Excerpted from CCHR’s submission to the FDA opposing its 2015 proposal to reclassify the ECT device as a Class II low risk device. CCHR’s submission was submitted in March 2016.
The U.S. Food and Drug Administration (FDA) undermines the scores of studies and patient testimonies that indicate ECT causes brain damage. Dr. Lawrence Park, the FDA Medical Officer, who wrote the Executive Summary on ECT for the FDA [in 2010] is a psychiatrist who has co-authored numerous studies on ECT.[1] Before he joined the FDA, he served as the Director of Research and Attending Psychiatrist for the Somatic Therapies Unit at Massachusetts General Hospital, where ECT is administered. Its website states ECT does not cause brain damage and is a safe and relatively comfortable experience—contrary to thousands of ECT “consumers” who presented comments to the FDA stating the opposite.[2] The National Institute of Mental Health (NIMH) lists ECT as a “brain stimulation therapy” in the same category as Deep Brain Stimulation and Vagus Nerve Stimulation. Dr. Park has participated in research for Cyberonics (maker of Vagus Nerve Stimulator) and Medtronic (manufacturer of the Deep Brain Stimulation device).[3]
The 2011 Neurological Devices Panel of the Medical Devices Advisory Committee Chairman, Dr. Matthew Brott, a neurologist, commented on the lack of any valid study using modern methodology/technology that substantiates one way or the other the brain damage ECT causes.
Of the biological markers cited as evidence that brain damage didn’t exist, he said, “None of them have been shown to be reliable. All of them have been shown to be unreliable. That’s why they’re not used in the hospital down the block or anywhere in the country to measure brain injury.
“We also have MRI scans that we use…we also have the EEG that’s going in the device, and with 100,000 people a year, as a neurologist, I’m asking, how many people have had MRIs to look at the structure of the brain? How many people have had serial EEGs to look at potential changes in the EEG? And how many people have had neuropathological examinations, which would be appropriate to judge whether or not this device impacts the structure of the brain? And I tried to look and I saw very little, and I concluded that the evidence is not there to really address the question either way….” [pp. 221-22, 28 Jan. 2011 hearing]
How then can the FDA conclusively believe that ECT does not cause brain damage?
Most neurologists regard it as self-evident that epileptic seizures cause brain damage and that all injury to an intact brain is harmful.[4] Fred Baughman, MD, an eminent neurologist, says: “Throughout the more than three decades of my neurological practice I have encountered patients treated with ECT who had permanent erasures of parts of their memory. Think of the extent of memory loss not immediately evident in these and in all patients. For their own selfish reasons, psychiatrists may wish to call ECT and such end-results ‘therapeutic’ but they never achieve anything but to diminish adaptability in the broadest sense and cannot be called ‘therapeutic or medically justifiable.”[5]
John Read and Richard Bentall in their literature review on “The effectiveness of electroconvulsive therapy,” concluded: “Given the strong evidence…of persistent and, for some, permanent brain dysfunction, primarily evidenced in the form of retrograde and anterograde amnesia, and the evidence of a slight but significant increased risk of death, the cost-benefit analysis for ECT is so poor that its use cannot be scientifically justified.”[6]
The FDA relies in part upon the American Psychiatric Association (APA) Task Force report, “Practice of Electroconvulsive Therapy,” 2001, which recommends “brain damage should not be included in the ECT consent form as a potential risk of treatment.”[7] The conflicts of interest behind such a recommendation can be seen in the 2001 APA ECT Task Force which was headed by Dr. Richard Weiner (a MECTA [ECT device manufacturer] consultant, who developed ECT devices for the company) and members, Harold Sackeim, Ph.D. (consultant to MECTA/SOMATICS [another ECT device manufacturer]) and Dr. Charles Kellner (consultant to MECTA/SOMATICS). Doctors Weiner and Kellner were also members of the 2010 APA ECT Task Force.
Dr. Kellner has also organized a training course on ECT that was sponsored in part by SOMATICS Inc. and MECTA.[8]
Nor do the ECT device makers respond to any concerns about brain damage. In 2004, under deposition from attorney Rick Moxon, MECTA owner and president, Robin Nicol provided revelatory information and exemplifies why the FDA should not rely upon evidence from psychiatrists with conflicts of interest with MECTA. According to Nicol:
- The company “does not do research.”[9]
- She made a decision to “disregard what it characterized as the minority view of ECT, the minority view being that it causes brain damage and causes memory loss.”
- When asked about whether MECTA had spoken with patient groups whose members had been gravely harmed by ECT, Ms. Nichol said she relied on “literature that supports our products, that it is a safe and effective treatment,” so “there’s nothing to be gained.”
- She admitted that if she had “information that [MECTA’s] devices were not safe, it would not be considered unless the information came from double-blind studies.”
- “We are not responsible for individual patients….They are not our responsibility from the FDA perspective or from our perspective as medical-device manufacturers.”
- MECTA could not provide evidence of how ECT works, except that their machines are designed to cause a grand mal seizure and, beyond that, the mechanism is entirely theoretical.
- More electricity is used by MECTA machines than is necessary to cause a grand mal seizure, because, “The patients were not getting better.”
- When asked, “Do you know what the point is of sending electricity through the brain if it’s not just to cause a convulsion?” she answered, “No.”
- Although the company was well aware of its responsibility to provide the FDA of all adverse events, the company had only done so ONCE in the 25 years she had run the company.
ECT Causes Harm
The FDA evaluated the risks of the devices but didn’t consider that serious adverse effects outweigh the benefit and there are no clinical trials proving safety. FDA undermines the severity of the adverse effects patients complain of.
Dr. Anna Georgiopoulos, Psychiatric Medical Officer at the Center for Devices and Radiological Health, Office of Device Evaluation, Division of Ophthalmic, Neurological and ENT Devices reported the FDA’s MAUDE database reports:
- As of December 7, 2010, the MAUDE database included “burns, neurological complications, ineffective treatment, brain damage, sleep disturbance, visual change…cardiac problems, stroke, improper consent, death, one instance of which occurred within two months of ECT, auditory complaints, dental or oral trauma, hypertension, hypotension, suicide with one completed suicide and one attempt…and a pulmonary complication.”
From this review of side effects, it was determined that the following were the most significant potential risks of ECT:
- Cognitive and memory dysfunction.
- Neuropathological changes or brain damage, and death. The basis of this determination was made with the following criteria: the frequency of reports from all sources of information, the estimated frequency of occurrence from literature reports, and the potential severity.[10] [Emphasis added]
However, despite the risks and in the reasoning for reclassifying the device, the FDA Proposal relies on a lot of “belief” that there’s “probable” safety, not irrefutable clinical data and irrefutable fact. For example:
- “FDA believes that ECT devices …should be reclassified from Class III to class II because, in light of new information about the effectiveness of these devices, special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness of the device, and because general controls themselves are insufficient to provide reasonable assurance of its safety and effectiveness.”
- “FDA believes that in the specified patient population, and with the application of general and special controls…the probable benefit to health…outweighs the probable injury or illness from such use.”
- FDA acknowledges significant risks associated with ECT but believes that…the probable benefit of ECT outweighs these risks. [11]
FDA underplays the risks, claiming, “Death associated with ECT appears to occur at a very low rate,” “cognitive and memory impairment” is “transient” and “there is no evidence that disorientation following ECT is long-term or persistent.” Further, “The literature review suggests that anterograde memory declines immediately post-ECT and then returns to baseline within 3 months post-ECT.”[12] [Emphasis added]
The FDA has relied, in part, on the neurological device advisory committee panel hearing held in January 2011, but is ignoring their concerns. [13] Many of the panel members voiced concerns about the lack of data about long-term effects of ECT, particularly with regard to memory loss and cognitive function. The FDA has included “treatment-resistant bipolar” as one of the indications for the ECT Device to be Class II, yet the majority of the panel members were against bipolar mania being an indication(12 vs 5).[14] Electricity applied to the brain and body cannot discern what is “treatment-resistant” bipolar as opposed to a manic phase or, indeed, bipolar generally or any other “disorder.” Any more than two people sticking their fingers in an electric light socket while standing in water could harm or kill one person but not the other.
Whether you mask ECT with anesthetic and muscle relaxants or add controls in an attempt to mitigate the risks, it doesn’t change the fact that it is not a proven safe and effective treatment and workability has not been established.
References:
[1] “Lawrence T. Park, MD,” Advisory Board, Mass. General Hospital, http://www2.massgeneral.org/allpsych/ced2/clinicians/park.html.
[2] “Somatotherapies Unit (ECT),” Mass. General Hosptial, http://www2.massgeneral.org/allpsych/PsychNeuro/ect.asp.
[3] Jennifer M. Park, et al., “Factors Associated with Extended Length of Stay for Patients Presenting to an Urban Psychiatric Emergency Service: A Case-Control Study,” Journal of Behavioral Health Services & Research, July 2009.
[4] Thomas Szasz, M.D., Coercion as Cure: A Critical History of Psychiatry,(Transaction Publications, 2010) p. 135, https://books.google.com/books?id=hYdLS6qyTwUC&pg=PA135&lpg=PA135&dq=%22The+association+for+convulsive+therapy%22+was+formed+in&source=bl&ots=rZXckU2m7I&sig=CGQukDAAWkHmVCY_uG-Nf6OqHWU&hl=en&sa=X&ved=0ahUKEwiTm7DM38PLAhVW6WMKHaIiAro4ChDoAQhCMAk#v=onepage&q=%22The%20association%20for%20convulsive%20therapy%22%20was%20formed%20in&f=false.
[5] http://behaviorismandmentalhealth.com/2013/03/27/shock-treatment-is-not-safe-and-provides-little-if-any-benefit/.
[6] Ibid.
[7] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM247594.pdf.%20Accessed%20December%203, 1/27/11, pp. 143-144.
[8] American Psychiatric Association, The Practice of Electroconvulsive Therapy Recommendations for Treatment, Training, and Privileging (A Task Force Report of the American Psychiatric Association), Second Ed (Washington, D.C.: American Psychiatric Association, 2001).
[9] Deposition from civil case Atze Akkerman vs MECTA, cited in submission to the FDA, 6 Jan. 2010.
[10] Op Cit., FDA Neurological Devices Panel of the Medical Devices Advisory Committee, 27 Jan. 2011, pp. 148-49.
[11] “Proposed Rule” dated 29 December 2015, Docket ID: FDA-2014-N-1210-000, under “Summary of Reasons for Reclassification.” http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-1210-0001.
[12] Ibid.
[13] http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-1210-0001.
[14] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM247595.pdf.%20Accessed%20December%203.