Things are heating up.
If the FDA thought no one was going to notice when they issued their proposed order to reclassify the ECT device (think One Flew Over the Cuckoo’s Nest) to a safer category on December 29, 2015, they just got corrected. In fact, they now have the focused attention of the one attorney they wish didn’t know their name.
Attorney Jonathan Emord holds the record for defeating the FDA in court more times than any other attorney in U.S. history. Yesterday, he filed a Citizens Petition with the FDA over their proposed order to down-classify the device used to deliver electroshock therapy, also called electroconvulsive therapy or ECT. This action was taken on behalf of 5 petitioners who were damaged by ECT.
“I hope this is the beginning of the path to do away with shock [ECT]. Hopefully it’ll go the way of lobotomies, another ‘miracle cure’.” ECT survivor, shocked as a teenager
Jonathan Emord definitely put the FDA on notice.
In the filing, Emord confronts the FDA with some inconvenient facts:
- They themselves admit ECT can cause brain damage and death, and many other severe problems.
- The manufacturers admit, in written submissions to the FDA, that ECT has no benefit once the treatment cycle ends.
- And yet, in issuing the proposed order, the FDA concluded the benefits outweigh the risks.
Wait, say that again. It can cause brain damage and death (permanent) and there are no benefits once treatment stops (so extremely short-term benefits, if any) andthat, according to the FDA, equates to the benefits outweighing the risks.
Significantly, the FDA has never enforced that the ECT device manufacturers submit data from standard clinical trials to prove the safety and efficacy of the electroshock therapy device (click here for more). Well, they are now being held accountable by Emord.
Meanwhile, electroshock therapy is getting a renewed push by those who profit from it and the American Psychiatric Association is urging the FDA to approve it more broadly for use on children.
I’ve heard people puzzle over the extreme rise in the use of psychiatric labels in our society, saying things like: “When I was a kid, we didn’t have ADHD. It was just being a kid to be hyper and not pay attention” or the funny Facebook post I saw “In my day, we didn’t have Oppositional Defiant Disorder. It was called being a brat.”
Well, I remember when up to 450 volts of electricity shot through the brain, causing a massive seizure, would have been called a terrible electrical accident and you would rush the person to the ER. But, today, not because of objective science, but because of persistently repeated authoritative assertions by those who profit, we are expected to override our common sense and think that 450 volts of electricity shot through the brain, inducing a massive seizure, is somehow not what it obviously is ― a trauma to the brain.
Jonathan Emord is not the only one trying to hold the FDA accountable for its handling of this device. The House Oversight and Government Reform committee is asking the FDA for some answers too. (click here and here for more).
Those who have been damaged by ECT now have some good people in their corner. This looks like the beginning of a worthy battle.