This is a petition concerning:

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•  Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff".

This is a Letter of Opposition to FDA down-classifying the shock device from a Class III device to a Class II device for any reason.

There is a long history of the FDA attempting to remove the experimental status of the shock device. There is an even longer history of those who have been subjected to shock treatment and their allies working to expose the damage shock treatment causes. Shock treatment as robbed people of the memories of their lives, their education, skills, passions, relationships, children, significant others, and total sense of oneself.  For decades, when proper rule-making processes were upheld, the voices of those whose lives were destroyed by shock treatment reached those in power and prevented the down-classification of the shock device from happening. 

The video attached to this petition illustrates one recent example of shock survivors and allies feeling as if their voices were heard. This video was taken after the close of the FDA 2011 hearings on the shock device, where it was recommended that the shock device ought to remain a Class III device. It is unconscionable that the FDA would make such a grand reversal, potentially subjecting untold numbers of people to the known devastations of shock treatment.

FDA, you say you have "new information" that has caused you to put forward a proposed rule for the down-classification of the shock device.  This information may include that shock for depression is "cost-effective". However, FDA it is important to note that you failed to mention that throughout the "new information" the perspectives of those who were subjected to shock treatment were redacted. 

 FDA you asked if the terms “treatment-resistant” and “require rapid response” provide sufficient clarity for what would be considered a Class II use of the shock device, if the proposed rule were to be approved for people who are accused of a “major depressive episode” experienced as part of “major depressive disorder” or “bipolar disorder”.

My answer is no, there is no reason the FDA ought to down-classify the shock device from a Class III device to a Class II device.

I challenge the entire concept of someone being “treatment-resistant” and argue that there is no situation that would “require [a] rapid response” of shock treatment.

This petition is a result of five national teleconferences coordinated by MindFreedom International. Over 100 people who are survivors of psychiatry, including people who are shock survivors, their allies, and members of MindFreedom International participated in these processes. I support the material generated in this letter of opposition.

I oppose the FDA decision to not hold a public hearing about this proposed rule because a meeting was held in 2011. The information was presented to people on the Neurological and Medical Devices Panel of the FDA in 2011 produced a recommendation to keep the shock device a Class III device. Not one of the people on the 2011 panel is on the current panel.  Therefore, the idea that the FDA does not need to hold a hearing because a hearing was held is not legitimate.

It is important for those making this decision concerning the potential down-classification of the shock device to be aware of the following information compiled through the National Teleconferences coordinated by MindFreedom International. 

Briefly,  

1. Psychiatric labels are not actual medical diagnoses; there are no biological tests to show evidence of any such ‘disease’. Psychiatric labels do not reflect any actual chemical imbalances in the brain.
2. Most psychiatric drugs are ineffective and even for people who voluntarily take them, the drugs can and do cause physical and psychological harm and injury.
3. Relying on a psychiatric label and lack of response to drugs that are known to fail, as determinants for who gets shock treatment, is not a valid method for any treatment protocol. It is particularly not a viable method for a treatment where the known risks outweigh potential unknown benefits, as is the case with shock treatment. The fact that the FDA acknowledges "significant risks" (p. 81227) of shock treatment as palatable for this particular class of people shows how a psychiatric diagnosis also results in experiences of discrimination. People who are psychiatrically labeled are being put in harms way. The government through this proposed rule is justifying severe risk and known negative consequence of shock treatment because of a label with no diagnostic validity.
4. Many people who have psychiatric histories are put on multiple types of drugs simply because they have been given a psychiatric label. None of these drugs are always effective. Most of these drugs are usually ineffective.  While there is no standard specified for the number of drug trials one must fail, and I do not believe there ought to be such a standard established, using the subjectivity of an individual psychiatrist to determine one as "treatment-resistant", or failure of some arbitrary number of drug experiment(s) as grounds for someone being “treatment-resistant” is punishing the person for the lack of effectiveness of the drug (and probably also, the lack of effectiveness of any psychiatric worker).
5. There is no situation that qualifies as an "emergency" to "require rapid response" of shock treatment. It is important for people to realize that the course of shock treatment the proposed rule suggests as outside of the bounds of Class II is "treatment in excess of 3 months" (FDA, 2015, p. 81233). This is particularly problematic because the "new evidence" cited for the establishment of the proposed rule was a supposed benefit seen in the "acute phase (less than 3 months after treatment)" (p. 81227). This is a gross misinterpretation of the findings, which already were questionable as "evidence". It is important to understand that the reality of shock treatment being haphazardly used on people is simply terrifying to those who may fall under the new definitions.
6. Emergencies do not last for three months. Justifying having electricity shot through your brain, general anesthesia, and a host of muscle relaxers and painkillers injected into your body, that create the need for a higher surge of electricity to induce the seizure to accomplish the desired brain damage because of an "emergency" is ludicrous and irresponsible. The fact that the findings showed a potential small and non-permanent benefit for no more than three months after treatment switched to promote treatment up to three months, again, slices at the idea of an emergency.
7. In the rule it specifies that after this "acute phase" of shock treatment it is expected that people will go back on drugs and back to therapy (p. 81227); what kind of "emergency" does this resolve?  
8. Concerning the "medical condition" clause, if pregnancy is still considered a "medical condition", does shock treatment for a pregnant woman who has been on psychiatric drugs which have been ruled deleterious to a developing fetus constitute a need for shock treatment as a "first line treatment" for pregnant women? What "medical condition" meets the subjective call for requiring a rapid response of shock treatment?  
9. Even if someone is on the verge of death--and that is the emergency--a thoughtful, researchable response--not a rapid response--is what is required.
10. "Require Rapid Response" is a euphemism for forced treatment. 

No, FDA, the terms “treatment-resistant” and “require rapid response” do not provide sufficient clarity to the population for which the FDA is, in my estimation, falsely stating shock treatment benefits outweigh risks.

The risks of shock treatment consist of one whole section of the proposed rule. Yet, there is not one specific known benefit that the FDA lists in the proposed rule, just a consistent "unknown" benefit. Concerning risk, Section V (FDA, 2015, p. 81227) is as follows:

"After considering the available information from the reports and recommendations of the advisory committees (panels) for the classification of these devices, FDA has evaluated the risks to health associated with the use of ECT devices and determined that the following risks to health are associated with its use:

• Adverse reaction to anesthetic agents/neuromuscular blocking agents. The muscle relaxing and sedating (or sleep inducing) drugs that are a part of the procedure may hamper the patient’s ability to breathe spontaneously.
• Adverse skin reactions. The patient contacting materials of the device may cause an adverse immunological or allergic reaction in a patient.
• Cardiovascular complications. The therapeutic convulsions may be accompanied by arrhythmias (irregular heartbeat) or ischemia/infarction (i.e., heart attack). Hypertension (high blood pressure) as well as hypotension (low blood pressure) may be associated with ECT treatment. ECT treatment may also result in stroke (impairment of blood flow to the brain or bleeding in the brain).
• Cognition and memory impairment. ECT treatment may result in memory impairment, specifically immediate post-treatment disorientation, anterograde memory impairment and retrograde personal (autobiographical) memory impairment.
• Death. Death may result from various complications of ECT such as reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke.
• Dental/oral trauma. Dental fractures, dislocations, lacerations, and prosthetic damage may occur as a result of strong muscle contractions during treatment.
• Device malfunction. Faulty hardware, software or accessories (electrodes) or improper use may cause electrical hazards, such as the risk of excessive dose administration, prolonged seizures, and skin burns.
• Manic symptoms. ECT treatment may result in the development of hypomanic or manic symptoms.
• Pain/discomfort. The patient may experience mild to moderate pain following the motor seizure induced by ECT treatment.
• Physical trauma. Inadequate supportive drug treatment may allow the patient to be injured from unconscious violent movements during convulsions.
• Prolonged or tardive seizures. ECT treatment may result in prolonged or delayed seizures, and status epilepticus (continuous unremittent seizure) may ensue if prolonged seizures are not properly treated.
• Pulmonary complications. ECT treatment may result in prolonged apnea (no breathing) or inhalation of foreign material, such as regurgitated stomach contents.
• Skin burns. Excessive electrical current or improperly designed electrodes may cause the patient’s skin under the electrodes to be burned.
• Worsening of psychiatric symptoms. ECT treatment may be ineffective and therefore may result in worsening psychiatric symptoms."

Again, there is not one specific known benefit that the FDA lists in the proposed rule.

Moreover, when considering the use of shock treatment for other classes of people, FDA while acknowledging limited scientific evidence of benefits, instead of curtailing the use of the shock device makes way for device makers and psychiatric workers to create situations for potential expanded use of shock treatment. Specifically, creating opportunities for the use of the shock device where there is no known benefit, and plenty of known risk and damage. Specifically, FDA creates a bridge for shock treatment to be used on classes other than those targeted in the proposed rule, effectively covering all of the other major psychiatric diagnoses one could be assigned--not one of these diagnoses, again, as addressed above, a validated actual disease.

Why is it that the long list of known injuries and damage caused by the shock device are ignored while potential "unknown" benefits are privileged? Why is the FDA holding onto the shock device? 

Perhaps the FDA is aware that the terms “treatment-resistant” and "require rapid response" are not sufficient determinants for people to be subjected to shock treatment and this is why the FDA is seeking public comment for an estimation that such subjective terminology is insufficient direction for such severe risk and known negative consequences.

The term “treatment-resistant” when used by psychiatric workers denotes a determination as to whether ‘treatment’ ‘helped’. The rule by which this standard is measured is arbitrary – fail two drugs? Five drugs? Drugs that are known half of the time to fail? 

Most importantly, the vast majority of people who are survivors of shock treatment say there is nothing therapeutic about shock treatment, that they are part of a class of people being targeted; and that it has nothing to do with the way they feel, but rather, how they make those around them feel.

I want the FDA to know that some people who even ‘voluntarily’ underwent shock treatment explained that their subjugation to shock had nothing to do with the way that they felt. Particularly for those who asked for shock treatment, having to admit that they were wrong and it had done them damage was incredibly difficult.  Still others who thought that they had given informed consent, only later to learn that their consent was based on misinformation, also battled with the knowledge and feelings that they were duped by the doctors they trusted.

While there is no accepted standard for determining someone failing an attempted ‘treatment’ for a ‘disease’ for which there is no biological test to prove exists, there is a standard at which shock is sometimes ordered: at the level of a person becoming a nuisance or embarrassment to those in psychiatric power. 

People who are shock survivors also felt that it is important for the FDA to understand the implications of the term “treatment-resistant” for people who may be enduring extenuating circumstances, that perhaps would take any person some time to recover. Lack of a positive response to a drug ought not determine one being a candidate for shock treatment, when one may be healing from loss or struggling to find a support system.

If the shock device is lowered to a Class II device—if people are told by a doctor that, now, based on the FDA's decision, the shock device is a significant risk but worth it, people will give even more trust to a doctor—especially if they are already in a place where they are desperate for a solution.  

From the template letter, addressed to Steven Ostroff, M.D., Acting Commissioner of the FDA, that the American Psychiatric Association urged its members to send to FDA in support of the down-classification was this sentence illustrating the way this information is already getting twisted from "significant risk" to "safe, effective". APA urges its members to write to the FDA, "Your proposed reclassification will greatly improve access to safe, effective treatment for individuals with serious and persistent psychiatric disorders" (American Psychiatric Association Template-Letter-ECT-MS, 2016).

It is the position of MindFreedom International that the APA ought to be held accountable for this type of disinformation campaign by the FDA and I support this call for accountability. 

Perhaps of most concern is the simultaneously released proposed document, "Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses Draft Guidance for Industry, Clinicians and Food and Drug Administration Staff" states: "FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited" (FDA, 2015, p. 1) 

There is a complete lack of accountability that will occur in the guidance if the shock device is down-classified to a Class II device. This is demonstrated by the fact that a) the guidelines for shock devices have been simultaneously put out with the proposed rule, reflecting the proposed rule, before the proposed rule has been past, and b) with little exception, as stated by FDA, these guidelines are by and large, suggestions, not requirements.  

The exceptions of special controls from the proposed rule make it so shock devices must have labels with the following warnings:

"Warning: ECT device use may be associated with: disorientation, confusion, and memory problems" (p. 13). 

"Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated" (p. 13).

One can see the disingenuous nature of "special controls" when one compares the two "must"-have warnings with the multiple pages of recommended "should"-have guidance. This recommended information will never get to the average person.  The information is not guaranteed to even get to those working in the psychiatric industry. Most importantly, this information is not guaranteed to get to those who will be subjected to shock treatment.

I say this with some sense of assurances that the pages of precautions, contraindications, potential risks, and known consequences of shock treatment will not be shared, because it is not mandated to be shared.

FDA (2015) specified, "The use of the word should in Agency guidances means that something is suggested or recommended, but not required" (p. 1).

The most concerning example of "should" as opposed to "must" in the draft guidance is that, "Each patient should have access to clear information in plain language to assist with forming realistic expectations of the treatment and its potential complications (p. 16).  Should have access to clear information, not must have access to clear information. 

I object to FDA plans to simply put a general label on the shock device as a legitimate means to mitigate the many known risks and negative consequences of shock, including destruction of autobiographical memory, death, and a host of other physical, psychological, and cognitive injuries.  

FDA reminded us that in 2009, among other strategies, in order to mitigate risk, "The manufacturers stated that safety and effectiveness of these devices may be assured by reducing the frequency of treatments, temporary or permanent interruption of treatments" (p. 81226).

As illustrated, the person subjected to shock treatment is not guaranteed to be informed of all of the risks of the shock device. As a matter of fact, the term "consent" does not appear anywhere in the FDA proposed rule.

It is offensive that the FDA, supposedly existing to protect people from potential and known damage caused by medical devices and other inventions of industries, does not see it as imperative to inform people about the many known body-damaging, brain-damaging, and spirit-damaging risks of the shock device. Someone drugged and restrained on a shock table is not going to see the shock device or read its label. 

There is a tremendous amount of work done by people trying to call attention to brain-damaging shock treatment. Some but not all resources you ought to thoroughly review include: ECT Justice; Aftershock; PsychRights; End of Shock; From the Files of Leonard Roy Frank; Linda Andre's (2009) Doctors of Deception;  Peter Breggin's Dangers; ECT Resources Center; Mad in America ECT Archives; and MindFreedom International's Electroshock Page.

So, 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. 

This concludes this petition. 

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”.

If you would like MindFreedom International to submit comments to the FDA on your behalf, please along with signing our petition to show the FDA you support MindFreedom International's opposition to FDA's proposed rule, 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’’

PROPOSED RULE COMMENT SUBMISSION TO FDA

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

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

PROPOSED GUIDANCE COMMENT SUBMISSION TO FDA

http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-1318-0001

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