90 Days to Tell the FDA No to Down-Classification of Shock Device

 

Are you 18 or older?  Labeled with ‘Major Depressive Episode’ as part of ‘Major Depressive Disorder’ or ‘Bipolar Disorder’? ‘Treatment Resistant’? ‘Require Rapid Response’?

Watch out!

The FDA has a proposed rule under public inspection[1], just for you! During this public inspection period, tell the FDA no to the down-classification of shock devices. Tell the FDA exactly how subjective “treatment resistant” and “require rapid response” are as concepts.

Shock Treatment is a crime against humanity.

At the 2011 hearings, I was privileged to present an analysis of the comments of over 80 people who sent letters of opposition to the FDA via The Opal Project[2].

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 opposition[3] to the down-classification of the shock machine that would render the device 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).

So what the FDA is calling for now is comments on its plan to down-classify the shock device to a class II device.  It is important to note that while they are pushing for it to be a class II device for “major depressive episode” as part of major depressive disorder or bipolar disorder — all of these concepts troubling and unfounded in themselves, this document also allows for the device to continue as a class III device for a variety of other psychiatric labels including schizophrenia, mania, and catatonia (pp. 81230 – 81231).

Concerning an action you can take, 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 seem to be the solution to risks, simply labeling the device as having such risk. Section V of the draft 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 2011 is on the panel now. 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.

There is video[4] of people who were at the 2011 meeting, afterward, discussing how important it was that the panel heard their testimonies, and how their testimonies informed the decisions of the panel.

I read the final published document on the Talk with Tenney Show at 9 AM Eastern, on December 29, 2015[5], which is permanently archived.

On December 30, 2015[6] 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.

We will be distributing more Information about a national response to the FDA. We will be seeing letters of opposition to [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.

We will have only 90 days to respond to Docket No. FDA-2014-N-1210. Comment closes March 28, 2016. One 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, if 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).

More information about the long history of the FDA and Shock Device will be forthcoming.

In 2010, 3,000 responses were generated and sent to the FDA, 80% of which were in opposition to the down-classification of the shock device. Think of how all of our social networks and advocacy reaches have grown in the last five years.

The time is upon us to bombard the FDA with opposition to Docket No. 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.

Get involved — tell the FDA NO to down-classifying the electroshock device.

References

[1] FDA Public Docket for public inspection of proposed rule: https://www.federalregister.gov/articles/2015/12/29/2015-32592/neurological-devices-electroconvulsive-therapy-devices-intended-for-use-in-treating-severe-major

[2] 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

[3] 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

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

[5] Talk with Tenney: Special Reading of Shock FDA Reclassification Document

device http://www.blogtalkradio.com/talkwithtenney/2015/12/29/talk-with-tenney-special-reading-of-shock-fda-reclassification-document

[6] Talk with Tenney: Tell the FDA No to Reclassifying the Shock Device

http://www.blogtalkradio.com/talkwithtenney/2015/12/31/talk-with-tenney-special-tell-the-fda-no-to-reclassifying-the-shock-device

 

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