ECT Final Rule

My position on electroconvulsive therapy (ECT) is that it is a safe and effective treatment for severe depression, bipolar depression, and catatonia.  It is typically used in the case of treatment resistant depression or acute life threatening psychiatric disorders. In the era prior to modern psychiatric treatment food and water refusal, extreme agitation, uncontrolled aggression, and suicidal behavior all occurred and resulted in excessive mortality. In the case of delirious mania or catatonia, the mortality was estimated as high as 80%.  In the acute care setting where I worked we established a practice where two or three physicians in the group specialized in ECT.  That was done initially because the malpractice premiums were higher for ECT practitioners.  As time went by we were told that from and insurance perspective the risk associated with ECT was not any greater than standard psychiatric practice and all of the premiums became the same.  From an actuarial standpoint ECT was considered a safe procedure.

From a cultural perspective ECT is a highly stigmatized treatment.  There are very few movies where the public gets a realistic perspective of how it is used. More typically it is presented as a punishment or torture rather than a safe and effective medical treatment.  The people I see in consultation are surprised to hear that it is still in use.

Sometime in about 2011, the Food and Drug Administration (FDA) decided to start an initiative about reclassifying ECT devices from Class III (high risk) to Class II (low risk) medical devices.  In their classification system for medical devices, Class III is the most restrictive because it requires premarket approval.  Class II is less restrictive because it can be approved with special controls or recommended measures to mitigate risk.  Class I is least restrictive and requires general controls.  The reason why the FDA initiated this reclassification attempt in 2011 is unclear to me.  The reason why it initially failed is fairly common knowledge. The antipsychiatry movement has been against ECT since before the time of Breggin's protest (1) in the New England Journal of Medicine over a book review by Mandel (2) that discredited his negative assessment of ECT.  A quote from Mandel's review from 40 years ago:

"Dr. Breggin's arguments fail because he uses supporting data uncritically and inaccurately. At a time when reasoned discourse and scientific exchange concerning ECT are needed, he simply calls for the abolition of the treatment on the basis of his personal conclusions. A critical reader will find this book of interest only as an example of how the fires of controversy can be fanned by emotion."

Any time I have attempted to debate the merits of ECT in a public forum (like Twitter) there is a generally trend among the antipsychiatrists to jump on whatever I say and with quote Breggin's book or post links to his dated and inaccurate work.  Irrespective of how the FDA initiative started it did offer some hope that a neutral federal agency could put some of this controversy to rest.

The FDA came out with the Final order on the reclassification of ECT devices on December 26, 2018.  As far as I can tell there was no fanfare.  Deflating controversy typically has that effect.  It took me about three hours to read through the document and it was a very interesting read.  The FDA used various sources to look at the issues of what they abbreviate as SE or safety and effectiveness.  They go though their decision making systematically including a section at the end where they address criticisms of ECT. the FDA, and in some cases professional organizations that suggest ECT is safe and effective like the American Psychiatric Association (APA).  The FDA gives an unequivocal response to these questions "The FDA disagrees with ......."

There is a very interesting section on the most controversial aspect of ECT - memory loss.  I have excerpted the studies and FDA summary statements in the table below:

Reference	FDA Comments (excerpted)
Fernie, G., et al., ‘‘Detecting Objective and Subjective Cognitive Effects of Electroconvulsive Therapy: Intensity, Duration and Test Utility in a Large Clinical Sample.’’ Psychological Medicine, 2014. 44(14): pp. 2985–2994.	Overall, the application of ECT had reversible cognitive deficiencies compared to preECT treatment scores, a measure of safety, and in some assessments (CANTAB, subjective reports of memory function, and MMSE) showed patient improvement.
Kirov, G.G., et al., ‘‘Evaluation of Cumulative Cognitive Deficits from Electroconvulsive Therapy.’’ British Journal of Psychiatry, 2016. 208(3): pp. 266–270.	Not all subjects were capable of performing all tests and parts of the battery changed over time. Results (linear mixed regression analyses) demonstrated that age, severity of depression at the time of testing, and number of days since the last ECT session were the major factors affecting cognitive performance, but the total number of previous ECT sessions did not have a measurable impact on cognitive performance, which further supports the safety of ECT in not leading to cumulative cognitive deficits.
Maric, N.P., et al., ‘‘The Acute and Medium-Term Effects of Treatment with Electroconvulsive Therapy on Memory in Patients with Major Depressive Disorder.’’ Psychological Medicine, 2016. 46(4): pp. 797–806.	At the same time, the neuropsychological tests did not detect any significant memory impairment and showed improvement on visual memory and learning at 1 month and in the immediate post-treatment period, indicating no prolonged or significant ECT-related memory deficits. These improvements correlated with improvement in depression while serious adverse events were not reported.
Spaans, H.P., et al., ‘‘Efficacy and Cognitive Side Effects After Brief Pulse and Ultrabrief Pulse Right Unilateral Electroconvulsive Therapy for Major Depression: A Randomized, DoubleBlind, Controlled Study.’’ Journal of Clinical Psychiatry, 2013. 74(11): pp. e1029–1036.	No significant difference was seen in retrograde amnesia between the two treatment groups. Change in recall performance and fluency tests were also similar between the two groups. There was not a significant difference in performance in the cognitive tests following ECT for any of the cognitive tests during the course of study. The authors also reported mitigating adverse effects on cognition by lengthening the time between treatments to provide patients with more time to recuperate, thereby further characterizing how ECT treatment can be applied safely.
Ghaziuddin, N., et al., ‘‘Cognitive Side Effects of Electroconvulsive Therapy in Adolescents.’’ Journal of Child Adolescent Psychopharmacology, 2000. 10(4): pp. 269–276	The comparison of pre-ECT and the immediate post-ECT testing demonstrated significant impairments of concentration and attention, verbal and visual-delayed recall, and verbal fluency. A complete recovery of these functions was noted in the cognitive testing conducted at 8.5 months. There was no deficit in the ability to problem solve during the initial or the subsequent testing. Cognitive parameters found to be impaired during the first few days of ECT were recovered over several months following the treatment. Therefore, there was no evidence of long-term damage to concentration, attention, verbal and visual memory, or verbal fluency. There were also no impairments of motor strength and executive processing, even during the early (within 7 to 10 days) post-ECT period.

The FDA considered over 400 scientific papers for this reclassification of ECT.  The examples of their conclusory statements about memory related problems in the table above is consistent with clinical practice. They are careful to point out that there are reports of some people who state they have had some permanent memory loss but they do not get into the potential explanations for that phenomenon. They emphasize that the FDA's role is to comment on safety and efficacy and not purported neurobiological mechanisms.

There is an extensive comments section where the FDA summarizes arguments from hundreds of comments and answers them definitively. Many of these comments are right out of the antipsychiatry playbook.  Consider the comment below from page page 66113.  This is a direct excerpt from the Federal Register:

(Comment 8) Several comments indicated that ECT should be banned. Several comments characterized ECT as inhumane. Commenters indicated that the United Nations Special Rapporteur on Torture and Other Cruel Inhuman or Degrading Treatment or Punishment February 16, 2013, defined ECT without consent as torture.

(Response 8) FDA disagrees that ECT should be banned. Section 516 of the FD&C Act (21 U.S.C. 360f) authorizes FDA to ban a device when, based on all available data and information, FDA finds that the device ‘‘presents substantial deception or an unreasonable and substantial risk of illness or injury.’’ During review of the scientific evidence, FDA did not identify sufficient evidence to ban ECT. FDA determined that special controls, in combination with general controls, can mitigate the identified risks of ECT for certain intended uses and mitigate risks associated with ECT use. FDA determined that there is a reasonable assurance of SE for ECT treatment for the identified indications for use and patient populations. Therefore, FDA has determined that ECT does not present substantial deception or an unreasonable and substantial risk of illness or injury

The FDA in its disagreement with most of these negative comments - is in line with psychiatric practice and the obvious facts that if ECT was ineffective or resulted in significant injury - psychiatrists would not be using it or doing more extensive research on similar neurostimulation techniques to make neuromodulation as noninvasive and effective as possible.

All things considered this was a very positive statement about ECT. The FDA points out the limitations of their regulatory scope.  For example, even though they did not include an extensive list of conditions as indications for ECT - they acknowledge that once a device is approved it can be used for off-label conditions. They are also careful to point out that they are not endorsing ECT as the treatment of choice for the named conditions and it is never used that way. Their regulatory language specifies  "treatment resistant" and "require rapid response" as specifying the clinical population for which ECT benefits out weigh the risks.

I don't see psychiatrists having any problem with that language since that is the population we have always used this modality for.


George Dawson, MD, DFAPA



References:

1: Breggin PR. Electroconvulsive therapy for depression. N Engl J Med. 1980 Nov27;303(22):1305-6. PubMed PMID: 7421975.

2: Mandel MR.  Electroshock: Its brain-disabling effects (book review). August 14, 1980
N Engl J Med 1980; 303:402 DOI: 10.1056/NEJM198008143030721.

3: Food and Drug Administration, HHS. Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses. Final order. Fed Regist. 2018 Dec 26;83(246):66103-24. PubMed PMID:30596410.

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Supplementary:

Brandolini's Law is well illustrated by the tactics used by antipsychiatrists in any public forum. In an ideal world the FDA document would be the definitive word on ECT.  I am not that optimistic but encourage people to bookmark this place in the Federal Register and refer to it if you see heated debates about ECT, especially where it is being portrayed as being toxic and/or ineffective.

Anti-ECT Rhetoric ........

There is probably no clearer example of the pernicious effect of rhetoric in psychiatry than what has happened with electroconvulsive therapy or ECT.  ECT has a demonstrated therapeutic and life saving effect for decades and yet it is a flashpoint for antipsychiatry groups.  I had the experience of being attacked for pointing this out and the people attacking me posted references from a book that was published in 1980 and it was debunked at the time of publication in a book report in the New England Journal of Medicine.  Ignoring what the facts are - often for decades is one of the rhetorical techniques. Interestingly that technique was pointed out in the book report.

There is no doubt that ECT is a very safe and effective treatment. The onset of action is also much faster than can be expected from medications of psychotherapy. But the most important aspect of the ECT recommendation is way it is recommended by clinical psychiatrists.  It is not recommended for everyone just because it is highly effective.  Clinical psychiatrists recommend ECT for treatment resistant depression. By definition, that means various treatment modalities have been tried and found to be ineffective.   That may have included many antidepressant trials. It is often forgotten these days that psychiatrists are seeing patients who have been treated for decades with antidepressants.  I often see people who have been taking the same antidepressant with dose modifications for 10-15 years or people who have been taking 5-9 different antidepressants over the same period of time.  Those antidepressants have been prescribed by various non-psychiatrists.  The majority of these patients have also seen psychotherapists and list the acronyms (CBT, DBT, IPT, ACT, REBT, etc) and specifics about the therapy. They are also clear that they were not helped by psychotherapy.

The process of being stuck in that situation by itself can lead to increasing hopelessness associated with the thought: "Am I always going to be depressed? Is there anything that can be done to get rid of this depression. Would it be better for myself and anyone else if I was just dead rather than hanging on like this?" In the case of more dangerous forms of depression, delusional thinking presents a greater level of danger in the form of suicide attempts and completions.  One of the ironies of depression is that the public perceives it as a minor condition that is easily treated.  That ignores the fact that most people that die from suicide are depressed.  Severe depression is a lethal condition and not a minor one. Ignoring severe depression and not treating it is an option only by denying that it exists.

A second group of people who need ECT as a life saving treatment are people with catatonia.  Catatonia is a potentially lethal condition that develops in association with other severe mental conditions - especially mood disorders.  Malignant or delirious catatonia had an extremely high mortality rate (80%) prior to use of ECT.  Death from catatonia typically occurred from severe food and water refusal, agitation leading to congestive heart failure, injuries from severe agitation, and in some cases autonomic dysregulation often seen as elevated body temperature with no evidence of infection.  This group of patients is hospitalized and cannot function outside of a hospital setting. Even inside a hospital they need very intensive monitoring to protect them from injury.  The fastest way to treat these patients, keep them safe, and help them to get out of the hospital is ECT.  In fact, it may be the only consistently effective therapy.   

People with severe medical problems who cannot tolerate antidepressant or antipsychotic medical constitute another group who can benefit immensely from ECT.  In many cases these patients are disabled by depression and do not appear to be recovering form their associated medical illness.  They may be in a coronary care unit and taking in inadequate amounts of food and fluids due to depression.  At the same time they may not be able to take medications due to an acute cardiac condition.   They can generally be safely treated with ECT.

A final important group of people are those with experience with ECT.  They typically have a form of disabling depression, know that most of the usual medications either do not work or cause unacceptable side effects.  They are also typically very functional people and know that they need to get back to work as soon as possible.  They request elective ECT for treatment.

Why should anyone want to deny ECT to people in the above groups when it is safe and effective?  Here is some of the rhetoric evident in any Internet discussion. 


1.  I don't like it and will never accept it!

You don't have to.  First it is only indicated for a limited number of severe conditions like treatment resistant depression, depression, catatonia, treatment refractory mania, psychosis, and high suicide risk. If you don't have any of those conditions no psychiatrist is going to recommend it to you.  But further - even if you have the conditions a psychiatrist may not recommend it because it is not available in the area.  Political rhetoric may have driven it out.  Other less effective treatments like ketamine infusions and transcranial magnetic stimulation (rTMS) may be recommended instead.

The second issue is informed consent.  You can decide you don't want it. Story over at that point.  I have no interest in talking anyone into it.  My job is to provide the latest information and the patient decides and consents or does not consent. 

2.  ECT causes brain damage!

Irrelevant based on the informed consent issue outlined above unless you are trying to make a political argument.  But more striking is the body of evidence that has accumulated that there is no evidence at all that ECT alters brain anatomy or leads to neuropathological changes. Denial or lack of scholarship are the most likely explanations of this problem.  Given the ease with which medical information can be accessed these days and the fact that many people making these arguments use antiquated and disproved data while ignoring the contradictory positive data - denial or intentional distortion of the data are the only obvious motives.

3.  There are important political and ethical considerations!  

Are there really?  Not when you look at the severity of the problem. Considering psychiatric illness and disease on par with other physical illnesses is difficult if you have never seen what happens on an acute care psychiatric setting where the most serious problems in psychiatry are treated.  In the current American healthcare system these patients are often committed and in some cases transferred to state hospitals if they do not get well.  In some cases, states have found it easier to close hospitals so that these extremely ill people are sent back to their families, to jail, or to the streets.  I routinely see patients who have had a severe psychiatric illness and were ill and unstable for decades.  In many cases they are chronically ill and never regain stability because of neglect or inability to treat them. All of those years of suffering and in many cases death could have been avoided with proper treatment early in the course. In many cases the proper treatment was ECT.

How does that compare with the rest of medicine? It does not. People with life threatening and/or disabling conditions are allowed access to high risk treatment options. A few examples can illustrate this point.  Cancer is a good example.  Chemotherapy agents are high risk medications that can lead to serious and in some cases lethal side effects. Giving informed consent for treatment with chemotherapy requires agreeing to accept the risk of congestive heart failure and many other serious and potential lethal side effects from those agents. The explosion of immunotherapy agents for autoimmune disorders provides similar risk.  Even more importantly, every patient consenting to the treatment are considered to be competent consentors.  In other words they are  considered able to understand the information, make rational decisions about it, and provide consent on that rational basis.  Patients consenting to ECT may not be competent cosentors based on vulnerability laws in states.  Consent is not considered to be competent necessarily based on status (on an inpatient psychiatric unit or outpatient clinic) or by specific statutes about diagnoses or recent behavior.  Those same rules do not apply to people giving consent for high risk medical or surgical treatments.  Keep in mind that ECT is portrayed as a high risk procedure - but in reality it is not.

4.  What about involuntary treatment with ECT?   

Some states have statutes that allow courts to decide on whether or not people who are civilly committed and have high risk psychiatric illness.  That is typically based on a hearing with opposing attorneys and a judge.  Unique state statutes provide the standards that must be met in those hearings.  The court typically hires examiners (psychologists, psychiatrists) to testify about diagnosis and recommendations.  Since ECT is a medical procedure psychiatrists may be required to examine the patient and testify about the recommendation.  These hearing may also be used because the patient is not competent to consent, but clinical competency is not a formal legal decision until it has been made by a court.  In these cases the state has an interest in preventing death and disability of its citizens. 

I have thought a long time about getting rid of involuntary treatment with ECT but how would that work?  The psychiatrist would be in a position that would be difficult to defend from a clinical standpoint.  Anyone with a severe disorder not responding to standard treatment needs to hear about ECT as an option.  Their treating psychiatrist needs to make sure that happens and that the discussion is documented as well as the patient's response. If involuntary treatment was not an option for severely ill people who were unable to consent, they would basically be maintained in a chronically disabled, high risk, or worsening course of illness. I don't think that is a decision that a psychiatrist can make because it is essentially one with a dubious basis.  At that level court intervention makes sense.

5.  What can be done to address ECT side effects if I get them?

First, like all medical procedures make sure the ECT is provided by an expert, working with an anesthesiologist who is used to providing general anesthesia for ECT.  Second, that expert needs to assess the results and side effects of those treatments on a treatment to treatment basis.  Modifications in techniques and side effect prevention need to occur on a regular basis if side effects are there.  In the case of voluntary ECT and significant side effects, stopping the treatment at any time is an option for the patient. In the case of involuntary treatment or substituted consent by a court involved family members or the patient can advocate for the same discontinuation.  The attending psychiatrist can also initiate discontinuing the treatment at any time based on side effects.

The perplexing issue is the number of people who write about numerous ECT side effects and that they have had a course of many treatments.  I ask myself, how does that happen?  Have they been told that they will get used to side effects?  Were the side effects ignored?  What happened?  Why didn't they just decide to stop? In those cases, the first step should always be to discuss the issues with the attending psychiatrist and psychiatrist performing the ECT.  If that is not effective, every state in the United States has multiple forums for investigation.  In the state of Minnesota, there is an Ombudsman for Mental Health and the Board of Medical Practice. Both of these agencies will exhaustively investigate any complaint brought to their attention. People are encouraged to complain about physicians and a national watchdog agency monitors how many complaints are made in each state and holds states with low complaint rates in a negative light.

More problematic is the political approach to ECT and how it has affected policy and has the potential to decrease the availability of this modality for very ill patients.  A recent editorial review pointed out how the process in the UK was factored into NICE guidelines that were restrictive and that those guidelines may adversely affect ECT practice in the US (1).  The restrictive nature of the NICE guidelines was apparently based in part on a flawed study suggesting more dissatisfaction and memory loss than expected.  A re-analysis of that data (3) describes the nature of those flaws that include in part:

"Two other studies selected individuals from user/advocacy groups generally biased against ECT and were probably overlapping. The significance of memory problems was not mentioned in any of the studies."

It is interesting that it took 9 years to reassess the original data and come to that conclusion and in the meantime it apparently was enough to alter ECT policy in the UK.

No other medical specialty allows political biases to affect practice standards, especially when it compromises the care of severely and potentially fatally ill patients. 

There is no reason why psychiatry should either.
 

George Dawson, MD, DFAPA 


 References:

1: McDonald WM, Weiner RD, Fochtmann LJ, McCall WV. The FDA and ECT. J ECT. 2016 Jun;32(2):75-7. doi: 10.1097/YCT.0000000000000326. PubMed PMID: 27191123

2: Rose D, Fleischmann P, Wykes T, Leese M, Bindman J. Patients' perspectives on electroconvulsive therapy: systematic review. BMJ. 2003 Jun 21;326(7403):1363. Review. PubMed PMID: 12816822.

3: Bergsholm P. Patients' perspectives on electroconvulsive therapy: a reevaluation of the review by Rose et al on memory loss after electroconvulsive therapy. J ECT. 2012 Mar;28(1):27-30. doi: 10.1097/YCT.0b013e31822d796c. Review. PubMed PMID: 22343578.

4:  FDA (Proposed Rule for reclassifying ECT devices):  Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses AGENCY: Food and Drug Administration, HHS. ACTION: Proposed order.

 https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf

5:  Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff.  

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM478942.pdf