The FDA downgraded Electroconvulsive Therapy (ECT) devices from Class III to Class II – meaning their use are now much less regulated. This follows the passing of the 21st Century Cures Act (H.R. 6) which “relaxes scientific standards, virtually guaranteeing insufficiently tested drugs will hit the market only to be recalled after the damage is done“.
At the same time U.S. authorities are also pushing for mandatory mental health screening for all American teenagers, meaning American teens may well be subjected to routine electroshock therapy in the near future.
In a January article, CCHRI, in commenting on the proposed rule change by the FDA, said that officials there sought to make the change “despite the federal agency’s admission that the ECT device has not been proven safe and effective.”
To date, the organization says that 5 million people have been treated with ECT devices, but none of the manufacturers have ever had to submit clinical trial evidence of their effectiveness or attest to their safety.
According to an announcement of the pending rule change from the FDA, the agency is proposing changing the classification of ECT devices “for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) 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.”
But wait! Aren’t these dangerous?
Oddly, the FDA also lists 14 health risks that are associated with ECT devices. The more serious complications and side effects include:
— Death, which could occur due to “reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke,” CCHR reported;
— Cardiovascular complications from convulsion-induced arrhythmias (irregular, and sometimes dangerous, heartbeat patterns), or from a heart attack or hypertension;
— Memory and cognition can be impaired or destroyed, “specifically immediate post-treatment disorientation, anterograde memory impairment and retrograde personal (autobiographical) memory impairment,” said CCHR;
— Device malfunction;
— Physical trauma;
— A worsening of psychiatric conditions.
“One has to wonder, then, why has such a possibly deadly device been allowed for decades to be utilized and never undergone clinical trials for safety and efficacy? Further, from what source will the patient obtain a ‘detailed summary of clinical testing pertinent to the use of the device…?” as required under the new reclassification, CCHR reported. “Clinical testing has never occurred on the devices.”
CCHR maintains in a separate alert that if the change in classification is initiated, it will mean that for some uses, ECT devices will be in the same category as contact lenses and air purification machines.
“Because the FDA does not regulate medical practice, classifying the ECT device as Class II for any ‘disorders’ opens the door to a massive potential for off label use and enforced treatment of involuntarily detained patients and children,” says Jan Eastgate, president of CCHR International.