The Food and Drug Administration is set to allow for the dramatic expansion of electroshock therapy for patients who have been diagnosed with clinical depression, through reclassification of the devices used to deliver shock treatment, despite the fact that experts and former patients have attested to the damage such treatment causes.
As noted by mental health watchdog organization Citizens Commission on Human Rights International (CCHRI), the FDA began the reclassification process for Electroconvulsive Therapy Devices (ECT) in early January. The change would lower the devices from their current highest-risk Category III classification, “to allow electric shock machines to be utilized in the treatment of specific alleged mental illnesses with less regulatory controls,” the organization noted in an alert.
The change, detailed here at Regulations.gov, is being sought, “despite the federal agency’s admission that the ECT device has not been proven safe and effective,” CCHRI noted further, adding that to date, some 5 million Americans have been given ECT treatments without their manufacturers having been required to submit valid scientific evidence (like clinical trials), that they were safe and effective.
“The proposal has reignited a firestorm that the FDA has colluded with the American Psychiatric Association (APA) to promote a dangerous treatment and protect the fiscal concerns of APA members rather than protect patient lives,” CCHRI reported.
The organization says that the FDA has been dragging its feet on the reclassification since it first made the proposal in 2009 – shortly after President Obama took office – requesting public input.
Further, at a public hearing in January 2011, some 80 percent of respondents, and another 92 group submissions representing more than 6,000 people, were against reclassification, the organization noted.
ECT devices work by sending up to 460 volts of electricity through the brain, with no scientific evidence to back up how the procedure works to reduce a patient’s psychological condition, CCHRI noted. Evidence and patient reports actually state that following ECT treatments patients have complained of memory loss, cardiovascular complications and lasting brain damage. CCHRI says that some patients have even died.
In fact, in 1979 the FDA classified the ECT device as Class III because of its “potential unreasonable risk of illness or injury.”
In January, Medicine.news reported that a bill had been introduced in Congress that would allow the testing of medical devices on patients without prior consent.
The bill, known as the 21st Century Cures Act, “essentially weakens the already weak standards for the approval process of prescription drugs and medical devices, solely benefiting the pharmaceutical industry while placing Americans directly in harm’s way as they unknowingly become guinea pigs,” Medicine.news reported.
Major depressive disorders will worsen
That includes the weakening of standards governing medical devices like ECT, according to Lee Spiller, CCHRI executive director.
“For years, the makers of psychiatric electroshock (ECT) machines have been unable to get their machines moved out of category III (dangerous or experimental) and into category II,” he said – this is the same category as condoms, contact lenses and air purifiers.
CCHRI says that ECT makers have never had to provide a Premarket Approval Application (PMA) with clinical trial results that prove the safety of the devices. In 1990 and again in 2009, the federal government required FDA to either reclassify Class III medical devices or make sure that manufacturers were submitting PMAs as required if they remained at the high-risk classification. But ECT makers have failed to meet this requirement.
Safety testing by manufacturers is largely omitted under the 21st Century Cures Act, Medicine.news reported, adding that drug and device makers “can even gain FDA approval for products based solely on the experience of individuals.”
The FDA’s current proposal would reduce the risk classification of ECT devices for treating “severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition,” the rule change states.
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