In December, 2018, the FDA published a new controversial rule about the safety status of the electric shock device, heinously moving it out of a class III experimental device status to a class II status with special controls. The labeling of the device was of great concern in the development of the rule. The New York State Office of Mental Health (OMH) is publishing false and misleading advertisements about electric shock services under the guise of educational materials without even acknowledging the Food and Drug Administration (FDA) December, 2018 Rule. However, Section ix of the Rule represents the warning labels that accompany the device as a class II device with special controls and warnings that must accompany the shock device, as advertised to the consumer of the product. As the reseller of the shock device, or its use, the OMH ought to be held to the same mandates for labeling warnings as the manufacturers. OMH diminishes known risks for injury and withholds or obfuscates multiple known injury-causing risks associated with the practice of electric shock. This likely extends to misbranding of the electric shock device under FDA rules.
New York State is not the only entity violating the labeling portion of the rule. It seems a common reality that the guild of psychiatry is also not following the FDA December, 2018 rule.
In the United States, people are legally subject to brain damaging, and soul crushing electric shock treatment, without their full informed consent or choice, via compulsion, or over objection via a court ordered compliance, meaning a judge’s order that a person must comply with psychiatric orders to undergo electric shock treatment.
Based on a Freedom of Information Law (FOIL) request to OMH and an exploration of the FDA rules, I have gained enough information to begin a national campaign for an FDA recall of electric shock devices, using the FDA’s own rules. I have filed an initial complaint of allegations of regulatory misconduct against the OMH with the FDA.
I have filed an initial complaint of allegations of regulatory misconduct with the FDA against the New York State Office of Mental Health, and have a window of time to add information, or begin another complaint. If you are interested in being involved in this effort, please contact me at 516-319-4295, [email protected].
Background: The FDA December, 2018 Electric Shock Device Rule
Despite the efforts of survivors of electric shock, doctors, lawyers, activists, and advocates to create accurate information and resources about the dangers of electric shock as well as won litigation strategies, today, many people are unaware that the practice of electric shock is currently used and deemed a legitimate medical offering, and covered by private health insurance, Medicaid, and Medicare.
Electric shock is an exceptionally controversial psychiatric procedure where an electric current shoots through someone’s brain, through electrodes affixed to the brow and scalp, which often burn during the procedure. The variations in what the procedure is called are based on how the procedure itself is delivered, meaning the way electricity is delivered through wires attached to electrodes at varying voltage levels, on a variety of locations on the head, until the desired seizure the psychiatrist wants to witness is achieved. FDA Part 882, Section 882.5940 Neurological Devices, sets the parameters of the electric shock device, referring to it as a “therapy device”:
including the pulse generator and its stimulation electrodes, used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient’s head.
From the near start of the federal government taking on the role of national regulation of medical devices, the legal class status of the electric shock device that produces the seizure to be sold on the open market, has been a controversial class III experimental device. If you have not yet read the groundbreaking book, Doctors of Deception: What They Don’t Want You to Know About Shock Treatment, by Linda Andre (2009), I urge you to do so.
For decades, people successfully held off the attempts from the FDA down-classifying the shock treatment device. In 1982 there were meetings trying to regulate the device, and then again in 1990, 1995, 2003, 2004, 2009, 2010, 2011, 2016, and then in the final rule, where those who had been lobbying for decades for the device to remain available on the market ingloriously prevailed in December, 2018.
The catalyst of the class change was one goal of the Obama-era FDA 515 Program Initiative to have all of the class III devices that were on the market because they existed prior to the FDA’s medical device regulation program either proven to be safe and effective or taken off the market. Along with other devices that already existed prior to the FDA, ECT had never had to demonstrate safety or efficacy before it was allowed on the market. The 515 Process includes the FDA collecting information about the current situation of each device, convening meetings about the device, issuing a proposed order, reviewing and considering comments on the proposed order, and issuing a final order. Because there was no such thing as an FDA premarket approval (PMA) application process for the electric shock device to prove it was safe and effective for use, it has been on the market without having to prove its efficacy or safety.
The FDA December, 2018 rule also puts everything that is not within the scope of class II with special controls, or anything that is off-label use, as a class III experimental use of the device.
The goal of the 515 Program was to have all class III devices removed from the market, if not proven safe and effective.
The shock device, up until December of 2018, was a class III device because it existed before the FDA’s existence.
In January 2011, along with others who were part of the opposition of the downgrade of the shock machine, including people who survived shock treatment, and doctors who wanted to see these devices taken off the market, on behalf of The Opal Project, I testified at the FDA hearings. The testimony I offered on the device was on behalf of people who were subjects of shock treatment, their family members, friends, and/or medical professionals who opposed the down-classification of the shock device.
It is important that people realize that while the FDA suggests that it took into account public opinion, and the experiences of those adversely effected by electric shock, the report that was used as “new evidence” that helped sway the decision of the down-classification of the device was redacted.
The FDA down-classified the electric shock device, after decades of contentious debate, from a class III experimental device to a class II device with special controls in December, 2018. Currently, and with my objection, on-label use of the electric shock device is:
limited to the treatment of catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients age 13 years and older who are treatment-resistant or who require a rapid response treatment due to the severity of their psychiatric or medical condition.
These diagnoses, such as “major depressive disorder,” of course, are fraudulent. As Dr. Paula Caplan has pointed out, psychiatric diagnosis is “the first cause of everything bad in the mental health system.” The FDA sanctioning and consequential shift of the use of electric shock to “depression” puts more people in America at greater risk for the use of shock treatment than ever before.
Catalyst: The Advertising in the NYS OMH Booklets Violates FDA Rules
Months before the FDA rule was published in December, 2018, in July, 2018, the OMH published booklets on “depression” in English, Spanish, and Russian, and on “bipolar disorder,” advertising the use of brain damaging electric shock treatment for senior citizens, pregnant people, and people with other medical conditions, for whom “medication and/or psychotherapy” did not work. Yes, in 2018, OMH specified pregnancy as a medical condition that might cause conflict for taking psychiatric drugs, and advertised instead for pregnant people and others to consider the use of electric shock treatment.
In some situations, the advertising of shock treatment in the OMH booklets is the antithesis of the spirit and word of the information and warning labeling of the electric shock device.
The FDA website has a section offering an overview of medical devices, that includes guidance for understanding “Device Labeling” that contains a section called “advertising”:
According to an appellate court decision: “Most, if not all advertising, is labeling. The term ‘labeling’ is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising.”
In the FDA’s guide, “Labeling. Regulatory Requirements for Medical Devices,” the FDA, in Section 502(a) under a heading titled: “False or Misleading Labeling,” sums: “the label that remains silent as to certain consequences, may be as deceptive as the label that contains extravagant claims” (p. 4).
The Mental Patients Liberation Alliance has attempted to call attention to New York State’s use of electric shock treatment and to obtain data about the use of shock treatment from OMH for nearly four decades. These two OMH booklets, advertising shock treatment, were motivating factors for initiating the FOIL request.
The English version of the OMH booklet on “depression” includes a heading: “Electroconvulsive Therapy and Other Brain Stimulation Therapies” where the vagus nerve stimulator and repetitive trans-cranial magnetic stimulation (rTMS) are also addressed, both of which are also problematic, and topics for concern.
Ignoring the whole sentiment of the consumer/survivor/ex-patient/peer and rights movements slogan, “I am not a case and I don’t need to be managed,” OMH advertises electric shock treatment:
For cases in which medication and/or psychotherapy does not help relieve a person’s treatment-resistant depression, electroconvulsive therapy (ECT) may be useful. ECT, formerly known as “shock therapy,” once had a bad reputation. But in recent years, it has greatly improved and can provide relief for people with severe depression who have not been able to feel better with other treatments. Before ECT begins, a patient is put under brief anesthesia and given a muscle relaxant. He or she sleeps through the treatment and does not consciously feel the electrical impulses. Within 1 hour after the treatment session, which takes only a few minutes, the patient is awake and alert.
A person typically will undergo ECT several times a week, and often will need to take an antidepressant or other medication along with the ECT treatments. Although some people will need only a few courses of ECT, others may need maintenance ECT—usually once a week at first, then gradually decreasing to monthly treatments. Ongoing NIMH-supported ECT research is aimed at developing personalized maintenance ECT schedules.
ECT may cause some side effects, including confusion, disorientation, and memory loss. Usually these side effects are short-term, but sometimes they can linger.
Newer methods of administering the treatment have reduced the memory loss and other cognitive difficulties associated with ECT. Research has found that after 1 year of ECT treatments, most patients showed no adverse cognitive effects. Nevertheless, patients always provide informed consent before receiving ECT, ensuring that they understand the potential benefits and risks of the treatment.
This following advertising is from the OMH booklet on “Bipolar Disorder,” supporting the use of electric shock treatment when a person is pregnant:
Electro-Convulsive Therapy (ECT): ECT can provide relief for people with severe bipolar disorder who have not been able to recover with other treatments. Sometimes ECT is used for bipolar symptoms when other medical conditions, including pregnancy, make taking medications too risky. ECT may cause some short-term side effects, including confusion, disorientation, and memory loss. People with bipolar disorder should discuss possible benefits and risks of ECT with a qualified health professional.
In the OMH advertising for electric shock treatment, dated months before the FDA rule went into effect, there is no mention of the risks associated with shock, as detailed by the FDA’s December, 2018 rule.
However damaging the rule is in allowing the continued use of electric shock, we minimally ought to be able to hold OMH accountable to the rule the FDA enacted, as the associated risks and known injurious consequences of shock are more realistic than the preferment OMH gave the procedure in the advertising in either booklet.
Section ix of the FDA December, 2018 Rule Down-Classifying the Electric Shock Device
The risks that the FDA mandates be communicated to people concerning the electric shock device take up a significant amount of space. Nonetheless, Section ix of the FDA’s Final Rule ought to be printed in full in all materials that the New York State Office of Mental Health or any arm of organized psychiatry prepares, or utilizes, concerning the practice of electric shock treatment. I include this information so you can hold it against the OMH advertising printed above. Section ix details what information must be included in “patient labeling” of the electric shock device:
(ix) Patient labeling must be provided and include:
(A) Relevant contraindications, warnings, precautions;
(B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(C) Information on how the device operates and the typical course of treatment;
(D) The potential benefits;
(E) Alternative treatments;
(F) The following statement, prominently placed: “Warning: ECT device use may be associated with:
Disorientation, confusion, and memory problems”;
(G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated”; and
(H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply:
(1) ECT treatment may be associated with disorientation, confusion and memory loss, including short-term (anterograde) and long-term (autobiographical) memory loss following treatment. Based on the majority of clinical evidence, these side effects tend to go away within a few days to a few months after the last treatment with ECT. Although the incidence of permanent cognitive memory loss was not supported by the clinical literature, some patients have reported a permanent loss of memories of personal life events (i.e., autobiographical memory);
(2) Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for; and
(3) The physical risks of ECT may include the following (in order of frequency of occurrence):
(i) Pain/somatic discomfort (including headache, muscle soreness, and nausea);
(ii) Skin burns;
(iii) Physical trauma (including fractures, contusions, injury from falls, dental and oral injury);
(iv) Prolonged or delayed onset seizures;
(v) Pulmonary complications (hypoxemia, hypoventilation, aspiration, upper-airway obstruction);
(vi) Cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); and
Why shouldn’t the FDA hold the State of New York to the minimal standards the FDA rule on electric shock devices set, when OMH engages in omission of known risks, misbranding, and false labeling instead of transmission of accurate information concerning the myriad of risks that the electric shock treatment device causes the people who are subjected to its use?
Electric Shock Advertising: Misbranded, Mislabeled, False Representations
The FDA’s own “Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers,” published in 2001, includes two main types of information that device labeling is used for. “Risk/benefit information” is one category, and “instructions for use” is the other category. The scope of “Risk/benefit information” is “information people need to decide to use a device or have it used on them” (p. 6). The FDA suggests, “If you have a Web site, consider placing patient labeling there to help patients get the most up-to-date information” (p. 10). The OMH booklets can be found on the OMH website. The FDA’s December, 2018 Rule on electric shock cannot be found on the OMH website.
Based on the excerpts from the OMH booklets, there are clear examples of issues of misbranding and misleading labeling of the electric shock device, defined by the FDA as, “The failure of the labeling to meet the requirements of the labeling regulations. This includes misleading statements, inadequate directions for use, or the exclusion of warning statements or contraindications” (p. 37), and “false representations” of “unsubstantiated claims of therapeutic value” (p. 4).
Misleading statements such as “ECT, formerly known as ‘shock therapy,’ once had a bad reputation,” in the OMH booklet are an example of “false representations” providing “incorrect, inadequate, or incomplete identification” (p. 4). This type of misleading statement implies that electric shock services being advertised are something substantially different than electric shock services of the past. There is no substantial difference in the procedure; hundreds of volts of electricity course through a person’s brain until they have a grande mal seizure. There are other differences now: during the procedure, a mask of massive sedation and paralysis via anesthesia are utilized. Paralyzing the body makes it look as if the seizure is not a dramatic torture, but something that barely causes a toe to flutter, fortifying the myth that only through technology produced by EEG/EKG machines can one detect the seizure.
General anesthesia carries an inherent risk of death that becomes more of a gamble when someone is overweight. Many people who receive electric shock are overweight. Weight and dietary issues may or may not have been a problem for some of these people before their contact with psychiatry. SSRIs, commonly prescribed for “depression,” are known to cause rapid weight gain; “antipsychotic” drugs like Zyprexa1 (also prescribed for people with “depression”) also cause weight gain and metabolic problems including diabetes by altering the way people process insulin.
In my estimation, this is a modern form of insulin shock treatment.
Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug.
OMH states, “Before ECT begins, a patient is put under brief anesthesia, and given a muscle relaxant,” as if these two things, anesthesia and muscle relaxants themselves, aren’t things the FDA regulates and full of issues of informed consent because of potential risks to health and life. I think this is an abominable case of misbranding.
Another glaring issue concerning labels, labeling, misbranding, and false representations is when “any required wording is not prominently displayed as compared with other wording on the device, or is not clearly stated” (p. 3). The word “WARNING” never appears in the OMH booklets, nor does a variety of the information that is required under the FDA rule.
OMH violates the principle of honest representation in their booklets, rendering their packaging of electric shock services utilizing the electric shock device misbranded. The degree of value of shock treatment comes under greater suspicion, and shows more damages to memory and less efficacy for “working,” the more it is utilized. FDA clearly states, “A device is misbranded if it is dangerous to health when used in the dosage, or manner, or with the frequency, or duration prescribed, recommended, or suggested in the labeling.”
To make this clear, the FDA oversees that products manufacturers sell to the public meet FDA standards.
In the situation of the public funding of the electric shock device, the manufacturers of the device sell the device not directly to the user of the device for whom the warnings are most applicable, and intended to be communicated, but instead to the State, the purchaser, who then determines where electric shock services will be delivered, and through which institutions the device will be made available.
The state institutions where the devices are planted then give permission for use of the device to a variety of people, in varying medical roles, such as people who are psychiatrists, anesthesiologists, and nurses, and defines payment schedules for the electric shock services to those very same electric shock service providers to use the electric shock device on a “patient,” a person who is either paying with cash, through private insurance, Medicaid, or Medicare.
When the state is the purchaser of the device from the manufacturer, who has to be in compliance with the FDA December, 2018 rule, the State too, ought to be in compliance with the FDA December, 2018 rule. However, based on my searches, nothing addresses this on the (OMH) websites, or in their response to the FOIL request submitted seven months after the publication of the FDA rule.
The advertising for electric shock services through the OMH booklets promoting the use of shock treatment on senior citizens and pregnant people uses federal taxpayer-funded National Institute of Mental Health (NIMH) research as a way to gain authority and support, by leaning on the weight of the NIMH, stating, “Ongoing NIMH-supported ECT research is aimed at developing personalized maintenance ECT schedules.”
The mixing of advertising for electric shock services and research, without even mentioning the required warnings, or an Institutional Review Board, brings up several concerns.
Firstly, people in the “ongoing NIMH-supported ECT research” are at increased risk, as the research would be beyond the scope of class II with special controls use of electric shock. Research would more likely make the practices the OMH is using to garner support for its electric shock services, use of a class III device.
Additionally, the OMH booklets nonchalantly mention anesthesia and other FDA-regulated drugs. Ultimately, the purpose of these sections of the booklets is to sell electric shock services to people, who will be the end users of the electric shock device.
The FDA rule states “a device is misbranded if it has any representation that creates an impression of official approval because of the possession by the firm of an FDA registration.” The use of the phrase, “ongoing NIMH-supported research” creates an official approval, if not specifically by an FDA representation, but specifically by using the power of the federal government in attempting to cast confidence and a positive light on electric shock by citing the National Institute of Mental Health.
Further, under the heading “False or Misleading Labeling,” there was reference to the meaning of “misleading” in the Act: “labeling is deceptive if it is such as to create or lead to a false impression in the mind of the reader” (p. 4).
The connection between the OMH advertising of electric shock services, in conjunction with the concept of federally funded ongoing research, is of grave concern.
FDA states, “A device can be misbranded by reference to an Investigational Device Exemption (IDE) or Premarket Approval (PMA),” positioning these issues right inside the most heated debates of the 515 Program, and a main nerve of the FDA down-classification of the shock device. Offered examples include a variety of criteria that the OMH advertising meets, but particularly, “use of the prefix ’U.S.’ or other similar indication suggesting Government Agency approval or endorsement of the product” (p. 4).
We must not allow public and private organized psychiatry to advertise electric shock treatment without full and complete honesty in their advertising, including acknowledging their materials as advertising. Section ix from the December, 2018 rule must always accompany any advertising for electric shock treatment.
In December, 2018, the FDA published its heinous ruling to allow the electric shock device to remain on the market as a class II device with special controls. If one survives the electric shock and accompanying FDA-regulated drugs, including anesthesia and muscle relaxants, the aftermath of electric shock involves a long list of known deleterious consequences including bodily injury, brain damage, memory loss, damage to recall, and death.
The FDA must hold State-operated psychiatric institutions, indeed all public and private institutions, and any settings of organized psychiatry, accountable in their labeling and advertising of electric shock services.
Do You Recall a Call for a Recall Due to Costs to Recall?
A Google search on “ECT recall” produces hundreds of results. The word “recall” in conjunction with “ECT,” predominately, within the first 10 pages of the search, was in relation to issues of memory loss or memory destruction. Nearly all of the results address the concept of “recall” as it relates to memory and memory loss from shock treatment. Throughout these search results, discussions of the concept of recall include an ability that one has to recall some distant or immediate past moment in time or bit of information they have gathered throughout their life.
Throughout the search returns, the concept of recall is addressed in terms of both long-term memory and short-term memory, questioning shock treatments’ implications involving autobiographical experiences, learned information, and some interwoven conscious experience, and assessment of these experiences. Damage to memory is also discussed in terms of what information was held before electroshock treatment (damage to retrograde memory), and what can be stored and accessed going forward, after the shock (damage to anterograde memory).
Two pages into the Google search for “ECT recall,” there is an advertisement for electric shock treatment performed at Butler Hospital in Rhode Island. Butler Hospital was founded, in part, with earnings from the Brown family’s involvement in the nineteenth century Rhode Island slave trade. The Butler Hospital advertisement names known injurious risks of electric shock treatment as “side effects.” Butler Hospital suggests the two main “side effects” of the electric shock procedure are “memory problems and headaches.” Butler Hospital specifies that, “Memory problems associated with ECT are often temporary and affect short-term recall of recent minor events.” There is no indication of the December, 2018 FDA rule on Butler Hospital’s advertisement of electric shock services.
Ten pages into the Google search on “ECT recall,” I found the FDA’s Final Order concerning the electric shock device. In the FDA December, 2018 rule, the word “recall” appears three times, all in relation to recall as a function of memory, which has been proven to be damaged and destroyed, wiped away, without control or prediction, by the electric shock device.
One main dispute at the FDA hearings in 2011, over whether or not electric shock treatment causes brain damage, was argued at the level of what percentage of loss of one’s autobiographical memory ought to pose too much of a risk for the use of the device? Thirty percent of one’s memory lost or eight percent? Any memory at all lost, is what people who have lived to tell their experiences of electric shock have said.
Five pages into the Google search for “ECT recall,” however, was the piece of information sought: precedence for a recall of electric shock devices. Indeed, there is precedence for a class II Recall by Zimmer Biomet, Inc. of 1,999 units that included an “ECT Internal Fracture Fixation Drill,” initiated on May 22, 2017, posted on September 22, 2017, and terminated on March 29, 2019 by Zimmer Biomet, Inc.
The paradox of the search results is significant. The search for whether there had ever been a recall of the electric shock device returned, nearly in full, examples of significant injurious damages that the electric shock device causes: damage to the function of memory, or recall.
FDA Recall Rules
Recall Activities are detailed in Chapter 7 of the Investigations Operations Manual 2020 of the FDA (p. 7-1). The definition of a recall under the FDA is “a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers, and against which it would initiate legal action (e.g. a seizure).”
Under the FDA definition of a recall, an item in question, if not voluntarily removed from the market by the manufacturer, is seized by the FDA and prohibited from being sold until whatever the recall strategy calls for is met. There are three classes of FDA recalls: classes I, II, and III.
A class I recall presents the most severe risk, “in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death,” the most severe risk.
A class II recall indicates that a product, “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Class III recalls are recalls that the situation or product is “not likely to cause adverse health consequences.”
The recall type is either voluntary, FDA Requested, or “Ordered under Section 508(e) of the FD & C Act [21 U.S.C. 360h (e)].”
The FDA also describes a “recall strategy,” and this sets the parameters of the implementation of the recall. The recall strategy details “the depth of recall, need for public warnings, and extent of effectiveness checks for the recall” (p. 7-1).
The “degree of hazard” is what determines the reach of the recall strategy, and what “level in the distribution chain to which the recall is to extend, i.e., wholesaler, retailer, user/consumer” (pp. 7-1 to 7-2).
We argue for two things: a “class I recall” of all electric shock devices categorized as class III devices under the FDA December, 2018 Rule, and a “significant class II recall” of all newly packaged and labeled class II electric shock devices under the FDA December, 2018 Rule.
Chapter 7, “Recall Activities,” published by the FDA in its Investigations Operations Manual (2020), outlines the specific process for “Complaint and Medical Device Reporting” (MDR) that begins with a check of whether adequate “complaint investigations were performed as required by 21 CFR 820.1982 “Complaint Files.”
According to 21 CFR 820.198, oral complaints to the manufacturing company are to be documented immediately, and written complaints are to be organized by course of action, and documented throughout the lifespan of the response to the complaint.
All complaints undergo evaluation for their merit. If a complaint meets standards of risk established by the FDA, the handler of the complaint is to act and report to the FDA under Chapter 803, Medical Device Reporting the nature of the complaint and steps taken to resolve any issues.
One of the specific criteria reviewed for whether a complaint meets established risk to act on and report the complaint to the FDA is: “Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed.”
The bulk of the issue that seems to persist in practice, as it did in policymaking, is holding States and other entities within organized psychiatry accountable to the labeling on the device. The warning and instruction labels on the device and the device having legal placement on the market were subjects of hot-blooded debates during decades of federally funded FDA investigations.
The decision to drop the Class status of the device from a class III device to a class II device was decided by information that was redacted in the new evidence. It turns out the redacted information was, in at least some situations, testimonials of people who had themselves had electric shock treatment, often with poor or deleterious results. The FDA also eventually issued orders that allowed them to reject responses to the Open Docket for feedback. The FDA posited petitions were “duplicate” if no original content was added.
Why is the information about the risks of known injurious consequences of electric shock, including brain damage, memory loss, and death, that was mandated to be placed on the labeling of the device, not making its way to the general public?
The lack of adequate information about electric shock treatment via advertising of organized psychiatry, sometimes through state-sponsored electric shock services, allows for the public to hold a less than realistic view of electric shock.
Unrealistic and ill-informed views of highly controversial electric shock procedures are dangerous. The FDA must support a campaign that makes the warning labeling of the electric shock device, including a long list of known injurious consequences, accessible to the public.
Within the general public, because of the down-classification of the shock device, there is an increased risk of exposure to electric shock as a treatment because more people are likely being assigned with fraudulent diagnoses of “depression,” or “bipolar disorder,” or as having a “psychiatric emergency,” than people ever would be labeled with “schizophrenia.”
In the twenty-first century, the diagnoses of “depression,” and “bipolar depression” are more common diagnoses than “schizophrenia,” therefore, more people, age 13 years and over, will be at risk for undergoing the electric shock procedure, since the rule approves electric shock for people over 13 years of age with these diagnoses, catatonia, and/or who are experiencing undefined, and surely subjective, psychiatric emergencies.
A Campaign for a Recall of Shock Devices is being developed. Under the recall strategy, it is within the FDA’s responsibility to address the updated warnings about the electric shock device as a public education and “user/consumer” issue.
Where the device is being marketed off-label, there ought to be wide-scale support for a “class I recall” of the electric shock device.
We simultaneously argue if not boldly for a class I recall of class II devices with special controls, a “significant class II recall,” for all class II electric shock devices with special controls.
We also make a demand for an immediate reconsideration of the FDA December, 2018 rule, since the rule was determined with pertinent information redacted.
The redacted information, negative experiences of shock treatment from people who experienced shock treatment, if made known, certainly could sway a thinker to reconsider an earlier position in favor of the down-classification.
The development and implementation of a public education campaign supported by the FDA ought to include mandating the removal of all false and misleading advertising and misbranding. There ought to be mandates that all public and private use of the electric shock device by organized psychiatry adequately reflect the inherent dangers of electric shock treatment. An assessment of public knowledge about the known risks of electric shock ought to be conducted and educational campaigns should remain vigilant until assessments of comprehension of the warnings return a positive rate of accuracy in understanding, by the public, about the severe risks associated with electric shock devices.
An immediate moratorium on the use of electric shock treatment until these issues can be resolved is called for here.
In June 2020, I will be kicking off a new season of Talk with Tenney to help create and coordinate media space for this national effort. The show, Electric Shock Update 2020: Allegations Filed with FDA, will run from 9:00 to 11:00 PM (Eastern Time) on Sunday, May 24, 2020.
If you would like to become a member of the advisory panel to my efforts of orchestrating a national campaign toward the FDA demanding a national recall of electric shock devices, contact me at 516-319-4295, [email protected].
Link to the MindFreedom International campaign, #FDAStopTheShockDevice petition to the FDA on Change.org, with 2,832 people opposing the down-classification of the electric shock device from a class III device to a class II device with special controls found in Docket No. FDA-2014-D-1318 for “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians and FDA Staff: https://www.change.org/p/fda-stop-fda-from-down-classifying-the-shock-device-to-a-class-ii-device-stop-shock-treatment.
Link to March 24, 2016 public letter to the 47-page Memo of Opposition to the FDA Ombudsman Office and Medical Device Ombudsman that was confirmed received on March 25, 2016. The public letter opposed both the down-classification of the electric shock device and the processes of the FDA that led to the down-classification of the device in the published rule. Major issues of concern included that the materials at the FDA hearings utilized to make the new rule included redacted information from the decision-making process. Additionally, we were underscoring the problems of the FDA rejecting signed petitions as duplicate comments. http://www.laurentenney.us/files/113651456.pdf
Link to #FDAStopTheShockDevice on Mad in America, containing multiple articles following and opposing the FDA down-classification processes of the electric shock device. https://www.madinamerica.com/tag/fdastoptheshockdevice/
Thank you to all who have participated in this, through listening to countless versions, and making time and space for me to explore these ideas, including: George Ebert, Kathryn Cascio, Angela M. Cerio, Celia Brown, Jennifer M. Padron, Tracy Puglisi, Ronald Bassman, Rebecca Edens, and to people participating in Surviving Race: The Intersection of Injustice, Disability, and Human Rights, Activism webinars where I explored early versions of this work. Finally, for collaborative supports, reviews, edits, and continuous input in framing, synthesis, syntax, and critical analysis, thank you, Richard J. Hall.
- If you have not read Jim Gottstein’s The Zyprexa Papers (2019) or listened to the audio book yet, do so. https://mindfreedom.org/front-page/the-zyprexa-papers-by-jim-gottstein-now-available/ ↩
- The most updated rule in the Electronic Code of Federal Regulations (e-CFR). ↩