Attorney Jonathan Emord and his co-counsel Kendrick Moxon have added to their Citizen Petition of August 2016, against the FDA’s Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give “shock-treatment.” The reclassification would make it easier for doctors to give the treatment, which – pointed out by Emord & Associates, P.C – is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo’s Nest.
More recently it was portrayed in the TV series Homeland when given to the star, destroying her memory and intelligence. Memory loss and brain damage are the central issue in the attorneys’ filing, Emord % Associates, says.
For 40 years, the FDA has been responsible to ensure evaluation of the shock devices, which send up to 460 volts through a person’s brain. Although federal law and FDA orders in the 1970s required manufacturers of these devices to prove they were both safe and effective, the FDA never enforced the order. This, according to attorney Moxon, has “allowed millions of persons over decades to be permanently damaged.” He further states, “Rather than enforce the law now, the FDA has proposed to simply change the law by reclassifying the devices, so no proof of safety or effectiveness need ever be provided.”
The original Citizen Petition was filed on behalf of 5 persons damaged by electroshock treatments. It requests that ECT be banned from the market or, at the least, that the Proposed Order be withdrawn as the manufacturers have never done pre-market clinical trials to prove it is a “safe and effective” device. No other treatment in medicine is so subject to objection and protest by patients – so much so that when the reclassification was proposed, thousands of patients, deeming themselves to be victims of the treatment, objected.
Attorney Emord, the specialist against the FDA said: “The FDA has utterly ignored clear-cut evidence of brain damage, memory loss and death resulting from ECT treatments. ECT is barbaric and should be removed from the market.” It is only fair to note that even the manufacturers have stated that a “risk” of the device is brain damage and severe memory loss.
The attorneys claim there are substantial conflicts of interest with ECT device manufacturers and the studies referenced by the FDA to support its proposed “declassification” of ECT devices. Attorney Moxon further says: “The FDA used ‘junk science’ to propose reclassifying ECT machines out of the most dangerous category of all devices, in which it has been classified since 1978. Worse, the FDA ignored contrary studies by researchers who did not have conflicts of interest.”
Image: Youtube: One Flew Over the Cuckoo’s Nest – Shock Therapy Full Scene