Shock Device Safe As Eyeglasses? 89 Days to Say No

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2093

The electroshock device, the actual machine that is used to deliver shock treatment (electroconvulsive treatment/ECT), is currently a Class III device as categorized by the Food Drug and Cosmetic Act of 1976. The FD&C Act requires all medical devices to be placed into one of three categories: Class I (general controls); Class II (special controls); and Class III (premarket approval)” (FDA, 2015, p. 81,224i).

Under FDA standards, a medical device is placed into Class III when its risks and benefits have not been assessed to a degree that allows it to be placed into Class I or Class II, and thus there is potential that its risks outweigh its benefits. A Class III device is one that either was in existence prior to 1976 and is therefore referred to as a preamendments device, or if it has come onto the market since 1976 and its manufacturer claims it is similar to a pre-1976 device, it is referred to as a postamendments device.

To help decipher this, I turn to the must-read groundbreaking work of Linda Andre, Doctors of Deception: What They Don’t Want You to Know about Shock Treatment.ii Andre tells the sordid history of the shock device and resulting procedure., crafting a meticulously-detailed account of the horrors of electroshock. Concerning the FDA’s classification system, Andre wrote:

“Class III is the high-risk classification for those devices for which general controls or performance standards are insufficient. The FDA defines Class III devices as those for which ‘benefits have not been shown to outweigh risks’ and which present ‘a potential unreasonable risk of injury or illness’ when used as directed by the manufacturer for their intended purpose. The degree of oversight necessary to ensure maximum safety was known as ‘premarket approval’. The name reflected the fact that even though a device might have been on the market for many years, its status was similar to that of a new device. It hadn’t proven itself to the FDA. Its manufacturers would, when called on by the agency, have to submit a premarket approval application (PMA) in which it would have to prove its safety and efficacy” (p. 139).

As discussed by Andre (2009) and the FDA (2015), over the decades there have been multiple attempts to down-classify the shock device to a Class II device, which would classify the shock device as safe and effective. This would put the shock device in the same category as eyeglasses or wheelchairs—other medical devices that are Class II, requiring “special controls.”

The most recent open comment period and meeting on the shock device was held in Gaithersberg, Maryland, January 27 – 28, 2011. Many people, including Dorothy Dundas, John Breeding, Loretta Wilson, Dan Fisher, and Vince Boehm on behalf of Leonard Roy Frank, testified about the horrors of shock and the immense damage it does to the physical body, mind, and spirit. At the 2011 hearings, I was privileged to stand with shock survivors as an ally, and someone who likely would have been shocked if not for the incredible work of the activists of the 1980s. I presented to the FDA an analysis of the comments of over 80 people, mostly shock survivors, who sent letters of opposition to the FDA via The Opal Projectiii. There is videoiv of people who were at the 2011 meeting, discussing afterward how important it was that the panel heard their testimonies, and how their testimonies informed the decisions of the panel.

According to the FDA (2015), the Neurological and Medical Devices Panel who heard the testimony and were given access to all of the research reached “consensus for recommending the device remain Class III for Schizophrenia, Bipolar manic states, Schizoaffective, and Schizophreniform disorder. The panel did not reach consensus on the classification of ECT for depression (unipolar and bipolar) and catatonia” (p. 81226v).

After nearly four years of silence, the FDA has the audacity to speak in a way that defies the calls of 80% of the respondents from the last time public comment was sought. 80% of the respondents were in oppositionvi to the down-classification of the shock machine that would classify the device as being as safe and effective as eyeglasses or wheelchairs (FDA, 2015, p. 13). FDA specifically stated:

“FDA received over 3,000 submissions to the docket, with the majority of respondents, approximately 80 percent, opposing reclassification of ECT. The majority of those opposing reclassification of ECT cited adverse events from ECT treatment as the basis for their opposition. The most common type of adverse event mentioned in the public docket were memory adverse events, followed by other cognitive complaints, brain damage, and death” (p.81226).

According to the FDA, on July 9, 2012, the Food and Drug Administration Safety Innovation Act (FDASIA) was amended to change the process (perhaps ease the process) for “requiring premarket approval for a preamendments Class III device from rulemaking to an administrative order” (p. 81224). This allows the FDA to reclassify a device if there is “new information” (p. 81224). The FDA apparently took it upon itself to reevaluate previously viewed information and concluded that:

“FDA, on its own initiative, is proposing to reclassify this preamendments Class III device into Class II when the device is intended to treat severe Major Depressive Episode associated with Major Depressive Disorder and Bipolar Disorder in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition” (p. 81226).

The FDA is calling for comments on its plan to down-classify the shock device to a Class II device. Despite seeing limited evidence for any long-term benefits, the supposed short-term benefit—“(e.g. 3 months)” (p. 81228)—is grounds for this bold move that sets back human rights work.

It is also important to note that while the FDA is proposing this rule for the shock device to be a Class II device for a “major depressive episode” as part of “major depressive disorder” or “bipolar disorder” (all of these concepts troubling and unfounded themselves), this proposed rule also calls for premarket approval for the device to continue as a Class III device for a variety of other psychiatric labels including “schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia” (pp. 81230 – 81231).

Concerning an action you can take to try to stop this dangerous downgrade of the shock device, the final document states:

“FDA is inviting comments on whether the term “treatment resistant” and the phrase “require rapid response” provide sufficient clarity to the population for which ECT benefits outweigh risks” (p. 81227).

I do not think we ought to limit our comments to their question. Though their question does get at the heart of the issue of subjectivity, I think there are plenty of things to respond to, such as what they deem to be the solution to known risks with the device, beyond simply labeling the device as involving such risk. Section V of the FDA document is “Risks to Health” and these include:

  • Adverse reaction to anesthetic agents/neuromuscular blocking agents
  • Adverse skin reactions
  • Cardiovascular complications
  • Cognition and memory impairment
  • Death
  • Dental/oral trauma
  • Device malfunction
  • Manic symptoms
  • Pain/discomfort
  • Physical trauma
  • Prolonged or tardive seizures
  • Pulmonary complications
  • Skin burns
  • Worsening of psychiatric symptoms” (p. 81227).

 

It is also suggested in the document that since there was a meeting in 2011, they do not need to hold another meeting to hear from people wanting to discuss their testimony.

Here is the exact quote from the FDA (2015):

“Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order for reclassifying a device. Specifically, prior to the issuance of a final order reclassifying a device,the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a  meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket. FDA has held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to ECT devices, and therefore, has met this requirement under section 515(b)(1) of the FD&C Act” (p. 81225).

However, not one person who was on the panel in 2011vii is on the panel now in 2015viii. Therefore, the whole idea that because they held a meeting in 2011 they do not need to hold a meeting in 2015 is ludicrous, since the panel that would make this decision is not the panel who made the recommendation to not down-classify the device in 2011 after the meeting.

One potential end result of this FDA process is that the shock device is down-classified to a Class II device for people who are deemed to have a Major Depressive Episode as part of Major Depressive Disorder or Bipolar Disorder, are treatment resistant, and require rapid response due to a severe psychiatric or medical condition (there is a question I have regarding whether pregnancy falls into this definition of medical condition or not).

Another possible end result is a ban of the shock device:

“If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f)” (p. 81225).

As mentioned earlier, in 2010, 3,000 responses were generated and sent to the FDA. 80% of those responses were in opposition to the down-classification of the shock device. I believe the FDA responded to us by largely keeping the shock device as a Class III device. Think of how all of our social networks and advocacy reaches have grown in the last five years! We need to do it again.

The new rules should not allow “limited scientific evidence” (p. 81231) (which will be scrutinized in a future entry) to dictate this move that will inevitably increase the use of shock. No amount of labeling a device can mitigate the actual risk to those subject to the procedure. We need to hold the FDA responsible for such an irresponsible suggestion.

The FDA wants feedback on creating special controls—labeling the device—for those who have a supposed “major depressive episode” and have been labeled with either “major depressive disorder” or “bipolar disorder” and are “treatment-resistant” and “require rapid response” due to the supposed psychiatric or medical condition. Can you imagine how the use of shock will soar if people are falsely informed that the benefits outweigh the risks for this “specified patient population”? (p. 81227)

If you think for two seconds that the phrases “treatment-resistant” and “require rapid response” are not code for coercion or treatment over objection, then perhaps you need to spend some more time with people who identify as psychiatric survivors.

We now have only 89 days to respond. The comment period closes March 28, 2016. To respond directly to the FDA, please visit:

https://www.federalregister.gov/articles/2015/12/29/2015-32592/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-intended-for-use-in

If you are writing a letter to the FDA to be included in the docket, please be sure to include at the top of your letter:

[Docket No. FDA-2014-N-1210] 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 for Certain Specified Intended Uses.

They will only accept the material into the public docket if that is published on it. The public docket is public. If you have confidential information to share with the FDA you can send two copies, one redacted, that will become part of the public docket. There are instructions on how to do this here: https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf

During this public inspection period, tell the FDA no to the down-classification of shock devices. Tell the FDA exactly how subjective and damaging the terms “treatment-resistant” and “require rapid response” are, and how they fail as legitimate medical concepts. The known risks of electroshock should not be ignored because one has been psychiatrically labeled.

Shock treatment is a crime against humanity. Psychiatric survivors, shock survivors and their allies have long spoken out against shock treatment. Our speaking-out has mattered. Our silence will matter more. Get involved—tell the FDA NO to down-classifying the electroshock device.

Today, December 30, 2015ix from 9-11 PM Eastern, there will be an open-lines call-in show spotlighting people who are shock survivors (and their allies) discussing initial responses to this stunning move by the FDA, and strategies being employed to combat it. If you would like to be part of the show, please call in at (267)521-0167 and press 1 or *1 to be put in the program to speak out. You can listen to a reading of the final published document on the Talk with Tenney Showx which is permanently archived.

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References

i FDA (2015). Proposed Rule for Public Inspection. Docket No. 2014-N-1210. Retrieved on December 29, 2013 from https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf.

ii Andre, L. (2009). Doctors of Deception: What They Don’t Want You to Know about Shock Treatment. New Brunswick Jersey and London: Rutgers University Press.

iv FDA Shock Hearings January 27 and 28, 2011. Retrieved on December 28, 2015 from https://www.youtube.com/watch?v=tQ4vKpJo2KA.

v FDA (2015). Proposed Rule for Public Inspection. Docket No. 2014-N-1210. Retrieved on December 29, 2013 from https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf.

vi FDA Document Docket No. FDA-2014-N-1210. Retrieved on December 28, 2015 from https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf

vii Roster of FDA Panel in 2011 Retrieved on December 28, 2015 from http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-adcom/documents/document/ucm265252.pdf

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25 COMMENTS

  1. If you think for two seconds that the phrases “treatment-resistant” and “require rapid response” are not code for coercion or treatment over objection, then perhaps you need to spend some more time with people who identify as psychiatric survivors.

    Yeah, that’s hardly even code. What kind of rapid response is required for “depression” anyway? It’s not appendicitis.

    So, they want to know what we think about this terminology? Is this just to get some sort of sadistic glee at our reactions or because terms like “treatment resistant” sound suspicious even to them?

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    • Since the `treatment’ offered i.e. psychotropic medications’ don’t work for nearly everyone except as a placebo, I think it’s fair to say that nearly everyone is `treatment resistant’. The claims that ECT is the best treatment available for depression, the `gold standard’ (Yes, David Healy), the penicillin of treatments (Good one, Max Fink), and the `safest treatment in all psychiatry’, might suggest that, rather than save it for the very few and most `dangerous’ cases, where a machine that causes an `unreasonable risk of harm’ is considered acceptable, we should offer it to everyone who is feeling `down’. If you’re `blue’ enough for a useless drug, maybe your GP could recommend ECT! Outpatient clinics are springing up and people can now have it once a week for the rest of their lives, even after they need full time care for the dementia they’ve got from it. Dementia? What the Hell, you’re not depressed!

      Report comment

    • I believe this entire process is a back door attempt to overturn the FDA’s 2011 ruling. I suggest that the APA realises that the FDA may be forced to act on the Class III ruling and insist that the routine testing required BEFORE use of Class III devices be carried out. The machines would have to be withdrawn pending animal studies, placebo trials, proper independent RCTs etc. This would spell disaster.. The back door = the thin end of the wedge? I think the APA believe this. They are operating in the past, where opposition was seen as belonging to `ratbag’, extremist rabble, religious `nutters’ and disgruntled patients.” This is the kind of thinking that permeates the psychiatric profession. They still hold a lot of power but have real problems with cognitive dissonance and insight. That even the somewhat frantic attempts to alert the profession by people like Ron Pies and Allan Frances are being ignored, shows that they can’t/won’t see that their world is collapsing. Psychiatric drug treatments are now exposed as failing and more and more evidence of corruption, misrepresentation and dishonest claims is surfacing.
      The current rush to ECT as a treatment is a last ditch stand to maintain a disintegrating profession in its artificially gained place of power, money and position. Understandable, yes, acceptable, NO.
      There is a general scrambling to find alternatives to the crumbling “chemical imbalance” to keep the biopsych sandcastle in place. These involve ECT which still claims this, but has veered off to the latest wild speculation on the causes of depression to prove that it’s a “modern” treatment.
      Depression is an inflammatory process and ECT’s “mild insult” activates the brain’s neuroprotective response, the brain’s built-in response to repair any damage”. This implies that the neurogenesis set off by the trauma of ECT will be used to repair some existing pathological condition rather than as a response to the damage caused by the treatment. (most of these new cells will die and the effect of the rest is `poorly understood’ , except by psychiatrists, but may be pathological).
      Depression is the result of “too many connections” in the brain. (see Moniz1938 to cure these patients”, it was necessary to “destroy the more or less fixed arrangements of cellular connections that exist in the brain, and particularly those which are related to the frontal lobes”) and Perrin 2012, “investigated this by performing brain scans on patients with severe depression before and after their ECT sessions. It found that, after treatment there was a reduction in the connections in an area of the brain previously linked to both depression and cognitive function.” (This is 3 bears science of course. What is “too many”, what is “too few” and what is “just right”?)
      All of this unsubstantiated rubbish is what the `new’ information is on about but the old…
      “…It is thought that the seizure `resets’ the brain.”
      “ECT is also known to adjust the levels of brain chemicals which are involved in mood regulation, such as serotonin and noradrenaline” 2012
      “The brain functions through complex electrical and chemical processes, which may be impaired by certain types of mental illness. It is believed ECT acts by temporarily altering some of these processes, thereby returning function towards normal.” Information for Patients, April 2003. © Professor JWG Tiller)
      …is still at the CORE (Kellner et al) of this push.
      The rationale behind this is an insult to our intelligence and to that of the non-psychiatrists on the FDA panel.
      Nothing proposed in the docket is new, everything recommended is or should be in place already and none of it is relevant to the safety of the machines.
      It’s ridiculous to suggest that one can classify a machine offering an “unreasonable risk of harm” as acceptable for some conditions but not others. This is a true “curate’s egg” situation. It either is or it is not.
      The claims of RCTs etc have not changed since 2011, the relevant studies re harm & suicide are still excluded and history is denied as usual.
      I think this move was planned after 2011’s failure, which I suspect was completely unexpected. The attempt to sneak it in in the “off season” is an example of the duplicity for which they are now famous. This will be exposed and hopefully serve them very ill indeed.
      Even if they succeed in this, and I don’t think they will, the momentum for collapse is in place. This push may well discredit the FDA/APA more than they can imagine. The fact that they are completely underestimating their opposition is further evidence that they are out of touch.
      This are my 1st questions to the FDA:
      1. Can the FDA please explain how they can re-classify these machines that in 2011 were found to cause an `unreasonable risk of harm’ (class lll) to safe and effective (Classes I and II) without testing the machines to verify this?
      Can the FDA explain why a medical device, Class III, (presenting an unreasonable risk of harm) has been permitted for use, including that listed in this submission, for 5 years after receiving that classification, when ALL other medical devices so designated are required to conform to testing and safety protocols without fear or favour, before being permitted for re-submission let alone use?
      Can the FDA explain how the machines can pose an `unreasonable risk of harm’ for one diagnosis but not for another?
      Given the serious questions regarding diagnosis in psychiatry generally, at what point does an `unreasonable risk of harm’ become `reasonable’, and what tests, checks and balances might be put in place to guarantee that harm is not `unreasonable’?
      There will be many more.
      A thought – they have specified that the DIAGNOSIS rationale should be the basis for objection = opportunity to use Tom Insell, Director of NIMH & Allen Frances Chair DSM VI. Both canned it! A Melbourne professor also said it was written for the drug companies and the courts and his university would not use or teach it.

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  2. I didn’t see a recommendation for where to respond to the FDA, but would appreciate your forwarding my concerns to the FDA regarding their query:

    “FDA is inviting comments on whether the term ‘treatment resistant’ and the phrase ‘require rapid response’ provide sufficient clarity to the population for which ECT benefits outweigh risks.”

    I do not believe the term”treatment resistant” provides “sufficient clarity to the population for which ECT benefits outweigh risks.” The reason being that I, and seemingly millions, including over a million children, have seemingly been misdiagnosed as “bipolar,” due to having the adverse effects of antidepressants or ADHD drugs, misdiagnosed as “bipolar,” largely due to pharmaceutical misinformation, resulting in medical ignorance and misdiagnoses.

    And when one deals with such a DSM-IV-TR “bipolar” misdiagnosis, one is not helped by the current “bipolar” drug treatment recommendations, thus one is judged as ‘treatment resistant,” but ironically for known medical reasons. Today’s “bipolar” drug treatment recommendations, according to the Mayo Clinic, include the following poly pharmacy recommendations:

    “Mood stabilizers … Antipsychotics …Antidepressants … Antidepressant-antipsychotic … Anti-anxiety medications. Benzodiazepines …”

    Despite the known reality that the interactions between these same drug classes are medically known to cause anticholinergic toxidrome, aka anticholinergic intoxication syndrome. The drug classes known to cause anticholinergic toxidrome are:

    “the four ‘anti’s of antihistamines, antipsychotics, antidepressants, and antiparkinsonian drugs[3] as well as atropine, benztropine, datura, and scopolamine.”

    And the central symptoms of anticholinergic intoxication syndrome are:

    “Central symptoms may include memory loss, disorientation, incoherence, hallucinations, psychosis, delirium, hyperactivity, twitching or jerking movements, stereotypy, and seizures.”

    Symptoms which are no doubt always misdiagnosed, since this drug induced pathway to symptoms which are almost identical to the positive symptoms of “schizophrenia,” are not even included as a potential cause of “psychosis” within the DSM. And doctors will almost never diagnose someone with a non-billable iatrogenic illness, when a billable illness, which explains the drug induced symptoms exists.

    And it’s highly unlikely that it’s just those of us who had the adverse reactions of a non- “safe smoking cessation med” / actual dangerous antidepressant, misdiagnosed as “bipolar,” who actually suffer from the known egregious adverse effects of today’s “gold standard” treatment recommendations for “bipolar.” Since these treatment recommendations are known to cause anticholinergic toxidrome in everyone.

    It is my contention that today’s “bipolar” treatment recommendations are known to cause symptoms indistinguishable to the medical community from those of the “serious mental illnesses,” thus medical claims of “treatment resistant” do not provide sufficient proof for ECT benefits to outweigh risks.”

    Report comment

  3. ECT strikes me as a fairly barbaric treatment. I wonder if persons struck by lightening spontaneously recover from any mental afflictions? Some years ago in a journal created by Dr. Peter Breggin I read an article wherein I learned that the two leading advocates of ECT no longer supported that treatment. I can not remember their names. Another article in the same issue I believe talked about a psychiatric nurse who after the treatment forgot all her education and experience — a rather heavy price. A comparable treatment for an automobile would probably leave it totaled!
    Any yet the insurance money is there for any of us if we can work up the symptoms. The great German poet Holderlin slide off the deep end in his late 20’s? and lived the rest of a rather long life on a farm being taken care of by a friend. He was quite manageable and even wrote some poems but was no longer able to care for himself on his own. Depending on when we chose in the 20th century he might have received a lobotomy, insulin shock, a cocktail of drugs, or ECT. And the result? I personally think he was happier in the early 19th century living on that farm–but I have nothing to gain from these rather primitive solutions to everyday problems. For a little more insight into psychiatry you might want to watch Side Effects on Netflix.

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  4. To respond directly to the FDA please visit https://www.federalregister.gov/articles/2015/12/29/2015-32592/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-intended-for-use-in

    If you would like your comments to be also taken into a compilation of comments, please share them here and they will be incorporated into a final document.

    If you are writing a letter to the FDA to be included in the docket – please be sure to include at the top of your letter:

    [Docket No. FDA-2014-N-1210] 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 for Certain Specified Intended Uses.

    They will only accept the material into the public docket if that is published on it. The public docket is public. If you have confidential information to share with the FDA you can send two copies, one redacted, that will become part of the public docket. There are instructions on how to do this here:

    https://www.gpo.gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592.pdf

    Report comment

  5. I listened in to several of your Talk With Tenney radio broadcasts. Tears just streamed down my face as I listened to the injured and devastated victims of this barbaric assault. The woman who spoke of being given psych drugs for a clearly situational crisis and spiralling into
    catatonia and then ECT decimating her life. She spoke of never feeling depressed or suicidal until she was shocked. The architect who lost her career, the student with frontal lobe dementia. All compliments of shock. How many victims will it take before this lunatic quack torture device and purported “treatment” goes the way of the regular lobotomy?
    Have the delusional members of the FDA been lobbied heavily by shock docs or the torture device manufacturers?? Are they bought and paid for??
    Given the heart-wrenching testimony from 2011, why was this “device” not completely “banned”??
    A possibility is a total ban? What, exactly, would it take for this to happen? Someone please explain to me what on earth it would take to produce this result? Is brain damaging people with electrical lobotomy banned anywhere in the world?

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    • I feel all my journey wIth psychIatry was a very organIzed trap. For stress crIses I got a gIft the worst possIble antIdepressant. Than I collapsed Into major depressIon and was overmedIcated wIth the worst coctaIl of psychotropIcs. Than I got catatonIc and was Introduced to ECT. I always was the worst scenerIo and after 19 ECT I became unfunctIonal???

      Before I was healthy functIonal person who had a huge heart and passIons. I was employed by hospItal In PhysIo. And now no lIfe for what put In to communIty and famIly lIfe?

      I do not understand that strategy that was done to me and I wIsh to get solutIon to get me to normalIty wIth help of honest advocates.

      Report comment

      • The “strategy”of what was done to you was probably the usual combination of stupidity, ignorance, and possibly greedy, the strategy the majority of “psychiatrists” employ.You were unnecessarily prescribed a dangerous drug that made you ill, and then driven into a worse state with more drugs and then, of course, electrocuted to injure your nervous system even more. And there you and your family were, worried, trusting, with this lunatic assault you were lied to about or had misrepresented.
        Have you found a doctor to do neuro testing and MRI and EEG scans? Have you considered a lawsuit? What reaction did your shrink have to your injuries?
        Are you in Canada?

        Report comment

    • I believe this entire process is a back door attempt to overturn the FDA’s 2011 ruling. I suggest that the APA realises that the FDA may be forced to act on the Class III ruling and insist that the routine testing required BEFORE use of Class III devices be carried out. The machines would have to be withdrawn pending animal studies, placebo trials, proper independent RCTs etc. This would spell disaster. The FDA is under increasing scrutiny for corruption and poor performance, so the non psychiatric members might just be happy to scapegoat the increasingly unpopular psychiatrists to make themselves look good.
      The back door = the thin end of the wedge? I think the APA believe this. They are operating in the past, where opposition was seen as belonging to `ratbag’, extremist rabble, religious `nutters’ and disgruntled patients who according to Max Fink, `get together and chatter and say all their troubles are due to ECT.” This is the kind of thinking that permeates the psychiatric profession. They still hold a lot of power but have real problems with cognitive dissonance and insight. That even the somewhat frantic attempts to alert the profession by people like Ron Pies and Allan Frances are being ignored, shows that they can’t/won’t see that their world is collapsing. Psychiatric drug treatments are now exposed as failing and more and more evidence of corruption, misrepresentation and dishonest claims is surfacing.
      The current rush to ECT as a treatment is a last ditch stand to maintain a disintegrating profession in its artificially gained place of power, money and position. Understandable, yes, acceptable, NO.
      There is a general scrambling to find alternatives to the crumbling “chemical imbalance” to keep the biopsych sandcastle in place. These involve ECT which still suggests that, but has veered off to the latest wild speculation on the causes of depression to prove that it’s a “modern” treatment.
      Depression is an infammatory process and ECT’s “mild insult” activates the brain’s neuroprotective response, the brain’s built-in response to repair any damage”. This implies that the neurogenesis set off by the trauma of ECT will be used to repair some existing pathological condition rather than as a response to the damage caused by the treatment. (most of these new cells will die and the effect of the rest is `poorly understood’ , except by psychiatrists, but may be pathological).
      Depression is the result of “too many connections” in the brain. (see Moniz1938 to cure these patients”, it was necessary to “destroy the more or less fixed arrangements of cellular connections that exist in the brain, and particularly those which are related to the frontal lobes”) and Perrin 2012, “investigated this by performing brain scans on patients with severe depression before and after their ECT sessions. It found that, after treatment there was a reduction in the connections in an area of the brain previously linked to both depression and cognitive function.” (This is 3 bears science of course. What is “too many”, what is “too few” and what is “just right”?)
      All of this unsubstantiated rubbish is what the `new’ information is on about but the old…
      “…It is thought that the seizure `resets’ the brain.”
      “The brain functions using electrochemical messages, and it is thought that ECT-induced seizures `interrupt’ these messages”. -Better Health Channel State Government Victoria, Department of Health last updated 2013.
      “ECT works by “turning down” an overactive connection between areas of the brain causing depression.” Professor Ian Reid from the University of Aberdeen, and colleagues 2012.
      “Some scientists have suggested it changes the pattern of blood flow or metabolism in the brain, while others believe it releases certain chemicals in the brain that battle the depression.”
      “ECT is also known to adjust the levels of brain chemicals which are involved in mood regulation, such as serotonin and noradrenaline” 2012
      “The brain functions through complex electrical and chemical processes, which may be impaired by certain types of mental illness. It is believed ECT acts by temporarily altering some of these processes, thereby returning function towards normal.” Information for Patients, April 2003. © Professor JWG Tiller)
      It is thought that ECT acts to correct imbalances in certain brain areas through changes in brain chemistry.
      …is still at the CORE (Kellner et al) of this push.
      The rationale behind this is an insult to our intelligence and to that of the non-psychiatrists on the FDA panel. Nothing is new, everything recommended is or should be in place already and none of it is relevant to the safety of the machines.
      It’s ridiculous to suggest that one can classify a machine offering an “unreasonable risk of harm” as acceptable for some conditions but not others. This is a true “curate’s egg” situation. It either is or it is not.
      The claims of RCTs etc have not changed since 2011, the relevant studies re harm & suicide are still excluded and history is denied as usual.
      I think this move was planned after 2011’s failure, which I suspect was completely unexpected. The attempt to sneak it in in the “off season” is an example of the duplicity for which they are now famous. This will be exposed and hopefully serve them very ill indeed.
      Even if they succeed in this, and I don’t think they will, the momentum for collapse is in place. This push may well discredit the FDA/APA more than they can imagine. The fact that they are completely underestimating their opposition is further evidence that they are out of touch.
      This is my 1st question to the FDA:
      1. Can the FDA please explain how they can re-classify these machines that in 2011 were found to cause an `unreasonable risk of harm’ (class lll) to safe and effective (Classes I and II) without testing the machines to verify this?
      My second is:
      2. Can the FDA explain why a medical device, Class III, (presenting an unreasonable risk of harm) has been permitted for use, including that listed in this submission, for 5 years after receiving that classification, when ALL other medical devices so designated are required to conform to testing and safety protocols without fear or favour, before being permitted for re-submission let alone use?
      There will be many more.

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    • Banned: Sicily, Slovenia, Luxembourg; severe restrictions: Italy. Countries that we more `sophisticated’ `high functioning’, high finance countries despise have a far greater respect for their fragile people than we do. Perhaps there, compassion overrides greed.

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  6. Has anyone done the efficacy tests? As in double blind? As in both groups are given anesthesia but only one group has electroshock. Then at different time interval 3 months 6 months 9 months tested for cognitive function and patient satisfaction rating ?

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    • Yes, see *Read & Bentall – 2010 – `The Effectiveness of electro-convulsive therapy: A literature Review.’ As far as I can tell cognitive function has never been systematically measured by any researchers, bur you have to remember that the only people who have access to ECT patients are those doing it to them. The last thing they want to know, for whatever reasons including their own self delusions, is exactly how much damage they’re doing. That is why I’m asking everyone who has had ECT, who can find, or raise the money, to have a full neuropsychological assessment done asap. If we can get a body of evidence it will go a long way towards stopping this scourge. You sound like you understand scientific method, if you read some of these studies you will be appalled at its lack in most of the work done by psychiatrists. Some is laughable, but not funny as it can destroy lives.

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  10. And these results would be the best available. Who is going to fill in a questionnaire that makes them look sloppy and incompetent? The fact that so many admitted poor performance indicates that they don’t know what good practice is, and this is what’s terrifying. One angle is just this – what controls would the FDA put in place to monitor the use of ECT? Of course they can’t. Most of these life threatening events are never reported to anyone. Many, of not most, aren’t even recorded in the patient files. Some aren’t recognised by staff as being `adverse’. I personally know of 2 cardiac arrests, an episode of extreme confusion (? ongoing seizures, or stroke) where a young girl was bedridden for 3 days, and a stroke, all directly related to ECT but never recorded or reported. The stroke was mine. I lost language, was unable to sit up, feed myself, eat or control my bladder for over 12 hours as a consequence of `titration’ during the 1st of 6 ECTs. The nurses recognised something was wrong but accepted it as `normal’ following `titration’ and did nothing. The `small infarct deep in the brain’ was found on a CT scan 18 months later. These episodes must occur in their thousands every day but are covered up/ignored in the general attitude of `who cares’ they’re just loonies. Here is some more stuff to send to the FDA re anaesthetics, http://www.ohchr.org/…/HRBo…/CRPD/GC/GuidelinesArticle14.doc
    PUBLIC RELEASE: 31-MAY-2013
    `Exposure to general anaesthesia could increase the risk of dementia in elderly by 35 percent’
    ESA (EUROPEAN SOCIETY OF ANAESTHESIOLOGY) and “vidan et al. J Alzheimers Dis 2011; 24: 201-16. (2) André D et al. Ann Fr Anesth Reanim 2011; 30: 37-46.General Anesthesia And The Human Brain: How Going Under May Impact Cognitive Function”. 30% of all recipients of ECT are elderly women. The elderly WILL be targeted under this push because a) they “cannot tolerate the (useless) meds”, b) they are more compliant, c) they are “more likely to be depressed than men” (the highest suicide rate is men over 70) and d)THEY ARE ON MEDICARE (US).
    As for deaths, Texas 2013-14 6 deaths in 2400 within 2 weeks of completing ECT = 1:400 NOT 1:12,000.
    Suicide prevention: 4 of these deaths were suicides = 1:600 – population suicide rate – 1:11,000. Can ECT actually CAUSE suicide? Munk-Olsen et al., 2007 and Sharma 1999 say YES. So does anecdotal evidence. I know of 3, people who, as far as I knew, were not associated with psychiatry at all. 1st, a tennis teammate’s brother, 2nd, another woman at the tennis club’s mother, and 3rd, a woman shop assistant’s 21 year old son. All were mentioned in passing, unsolicited. They don’t figure in the stats anywhere because the doctor’s all claimed it was the DEPRESSION that made them do it. Except the depression was caused by the consequences of ECT in all 3!
    It has to be stopped.

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  11. Again, few people are reading this and few people are commenting. Put “antipsychotic” or “Seroquel” or “Pharma” in the title and people are interested. ECT? Not much interest or concern it seems. Where is the outrage? In the 8 people with multiple posts? Is that why this lunatic “treatment” continues?

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  12. That’s the push from psychiatry. The drugs are under fire – In Australia, ECT capital of the world, a very respected medical reporter, a DOCTOR no less, has said publicly that ADHD drugs are no good, the government is putting serious controls on Drug Companies access to doctors. The entire house of cards is falling, so ECT with its `unknown’, `miraculous’ action has to be the only cab in the rank! It’s the SAME as MESMERISM was, BOGUS! Wrap it in jargon as much as you like, it’s BOGUS!

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  13. Opposition to Re-classifying ECT to a class II Devise
    By R.S. Bennett
    https://www.federalregister.gov/articles/2015/12/29/2015-32592/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-intended-for-use-in?utm_campaign=comment%20copy%20email&utm_source=federalregister.gov&utm_medium=email
    I am opposed to re-classifying electroconvulsive therapy (ECT) down to a class II devise for use in depression, bipolar or any other condition. Aside from the very well documented reports of harm and damage done to individuals who have received this form of abuse, and I do consider this a form of abuse and not treatment, there is the very real problem that up to 75% of individuals who have received a psychiatric diagnosis actually have often treatable physical condition which cause or exacerbate psychiatric symptoms. (1)
    Additionally many of those who have received a mental health diagnosis, including that of bi-polar or depression have not had the benefit of the Koran Algorithm(2) , developed at Stanford more than 25 years ago to address this problem. The Koran medical algorithm requires ten items of medical history, measurement of blood pressure, and sixteen laboratory tests (thirteen blood tests and three urine tests). While these tests will not identify all possible conditions which can cause or exacerbate psychiatric symptoms, failure to run these tests pretty much guarantees individuals will needlessly suffer. “California’s state mental health programs fail to detect many diseases that could be causing or exacerbating psychiatric disorders”(3) Re-classifying ECT will undoubtable increase the number of individuals who will be forced to undergo great personal harm or damage due to sanctioning of unneeded abuse.
    “No crime is greater than approving of greed, No calamity is greater than discontent, No fault is greater than possessiveness. (4) The enlightened and the good get things done only from time to time while petty bureaucrats always support one another. Once slanderers and flatters get their wishes Sages and philosophers are deterred.”(5)
    Pharmaceutical companies have claimed that mental illness is caused by a chemical imbalance, but they often omit the other three factors in the medical model for brain dysfunction: anatomical abnormalities or damage; lack of oxygen or glucose; and electrolyte imbalance. (6)
    It is likely, however, that chemical imbalances may simply be a means by which some symptoms of mental illness result, not a cause. Various factors and combination of factors likely cause the personal unease which, if not adequately addressed can result in the various symptoms which cause people to be labeled mentally ill.

    Trauma has been proven to shrink a portion of the brain(7) , resulting in various symptoms which can increase in severity over time. Therefor psychological trauma should be considered as evidence of a physical abnormality, or damage to the brain, and not the result of a chemical imbalance.
    There are various proven non-drug therapies for treating trauma. The least expensive – and possibly the most effective of these are a series of simple Tension &Trauma Releasing Exercises. (8) This method should be taught during basic training in all military services – and practiced at least weekly in conflict areas to prevent service people from developing PTSD. It should also be widely available for any who have received significant psychological trauma regardless of the origins of the trauma.

    Somatic Experiencing (9)(SE) is a body-awareness approach to trauma being taught throughout the world, the result of over forty years of observation, research, and hands-on development by Dr. Peter Levine. Based upon the realization that human beings have an innate ability to overcome the effects of trauma, SE employs awareness of body sensation to help people “renegotiate” and heal rather than relive or reenact trauma. Dr. Levine’s interest in trauma began when the police sent him a man who over several years had held up several convenience stores – each time on July 5th at about 6:30 in the morning, and then waited in his car for police to show up. It turned out that in Vietnam, the man’s squad, except for him and one other soldier who was severely wounded was killed on July 4th. It was about 6:30 in the morning on July 5th that the rescue helicopter showed up – at about the same time his buddy died. One of Levine’s findings was that “A compulsion can develop to repeat the actions that caused the problem in the first place. We are inextricably drawn into situations that replicate the original trauma in both obvious and less obvious ways.” (10)
    Eye Movement Desensitization and Reprocessing (EMDR) is considered to be an evidence-based practice by the Substance Abuse and Mental Health Services Administration (SAMHSA). Counseling is only a small portion of this therapy, which was developed for children. It is briefer than most programs designed to treat trauma, rarely lasting more than three or four sessions. It also works with adults. This method of treating trauma doesn’t require the patient to divulge all information regarding the trauma to the provider. While the client recalls the incidents in his or her mind, the eyes are guided in a smooth pattern. Individuals have claimed this therapy is roughly 50% effective.

    “Magnesium [an electrolyte and key component in the production of serotonin] is essential in regulating central nervous system excitability thus magnesium deficiency may cause aggressive behavior, depression, or suicide .” (11)Before anyone receives the label of mentally ill, magnesium levels should be checked. A Hair Test Mineral Analysis (HTMA) can identify magnesium deficiencies as well as other mineral deficiencies. The presence of various toxic substances, such as arsenic, which in low dosage can impede good mental functioning, can also be identified by HTMA. This is of particular concern in areas, like Nevada, where mining operations have used arsenic.

    Personality type and substance abuse are why people turn to violence, as well as those who fail to adequately deal with their anger. There is considerable evidence that learned responses to stress factor in the development of various personality types. Indeed, the Grenade personality type (12)–when individuals explode when they believe their need for appreciation is thwarted is a much greater indicator of possible violence than those who have been labeled mentally ill. Many other symptoms of mental illness can also be attributed to personality type. Buddhist psychology (13) identifies five personality types, each with a wisdom and neurotic aspect, and focuses on helping people identify neurotic aspects in order to give opportunities for change.

    Various programs and therapies have been developed which enable people to cope better with the stresses life has thrown at them. Cognitive therapy(14) identifies ten common schemas – or learned responses to stress which are usually developed during childhood, and how to overcome them. Other effective programs include Nonviolent Communications, Choice Theory, Rational-Emotive Behavioral Therapy, NAMI Peer to Peer courses, the Wellness Recovery Action Plan, and even videos such as How To Deal With Difficult People, which can be a great aid for those going through therapy as it helps them become aware of their problematic behavior in a humorous way. There are probably hundreds of others programs which can help individuals as well, but these are the ones I am most familiar with.
    “When social cohesion waned and the Warring States era set in, the course of military science changed: humanitarism and justice faded out; instead military affairs came from violence and went to treachery. Strong states became unrestrained through militarism, large states grew arrogant because of their armies, angry states used their weapons to incite disturbance, and greedy states used their armed forces to invade others. ” (15)
    Re-classifying ECT down to Class II merely would incite disturbance, loosen social cohesion and help fade out justice.
    More about true reform of the mental health system can be found in my book Liberty & Mental Health – You Can’t Have One Without the Other – http://www.libertymentalhealth.com – while a humorous view of the mental health and criminal justice systems can be seen in my play Scapegoat(s) https://youtu.be/2-ysLBxhfgU

    1.Allen MH, Fauman MA, Morin SF. Emergency psychiatric evaluation of “organic” mental disorders. New Dir Mental Health Serv 1995;67:45–55. A Dose of Sanity by Sydney Walker III, MD, 1996, pg 13/ Hoffman, Robert Science News, Vol. 122, September 11, 1982; Herringm M. M., Debate over ‘false positive schizophrenics’ Medicine Tribune, September 25, 1985. Pg 3; Koranyi, Erwin K., “Undiagnosed physical illness in psychiatric patients,” American Family Physician, Vol. 41, No. 4, April 1990; Christensen RC, Grace GD, Byrd JC. Refer more patients for medical evaluation. Curr Psychiatr 2009;8:73–74.

    2. A Medical Algorithm for Detecting Physical Disease in Psychiatric Patients, Hospital and Community Psychiatry Vol. 40 No. 12 Dec 1989, p. 1270 by Harold C. Sox, Jr., MD, Lorrin M. Koran, MD, Carol H. Sox, MS, Keith I. Marton, MD, Fred Dugger, PA, Teruko Smith, RN
    3. IBID
    4. The Art of War by Sun Tzu © 2000 by Thomas Cleary pg. 183
    5. IBID pg. 191
    6. Biology and Human Behavior: The Neurological Origins of Individuality, Professor Robert Sapolsky, Stanford University, The Great Courses, The Teaching Company 1996
    7. Does Stress Damage the Brain, by J. Douglas Bremmer MD, Biologivcal Psychiatry 1999; 45:797-805; Traumatic Amnesia, Repression, and Hippocampus Injury due to Emotional Stress, Cortisosteroids and Enkephalins by R. Joseph,Ph.D. Child Psychiatry Hum Dev.1998Winter; 29(2):169-85 http://www.ncbi.nlm.nih.gov/pubmed/9816735
    8. TheRevolutionary Trauma Release Process: Transcend Your ToughestTimes by David Berceli, PhD. http://www.traumaprevention.com
    9. Somatic Experiencing Trauma Institute, http://www.traumahealing.org ; Healing Trauma by Peter Levine PhD, 2005
    10. Healing Trauma by Peter Levine PhD, 2005 (pg. 20)
    11. Transdermal Magnesium Therapy 2007 by Mark Sircus, Ac., OMD p. 5
    12. How To Deal With Difficult People by Dr. Rick Brinkman and Dr. Rick Kirschner,©1982, http://www.CareerTrack.com and http://rickbrinkman.com/store/

    13. The Five Wisdom Energies – A Buddhist Way of Understanding Personalities, Emotions and Relationships by Irini Rockwell © 2002
    14. Emotional Alchemy – How the Mind can Heal the Heart by Tara Bennett – Goleman © 2001
    15. The Art of War by Sun Tzu © 2000 by Thomas Cleary pg. 190

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