40 Days to Tell the #FDAStoptheShockDevice

People who are psychiatric survivors, including many survivors of shock treatment (ECT) along with our allies and members of MindFreedom International, have joined together and held six teleconferences since December, 2015 when the FDA first released its proposed rule and draft guidance attempting to down-classify the shock device to a Class II device. As discussed in a previous blog, if the FDA’s effort is successful the shock device would be removed from the category of a Class III experimental device, and placed in the same category as eyeglasses or a wheelchair.

Please join us in demanding that the FDA stop the shock device from being down-classified to a Class II device. We have until March 28th, 2016.

A petition has been started:

https://www.change.org/p/fda-stop-fda-from-down-classifying-the-shock-device-to-a-class-ii-device-stop-shock-treatment

The final lines:

FDA, by signing this petition, I affirm that my short answer is no.

I oppose FDA down-classifying the shock device from a Class III device to a Class II device for any reason.

I oppose FDA making this rule without public hearings.

I support MindFreedom International’s call for the FDA to hold public hearings prior to making any decisions about the future of shock treatment in the United States.

PLEASE NOTE:

As we were finalizing the points to include in our template, we learned that the FDA may “choose to redact, or withhold . . . duplicate/near duplicate examples of a mass-mail campaign.” Since it appears that the FDA is censoring comments, please document your comments to the FDA with a screenshot or a copy of the comment and time/date it was submitted. If your comment is not posted to the FDA site because it rejects your comment, please contact Lauren Tenney to discuss (LaurenTenney AT aol dot com or (718) 273-8708).

Along with signing our petition to show the FDA you support MindFreedom International’s opposition to the FDA’s proposed rule, if you would like MindFreedom International to submit comments to the FDA on your behalf, please include your own original comments in the space provided.

If you want to sign our petition, but also want to submit your own comments to the FDA concerning the proposed rule, please be aware that you must include the docket number to which you are responding.

All submissions on the proposed rule must include:

Docket No. 2014-N–1210 for ‘‘Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment-Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses”

Click here to submit a comment to the FDA on the proposed rule.

You can also submit a comment on the FDA’s ‘‘guidance document” for industry, clinicians and FDA staff. To do so, please visit http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1318-0001 and click Comment Now.

All submissions on the guidance document must include:

Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff”

We will be holding another national teleconference on Wednesday, February 24, 2016 at 2pm eastern time, 1 pm central time, 11 am pacific time, 12 pm mountain time.

1-605-475-2090 pin code: 873270 to be part of the call to create a national strategy to respond to the FDA and prevent the shock device from becoming a Class II device.

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6 COMMENTS

  1. The first time I was inpatient psych after that doctor MADE me psychotic with that combination of ADHD pills Anti depressants I met this girl who just wanted to get out and goto her friends bar mitzvah. Very upset she was going to miss this party and would constantly state “I hate this effing hospital” just wanted out to be with her friends.

    That “doctor” did that ECT thing and she came back all zombified but also with this bugged out smile on her face. Reminded me of that old TV ad for the lottery that showed winners with “smilitis.”

    After that she no longer interacted with us and was just damaged.

  2. There are a number of devices for this electrically induced somatic therapy. The guy who adjusted my B3 after 6 months on my own was the former somatic therapy guy at a large private hospital downstate who’d become a student of Theron Randolph MD, an allergist who was able to successfully treat “psychiatric” conditions by avoidance of symptom-inducing foods and inhalants identified through water fasting for several days until symptoms vanished and reintroducing foods one at a time to see which ones evoked reactions. He trained other professionals by having them experience the fasts and follow-up testing themselves. My shrink had gotten hospital privileges at an upstate hospital near me, but had to go elsewhere because the hospital found out about the fasting and rejected it as “too dangerous”, leaving the 70-year old doc quite displeased- the hospital mavens apparently thought he was going to do ECT, etc. on a contract basis for all the area shrinks like he had downstate.
    Later, I saw an article by him concerning the 15.000 or so patients he’d treated which led me fo suspect he wasn’t the sort of somatic therapy guy who liked to have his patients grand mal bouncing on the bed. I suspect he also gave them niacin to preserve their long-term memories (I was also referred by friends from a Schizophrenia Association, one of whom had had 200+ ECT from idiots). From the article’s tenor, I also suspect these electro-treatments are also dependent on the skill of the practitioner and thus shouldn’t become used by too many guys, particularly the bed bouncers.

  3. ECT = Electrocution TORTURE
    Why, how, and *WHO* wants to “downgrade” ECT equipment from class II to class III….????….
    I mean, c’mon, *MindFreedom*, can somebody please do a bit of research, and find out what’s behind this? Looks to me, that the pseudo-science of psychiatry is cracking, and the quacks are trying to bolster their defenses, by making ECT more common…. Something like that. But WHO, and WHY?….
    One of my best friends -we had coffee today – was a victim of ECT = Electrocution Torture, years ago….
    It has NOT helped my friend. The psych drugs are not helping my friend, either.
    I’d love to see a full range of brain scans of my friend. Are there any studies available, that show scans of brains that have been subjected to Electrocution Torture? Thank-you
    PLEASE, Please, *please* can somebody more tech savvy than I, post THIS comment to the FDA?
    You’ve got my permission. ECT = Electrocution Torture.
    Even years later, the few (thank God it was only a few!) Electrocution Torture sessions my friend endured, are STILL a source of pain, and suffering. ECT is NOT THERAPEUTIC…

  4. Thank You Lauren for your honest and tireless work . I hope it bears good fruit . It’s hard for me to talk about shock treatments because I’ve had 15 bilateral high voltage electro shock “treatments” forced on me , one every other day and even felt the full explosive pain and saw internally the visual explosion as well , at one of the “sessions” before anesthesia took effect . I was disbelieved and ridiculed about it when I reported the excruciating pain I had felt , then despite feeling over the top terrorized had more forced on me .It was just before I turned 18 years old . I admit it electro-shock is my great fear just like rats were for the character Winston in George Orwell’s book 1984 . Just 2 years ago ( I’ll be 69 in March) a friend I went to high school with showed me how I looked in a class photo . She said “look at you you weren’t there “. I looked and saw my expression and my eyes in the photo and said back to her “yeah I wasn’t there”. As I look back I remember it was the chemical lobotomy “drug” Thorazine and the electro- shock that provides the 1 2 zombifying super punch . Although each can do it alone easily . Maybe thats why I’m Anti-Psychiatry .
    I was unaware back then of any activism opposing psychiatry or electro-shock . I thought I was as alone as one of the turtles on the Galapagos – Islands . Eventually I escaped 5 or 6 times from mental institutions and in the middle of that when a natural doctor who taught people in his health food store, mercifully started teaching me another way to survive. After gaining new understanding I came to believe I could try and invent a first do no harm substitute modality to electro-shock . I was driven to find a way to help people to not have to go through the unbearable tortures I experienced . I read books on natural healing and also the use of supplements. I tried any substances in the HealthFood store that I thought could possibly help . Joseph Liss ND answered most any questions that came up. Some months later I felt I had a workable meanwhile solution and years later another addition as options usable at various stages of extreme states that could safely be used at home or at some relatively free shelter space so that psychiatry and electro-shock could be bypassed altogether if a person so choose .
    People always ask what else there is . When you tell them they cry antidotal at you , don’t believe you , or find some creative verbal gymnastic ( We are all so different ! ) Yeah but we are still the same species and are able to offer help to each other even though we are not some guild member . ( Where is the Science ?) We are talking about first do no harm options . And on and on . Anyways here goes.
    Yes I do agree betrayal trauma of one type or another is a huge factor . Having the right people to talk to does help . But I also say that heavy metal and other types of poisoning are also a huge factor that generally has not been quantified . And I’m not even including “psych-drug ” poisoning as part of the last sentence .
    I found that taking the flushing type of niacin ( I took 1200 mg) then upon flushing , entering a hot mineral bath I used BathTherapy not the original green mineral powder ) , a loofa quickly eases the itching and a profound relaxation appears with no voices, a great aid to that sleepless insomnia state . Be aware you could easily fall asleep in the tub .
    Also made an herbal extract that relaxes and even stops voices . Also found that juicing green vegetables then mixing 50 50 with spring or distilled water helps .
    Main thing for me was advanced Hal Huggins dental work . I was being mercury poisoned and heard voices do to conventional dental work including root canals . There were also infected gums and teeth. Poverty sucks . If necessary beg borrow or steal if you won’t get caught, the money needed for advanced dental work . Conventional ADA dentists for real don’t know squat and cause untold suffering . Check out over the net what they do at Paracelsus Klinic ( yes with a K) in Switzerland for state of the art info .
    Anyway I’ve followed what the FDA has done in regard to the use of Mercury in dentistry . There record is dismal . And they are definitely bought and paid for by the therapeutic state and will over ride real science in the interests of controlling populations and mainly for corporate cartel mindless and heartless greed. I did sign the petition but I can’t ignore the FDA’s track record . Abolish Electro-Shock ! I look forward to the day when at least coercive psychiatry is submerged deep within the dustbin of history never to arise again .

  5. Dear Fred,

    Thank you so very much for imparting some of what you have learned during and after suffering the application of a horrific psychiatric/pharmaceutical science. More and more people are waking up to the realization that it is truly criminal behavior. This false science thrust upon you and being perpetrated on millions of us, and which has proven itself the opposite of safe and effective, has done nothing to deter your wonderful spirit and desire to help others to avoid such scurrilous medical behavior.

    I, for one , plan to cut and paste this masterpiece of helpful information onto an e-mail to myself so I can refer to it easily. Again Fred, many thanks. It is also with great appreciation I thank everyone else who took the time to enlighten all of us through utilizing the MADINAMERICA forum.

  6. I plan to submit. I know one thing I want to say, and will state here, that those of us who submitted to ECT willingly, or even asked for ECT, later on, most naturally, due to human nature, would have a very hard time facing up to having willingly taken part in the destruction of one’s own precious brain.

    Today while on the bus I thought of an analogy. I wonder if the FDA is like the shrinks I used to see, who hated my analogies and refused to listen to any of them. Maybe I was too much of a smart aleck. I am so glad I left that world. Here it is: Say you had ordered from a craftsman, a beautiful, custom-made polished wood coffee table for your mother. This cost you, say a thousand dollars, and you know the person who made it. you waited a month. The man calls you a week before your mom’s birthday so you go pick it up.

    You decide to make a card for her, and since she is somewhat vision-impaired, you write clearly on the card in felt tip marker and bright colors. “I love you, Mom.” You so much believe in what you are doing. Those words sink in deep.

    Yep, so deep, and that wasn’t a felt tip. It was a Sharpie. Oh shit.

    You are saying the absolute worst swear in your mind right now, staring at those ink stains on that coffee table, that will never come out. You ruined it. You ruined it through your own doing.

    What now? Cover it with a placemat? How about buying another table, and hiding this one, shoving this one in the corner and pretending all this never happened? Or spending a whole lot patching up the boo-boo you did, but didn’t do willingly?

    How many years will it take before you admit to all that? Will you EVER tell Mom? Will you ever tell your buddy the craftsman? In ten years? Fifteen? By then, in your own mind, you’ve forgotten it ever happened.

    Many of us, during our childhood, break a favorite toy, and we are so, so ashamed, we hide it in our closets, never wanting anyone to know. I believe this is what causes people to deny ECT harm. I wrote my entire memoir, my master’s thesis, and even when it was finally published, I still never realized the entire chapter, “Walking the Line,” was not about “illness,” it was all about my experience at McLean post-ECT. My ECT was in 1996!

    My own mind, my own self-defense system sufficed to cover up my deep shame. All they had to do was avoid admitting the truth to me for about a year and a half, and avoid answering, “What’s wrong with my brain”? Most likely, this works almost every time.

    Julie and Puzzle