Join psychiatric survivors, our allies, and members of MindFreedom International. Our next call is on February 3, 2016 at 2PM eastern time, 1 pm central time, 11 am pacific time, 12 pm mountain time.
Call: 1-605-475-2090 pin code: 873270
Notes from January 27, 2016
Texas now added to the list of states participating in the calls. (California; Colorado; Idaho; Illinois; Kansas; Massachusetts, Michigan; Minnesota; New Hampshire; New Jersey; New York; Vermont; Virginia; and Washington, D.C. .)
A Related Note:
The call started with a reminder that downgrading the shock device to a Class II device is just one part of a larger plan that the government has to have individuals used as guinea pigs, and there was another plea made that people pay attention to the Brain Initiative. Nanotech is big money and there are clear private/public partnerships formed. There is an interest of those involved in the Brain Initiative to have the shock device declared safe. Links to info on the Brain Initiative:
https://www.whitehouse.gov/blog/2015/02/13/investing-research-help-unlock-mysteries-brain
To keep in mind when recruiting support to oppose down-classification from people who have had shock treatment:
“If the shock was voluntary: for one to pull back from what one asks for—to come to terms that what one asked for is another to destroy one’s brain—to face up to that one didn’t say no, and so one couldn’t say no, because of asking for it–one grieves. To turn back and say one was wrong – in some ways it is comparable to having it forced – when you know the response to any complaint will be, “Well you volunteered, didn’t you?”
and
“When someone is suicidal for a long time and experiences so much pain and suffering, one can feel one needs something to get out of the ‘state’. The more drugs they give you, the more drugged and desperate people become. Psychiatry needs to not be seen as the profession to go to for assistance. Psychiatry just gives you drugs and shock. The powers make it tantalizing for one in that position to say, ‘Zap my brain and this will all be over’. There need to be alternatives.”
and most importantly:
“Drug treatments, per se, is justified based on the idea that there is a biochemical imbalance without evidence for said imbalance. Second, we need to keep upfront the whole ideas of drugs, in regard to lack of safety and effectiveness.”
The Focus of the Call
The focus of this call was to start to bring together information for a template that people can submit to the FDA concerning the downgrading of the shock device to a Class II device.
The FDA specifically wrote in the proposed rule:
“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).
While there is general agreement that we should not just be responding to the FDA call for comments on “treatment resistant” and “require rapid response”, and general agreement we should be launching a national campaign against the downgrading of the shock device, there is also general agreement that we should respond to what the FDA has requested. Therefore, our conversation focused on what do we want to say concerning “Treatment-Resistant” and “Requires Rapid Response”.
Following is NOT the template we are suggesting for a national campaign. The notes below only represents information gathered on the call. We are still in the process of putting together the template.
If you have something to add, please contact Celia Brown or Lauren Tenney and we will add information.
Our next call is on February 3, 2016 at 2PM eastern time, 1 pm central time, 11 am pacific time, 12 pm mountain time.
Call: 1-605-475-2090 pin code: 873270.
The Term “Treatment-Resistant”
At the start, part of the response to the term “treatment-resistant” must include that this concept existing as criteria for being subjected to the shock device legitimizes the fraud of the psychiatric industry. This is addressed further on in the notes, but the whole concept of “treatment-resistant” based on the lack of evidence of “disease” is crucial to remember, and will be part of the template we put forth.
Early on in the call it as established that many of us have been labeled “Treatment-Resistant” and there was an immediate caution to not necessarily confuse “treatment-resistant” as non-compliance. This, was pointed out, is a separate discussion. The type of “treatment-resistance” the FDA is referring to does not have a definitive definition, but does include the idea that someone repeatedly being subjected to different drugs and not responding to them in a way that those distributing the drugs marks as acceptable.
As there were people on the call who experienced being assigned this label of “treatment-resistant” we want people to see this as a “class” of people that the FDA is creating – and most specifically those assigned:
“major depressive disorder (MDD) or bipolar disorder (BPD) 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”. (FDA, 2015, p. 81223)
There was at least one person on the call who had formally been a human subject where the requirement for enrollment was being “treatment resistant”. This person said:
“I am in class of people they are targeting, I have been in a human subject trial for people they think are ‘treatment resistant’”.
This idea of “treatment-resistant” that the FDA refers to is not about people who are not compliant with psychiatric orders. That is in part what the term “requires rapid response” is about. Rather, ‘treatment-resistance’ is about people who are not getting ‘better’ from ‘depression’.
This ‘treatment-resistance’ is about whether ‘treatment’ (read: drugs) ‘helped’. This one study that the person on the call was a subject of, shared that the bar at which one can be thought to be “treatment resistant” was a person had to have 5 ‘failures’ on ‘antidepressants’ of different and similar classes.
To psychiatry, if a person does not respond very well to a variety of different drugs – the disorder – the ‘depression’ was considered “treatment-resistant”.
It was quickly argued that while there is no standard for what “treatment-resistant” can be there is a standard at that is the level of nuisance one is to those in psychiatric power.
If you are a nuisance the institution you are deemed “treatment-resistant”. Another person on the call offered:
“It had nothing to do with me or how I felt”.
Also underscored was the idea of where one is in one’s life course has implications for how one feels. There may be extenuating circumstances which may explain why one is not “responding” well enough for the psychiatric workers.
“If people have other extenuating circumstances, if people do not have others to go to for support for example, family, you get shocked”.
It was concluded that there is no definition of “treatment-resistance” and therefore, the term “treatment-resistant” ought not be considered guidance for the shock device to be qualified as a “safe” or “effective”. We do not think a definition for “treatment resistance” ought to be created. We are opposed to the concept of “treatment-resistant”.
The FDA ought to realize that since there is no standard accepted definition of “treatment-resistant” it could me someone “fails” 2, or 5, or antidepressant plus antipsychotic—or whatever determination the psychiatric evaluator makes of the person. The individual psychiatrist is who defines it – this is one of the problems of psychiatry. When these decisions are left up to individual practitioners to determine what is “treatment-resistant” a wide swath of people can now more easily be dragged into this class, who would now qualify for shock treatment and all of the body and brain damage that it causes.
There is a concern that the FDA is asking for input about whether “treatment-resistant” provides enough guidance because they know that there is no standard. We should be cautioned that what the FDA is asking can become input for setting the standard.
So here, we re-affirmed our goal: that we are opposed to the down-classification of the shock device to a Class II device.
A discussion (which toward the end we realized still ended in confusion) was also had about what exactly it is the FDA is wanting to do, so here, I hope to clarify my understanding of the situation:
In short, the FDA wants to downclassify the shock device from a Class III device to a Class II device, requiring special controls, but ultimately calling it safe an effective, specifically for people who are 18 or over, have a “major depressive disorder who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition”. This rule has the intention of keeping the shock device a Class III device for use on people assigned other psychiatric labels.
One possible outcome—if we really rally people to respond to the FDA—is the shock device being taken off the market (FDA, 2015, p. 81225). However, before that can happen, we need to explain why these concepts of “treatment-resistant” and “require rapid response” conceptually illegitimate.
Discussion on the call included the idea that there was no reason to suggest people were treatment resistant. We weren’t “treatment-resistant”. It’s diabolical. Their drugs failing us doesn’t get them any retribution—there was agreement on the call that “the drugs ‘failing’ gets us further punished”.
The template must include the idea that there is no definition of “treatment-resistant”. No one believes a definition for “treatment-resistant” should be created. What needs to be spotlighted is how arbitrary psychiatry is.
It is completely up to the individual psychiatrist to determine that – if someone is “treatment-resistant”. This can vary even within the practice of a particular psychiatrist –and to your psychiatrist if you are “treatment-resistant” this new administrative order means you are going to get shock.
Depending on your insurance and economic situation—if you are in any institution, you don’t have the ability to make daily life choices—you certainly don’t have the choice as to who the psychiatrist is. So if you have a psychiatrist who insists you have this ‘disease’ that s/he cannot prove exists, and determines that the way you answer questions on some pre-determined scale will reflect your “improvement” or “resistance”, and you are not answering in a way that pleases the psychiatrist, you are now qualified for brain-damaging shock treatment.
The FDA would be putting people in harms way if they allowed the idea of “treatment-resistant” to be guidance for calling brain-damaging shock treatment supposed benefits that may last for less than 3 months outweighing the long list of risks and known outcomes of shock treatment. If it is the same psychiatrist diagnosing and saying resistant –and shocking—A psychiatrist may not even have to document the supposed “treatment-resistant” under this administrative order.
The power that exists in that kind of a situation is outrageous. A “doctor” gives you two different drugs, says you aren’t improving, and gives you shock. The entire concept is fraudulent.
In terms of responding to the idea of “treatment-resistant”, the main thing is just to challenge the whole concept of “treatment-resistant” as based on a whole set of false premises that psychiatry promotes.
As noted at the beginning of these notes, it is important to say this upfront. Drug treatments, per se, is justified based on the idea that there is a biochemical imbalance without evidence for said imbalance.
Second, we need to keep upfront the whole ideas of drugs, in regard to lack of safety and effectiveness. The lack of safety and effectiveness of the drugs they are using as the bar for treatment offered is clearly demonstrated in the scientific and mainstream literature (DECIDE ON REFERENCES HERE). There is also evidential information that counteracts anything that they say defining drug resistance (DECIDE ON REFERENCES HERE).
Some of these drugs given to alleviate “depression” actually exacerbate “depression”. The iatrogenic effects are well documented. The research on the drugs is clear: they’re not better than placebo.
If we are starting from a point of where half of the people involved with drugs are now “treatment-resistant” because they are not getting the “therapeutic effect” of the drug . . . then if this passes, the amount of people who will be subject to shock will dramatically increase.
The whole concept of “treatment-resistant” as a legitimate concept is severely flawed and dangerous. What the FDA needs to own up to is this supposed “treatment resistance” or worsening is not even necessarily a failure of the drugs, but can be a worsening effect as a result of the drugs—because psychiatry is treating a supposed “disease” without any evidence of such as “disease” existing.
Instead of administrative motions to allow shock as a Class II device, the FDA ought to be re-evaluating its approval for these psychiatric drugs.
On the call, it was offered from a psychologist’s point of view that this idea of “treatment-resistant” on top of the illegitimacy of it as a valid concept, also masks the truth that there are many better ways to help people—not just drugs and shock as the only responses to emotional crises. “Treatment-resistant” needs to be taken off the rule.
It was re-affirmed that we cannot get bogged down by this standard.
It was re-affirmed that we are opposed to down-classification of the shock device.
Concerning people being prescribed psychiatric drugs we were also reminded by one person who was subjected to shock that the drugs can be mistakenly given based on an incorrect diagnosis. The example offered was someone who was misdiagnosed with a psychiatric issue when the real issue was medical.
For this person, now assumed to have a “mental illness” being subjected to shock nearly cost one’s life. When the person did not experience relief of what were actually medical symptoms, the ‘doctor’ overprescribed drugs, rapidly changed from one drug to another and eventually added benzos. This person described that she couldn’t stand or walk a straight line, she was like a zombie. It was declared that she was “treatment-resistant” then given shock. She urged:
“Enough about this madness. This is not right. I literally crawled on floor for two years”.
The drugs were wrongly prescribed. Treatment-resistant” is fraudulent concept when so many people are being misdiagnosed with a psychiatric label and undiagnosed with an actual medical condition. This person explained how the shock that she was subjected to because of being “treatment-resistant” had negative consequences on her overall health and qualify of life. Her heart, vision, balance, work now, for many years unable to do what she was able to do before the shock. The iatrogenic effects of shock are horrendous.
“Shock needs to be eradicated. The FDA needs to understand there may also be underlying physical conditions that are assumed to be “mental illness”.
Also discussed on the call was, how insurance companies and their hospitalists who track data such as numbers of admissions a person has per year, length of admission, and so on, are going to play a role in now determining who is “treatment-resistant”. It is important for the FDA to take into account the measures that are used to determine “treatment-resistance” such as length of stay or frequency of admissions might have zero to do with what a person is actually experiencing. It is ialso important to realize this in some ways strengthens the psychiatric industry as another type of position (i.e. “hospitialist”) is created.
Equally important—these type of data being tracked may have the same final number, but the trajectory for getting there is arbitrary. People are kept and discharged from institutions for a variety of arbitrary reasons including the weather, holiday schedules, having no place to go, or mistakes in paperwork. While these issues hold you in the institution longer, if someone is just counting days and not paying attention to why one is institutionalized (obviously a problem in itself), it might make someone look “treatment-resistant”. That is the beauty of the term in the eyes of psychiatry—nearly anything can come under the phrase, if packaged well enough.
People discussed horrible stories about shock treatment. The FDA must address the truth. Brain- and body-damaging effects of shock does not differentiate by diagnosis. Because someone has been declared “treatment-resistant” does not mean they are now immune to the risks and known consequences of shock treatment. The shock does not do less damage based on some fraudulent label that has been applied to a person. Despite what the FDA suggests as the requirement for the shock device to be labeled with known risks and consequences of shock, the damage caused by the shock device is not mitigated by labeling the device.
Requires Rapid Response
There is a concern that shock treatment may be delivered in a psychiatric emergency room as a first line treatment if someone is seen as “requiring a rapid response”.
On the call there was an outright rejection and total opposition to the idea that there was any kind of “crisis” that would “require rapid response” of shock treatment.
There was also total opposition to the idea that the FDA could craft some kind of statement that would provide guidance on what that definition would look like. .
It was discussed that “psychiatric emergencies” as a concept is a problem and there were issues with any potential crises people may have being put into the hands of psychiatry as an authoritative body for oversight of the human population.
There was a clear objection to suggesting to the FDA that any chemical response to a perceived psychiatric emergency given as an alternative to shock treatment was acceptable.
No chemical or electrical response to any perceived supposed crisis will be supported in the template letter to the FDA.
The reality of “requires rapid response” was then addressed. It is someone who is seen as hanging around on a ward or not being allowed to leave an institution. They are told shock is the only option left.
On the call it was clear: it is the institution’s need for “rapid response” not our need for rapid response.
There is no immediate need for shock, ever, period. It is the institution that has an immediate need to get the patient off the floor.
Suicide is not the emergency. The person’s insurance running out is the emergency. This is the problem for the private institution. Get the person shock in a hurry and get the person put into a state institution. The person causes embarrassment for the institution and resolving the embarrassment is the emergency.
Also, whenever we are talking about suicide, we ought to remember that ‘suicidal’ is a very broad term.
Most important, when talking about suicide, it is urgent to remember that people are drugged and the drugs literally made them that way.
Even if they see a supposed need for a rapid response (which there is not), it does not make shock a safe device.
What is the emergency – someone not eating for 2 or 3 days because they decided to fast? Those things that fall under the category of emergency are hardly emergencies at all.
Point to the claim of shock as a means toward reduction of suicide and point to shock actually causing suicide (Burstow, 2015; Other References?).
We should oppose the FDA being able to declare what qualifies as an emergency.
Also, even if someone is on on the verge of death and that is the emergency, a careful, thoughtful, researchable response—not a rapid response—is what is required—if a response is even being sought out at all.
Further, a course of shock treatment is not a one-time event, so what kind of emergency is there that requires weeks if not months to fulfill?
There is a political underpinning to what situations “require rapid response”. This is often for the doctor or institution to save face for embarrassment the institution experiences when people do not act the way the institution prescribes. People become so compliant after shock. They are no longer causing a problem for the image of the institution, no longer an embarrassment to the methods of the institution.
The idea that there is a medical or psychiatric emergency that require rapid response of shock treatment specifically for people who have a major depressive episode as part of major depressive disorder or bipolar disorder is ludicrous. This is nothing more than a euphemism for forced psychiatry. You are in an emergency, you do not know better, psychiatry knows what is best for you, so, it’s okay, we are going to do this to you, regardless of what you think.
Does pregnancy constitute a medical emergency?
What is the FDA’s position on the use of shock treatment on pregnant women?
Other Issues Addressed
Continued work on national campaign and meme development.
Possible inclusion for campaign and template:
Get the FDA to End Direct-to-Consumer Advertising of Shock Treatment. Hold the industry legally responsible for false advertising.
With greater frequency, local hospitals are promoting shock as a treatment. Shock is being advertised to people who are outpatients, people who are living in the community, advertising to people in our homes. The advertising and use of shock treatmentis not limited to people who are institutions – which was bad enough. Eliminating advertising of shock treatment is urgently important.
The (re)newed trend of advertising shock as safe and effective—that it’s like a trip to the dentist’s office—that shock treatment is like eyeglasses—with no rebuttal to the advertising must end. This is making false statements in advertising—it is false advertising.
What legal angle can this be approached?
Some questions that should be thought about for what the FDA could instead be doing include:
What are the insurance protocols for alternatives to be offered prior to shock treatment—and true alternatives?
What is the current protocol as the person who is being subjected to shock been given adequate information and a variety of alternative choices to make an informed decision about whether they will undergo shock treatment?
Has the person, prior to being given shock treatment, met with an independent external advocate? Has the person spoken directly with someone who has had a negative experience with shock treatment?
Is there an outside social worker or peer advocate who can help formulate an alternative?
There was general agreement and no objection that one thing people who are faced with psychiatry ought to do is get away from psychiatry.
We are a population that is thought to be in need of control. There is a general belief that we do not have any idea of what’s good for us–this is what allows supposed medical people argue for coursing electricity through the brain of another human being.
We have evidence that the shock device ought to remain a Class III device and ultimately be taken off of the market as a “medical” device.
There is testimony from previous hearings, decades of historical evidence of attempts on the part of the FDA, manufacturers of the device, and psychiatric industries to call shock treatment safe and effective denied.
Since this “administrative” decision reverses all previous rulings, there ought to be hearings.
We have an opportunity to respond. We should respond. They need to hear from us, regardless of what happens. Even if they reject us out of hand, we will have responded and will continue to move to repeal and administrative decisions.
We continue to seek the input from others and lawyers who may want to take on such endeavors.
TASKS:
Decide on references for template.
Other work, on-going.
Our next call is on February 3, 2016 at 2PM eastern time, 1 pm central time, 11 am pacific time, 12 pm mountain time.
Call: 1-605-475-2090 pin code: 873270
Please see previous calls’ notes:
January 20, 2016 Notes
https://talkwithtenney.wordpress.com/stop-shock-national-call-notes-january-20-2016/
January 13, 2016 Notes
Links
Shock Device Safe As Eyeglasses? 89 Days to Say No (This is me, Lauren Tenney) http://www.madinamerica.com/2015/12/shock-device-safe-as-eyeglasses-89-days-to-say-no/
Referneces included in my MIA article if you want to go from here direct:
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.
iii FDA Testimony 2011 Retrieved on December 28, 2015 from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM247594.pdf.%20Accessed%20December%203http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevicesAdvisoryCommittee/neurologicalDevicesPanel/UCM247594.pdf.%20Accessed%20December%203
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 fromhttp://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-adcom/documents/document/ucm265252.pdf
viii Roster of FDA Panel in 2015 Retrieved on December 28, 2015 fromhttp://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm124535.htm
ix Talk with Tenney: Tell the FDA No to Reclassifying the Shock Device
x Talk with Tenney: Special Reading of Shock FDA Reclassification Documenthttp://www.blogtalkradio.com/talkwithtenney/2015/12/29/talk-with-tenney-special-reading-of-shock-fda-reclassification-document
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Our next call is on February 3, 2016 at 2PM eastern time, 1 pm central time, 11 am pacific time, 12 pm mountain time.
Call: 1-605-475-2090 pin code: 873270
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