Sunday, January 24, 2016

Keep Electroconvulsive Therapy (ECT) Available. Comment Online to FDA

ACTION ALERT. KEEP ELECTROCONVULSIVE THERAPY AVAILABLE. Comment now.
It is a little difficult to explain, but the FDA has to reclassify ECT ("Shock") in order to keep it available. They have to solicit comments on whether people are OK with reclassification and I expect that antipsychiatry will organize submission of comments against it. ECT helps some people who have not been helped by other treatments.
Please submit your comments online. Go to the following link.
Click on the Green Button and COPY AND PASTE the following TWO paragraphs into the form. You have to CUSTOMIZE THE FIRST SENTENCE IN 2nd PARAGRAPH , and you are encouraged to insert your own story and thinking at the end to make it personal. Note that this language I am giving is very specific as to what they are asking and what I suggest we say. Include both of the following paragraphs. The form asks for your name/address but that is not publicly available.
" [Docket No. FDA-2014-N-1210] Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses." 
"As the (INSERT YOUR INTEREST IN ISSUE, ex. “mother of someone with mental illness”) I SUPPORT the reclassification of electronconvulsive therapy devices to a Class II device to treat severe Major Depressive Episode associated with Major Depressive Disorder and Bipolar Disorder in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. The terms "treatment resistant" and the phrase "require rapid response" do provide sufficient clarity to the population for which ECT benefits outweigh risks. I appreciate that in making this reclassification, the FDA is relying on the voice of science, rather than anti-psychiatry. The FDA previously held hearings on the issue in 2011. Reclassification is important. " 
(INSERT YOUR STORY HERE)

2 comments:

  1. Thank you Mr. Jaffe for providing this action alert and how to respond (which I have done) to the Food and Drug Administration on this important issue.

    ReplyDelete
  2. I read that Post and got it fine and informative. reiki brisbane

    ReplyDelete