Director, Office of the Executive Secretariat
US Food & Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-mail: [email protected]
28 December 2021
Dear Director Kotler,
I write to appeal your denial of request number: 2020-7319 for the expedited processing of the Electronic Freedom of Information Act request submitted on 9 October 2020. I received your denial October 27, 2020 and have 90 days to appeal your decision. Please note my appeal is an open letter with 97 citations co-signed by 14 Professional and Paraprofessional organizations, 168 Americans, and 49 international citizens whose countries base their guidelines in part on the FDA’s decisions. Signatories included up to eight words to describe their perspective on “Real-World Data” and “Real-World Evidence” regarding electroconvulsive therapy’s (ECT) post-market safety, adverse events and regulatory decisions.
Here is our appeal:
FOI #2020-7319 requested the following:
• ECT manufacturers’ premarket approval applications (PMA) for all uses not presently classified as class II (i.e., schizoaffective disorder, parkinsonism, dementia, bipolar manic state, OCD, autism, etc)
• Notices of completed product development protocols (PDP) submitted to the FDA before March 27, 2019 for any electroconvulsive therapy device with an intended “use to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition” (21CFR882.5940).
As you stated in your email, “The Electronic Freedom of Information Act (EFOIA) Amendments of 1996 amended the FOIA by adding section (a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to consider requests for expedited processing and grant them whenever a “compelling need” is shown and in other cases as determined by the agency. The term “compelling need” is defined as (1) involving “an imminent threat to the life or physical safety of an individual,” or (2) in the case of a request made by “a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal Government activity.””
Imminent threat to the life or physical safety for ECT recipients
The following imminent threats to life or physical safety of people receiving electroconvulsive therapy (ECT) are based on published research which follows guidelines established by the American Psychiatric Association’s “The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and
FOI #2020-7319 1
Privileging,” and the medical device user’s manuals and regulatory updates for the Thymatron and MECTA ECT devices presently used in in community settings1–4:
• All-cause mortality during ECT treatment is 0.42 [0.11 – 1.52] deaths per 1,000 patients. 29% of ECT deaths are Cardiac related.”5
• “Major adverse cardiac events (MACE) and death after ECT … occur in about one in 50 patients and after about one in 200 – 500 ECT treatments. (MACE is defined as “myocardial infarction, arrhythmia, pulmonary edema, pulmonary embolism, acute heart failure, and cardiac arrest.”)5
• People receiving ECT are 4.8 times more likely to complete suicide within first week after discharge.6
• ECT’s “severe stress-exposure or trauma”7causes pervasive microstructural damages (petechial hemorrhaging, gliosis, astrocytosis, myelin sheath damage, cerebrovascular vascular) most concentrated in the current’s path 2,8–15, increased immunoreactivity16–19, metabolic abnormalities18,20–25 including acquired channelopathies26–34, and loss of astrocytes effects tight junctions of the blood-brain-barrier integrity increasing potential for neurodegenerative disorders35. These microstructural damages, only visible in neuropathological animal and human studies, identify injuries throughout the brain consistent with electrical injury from sources of electricity other than ECT all of which have long-lasting neurological consequences.27,28,31,36–65
• Though microstructural damage occurs through the entire brain, the brain stem and anterior of the frontal lobes carries the brunt of up to 450 volts, 900 mA current, 576 mC Charge (1200 mC in the UK) electricity because it is the focal point of the electrical path.1,2,10
• Electroconvulsive therapy is not a singular event. Index courses are 8-12 treatments, typically given three times a week. Like all repetitive brain injuries, the greater the amount of time between insults, the fewer cognitive and neurological side effects. Acute treatment calls for ECT to be given as often as three times a week—and if a seizure doesn’t last at least 25 seconds, the APA recommends repeating the procedure at a higher electrical dose within moments of the first attempt.3“Maintenance ECT” is recommended when patients relapse. There are is are no PMA or PDP on record to establish safety limits on “maintenance ECT,” Research demonstrates that spacing treatments at least 38.6 days apart will avoid a “cumulative effect.” 66 Some psychiatrists give patients repeat, back-to-back “index courses” as evident by the woman in Connecticut with an active court case to end her ECT treatments after having received more than 500 in five years—which “likely happens more often than people realize.”67
• ECT’s “Therapeutic effect” is caused by a temporary Postictal Suppression or “electrical silence,” the absence of brain activity. (a sign of severe damage and impending brain death) by forcing 2.5-6 times the body’s seizure threshold worth of electricity through the brain. Electrical silence is documented to last up to more than six minutes in some patients given ECT at levels above the threshold. When/if spontaneously resolved, brain activity slowly resumes in bursts of sporadic coma (delta) waves until “silence” is completely replaced with delta waves and the patient later awakes from coma activity.1,2,68–73“The process always damages the brain, resulting each time in a temporary coma and often a flatlining of the brain waves, which is a sign of impending brain death. 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.”74
FOI #2020-7319 2
• 55% of ECT recipients self-reported negative effects on memory. Tests which accurately capture the extent and type of memory loss and cognitive deficits reported by patients, are not routinely used on every ECT patient, though FDA guidelines recommend it. Consequently, ECT patients are rarely, referred for timely, comprehensive brain injury assessment or rehabilitation.
• The more ECT Treatments a patient has, the greater the likelihood they will suffer seizure, respiratory distress, syncope, paralysis, dizziness, Loss of consciousness and/or death with the introduction of lidocaine during subsequent, unrelated medical and dental procedures. 30,75
Manufacturer & APA recognized risks of “Permanent Memory Loss and Permanent Brain Damage”
Brain damage is defined by the American Heritage Medical Dictionary as “the physically subtle, but functionally serious, injury … [including] repeated multiple small hemorrhages sustained in boxing. Brain damage often affects the areas of higher function in a patchy way with loss of certain functions and retention of others. … A proportion of brain-damaged people end up in a state of almost complete loss of the higher mental functions (amentia).76 The American Psychiatric Association [and Somatics, LLC (Thymatron ECT device manufacturer) recognizes [seven] treatment parameters are each independently associated with more intense cognitive side effects … [including] permanent memory loss or permanent brain damage.”2,3 (Patients can potentially be subjected to more than one risk at a time with each treatment.)
How many people receive ECT yearly?
In 2004, Dr. Harold Sackeim, America’s leading researcher on ECT use in clinical settings, testified in court deposition that an estimated two million people receive ECT yearly worldwide.77 American ECT use has never been routinely audited nationwide to confirm how many Americans receive ECT, how many treatments each patient receives, how closely spaces treatments are, and what form of ECT they receive.78 Yet modern media routinely quotes an arbitrary 1970’s statistic that estimated 100,000 Americans receive ECT yearly. Since the beginning of ECT use in the United States, no one has conducted a nationwide audit to confirm or refute that estimate.
Since the 2018 reclassification of ECT as a Class II device for treatment resistant depression and catatonia in children (13+ years old) and adults, the 2020 Substance Abuse and Mental Health Services Administration’s National Directory of Mental Health Treatment Facilities shows a 34% increase in the number of facilities providing ECT across the nation when compared to the 2018 directory.79,80
ECT and death
Deaths of ECT patients are rarely acknowledged publicly, investigated, or properly addressed to ensure future patient safety.
For example, on 21 February 2020, an outpatient ECT recipient and resident of Stepping Stones for Living “received electroconvulsive therapy from a specialized clinic and was told to expect to be groggy and sleepy. Upon returning to [Stepping Stones for Living], the person went to bed and never left it, and was declared dead almost 24 hours later.81 Autopsy report given to newspaper reporter by family, stated medical examiner, Dr. A. Quinn Strobl, determined “Sudden Cardiac Death in Schizophrenia” as cause of death (Slater, B. personal communication, June 17, 2020). Though patient safety violations are now acknowledged by investigation, “due to the unprecedented public health challenges during Minnesota’s peacetime state of emergency due to the COVID-19 pandemic, a correction order will not be issued.”82
FOI #2020-7319 3
Aging after ECT
“A single mild traumatic brain injury (mTBI) typically causes only transient symptoms, but repeated mTBI (RmTBI) is associated with cumulative and chronic neurological abnormalities.” In addition to all ECT recipients who died in all-cause mortality from ECT this year, every person with a history of ECT has increased morbidity proportionate to the number of treatments received, length of time between treatments, stimulus type, electrode placement, and whether they were taking psychiatric medication while undergoing treatment. The more ECT treatments a person has the more electricity must be used to cause a seizure because the body’s natural defenses strive to protect it from seizures. Elderly people require higher doses of electricity to cause seizures.3 Doctors break through the body’s defenses by using intravenous caffeine to push the body to the brink.85,86 There are no recognized safety limits or PDP for IV caffeine use with ECT. Augmenting ECT with caffeine causes neuronal loss in the hippocampus and striatum.87 Animal and human ECT neuropathology studies and research specific to high-field strength electrical contact with human cells document the following evidence for brain, nerve and muscular damage in animals and humans. Consider quality of life while aging with the following microstructural damages caused by ECT:
• “increased gliosis; diffuse degeneration; petechial hemorrhages in the brain stem with fat embolism; and more commonly edema and subarachnoid hemorrhage”10
• Reactive gliosis88
• Neuronophagia and shadow cells 14
• An “edematous brain” with neuronal damage and increased lipofuscin pigmentation.10 • Neuronal loss in the hippocampus and striatum87
• neurovascular insults8,9
• petechial and capillary hemorrhages1,2,8–10,12,13
• Frontal Lobe atrophy89
• Severe and irreversible injury to the nervous system16
• Astrocytosis and its resulting effects on the Blood-Brain Barrier (BBB) integrity and motor neuron function subsequent neurodegeneration.9,14,35,90
• Permanent changes in how the body regulates electrolytes (Acquired channelopathies).26–34 • Long-term sequelae of low-voltage electrical injury40–42,53,58
• Permanent EEG abnormalities after ECT73,89
• Changes in Evoked Potential testing19,48
• Doctor acknowledged and patient reported movement disorders and sleep disorders after ECT. 11,91,92
• Repeated ECT causes hyper immune reactivity 17,92
• ECT can potentially permanently change brain metabolism 16,18
• Non-dominant Unilateral ECT uses “six times the seizure threshold to achieve therapeutic effect means confining most damage to the nonverbal side of the brain, usually the right hemisphere. This exploits the well-known neurological phenomenon of anosognosia, or denial, that is associated with right-hemisphere lesions.” Patients cannot recognize something is wrong, nor can they express it. 1,15
FOI #2020-7319 4
How much electricity do doctors use to force a seizure compared to what is required?
ECT providers tell the public that treatment uses just enough electricity is used to cause a seizure. The APA and device manufacturers recognize “High electrical dosage relative to seizure threshold” as one of the seven independent risks associated with “permanent memory loss and permanent brain damage.”3,4 But MECTA instruction manual states “when an ultra-brief stimulus is used, the traditional bilateral (bifrontotemporal) placement has reduced efficacy even when dosage is set at 2.5 times the initial seizure threshold. At a traditional pulse width of 1.0 ms or more, right unilateral ECT has been shown to match the efficacy of bilateral ECT, when dosage is 6.0 times the initial threshold.”1Some doctors do not adjust for electrical output based on electrode placement, nor are they mandated to do so. Consequently, some patients receive bilateral ECT with six times the electricity required to cause a seizure. This likely causes extensive microstructural damage in their brain stem. Perhaps that’s why bilateral electrode placement is listed as one of the risks associated with permanent brain damage?
Unstandardized Medical Devices
Psychiatric facilities give patients ECT using a variety of ECT machines with varying electrical outputs. Not only does the output differ by manufacturer, the same manufacturers sell machines which produce vastly different electrical output depending on the country in which its sold. This renders doctors unable to apply the research conducted on one machine in one country, to the same manufacturer’s device sold in another country, nor can they apply outcomes to different ECT devices. None of the devices ever underwent the rigorous scrutiny of a premarket approval application (PMA) for safety testing using modern clinical parameters prior to use on humans. Devices were originally grandfathered into FDA approval when the FDA began giving approval because the devices were already in use. With the introduction of anesthesia, it requires more electricity to cause a seizure, so manufactures made new, stronger machines which also never underwent rigorous PMA testing.
Due to a lack of PMA, there are no universally recognized dosing protocols (Product Development Protocols (PDP)) to establish the limits of safe use in medical devices for people of varying ages or diagnoses. According to personal communication with Dr. Kenneth Castleman, retired NASA biomedical engineer and forensic expert, “On the Thymatron, the pulse width, pulse frequency, and output power can all be set independently … Doctors set the pulse width, pulse frequency, and output power (0 – 100%), and the device figures out the duration of the treatment.
The current is always 0.9 amp, and the voltage goes up to whatever is required to force 0.9 amp through the patient’s head. Some combinations of low frequency and narrow width can’t produce 100% output in 8 seconds and it will tell you to increase one or the other.”
Imagine having 900mA electricity flowing through the brain for up to eight seconds, repeatedly.
Consequences of using anecdotal evidence which cannot be replicated instead of Evidence-Based Medicine
Without safe PDP administration universally built into the standard of care for Electroconvulsive Therapy, every positive and negative research finding and patient experience is mere anecdotal evidence. More than seven independent administration variables make it impossible to replicate
FOI #2020-7319 5
outcomes universally in community settings. Sackeim et al inadvertently demonstrated how a lack of strictly regulated PDP impacted 347 patients living with depression who received ECT at seven facilities in the New York City metropolitan area. They concluded:
adverse cognitive effects were detected 6 months following the acute treatment course. Cognitive outcomes varied across treatment facilities and differences in ECT technique largely accounted for these differences. Sine wave stimulation and Bilateral electrode placement resulted in more severe and persistent deficits.95
The public believes that because Electroconvulsive therapy’s FDA approved, it met rigorous safety testing to establish safety limits using modern clinical parameters. It was not. They believe all ECT is created equal and that everyone who has it can reliably expect the “same safe and effective” results. They cannot. There is no specific product protocols for the devices’ special controls (technical parameters, waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring. Consequently, there is a vast outcome dichotomy ranging from symptom improvement to death.
Problem is, without routine comprehensive assessment which measures recognized severe effects in every single recipient, after every procedure and the tracking of neurological symptoms after treatment, there is an absence of published evidence specific to life after ECT. Doctors, hospitals, manufacturers and other proponents of ECT, state severe effects rarely happen. In reality, “the absence of evidence is not evidence of absence.”
Is memory loss the only side effect of ECT?
While 29-55% of ECT recipients state they have long-lasting or permanent memory problems, memory loss is but one aspect of negative outcomes associated with ECT. According to Somatics’ user manual for Thymatron System IV, other lasting severe effects include:
cardiac complications, brain injury, stroke, deficits in cognition and executive
functioning, dental/oral trauma, general motor dysfunction, physical trauma (including fractures, contusions, injury from falls, dental or oral injury), treatment emergent mania and postictal delirium, neurological symptoms (e.g., paresthesia, dyskinesias), tardive seizures; prolonged seizures; non-convulsive status epilepticus; pulmonary
complications (e.g., aspiration/inhalation of foreign material, pneumonia, hypoxia, respiratory obstruction (laryngospasm, pulmonary embolism, prolonged apnea); visual disturbance; auditory complications; onset/exacerbation of psychiatric symptoms; completed suicide; homicidality; substance abuse; coma; and death.2
Given the lengthy detailed severe effects outlined in the Thymatron User Manual, it appears they acknowledge their device is “an imminent threat to the life or physical safety of an individual.”
Pay attention to both the good and the bad ECT stories
While we acknowledge patients and doctors reporting mood improvement after ECT, we must also acknowledge “the lack of reports of movement disorders and dementia …. iatrogenic diseases generally go underreported.”11 For that reason, every patient experience, positive and negative must be taken into consideration when weighing eminent threat to life or physical safety. We must error on the side of
FOI #2020-7319 6
caution. It’s the patient and their family, not the doctor, who must endure treatments’ lasting negative effects for the duration of their life.
Medical Device’s Mechanism of Action
Contrary to CFR Section 882.5940 (E), medical device manufacturers must legally provide “Information on how the device operates and the typical course of treatment,” ECT device manufacturers have never provided “a description of the principle of operation or mechanism of action for achieving the intended effect” as directed by the 510(k) checklist (non-binding) stipulations for medical device information.
Patients receiving ECT and doctors providing it do not know the devices’ mechanism of action works. Consequently, in when severe adverse events occur, doctors are unprepared to provide routinely comprehensive neuropsychiatric, cardiopulmonary, optical, and auditory assessments to every patient receiving ECT. They have never studied the neuropathology of repetitive high field strength electricity to the brain with a focal point on the brainstem (in the case of bilateral treatment) and are simply at a loss as to how to provide follow-up care for the duration of a patient’s life after ECT.
This letter requests the expedited release of ECT’s PMA and PDP in an effort to “disseminate this information with urgency to inform the public” so that the public can understand how FDA approved ECT for human use is being conducted to reduce the life-altering risks of permanent brain damage and permanent memory loss. The public deserves to understand which safety testing has been conducted and what protocols are in place to ensure safety. The public also need to know what is being done to routinely assess for each of the severe effects outlined in user manuals and how patients will be cared for as they age after ECT’s repetitive brain injury.
If at this time, you do not feel we have provided sufficient information to adequately demonstrate “imminent threat to the life or physical safety” or the need to provide information to the public, please consider this FOI request in light of the devices having been grandfathered into use without PMA or PDP and the reclassification as a Class II devices for use on children 13 and older. This request is but an echo of your own office’s request in their final ruling of 1979. In which case, the request was first processed nearly 41 years ago.
Protecting children, adults and elderly adults protected as a marginalized demographic by the Americans with Disabilities Act should be a priority for the FDA. The continued use of unstandardized medical devices used in delivering ECT without product development protocols causes imminent danger to uncalculated number of American and international ECT patients whose countries rely on FDA data to develop safety standards.
Recently, the associate director of placebo studies at Harvard Medical School, Dr. Irving Kirsch co authored an analysis of all ECT’s randomized control trials (ECT vs Sham-ECT) with Dr. John Read (University East London) and Dr. Laura McGrath. Their recent publication peer-reviewed article entitled “Electroconvulsive Therapy for Depression: A Review of the Quality of ECT versus Sham ECT Trials and Meta-Analyses” concluded:
“The quality of most SECT–ECT studies is so poor that the meta-analyses were wrong to conclude anything about efficacy, either during or beyond the treatment period. There is no evidence that ECT is effective for its target demographic—older women, or its target diagnostic group—severely depressed people, or for suicidal people, people who
FOI #2020-7319 7
have unsuccessfully tried other treatments first, involuntary patients, or adolescents. 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”(italics added for emphasis).97
Below are the signatures of people who would like access to the PMA and PDP of a treatment which carries significant risks. I invited people to share their name, and up to eight words on how ECT impacted them, their families or people with whom they work who have a history of ECT. Since other countries look to the United States FDA as the gold standard upon which to base their own guidelines for ECT use, I included international signatories below those living in the United States. Research citations follow the signatories.
The significant risks detailed in this open letter is echoed in the graphic adjectives used to describe ECT’s after-effects by ECT recipients, family members or someone who cares for an ECT recipient or people who work ECT recipients. We look forward to receiving an expedited response to request number: 2020- 7319.
Respectfully,
Sarah Price Hancock, MS, CRC
Former Professor of Psychiatric Rehabilitation & ECT Recipient: Profound memory loss, general motor dysfunction, acquired channelopathies, BBB Dysfunction
Organizations-United States & International
Connecticut Legal Rights Project
Law Project for Psychiatric Rights
Disability Rights—Vermont, USA
National Association for Rights Protection and Advocacy
MindFreedom International
Mental Patients Liberation Alliance
MadFreedom, Inc.
Legal Guidance
Global Wellness Warriors
Ruh Global Impact
Hopeworx, Inc.
Progressive Voices
Consumers Health Freedom Coalition
OCSC
Signatories—United States
(A=ECT Recipient, B=Family member or someone I care for is an ECT recipient, C= Family or someone I care for may be an ECT recipient, D=Works with ECT recipient(s), E=May work with ECT recipient(s), F=No direct connection to ECT recipient(s), but value transparency in FDA safety testing & support releasing ECT’s PMA & PDP)
FOI #2020-7319 8
• David J Hancock (La Mesa, CA)B: Inhumane Human Torture with Ever Increasing Repercussions • John A Price (La Mesa, CA)B: insufficient informed consent on terrible long-term consequences • Janet Price (La Mesa, CA)B: not enough information to make a conformed consent • Klint Price (Aurora, IL)B, D: devastating disability and memory-loss
• Jeff Price (Powder Springs, GA)B, E
• Michelle Price (Powder Springs, GA)C: Life-altering, awful
• Amy S. Palmer (Oakton, VA)C: detrimental, life-altering effects every aspect of life • Dr. Kyle Kamran Jahangiri, DC (San Diego, CA) C, D: Sad, frustrating, excessive, a complex mess • Dr. John Humiston, MD (Carmel, IN)C, D: Serious lasting injury not seen in other patients • Alma Rosa Parker (La Mesa, CA)B: Challenges with everyday activities emotionally and physically • Margaret King (Hamburg, NY)A: Barbaric, torture, crippling, misinformed, frightful, sickening, dehumanizing, heartbreak
• Christina Delfino (Peekskill, NY)A: Misleading, Traumatic, Unprepared, Ill-Informed, Under Researched, Damaging
• Deborah Schwartzkopff (McMinnville, OR) A: battery, abuse, deceptive, malpractice, unethical, destructive & inhumane
• Dana Johnson (Winona)A, B: Horrific, unjust, damaging, harmful, abusive, isolating, violent, & hell • Heike Kessler-Heiberg, Acquired Brain Injury Rehabilitation Professional (San Diego, CA)D: Needing more protocol uniformity; significant memory impairment risk
• Allison Stiles (Downingtown, PA)B, D
• Caren L Sax (San Diego, CA)B,D: Horrific, life changing for the worst
• Colleen Whitley (Salt Lake City, UT) B
• Julie Plunkette (Paducah, KY) A: Not fully informed Torture terrifying damaging negative abusive • Colleen Murphy (Apalachin, NY) A,B: Causes irreparable brain damage that lasts forever • Jocelyn Pedersen (American, UT)B: Barbaric, inhumane, cruel, unethical, unconscionable, & horrific
• Amy Peltekian, CEO, Global Wellness Warriors (Escondido, CA)B: Horrific and life-changing not in a good way
• Amber DeRosear (Springfield, IL) A, B: Torture, Permanent memory loss, Traumatizing, Barbaric, brain damage
• Jason DeRosear (Springfield, IL) C: Took away her memory and cognitive thinking! • Sallie Snyder (Lincoln, CA) A: Horrifying, life-altering, damaging, devastating, worse than death • Lesley A Safer (Pigeon Forge, TN)A
• Samantha Moreno (Ypsilanti, MI) A: Brain Damage, Disability, devastating, permanent memory loss debilitating
• John Breeding, PhD (Austin, TX)B, D: horrific experience, terrible fear, and severe memory loss • April Ricks (Draper, UT)D: Delayed, Incalculable neurological damage, Unmeasured damage without oversight
• Makenna Bell (Addison, TX) B: Mom forgot who I was at 12 years.
• Amanda Wilson (Springfield, IL) B: Mom is not the same after ECT torture. • Kathy Flaherty, Executive Director, Connecticut Legal Rights Project (Newington, CT) A, D: Used as last resort because desperate; didn’t work.
FOI #2020-7319 9
• Maren Klawiter (Quaker Hill, CT) B,D: Inhumane and harmful if not voluntary; lacking transparency.
• Sara Elizabeth Liss (Middletown, CT) B, D: Awful; caused severe, permanent amnesia • Sharil Follman (Sedro Woolley, WA) A: Most horrific, physically, mentally damaging experiences of my life.
• Lauren J. Tenney, PhD, MPhil, MPA, BPS (West Palm Beach, FL)D
• Virginia M. Teixeira, Esq (Middletown, CT) B, D: Involuntary, Frightening, Unconstitutional, loss, lonely, nonmedical, torture, experimental
• Jim Gottstein (Anchorage, AK)B, D: horrific, damaging, fraudulent, memory-loss • Kirk W. Lowry, Legal Director, Connecticut Legal Rights Project (Middletown, CT) D • Colleen K. Whitley (Millcreek, UT)
• Laura Ziegler (Plainfield, VT) B, E: closed head injury in the guise of medicine • John Breeding, PhD, Psychologist (Austin, TX) B, D: Terrible fear, brain damage and profound memory loss
• Michael Sabourin, formerly VPS psychiatric resident representative (Marshfield, VT) B, D: short term memory loss with negligible long-term benefits without maintenance
• Wilda L. White (Poultney, VT) B,D: Unsettling memory loss that was not adequately revealed before treatment
• Ed Paquin, Executive Director, Disability Rights-Vermont (Montpelier, VT) B, D • Nicole Calhoun (Houlton, USA)A: Permanently disabling and not effective • Judith Shalitt (Lakewood, NJ) B: Never worked again, cognitively damaged, remained depressed, later suicided
• Kerry M., Peer Support Specialist (Santa Clara, CA) A,D: Frustrating, terrifying, painful, life destroying, infantilizing, isolating.
• Madelyn Jean Jones (Roseville, CA) A: Terror, Death, Anxiety, Helpless, Violated, Triggers, Ignored, & Emergency.
• Jacob Z Hess (Paradise, UT) B, D: Long-term impacts on memory and capacity • Bridget Youngdale, Family Support Specialist (Vista, CA) B: Effective in treating depression but traumatic side effects
• Christine P. Sharp (La Mesa, CA) B: Horrific, resulting in extreme life-long disability • Autumn Johnson (Royse City, TX) B
• Melinda James (McKinney, TX)B: One of the worst experiences ever
• Burgandy Brittain, Medical Laboratory Scientist (Orem, UT) B, D: Understudied and potentially dangerous
• Karen D. Canfield (Orem, UT) B: Devastation, memory loss, dysfunction, altered, personality change, unsafe
• Hallam May, Family Support Specialist (San Diego, CA)B: Scary, uninformed, confusing, lack of alternatives explained
• Marla Foulger (Potomac, MD)B: ECT has caused multiple severally negative effects • Savio Chan (Hayward, CA)B: Horrifying seeing ECT still in practice ignoring long-term impacts. • Melissa Gomez (San Diego, CA)E
• Nancy Alisberg, Chair of the Public Policy Committee, National Association for Rights Protection and Advocacy (West Hartford, CT)
FOI #2020-7319 10
• Debra Ruh (Rockville, VA)C,D: They deserve the best treatments that do not make them worse. • Deborah Abrams (Lakeside, CA)—Friend became wheelchair bound with cognitive and speech challenges
• Cassandra Casey (Lehi, UT)
• Joel Zwanziger (Carsbad, CA)D
• Patricia Burke (Manchester, CT)B,D: Lost part of his life
• Tiffany Sharp Broberg (Wichita, KS)B
• Jennifer Mietus (Round Rock, TX) B,E: Latent significant problems
• Kasey Johnson (Austin, TX)B
• Sarah Gardner (Portland, OR) B: ECT caused numerous irreparable damages to their brain. • Maria Wuthrich (Kaysville, UT)
• Toby B Csiszer (Las Vegas, NV): Horrifying, inhumane, malpractice, lacking scientific merit or validity.
• William Price (North Salt Lake, UT) B,D: Devastating
• Karen Michelle Welch, Andrologist (Orem, UT)B,D: Hell. Evil. Satanic. Barbaric. Destructive. Damaging. Deceit. Unconscionable.
• Sharla W. Moyes (American Fork, UT) B: Devastating long-term effects, Insufficient informed consent
• Sarah Smith (Eugene, OR)D: Barbaric, frightening, harmful, debilitating, outdated, medieval, torture, lack of informed consent
• Danny Plunkette (Paducah, KY)B: Horrible, frightening, damaging, sad, angry, empathetic, wrong, unnecessary
• Janine Hardman (La Mesa, CA)A: Permanent Long-term memory loss, continuing cognitive impairment, migraine
• Jacqueline Hall (Somerville, MA) A
• Deanna Herrod (La Mesa, CA): Serious Regret
• Kathy Deane (La Mesa, CA)
• Nicole Calhoun (Houlton, USA) A: Traumatic, disabling, and ineffective
• Kurt Buske (San Diego, CA) D
• George Ebert (Sterling, NY) A,E
• Anzania Carter, Vocational Counselor (Atlanta, GA) E
• Dr. Jay Seitz, CEO, Neurocognitive Therapeutics, LLC (Boston, MA) We need up-to-date research on ECT, long-term outcomes, as well as newer alternatives
• Oliver Lu (Lancaster, PA)
• Anne Trudeau (Portland, OR)
• Cassandra Auerbach (Thousand Oaks, CA)
• Julia A. Sherman, PhD, clinical psychologist (ret.), (Tuscon, AZ) D
• Carolyn Barnes (Leander, TX)B: predatory, abusive, and barbaric
• Robert E Nikkel (Wilsonville, OR)
• Paula Joan Caplan, Ph.D., Psychologist, Independent activist, writer, & filmmaker, (Rockville, MD)D: Horrific
• Dean Myers (Strarford, NY)B, D: They cried, as if they lost their minds!
• Cynthia Grier, Peer Support Specialist (Portland, MD)B, D
FOI #2020-7319 11
• (Shelley) Robin Weiss, Peer Support Specialist (Lindenwold, NJ)B, D: Treatments given for financial reasons nearly as much as therapeutic
• Dr. Lee Coleman, MD, Psychiatrist (Berkley, CA)D
• Berta Britz (Newtown Square, PA) B, D: Life stealing
• Darlene Plumly (Houston, TX)B: Life changing in a very good way
• Katharine Adams (New York City, NY) F
• Bonnie Jo Schell (Asheville, NC) Former Executive Director, Mental Health Client Action Network, Santa Cruz, CABD: Lost memory, talked childlike, could no longer piece together their life story • Jacqueline DiPillo (Johns Creek, GA)B: Permanent memory loss. No mood improvement • Susan ElkinsB
• James Nordlund, Mental Health Counseling Supervisor (Moorhead, MN) B D: Horrifying, they were lost, never the same person.
• Jonathan Post (Covington, GA)F
• Howard Diamond, Certified Peer Specialist (Lynbrook, NY) D: Horrific, Life-Destroying, Mindless, Destructive, Foolish
• Kelli Yvonne Hitsman (Ames, IA)B: Causes brain damage
• Patricia Harrild (Vashon, VA)B: It ruined my sister’s life. Terrible experience! • Cheryle Morgan (Hawthorne, FL)F
• Elizabeth A. Richter (Canton, CT)B: Horrific. He was conscious at the time. • F Miller (Astoria, NY)A: Horrific. Cruel very unpleasant
• Nadia Gomez (Brooklyn, NY)F
• Ann Harrild (Pocatello, ID) —We weren’t advised of the devastating side effects • Kristina Yates (Oakland, CA) A, B & D: brain damaging, torturous, disorienting, terrifying, abusive, controlling, inhumane
• Pamela Green (Tulsa, OK)B: Barbaric, torture, IQ-damaging, mind-erasing, depressing, hellish, traumatizing, fear-inflicting
• Andrea Tabbat (Towson, MD): Disorienting, Damaging
• Sarah Edmonds, PhD, Licensed Psychologist (Flagstaff, AZ) D: memory loss, did not work • Natasha Crow, therapist (Eugene, OR)E
• Anna H. (Pocatello, ID)A: mind, body and soul murder
• Minnie Yee (Bronx, NY)B: It was a very negative experience and not healing. • Jason Hoobler (Cincinnati, OH) F: Brutal, barbaric, intimidating, superstitious and ineffectually promoting escalations
• Mari Marks, PhD, Licensed psychologist (Los Angeles, CA)B, D: No lasting benefit, long term heartbreaking memory loss
• Tipton McMahon (Katy, TX)F
• Amy M Smith (Olney Springs, CO) B & D: torture
• Judith Brown (Seneca, NE) C, E
• William J Dowling, Jr (Lakewood, OH) A, B: Damaging. Inhumane. Torture. Cruel and unusual. • Jared Crossland (Hot Springs, USA)F
• Susanna Smith (Seattle, WA)B: Painful, terrifying, and she had memory loss. • Patricia A. Wolfe (Dumont, NJ)D
FOI #2020-7319 12
• Thomas O. (Chicago, IL)C, E: Crippling, brutal, medieval, barbaric, inhumane, unscientific, immoral, unethical
• Arnold Gore (Brooklyn, NY)
• M. A. Malczewski (Philadelphia, PA)A: Without a slightest degree of objective or subjective benefit
• Wenona Lee Gardner, Peer Support Specialist (West Allis, WI)D: Grueling Torture, Devastating, Horrific, Tragic, Mind Raping, Memory Loss
• Loretta A. Wilson (Flushing, USA) A, C, E: brutal, castrated, barbaric, excruciating, debilitating, isolating, intimidating
• Shango Los, Patient Educator (Vashon, WA) B,D
• Amy Harlib (New York, NY)F
• Tyler Markwart (Moses Lake, WA) F
• Bruce C. Faurot, Peer Support Specialist; Medical Services Worker; &/or Psych Tech (Santa Rosa, CA) B,D: Depends on the patient & year of treatment
• Nichole Oates (Seattle, WA)F
• Maureen Schiener (Amherst, NY)B: I don’t believe this procedure is safe or effective. • Gerald Lawrence Bliss (Blaine, TN)B: You are stealing their lives.
• David Cohen (Los Angeles, CA)F
• David Potter (Portland, OR) B
• Angela Peacock, Community Organizer (Livingston, TX) B,D: They are brain damaged and traumatized
• Kathleen Labriola, Counselor & Nurse (Berkeley, CA)B & D: torture, terror, memory loss, severe headaches, dizzy spells
• Kent Reedy (San Diego, CA)A: Hours of total unconsciousness, years of fragmented memories. • Luke Evans (Omaha, Nebraska) B,E: Torture, unconscionable, life destroying, identity theft, NDE inducing
• Adrienne Lauby, volunteer (Cotati, CA) A,E: It took away too much of my life. • Ian Ashton-Miller (Ann Arbor, MI)E
• Julia Glanville (San Francisco, CA)F
• Barnett J Weiss, Therapist LCSW (New York City, NY) B, D: The horror!
• Kimberly Doyle (Evergreen, CO)A: Caused permanent memory-loss, cognitive damage, PTSD, BARBARIC
• Anna Rudzinski (Chicago, IL)F
• Ariella Lee (Winston-Salem, USA)F
• Diane M Rivas (Eugene, OR)F
• John Peterson (South Jordan, UT)B: It was a horrible experience!
• Crystal Yvonne Sweeney (Baltimore, MD)F
• Rebecca Edens (Salem, OR) B,D: Shocking! Traumatic Brain Injury Brain & Spirit Damaging Experience
• David F. Zupan (Eugene, OR) B: Unnecessary, intrusive, debilitating, disempowering, outrageous, inhumane, frightening, excessive
• Jamie Mack (Round Rock, TX)A, B
• Jennifer Bangerter (West Valley City, UT)B: Completely stole any chance of a normal life.
FOI #2020-7319 13
• David James (Pueblo, CO)F
• Pamela Green (Tulsa, OK)B: hellish, barbaric, torturous, mind-eraser, depressing, fear-creating, life-wreaking, family-wreaking
• Michael Myers (Seattle, WA)C
• Kimberly Renninger, Director of Advocacy (Pennsburg, PA) D: Traumatic, Coerced • Alan Podber (Battleboro, VT)F
• Vicky Escoe (Muskogee, OK)F
• Andrew Katsetos (Austin, TX)B
International Signatories
• Diane Botterill (Nipawin, Saskatchewan, Canada)A: Traumatizing, barbaric, memory destroying, soul-destroying, cruel, abusive, misrepresented
• Dr Sue Cunliffe (Worcester, UK)A, D: Destroyed me. Not monitored nor honestly consented. • Dr Lucy Johnstone (Bristol, Somerset, UK)D: Terrifying, damaging, unjustified • Dr Gareth Morgan (Leicester, Leicestershire, UK)E:
• Tamar Harris (Kiryat Tivon, Israel) A,B: brain damaging, traumatic, disabling, destroyed life, identity, & trust
• Jo Watson, Mental health professional (Birmingham, UK)D: Imposed, damaging, misleading, destructive, harmful, distressing & enraging
• Dunja Grisell (Stockholm, Sweden) A: Traumatic, debilitating, devastating. • Una M. Parker (Leeds, West Yorkshire, UK) A: Undermining memory, confidence, ability to concentrate
• Jill Davies, Counsellor (Hereford, Herefordshire, UK) B,E: Disabling, violating, humiliating, devastating, life-limiting, distressing, sad
• Andy Luff (Hereford, Herefordshire, UK) A: Violated, lost, confused, humiliated, lonely, embarrassed, helpless, childlike
• Dr Rex Haigh, FRCPscyh (London, UK) D: Variably amnesic
• Dr W Larkin (Chorley, Lancanshire, UK)D
• Sami Timimi (Lincoln, Lincolnshire, UK)D
• E. Miller (Winchester, UK) B: Violation ,desperate, Rights removed, not fully informed • DMM (Winchester, UK) A,B: Memory loss. Loss of rights, not fully informed. • Jo McCarthy (Whitehorse, Yukon, Canada) A: Devastating consequences, dramatically debilitating, then zero rehabilitation/support
• Jennie Williams, Clinical Psychologist (Faversham, Kent, UK) B,D: Frightening, disempowering, primitive, damaging, ineffective, punitive
• Sue Irwin, Horticultural health & Wellbeing Officer (Worcester, Worcestershire, UK) A,B,D: ECT mirrored my experiences of childhood abuse
• Professor Rhiannon Corcoran (Liverpool, Merseyside, UK) B, E: Traumatic, un-evidenced, debilitating, unethical, unjustified, unsuccessful
• Anne Guy, PsychD (Basingstoke, UK)F
• Lucy Williams (Margate, Kent, UK) B: Traumatic, damaging, harmful, unhelpful • Professor Michelle McCarthy (Canterbury, UK)F
• Nick Webb (Gold Coast, Australia)B
FOI #2020-7319 14
• Danielle Egan, Journalist (Vancouver, BC, Canada) D: No benefit, numerous cognitive side effects, brain-disabling
• Cas Schneider (Newton Abbot, Devon, UK) B,D: Terrifying
• Don Weitz (Toronto, Canada)B: My friend is Traumatized. It destroyed many memories. • Pat Butterfield (Keighley, West Yorks, UK) A, B,C,D: Soul destroying. Many years of therapy to reverse.
• Ruth Dixon (Barton Upon Humber, North Lincolnshire, UK)B: it caused brain damage • Dr Steven Coles (Loughborough, Leicestershire, UK)B, D: Horrifying, destructive, useless, controlling, ineffective treatment, devastating impact
• Professor John Read, Psychologist (London, UK)F
• Hilla Komem (Kiriat Ono, Israel)B,E
• Andrew Gordon Towgood Bett (Forfar, Angu, UK)A: Frightening, Dangerous, Useless, Harming, Criminal, Ignorant, Barbaric, & Abusive
• Lila Hefer, Social Worker (Pardes han, Israel) B,D
• Yossef Shoshan (Ilaniyaistarl, Israel)B: Terrible, Barbaric & Cruel
• Fray Daniel Klementy, OFH (Olesh, Israel)F
• Adi, Social Worker (Rosh Haayin, Tel Aviv, Israel)B,D: Memory loss
• Yael Lindner (Modiin, Israel) B: An experience of irreversible damage
• Elizaberh Gilarowski (Toronto, Ontario, Canada)F: awful unnecessary necessary memory loss • Alana Didur, Community worker (Hamilton, Ontario, Canada)B, D: Lacking information • Tuba Yektaii (Ottawa, Ontario, Canada)B: Savage memory-loss, barbaric
• Joy Dyck (Edmonton, AB, Canada)A: Tragic. I lost all sense of identity.
• Rosalee Dubuc (Edmonton, AB, Canada)B: Harmful, contributed to a downward spiral • Diana Epperson (Vancouver, BC, Canada)B: erased memories, frightening, brain damage • Michael Woolard (Melbourne, Victoria, Australia)D: Desperation, violation and anger • Irit Shimrat (Vancouver, BC, Canada)B: Life-wrecking, mind-destroying, horrific, debilitating. devastating, zombifying, cruel, torturous
• Chris Chapman (Toronto, ON, Canada)F
• Corinne Chepil, Program Coordinator, Adult Day Centre where some had ECT (ret.),(Vancouver, BC, Canada)D: Memory-robbing, soul-sapping, immoral, torturous, unjust, archaic, cruel, primitive
• Marilena Stylianou (Larnaca, Cyprus): Inhumane insensitive cruel stupid dehumanizing harmful brain-damaging medically unethical
References
1. MECTA. MECTA-Instruction Manual. 6th ed. MECTA Corporation; 2008.
2. Somatics LLC. User Manual Thymatron® System IV.; 2019.
http://thymatron.com/downloads/System_IV_Instruction_Manual_Rev21.pdf
FOI #2020-7319 15
3. American Psychiatric Association. Committee on Electroconvulsive Therapy, Weiner RD. The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging: A Task Force Report of the American Psychiatric Association. 2nd ed. American Psychiatric Association; 2001. Accessed October 13, 2019. https://psycnet.apa.org/record/2001-06855-000
4. Somantics. Regulatory Update to Thymatron System IV Instruction Manual. Somatics, LLC; 2018. Accessed November 21, 2018.
http://www.thymatron.com/downloads/System_IV_Regulatory_Update.pdf
5. Duma A, Maleczek M, Panjikaran B, Herkner H, Karrison T, Nagele P. Major Adverse Cardiac Events and Mortality Associated with Electroconvulsive Therapy: A Systematic Review and Meta analysis. Anesthesiology. 2019;130(1):83-91. doi:10.1097/ALN.0000000000002488
6. Munk-Olsen T, Laursen TM, Videbech P, Mortensen PB, Rosenberg R. All-cause mortality among recipients of electroconvulsive therapy: Register-based cohort study. British Journal of Psychiatry. 2007;190(MAY):435-439. doi:10.1192/bjp.bp.106.026740
7. Fosse R, Read J. Electroconvulsive treatment: Hypotheses about mechanisms of action. Frontiers in Psychiatry. 2013;4(AUG):1-10. doi:10.3389/fpsyt.2013.00094
8. Alpers BJ. The Brain Changes Associated with Electrical Shock Treatment: A Critical Review. The Lancet. 1946;Nov;66(11):363-369.
http://www.ectresources.org/ECTscience/Alpers_1946____AAA__Overview_of_Brain_Damage_. pdf
9. Alpers BJ, Hughes J. Brain changes in electrically induced convulsions in the human. Journal of Neuropathology & Experimental Neurology. 1942;1 (April)(2):173–180. doi:10.1097/00005072- 194204000-00005
10. American Psychiatric Association. Electroconvulsive Therapy: Task Force Report.; 1978. https://www.psychiatry.org/File Library/Psychiatrists/Directories/Library-and-Archive/task-force reports/tfr1978_ECT.pdf
11. Friedberg J. Neuropathologic Effects of ECT. American Journal of Psychiatry. 1981;138(8):1129. doi:10.1176/ajp.138.8.1129b
12. Ferraro A, Roizin L. Cerebral Morphologic changes in monkeys subjected to a large number of electrically induced convulsions (32-100). The American Journal of Psychiatry.
1949;106(October):278-284. doi:10.1176/ajp.106.4.278
13. Ferraro A, Roizin L, Helfand M. Morphologic changes in the brain of monkeys following convulsions electrically induced. Journal of Neuropathology & Experimental Neurology. 1946;5:285-308. doi:10.1097/00005072-194610000-00002
14. Hartelius H. Cerebral Changes Following Electrically Induced Convulsions: An Experimental Study on Cats. Vol Supplement.; 1952.
http://www.ectresources.org/ECTscience/Hartelius_1952___Animals___Brain_damage__Definiti ve_.pdf
FOI #2020-7319 16
15. Friedberg J. Shock treatment, brain damage, and memory loss: a neurological perspective. American Journal of Psychiatry. 1977;134(9):1010-1014. doi:10.1176/ajp.134.9.1010
16. Orzi F, Passarelli F, Diana G, Fieschi C. Effects of single and repeated electroconvulsive shock on localcerebral glucose utilization in the conscious rat. Brain Research. 1987;423(1-2):144-148. doi:10.1016/0006-8993(87)90834-1
17. Orzi F, Zoli M, Passarelli F, Ferraguti F, Fieschi C, Agnati LF. Repeated electroconvulsive shock increases glial fibril- lary acidic protein, ornithine decarboxylasc, somatostatin and cholecystokinin immunoreactivities in the hippocampal formation of the rat. Brain Research. 1990;533:223-231. doi:https://doi.org/10.1016/0006-8993(90)91343-F
18. Nobrega JN, Raymond R, DiStefano L, Burnham WM. Long-term changes in regional brain cytochrome oxidase activity induced by electroconvulsive treatment in rats. Brain Research. 1993;605(1):1-8. doi:10.1016/0006-8993(93)91349-W
19. Burnham WM, Cottrella GA, Diosy D, Racineb RJ. Long-term changes in entorhinal-dentate evoked potentials induced by electroconvulsive shock seizures in rats. Brain Research. 1995;698(1-2):180-184.
20. Nobler MS, Oquendo MA, Kegeles LS, et al. Decreased Regional Brain Metabolism After ECT. American Journal of Psychiatry. 2001;158(2):305-308. doi:10.1176/appi.ajp.158.2.305
21. Guloksuz S, Arts B, Walter S, et al. The impact of electroconvulsive therapy on the tryptophan– kynurenine metabolic pathway. Brain, Behavior, and Immunity. 2015;48:48-52. doi:10.1016/j.bbi.2015.02.029
22. Suwa T, Namiki C, Takaya S, et al. Corticolimbic balance shift of regional glucose metabolism in depressed patients treated with ECT. Journal of Affective Disorders. 2012;136(3):1039-1046. doi:10.1016/j.jad.2011.11.040
23. Michael N, Erfurth A, Ohrmann P, Arolt V, Heindel W, Pfleiderer B. Metabolic changes within the left dorsolateral prefrontal cortex occurring with electroconvulsive therapy in patients with treatment resistant unipolar depression. Psychological Medicine.
2003;33(7):S0033291703007931. doi:10.1017/S0033291703007931
24. Yatham LN, Clark CC, Zis AP. A Preliminary Study of the Effects of Electroconvulsive Therapy on Regional Brain Glucose Metabolism in Patients with Major Depression. The Journal of ECT. 2000;16(2):171-176. doi:10.1097/00124509-200006000-00008
25. Altschule MD, Altschile LH, TILLOTSON KJ. Changes in Urinary Uric Acid-Creatinine Ratio After Electrically Induced Convulsions in Man. The Journal of Clinical Endocrinology & Metabolism. 1949;9(6):548-554. doi:10.1210/jcem-9-6-548
26. CHEN W, LEE RC. Evidence for Electrical Shock–induced Conformational Damage of Voltage‐ gated Ionic Channels. Annals of the New York Academy of Sciences. 1994;720(1):124-135. doi:10.1111/j.1749-6632.1994.tb30440.x
FOI #2020-7319 17
27. Chen W, Zhongsheng Z, Lee RC. Supramembrane potential-induced electroconformational changes in sodium channel proteins: A potential mechanism involved in electric injury. Burns. 2006;32(1):52-59. doi:10.1016/j.burns.2005.08.008
28. Chen R, Li YJ, Li JQ, et al. Electrical injury alters ion channel expression levels and electrophysiological properties in rabbit dorsal root ganglia neurons. Burns. 2011;37(2):304-311. doi:10.1016/j.burns.2010.08.006
29. Hjaeresen M-L, Hageman I, Wortwein G, Plenge P, Jørgensen MB. Chronic Electroconvulsive Stimulation but Not Chronic Restraint Stress Modulates mRNA Expression of Voltage-Dependent Potassium Channels Kv7.2 and Kv11.1 in the Rat Piriform Cortex. Brain Research. 2008;1217:179- 184. doi:10.1016/j.brainres.2007.09.071
30. Kragh J, Seidelin J, Bolwig TG. Seizure threshold to lidocaine is decreased following repeated ECS ( electroconvulsive shock ). Psychopharmacology. 1993;111:495-498. doi:10.1007/BF02253542
31. Lee RC. Cell Injury by Electric Forces. Annals of the New York Academy of Sciences. 2005;1066:85- 91. doi:10.1196/annals.1363.007
32. Leibovici D, Shemer J, Shapira SC. Electrical injuries: current concepts. Injury. 1995;26(9):623- 627. doi:10.1016/0020-1383(95)00130-2
33. Pei Q, Burnet PW, Grahame-Smith DG, Zetterström TS. Differential effects of acute and chronic electroconvulsive shock on the abundance of messenger RNAs for voltage-dependent potassium channel subunits in the rat brain. Neuroscience. 1997;78(2):343-350. doi:10.1016/s0306- 4522(96)00574-x
34. Streck EL, Feier G, Búrigo M, et al. Effects of electroconvulsive seizures on Na+,K+-ATPase activity in the rat hippocampus. Neuroscience Letters. 2006;404(3):254-257.
doi:10.1016/j.neulet.2006.06.002
35. Heithoff BP, George KK, Phares AN, Zuidhoek IA, Munoz-Ballester C, Robel S. Astrocytes are necessary for blood–brain barrier maintenance in the adult mouse brain. Glia. 2020;(August):1- 37. doi:10.1002/glia.23908
36. Silversides J. The Neurological Sequelae of Electrical Injury. Le Journal de L’Association Medicale Canadienne. 1964;91(5):195-204. Accessed April 13, 2019.
37. Grube BJ, Heimbach DM. Acute and delayed neurological sequelae of electrical injury. In: Lee RC, Cravalho EG, Burke JF, eds. Electrical Trauma. ; 2010:133-152.
doi:10.1017/cbo9780511663291.008
38. Morse JS, Morse MS. Diffuse electrical injury: Comparison of physical and neuropsychological symptom presentation in males and females. Journal of Psychosomatic Research. 2005;58(1):51- 54. doi:10.1016/j.jpsychores.2004.06.001
39. Morse MS. Don’t Discount the Danger of 120V:An expectation of very low risk leads to life altering and career-ending injury for one unsuspecting electrician. Electrical Construction and Maintenance Magazine. Published online 2006:18-20.
FOI #2020-7319 18
40. Morse MS. A report on the current state and understanding of human response to electrical contacts. IEEE IAS Electrical Safety Workshop. 2013;(March):29-33.
doi:10.1109/ESW.2013.6509001
41. Berg JS, Morse MS. A Shocking Neurological Rarity. Practical Neurology. 2004;4:222-227. https://pn.bmj.com/content/practneurol/4/4/222.full.pdf
42. Morse MS, Berg JS, TenWolde RL. Diffuse electrical injury: A study of 89 subjects reporting long term symptomatology that is remote to the theoretical current pathway. IEEE Transactions on Biomedical Engineering. 2004;51(8):1449-1459. doi:10.1109/TBME.2004.827343
43. Morse MS, Berg JS, ten Wolde RL. Diffuse Electrical Injury – A Study of 136 Subjects. Annual International Conference of the IEEE Engineering in Medicine and Biology – Proceedings. 2003;2(March):1694-1697. doi:10.1109/iembs.2003.1279716
44. Kroll MW, Panescu D. Physics of Electrical Injury. In: Ho J, Dawes D, Kroll M, eds. Atlas of Conducted Electrical Weapon Wounds and Forensic Analysis. Springer; 2012:25-45. doi:10.1007/978-1-4614-3543-3_2
45. Lee RC, Kolodney MS. Electrical injury mechanisms: Electrical breakdown of cell membranes. Plastic and Reconstructive Surgery. 1987;80(5):680-681. doi:10.1097/00006534-198711000- 00003
46. Wu Y-C. Electrical Injuries – A Literature Review.; 1979.
47. Martin TA, Salvatore NF, Johnstone B. Cognitive Decline over time following electrical injury. Brain Injury. 2003;17(9):817-823. Accessed March 21, 2019.
48. Hooshmand H, Radfar F, Beckner E. The Neurophysiological Aspects of Electrical Injuries. CLINICAL ELECTROENCEPHALOGRAPHY. 1989;20(2):111-`120.
49. Jafari H, Couratier P, Camu W. Motor neuron disease after electric injury. J Neurol Neurosurg Psychiatry. 2001;71:265-267. doi:10.1136/jnnp.71.2.265
50. Wesner ML, Hickie J. Long-term sequelae of electrical injury. Canadian Family Physician. 2013;59(September):935-939.
51. Lee RRC, Zhang D, Hannig J. Biophysical Injury Mechanisms in Electrical Shock Trauma. Annual Review of Biomedical Engineering. 2000;2:477-509. doi:10.1146/annurev.bioeng.2.1.477
52. Theman K, Singerman J, Gomez M, Fish JS. Return to work after low voltage electrical injury. Journal of Burn Care and Research. 2008;29(6):959-964. doi:10.1097/BCR.0b013e31818b9eb6
53. Singerman J, Gomez M, Fish JS. Long-Term Sequelae of Low-Voltage Electrical Injury. Journal of Burn Care & Research. 2008;29(5):773-777. doi:10.1097/BCR.0b013e318184815d
54. Lee RC. Injury by Electrical forces: Pathophysiology, manifestations, and therapy. Current Problems in PTCA. 2011;34(9):680-764. doi:10.1007/978-3-642-72407-7
FOI #2020-7319 19
55. Cherington M. Central nervous system complications of lightning and electrical injuries. Seminars in Neurology. 1995;15(3):233-240. doi:10.1055/s-2008-1041028
56. Cherrington M. Central Nervous System Complications of Lightning and Electrical Injuries. Seminars in Neurology. 1995;15(3):233-240. Accessed August 4, 2019. https://www.thieme connect.com/products/ejournals/pdf/10.1055/s-2008-1041028.pdf
57. Reisner AD. Possible mechanisms for delayed neurological damage in lightning and electrical injury. Brain Injury. 2013;27(5):565-569. doi:10.3109/02699052.2013.766928
58. Fish JS, Theman K, Gomez M. Diagnosis of Long-Term Sequelae After Low-Voltage Electrical Injury. Journal of Burn Care and Research. 2012;March/Apri:199-205.
doi:10.1097/BCR.0b013e3182331e61
59. Ko SH, Chun W, Kim HC. Delayed spinal cord injury following electrical burns: A 7-year experience. Burns. 2004;30(7):691-695. doi:10.1016/j.burns.2004.03.007
60. Ramati A, Rubin LH, Wicklund A, et al. Psychiatric morbidity following electrical injury and its effects on cognitive functioning. General Hospital Psychiatry. 2009;31(4):360-366. doi:10.1016/j.genhosppsych.2009.03.010
61. Ramones A, Pita A, Keator D, Wu J. Case report: Significant quantitative MRI brain volumetric finding associated with electrical brain injury. Burns Open. 2018;2(3):154-159.
doi:10.1016/j.burnso.2018.03.002
62. McCreery D, AGNEW WF, YUEN TGH, Bullara LA. Charge density and charge per phase as cofactors in neural injury induced by electrical stimulation. Biomedical Engineering, IEEE Transactions on. 1998;37(10):1-6.
http://ieeexplore.ieee.org/document/102812/%0Apapers3://publication/uuid/DAE99EA9-80E8- 4FA1-A763-6754AFAE10D5
63. Stockly OR, Wolfe AE, Espinoza LF, et al. The impact of electrical injuries on long-term outcomes: A Burn Model System National Database study. Burns. 2019;46(2):352-359.
doi:https://doi.org/10.1016/j.burns.2019.07.030
64. Duff K, McCaffrey RJ. Electrical injury and lightning injury: A review of their mechanisms and neuropsychological, psychiatric, and neurological sequelae. Neuropsychology Review. 2001;11(2):101-116. doi:10.1023/A:1016623318049
65. Andrews CJ, Reisner AD, Cooper MA. Post electrical or lightning injury syndrome: A proposal for an american psychiatric association’s diagnostic and statistical manual formulation with implications for treatment. Neural Regeneration Research. 2017;12(9):1405-1412. doi:10.4103/1673-5374.215242
66. Rami L, Bernardo M, Ph D, et al. Cognitive status of psychiatric patients under maintenance electroconvulsive therapy: a one-year longitudinal study. The Journal of Neuropsychiatry and Clinical Neurosciences. 2004;16(4):465-471. doi:10.1176/jnp.16.4.465
67. Simonson M. Psychiatric Hospitals Can Still Force Patients to Accept Shock Treatment . One Connecticut Patient Has Been Shocked 500 Times in Five Years . Reason.
FOI #2020-7319 20
https://reason.com/2020/02/11/psychiatric-hospitals-can-still-force-patients-to-accept-shock treatment-one-connecuticut-patient-has-been-shocked-500-times-in-five-years/printer/. Published February 11, 2020. Accessed October 25, 2020.
68. Nobler MS, Sackeim, Harold A. Solomou M, Luber B, Devanand DP, Prudic J. EEG manifestations during ECT: effects of electrode placement and stimulus intensity. Biological Psychiatry. 1993;34(5):321-330. https://www.sciencedirect.com/science/article/abs/pii/000632239390089V
69. Sackeim HA, Prudic J, Devanand DP, et al. A prospective, randomized, double-blind comparison of bilateral and right unilateral electroconvulsive therapy at different stimulus intensities. Archives of General Psychiatry. 2000;57(5):425-434. doi:10.1001/archpsyc.57.5.425
70. Akiyama M. Electroconvulsive Therapy. Journal of Nihon University Medical Association. 2013;71(6):401-404. doi:10.4264/numa.71.401
71. Krystal AD. Ictal Electroencephalographic Response.; 2010.
72. Singh A, Kar SK. How Electroconvulsive Therapy Works?: Understanding the Neurobiological Mechanisms. Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology. 2017;15(3):210-221.
doi:10.9758/cpn.2017.15.3.210
73. Robin A, de Tissera S. A Double-Blind Controlled Comparison of the Therapeutic Effects of Low and High Energy Electroconvulsive Therapies. The British Journal of Psychiatry. 1982;141(4):357- 366. doi:10.1192/bjp.141.4.357
74. Breggin PR. ECT Resources Center. Accessed October 25, 2020. http://www.ectresources.org
75. MAUDE Adverse Event Report: Somatics, LLC Electroconvulsive Therapy Device Thymatron System IV Device, Electroconvulsive Therapy. US Food & Drug Administration; 2020.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9877701& pc=GXC
76. Youngson RM. brain damage. The Free Dictionary [Internet]. “brain damage”. Collins Dictionary of Medicine. Published 2005. Accessed October 20, 2020. https://medical
dictionary.thefreedictionary.com/brain+damage
77. Sackeim HA. Sackeim Says 2 Million a Year have ECT. Published online 2004. https://youtu.be/12oScZatwKg
78. Hancock SP. Whose Finger is Taking the Pulse of America’s Shock Treatment Controversy? Mad In America. https://www.madinamerica.com/2020/07/finger-pulse-shock-treatment controversy/. Published July 16, 2020.
79. Substance Abuse and Mental Health Services Administration. 2018 National Directory of Mental Health Treatment Facilities.; 2018. Accessed May 11, 2019.
FOI #2020-7319 21
80. Substance Abuse and Mental Health Services Administration. 2020 National Directory Of Mental Health Treatment Facilities.; 2020. https://www.samhsa.gov/data/report/2020-national directory-mental-health-treatment-facilities
81. Slater B. Duluth group home avoids penalty for resident’s death. Duluth News Tribune. https://www.duluthnewstribune.com/newsmd/health-news/5921381-Duluth-group-home avoids-penalty-for-residents-death. Published April 22, 2020.
82. Department of Health and Human Services: Office of Inspector General. Minnesota Department of Human Services Maltreatment Investigation Memorandum:202001435. Minnesota Department of Human Services; 2020.
dhs.state.mn.us/main/idcplg?IdcService=GET_DYNAMIC_CONVERSION&RevisionSelectionMetho d=LatestReleased&dDocName=LLO_453221
83. Omalu B, Hansen S, Williams E, et al. Traumatic Brain Injury Advisory Board Meeting Minutes.; 2019. https://www.dor.ca.gov/Content/DorIncludes/documents/TBI/TBI Full Committee Meeting Minutes 8-26-19.docx
84. Pan J, Connolly ID, Dangelmajer S, Kintzing J, Ho AL, Grant G. Sports-related brain injuries: connecting pathology to diagnosis. Neurosurgical Focus. 2016;40(April):E14.
doi:10.3171/2016.1.focus15607
85. Coffey CE, Figiel GS, Weiner RD, Saunders WB. Caffeine augmentation of ECT. American Journal of Psychiatry. 1990;147(5):579-585. doi:10.1176/ajp.147.5.579
86. Shapira B, Zohar J, Newman M, Drexler H, Belmaker RH. Potentiation of seizure length and clinical response to ECT by caffeine pretreatment. A case report. Convuls Ther. 1985;1(1):58-60. Accessed May 11, 2019. https://www.researchgate.net/publication/11425225
87. Enns M, Peeling J, Sutherland GR. Hippocampal neurons are damaged by caffeine-augmented electroshock seizures. Biological Psychiatry. 1996;40(7):642-647. doi:10.1016/0006- 3223(95)00450-5
88. Wennström M, Hellsten J, Ekstrand J, Lindgren H, Tingström A. Corticosterone-induced inhibition of gliogenesis in rat hippocampus is counteracted by electroconvulsive seizures. Biological Psychiatry. 2006;59(2):178-186. doi:10.1016/j.biopsych.2005.08.032
89. Weiner RD. The Persistence of Electroconvulsive Therapy-Induced Changes in the Electroencephalogram. The Journal of Nervous and Mental Disease. 1980;(April):224-228. https://journals.lww.com/jonmd/Abstract/1980/04000/The_Persistence_of_Electroconvulsive.6. aspx
90. Krishnan A, Wu H, Venkataraman V. Astrocytic S100B, Blood-Brain Barrier and Neurodegenerative Diseases. In: Spohr T, ed. Blia in Health and Disease. IntechOpen; 2020. doi:10.5772/intechopen.92146
91. Ruff RL. A case report of cognitive impairment and movement disorder associated with ECT. American Journal of Psychiatry. 1980;137(12):1615-1616. doi:10.1176/ajp.137.12.1615
FOI #2020-7319 22
92. Surviving electroshock – International support group for ECT survivors. Facebook. Accessed October 22, 2020. https://www.facebook.com/groups/ECTsurvivors
93. Leiknes KA, Schweder LJ, Høie B. Contemporary use and practice of electroconvulsive therapy worldwide. Brain and Behavior. 2012;2(3):283. doi:10.1002/brb3.37
94. Luster MA. NYS Assembly Report on Electroconvulsive Therapy (ERT).; 2002. Accessed May 11, 2019. https://assembly.state.ny.us/comm/Mental/20020416/
95. Sackeim HA, Prudic J, Fuller R, Keilp J, Lavori PW, Olfson M. The cognitive effects of electroconvulsive therapy in community settings. Neuropsychopharmacology. 2007;32(1):244- 254. doi:10.1038/sj.npp.1301180
96. Sun T, Dasgupta A, Zhao Z, Nurunnabi M, Mitragotri S. Physical triggering strategies for drug delivery. Advanced Drug Delivery Reviews. doi:10.1016/j.addr.2020.06.010
97. Read J, Kirsch I, McGrath L. Electroconvulsive Therapy for Depression: A Review of the Quality of ECT versus Sham ECT Trials and Meta-Analyses. Ethical Human Psychology and Psychiatry. 2019;21(2):64-103. doi:10.1891/EHPP-D-19-00014
FOI #2020-7319 23
