Letter Regarding Appropriate Classification of Electroconvulsive Therapy (ECT) Devices
February 24, 2011
Jeffrey E. Shuren, M.D., J.D.
Director, Center for Devices and Radiologic Health
Food and Drug Administration
Department of Health and Human Services
WO 66, Room 5442
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Dr. Shuren,
These comments from the Public Citizen Health Research Group are being submitted in response to the deliberations of the Food and Drug Administration’s (FDA’s) Neurological Devices Panel (NDP) of the Medical Devices Advisory Committee on January 27-28, 2011 regarding the appropriate classification of electroconvulsive therapy (ECT) devices, which have been estimated to be used in the treatment of approximately 100,000 patients per year in the United States., 
(1) We strongly urge FDA to maintain the classification of ECT devices as class III given the serious risks that these devices present.
(2) FDA should require that—within a reasonable but specified time frame—rigorous, ethically justifiable clinical trials be conducted to evaluate the safety and effectiveness of ECT devices for their current indications for use, and that data from such trials be submitted to FDA for review and evaluation under a Premarket Approval Application (PMA). Further premarket studies, both pre-clinical (bench, animal) and clinical, also should be required for any significant changes in ECT device technology or proposed new indications for use.
ECT has many well-documented serious risks including adverse effects related to anesthetic agents and neuromuscular blocking agents, acute hypertension, cardiac arrhythmias, cardiac ischemia, stroke, prolonged seizures (including status epilepticus), pulmonary complications (including aspiration), skin burns, dental/oral trauma, memory deficits, and death. Therefore, treatment with ECT devices indisputably involves very high risk, and the only appropriate classification of such devices is class III.
Furthermore, it is imperative that there be sufficient data from rigorously conducted clinical trials demonstrating clinically significant long-term effectiveness of ECT in order to justify exposing patients to the serious risks of ECT devices. In summarizing the data currently available in published systemic reviews, meta-analyses, and practice guidelines for various uses of ECT, FDA noted the following:
(1) For depressive illness:
- “Evidence for the effectiveness of ECT exists only for acute effect (immediately post-ECT course to one month).”
- “Little evidence exists supporting the long-term effectiveness of ECT.”
(2) For schizophrenia:
- “Evidence for the effectiveness of ECT for schizophrenia exists only for acute effects; there is no evidence of effectiveness beyond the acute phase.”
- “There is conflicting evidence that ECT may be more effective than antipsychotic medication for acute episode (for certain types).”
- “There is no evidence that ECT demonstrates effectiveness in other than the acute setting.”
(3) For bipolar mania and bipolar mixed states:
- “There is limited evidence that ECT may be effective in treating mania.”
- “There is limited evidence that ECT may be an effective, and potentially underutilized treatment of mixed states.”
(4) For schizoaffective disorder:
- “There is no evidence that ECT is effective for schizoaffective disorder at any time point.”
FDA conducted its own review and meta-analysis of the published randomized clinical trials studying the effectiveness of ECT. This analysis revealed the following:
(1) For depression:
- “In terms of immediate post-ECT effects, there is sufficient evidence to conclude that ECT may be more effective than sham. At one month or longer, there is no evidence that ECT is superior to sham.”
- For ECT versus placebo, “[i]mmediately post-ECT, there is conclusive evidence to show that ECT is more effective than placebo. At six months post-ECT (long-term), one study demonstrated that ECT was more effective than placebo. Meta-analysis could not be conducted for this comparison.”
- “Immediately to one month post-ECT, there is conflicting evidence that ECT is more effective than antidepressant medication. At greater than one month post-ECT, there is conclusive evidence that ECT is more effective than antidepressant medication. A meta-analysis (random effects model) comparing ECT vs. antidepressant medications demonstrates that the mean improvement in HDRS for subjects treated with ECT was about 5.0 points (95% CI: 0.8, 9.1) greater than for those treated with some form of antidepressant therapy. A fixed-effects model was also considered, and the effect of ECT was estimated to be 5.1 (95% CI: 2.7, 7.6) points greater than antidepressant.”
(2) For schizophrenia:
- “In ECT vs. sham comparisons, the effectiveness of ECT and sham were not found to be significantly different. In ECT vs. sham augmentation of antipsychotic medication treatment, there is conclusive evidence that out to six months post-ECT, there was no significant difference between groups.”
(3) For mania:
- “One study employed an ECT vs. sham design for the treatment of acute mania. This study demonstrated that ECT was significantly better than sham immediately post-ECT. Another study demonstrated that ECT was as effective as lithium in the treatment of mania immediately post-ECT.”
FDA was unable to identify any randomized controlled trials for catatonia, schizoaffective disorder, or schizophreniform disorder.
In light of the risks of ECT and the limited, conflicting data regarding its effectiveness for most of its clinical uses, a majority of the NDP members favored maintaining ECT devices as class III devices for all indications except catatonia. We endorse the positions taken by the majority of the NDP members, except for their position regarding classifying ECT devices as class II for catatonia.
In summary, in order to protect the health and welfare of patients, ECT devices should remain classified as class III, and FDA should require that rigorous, ethically justifiable clinical trials be conducted to evaluate the safety and effectiveness of ECT devices, and that data from such trials be submitted to FDA for review and evaluation under a PMA. Further premarket studies, both pre-clinical (bench, animal) and clinical, also should be required for any significant changes in ECT device technology or proposed new indications for use.
In closing, we recognize that FDA needs to take a reasonable amount of time to issue a notice of proposed rulemaking (NPRM) in the Federal Register describing the requirements for PMA applications for ECT devices and soliciting public comments, to review comments submitted in response to the NPRM, and to issue a final rule. We urge that the NPRM be issued by July 2011 and that the remaining steps be effected as quickly as possible thereafter in order to minimize the risks and maximize the benefit/risk ratio for patients exposed to ECT.
Michael A. Carome, M.D.
Sidney M. Wolfe, M.D.
Health Research Group
cc: Dr. Margaret A. Hamburg, Commissioner, FDA
Dr. William Maisel, Deputy Director for Science and Chief Scientist, Center for Devices and Radiological Health, FDA
Dr. Malvina Eydelman, Director, Division of Ophthalmic, Neurological, and ENT Devices, Office of Device Evaluation, Center for Devices and Radiological Health, FDA
 Hermann RC, Dorwart RA, Hoover CW, Brody J. Variation in ECT use in the United States. Am J Psychiatry 1995;152(6):869-75.
 Payne NA, Prudic J. Electroconvulsive therapy: part I. A perspective on the evolution and current practice of ECT. J Psychiatr Pract. 2009;15(5):346-368,