Notes from 1/13/16 Stop Shock: National Call to Defeat FDA Proposed Rule on Shock Devices

 

Notes from 1/13/16 Stop Shock: National Call to Defeat FDA Proposed Rule on Shock Devices

Present: Shock Survivors; Psychiatric Survivors; Allies; MindFreedom Members

 

Known States Represented: California; Colorado; Idaho; Illinois; Kansas; Massachusetts, Michigan; Minnesota; New Jersey; New York; and Vermont.

 

 

Background: There is a long history of the FDA attempting to classify the shock device as a Class II device. It was grandfathered into the FDA as a Class III device – meaning it cannot be a Class I or Class II device because it has not been declared safe or effective.

 

Discussion: The call started with a question as to what spurred the FDA into action now. A possible answer:

 

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).

It was agreed that the above statements, in combination with the following statement by the FDA ought to be enough for an injunction:

“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.

Therefore, it was agreed upon the call that we probably can take some legal actions: there should be an injunction against the way the FDA is going about this, not holding a meeting, and attempting to lower the shock device to a class II device, in general. We should find lawyers willing to take it to court.

 

The FDA has the audacity to suggest putting a label on the shock device with the following warnings mitigates the risks of shock treatment. The warnings 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” (FDA, 2015, p. 81227).

The person having shock will not see the warnings. It is ridiculous to think that this information will get to someone. It is offensive that the FDA would do this in the name of protecting people from the many known body-damaging, brain-damaging, and spirit-damaging risks of the shock device. Someone lying on a shock table is not going to see the shock device, let alone be given the time to read its label.

The FDA down grading the shock device from a Class III device to a Class II device is such a huge problem, because in part, people trust doctors. If the shock device is lowered to a Class II device—if people are told by a doctor that the shock device is safe and effective, people will give even more trust to a doctor—especially if they are already in a place where they are desperate for a solution.

We need to have action to stop the FDA from being able to make this drastic move. The public needs to be aware that the FDA is in bed with the shock device manufacturers.

It is important to remember that we are living in a time where the FDA is not trusted in general, by the public. It is the spirit of the times—the general public feels sold out by the government and we ought to be using the FDA’s attempt to downclassify the shock device as an example of them selling out the public.

Shock treatment is an emotional and unpleasant subject for most people—they would rather avoid talking about it. Or, if it is reported that shock “saved” someone’s life – people back off and are not as comfortable being vocal. We need to remind the public of all the people who are dead, or so severely damaged or afraid that they cannot speak out.   We need to get the public to be interested in this—if not because if the FDA is doing this – what else are they doing? We need to reach the public by affirming that yes, this may not ever affect you – but if the FDA is doing this, what else is the FDA doing with this new administrative directive option, that is affecting you?

We are actively seeking allies outside of our own circles. This includes stores like “Natural Foods”, and other movements such as the health freedoms movement as an example. Those involved with the health freedoms movement–such as those diagnosed with cancer who can refuse medical treatment are horrified to hear that there are medical dictates for treatment over objection in psychiatry, because they want to prevent it from ever getting to the realm of cancer treatment. Also we should be reaching out to people involved in alternative health movements in general.

One strategy for showing the public the real results of shock treatment is to create a national campaign of people who were injured by shock who had consented, only to learn that there was not adequate informed consent actually given. And additionally, to turn this into a legal issue, as every state has laws regarding adequate informed consent.

The public ought to realize that medical places are going to have to treat everyone under the Affordable Care Act (although some remain more equal than others). Nonetheless, shock is going to be used as both a cheap alternative to the drugs—and something that the doctors can perform themselves. Something that causes quick damage. Irreparable damage.

There are other movements—such as the Self Advocacy Movement that is successfully calling public attention and outrage to other uses of electricity by psychiatry– such as the electric skin shocks used at the Judge Rottenberg Center. Skin shocks, shock treatment, restraints, seclusion, and forced drugging all can meet the requirements for torture or ill treatment under the United Nations Convention Against Torture. These are other groups we ought to be working with in trying to bring public attention to what the FDA is doing, in terms of its plans of downgrading the shock device.

While shock treatment has been referred to as differing names – we really ought to be calling it shock treatment because that is what the public knows it as. Electroshock, Electroconvulsive Treatment (ECT)—these names were all part of a well-planned public relations ploy of psychiatry to make shock treatment sound more acceptable to the public. Shock treatment is torture and it ought not be allowed to be thought of as a medical treatment, and certainly not a therapy.

Responding to the FDA, gaining public attention, seeking an injunction – these are all immediate strategies to combat the FDA potentially downgrading the shock device. It is also important to get some long-term studies. Longitudinal, or retrospective studies to show exactly what kind of damage shock treatment does to people. Shock treatment diminishes life. It does not help. People do not come back, not because shock treatment is a success, but rather they do not come back because they die. The kind of dementia that happens at the end – this is the real kind of information doctors should have for themselves – and that they have to give to people potentially being sold this fraud. One possible retrospective study could be to track atypical dementia and see how often people diagnosed with atypical dementia also had been subjected to shock treatment.

There remains a large question about why is there no other meeting that is going to be held by the FDA, and why the January 27-28, 2011 meeting is adequate to meet the requirement? None of the panel members who were at the FDA meeting in 2011 (who voted to keep the shock device a Class III device) are currently on the panel.

There is a cautionary here about the use of the shock device on children. Even though the proposed rule specifies adults 18 years and older, we need to remind the public that young children and developing fetuses are getting shock treatment. It is legal in nearly all states to subject a minor to shock treatment. Pregnant women are given shock treatment as a first line treatment, especially if they are on the drugs. Getting other groups involved – including groups like the Children’s Defense Fund – they should be set up to deal with exactly these kinds of issues, and are in a position to inform the public.

We ought to have our eye on the larger agenda . The Brain Initiative is an example of this. FDA in part is taking on this downclassification because of the larger agenda – – the Office of Technology – NIMH – all kinds of federal government agencies are involved. The Brain Initiative started in 2013. The FDA is responding to policy and we need to pay attention to policy at the federal level. The Brain Initiative is going to need human guinea pigs. The public needs to be informed of the dangers of shock treatment. Instead of stopping this product from availability on the market as a medical device – the government has invested $400 million in funding. There are larger industry incentives (NAMI etc). People need to be aware that they’re in danger. The Brain Initiative Research Agenda is leading toward a push for Genetics Registry. http://braininitiative.nih.gov/

A national research-based campaign to illustrate that shock treatment is not therapeutic – it’s treatment. This “treatment”, through the psychiatric establishment wrecks families, relationships, adults and children’s lives.

There ought to be a way to get the public to understand the frustration that people who are shock survivors and their allies feel. People have been writing letters for 40 years. There are people who have been trying to get publics attention for over 40 years and there’s a lot of people that don’t know electroconvulsive treatment – shock treatment – ECT – people don’t know shock treatment is being done over objection, without informed consent. They don’t know shock treatment is done even on children. People have to know this is happening. When you look at other groups who are trying to get public attention and the extremes to which they must go to get even 20 seconds of coverage. We have to act. We need nonviolent direct actions to bring public attention to what’s being done in the psychiatric empire, the medical establishment, the overlords.

There are also other natural allies such as the neurologists and others who voted to downgrade not to downclass the shock device in 2011. Where are they? How can they be reached? What do they think about this move by the FDA to downclass the shock device as they were the people who voted no when the FDA asked for their recommendation?

It was agreed that we absolutely need a national campaign appealing to public, alternative health services and any psychologists/psychiatrists/neurologists/anesthesiologists/etc. who agree with us. Even though it is easy to demonize all people while demonizing psychiatry, we want anyone who agrees with us that the shock device should not be allowed to be downgraded to a class II device to join us in stopping it. There was agreement that the national campaign ought to include mandates for medical people to have some kind of major training in the risks of shock treatment developed by shock survivors and their allies.

Concerning nonviolent, direct actions, the Mental Patients Liberation Alliance will be holding a week of activities in Albany New York the week of July 14, 2016 for the 36th Annual Bastille Day Vigil and Demonstration to Celebrate the Human Spirit and Speak Out Against Psychiatric Oppression. This will take place the week of July 10 – 16. Contact The Alliance at (800) 654-7227 for more information, to support the effort, and get involved in organizing.

When you send your letters to the FDA also send your letter to the FDA to your legislators – Senators, Congressman, etc. When you send the letter, send it certified and request for return confirmation .

People need to be aware that shock causes brain damage. Surviving brain damage can be traumatic to people. Post traumatic stress leads to depression. This is the business model of psychiatry – Munchhausen by Proxy. Psychiatry is creating its own business on our backs.

We should also look at work being done on Traumatic Brain Injury research with veterans.

Shock is torture and ill treatment

Visual representations suggested include making memes.

For a demonstration, psychiatry has long been compared to the inquisition. To grab public attention – a life-size crucifix – with a woman’s body hung on it – an elderly woman’s body, with syringes coming out of arms, and electrical device attached to head.

We should see about renting billboards –and having information about the hazards of shock on them. Shock Treatment always causes brain damage.

Creating shows and posting them on Youtube will also be used as a way to communicate with the public.

On the next call we will continue to discuss strategies and actions.

NEXT CALL:

January 20, 2016 @ 2 PM Eastern, 1 PM Central, Noon Mountain, and 11 AM Pacific

Call in: 1 (605) 475-2090 PIN Code: 873270#

 

If you would like to add to/correct this, please do.

references:

Shock Device Safe As Eyeglasses? 89 Days to Say No

To respond directly to the FDA please visithttps://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