The electroshock device, the actual machine that is used to deliver shock treatment (electroconvulsive treatment/ECT), is currently a Class III device as categorized by the Food Drug and Cosmetic Act of 1976. The FD&C Act requires all medical devices to be placed into one of three categories: Class I (general controls); Class II (special controls); and Class III (premarket approval)” (FDA, 2015, p. 81,224i).
Under FDA standards, a medical device is placed into Class III when its risks and benefits have not been assessed to a degree that allows it to be placed into Class I or Class II, and thus there is potential that its risks outweigh its benefits. A Class III device is one that either was in existence prior to 1976 and is therefore referred to as a preamendments device, or if it has come onto the market since 1976 and its manufacturer claims it is similar to a pre-1976 device, it is referred to as a postamendments device.
To help decipher this, I turn to the must-read groundbreaking work of Linda Andre, Doctors of Deception: What They Don’t Want You to Know about Shock Treatment.ii Andre tells the sordid history of the shock device and resulting procedure., crafting a meticulously-detailed account of the horrors of electroshock. Concerning the FDA’s classification system, Andre wrote:
“Class III is the high-risk classification for those devices for which general controls or performance standards are insufficient. The FDA defines Class III devices as those for which ‘benefits have not been shown to outweigh risks’ and which present ‘a potential unreasonable risk of injury or illness’ when used as directed by the manufacturer for their intended purpose. The degree of oversight necessary to ensure maximum safety was known as ‘premarket approval’. The name reflected the fact that even though a device might have been on the market for many years, its status was similar to that of a new device. It hadn’t proven itself to the FDA. Its manufacturers would, when called on by the agency, have to submit a premarket approval application (PMA) in which it would have to prove its safety and efficacy” (p. 139).
As discussed by Andre (2009) and the FDA (2015), over the decades there have been multiple attempts to down-classify the shock device to a Class II device, which would classify the shock device as safe and effective. This would put the shock device in the same category as eyeglasses or wheelchairs—other medical devices that are Class II, requiring “special controls.”
The most recent open comment period and meeting on the shock device was held in Gaithersberg, Maryland, January 27 – 28, 2011. Many people, including Dorothy Dundas, John Breeding, Loretta Wilson, Dan Fisher, and Vince Boehm on behalf of Leonard Roy Frank, testified about the horrors of shock and the immense damage it does to the physical body, mind, and spirit. At the 2011 hearings, I was privileged to stand with shock survivors as an ally, and someone who likely would have been shocked if not for the incredible work of the activists of the 1980s. I presented to the FDA an analysis of the comments of over 80 people, mostly shock survivors, who sent letters of opposition to the FDA via The Opal Projectiii. There is videoiv of people who were at the 2011 meeting, discussing afterward how important it was that the panel heard their testimonies, and how their testimonies informed the decisions of the panel.
According to the FDA (2015), the Neurological and Medical Devices Panel who heard the testimony and were given access to all of the research reached “consensus for recommending the device remain Class III for Schizophrenia, Bipolar manic states, Schizoaffective, and Schizophreniform disorder. The panel did not reach consensus on the classification of ECT for depression (unipolar and bipolar) and catatonia” (p. 81226v).
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 oppositionvi to the down-classification of the shock machine that would classify the device as being 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).
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).
The FDA is calling for comments on its plan to down-classify the shock device to a Class II device. Despite seeing limited evidence for any long-term benefits, the supposed short-term benefit—“(e.g. 3 months)” (p. 81228)—is grounds for this bold move that sets back human rights work.
It is also important to note that while the FDA is proposing this rule for the shock device to be a Class II device for a “major depressive episode” as part of “major depressive disorder” or “bipolar disorder” (all of these concepts troubling and unfounded themselves), this proposed rule also calls for premarket approval for the device to continue as a Class III device for a variety of other psychiatric labels including “schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia” (pp. 81230 – 81231).
Concerning an action you can take to try to stop this dangerous downgrade of the shock device, 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 deem to be the solution to known risks with the device, beyond simply labeling the device as involving such risk. Section V of the FDA 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 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.
One potential 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 regarding whether 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).
As mentioned earlier, in 2010, 3,000 responses were generated and sent to the FDA. 80% of those responses were in opposition to the down-classification of the shock device. I believe the FDA responded to us by largely keeping the shock device as a Class III device. Think of how all of our social networks and advocacy reaches have grown in the last five years! We need to do it again.
The new rules should not allow “limited scientific evidence” (p. 81231) (which will be scrutinized in a future entry) to dictate this move that will inevitably increase the use of shock. No amount of labeling a device can mitigate the actual risk to those subject to the procedure. We need to hold the FDA responsible for such an irresponsible suggestion.
The FDA wants feedback on creating special controls—labeling the device—for those who have a supposed “major depressive episode” and have been labeled with either “major depressive disorder” or “bipolar disorder” and are “treatment-resistant” and “require rapid response” due to the supposed psychiatric or medical condition. Can you imagine how the use of shock will soar if people are falsely informed that the benefits outweigh the risks for this “specified patient population”? (p. 81227)
If you think for two seconds that the phrases “treatment-resistant” and “require rapid response” are not code for coercion or treatment over objection, then perhaps you need to spend some more time with people who identify as psychiatric survivors.
We now have only 89 days to respond. The comment period closes March 28, 2016. To respond directly to the FDA, please visit:
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
During this public inspection period, tell the FDA no to the down-classification of shock devices. Tell the FDA exactly how subjective and damaging the terms “treatment-resistant” and “require rapid response” are, and how they fail as legitimate medical concepts. The known risks of electroshock should not be ignored because one has been psychiatrically labeled.
Shock treatment is a crime against humanity. Psychiatric survivors, shock survivors and their allies have long spoken out against shock treatment. Our speaking-out has mattered. Our silence will matter more. Get involved—tell the FDA NO to down-classifying the electroshock device.
Today, December 30, 2015ix 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. If you would like to be part of the show, please call in at (267)521-0167 and press 1 or *1 to be put in the program to speak out. You can listen to a reading of the final published document on the Talk with Tenney Showx which is permanently archived.
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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 from http://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 from http://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 Document http://www.blogtalkradio.com/talkwithtenney/2015/12/29/talk-with-tenney-special-reading-of-shock-fda-reclassification-document
