WASHINGTON, Aug. 25, 2016 /PRNewswire/ -- In December 2015, the FDA issued a proposed order to down-classify the device used to deliver electroshock therapy. Today, Attorney Jonathan Emord filed a Citizens Petition with the FDA on behalf of 5 individuals who were damaged by electroshock.
"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 treatment'." ECT survivor, shocked as a teenager
Most people surveyed thought electroshock therapy, also called electroconvulsive therapy or ECT, did go the way of lobotomies. In fact, a conservative estimate is that over 100,000 individuals receive electroshock therapy each year in the U.S. Actual numbers are not available because there is no tracking of this.
The ECT procedure involves shooting up to 450 volts of electricity through the brain, intentionally causing a massive seizure. According to the FDA, electroshock therapy can cause cognitive impairment, memory impairment, prolonged seizures, dental trauma, manic symptoms, pulmonary complications, worsening of psychiatric symptoms, and death.
The ECT devices have never gone through standard clinical trials to establish safety and efficacy. The FDA has requested studies a number of times and the manufacturers have ignored them an equal number of times. The FDA has neglected to follow through, failing to take action to protect the public. Instead, the FDA issued the proposed order to reclassify the ECT device to a safer category, in the absence of clinical trial data establishing safety.
According to Emord, the FDA has gone against its own precedents and policies in its handling of the ECT device.
The FDA has reasons to be concerned:
- Emord has defeated the FDA in court more times than any other attorney in American history. He is a preeminent expert on the FDA.
- The Citizens Petition he filed cites numerous violations of the Administrative Procedures Act by the FDA in issuing their proposed rule to reclassify the ECT device to a safer category. The Petition makes a strong case that, in issuing the proposed order, the FDA's actions constitute an "abuse of discretion and arbitrary and capricious agency action".
- The petitioners, on whose behalf this action was taken, have compelling and haunting stories of the damage ECT did to them — dramatic memory loss, clear cognitive damage, lowered IQ, physical damages, and immeasurable emotional damages and want to speak out finally.
"People talk about the memory loss, but what's worse is shock [ECT] destroys your ability to form relationships. You can't trust anybody because you've been betrayed so bad." ECT survivor
Emord's petition exposes step-by-step how the FDA failed to protect patients in its proposed rule.
The FDA admits ECT can cause death, cardiovascular complications, memory loss, and cognitive impairment. The manufacturers admit in written submissions to the FDA that ECT does not provide benefits after the treatment stops. The petition confronts the FDA with these facts and their conclusion that the benefits outweigh the risks. Emord points out the FDA provides no explanation for why a device that can cause death and brain damage has not been required and is not now being required to submit standard clinical trial data to prove safety and efficacy.
For more information contact Dr. Linda Lagemann, who represents the damaged persons.
Contact: Dr. Linda Lagemann 415-640-7343
Email: [email protected]
SOURCE Emord & Associates, P.C.