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FOR PEOPLE IN USA - PLEASE GO ONLINE AND FILE A COMPLAINT TO YOUR FEDERAL GOVERNMENT.
IF ENOUGH PEOPLE STAND UP AND DEMAND
THEIR RIGHTS, WE MIGHT HAVE SOME HOPE
IN THE FUTURE FOR A BAN ON ECT.
IF ENOUGH PEOPLE STAND UP AND DEMAND
THEIR RIGHTS, WE MIGHT HAVE SOME HOPE
IN THE FUTURE FOR A BAN ON ECT.
For what it is worth here it is. My own experience as a psychiatric survivor includes being experimented on with some of the deadliest weapons in the psych-establishment's torture arsenal.Among these was ECT. It was so searingly painful that I swore to myself that I would discover how no other human being would ever have to fall victim to the eugenic ,white robed, parisitic, pharma-electro-meat grinder business. After much deep objective study,prayer,and suffering I gradually,with help from alternative healers and teachers learned,discovered,and invented even more then I was at first looking for.I had become a wounded healer without credentials.I would tell people safe modalities that work but no one could understand me or believe me.The evil eugenic medical psychiatric jugernut had brain-washed most everyone.To those of you that hold to the truth and sell not out our fellow human being for a few dollars more I salute you and call you brother and sister.Sincerely,Fred Abbe
Colin A. Ross, M.D. - Testimony from a Psychiatrist

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Cheryl van Daalen-Smith, RN, PhD, CCHN - COMPLAINT TO FDA

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After ECT I could not find my way home from the hospital. I didn't know how to get into my apartment.
After ECT I lost almost total memory of over 20 years of my life. I have not regained much.
After ECT I had severe headaches which lasted almost non-stop for several years. I still have pains.
After ECT my eyes were full of 'fireworks' - flashes, t1oaters and clouds. I have vitreal detachments.
After ECT I had heart palpitations. I still have them, though not as frequently. After ECT I discovered damage to my teeth and to my dental restorations. After ECT my legs tremored non-stop.
After ECT I had balance problems. I still have balance problems.
After ECT I had spontaneous seizures. I still have them, but less frequently. I feel weak, I lose consciousness, I collapse, I froth at the mouth, and my arms and legs spasm in all directions.
After ECT I had a pronounced twitch in one foot. It is still there, but less visible.
After ECT I had difficulty breathing. I continue to have difficulty and have just been diagnosed with an hiatus hernia which interferes with the movement of my diaphragm.
After ECT I watched my husband collapse from grief, from stress, from guilt, and from heart failure. He had been informed that ECT was safe and effective, and he had been coerced into giving approval.
After ECT I lost almost total memory of over 20 years of my life. I have not regained much.
After ECT I had severe headaches which lasted almost non-stop for several years. I still have pains.
After ECT my eyes were full of 'fireworks' - flashes, t1oaters and clouds. I have vitreal detachments.
After ECT I had heart palpitations. I still have them, though not as frequently. After ECT I discovered damage to my teeth and to my dental restorations. After ECT my legs tremored non-stop.
After ECT I had balance problems. I still have balance problems.
After ECT I had spontaneous seizures. I still have them, but less frequently. I feel weak, I lose consciousness, I collapse, I froth at the mouth, and my arms and legs spasm in all directions.
After ECT I had a pronounced twitch in one foot. It is still there, but less visible.
After ECT I had difficulty breathing. I continue to have difficulty and have just been diagnosed with an hiatus hernia which interferes with the movement of my diaphragm.
After ECT I watched my husband collapse from grief, from stress, from guilt, and from heart failure. He had been informed that ECT was safe and effective, and he had been coerced into giving approval.
See attached file(s) Dear People, I am submitting the attached letter as written testimony for the public hearings on reclassification of ECT devices. There is no valid reason to bypass full, rigorous PMA procedures for ECT devices. The data is clear that electroshock is brain-damaging and ineffective; the PR campaign should not suffice to overrun the need to fully prove otherwise. Sincerely, John Breeding, PhD Coalition for the Abolition of Electroshock in Texas www.endofshock.com

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Our organization strongly opposes the FDA's decision to down-classify the ECT device from Class III to Class II. The attached document is our formal posting of our comment. Hakan Johanson, CCHR Florida, Inc. Attachment: "Comment Docket ID- FDA-2009-N-0392.doc" Hakan Johanson

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Testimony Against Electroconvulsive Therapy Device - Moira Dolan, MD

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My family has been severely damaged by the use of this device - Margaret Topete

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Law Project for Psychiatric Rights - Comment Against ECT Devices

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Docket number; FDA 2009-N-0392 I oppose the reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety, and request that the FDA call for Pre-Market Approval Applications for the device. My aunt was subject to electric shock "therapy" and was permanently disabled; she couldn't even do the normal tasks of personal care after her shock treatments. It made her condition worse not better. Thank you, Victoria Carrara
Between the many articles I have read over the years written by psychologists, psychiatrists and neurologists, as well as information received from CCHR, it is abundantly clear to me that psychiatric electro-convulsive treatment has many more risks and side-effects than it has benefits. No one would consider it a reasonable action for a computer repairman to hook up the microprocessor of a PC to a 150 volt electrical line to "repair it." It would be obvious that such a delicate piece of equipment required a subtler approach. And yet, the human brain, a far more sophisticated, intricate and in many ways more mysterious device is subjected such brutal treatment with ECT under the guise of repairing mental difficulties. The practice should be ban. The fact that the FDA or anyone else is considering relaxing the restrictions or regulations of this barbaric treatment, makes it clear that the manufacturers of electro-convulsive equipment and others with a profit motive in this industry have undue influence on the science of mental treatment. Please do not relax the restrictions on ECT medical devices. Joe Scoglio
Electric Shock Therapy is a brutal, barbarian way to treat another human being. I have seen the results and heard from the victims that if they could have it undone they would. It is not a cure or even a valid treatment. I encourage regulations against it or warning of the dangers. Kathleen Dunford
I am outraged that in our "modern" times, Electric Shock Machines & procedures are legally used on any living being. A person's quality of life is not improved by frying parts of the brain. Brain mutilation creates a less aware and less capable individual. All Electric Shock machines should be banned from all use. They are torture machines which create unawareness. In 1946 my Grandfather died in an Illinois State Mental Hospital in Elgin, Illinois. His death certificate states he died of brain congestion. Brain congestion translates to Electric Shock treatment. He and millions of other deceased are victims of Psychiatric killing. To ease or eliminate machinery standards is a step backward into the dark ages of "Ice Pick" Brain Gouging. Carlene G. Eckhart
I am a therapist, advocate, and have recovered from a diagnosis of schizophrenia. Please listen to the voices of people harmed by ECT and limit its use, and put ECT devices in a more restricted category as a step towards ECT's elimination. My father lost memory, lost parts of his personality, and was deeply traumatized by his ECT treatments. His suffering caused great damage to our family. As a therapist I have met many clients also harmed, and as an advocate and public speaker I have met many more. There is a worldwide movement against ECT which deserves to be heard - in what other area of medicine does a treatment generate such strong opposition from people who have received it? Ignoring this outcry is a shameful throwback to the era of lobotomy and insulin coma therapy, when patient's experience was routinely disregarded. ECT was recommend to me when "all other treatments had failed," yet the hospital had not even begun to try any alternative treatments, they had only tried a series of medications. There is an abundance of effective and safe alternatives to ECT that deserve support. ECT device manufacturers have a long history of improper influence on the science and regulation surrounding ECT, and industry manipulation deeply corrupts research claims of ECT effectiveness (as discussed in Linda Andre's excellent book Doctors of Deception).
Short term benefits are attributable to the paradoxical effects of head injury, placebo, and expectations by providers. There is no research evidence of any kind that ECT treats or corrects any disease process. Do not be part of the same historic blunder that medicine made when lobotomy was widely supported and even earned its inventor the Nobel Prize. Do not go along with biased and inaccurate research and industry advocates. Do not ignore the overwhelming evidence that ECT is harmful. Move to limit the use of ECT, classify the devices in a more restricted way, and work towards elimination of ECT. -- Will Hall
Short term benefits are attributable to the paradoxical effects of head injury, placebo, and expectations by providers. There is no research evidence of any kind that ECT treats or corrects any disease process. Do not be part of the same historic blunder that medicine made when lobotomy was widely supported and even earned its inventor the Nobel Prize. Do not go along with biased and inaccurate research and industry advocates. Do not ignore the overwhelming evidence that ECT is harmful. Move to limit the use of ECT, classify the devices in a more restricted way, and work towards elimination of ECT. -- Will Hall
It is amazing that ECT is even being considered for use at all, let alone broadening its use. Having studied psychology, the mind, the human spirit; having observed the effects of ECT on people who were given it - I can say without reservation - IT IS A DESTRUCTIVE ACTION. It is harmful, it is destructive of a personality. It is something that can only be used to make people LESS able. So, if you are approving it, then we know that that is your intention! Most sincerely, Lou Teff
Have browsed through many of the comments here I ask Isn't it ironic that everyone with a financial gain in administering ECT always give it great reviews and can not find anything to be concerned about all the it while third parties comments are all voicing concerns abut the likelihood of abuse with ECT and those with first hand experiences with the barbaric device all seam to consider its defects disabling and torturous? This should speak loud and clear that the comments of those with a conflict of interest are blinded to their greed for financial prophet and can not see the harm that they are doing society by damaging peoples ability to think and be a productive member of their community. Nadine Stolle
Neurological Devices Panel of the Medical Devices Advisory Committee. I have had first hand observation and knowledge with patients receiving the 'treatment' of ECT. Suffice to say that this method of so called treatment is no less than barbaric. It is a complete 'shot in the dark' and if your committee carry out research into its validation you will find that there is no scientific or logical reasoning behind it. It should definitely not have less regulation than it currently has (class 111). I recommend instead that it be prevented from being used for any form of humane treatment. Ray Pembroke
I want to write a personal outcry against ECT in general, although this has to do with being against changing ECT to Class II. Both of my grandparents were forever changed by ECT in an utmost depressing and negative way. They became slow, sullen and lifeless. I recall being seven years old and seeing my grandma going into the shower and forgetting to take her panty hose off. This is only one of many sad instances of her doing mindless mistakes. My grandfather just fell into a robotic routine, eating, watching television, and napping. ECT not only removed the negative emotions he had been experiencing to prompt the ECT in the first place, but also destroyed all other emotions. He was never happy, rarely smiled, and never communicated to his family members beyond the bare necessities, such as asking to pass the salt. This is no quality of life and is barbaric. I considered both my grandparents to be vegetables. Zombies is more the word. Yes, ECT makes a person more "tractable". But this is in no way curing a person or addressing the true source of any emotional issue. It simply annihilates any and all emotion.
If ECT is "safe", then may I suggest that all manufacturers of the device, and doctors who administer it receive it themselves during training? The way all police officers are required to be tasered when they are trained on taser guns? Of course this would never happen, but maybe it would give mental health professionals a second thought about what they're involved in. That is, if it doesn't fry their ability to reason and think in the process. I feel it killed the life and soul and vigor of Betty and Al, my grandparents, and hope my story is regarded. Sincerely, Brie Shaffer
If ECT is "safe", then may I suggest that all manufacturers of the device, and doctors who administer it receive it themselves during training? The way all police officers are required to be tasered when they are trained on taser guns? Of course this would never happen, but maybe it would give mental health professionals a second thought about what they're involved in. That is, if it doesn't fry their ability to reason and think in the process. I feel it killed the life and soul and vigor of Betty and Al, my grandparents, and hope my story is regarded. Sincerely, Brie Shaffer
I have been a tutor for 30 years and am horrified at seeing the mental blankness, loss of memory, and confusion in students who have undergone ECT. It is most certain the ECT causes irreparable brain damage and post ECT agony. Anyone who would even think of using this unhumane torture on a human or animal is in my opinion a very lost individual. And now I hear that the FDA is going to look into lowering the destructive ECT equipment to a less restrictuctive device. No. I want to know the names of all involved should this happen. We will take note of those who forward this horrendous act of punishment. Absolutely monstrous. How dare the FDA do what it has done to mankind. Tracy Sherwood
I wanted to state for the record I am against this procedure after having undergone at the age of 16 years of age 6 times after have a supposed psychotic break after later learning it had been magnified by the use of flonase to treat my allergy to chlorine. Clearly many traditionally trained psychiatrists lack in any healing skills like that of traditional medicine people, or even or good friend to confide in for that matter. Its a shame that we have such intolerance for those undergoing traumtic experiences or spiritual crisis and especially when their subconcious minds are trying to deal with it in the best ways they know how. I just wanted to say I against the procedure and its unfortunate that a bunch of knuckle heads came together and thought it would be a good idea to make such a machine. Derek Simpson
Dear Sir, The FDA should place a complete ban on ECT machines in the United Staes. These abberations of Industry are completely destructive to te human race and are manufactured by Criminals who would never ever try this insturments of murder on themselves. The FDA should be held liiabel in a Class Action Lawsuit initiated by all ect victems. All FDA executives should be held accountable corprately and as individuals for the crimes commited by ect on the Human race ( crimes against humanity) James Michael Blunt
I urge you to not approve the use of the ECT device. Such use reduces the mental capacity and vitality of the individual. It is psychiatry's way of making someone easier to control. It is a barbaric form of treatment and should not be allowed to be used. On a personal note I have a friend who under went 38 ECT treatments... today his concentration is fuzzy at best and he is nervous most of the time... all this in an effort to "cure" him. Sheila Paula Jindela
I am totally against any use of the medical devices using electricity and shock to treat patients. Please do not lessen any of the legal restrictions- in fact, I wish you would stiffen the restrictions to decrease the use of these devices. These devices create long term terrible effects that are masked by the initial docility of the patient. You will not find any doctor who will agree to receive any of these treatments. Paul Rodeghero DDS
I am totally against the use of ECT. It is barbaric to use such a device on individual. I have seen the results of its use. The woman said she wished she'd never had it done. The statistics for the efficacy of its use are dismal. I strongly recommend that the device be taken off the market completely. The least you could do to safeguard the American people is keep this device hightly restricted. Thank You, Mary Jo Sterzenback
Please do not re-classify the use of Electroconvulsive Therapy down to class II. This would open the use of the very dangerous ECT to thousands of poorly trained or even untrained staff. What is the purpose of this change? There are no benefits available from ECT. The results give only pain, torture and degradation which is an inhuman approach to therapy. Karen Bakshoian
Please know that I am COMPLETELY OPPOSED to the reclassification of ECT ( Electro Convulsive Therapy) devices from Class III to Class II status. The fact that these devices have not already been banned by the FDA is really unbelievable. The question you might want to ask yourself is...would anyone who uses these devices to electroshock their patients be willing to be electro shocked themselves? Leave the classification as it is. Lisa Doughty
I would adamantly like to voice the opinion that electro shock therapy NOT be reclassified as a II instead of it's III status. It is an invasive procedure that already is being abused today---perhaps even more than it has been abused in the past.(I am shocked, for instance, on how the numbers of elderly receiving electro- shock have risen). If anything, this procedure should be outlawed- not made more accessible and less monitored! Please do the responsible thing and do not loosen it's regulation. Chris J Callen
ECT is not the answer!! Mental problems are not answered by removal or destruction of body parts, on the contrary - it only adds to the problem. ECT is a cruel way of maiming a person, a human being. ECT is in violation of Human Rights, the right to choose, and is an imposition by a profession which has nothing to show as positive results, on the contrary. Psychiatry. ECT is an attempt to control and make money by a group of vested interests. ECT is a crime against humanity and is parallel to murder. A zombie is not really a live person. By approving the change of restriction on its use and reducing the responsibility of the money makers to it - you are participants to the crime, which is not what we pay your salaries for. Please, do not change the current status of this cruel operation. Thank you. Heela
In 1975 during a lecture in Neurology at the Los Angeles College of Chiropractic, Dr. J.G. Anderson remarked that ECT had been used in the United States Nevy for punishment. It never helpped anyone and only "made them stupid." Please keep this barbaric proceedure where it belongs, in the archives. David S Minken
Electroconvulsive therapy is a complete misnomer. There's nothing therapeutic about it. People die from it, or lose their memories, it's a proven brain tissue destroyer. Don't be fooled by pyshicatrists who lie to you. They are taking people toward death with these machines, taking people closer to the vegetable end of the spectrum. DO NOT okay these machines for any category of approved device. Pychiatrists are murderers. That is also a proven fact. Peter Myers
Do we live in Natzi Germany that we use such criminal methods as ECT on humans? ECT should be banned - period! The FDA should be doing everything to end this miserable and killing practice immediately. David Douthat
My name is Odelya M. Levy and I am not in favor of ECT. Further I would do everything in my ability to prevent it. It kills. I am stunned to know how the government allow to kill people under the title "medical treatment". Seems to be back to the WWII that the government killed people for the name of the Reich. The Psychitrists kills people under the name of treating them. Go and check how many people are successful after ECT. Which mean have a great condition as self, prosperous family, finance, getting along with their environement etc I doubted if you find ONE that is successfull on all aspects of his life. Again, it is scary to know that something that called ECT is allow to take place in this society. The public doesn't want ECT and at least having less regulation than it does now. Odelya M Levy
The electo convulsive shock machine is the most barbaric, inhumane, evil thing that can be done to another human being. To say that these machines are beneficial or help anyone at all, with the exception of the creeps that manufacture the machines or doll out these treatments, is a balled faced lie. These machines should have been banned from the initial concept and that is the truth. Stan C Tabor
Dear Sir or Madam: This matter is of grave concern to me and should be to everyone in this civilization, having to do with electro convulsive shock treatment device. This device is barbaric and useless--it doesn't treatment anything--it is torture and destroys a mind -- a valuable thing to waste and/or destroy. I met a young person in a hospital once, in the early '70's. She was the daughter of two professors in a major university in the state of Michigan. She told me that she and her brother were going through some personally emotion times after college. Her parents took them both to a psychiatrist. He prescribed her shock treatments after earlier treatment was not helping her. She ended up having 7 treatments. Her name was Regina Curtis and I will never forget her. I used to watch her as she walked through the hospital hallways, having to touch the walls as she walked.
I asked her why she did that and she told me. Because I feel like I'm falling; I have no recollection of my past; my childhood, my education (she was been through a 3 year college, Wayne State University, a sociology major, but now she doesn't remember anything about the schooling there nor much of her earlier education. She felt like she was always walking on the edge of a black hole and would fall in. Her memories were gone. Regina used to wake up in the middle of the night (we shared a room) screaming--blood-curdling screams. Horrible nightmares she told me. She never smiled and was distrustful of everyone, except me and another girlfriend she had met. She told me that she wished she had met me years ago as she felt all she needed was a friend, someone to talk to and confide in but these shock treatments destroyed her life. She always just wanted to die rather than live on like this. This is just one example of he destruction these shock treatments cause. Stop the harming and maming of people; this device should be outlawed and banned from utilization. I pray this stops. Andrea Bernadette Zastawny-Moreno
I asked her why she did that and she told me. Because I feel like I'm falling; I have no recollection of my past; my childhood, my education (she was been through a 3 year college, Wayne State University, a sociology major, but now she doesn't remember anything about the schooling there nor much of her earlier education. She felt like she was always walking on the edge of a black hole and would fall in. Her memories were gone. Regina used to wake up in the middle of the night (we shared a room) screaming--blood-curdling screams. Horrible nightmares she told me. She never smiled and was distrustful of everyone, except me and another girlfriend she had met. She told me that she wished she had met me years ago as she felt all she needed was a friend, someone to talk to and confide in but these shock treatments destroyed her life. She always just wanted to die rather than live on like this. This is just one example of he destruction these shock treatments cause. Stop the harming and maming of people; this device should be outlawed and banned from utilization. I pray this stops. Andrea Bernadette Zastawny-Moreno
ECT has to have stiff regulations because there are physicians that would choose to send high voltage through the brains of patients, frying brain cells and call it “treatment” before looking at alternatives. I would like the FDA Panel actually think about what ECT is. Would you use ECT on your self, your own children, a friend or anyone you cared about. ECT used in interrogation of a Terrorist would be considered a violation of the Geneva Convention as Torture. If ECT is considered Torture to use on a Terrorist to secure information that could save human life, how could any American Citizen endowed with any decency whatsoever consider using this type of treatment on another American citizen or any human being who has committed no crime. I implore the FDA panel to look at this issue and look at the implications of any decisions to make ECT easier to use on our American Citizens or any human being for that matter. George Horton
The electrodes were placed on her head. With the push of a button, enough electricity to light a 50-watt bulb passed through her skull. Her teeth bit hard into a mouth guard. Her heart raced. Her blood pressure soared. Her brain had an epileptic-style grand mal seizure. Then, Ocie Shirk had a heart attack. Four days later, on Oct. 14, 1994, the 72- year-old retired health department worker from Austin, Texas, was dead of heart failure - the leading cause of shock-related death. After years of decline, shock therapy is making a dramatic and sometimes deadly comeback, practiced now mostly on depressed elderly women who are largely ignorant of shock's true dangers and misled about shock's real risks. Some lose already fragile memories.
Some suffer heart attacks or strokes. And some, like Ocie Shirk, die. A four-month USA TODAY investigation found: The death rate for elderly patients who receive shock is 50 times higher than patients are told on the American Psychiatric Association's model ECT consent form. The APA sets the chance of dying at 1 in 10,000. But the death rate is closer to 1 in 200 among the elderly, according to mortality studies done over the past 20 years and death reports from Texas, the only state that keeps close track. To change the severity classification of this suspect and often deadly practice would be unconscionable. Please do allow this to happen. Ed Sachs
Some suffer heart attacks or strokes. And some, like Ocie Shirk, die. A four-month USA TODAY investigation found: The death rate for elderly patients who receive shock is 50 times higher than patients are told on the American Psychiatric Association's model ECT consent form. The APA sets the chance of dying at 1 in 10,000. But the death rate is closer to 1 in 200 among the elderly, according to mortality studies done over the past 20 years and death reports from Texas, the only state that keeps close track. To change the severity classification of this suspect and often deadly practice would be unconscionable. Please do allow this to happen. Ed Sachs
I have treated several people who have tried out ECT. Almost all of them have had severe problems after their ECT treatment. Knowing that energy psychology in most situations will help people overcoming their problems in a faster and less dangerous way I strongly recommend NOT to give ECT a Type 2 label. ECT can damage the brain and body in much more ways than we know about today and since nobody really knows how it functions we should avoid using it at all. Stronger electricity than before is used to overcome the paralysis created by the medication and anesthetics that people get before the body is hit by the current. Since less strong ECT is used as a well known torture instrument throughout the world it is obvious that the body do not get healthier by this intervention. Mats
I was subjected to electric shock. I came to, disoriented and terrified. I escaped after four blasts. Just like with any horror too horrible to be real the next day I had hysterical amnesia. PTSS. Post Traumatic Stress Syndrome. On the bus ride home, I dimly remembered I had been locked up by psychiatry, but none of the details. Hysterical amnesia is what psychiatrists call relieved mental illness. It was a period of strangeness, just being, hysterical laughter, eating, sleeping, a frightful waiting.
Then the Flashbacks. One morning I woke up to the smell of camphor, the oil they had smeared on my temples so the burn would not show on the outside. I exploded into suicidal and homicidal terror. I was committed to psychiatry. Now, knowing I could not trust psychiatrists, I was labeled paranoid schizophrenic. Incredibly still alive, I escaped psychiatry after 31 years via a 12 step program changing me in six months from the terrified child mind to the love-directed, self dependent, adult mind.
Clover Leona Greene
Then the Flashbacks. One morning I woke up to the smell of camphor, the oil they had smeared on my temples so the burn would not show on the outside. I exploded into suicidal and homicidal terror. I was committed to psychiatry. Now, knowing I could not trust psychiatrists, I was labeled paranoid schizophrenic. Incredibly still alive, I escaped psychiatry after 31 years via a 12 step program changing me in six months from the terrified child mind to the love-directed, self dependent, adult mind.
Clover Leona Greene
"Electric shock" and all it's forms have been and always will be a form of torture and have been used in and for that sole purpose . To call it anything else is a fraud that shouldn't be allowed to be perpetrated . Dont allow it. Rolando de la Maza
Frying brain cells and nervous system connections has been frantic desparate cultism since the 40s. Let's not start this "kill the patient to save him" witchdoctorism again please. NEVER has there been credible scientific evidence of positive cure, only suppression of some symptoms along with the personality of the victim (excuse me...patient). But the harmful effects didn't have to be viewed long before a high percentage of these victims (there I go again) kill themselves and sometimes slowly with drugs and medicines or quickly. Please let the promoters of the panacea, use it on themselves first to show it will follow the oath of "do no harm" Rev. Richard M Henley
Oh my! It is hard to believe you are even thinking about easing the regulations on ECT devices. ECT is a barbaric treatment, and these devices should be taken off the market entirely. The lives of people I have known have been ruined by ECT. Please reject this easing of the restrictions. John k Hackbarth
The idea of downgrading from class III to class II ECT devices is suprising and I think wrong. The practice of Electro shock therapy by it or its many other names is questionable at best. To make it easier for there to be sales and distrubution of these devices only contributes to the practice. Keep the device in the class III category and I suggest the opening up of other investigations into the actual efficacy of the treatment. Ray Bunch
RE: ECT Shock Treatment devices: Please do not make these devices less secure. They have ruined lives, destroyed ambition and creativity. I am not aware of any good from these other than short-term emotional sedation through lack of recall. These are really dangerous. I have known three people who have become virtually onfunctional after having this treatment. We sure don't need more problems in the health care arena and we sure don't need more people in a dependent state with the probability of being permanently damaged. Let's look at healthy diets, healthy food and exercise for all Americans and not make these machines more widespread. Janet K Gildersleeve
Dear Sir, I have had three of my family members receive Electo Convulsive Therapy (ECT), my mother, grandmother and step-mother. The results were to leave them each in a zombie like state. This is even years after. Sure they appeared to function in life but they all became distant, less loving and less approachable. The results were in my estimation. criminal. You must regulate the use of ECT devices with the highest restrictions., if not outright outlawed. One only needs to know a loved one before and after ECT to know the use of this "technology device" is both destructive and inhuman. I urge you to keep this device highly restricted and regulated (until such time it becomes outlawed in the USA). Joe Pinelli
I truley believe that a survey on all previous recipients of ECT should be conducted so that the FDA can determine that these devices should be outlawed. There is no clinical proof of any benefit with this type of "treatment". Only harm. ECT is a last ditch effort when psychiatrist don't know what else to do. Thank you. Eric Roland Whittier
I am convinced that electro-shock therapy can be destructive to the patient and/or the patient's family. I believe that this experimentation should continue to be in the highest level of scrutiny and control by the FDA. To be specific, ECT should continue to have a class 3 restriction. Scott Raymond Rainey
Please do not change the current restrictions on ECTs. They are a
barbaric "treatment". Ultimately, you are a spiritual being housed in a
body and to allow yourself or your fellow man to be reduced to the
level of a piece of meat to shock does not help yours or mankind's
ability to survive very well.
Please do us a favor and limit, or better yet, terminate there use. Shane Greene
ECT should not be reclassified from Class III to Class II. This is a barbaric, desperate and highly dangerous-to-the-public "treatment" and should remain in the highest possible regulated classification. I prefer it be investigated and completely banned as a mental treatment alternative, but short of that it should be extremely regulated by the Government as protection for the general public. John Repetto
I am familiar with ECT and from the persons I have encountered that have had this treatment were NOT helped, but harmed. The ECT is used as a torture device in some countries. Perhaps in extreme cases where you have a rabid lunatic assaulting people and harming people, it has been used to make the person more docile or tractable - but on the long term caused irreparable damage to the person. . Such persons can be handled by giving them light soporifics to get them to sleep. Then given a calm environmental area like the mountains with nutrition and helpful techniques to orient the person. This is a humane treatment. Not volts through the guys head! I urge you DO NOT re-classify ECT from Class III to Class II. ECT should be outlawed altogether. Best regards, John Reed
ECT should never be used on anyone. It is a barbaric and evil practice that should be banned permanently! Anyone who advocates for ECT should be given a dosage themselves to see exactly what it is that is being promoted. This Nazi concentration camp excuse for a "treatment" has got to stop it has never helped anyone but kill their brain cells! Sue Whitney
I disagree highly with the use of ECT and urge you to STOP allowing shock therapy anywhere in the US...obviously in my opinion anywhere on planet Earth. It is actually cruelty to mankind and I have even had people that have administered it say they have NO idea if it works and it is experimental. To then use this as a form of therapy is barbaric.
Please stop! - Rebecca Rigney
Please stop! - Rebecca Rigney
It is rediculous to even consider the Electro Convulsive Shock Theapy would "Help" someone. Oh sure - they'll calm down - let's just create a society of zombies. It's just not a good thing to scatter a persons brain with electricity. Shellie Benton
The electric charge going through a person with ECT is largely greater than the charge in your wall outlets and causes damage directly to the brain as well as the nerves in the rest of the body. To say that this isn't as dangerous as once believed, is to say that it's okay to torture people in the name of "help" and "good health". I would not agree to being tortured with electricity when there isn't even a test that can prove I'm being helped or that it's even calculated to improve my condition. I don't see how being shocked is supposed to help me be healthier or happier. I might as well throw a toaster in my bathtub-that's about how effective it is. I've seen patients undergo ECT and they do NOT improve. They are more docile, but they are only vestiges of the people I knew. The person's liveliness and personality are shot with ECT, leaving a virtual zombie in their place.
If torture cured people, then our rape cases and physically abused cases would theoretically be sane and happy. If that's the logic being used by psychiatry to "cure" their patients, my friends and neighbors, then I don't feel that I or my friends, family or neighbors are safe. So, allowing ECT to be more freely distributed and administered, only makes it easier for someone I care about to become a victim. ECT is dangerous as it is, with the numbers dying from it each year, so to market it more broadly is to invite death to our society. Tell me how that sets on your conscience. I know I wouldn't be able to sleep at night, knowing that more people are dying around me, because someone provided better funding to the FDA in order to have them look the other way and relabel one of their tools of torture as a toy. Natalie Marie Pyle
If torture cured people, then our rape cases and physically abused cases would theoretically be sane and happy. If that's the logic being used by psychiatry to "cure" their patients, my friends and neighbors, then I don't feel that I or my friends, family or neighbors are safe. So, allowing ECT to be more freely distributed and administered, only makes it easier for someone I care about to become a victim. ECT is dangerous as it is, with the numbers dying from it each year, so to market it more broadly is to invite death to our society. Tell me how that sets on your conscience. I know I wouldn't be able to sleep at night, knowing that more people are dying around me, because someone provided better funding to the FDA in order to have them look the other way and relabel one of their tools of torture as a toy. Natalie Marie Pyle
BAN ECT!! This device is inhumane and causes more damage to an individual and causes permanent neurological damage as opposed to providing actual treatment of the mind and a persons ills. WAKE UP! By allowing these devices you are putting a death sentence on life.
http://www.cchr.org/videos/psychiatry-an-industry-of-death/brain-damage-psychiatrys-miracle-cure.html Justin Michael
http://www.cchr.org/videos/psychiatry-an-industry-of-death/brain-damage-psychiatrys-miracle-cure.html Justin Michael
I have personally experienced the devastating effects of ECT on others who are in my life, their ability to function and think and remember, the lasting trauma after ECT. I find it very telling that vested interests, such as pharmaceutical companies with no scientific proof of a chemical imbalance in the brain, use this as a marketing tool for psychiatric drugs, yet we are not being told of the actual permanent damage massive amounts of electricity being forced though a brain will do. Brains were not supposed to be exposed to this amount of electricity. I imagine I would go through personality changes myself if that happened to me. I'd probably be more subdued. So, tell me, whoever reads this, pass this on to your colleagues and ask yourself and them if you would expose yourselves and your children to ECT without worry of ill effects? I challenge you to try it yourself and on your children before you deem it safe or effective for the most vulnerable mentally ill or anyone else. Go on, try it! ECT is not safe and causes permanent devastating damage. Don't allow it, or then do it to yourself first to prove it's safe Sincerely Patricia Nicklaus
To whom it may concern, I heard you were considering reclassifying shock treatment machines to a less dangerous category and are accepting public opinions on this matter. As such, I would like to express my view. I have a close relative that received shock treatment many years ago. He was an alcoholic but a decent person. After a disruptive drinking binge he was arrested by the police and sent to an institution where he received shock treatment. After he was released and for the next 50 years he was basically a vegetable and completely useless to sociey as he could no longer hold a job or face people. He became a recluse. I am confident that there were other alternatives that would have left him in the social state that he most often displayed. I also have friends that have had similar experiences. This is very dangerous insrument that does not cure anything and as I have observed tends to remove ones humanity. As far as I am concerned, it should be eliminated altogether as it is clearly a barbaric and inhumane treatment. Short of that, it should certainly not put into a lessoned category. This is a very dangerous machine. Sincerely, John Kretz
We strongly oppose easing the restrictions on ECT machines, which are all too frequently involved in fatalities. We have been involved in the health care field for decades and have seen a great deal of damage from these machines and their use. Any action making it easier to access them would be destructive. Please decline any motion to ease restrictions on this. Sincerely, David Sanders Vision Practice Management David Sanders
Any device that put electricity into the body is not only damaging to the body, but the person as well. All devices of this kind, electroshock therapy, are barbaric in nature and should be bad. The rule should be, if you wouldn't want it done to you, then it shouldn't be subjected to anyone. No one should become a vegetable because there is an opinion that he needs a "personality" change. L Carole Kight
My mother was ECTed as a young girl. I don't think she has ever recovered. Symptoms are listlessness, lack of ambition and depression. So, how is damaging someone's brain supposed to help them? Should we braek spained arms so they are more apt to heal. Nowhere in the medical field is damage condoned as treatment ...except in the psychiatric profession. They are a disgrace to the medical community and should be held responsible for the permanently damaged lives they create.
Keith L. Jarvis
Keith L. Jarvis
First of all, NO one should be able to use and ECT machine on ANY individual, with or without their consent. If you doubt what I am saying, then subject yourself to an ECT "treatment" or two and see how you like it. A person would be jailed if they gave their pet an ECT "treatment" for animal cruelty. Why it is OK to do this to a human when it would be considered cruelty to an animal is beyond reason. Doctors shouldn't be allowed to have these machines. So clearly they should not be allowed in the hands of anyone else. Do NOT make it easier for these machines to be obtained. They should be illegal for ANYONE to have for USE. Jeniffer Lou LeBaron
Absolutely under no circumstances should restrictions on ECT or ECT devices be less restrictive. They should be tightened up further if not banned altogether. The amount of cognitive harm done to people by these barbaric procedures, that I come across while trying to train them, is highly disturbing and amounts to little less than blatant destruction of the mind. Barry N Watson
In 1960, at 15 yrs. old, I had the first
of many "shock" treatments. You can only imagine the horror I went
through as a teenager experiencing these treatments at that time. Over
my lifetime I've had 146 treatments against my will. To my complaints
of long term memory loss I was told that was impossible. To my
complaints of "twitching", PTSD, and hearing loss - again-impossible. I
don't know how I do what I do having had so many treatments but with
therapy 8 hours a week and psych medicines I manage to get by. The
American Psychiatric Association and the manufactures can argue all they
want to reclassify the device to a Calss II and forgo any safety
investigation but the fact remains that this ECT device has long term
side effects that can destroy a persons quality of life. I feel certain
that if a safety investigation was conducted this device would be found
unsafe and would be taken off the market. I don't believe the effect
that ECT has had on thousands of people can be denied. Again, these
devices should be eliminated as "treatment". You may say I'm dreaming
but if you could walk in my shoes and the many thousands of others that
are experiencing the adverse effects of ECT, you would dream my dream
too. Ronda R. Ames
The only result of ECT has been to make people dull, stupid, and barely able to function in life. Please remember that the original ect was done on pigs, and killed them, and upon this basis the psychiatric industry decided it was good for humans. Please do not approve this device...ect...it is barbaric and definitely cruel and inhuman. Man is not a pig. Rozelda Jerrye Albert
The use of these machines should have the utmost restrictions from the FDA. they are high voltage devices which if marketed and sold without proper thought, could kill more people than this already deadly practice does every year. Let's face it, the practice of ECT is barbaric to say the least. Just imagine your child sticking their finger in an electicsl outlet and doing that every day for a week or two. That is essentially what these machines do: pump extremely high voltage through the human body, destorying tissue, and cognitive ability for the rest of a persons life. We are not animals, we are sentient, living humans that dont need to be sold a legalized method of making others more suggestible, nor do we need to open ther door to more unsightly deaths (slow or immediate) from this antiquated technology. Let's get real. Let's grow up. Let's do something effective. Anony
ECT isn't treatment, its torture. It has always been a brain destroying barbaric practice born out of slaughter houses. We ALL KNOW this. the public, doctors, even Psychiatrists. Most people I know no longer believe in the FDA as a regulatory body, but rather an arm of big Pharma and other powerful lobbying groups. Prove me wrong. Prove us wrong. Protect the population from torture in the guise of "treatment". Ron S Meyerson
I have seen what ETC has done to individuals and seen what proper medical handlings have done and believe me, often times there is an un-addressed medical condition causing sever emotional and neurological problems. Using ETC is as effective as a base ball bat in making a person submissive if that is what you want. It does not address the cause of the illness which is what your job actually is. Mark Acciani
ECT does not cure anything. It only makes the human being being "treated" into a zombie. It has no scientific prof of helping anyone. It is a barbarous way to quiet someone down. Please do not allow these machines to be even less regulated than they are now: they are too dangerous already!!! Giovanna Maria Gallo
Anyone with any brains (left) would not allow themselves to be fried with huge jolts of electricity --- one of the most insane, barbaric failures to cure anything in history. So, only those who have evil purposes and no resultant conscience would consider such abuse. There are insane people who get pleasure from torturing others --- witness Nazi concentration camps. Decent, humanitarian people would not treat their dog that way, let alone other human beings. The FDA would only condone such gross treatment if it were a minion of greed for profit and blind to such crimes against humanity. But then, the FDA is already known to be unbelievably corrupt, so go ahead and prove it some more. Gary M. Knutson
I studied psychology and worked in the Eastern Kentucky State Hospital as part of my Abnormal Psychology major. This was in 1967 and 1968. I observed the effects of ECT and other forms of "therapy." The deceptive factor is calling it "Therapy." It was not then nor is now nor is it ever going to be true therapy. It heals nothing. It destroys tissue. It blots the patient's perception of psychic pain that can be treated in many other, non-destructive manners. After four years of studying psychology at 4 different schools it was apparent that "therapy", particularly electric and drug therapies, were devised as masks to cover the failures of the subjects of psychology and psychiatry to deliver meaningful help to mankind. By blasting the patients perception of the pain the psychiatrist pretends he has helped the person. Actually he has impeded or destroyed the person's ability to get better.
Humane therapies that would have worked prior to psychiatric abuse become harder if not impossible to use on the damaged person. The results of ECT are: diminished lifespan, diminished health, increased pre-disposition to suicide, memory loss, personality loss, suppression of creativity and the list goes on. You cannot blast a person's brain with that much electricity and not do damage just as you cannot load a person with toxic petro-chemical drugs and expect improvement. Just as petro-chemical fertilizers stimulate a plant into appearing bigger and greener while diminishing its nutritional content and ability to procreate so damaging the person to get an appearance of improvement is shortsighted and, eventually, malicious. Modern psychology and psychiatry has failed to understand the human mind and calling electroshock "therapy" is the greatest proof of not only its failure but the malignancy of its intent. Stephen Bradford Groton
Humane therapies that would have worked prior to psychiatric abuse become harder if not impossible to use on the damaged person. The results of ECT are: diminished lifespan, diminished health, increased pre-disposition to suicide, memory loss, personality loss, suppression of creativity and the list goes on. You cannot blast a person's brain with that much electricity and not do damage just as you cannot load a person with toxic petro-chemical drugs and expect improvement. Just as petro-chemical fertilizers stimulate a plant into appearing bigger and greener while diminishing its nutritional content and ability to procreate so damaging the person to get an appearance of improvement is shortsighted and, eventually, malicious. Modern psychology and psychiatry has failed to understand the human mind and calling electroshock "therapy" is the greatest proof of not only its failure but the malignancy of its intent. Stephen Bradford Groton
Keeping it simple, ECT is nothing more than a torture device. It aims at removing the symptoms of sporadic thoughts and actions by killing the brain. The solution is easy, solve the problem of malnutrition and emptiness by using nutritional therapy and building community. Those who are at risk of ECT are the ones who will miss out on the rest of their lives because some ignorant (about True Human Nutrition) medieval witchdoctor performed inhumane torture. Please ban these devices completely or use them only on those who believe it will help others. Similar to a retroactive abortion. Dick Mine Hamhead
I am fully agaist ECT and feel that it destroys people. There are already so many people in the world already destroyed due to the Psychiatry and ECT that I do not feel it should be promoted at all. I am 100% a gainist it. People who promote ECT should get ECT first and then tell the world How they feel! Any reduction in the regulation of ECT I am FULLY againist. Laurie Halligan
I am an American writer living and working in Montrose, California. For some years, since learning that the FDA has issued approval on the use of ECT machines, I have not been able to shake the general sense of disbelief over such a policy at the federal level. Does the FDA not know that there is actually not a single meaningful difference between the use of ECT to "help" the deeply distressed people of this society than the water torture or beatings delivered at Bedlam hospital these centuries past?
There is no more science to the electrocution of people to "improve" them than there was to near drowning of the insane two hundred years ago. All the professorial psychiatric nonsense in the world doesn't change ECT from what it actually is: a barbaric, inhumane "treatment" serving only to highlight the depth of primitive depravity of those devising, condoning or prescribing such tortures to helpless people. That a modern "doctor" throws a switch on a bound and gagged victim does not in the least lessen the crime done to these people. That the FDA would further make the devices used in this unconscionable assault on American citizens less subject to scrutiny and oversight is just not acceptable. Before FDA signs off on this, each reviewing member should put himself in the place of these intended victims, all of them grist to the mill of psychiatric drooling for profit regardless of the harm done. Would the FDA member like to see himself, his loved one, distressed by whatever difficulties in a too often hard and violent world, lying on that steel gurney with some charlatan's hand poised to send high voltage ripping through their own or loved one's brain? Would the FDA sleep well at night knowing they had consented to the torture of a family member? Well, why be party to this institutionalized criminality against fellow beings to fill the coffers of a completely morally bankrupt profession? I urge you: DO NOT facilitate ECT further. Richard Sullivan
There is no more science to the electrocution of people to "improve" them than there was to near drowning of the insane two hundred years ago. All the professorial psychiatric nonsense in the world doesn't change ECT from what it actually is: a barbaric, inhumane "treatment" serving only to highlight the depth of primitive depravity of those devising, condoning or prescribing such tortures to helpless people. That a modern "doctor" throws a switch on a bound and gagged victim does not in the least lessen the crime done to these people. That the FDA would further make the devices used in this unconscionable assault on American citizens less subject to scrutiny and oversight is just not acceptable. Before FDA signs off on this, each reviewing member should put himself in the place of these intended victims, all of them grist to the mill of psychiatric drooling for profit regardless of the harm done. Would the FDA member like to see himself, his loved one, distressed by whatever difficulties in a too often hard and violent world, lying on that steel gurney with some charlatan's hand poised to send high voltage ripping through their own or loved one's brain? Would the FDA sleep well at night knowing they had consented to the torture of a family member? Well, why be party to this institutionalized criminality against fellow beings to fill the coffers of a completely morally bankrupt profession? I urge you: DO NOT facilitate ECT further. Richard Sullivan
I write you as a concerned individual, a member of the California Network of Mental health Clients, and as a member of the Monterey County Mental Health Commission. I feel the "success rate" of ECT using neurological devices is not only low, but it means that 70% or more of the time, the device's application fails to act as intended. This high rate of failure includes negative consequences for patients that extend far beyond the application of ECT. Research is showing patients receiving treatments for mental health issues respond better to other supports. I urge you to restrict even further any use of neurological devices until safer, more consistent results are available. Cecile Mills
ECT should not be made legal at a lower level of selling. It is a life threatening machine that HAS to be monitored at the highest level. There have been many deaths associated with this machine. Witness the shut down of Italy Institutions that had being using this and the people who were taken out of these institutions who were totally messed up. This machine is a danger to all who it gets used on and should be made illegal in general. Sandy Elaine Acciani
Do not allow this to go any further. This is one of the most egregious assaults on humanity. The effects on brain tissue are permanent. I have seen many patients who have had this done and have always regretted it. The fact that psychiatrists and neurosurgeons have resorted to this reflects their wanton inability to actually know how the mind and spirit actually work, so they resort to any means to incapacitate a person and then create research which they interpret their own way to justify it's use. They have place millions on medication and now they want to destroy their minds with finality. Stop this insanity! I remember one woman who had a husband that abused her physically and her psychiatrist recommended 5 separate shock treatments. He couldn't solve her problem so he found a way to shut her up, Shock Treament. Zenon M. Duda
We and other electroshock survivors worldwide find it outrageous even to consider reclassifying 'ECT' machines from class iii to class ii. This adds insult to injury as from 1976 'ECT' never went through the approval progress now required for new decives by the FDA. Class ii does not require proof or efficacy of safety. Members of MindFreedom Ireland cannot be present on the 27th of January. We speak for ourselves and many people who we have met and contacted over the years. If you care about our lives please do NOT reclassify these products. However, you need to make sure these devices are safe and effective. We do not believe they are. Scientific evidence to date continues to show that 'ECT' has no longterm benifical effect. It causes much more harm than good. www.mindfreedomireland.com, Mary Ellen Maddock
This is one more horrific bad judgment on the part of the FDA..can you please tell me to whom you are working for? You 'ok' companies putting fluoride in drinking water and toothpaste...knowing it is a toxic by-product. You allow monsanto to sell and produce aspartame, calling it 'hollywood' names like 'nutrisweet', knowing the side-effects that exist. You ban cigarettes, and yet, allow the drug companies to promote HIGHLY addictive drugs to be aired on television with no back off on naming the side effects of each...but glorify their use. NOW, even contemplating changing the category of ECT use. This is criminal. I have seen first-hand what people are like AFTER having ECT. It is a tragedy. People do not snap out of it, and they are no longer themselves. Just a smokey shady of what was once a vibrant human beings. Human beings do have occasional problems and set backs. Allow people to be human without stepping in and drugging them into silence, or shocking them into quietness and silent dispair! Mary Imburgia
The fact that ECT still exists is literally terroristic. Especially to people who are already frightened. This is hell on Earth. I've heard story upon story from relatives of people who have died from ECT. If you permit this, you permit cruel and unjust practice-genocide of the soul, which is Blasphemy-if not also to the body. Rose E Dimond
Dear Sirs, I know people who have been irrepairable damaged from ECT. I know a man who lost his entire memory permanently. It has been over 10 years and still he does not remember his life or his loved ones prior to ECT. Other's I have met have partial permanent memory loss from ECT. Please do not make this horrible treatment any easier to deliever. Personally I would like to see this treatment banned. Carol Horton
To: FDA, DEPARTMENT OF HEALTH AND HUMAN SERVICES RE Docket No. FDA-2010-N-0585 Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting I am outraged to find that ECT is still on the docket and still being considered as a legitimate tool to assist people with their human issues. Since when has electricity, sent through the brain, ever been successful at helping anyone or any test animal for that matter? How many of the people on the panel and in your meeting are willing to go through that treatment personally? How many have actually seen the results first hand? In the face of all the psychiatric "help" which has been foisted on Americans for decades, this issue is a waste of time and the tax payers money not to mention criminal to the human soul. It is fraud to even suggest that this device can help anyone. The ECT device should be outlawed not elevated in status or use. Respectfully, Sigal
I would like to invite each member of the Devices Panel to 1. witness ECT being done and also 2. volunteer to be given ECT treatments. It's torture, plain and simple and should be outlawed. Those who are still engaging in this barbarism should receive ECT themselves (that would finish them) or just be arrested. This is NOT TREATMENT. IT'S PUNISHMENT AND IT'S RESPONSIBLE FOR BRAIN DAMAGE AND SUICIDES. It must be outlawed, not made easier to administer, especially to young people and the elderly. Caralyn B Percy
Please do not let ECT have less regulations. It is harmfull enough to people who receive it. It should not be less controlled. ECT is going to be used on a lot more people without the proper regulations. IT hasn't proven to be WORKING for God's Sakes. Is money more important to Psychiatrists then people's lives? Can't you see it? Why are you agreeing with them? It's all about money, pure and simple. There is NO cure by using ECT. Hanna Zetzer
Absolutely under no circumstances should restrictions on ECT or ECT devices be less restrictive. They should be tightened up further if not banned altogether. The amount of cognitive harm done to people by these barbaric procedures, that I come across while trying to train them, is highly disturbing and amounts to little less than blatant destruction of the mind. Barry N Watson
Electroconvulsive therapy (ECT) devices are neither particularly safe, nor particularly effective, and should remain classified as "high-risk" devices until adequate safety and efficacy trials – the very basic kind the FDA requires for any medication – have been conducted. ECT doesn’t appear to be effective in the majority of cases where it is used — its efficacy in fact varies from about 25% to 65% (see, for example, Eschweiler, et. al., 2007; Kellner, et. al. 2006; Kho, et. al., 2005). One of the few studies that has assessed longer-term memory deficits found that at a 6-month follow, deficits "persisted for the measure of global cognitive status and the primary outcome measure that assessed retrograde amnesia for autobiographical events" (Sackeim, et al. 2007). These are significant and potentially debilitating side effects. Memory loss and other cognitive deficits remain a significant concern in ECT treatments. Despite over 40 years of research, there remain very few longitudinal studies on ECT;
even fewer that look at cognitive deficits and memory loss (as opposed to simple symptom relapse). Add to that that many of ECT's leading researchers and textbook authors receive direct financial benefit from the sale of ECT machines, and you have an industry ripe for continued exploitation of unsuspecting patients. References Eschweiler, G.W. et. al. (2007). Clinical efficacy and cognitive side effects of bifrontal versus right unilateral electroconvulsive therapy. J of Aff Dis, 101, 149-157. Kellner, C. H. et. al. (2006). Continuation Electroconvulsive Therapy vs Pharmacotherapy for Relapse Prevention in Major Depression. Arch Gen Psych, 63, 1337-1344. Kho, K.H. et. al. (2005). Predictors for the Efficacy of Electroconvulsive Therapy: Chart Review of a Naturalistic Study. J of Clinical Psychiatry, 66, 894-899. Sackeim, H.A., et al. (2007). The cognitive effects of electroconvulsive therapy in community settings. Neuropsychopharmacology, 32, 244-254. John M. Grohol, Psy.D
even fewer that look at cognitive deficits and memory loss (as opposed to simple symptom relapse). Add to that that many of ECT's leading researchers and textbook authors receive direct financial benefit from the sale of ECT machines, and you have an industry ripe for continued exploitation of unsuspecting patients. References Eschweiler, G.W. et. al. (2007). Clinical efficacy and cognitive side effects of bifrontal versus right unilateral electroconvulsive therapy. J of Aff Dis, 101, 149-157. Kellner, C. H. et. al. (2006). Continuation Electroconvulsive Therapy vs Pharmacotherapy for Relapse Prevention in Major Depression. Arch Gen Psych, 63, 1337-1344. Kho, K.H. et. al. (2005). Predictors for the Efficacy of Electroconvulsive Therapy: Chart Review of a Naturalistic Study. J of Clinical Psychiatry, 66, 894-899. Sackeim, H.A., et al. (2007). The cognitive effects of electroconvulsive therapy in community settings. Neuropsychopharmacology, 32, 244-254. John M. Grohol, Psy.D
To the Federal Drug Administration Please do not reclassify electric shock therapy to class 2 from class 3. My Uncle died from this procedure as it was not deemed to be effective . He was then administered pre-frontal lobotomy which did finally kill him.
His first symptom as a prominent attorney was sadness. He was administered drugs to correct this condition and each treatment made his condition worse. We are already a drug fueled society and we don't need more lapses by our health professionals to exascerbate the conditions. Thank you for your consideration to this matter. Elizabeth Sugg
His first symptom as a prominent attorney was sadness. He was administered drugs to correct this condition and each treatment made his condition worse. We are already a drug fueled society and we don't need more lapses by our health professionals to exascerbate the conditions. Thank you for your consideration to this matter. Elizabeth Sugg
Electro Convulsive Therapy, better known as shock treatment, is a barbaric method developed by Spanish fascist Muniz based on the idea that "loco" cows can be calmed by a severe blow to the head. The procedure destroys brain cells, a form of menticide, and creates petit mal seizure responses from the electric shock. Destruction of long term memory is common as well as disorientation and interference with the ability to concentrate according to the victims. Suicide is a common "side effect" that follows the treatment, even though it has been touted as the cure for suicidal tendencies. Author Earnest Hemmingway, who killed himself following the treatment, said "What the doctors don't understand is that for a writer, our memory is our capital."
Dr. Peter Beggin has written about Electroshock: It's Brain Disabling Effects, and a good historical review has been compiled by victim Leonard Frank. This "treatment" applied elsewhere on the body would be seen as torture, and it should be abolished as dangerous and harmful by the FDA, which has allowed many psychiatric "treatments" on the market which could never be approved as food or medicine otherwise given their deleterious effects. Failing that, fully informed consent, minimal levels of current and frequency, and follow up studies on results should be minimal, including some oversight and patients rights to refuse at any point being part of the regulations. Better to end it completely in my view, as many other psychiatric tortures have become obsolete. Please listen to the victims who plan to attend your public hearings on this matter. Some years ago I attended a similar event at NIH where "Truth in Psychiatry" members asked for informed consent forms and were ignored. One of them told me she had been in the Navy as a cryptographer and had broken the East Wind code that alerted them to the Pearl Harbor attack. She was immediately given a serious of electroshocks which ruined her recall of this even for years. John Patrick Judge
Dr. Peter Beggin has written about Electroshock: It's Brain Disabling Effects, and a good historical review has been compiled by victim Leonard Frank. This "treatment" applied elsewhere on the body would be seen as torture, and it should be abolished as dangerous and harmful by the FDA, which has allowed many psychiatric "treatments" on the market which could never be approved as food or medicine otherwise given their deleterious effects. Failing that, fully informed consent, minimal levels of current and frequency, and follow up studies on results should be minimal, including some oversight and patients rights to refuse at any point being part of the regulations. Better to end it completely in my view, as many other psychiatric tortures have become obsolete. Please listen to the victims who plan to attend your public hearings on this matter. Some years ago I attended a similar event at NIH where "Truth in Psychiatry" members asked for informed consent forms and were ignored. One of them told me she had been in the Navy as a cryptographer and had broken the East Wind code that alerted them to the Pearl Harbor attack. She was immediately given a serious of electroshocks which ruined her recall of this even for years. John Patrick Judge
I am wholeheartedly opposed to the FDA reducing the classification of Electric Shock machines from Class III to Class II. As a Registered Nurse who has worked with patients who have had shock therapy, I am very aware of the damaging effects of these machines - the public should be informed of the effects on the individual and their families who then have to care for them. The FDA should be responsible for the citizens they serve (the American public) and test these machines for efficacy and harmful effects. Until they see the damage on brain cells and the resultant horrific effects on the patient and family the FDA is being totally irresponsible! Patty L. Cota
Docket #FDA 2009-N-0392 The electric shock machines have never been FDA tested for safety. The purpose of the machine is to produce a convulsive seizure (ECT = Electro Convulsive Therapy). Ask any neurologist or even a family practice physician, and you find that convulsions are caused by something which adversely affects brain tissue: toxins, encephalitis, trauma, and
so forth. A convulsion is damage, not therapy. Electrodes are placed on the outside of the head, so it is impossible that there
is some specific brain area targeted. Even if there were a specific target, recent publications show that assertions based on function MRI scans are based on specious data. These tests (often cited as showing specific brain areas having specific function), have been shown to be of little value. In a recent issue of Science News, dramatic functional results were obtained when the instrument was used on a dead salmon. It is criminal to allow the use of these ECT devices with no proof of safety or efficacy, and the concept of avoiding scrutiny by making electric shock machines a Class 2 device is a criminal abuse of the public trust. Despite their long and lucrative use by the psychiatric profession, electric shock machines are dangerous and untested. Keep it Class 3, test the device and let the public know. Thomas Everett Mobley
so forth. A convulsion is damage, not therapy. Electrodes are placed on the outside of the head, so it is impossible that there
is some specific brain area targeted. Even if there were a specific target, recent publications show that assertions based on function MRI scans are based on specious data. These tests (often cited as showing specific brain areas having specific function), have been shown to be of little value. In a recent issue of Science News, dramatic functional results were obtained when the instrument was used on a dead salmon. It is criminal to allow the use of these ECT devices with no proof of safety or efficacy, and the concept of avoiding scrutiny by making electric shock machines a Class 2 device is a criminal abuse of the public trust. Despite their long and lucrative use by the psychiatric profession, electric shock machines are dangerous and untested. Keep it Class 3, test the device and let the public know. Thomas Everett Mobley
This is regarding the ECT re-classifying to Class II. This machine is a brutal and in-humane way to "treat" mental disorders. How can any person consider something helpful which blasts voltage into someone's brain? The result of the machine is a vegetable state, rendering the person incapable of routine abilities, the more it is applied. I really question the intention of someone who feels they have to drug and shock and put persons into a vegetable state. Please reconsider the consequences of usage of this machine and work to get it BANNED. Thank you Barry Matson
ECT is a massively invasive treatment that boarders on barbaric. If anything it needs to be me more restricted, not less. The data do not support the claimed benefits of ECT treatment. I believe there is even one organization offering any prescribing Doctor $10,000 to undergo ECT themselves. In 20 years there have been no takers. Consider this a clear comment AGAINST the lowered regulatory status of ECT and ECT related instruments. John Nesbit Atlanta, GA
We live in the 21st century for god's sake! Please stop this madness. From the previous years we all realised that if you want to turn a human being into a vegetable you electrocute him. It's clear to me that whoever takes the decision to apply electroshock definitely is against human race, against values such as honesty, love towards our fellowman. I want to ask all these people that are in favor of this cruel practice: Would you apply this to your children or even to yourselves if needed? Olga Papadopoulou
The International Campaign to Ban Electrosck (ICBE) based in Ottawa, Canada (URL) http://intcamp.wordpress.com is submiting comments re electroconvulsive machines. Contact: sue.clarl.wittenberg@gmail.com THE ICBE is concerned about: - the safety issue of the machines - the damage produced by these machines as proven in numerous studies and scientific tests that prove these machines always cause brain damage. see breggin.com for more info on this - Sue Clark-Wittenberg's heart stopped on her 5th electroshock in 1973 at the Brockville Psychiatric and had to be revived. A test at the Ottawa General Hospital in 1995 deemed Mrs. Sue Clark-Wittenberg to have a limited memory. As a result Sue has difficulty learning anything new. - these machines should be taken off the market completely. - the ICBE deems electroshock to be unethical, barbaric and a crime against humanity. Sue Yvette Clark-Wittenberg
The evidence is overwhelmingly not in favor to re-classify ECT. I would be hard-pressed to come up with a more barbaric treatment for mental problems than this device. Do the humanity a favor and refuse to re-classify this thing. How it ever came to be a "medical device" in the first place is beyond sensibility. Kyle T Williams
My experience with ECT, then termed EST (Electro Shock Therapy), began in 1964 with a medical school lecture. The sedated adult was strapped to a platform, bilateral skull electrodes attached, and current turned up until a marked grand-mal convulsion could be viewed from any point in the large hospital amphitheater. As a psychiatric intern (1966-67) I watched ECT applied to15-30 patients, mostly with a diagnosis of depression or schizophrenia. While remarkable partial remissions sometimes fueled enthusiasm, characteristic brief relief required repeat application. Dr. Ewen Cameron, one of my mentors and head psychiatrist at the VAH, observed “a proportional relationship [exists] between the number of electroshocks given within a period of time and the extent of the amnesias." In four decades in several states, I confirmed the correlation of repeat maintenance ECT with mnemonic dysfunction. In 1999, as a psychiatric consultant in a challenging case of acute-onset malignant catatonia
(after telephone discussion with ECT expert Dr. Max Fink), I recommended ECT. After six months and twenty-two consecutive ECT sessions the patient evidenced delusional psychosis, marked autobiographical memory deficits, and continued fluctuating catatonia. Studies from the past decade, including a recent 2010 meta-analysis of ECT reports, consistently find variable prolonged retrograde memory deficit. In this respect, the words of Dr. Cameron reverberate: "memory is the bastion of his being. Without memory, there is no personal identity, there is no continuity to the days of his life." ECT device manufacturers should be required to submit safety and efficacy data. The witholding of negative data on the part of ECT manufacturers, distributers, facilities, and privileged ECT specialists remains suspect. The absence of such data entails that ECT treatment of patients is little more than unacknowledged experimentation on humans absent their knowing consent. Seth E Many
(after telephone discussion with ECT expert Dr. Max Fink), I recommended ECT. After six months and twenty-two consecutive ECT sessions the patient evidenced delusional psychosis, marked autobiographical memory deficits, and continued fluctuating catatonia. Studies from the past decade, including a recent 2010 meta-analysis of ECT reports, consistently find variable prolonged retrograde memory deficit. In this respect, the words of Dr. Cameron reverberate: "memory is the bastion of his being. Without memory, there is no personal identity, there is no continuity to the days of his life." ECT device manufacturers should be required to submit safety and efficacy data. The witholding of negative data on the part of ECT manufacturers, distributers, facilities, and privileged ECT specialists remains suspect. The absence of such data entails that ECT treatment of patients is little more than unacknowledged experimentation on humans absent their knowing consent. Seth E Many
The electric shock devices that are used are barbaric and mid-evil. By you lowering their threat simply means you have not watched someone be electro shocked. This is a joke of sorts as no one deserves to be tortured like this under the guise of "therapy". Let the world know how dangerous these things are. Joan L Ramm
The reclassification of the ECT device to Class II in the absence of adequate scientific evidence of its safety is a mistake that just cannot be made. Going down in history as the barbarians of modern society is not something that we should be partaking in. These are people's lives. It is well known that forced seizure through electric shock CAN have almost miraculous results, but the overactivation to the amygdala and hippocampus is detrimental to learning and memory. I am just a sophomore in a state college, so I don't know the specific in's and out's of Electroconvulsive Therapy, but I do know that electricity is not something we have mastered just yet. And shocking the outside of the brain, to get to something in the middle doesn't seem anywhere near exact. The the mesolimbic pathway (target area) is surrounded by multiple brain areas, and not only holds the key to reward (the goal) but is tied very closely to memory and learning. Even goal seeking (appetitive) behavior. Unless you are purposely trying to make a certain group of the populace a group of mindless zombies, I implore you to look closer at how dangerous this technique truly is. Anonymous
I am concerned that this action will make it so that electric shock devices will no longer be regulated which opens up the door
to more abuses and more deaths. Dr. Peter Breggin covers the debilitating and scary effects of electroshock therapy on his website at http://www.breggin.com/index.php?option=com_content&task=view&id=40. An excerpt: "Patients given ECT are administered an electric current of sufficient intensity and duration to produce an acute organic brain syndrome, characterized by the classic symptoms of disorientation to time, place, and person; mental deterioration in all intellectual spheres such as abstract reasoning, judgment, and insight; emotional lability with extremes of apathy or euphoria; and overall childlike helplessness." I have also attached an excerpt from the Citizen's Commission for Human Rights that goes over ECT. ECT devices should remain regulated. Sincerely, Tim Stoner Business Owner
to more abuses and more deaths. Dr. Peter Breggin covers the debilitating and scary effects of electroshock therapy on his website at http://www.breggin.com/index.php?option=com_content&task=view&id=40. An excerpt: "Patients given ECT are administered an electric current of sufficient intensity and duration to produce an acute organic brain syndrome, characterized by the classic symptoms of disorientation to time, place, and person; mental deterioration in all intellectual spheres such as abstract reasoning, judgment, and insight; emotional lability with extremes of apathy or euphoria; and overall childlike helplessness." I have also attached an excerpt from the Citizen's Commission for Human Rights that goes over ECT. ECT devices should remain regulated. Sincerely, Tim Stoner Business Owner
Having been raised by two psych majors and and with many years experience being around the subject, I can say without doubt that ECT is extremely harmful and provides NO benefits. The machine MUST be banned from use and banned from manufacture world-wide. Anonymous
To allow this device "electro-shock" "therapy" to be allowed to be used as a "medical tool" is like saying the electric chair is a vitamin. It's insanity. I hope this can be read by a person with a heart that will guide their decisions on how crazy it is to shock people. I say if you want to know what a weapon like that feels like, try it on yourself. Tesla helped bring directed electrons, light and communications with the dream of a peaceful healthy planet. An African man who never received credit invented the refrigerator. You can do your research if you want to know his name. That's a good invention. This device and many pharmaceutical chemical "patents" are a disgrace to humanity. Enough to make a well paid Organic Chemist _quit_ working for Eli Lilly. http://www.cchrint.org/videos/experts/shane-ellison/ Please start caring about people's lives, families, and hearts and minds. They're all connected... a device like that will cause harm. People are batteries to throw away. Peace, T.B
As a survivor of psychiatric mistreatment and an educated psychotherapist and trauma specialist, I urge you to regulate the use of electro-convulsive "therapy" as a LAST RESORT prescription under the strictest of guidelines. The issue alone of selectively informed consent that includes deliberate misinformation and absence of facts presented to most individuals for whom this is proposed should be enough to warrant severe limitations on the use of this dangerous procedure. The interference with memory, mood, and the capacity to participate in alternative treatments, no less many tasks of everyday life, are not short-term but long-term both consistently and intermittently for many more individuals than psychiatrists and manufacturers of e.c.t. equipment, no less insurance companies, would have one know. Please end as soon as possible this particular form of psychiatric abuse and begin to support humane and fully informed choices for those in psychiatric "care." M.W. Auslander
Please know that I am COMPLETELY OPPOSED to the reclassification of ECT ( Electro Convulsive Therapy) devices from Class III to Class II status. The fact that these devices have not already been banned by the FDA is really unbelievable. The question you might want to ask yourself is...would anyone who uses these devices to electroshock their patients be willing to
be electro shocked themselves? Leave the classification as it is. Lisa Doughty
be electro shocked themselves? Leave the classification as it is. Lisa Doughty
Electro Convulsive Therapy or 'ECT' should never be administered to a living person. 'ECT' causes permanent and irreversible damage to the persons' health and shortens life expectancy. I am opposed to its even being categorized as "therapy". It has no curative or healing properties and simply brutalizes people into a different and worsened state. Raoul
Based on my personal irrefutable knowledge, I implore you to NOT down-classify electro-convulsive therapy (ECT) from class III to the less-restrictive class II. Even as a class III therapy, ECT was used by a male criminal psychiatrist to victimize the beautiful wife of a friend. He kept her sequestered in his clinic—without notifying her family—on a bogus 72-hour hold for an entire weekend. Her family did not learn her whereabouts for three days. ECT and its accompanying drugs were used to blot out all memory of the events. Evidence of her rape was equivocal, so his credentials protected him. Upon leaving the clinic, her once-vivacious personality was wiped away. She sat motionless for hours, not wanting to dress or bathe.
If ECT is down-classified to a class II therapy, even more criminal male psychiatrists will be able to use ECT and its concomitant narcotics to victimize female patients before and after the ECT. Then the victims will have no memory of their attacks or attackers. The oversight will be less, the inspections fewer, the policing more lax. ECT is an iffy and randomly successful therapy at best. When you randomly stir the stew, will a carrot come to the top? Please do not relax even one small bit the already dodge-able restrictions on this pseudo-therapy that too often maims bodies and ruins minds, and is so easily misused for the pure evil that my friend's family suffered. Jon E. Von Gunten
If ECT is down-classified to a class II therapy, even more criminal male psychiatrists will be able to use ECT and its concomitant narcotics to victimize female patients before and after the ECT. Then the victims will have no memory of their attacks or attackers. The oversight will be less, the inspections fewer, the policing more lax. ECT is an iffy and randomly successful therapy at best. When you randomly stir the stew, will a carrot come to the top? Please do not relax even one small bit the already dodge-able restrictions on this pseudo-therapy that too often maims bodies and ruins minds, and is so easily misused for the pure evil that my friend's family suffered. Jon E. Von Gunten
"A case is before the Unites States Supreme Court and the U.S. Solicitor General involving the misuse ofECT and citing Appeal cases: In re Winifred Branning, ECT found unconstitutional, Johnson v Florida, ECT potential for abuse, torture, and mind control. See also: Operation Paperclip, Monarch, Bluebird, and MK ULTRA, sponsored by the CIA. Also, 42 U.S.C.12131, failing to protect patients from harm, 42 C.F.R 46.116, failure to provide informed consent for treatment, and Amendment IX to the United States Constitution, State governments can no longer deny citizens the rights and privileg.es listed in the Bill of Rights. ECTis a violation of Human Rights, and it doesn't work. If someone wants ECT, they can just as well take psychiatric drugs, because they permanently damage the brain. ECT has caused death, grand mal seizures and many other permanent damages to human beings. Stop the carnage." ECT Device hearing January 27, 2011 To: Neurological Devises Panel of the Medical Devices Advisory Committee, Date: Jan 22, 2011 Document ID: FAD-2010-N-0585-0001: Darlene C. Sammarco
I am writing as a psychiatrist to urge the FDA to reclassify ECT devices as a Class II device based on the strong evidence of ECT's safety and efficacy. I have been administering ECT regularly for 23 years and conducting international research in ECT for 16 years until now. The evidence base for its efficacy in major depressive disorders is of the highest level and far exceeds that of any medications or other treatments. Moreover, a substantial number of studies in ECT demonstrate a high level of efficacy in treating mania, catatonia, and acute psychotic disorders. ECT is an essential and often a life-saving treatment for some of these patients' groups. This evidence base of ECT?s efficacy and safety are well recognized by the APA, the AMA, the NIMH, and by many other similar organizations in almost all countries worldwide.
At present, there has been no evidence that ECT damages the brain. According to our surveys of the practice of ECT in Asia (34% response rate) and Australia (83% response rate) conducted between 2002 and 2004, approximately 50,000 patients were administered 300,000 ECT treatments during one year before our surveys. The efficacy and the safety of ECT treatment are properly recognized by the psychiatrists and the patients and their relatives in those countries. The pre-anesthetic assessment of the patients' medical condition was always examined carefully before prescribing each treatment.
We have to move forward to further improve the efficacy of this excellent psychiatric treatment and to increase the accessibility of ECT to most patients who really need it. The proper guidelines for ECT use have already been developed by the World Bodies (e.g., the APA, the Royal College of Psychiatrists) and have been regularly updated several times. Changing the classification of the ECT devices will inevitably lead to a substantial decrease in its use so that a large number of patients would have been suffered from these treatable psychiatric disorders. Worrawat Chanpattana
At present, there has been no evidence that ECT damages the brain. According to our surveys of the practice of ECT in Asia (34% response rate) and Australia (83% response rate) conducted between 2002 and 2004, approximately 50,000 patients were administered 300,000 ECT treatments during one year before our surveys. The efficacy and the safety of ECT treatment are properly recognized by the psychiatrists and the patients and their relatives in those countries. The pre-anesthetic assessment of the patients' medical condition was always examined carefully before prescribing each treatment.
We have to move forward to further improve the efficacy of this excellent psychiatric treatment and to increase the accessibility of ECT to most patients who really need it. The proper guidelines for ECT use have already been developed by the World Bodies (e.g., the APA, the Royal College of Psychiatrists) and have been regularly updated several times. Changing the classification of the ECT devices will inevitably lead to a substantial decrease in its use so that a large number of patients would have been suffered from these treatable psychiatric disorders. Worrawat Chanpattana
My name is John Read. I am a Professor in the Psychology Dept. of the University of Auckland, New Zealand. Before entering adademia in 1994 I worked as a Clinical Psychologist and manager of mental health services in the USA, the UK and New Zealand. I have assisted in the adminstration of ECT - as a nursing attendant, many years ago. Professor Richard Bentall of the University of Bangor (UK) and I have just published a review of the research on the efficacy and safety of ECT in an international peer-reviewed journal. This review finds that ECT is ineffective for the majority of people receiving it and causes memory loss - sometimes permanent - for a significant number of recipients. We found no evidence that it prevents suicide,
as is often claimed. We also found that the memory loss is caused by the ECT and not, as often climed, by the depression.
We formally submit this paper (attached) for consideratoin in the forthcoming deliberations of the Neurological Devices
Panel on January 27-28, 2011. John Read
as is often claimed. We also found that the memory loss is caused by the ECT and not, as often climed, by the depression.
We formally submit this paper (attached) for consideratoin in the forthcoming deliberations of the Neurological Devices
Panel on January 27-28, 2011. John Read
I being a Mental Health Consumer for more than 15 years have seen the affects of this on fellow MH consumers and realize that this is cruel and nor a trust worthy method of serving people with a Mental Illness. I have been seeing people lose what self esteem they had be lost with ECT . Please study more and employ us who can do Peer Support that will make a difference in the life of our friends and MH consumers do not believe that electrical devices can do more than what Human Compassion can accomplishI have helped many more through Human speech, laughter and touch than science ! Gina Mary Jones
Please reassess the current scientific evidence regarding what ECT devices actually do inside the brain. I believe you will find no credible scientific evidence that suggests we know what is happening inside the brain when ECT devices are used. And it follows logically that, If we do not know that is happening, we cannot justify their use as valid, verified, scientific, medical "treatment." Therefore, ECT devices are more like an experimental process (on human brains) than a real, effective medical treatment. Robert E. Emerick, Ph.D. Professor Emeritus Department of Sociology San Diego State University San Diego CA
As the director of MindFreedom International, I can say we've heard from survivors of heart breaking significant memory and cognitive problems related to electroshock. It's incredible that after 70 years of use, this is one of the very few devices in all of medicine that has never been fully investigated for safety and efficacy. I've invited MindFreedom members to show there is widespread public concern about the abuse, corruption, and human rights violation inherent in the use of electroshock in the USA, and internationally. Perhaps it will take another book like "The Jungle," that helped launch the FDA, to illustrate that those who are marginalized by our society -- such as the elderly women diagnosed with depression typically targeted by electroshock -- have a right to expect comprehensive FDA oversight of one of the most controversial devices in medical history.
Sincerely, David W. Oaks, Director, MindFreedom International
Sincerely, David W. Oaks, Director, MindFreedom International
I am commenting on behalf of MPOWER, a Massachusetts statewide organization run by and for people with lived experience and/or trauma. MPOWER is very against the FDA downgrading ECT to a Class II device. ECT carries tremendous risk and has never been proven to be safe or effective. Many of our members have had ECT in the past and all have reported permanent memory loss. Many were coerced into agreeing to ECT when they were so desperate for relief from depression. It is our hope that ECT will eventually be banned as it causes brain damage. We hope that in fifty years ECT will be viewed in the way we now view ice baths---an archaic and barbaric attempt at "treatment" for mental illness. Again, MPOWER urges the FDA not to give in to the wishes of the industry that profits from the sale and use of the ECT machines. We urge the FDA to not downgrade ECT from a Class III device. Thank you for this opportunity to comment. Ruth Ann Poole
Dear Sir, The currently used procedure used by the industry to administer ECT causes brain damage, cognitive dysfunction and permanent memory loss. The procedure is dangerous and harmful. The equipment used for this procedure needs to be properly accessed. This is an incredibly invasive procedure and the harm is well documented. Cyndi Lynn Gabelein
I support all government regulations that protect the safety and freedom to choose and refuse all kinds of heath care and treatments! I have never had Electroshock but believe my grandfather probably did because he finally had a forced lobotomy in the 1930's according to my father who is now deceased. I must speak about all my terror because of the pain I remember my father sharing with me. Wrong decisions effect more than the one being deprived of his / her liberty. Forced or unregulated or poorly regulated health care destroys whole families. My entire family lived in fear because of what the government did to my father. I am a liberal Democrat and proud that Democrats are fighting for the freedom to choose and refuse healthcare that gets regulated by government as a duty of government. Bonnie Marie Nelson
Please don't move ECT machines from a class III to a class II without proper testing. The FDA should not be relying on information that comes from people who ultimately profit from the use of this controversial, experimental device which has never been tested. Tracy Puglisi
COMMENT I have had three friends mentally destroyed by electroshock treatments. My boss at a publishing company in Texas began to suffer depression at age 45. Her psychologist convinced her to undergo shock treatment. She lost so much of her memory she could no longer work. A friend in her early 20s, who worked as a university departmental secretary, became depressed when her husband left her with a two year old child. She cried a lot and was diagnosed with depression. Her parents put her into a private mental health facility in Austin, which shocked her. She developed schizophrenia and spent the next 20 years in mental hospitals. When she was released she was still out of touch with reality, emotionally unstable and unable to work at any job. In 2002, my closest friend, then in her 70s, went off of hormone replacement therapy and entered a depression.
She was an extremely intelligent woman who had published 11 books. She was one of those patients who developed suicidal ideation after taking anti-depressants. A mutual friend of ours, a psychiatrist, recommended shock treatment - strongly against my advice. Brain scans taken before and after the treatments suggested that shock caused damage in her frontal lobe. In 2004, a few months after the shocks, she shot herself to death. Our psychiatrist friend apologized. Her training had taught her that shock was a good option. In my radio work, I recorded Dr. Bonnie Burstow, a psychologist at the University of Toronto.
Her research indicates that the way shock "works" is by damaging the brain. This can create short-term euphoria and can sometimes erase memories, but not necessarily the target memories. It can also damage emotional centres, leaving people unable to work through memories that underlie depression. Unfortunately, it is cheap, traditional, and profitable, and being used more often. Here is Burstow's university web page: http://aecp.oise.utoronto.ca/main/faculty/burst
My experiences over a lifetime agree. Frieda Lindfield Werden
She was an extremely intelligent woman who had published 11 books. She was one of those patients who developed suicidal ideation after taking anti-depressants. A mutual friend of ours, a psychiatrist, recommended shock treatment - strongly against my advice. Brain scans taken before and after the treatments suggested that shock caused damage in her frontal lobe. In 2004, a few months after the shocks, she shot herself to death. Our psychiatrist friend apologized. Her training had taught her that shock was a good option. In my radio work, I recorded Dr. Bonnie Burstow, a psychologist at the University of Toronto.
Her research indicates that the way shock "works" is by damaging the brain. This can create short-term euphoria and can sometimes erase memories, but not necessarily the target memories. It can also damage emotional centres, leaving people unable to work through memories that underlie depression. Unfortunately, it is cheap, traditional, and profitable, and being used more often. Here is Burstow's university web page: http://aecp.oise.utoronto.ca/main/faculty/burst
My experiences over a lifetime agree. Frieda Lindfield Werden
The Alpha Stim device which is based on micro-current and is expressly non invasive has shown to have a number of beneficial effects and is approved for use through appropriate testing and scrutiny. More however, is not necessarily better. Contrast this with the massive, convulsive, memory erasing, short circuit that is ECT and the untested high voltage devices that are used, which are relied on because they were the first 'electrical' intervention that was invented.
At the very least, there should be tiered levels up to the point of effectiveness so that the client does not start at the maximum and potentially most harmful voltages, and clients should be informed of the potential risks that are involved all the way along the line. All invasive treatments should have the informed consent of the participants as a requirement, as too many of the extreme treatments of the past have resulted in damage to the health of clients only later to be discovered to be needlessly harmful. Please regulate and scrutinize these devices. R Ewbank
At the very least, there should be tiered levels up to the point of effectiveness so that the client does not start at the maximum and potentially most harmful voltages, and clients should be informed of the potential risks that are involved all the way along the line. All invasive treatments should have the informed consent of the participants as a requirement, as too many of the extreme treatments of the past have resulted in damage to the health of clients only later to be discovered to be needlessly harmful. Please regulate and scrutinize these devices. R Ewbank
It must implement the solutions of the experts appointed to fully eliminate the use of this "practice" called electrical seizures (ECT for short in English): John Breeding, Dorothy Dundas, Dan Fisher, Leonard Roy Frank, Dianna Posthauer, Lauren Tenney, Loretta Wilson, MindFreedom. Through the organization MenteLibre (Mindfreedom), advocacy for survivors of bad practices in the field of mental health and wellness, I am aware of these views and asked for public input related to the use of electric convulsions, which, must be removed. As indicated anteriromente, should allocate more public funds for the implementation of methods, programs and alternative practices to help the physical and emotional wellbeing of people in every community. Sincerely, Eric O. Jackson-Rivera, BA-writer and Recovery Affairs Advisor. Carolina, Puerto Rico.
We don't need to break the brain down in order to build it up. Memory loss & confusion are univerasal outcomes of this hightly invasive, unethical protocol. As the saying goes, "electricity is cheap." This fact, more so than any demonstrative evidence of healing, quite clearly drives individuals away from respectful modes of relief. Shane Derrick Hrichena
I am providing this testimony in the hope that no other patient seeking help will be subjected to the devastating effects of ECT. Following the death of my husband due to cancer, I ended up with a severe alcohol dependence. In Dec. 2007, a psychiatrist diagnosed me with severe depression and recommended aggressive ECT. He told me this intervention was necessary, was the only effective treatment for my malady and that “mild memory loss may occur, but it resolves within a few weeks”. He stated I would feel better as a result of ECT, and would not want to drink alcohol anymore. In Jan. 2008 I began receiving bilateral ECT sessions. No improvement occurred. In Mar. 2008 I received a second series of ECT treatments. After 12 treatments the psychiatrist decided the intervention was obviously not working, discontinued treatments and discharged me from his care. Within one week my alcohol abuse resumed. In Apr. 2008, intensive counseling and rigorous relapse prevention education from an addictions treatment service effectively handled my original problem. I’m happy to say I no longer abuse drugs or alcohol.
However, now I have to live with the damage from ECT. ECT left me with significant memory deficits that have significantly impacted my life. I have little memory of my children’s early lives, or life with my husband of 18 years. I cannot resume my previous professional work as a medical provider due to lack of memory of medical pathology, diagnosis and treatment. I am frustrated at how much memory is gone. I am a medical school graduate having to re-learn basic biology. Even though I’m an MD, I put my care in these doctors’ hands. I believed what they told me about ECT. Now that I am able to think more critically I can see that ECT caused me great harm. As an MD, and after experiencing firsthand the effects of ECT, the message I want to convey is that ECT has neither the effectiveness, nor the safety to justify its continued use. Theresa Monteverdi MD
However, now I have to live with the damage from ECT. ECT left me with significant memory deficits that have significantly impacted my life. I have little memory of my children’s early lives, or life with my husband of 18 years. I cannot resume my previous professional work as a medical provider due to lack of memory of medical pathology, diagnosis and treatment. I am frustrated at how much memory is gone. I am a medical school graduate having to re-learn basic biology. Even though I’m an MD, I put my care in these doctors’ hands. I believed what they told me about ECT. Now that I am able to think more critically I can see that ECT caused me great harm. As an MD, and after experiencing firsthand the effects of ECT, the message I want to convey is that ECT has neither the effectiveness, nor the safety to justify its continued use. Theresa Monteverdi MD
Electroshock has been proven to be not only harmful, but dangerous and also not effective. If this were a drug, it does not meet criteria for approval to be marketed. If you have absolutely no reservations with having this device used on you or your loved ones, then let the use of this device continue. If you have the slightest doubt, then you know the right course of action to undertake. Mary Ann Strauch
I was coerced into ECT by virtue of misinformation by Dr. Karl Lanocha of Concord, NH, who convinced my family that because my severe depression had not abated (but worsened) after being bombarded with thousands of miligrams of untested drugs in dozens of untested combinations, that ECT was "Necessary, Safe, and Effective", and that my "intellectual ability would not be affected". I had been a concert musician and composer, as well as the mother of three young girls. Not only did I lose all memory of my music, I have no memory whatsoever of years of my children's lives. ECT destroyed my life.....and my children's lives, and there is no excuse in any civilized society for it not to be banned as an inhumane brain damaging form of torture. Sincerely, Nancy Rubenstein Del Giudice
I am concerned about this practice being used at all. The damage done certainly out weights the benefits. Numerous clients embrace this option only after interventions as destructive as questionable pharmeuctical blends have resulted in less than favorable outcomes. I professionally have witnessed benefits from more holistic interventions. These interventions are usually not presently supported by reimbursible insurances thus causing an "elite-ism" in availability to many who would be willing to commit to these alternatives. Shock Therapy results in lapses in memory and although not researched enough the permenant shifts in personality in clients. PLEASE DO NOT RUSH TO EMBRACE THIS PROCEDURE!!! Sincerely, Ms Dorothy J. Curtis
Please do not reclassify ECT down to class II without the testing and proof of safety that is required for other medical devices. There are no studies that show the safety of ECT or its effectiveness. If it is so safe and effective, let the APA furnish the data to prove that. All the studies I have read show increased levels of dementia, memory loss and irreversible brain damage. Have you investigated those problems? Please do your job and safeguard the American public. Thank you, Robert McCarty DDS.
I have known several people over the years who have been given ECT and had problems with memory afterwards. Some had
it 20 years ago and some only a few years ago. None of them thought it was helpful in the long run and all of them were upset about receiving it. I do not believe it is a humane or useful treatment and think it should be stopped. Joan V MacKenzie
it 20 years ago and some only a few years ago. None of them thought it was helpful in the long run and all of them were upset about receiving it. I do not believe it is a humane or useful treatment and think it should be stopped. Joan V MacKenzie
I have too many friends who have been hurt by this device. It is damaging to the memory and the functioning of people. It has been shown in studies to be especially dangerous to the elderly and to women, and oddly these are the two groups most likely to be shocked. ECT is outdated and barbaric. It is not far removed from the lobotomy. The funny thing is when I talk to people about my adversion to this device, especially when it is used involuntarily, they are shocked because they thought it was no longer done. "No! They don't still use shock therapy anymore," they exclaim. "Not in America!"
It is hidden behind hospital doors and few people want to talk about it. Please do not approve this device. I think that it will be a blackmark on the history of the FDA. I mean think about it at one point a respected psychiatrist was cutting apart his patients.
Dr Henry Cotton amputated fingers, reproductive organs, and even removed patient's stomachs. He pulled their teeth out first and then continued to dismember them to root out the cause of the "infection of their mind." He was highly respected in the 20th century! Let us not be so barbaric and backwards as to approve this device that hurts so many. If it is approved it should never be used involuntarily. Jennifer P Urbanek
It is hidden behind hospital doors and few people want to talk about it. Please do not approve this device. I think that it will be a blackmark on the history of the FDA. I mean think about it at one point a respected psychiatrist was cutting apart his patients.
Dr Henry Cotton amputated fingers, reproductive organs, and even removed patient's stomachs. He pulled their teeth out first and then continued to dismember them to root out the cause of the "infection of their mind." He was highly respected in the 20th century! Let us not be so barbaric and backwards as to approve this device that hurts so many. If it is approved it should never be used involuntarily. Jennifer P Urbanek
Hello, I work as a Licensed Mental Health Counselor in New York state. I think the use of Electro Shock Treatment is barbaric and should be stopped. I have worked with many people who deeply regret their coerced/forced shock treatments. ECT will never help people heal from the traumas and life stressors that contribute to mental helath problems. ECT will simply cause
\mild to moderate disruptions in their brain and cause permanent brain injury. Like psychosurgery, this will interrupt their previous brain function. Thus, if they were depressed they may no longer be depressed, but they will be worse off in the long run. Brain damage is not treatment. Psychotherapy and wellness practices such as meditation and yoga are much more effective and are true treatments that promote healing from psychiatric conditions. Cindy L Peterson-Dana
\mild to moderate disruptions in their brain and cause permanent brain injury. Like psychosurgery, this will interrupt their previous brain function. Thus, if they were depressed they may no longer be depressed, but they will be worse off in the long run. Brain damage is not treatment. Psychotherapy and wellness practices such as meditation and yoga are much more effective and are true treatments that promote healing from psychiatric conditions. Cindy L Peterson-Dana
The age-old, but still relevant admonition, "Non Nocere" applies now, more than ever, to the recent resurgence of interest in using ECT. ECT effects memory by destroying brain cells. There is ample evidence to support this, derived from CAT scans, etc. No longer can it be refuted. No admixture of smoke and mirrors or sophistry nor pseudo-logic is applicable anymore. It is time to regulate or abolish ECT the same way we would with any dangerous appliance. These are my wishes as well those of family, relatives, and the International Center for the Study of Psychiatry and Psychology. There is a great deal of information on this subject--which should not be overlooked, dismissed, or given short schrift. Please see the work of Leonard Roy Franks, or Linda Andre for testimony of victims of ECT, who survived--it is true--but who paid a terrible price, one which required them (and too many others who underwent ECT) to rebuild new memories in the spaces where old memories and skills, and aptitudes once resided, but were now obliterated. Burton N. Seitler, Ph.D
To Whom it May Concern: I think that ECT is a draconian, barbaric, and cruel form of therapy. The only thing worse is lobotomy. It destroyed the lives of my grandmother in-law and great aunt. It is outdated as one of the horrific "therapies" of the past. We have new psychiatric research and holistic therapies that reflect a humane way of treating mental illness. ECT should be immediately outlawed as an outmoded treatment that our medical communities have unfortunately tried and most certianly failed. Ban ECT now!!! We no longer need to punish the ill. Sincerely, Rhiannon Barton
See attached file(s) Thank you for the opportunity to share my views on ECT with you today. I base my testimony on my thirty years of practice as a board-certified psychiatrist, my five years of postdoctoral neurochemical research at NIMH, and my 19 years as director of the National Empowerment Center, a federally-funded technical assistance center. I am appalled that ECT has never been required to validate its efficacy or its safety before the FDA. I was heartened to hear that in 2008 the FDA did require such verification. However, today I am dismayed to learn that the manufacturers want the status of their devices downgraded from Class III to Class II or the same classification as a wheel chair. In my expert opinion and that of a recent review of the ECT literature by Drs. John Read and Richard Bentall (Read and Bentall, 2010), the short-term gains of ECT do not justify its associated brain damage, memory loss, cognitive deficits and increased risk of death. I therefore recommend:
1. That ECT devices continue to be designated as class III devices and 2. That, in keeping with the approval process of a Class III medical device, their use be suspended unless and until their manufacturers can produce independently obtained evidence with government oversight of meaningful long-term efficacy and minimal short- and long-term risks of memory loss, cognitive deficits, brain damage, and mortality to warrant the resumption of its use. National Empowerment Center
1. That ECT devices continue to be designated as class III devices and 2. That, in keeping with the approval process of a Class III medical device, their use be suspended unless and until their manufacturers can produce independently obtained evidence with government oversight of meaningful long-term efficacy and minimal short- and long-term risks of memory loss, cognitive deficits, brain damage, and mortality to warrant the resumption of its use. National Empowerment Center

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supporting notes for submission 0161 McLoughlin "Objective Cognitive Performance" [Meta-Analysis of ECT] Biol Psychiatry. 2010 Sep 15;68(6):568-77 (NB read full report, abstract misleading) R Flavin "The Tragedy of Ewen Cameron" http://www.flavinscorner.com/cameron.htm Seth E Many
As a survivor of psychiatric mistreatment and an educated psychotherapist and trauma specialist, I urge you to regulate the use of electro-convulsive "therapy" as a LAST RESORT prescription under the strictest of guidelines. The issue alone of selectively informed consent that includes deliberate misinformation and absence of facts presented to most individuals for whom this is proposed should be enough to warrant severe limitations on the use of this dangerous procedure. The interference with memory, mood, and the capacity to participate in alternative treatments, no less many tasks of everyday life, are not short-term but long-term both consistently and intermittently for many more individuals than psychiatrists and manufacturers of e.c.t. equipment, no less insurance companies, would have one know. Please end as soon as possible this particular form of psychiatric abuse and begin to support humane and fully informed choices for those in psychiatric "care." M.W. Auslander
CONCLUSION: Given the strong evidence of persistent and permanent brain dysfunction, 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. http://issuu.com/wellbeing/docs/read___bentall._ect._2010_1_?viewMode=presentation Pete Mosely
Electroshock is brutal. It causes brain damage. It is torture. This is obvious. I should no more be having to write comments against electroshock than against forced drilling of holes in people's heads. What kind of idiocy cannot see such patently obvious facts? David F Potter
From my personal experience of working with people who have undergone ECT, this procedure often produces long-term, irreversible cognitive effects without providing any significant reduction or relief in the symptoms of depression. In addition,
given that the efficacy of this device and the treatment for which it is used has never been established based on randomized clinical trials, and that the treatment is often given involuntarily or without full and proper consent, I believe this device
should not only be regulated, but it's very use should be seriously scrutinzed. Lori R Wallace
given that the efficacy of this device and the treatment for which it is used has never been established based on randomized clinical trials, and that the treatment is often given involuntarily or without full and proper consent, I believe this device
should not only be regulated, but it's very use should be seriously scrutinzed. Lori R Wallace
I am opposed to electroshock treatment because of deleterious side effects. I am especially opposed to involuntary electroshock. I am a professor at the University of Rhode Island who has published widely in the area of supporting the
rights of consumers in treatment. Jacqueline Sparks
rights of consumers in treatment. Jacqueline Sparks
How does any Dr. exactly know how the ECT is going to work on the brain. How do they know what specific neurological pathway the electricity is going to take in order to help the patients depression. It appears that none of them know what actually happens and then they delude themsleves into beleiveing that this is some kind of therapy. Sending electricity through the brain aimlessly with the deluded good intention of this being hepful only to have them repeat this therapy 4 to 6 months later.
How can anyone in their right frame of mind beleive this stuff. Sadly many neo nazis beleived in what they were doing as well. Maurice k temerllin proved that one doctor's suggestion can influence 90% of other Drs into beliveing something as fact when it is not true. The whole feild of psychiatry is fraught with misdiagnosis, no informed onsent, no alternatives offered, Forced commitment, coerced confessions that the medication is working, deaths, suicides, illegal experiments (mkultra) etc. conflict of interests with big pharma companies etc.
Where are all those nazi psychiatrists that the US brought back from Germany and employed in various universities and companies. They were all very intelligent and INFLUENTIAL, authoratative intellectuals. The milgrim experiment proves people obey authority Psychiatry and its present harmful pratices have to be investigated and changed Doug a Simpson
How can anyone in their right frame of mind beleive this stuff. Sadly many neo nazis beleived in what they were doing as well. Maurice k temerllin proved that one doctor's suggestion can influence 90% of other Drs into beliveing something as fact when it is not true. The whole feild of psychiatry is fraught with misdiagnosis, no informed onsent, no alternatives offered, Forced commitment, coerced confessions that the medication is working, deaths, suicides, illegal experiments (mkultra) etc. conflict of interests with big pharma companies etc.
Where are all those nazi psychiatrists that the US brought back from Germany and employed in various universities and companies. They were all very intelligent and INFLUENTIAL, authoratative intellectuals. The milgrim experiment proves people obey authority Psychiatry and its present harmful pratices have to be investigated and changed Doug a Simpson
I urge the FDA to conduct clinical trials to establish whether the administration of ECT is either safe or effective. Much scientific literature exists that indicates it is not. Individuals who have complained to my organization about ECT have told me that it did not help with their depression, it subjected them to terror, and they suffered permanent memory loss -- i.e., ECT was neither safe nor effective. Anne Joachim
Like any other procedure or drug, electroconvulsive therapy should be properly tested, administered, and reviewed for positive and effective consumer results BY THE FDA. It is clear that ECT works for some individuals as a treatment for neurological disorders. It is also clear that ECT has lead to both traumatic and irreversible physical damage. While involuntary treatment should never be forced on a patient, what is absolutely clear is that the FDA should be involved in this high-risk and high-impact procedure. Sara Woody
I believe the practice of electroshocking should be outlawed or at least very closely regulated. When I attended the University of Iowa, I worked in the University Hospital medical records department. I found several cases in which families were notified that their relative died unexpectedly of a heart attack, when in fact the person had been accidentally electrocuted.James W. Syfers
Electro Shock is dangerous. There are safer ways to help patients which is a gross understatement. Please regulate electro shock as strict as you possibly can or ban it. Terry L. Wiley
ECT is a brutal pyschiatric practice and should be entirely eliminated as a form of mental therapy. It is not therapy. It's torture. Dorothy Millan
We are a government for the people, by the people. As the duly appointed protectorate of the citizens of the United States in regards to all therapeutic devices and technology, I implore you to initiate an investigation into the safety of these wholly untested Electroshock (ECT) machines. Though it has been 20 years since your agency first ruled that these devices were a high risk, and much time has passed, there is now an opportunity for action. We see this as an opportunity to right a situation that is clearly wrong, and to uphold your agency’s central mission. As Virginia’s statewide mental health consumers organization, we believe deeply in the tenet of informed consent. If these devices are to be offered to the public as a potential therapy, the public must be informed of their potential risks, in order to make a fair and balanced decision. Therefore, we oppose the reclassification of Electroshock (ECT) devices to Class II by the FDA in the absence of adequate scientific evidence of their safety, and ask your agency to call for PreMarket Approval Applications for the devices. Thank you. Brian Parrish