulatory affairs, the fact that a treatment causes such initial trauma would in itself require it to be withdrawn from the market; it certainly requires a thorough examination of ECT by the FDA, starting with animal studies.

He referred to large animal studies that demonstrated generalized brain damage from ECT. He pointed to a 2007 study confirming that ECT produces lasting memory dysfunction and more generalized persistent cognitive deficits. “Except in regard to a psychiatric treatment, substantial evidence on this scale for persistent damage would lead to an inquiry into withdrawing a treatment from the market.” And despite several decades of effort, ECT advocates have not been able to demonstrate any lasting improvement.

The Consensus Development Conference on ECT found that controlled clinical trials failed to demonstrate any positive effect beyond four weeks. Thus the risk/benefit ratio is very poor. This four-week period corresponds to the period of the acute delirium, when the ECT effects of emotional blunting and/or euphoria are mistaken for clinical improvement. Typically, the patient stops voicing complaints and may display an artificially elevated mood.

The result of the hearings was a FDA advisory panel recommended in 2011 that ECT devices be designated as high risk for all patients: “FDA panel advises more testing of ‘shock-therapy’ devices.” Note the contradiction to what Dr. Lieberman claimed.

FDA staffers who reviewed hundreds of studies reported that as a group, they were poorly designed and had too few patients to allow firm conclusions to be drawn. “Many failed to follow patients long enough to discover the duration of ill effects.” The majority of the 18-member committee said not enough was known about ECT and more research was needed into the usefulness and hazards of the ECT devices.

That ruling led to an ongoing controversy, with the FDA tabling the issue until in 2015 it drafted a ‘proposed order’ that 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. However, it would also impose new requirements, like requiring physicians to warn patients that the side effects of ECT can include confusion and memory loss, and that its long term safety in not proven. They would also have to monitor patients’ memory and cognitive skills before and during treatment. “And the FDA would also classify ECT as high risk for psychiatric conditions other than depression and for children and adolescents.”

STAT News said psychiatrists are concerned that classifying ECT as a high risk procedure for psychiatric conditions other than depression, and for children and adolescents “could prompt insurers to stop covering and doctors to stop recommending ECT for younger patients” and those with other psychiatric conditions, like schizophrenia, bipolar mania and catatonia. It would require ECT manufacturers to conduct clinical trials for these indications. “It’s widely expected they will decline to do so because of the cost.” Doctors could still provide ECT “off label,” but insurance companies could refuse to pay. “And physicians may worry about the potential for malpractice lawsuits if anything goes wrong.”

Stop and think for a minute about these last statements. ECT device manufacturers are expected to decline to do expensive clinical trials to confirm that their device is safe and effective for patients who are children, adolescents, and suffer from psychiatric conditions other than severe depression. If there were studies provided to the FDA in 2010 to support the use of ECT to treat these populations, they were poorly designed and had too few patients to allow for conclusions to be drawn. So they have been using ECT devices to treat these populations without reliable clinical trial evidence. And apparently the doctors who do ECT want to continue doing so without worrying about “the potential for malpractice lawsuits if anything goes wrong.”

The American Psychiatric Association and the consumer group NAMI (National Alliance of Mental Illness) think the FDA should classify ECT as moderately risky for all conditions for which it is now commonly used. The FDA received 2,040 comments on its draft rule during the public comment period closed in March of 2016. “The agency has not given a timetable for issuing a final rule.”

While we await the FDA decision on its draft guidance for ECT devices, consider these comments from Peter Breggin’s “Introductory Information About ECT”:

After one, two or three ECTs, the trauma causes typical symptoms of severe head trauma or injury including headache, nausea, memory loss, disorientation, confusion, impaired judgment, loss of personality, and emotional instability. These harmful effects worsen and some become permanent as routine treatment progresses.ECT works by damaging the brain. The initial trauma can cause an artificial euphoria which ECT doctors mistakenly call an improvement. After several routine ECTs, the damaged person becomes increasingly apathetic, indifferent, unable to feel genuine emotions, and even robotic. Memory loss and confusion worsen. This helpless individual becomes unable to voice distress or complaints, and becomes docile and manageable. ECT doctors mistakenly call this an improvement but it indicates severe and disabling brain injury.Abundant evidence indicates that ECT should be banned. Because ECT destroys the ability to protest, all ECT quickly becomes involuntary and thus inherently abusive and a human rights violation. Therefore, when ECT has already been started, concerned relatives or others should immediately intervene to stop it, if necessary with an attorney.

Meanwhile, two Pennsylvania state representatives are not willing to wait and see what the FDA recommends. They introduced a bill to prohibit the use of ECT on individuals age 16 and under. The co-sponsors thought it was deplorable when ECT was done to children who have no say on whether to agree or not to the treatment. One of them said he thought it was a form of child abuse. According to the Pennsylvania Department of Human Services, 13 children under the age of 5 were given ECT in 2014. Three adolescents between 13 and 17 were electroshocked as well that year. “Children should not be forced to undergo a treatment that can have a lasting impact on their physical and mental well-being.”

Also see: “The Frankenstein Monster of ECT,” “Is ECT Brain Disabling?” and “The Appalling Silence on ECT” on this website.

09/20/16

Appalling Silence on ECT

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 1^st, 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?

09/10/14

Is ECT Brain Disabling?

I’ve only had a couple of up-close-and-personal experiences with people who have had electroconvulsive therapy (ECT). Both were residents of a long-term addiction treatment facility for women. One woman was in her late 20s who didn’t appear to have suffered any serious side effects after her ECT treatment. But the ECT didn’t seem to have a clearly positive effect on her depression. Actually, her mood seemed rather flattened afterwards.

The other woman had been a resident for a few months and suffered a severe depressive episode for which she agreed to have ECT. A small group of the residents gathered around her when she returned from her stay and ECT treatment at Western Psychiatric Institute and Clinic (WPIC). The other residents were supportive, asking how she was doing; telling her they were glad to see her, etc. She responded in a quiet, timid manner, thanking them for their support. As the group broke up and we entered the facility, she whispered to me: “Who were those people?”

Since then, I’ve read some of the material of the opponents to ECT, particularly Peter Breggin, who has a long history of activism against ECT. Dr. Breggin, has gathered an incredible amount of information on the website ECT Resources Center.

So I was interested when I saw an online article in the Pittsburgh Post-Gazette in December of 2013 on ECT treatment at WPIC, “Electroconvulsive therapy a surprisingly common treatment for mental illness.” The psychiatrist who treated the woman in the article said that ECT “is the most effective antidepressant still out there.” The article was clearly positive about the use of ECT, but a sentence stood out to me: “Doctors are still not sure why ECT works.” Yet, Dr. Breggin wrote on his website:

ECT works by damaging the brain. The initial trauma can cause an artificial euphoria which ECT doctors mistakenly call an improvement. After several routine ECTs, the damaged person becomes increasingly apathetic, indifferent, unable to feel genuine emotions, and even robotic. Memory loss and confusion worsen. This helpless individual becomes unable to voice distress or complaints, and becomes docile and manageable. ECT doctors mistakenly call this an improvement but it indicates severe and disabling brain injury.

A 78-year-old Beaver Falls woman, who had been treated for a bipolar disorder since the 1960s, was the featured patient in the Post-Gazette article. The reporter, Mark Roth, was permitted access to observe her ECT treatment. He wrote that she was unconscious and her muscles were paralyzed from anesthesia, “It was over in 8 seconds. . . . For her and for anyone watching, it was far less dramatic than they might have imagined.” After her series of 10 shock treatments, the woman felt that ECT helped her tremendously. She said that ECT made it possible for her to climb out of the deepest depression she had ever experienced.

The comment of ECT being “far less dramatic” was an allusion to the 1975 movie “One Flew Over the Cuckoo’s Nest,” where Jack Nicholson’s character was held down by attendants as he went through ECT treatment and the resultant seizure.

The modern use of anesthesia and muscle relaxants means that physical restraint, as portrayed in the movie, no longer occurs. But as Dr. Breggin pointed out in a debate with Dr. Helen Lavretsky, anesthesia makes it more difficult to initiate a seizure, so the patient has to have a greater shock than was given in the past. Listen here to the debate with Dr. Helen Lavretsky located on the ECT Resources Center website.

Dr. Lavretsky said that ECT was rarely performed, but Dr. Solia of WPIC, said that was a common misconception, at least at WPIC. He said that WPIC was one of the largest operations in the nation, performing “more than 300 electroshock procedures per month.” An assembly line procedure had “one set of patients being prepped with IV lines as another one is getting the treatment and still others are coming back to consciousness in a recovery area.”

There hasn’t been any follow up to the Post-Gazette article, even though the original article did say it was the “first of five parts.” In preparing my own article, I read the comments to the original article and I think I understand why. What was supposed to have been a positive public relations story about the ECT clinic at WPIC became a lightening rod that attracted strong negative attention. The majority of comments were negative like the following:

Not everyone’s ECT experiences are as positive as this article suggests. After my ECT I lost all memories of the year of my life before the treatments. This caused social and professional problems, as you can imagine, and also considerable personal pain. I also acquired some cognitive deficits with which I continue to struggle. (Sonia)I found ECT severely traumatizing, rendering profound memory loss that continues to manifest itself even 1 1/2 years later. I continue to suffer with cognitive defects and emotional pain that interfere with my work, social and personal life. I have repeatedly encountered others with very negative experiences. ECT does have positive results in some, but there are many for whom the treatment fails and wreaks havoc. (Kelly)

At least some of the individuals thought the article sounded like a “PR piece.” Cheryl asked: “Why not write another piece of equal length, focusing on the points of view medical professionals and former patients and their families who have the opposing viewpoint.” Don’t continue to wait for that to happen. I don’t think there will be any follow up articles. Just go to Dr. Breggin’s ECT Resources Center and get credible information on the problems with ECT.

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag: electroconvulsive therapy