Is the FDA Deaf or Just Deceitful about ECT Safety?

    In December, 2018, the FDA reclassified ECT devices from Class III to Class II, but only for treating catatonia, major depressive disorder, or bipolar disorder in treatment resistant patients thirteen or older. If the devices had remained Class III, they would have required premarket approval for their use. However, these now Class II devices that had been in commercial distribution before May, 1976, were not required to be tested for safety or efficiency. The FDA considered their long term use satisfactory “evidence” that they posed no danger.

     This ruling was based mostly on the recommendations of an FDA device classification panel, an advisory committee that reviewed existing clinical trial data, 3400 personal accounts from ECT recipients, reviews of ECT literature, and notes from earlier ECT advisory panels. They concluded there was “valid scientific evidence” for approval of the electrical as a Class II device.

     That FDA ruling was controversial. Many of those earlier ECT trials were, at best, questionable in their scientific rigor as well as lacking in any long term follow-up of memory loss and cognitive decline from ECT. Additionally, more than 1500 letters, joint forms, and individual comments had been submitted to the FDA around 1990 detailing the extreme damage done to ECT recipients. Severe memory loss, cognitive decline, heart problems resulting in loss of jobs, family dissolution, and personal incapacitation were all chronicled in horrifying detail.

     Many of these letters are available to be read on “1990 FDA Dockets” at lifeafterect.org. The final one, from a Dr. Karen Rian, is especially horrifying, but it is also exemplary. Karen says that ECT did get rid of her depression…for three weeks. However, the confusion she experienced immediately after and into the months that followed included “not even knowing what I was, let alone who or where I was…”  She could not even recognize what her vacuum cleaner was. She did not know who people were she should have recognized, she could not drive her car, and she lost the basic skills she had had for performing her work.

     “No one, under any circumstances, should ever be subjected to ECT without his/her fully informed consent,” she wrote. “And if I were faced with the choice today, I would unhesitatingly prefer death to ECT.”

     When she was later told she needed more ECT, she did commit suicide instead. Although her choice for suicide rather than receiving more ECT may have been extreme, the impairments she suffered from ECT were echoed by the majority of the others who communicated their horrific experiences to the FDA. Any one of these testaments to the damage caused by ECT could be considered personal or anecdotal by itself, but the sheer number of similar documentation from does qualify as evidence of significant ECT damage.

     That was more than thirty years ago. The FDA ignored those victims then, and the FDA continues today to ignore the stories of ECT victims…even those from such comprehensive studies as John Read’s last year which chronicled equally severe damage to the lives of hundreds and hundreds of ECT recipients today.

     Why?