The Food and Drug Administration – you know, that friendly government agency that’s supposed to make sure all the products we eat, makeup we wear, drugs we take and medical devices we use are safe for consumption or employ – has been engaged in some curious, quiet re-labeling efforts that could, in a cut-to-the-chase type assessment, leave untold numbers of Americans in states of drooling “One Flew Over the Cuckoo’s Nest” idiocy.
Well, maybe not that horrific – but the stage is nonetheless set for government-sponsored medical harm to some of America’s most vulnerable. What’s up?
What’s up is the FDA’s recent call to reclassify electroshock therapy from Class III, meaning high risk, to Class II, a lower risk. The various classifications translate into regulation; the lower the risk, the less the government control and restriction on medical use. For comparison purposes, there’s this, from the FDA: “Class I devices are deemed to be low risk … for example, dental floss. … Class II devices are higher risk devices than Class I and require greater regulatory controls … For example, condoms. … Class III devices … must typically be approved by FDA before they are marketed. For example, replacement heart valves.”
So shifting ECT devices from Class III to Class II not only takes away much of the FDA’s oversight. But it also relegates the shocking of someone’s mind to about the same danger level as the wearing of a condom. Does that mean the guy in charge of making sure all the condoms sold in America are safe for use will soon be responsible for making sure all the brain-zapping devices for the mentally ill are safe for use, as well?
In the FDA’s defense, the reclassification, which is supported by some in the psychiatric and medical communities, is aimed at delivering speedy care to those over the age of 18 experiencing Major Depressive Disorder or Bipolar Disorder and “who are treatment-resistant” or suffering from severe mental conditions, the draft guidance for the proposed action states.
But look at where those treatments are leading.
Jonathan Emord, a constitutional attorney with Emord & Associates, P.C., has filed a citizen’s petition with the FDA on behalf of five individuals whose lives and mental health were damaged by electroshock therapy, and who now want the agency to admit the treatment’s true dangers.
“Petitioner Atze Akkerman was given a round of 10 shock therapy treatments in 2003,” Emord said, in an email. “He experienced dramatic memory loss and amnesia … including all memories of his children, his parents and his wife.”
Akkerman had been a professional musician with the Navy Band, but following electroshock therapy had to quit – because he couldn’t recall how to play.
“Petitioner Evelyn Scogin is a resident of Texas who … experienced dramatic memory loss, wiping out, for example, knowledge of friends and family,” Emord wrote. “The shock damaged her ability to walk, resulting in the necessity of using a wheelchair.”
Scogin also reportedly suffered broken teeth during the actual ECT procedure, and wants the treatment banned in America.
But wait; there’s more.
Emord wrote of Dianna Loper Posthauer, who underwent ECT for post-partum depression and as a result, “didn’t know her child, didn’t remember being married or even bearing her child,” and saw her IQ number tumble. Then there’s Kenny Fleischman, a high school honor student with a difficult family situation who, at age 21, was given 30 rounds of ECT and “had to relearn to tie his shoes,” minus 50 IQ points, Emord said. Or, Tony Buonfiglio, a Florida resident who underwent ECT at the age of 16 and shortly after, moved from his regular school classes to special education “because his memory and cognitive abilities were so diminished,” Emord said.
Hey, FDA: What about them?
“ECT involves forcing up to 450 volts of electricity into the brain … over and over again, session after session,” Emord said. “It is barbaric and should be banned.”
Amen. But at the very least, it shouldn’t be deemed worthy of only the same level of regulatory oversight as a condom.
Cheryl Chumley, a writer, speaker and journalist, is the author of the 2016 release, “The Devil in D.C.: Winning Back the Country From the Beast in Washington,” available now on Amazon, and of “Police State USA: How Orwell’s Nightmare Is Becoming Our Reality.” She may be reached at firstname.lastname@example.org or through her blog, cherylchumley.blogspot.com, or at Twitter @ckchumley.
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