FDA Reclassification of Electroconvulsive Therapy Devices

A new rule by the Food and Drug Administration (FDA) went into effect on 12/26/2018 that reclassifies certain uses of ECT machines from Class III (high risk) to Class II (moderate risk).

Although the FDA solicited comments regarding the use of ECT, many of which described the harm done by ECT and were against the reclassification of ECT devices, the FDA does not consider such comments to be valid scientific evidence, and basically ignored them.
Contrary to the psychiatric community’s position, the FDA is supposed to recognize “reports of significant human experience with a marketed device” as a form of valid scientific evidence.

The new rule is somewhat complicated, and has some “ifs, ands and buts” that require some explanation. Here is the actual rule:

The FDA reclassifies the electroconvulsive therapy (ECT) device from Class III to Class II for use in treating 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 due to the severity of their psychiatric or medical condition; and requires the filing of a premarket approval (PMA) application or a notice of completion of a product development protocol (PDP) for all other uses of ECT.

Practically speaking, Class III means that a device presents a high risk of illness or injury to the patient and requires a premarket approval or product development protocol. A PMA is documentation which demonstrates the safety and effectiveness of the device before it can be sold and used. A PDP is documentation which demonstrates the clinical evaluation of a device and the development of necessary information for marketing approval; it may not involve actual clinical testing.

Practically speaking, Class II means that a device presents a moderate risk of illness or injury to the patient, and may require special labeling. Powered wheelchairs, x-ray machines and condoms fall under this category. Special labeling for ECT machines includes warnings that “ECT device use may be associated with: Disorientation, confusion, and memory problems” and “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.”

While the FDA acknowledges that the individuals for whom ECT therapy may be prescribed are at significant risk for complications, they are effectively ignoring these complications at the urging of the psychiatric industry, and doing so with a lot of psychobabble and pseudoscience, and the expectation that putting warning labels on the devices is protection enough.

Here are some facts which the FDA does not want you to know

In the forty years that the ECT device manufacturers have had the device on the market they have never conducted a clinical trial to support its safety and efficacy from which they have profited.

The procedure administers up to 460 volts of electricity through the brain causing a grand mal seizure.

Adverse effects from ECT include: irregular heartbeat; heart attack; stroke; cognition and memory impairment [sometimes permanent]; dental or oral trauma and physical trauma; manic symptoms; prolonged seizures; worsening of psychiatric symptoms and death.

Based on a 0.3% death rate found with ECT administered in Texas, an estimated 300 people receiving ECT may die each year in the U.S. and 3,000 worldwide.

Claims that ECT is safe and effective are not supported by clinical science and its use remains a theoretical practice with no conclusive mechanism determined to prove how ECT works. We have repeatedly suggested that psychiatrists stick their finger into an electric wall socket to see how well that works. So far, we have no takers.

ECT is not a cure. There is a high failure (relapse) rate within six months of receiving ECT, requiring more electroshock that creates more damage. Called “continuation” and “maintenance ECT,” antidepressants and/or other psychotropic drugs continue to be administered — the very drugs said to have failed, “requiring” ECT. A person might as well smack their thumb with a hammer, since this will take their mind off their mental troubles with less permanent damage than smacking their brain with electricity. (We’re not actually recommending this! Please do not try this at home!)

We do, however, recommend that a person consult a competent, non-psychiatric medical doctor for a thorough physical examination to determine whether an underlying, undiagnosed and untreated physical problem is causing the mental condition.

Pregnant women are electroshocked as late as their third trimester, despite adverse events that include miscarriage, premature labor, stillbirth, fetal heart problems and malformations.

In some countries children aged six and younger (U.S., Australia, and Canada) are electroshocked, damaging their developing brain and body. Psychiatrists are continually pushing the boundaries on whom they can shock. One of the current efforts is called external Trigeminal Nerve Stimulation (eTNS), where an electric current is sent into the brains of children as young as 7 years old.

A 2017 published review of more than 90 ECT studies since 2009 showed they remain “methodologically flawed” and “Given the well-documented high risk of persistent memory dysfunction, the cost-benefit analysis for ECT remains so poor that its use cannot be scientifically, or ethically, justified.”

In 2005 and again in 2015, the World Health Organization (WHO) warned against electroshocking children, and reported: “In addition to inappropriate use of medication, children with psychosocial disabilities in institutions around the world are subjected to other severe forms of inappropriate treatment such as electroconvulsive therapy (ECT, also known as electric shock therapy). WHO has stated that there are no indications for the use of ECT on minors, and hence this should be prohibited. The United Nations Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment has remarked that ECT without anaesthesia, muscle relaxant or oxygenation amounts to torture. However, monitoring efforts worldwide continue to uncover instances of ECT being administered to children and adolescents.”

The FDA and state and federal legislators must put patient protection above the financial interests of companies that have failed to conduct clinical trials and provide a PMA for 40 years.

Write your state and federal legislators and tell them to ban ECT. For more information go to http://www.cchrstl.org/ect.shtml.

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