GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.
No formal vote was taken, but a majority of members supported keeping ECT devices for most indications as Class III -- the highest-risk category -- in the FDA's regulatory structure for medical devices, an FDA spokeswoman said.
There was one exception, she said. Panel members were divided on whether ECT devices could be reclassified into the moderate-risk Class II for treating catatonia or whether they should stay in Class III for that indication.
ECT devices are already considered Class III, but the FDA has never developed standards for approving new machines with the premarket approval (PMA) process that is supposed to be used for high-risk products. Instead, the agency has cleared new models under the 510(k) process that merely requires manufacturers to demonstrate that the products are "substantially equivalent" to devices already on the market.
In 2009, the Government Accountability Office (GAO) recommended that the 510(k) process not be available for Class III devices. Such devices, the GAO said, should either be reclassified into the less-risky Class II category or else their manufacturers should have to go through the PMA process, which typically requires clinical safety and efficacy testing.
Consequently, the FDA was seeking guidance from its neurological devices advisory panel on whether ECT equipment deserved a lower-risk classification. Earlier in the week, the agency posed a similar question to its cardiology devices committee regarding automated external defibrillators. (Answer: no.)
ECT has been shown to be highly effective for treating acute, severe unipolar and bipolar depression and is also approved for schizophrenia, bipolar mania, schizoaffective and schizophreniform disorders, and catatonia.
On the other hand, the treatment has been controversial almost since it was first introduced in the 1930s. Patients complained of persistent adverse effects such as memory loss and cognitive dysfunction. Although protocols have changed dramatically since then, and adverse event rates in systematic analyses have plummeted, the complaints have not gone away completely.
Advocacy groups opposed to ECT urged the FDA not to reclassify the devices out of Class III. A briefing document prepared by FDA staff included a long list of known risks associated with ECT, ranging from skin burns and oral fractures to stroke and death.
The agency is not required to follow the advice of its advisory committees, but it usually does.
One middle-ground option available to the FDA is to reclassify the devices as Class II, but require so-called special controls, such as restrictions on which physicians may apply ECT, or more detailed instructions on how the devices should be used.
TESTIMONY BEFORE THE NEUROLOGICAL DEVICES PANEL OF THE MEDICAL
DEVICES ADVISORY COMMITTEE
DOROTHY WASHBURN DUNDAS
I have been waiting 50 years to give this testimony before those of you who have the power to make a humane difference. When I was 19 years old, I became sad and lonely and tried to kill myself. I swallowed one-half bottle of Aspirin. My parents took me to the Massachusetts General Hospital, and thus began my three-year hellish odyssey as a prisoner in the horrors of the mental health system.
I was transferred to Baldpate Hospital, diagnosed with schizophrenia and given 50 shock “treatments” against my will - 40 insulin comas and 10 superimposed electroshocks. Very early on the dark winter mornings of 1961, three other teenaged girls and I were awakened, dressed in johnnys, and told to lie flat on our beds which were lined up right next to each other. We were then injected with insulin, and on ten of
those mornings a dark-suited man would walk through the door. He carried all his equipment in a small black suitcase in one hand, this man of death and destruction. He set up his machine behind our heads, one by one. We were curled up beneath our sheets, as though seeking womb-like protection, when they peeled the sheets off of us, forcing us onto our backs, bare and open and vulnerable. I was second in the line-up.
Before being turned, I would often peek out from a small, secret opening in my sheet to see what they were doing to Susan, the first to receive the treatment. I would make myself watch as if it might prepare me in some way. And when she would shake violently all over, I could no longer watch. I would shiver beneath my sheet in fear. And then they would come to me. I can still feel the sticky, cold jelly they put on my temples. My arms and legs were held down. Just before he pushed the shock button, he would ask, “Is everybody ready?” Of course, he was not speaking to me - petrified and stone silent. Each time, I expected I would die. I would wake up with a violent headache and nausea. My mind was blurred. And I permanently lost eight months of my memory for events preceding the shock treatments. I also lost my self-esteem. I had been crushed as flat as a pancake. But I was very, very lucky. On one of those cold, winter mornings exactly fifty years ago my friend Susan never woke up after the shock. She had just turned seventeen. When she died, she became a part of me.
The ECT was a violent and damaging assault on my brain and my very soul. It made me emotionally worse, not better. I became catatonic and desperately in fear for my life.
EFFECTS OF ECT:
-----To this day, I have great trouble staying focused in a conversation, keeping my train of thought.
-----I forever lost the ability to do math in my head. Before that time, I had done very well in school.
-----When I was given an IQ test a few months after the ECT and asked the population of the USA, I answered 1,000. When he asked me to guess again, I answered 2,000. I remember having no idea where to find the answer in my head.
-----For me, in addition to losing my train of thought, the most troubling residual effect, by far, has been the memories of those traumatic mornings, the violent and abusive assaults on my brain.
For far too long there has been a collusion between the FDA, the APA, the AMA, and the companies which manufacture the shock machine. This is big business, and a lot of money is being made by many at the shameful expense of those who have been harmed over the years. To me, informed consent is meaningless. Those of us who have already experienced the ECT are the only truly informed. Right now, this is a human rights issue. And this is a torture issue.
In the end, after three years of hell, it was a kind young doctor, who spoke to me in a gentle voice, who gave me hope. He took me off all medication, expressed horror when hearing of my experience with ECT, and recognized that whatever my original problems had been, they were dwarfed by the magnitude of the subsequent ECT trauma. I am the person I am today because of his compassion and caring 47 years
ago. Quite simply, he believed in me.
I urge you to BAN the use of this dangerous and barbaric machine, and by doing so finally to show the courage and understanding to support the many more humane and holistic approaches to healing emotional pain.
Dorothy Washburn Dundas
15 Moreland Avenue
Newton, MA 02459
Read the entire Mindfreedom report Here
Now, for the unquestionable Pick of the Coverage Litter the Huffington Post has Dr Peter Breggin:
Monday, January 31, 2011
FDA Panel Votes On ECT
Medpage Today has;
FDA Panel: Keep ECT Devices As High Risk