Re: Docket #FDA 2009-N-0392
The Center for Disability Rights, Inc. (CDR) is a non-profit service and advocacy organization devoted to the full integration, independence and civil rights of people of all ages with all types of disabilities.
With services in 13 counties and offices in Rochester, Corning, Geneva and Albany, CDR represents the concerns of many thousands of people with disabilities.
We are a support and advocacy organization for people with disabilities, including psychiatric disabilities or labels.
Our organization includes those who have received ECT (electroconvulsive therapy) or may be considered for ECT.
We are writing with concerns about the FDA’s regulation of ECT devices, which have never been through a scientific investigation to determine whether they are safe and effective.
We understand that you are finally ready to require that these devices undergo the same scrutiny as all other medical devices, and concerned that pressure from the manufacturers and the psychiatrists who use these devices might sway you to simply declare the devices safe without any safety investigation.
We do not believe the FDA should put the interests of industry before the interests of patients.
It was largely due to the testimony of former patients who experienced severe and permanent amnesia that the FDA classified the ECT device in Class III, the high risk category, in 1979.
At that time the FDA recognized memory loss and brain damage as potential risks of the device.
The Class III designation meant that the ECT device was to undergo the PreMarket Approval (PMA) process to establish safety and efficacy, a process that includes clinical trials.
But that never happened, even as the device was used on hundreds of thousands of patients over the next thirty years.
There is a great deal of evidence in the scientific literature and in the FDA’s own files to suggest that shock machines when used as intended routinely cause permanent amnesia and cognitive disability in a large percentage of patients.
Please carefully review these files again as you make your financial decision, especially Docket #82P-0316.
We know that patients may not be informed about the extent and nature of possible permanent adverse effects, and that ECT is sometimes administered involuntarily, by court order.
Those who are referred for ECT are usually in crisis and extremely vulnerable to persuasion or coercion from medical professionals who may misrepresent or be unaware of the treatment’s true risks.
Under these circumstances it is extremely important for the FDA, the nation’s highest authority on medical matters, to be extremely cautious about designating the ECT device (alone among medical devices) as safe by simply reclassifying it to Class II.
We understand that the device manufacturers have requested that you reclassify simply for their own financial benefit, because they are unwilling to pay the fees associated with the PMA application.
They have not submitted scientific proof that their devices are safe or effective.
There is no justification for reclassification of the ECT device.
If the device is reclassified a scientific safety investigation of these devices will never take place, and patients will not have the information they need to make an informed choice about the treatment.
Please maintain the ECT device in Class III and require the manufacturers to submit PMAs….