To stop the FDA’s down-classification of the shock device, we only have about 72 hours left—the length of time the state can involuntarily hold people in a psychiatric institution for “evaluation.” If you have ever been subjected to this involuntary detainment, or sat through a 72+ Hour Bastille Day Vigil and Demonstration to Speak Out Against Psychiatric Oppression and Celebrate the Human Spirit, then you know how long 72 hours can be. However, it may not be long enough to truly bring in the response we need to put the FDA on notice without your help.
The deadline for public comment is March 28, 2016. You can submit your comments here and here (make sure to include the docket information found at the bottom of this post), and also sign the petition. Help us convey to the FDA that the American public will not tolerate the shock device being down-classified to a Class II device (the same category as eyeglasses and wheelchairs) and called “safe enough” for people who are said to be experiencing a “depressive episode” and have been assigned the label of “major depressive or bipolar disorder” said to be “treatment-resistant” or to “require rapid response.”
As part of the effort to stop the down-classification of the shock device, on March 24, 2016, people who are psychiatric survivors, shock survivors, allies, and MindFreedom International members sent a 47-page public complaint to the FDA Ombudsman Office and Medical Devices Ombudsman concerning the FDA’s attempts at down-classifying the shock device. The full text of the complaint can be read here and downloaded here.
Here are some excerpts:
This is a public official complaint concerning the processes the FDA is using in above referenced dockets. The dockets in question include one, proposing a rule to down-classify the shock device from a Class III device to a Class II device, which would place the shock device in the same category of devices such as eyeglasses or wheelchairs and two, draft guidance for the shock device as a Class II device.
Please see this complaint underscored by the fact that in 2008 the Special Rapporteur on Torture and Other Cruel, Inhuman and Degrading Treatment of the United Nations Human Rights Council reported that electroshock may constitute torture or ill treatment (Interim Report to the General Assembly, July 28, 2008i). He specified that “it is of vital importance that ECT be administered only with the free and informed consent of the person concerned, including on the basis of information on the secondary effects and related risks such as heart complications, confusion, loss of memory and even death.”
In 2015, two United Nations Special Rapporteurs, the Rapporteur on the Rights of Persons with Disabilities and the Rapporteur on the Right to Health, issued a statementii calling on all countries to “eradicate all forms of non-consensual psychiatric treatment” (“Dignity must prevail” – An appeal to do away with non-consensual psychiatric treatment World Mental Health Day – Saturday 10 October 2015).
Also in 2015, the United Nations Committee on the Rights of Persons with Disabilities, which monitors the Convention on the Rights of Persons with Disabilities that has been signed (although not yet ratified) by the United States, found that forced treatment is an act of torture or other cruel, inhuman or degrading treatment in its Guidelines on Article 14iii, and has specifically expressed concern about forced electroshock in calling for abolition of forced treatment in two states parties to the Convention, Denmarkiv and Swedenv (both in 2014).
As for our complaint, there are thirteen main issues (each with sub-issues) that we take with the process FDA has used for the proposed rule to down-classify the shock device and the draft guidance. Our issues are as follows:
First, the FDA announced the proposed rule and draft guidance on December 29, 2015, when the bulk of the world was otherwise involved with holiday. Due to the dedication of people who monitor the FDA and first noticed the proposal we are trying to respond to both dockets. It is a cruel reality that the deadline suggested by FDA, March 28, 2016, also falls over another holiday (although not a federal holiday).
We take issue with the way the proposals were released, in terms of their timing.
Skipping to the third issue:
Third, FDA has suggested that since it held hearings in 2011 on the shock device (where it was recommended by the panel to keep the shock device at a Class III level) that FDA does not need to hold hearings now—even though the current panel is made up of entirely different people from the 2011 panel. We find this new ability for the FDA to make an order and not have to go through rule-making processes particularly deleterious to the future lives of people who may be subjected to shock treatment because of this new rule.
Jumping to the eight issue:
Eighth, we want to see FDA hold the American Psychiatric Association and National Institute of Mental Health and other organizations promoting misinformation about the shock device held accountable. As an example, the American Psychiatric Association published an article, “Time is Now to Support the Reclassification Effort” (January 29, 2016). APA writes to its membership—and anyone who has access to the internet as it is newsletter is prominently placed on their website, “The FDA recently proposed a rule change that would reclassify electroconvulsive therapy (ECT) devices used for treating major depressive disorder from class III (high risk) to class II (low risk)vi.” This is blatantly untrue. A Class II device is not “low risk”. It is a device that requires both general and special controls because of its known risks.
It is important to underscore that the shock device has never been tested for safety or efficacy, and while there are anecdotes of a short-lived “euphoric” result, often confused for mania, there is a tremendous amount of evidence of the damage that shock treatment inflicts on the body and the brain. Some of this record of damage, admittedly, is also anecdotal.
The American Psychiatric Association credits “testimony from former patients, who state that they suffered permanent memory loss and brain damage” for the 1976 failed attempts at down-classifying the shock device. APA also credits the 2010 (and 2011 hearings not mentioned) failures to down classify the shock device to “significant resistance from the anti psychiatry groups” and stresses “ That is why it is so important for psychiatrists to take the lead in expressing their views in regard to the role that ECT plays in practice and in the treatment of major depressive disorder”. Another point of misrepresentation –APA states, “The government does give importance to the number of letters or emails received, pro vs con, in its deliberations” and APA created form letters for psychiatrists to use, “supporting the reclassification effort”.
The form letter espouses the idea that shock treatment is “safe and effective”. This disinformation campaign ought to be punished. Even the FDA rule is clear that for some, a short-lived potential relief may outweigh the many known risks. To allow psychiatrists to reposition shock treatment as “safe and effective” without recourse is akin to allowing drug companies to not list the known adverse ramifications of their drugs.
Additionally, APA is not stopping with their blog, they have also taken to twitter with tweets such as: “Extensive body of evidence for safe, effective use of #ECT supports reclassification. Read our letter to the #FDA: http://apapsy.ch/fda-ect” and “We urge APA members to reach out to the FDA and support a class II designation for #ECT. Here’s how you can help: http://apapsy.ch/ect-class”; and “#ECT is safe, effective, should be available to patients. We urge FDA to reclassify ECT. Show your support: http://apapsy.ch/ect-class.”
It might be of interest to FDA that under a heading of “What APA is Doing for You”, APA writes that the above mentioned “blog post is part of an occasional series highlighting how APA advocates on your behalf to support the profession of psychiatry and put our interests before key policymakers”. Considering their knowledge of the contestations of people who have been subjected to shock treatment, one might argue, it is clear evidence that they are also putting the interests of psychiatrists before those that they might come in contact with and have power over in their practices.
Repeating a falsehood does not make it true.
Concerning the National Institute of Mental Health, the disinformation campaign on shock treatment must be stopped, immediately. On March 17, 2016 NIMH hosted a “Q & A on Electroconvulsive Therapy”. The government and psychiatric industries have been working together through a concentrated effort to repackage brain damage resulting from shock treatment as “brain stimulation”. The profound lie-protection that psychiatric power has via state-power and government sanction and support of work is going to have negative consequences on the American population, and people across the world who will be more likely to be subjected to shock treatment because of the disinformation campaign. We have photo evidence of comments and questions asked of NIMH during the Q&A that were deleted and people were blocked from participating. One such comment was the list of known Risks to Health printed in Section V. of the FDA’s (2015) Proposed Rule to down-classify the shock device.
It is amazing to see, for example, how Dr. Lisanby has risen through the ranks of government, from her 2011 role as Chair of the committee on shock treatment, to now, the director of “translational research” at NIMH, as a special guest on Facebook events. Lisanby, who in 2011 argued informed consent process could happen in 30 minutes, but take as long as 90 minutes (90 minutes!) is literally writing the rules for shock treatment in America.
The misinformation people are being given by these entities is of grave concern. The fact that there is no mechanism built in to measure whether consent is genuine, informed, and based on an array of choices, is an outstanding issue that must not be ignored. FDA, have you ever wondered why the psychiatrists and manufacturers ‘care’ so much, they are not demanding safety and efficacy themselves? FDA, you do see the conflicts of interest (if not financial, in terms of power and professional accolades), don’t you? There are lobbyists pushing this through, pushing down the safety risks, covering up the death data, disregarding the animal studies—or any study that is in-depth. FDA cannot down-classify shock devices that have never been tested for safety or efficacy and the long known consequences and high risks of shock treatment.
Sham-ECT achieves no better outcomes than real shock treatment achieves no better outcomes than Sham-ECT. Sham ECT! Really – the whole idea that something called Sham-ECT even exists. Sham-ECT is basically where people are told they are being subjected to shock treatment and then, while s/he is under anesthesia, the electricity is actually withheld. Are the people who have been subjected to Sham-ECT ever told? FDA must hold researchers, trade organizations, and state-sponsored psychiatry accountable.
From the ninth issue:
. . . Concerning off-label use of the shock device, and the push for what situations ought to be included in Class II use of shock, we turn for a moment to a disturbing response to the FDA docket from the American Academy of Child and Adolescent Psychiatry, who writes:
Based on successful outcomes in adolescents treated with ECT, we propose that ECT should be classified as a Class II procedure for all major psychiatric disorders which have known positive response to ECT, (i.e. major depression, bipolar disorder, SSD, catatonia and neuroleptic malignant syndrome (NMS)) while imposing special precautions.
The industry will consistently work to protect the industry. In the AACAP’s comment it is acknowledged that there are no comprehensive studies but there are dozens of footnotes on “case studies” or other research on shock treatment on minors.
The researchers who are experimenting on minors who have been psychiatrically assigned and minors who have developmental disabilities, or who are victims of psychiatric drugs and suffer Neuroleptic Malignant Syndrome, ought to be charged with Crimes of Humanity.
The field of psychiatry builds itself on its own claims. We want FDA to hold responsible psychiatrists who are using—or promoting the use—of shock treatment on minors—especially if that use is in the form of published experimentation. . .
Then to the final issue:
Thirteenth: Our general concerns about the FDAs ties to the pharmaceutical industries cannot go without comment. The financial and personal interests that certain individuals have are now publicly discussed. We cannot help what the implications of the new leadership of FDA are and how it will affect fair and accurate processes of decisions that FDA makes. Certainly, this is of concern beyond the shock device and is routinely being discussed in the general public.
We conclude our public complaint in this way:
In Conclusion, we believe that we have offered you, the Ombuds Office and the Ombuds for Medical Devices, a wealth of information that must be considered as FDA attempts to down-classify the shock device. Be sure, that if the FDA is allowed to ignore and suppress this information and order the rule that is proposed with the draft guidance becoming the intent of the order, shock treatment in the United States will soar. People—with one of the most common and controversial psychiatric assignments—depressive episode—who are being given drugs that are known to be dangerous and routinely fail—will now be subjected to electrical assaults on a regular basis—three times a week. That is electricity shot through a someone’s brain three times a week, general anesthesia three times a wake, muscle relaxers and pain killers continuously ingested for months, and food intake prohibited for large swaths of time, meaning food withheld in excess of 12 hours every 24 hours, for months on end. All this for a procedure that does not work, has never been tested for safety or efficacy and shows a wealth of known negative consequences with high risk of occurring.
To the people of the FDA Ombuds Offices and Ombudsperson for Medical Devices, we want you to respond to this public complaint with more than a “thank you for your concern”.
We want you to respond to this public complaint with immediate and swift actions to put a moratorium on this proposed rule and draft guidance until proper and accessible hearings can be held.
We want you to put a moratorium on the use of shock treatment until these major issues of concern are adequately addressed.
We also want you to hold those who have been saying that shock treatment is “safe and effective” such as trade organizations such as the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, and government, state-sponsored psychiatry, such as the National Institute of Mental Health, to be held publicly accountable by FDA for the disinformation they have been producing and promoting.
We want FDA to create a process for reparations for those who have been lied to about shock treatment and suffered its known consequences.
Shock treatment is a mechanism of injury. Having 600 volts of electricity—or any amount of electricity—shot through one’s brain is a trauma.
In short, our public complaint requests that the FDA Ombudsman Office intervene on all thirteen major issues we take with the processes FDA used/is using concerning this attempt to down-classify the shock device. Our overall requests are:
First, we do not want the shock device down-classified for any reason, but particularly the fraudulent reason that it is ’safe enough’ for people who are ‘depressed’ ‘bipolar’, ‘treatment-resistant’ or ‘require rapid response’;
Second, we want FDA to hold public accessible hearings based on the balance of this new information prior to approving the proposed rule and draft guidance;
Third, we want a complete moratorium on all shock treatment until these issues are resolved; and
Fourth, we want all of the issues publicly asserted in this complaint addressed.
Please sign the petition and add your support to our growing strength! Join the 1,365+ people who have said #FDAStopTheShockDevice:
When leaving a comment on federalregister.gov about the FDA’s Proposed Rule, make sure to include the following:
This comment is in relation to:
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 to leave a comment on regulations.gov about the FDA’s “guidance document,” please include:
This comment is in relation to:
Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff”
You can read my previous blogs about the FDA’s 2015/2016 attempts at down-classification of the shock device here:
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iii Guidelines on Article 14 can be found at http://www.ohchr.org/Documents/HRBodies/CRPD/GC/GuidelinesArticle14.doc See also Committee on the Rights of Persons with Disabilities, General Comment No. 1 on Article 12, Equal recognition before the law, UN Doc. No. CRPC/C/GC/1, 19 May 2014, para 42 (“States parties must abolish policies and legislative provisions that allow or perpetrate forced treatment, as it is an ongoing violation found in mental health laws across the globe, despite empirical evidence indicating its lack of effectiveness and the views of people using mental health systems who have experienced deep pain and trauma as a result of forced treatment.”) http://tbinternet.ohchr.org/_layouts/treatybodyexternal/Download.aspx?symbolno=CRPD/C/GC/1
iv UN Doc. No. CRPD/C/DNK/CO/1, 30 Oct 2014 http://tbinternet.ohchr.org/_layouts/treatybodyexternal/Download.aspx?symbolno=CRPD%2fC%2fDNK%2fCO%2f1&Lang=en
v UN Doc. No. CRPD/C/SWE/CO/1, 12 May 2014. http://tbinternet.ohchr.org/_layouts/treatybodyexternal/Download.aspx?symbolno=CRPD%2fC%2fSWE%2fCO%2f1&Lang=en
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