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.