Posted by YOGI BRONX on April 19, 2009, at 14:25:53
In reply to Re: ECT, posted by fattoush on April 18, 2009, at 8:14:41
The FDA recently banned numerous morphine drugs as well as ALL ECT machines because they were never determined to be safe and effective, having been in existence before the FDA started testing and having been grandfathered heretofore. Manufacturers are to stop manufacturing within sixty days of the order and to stop shipping within ninety days.
What this means to the future of ECT is anyone's guess. I don't know if it means that the existing ECT machines can be used beyond ninety days, (I suspect that the answer, for existing patients, at least, is yes), but what about repairing them when they malfunction?
As a columnist noted, the expense of obtaining FDA approval is likely to dissuade a current manufacturer from continuing production, especially since the safety and effectiveness of ECT IS constantly debated. Then there is the length of the approval process which, even if a manufacturer submits to it, will take years.
The FDA has already backtracked on one of the morphine drugs, a concentrated morphine that is the only drug available to treat terminally ill cancer patients without resorting to painful, or impossible due to physical deterioration, alternative delivery systems. Perhaps it will be compelled to do the same with ECT devices.
[Insert jeremiad here about ham-fisted bureaucrats.]
So, everyone considering ECT now has yet another reason to be anxious about their decision. It may soon be moot.
Personally, I think one resorts to ECT when nothing has worked and one doesn't care about a bad outcome because, if it doesn't work, one can always kill oneself as one had been planning prior to treatment. That is the degree of pain that I think one has to be in to consider the ECT alternative.
I know people for whom it HAS worked and know of people for whom it has worked very well indeed. I would hate to see the FDA remove choice from individuals once more in the name of safety.
Cordially,
YOGI
poster:YOGI BRONX
thread:890415
URL: http://www.dr-bob.org/babble/20090416/msgs/891614.html