Dear FDA, Docket Number FDA-2010-N-0585

Dear FDA, Docket Number FDA-2010-N-0585

I am compelled to write to urge the FDA to not diminish the dangerousness of the ECT devices by reclassifying the devices to class II. The devices should remain in the class III category as the most dangerous devices. The devices should be scientifically tested in order to determine the true level of danger involved in the use of the devices without regard to the subjective efficacy of the devices or financial implications in classifying the device.

Because the devices have been grandfathered into the FDA’s system that is no reason to accept the devices as safe. It is the FDA’s sole purpose to determine (scientifically) that the devices are safe for public use. Many citizens’ lives have been destroyed and continue to be destroyed because the FDA is not protecting its citizens from the unscrupulous use of this device. It does not matter that some individuals may be helped by the use of the device; it is the FDA’s job to document the safety for all. It is incredible (and corrupt) to think that the FDA would consider reclassifying the ECT device into the same category as condoms as indicated on the FDA’s website as an example of Class II devices.

My family has been severely damaged by the use of this device and to my amazement I have discovered that my government (FDA) has not protected me from the unscrupulous use of the ECT device and in fact has changed the way I view my government. Because of the ECT procedure, I now believe my government is corrupt with our medical system the most corrupt. I will teach my children to beware. I will describe what happened to my family and why I came to have this sad belief.

My husband received the last of 22 ECT treatments in December 2009. His mind has been erased of all life events, emotions, memories, and skills for his entire life up to January 2010. He is 52 years old. We have been married for 26 years and have two children ages, twelve and sixteen. We have both worked as tax auditors for our state government for many years. My husband can no longer work. Up to this day I have been unable to get medical care for his injury. Yes, we have been to neurologists who will not acknowledge the amnesia or other cognitive deficits. Our insurance company has denied a referral to a brain injury facility because we can’t get a diagnosis of brain injury. Psychologist’s can give us no help because they are dumbfounded when they confront our situation. How do you help a family grieve and understand that while their husband and father is standing in front of them, he is no longer here is mind and why? Medical professionals just seem to fade away. I later learned that because my husband’s depression was a recent development and was medication induced, ECT should not have been considered as treatment. But it is too late now to say “oops”; the effects of the brain injury are permanent.

It is like my family is in some alternate reality similar to something you would watch in the movies or on programs like the “The Outer Limits”, “X-Files” or “Startrek”. Our situation is not fiction it is our devastating reality.

I have no affiliation with any of the groups fighting the use of ECT only affiliated by the outrage that the FDA has not protected its citizens by denying the damage done by the ECT devices and continues to allow the ECT device manufactures, the psychiatric community (doctors, nurses, hospitals and other related entities), and FDA officials, to profit and deceive the public to believe that the use of this devise is safe and should be reclassified to a Class II device.

Please do not allow the reclassification of the ECT device and allow the real safety testing of the device to proceed. It does not matter that some feel they are helped by the use of ECT, or that many jobs will be lost if the device cannot be used. If the device causes injury, the FDA should not allow its use. By not testing the device and allowing its use, I hold the FDA accountable for the damage done to my family. Isn’t it your job to protect the citizens from abuses of marketers? I thought that was what the FDA was doing for me. It is shameful.