URGENT: FDA Wants to Declare Shock Treatment Safe Without a Safety Investigation! Public Docket is Now Open (Sept. 10, 2009-Jan. 8, 2010)For Your Comments—Tell Them No!
The Food and Drug Administration is in charge of regulating medical devices just as it does drugs, including the machines used to give shock treatment. But it’s not doing its job. It has allowed these machines to be used on millions of patients over the past generation without requiring any evidence whatsoever that shock treatment is safe or effective! This is so even though shock machines are Class III—high risk—devices, which by law are supposed to be investigated by clinical trials as thoroughly as new drugs and devices just coming onto the market. But because of intense lobbying by the American Psychiatric Association—which claims the devices are safe but opposes an investigation—the FDA has disregarded its own law. (For the full story of how shock survivors have fought for a scientific safety investigation of ECT for the past 25 years, see the new book Doctors of Deception: What They Don’t Want You to Know About Shock Treatment by Linda Andre.)
In April 2009—30 years after it first ruled the devices high-risk and named brain damage and memory loss as risks of the treatment—the FDA belatedly announced it would call on the manufacturers of the devices to provide evidence of safety and efficacy. The deadline for submissions has passed, but the manufacturers have not conducted any clinical trials, claiming they cannot afford them. They simply point to the opinions of shock doctors (including those who have financial interests in the device companies) as evidence that shock is safe.
The FDA is now supposed to require the ECT device to undergo the rigorous PreMarket Approval process (PMA) that is required of new devices, including clinical safety trials. But the FDA could have called for this investigation any time in the past 30 years and has steadfastly refused to do so. It has never wavered from its intention (as stated in 1990) to declare the shock machine safe, and downclassify it to the low-risk Class II, without scientific evidence of its safety. As a Class II device, the shock machine would never have to go through the PMA process. After all, if a PMA showed shock to be unsafe, the FDA would have to take shock machines off the market, and it knows that the American Psychiatric Association would never allow that.
In a news item which appeared in FDA News, a trade journal, on September 22, the shock machine manufacturers expressed concern….not for the patients who have been treated and injured by their untested and unsafe device, but for themselves. They said they would go out of business if they had to pay to conduct clinical trials to prove their devices safe, and for that reason they are lobbying the FDA for reclassification to Class II. Not because they have proof that their devices are safe, but because they want to keep making money. (No wonder shock device company owner Gorham Nicol has been elected to the ect.org Hall of Shame.)
Recognizing the long history of “significant public interest” in the ECT device, the FDA has opened up a new docket for public comments on the device. If we don’t write in, they will almost certainly reclassify. Comments will be accepted up through January 8, 2010. Do you think shock is safe? Have you evidence you want FDA to consider, including your personal experience? Write a letter to the address below or send in the coupon. You can also make electronic comments at by entering “Notices” and then the docket number FDA-2009-N-0392.
This is urgent! After 30 years FDA will certainly cave in to organized psychiatry if we aren’t watching and we don’t ALL take action.
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To: Food and Drug Administration, Dockets Management Branch (HFA-305), 5630 Fishers Lane, Room 1061, Rockville, MD 20852
Re: Docket #FDA-2009-N-0392
The undersigned opposes the reclassification of the ECT device to Class II by the FDA in the absence of adequate scientific evidence of its safety, and asks the agency to call for PreMarket Approval Applications for the device.
Name: ________________________________________________________________________________
Address: ________________________________________________________________________________
________________________________________________________________________________
Signature: _____________________________________________________________________________
I have been a victim of ect therapy. I suffer from permanent memory loss and cognitive disordes are apparant on a daily basis… Research is required before this is declared safe…If i had known the effects of this procedure beforehand I would not have had it done…My whole life has changed.
I was 10 years old at Lake-shore Psychiatric Hospital in Toronto, Canada, 1965 when they administered shock treatment to me. This machine had essentially robbed me of my childhood!! Who should pay for that?, can you place a value on a lost childhood? Is the Ontario Govt. responsible? I will never know. All I know is that they did this to me and someone should pay!
It’s an insult to those (such as myself) that has gone through the ‘treatment’ and have had major side effects. The doctors didn’t listen to us before about how we suffer, and they’ll listen even less now that the FDA is saying these machines are safe.
I got my ECT done at the Homewood in Guelph, Ontario.
I agree 100% with a PMA being implicated in ALL devices that need to be surgically implanted, not just Class II devices. There’s only one problem. I don’t think the FDA will ever fully honor any PMA they have given or any Conditions of Approval. They have proved that in the approval of the Cyberonics VNS device. My sister almost died after having that device implanted for a seizure disorder, and now she is permanetly disabled because of it, even after having it removed. The company which manufactures that device, Cyberonics, was also given Conditions of Approval, but were allowed to submit a proposal to the FDA to have those conditions lessoned, and the FDA accepted. This device was a Class III medical device, the class that has the possibillity of causing the most harm of any device, and even death, and yet the FDA accepted. That is despite the fact that their approval document very clearly states: FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA. I don’t feel that our tax dollars should pay the salaries of the very people who are killing us. Whether it is ECT or VNS, it doesn’t really matter. The safety of the American people is no longer a concern of the FDA.
interesting noting the comment of individuals who have had the treatment. I am watching someone fighting a loosing battle, to prevent a family member from having the treatment, the family has been informed its the only option avilable, medication has had no effect, the patient has no surviving parent, siblings are not able to make the decision on the patient’s behalf. the law as it stands in the UK. the patient eating pattern is eratic, and she is not drinking sufficiently.
the only thing that stands in the way, is the investigation of an independant body.
I started my ECT treatments last week and I have had 3 so far and feel worst off then what i did before the ECT treatments started. Headaches, fogginess and very aggravated. I called my doctor and told him I will not be doing any more treatments because of the after affects. I also was very
forgetful and couldn’t find places or remember things. I don’t know. after much thought I don’t know what I was thinking when I agreed to do ECT. I have been on medications for over 5 years and nothing seemed to work so my doctor recommended I start ECT treatments. I don’t know what I will do with my depression but I rather deal with my depression then feel the way I felt after doing ECTs.
ECT and VNs [Cyberonins' pathetic device] is killind and completely destroyoying thr lives of the people it is suppossed to help. These are injuries and deaths, YES YOU HEARD ME RIGHT, DEATHs that cannot be reversed. Since appently noone in the government ids looking into this, them my next best action is to contact everysingle newpaper and publication that you can possibly get your hands on. Not just local ones, but international ones.Include all the defestating effects that these devices and treatments have caused you. Don’t be afraid, there is nothing they can do as long as you speak the truth. Hold unto ALL you doctr and hospiatal papers, in fact make many copies. ALWAYS ,NO MATTER WHAT, KEEP A ORIGINAL.Demand your hospiatal recorde and keepthose also. KEEP A JOUNAL DESCIBING IN GHREAT DETAL’
Do you want to know what I think is really pathetic? Because of “REIGEL vs. MEDTRONICS” any device, treatment, or any kind of perscription drug that has that little “worthless” FDA approved sticker on it cannot be sued. As long as the FDA says it’s okay and is approved for use you cannot sue the company. And since the FDA is part of the government and we all know you can’t sue the government, then their death devices and drugs are safe from any kind of financial lawsuits. What we ALL have to do is contact your states Congressmen and Senators and DEMAND that Reigel vs. Medtronics be reversed. Untill this gets done, these companies will continue to get by with MURDER. They are in it to make money, not to save lives. And the way the laws now stand, protecting them and not us, they have nothing to lose. We outnumber them. LET”S LET OUR VOICES BE HEARD!!!!!
I just now got off the Maude Data Baseand typed into the search bar: death caused by ECT 439 death resulting in ECT 463 death after ECT 452 lifethreatening injury after ECT 154 death caused by TMS 1,140 death caused by VNS 2,820 death caused by DBS 144 This pretty much tells me that depending how you word it, the results of the death toll are different. How very convienent.
I had my ECT a year ago.I don’t even know what it was given for. I don’t remember being told about any side affects, although I am sure I would have been. I have lost my memory for what I can work out to be around 18 months prior to the treatment. In that time I had sold a house and bought another, that memory has gone. I lost my partner of 3 years,that memory has gone. I lost my job, that also gone. No memories of birthdays, christmas or other family events. All of it gone and I’m being told that it may never return. It was too high a price to pay. I had depression and only remember being suicidal and nothing more. I say if you need to choose then say no to ETC. The medical professionals have all said it was an acceptable risk to take.
The more I am reading, the more it is appearing that all of you have been guinni -pigs in Dr. Frankensteins’ lab. How can these “doctors” be so sure that one day all these memerories that they are trying to suppress won’t come back? Didn’t they feel that your lives were worth the effort to try to teach you the skills to deal with these problems? As far as the medical “professionals” claiming it was an “acceptable risk” to take, what do they care? They’re not risking anything. Are they in fact telling you that your lives are so meanningless that who cares if you can’t remember half of it? That’s pretty sad.
What is accountability anyway? I cannot remember any of my childhood. I am told that having childhood memories is a wonderful thing. I would not know because I do not have any. I have tried to sift them out through the fog but they simply are not there. Can anyone tell me if there can be a value placed on this and how much? I wish I knew more but I was only 10 years old at the Lakeshore Psychiatric facility in Ontario. I wanted to go back there and ask them to give me back my childhood but now it is a school. So I feel I have been robbed by the Ontario Govt. of my childhood. Does anybody know a good lawyer, I think childhood memories could be worth millions!!
Wait a minute, Gert. Are you trying to tell me they did this to you at the age of 10? What the heck could a little 10 year old child do that would justify anybody, and I do mean ANYBODY, to subject them to this barbarric treatment? That is so completely inexcusable. Did you have a family member that agreed that this should be done to you? I am trying to understand who justified doing this to a child, it’s bad enough when you are an adult.
Remember this was in the middle 1960’s when they did this. Yes my mother had apparently signed me into this place because I was incorrigible. So at that time I was a ward of the state and they could do anything they wanted to me and they did. Back then they called me hyperactive, today it is called ADD. They had used me as an experiment and tried all kinds of drugs and treatments on me. I am probably one of the first Ritalin babies. I have siblings who are all filthy rich and do not talk to me because for 2 years from age 9 through 11, I was incarcerated in that institution. Today I am 55 years old and live on a meager disability pension of less then $1000 per month. My mother is still not talking to me (abandonment), My father is remarried and also is a multi millionaire. He talk to me but is remarried and has converted to Muslim. So I am considered an infidel. Nancy do you know of any good lawyers I want to sue the govt. of Ontario for doing this to me. You can call me at 604 282 5706
Has anyone benefited from CET?