ECT - Shock Therapy - Proof of Safety?

Electroconvulsive Therapy or ECT or Shock Treatment has been used to treat mental illness at least since the 1940s though the concept of shocking the brain or body to treat maladies is much much older.  Instead of going the way of bleeding and leeching; however, ECT has been revised.  It is now conducted under more human conditions.

Longtime readers would recall that when I started my weekly newsletters, I was a psychiatric social worker and in fact, worked with people who received ECT.  I did not blog about it of course.  I supported the treatment decisions of patients and their families and I respected the psychiatrists and psychologists with whom I worked.  At the same time - after witnessing the treatment itself (in an hospital room, with anesthesia, muscle relaxants and the monitoring of vitals - electrodes are attached to the head - shock can be unilateral or bilateral and lasts a minute at most) and seeing the affects on mood (it usually worked) and memory (it sometimes impaired it) I went home and made sure that my living will excluded the use of ECT.  I think I may have written that I had to be on the verge of death with no chance of recovery before it could be considered.

ECT is primarily meant for the treatment of severe, resistant and recurring depression.  Some persons who suffer a nihilistic type of depression will think that they are already dead or will die.  They lose touch with reality, are unable to function, and stop eating.  I have written letters to support emergency ECT in such cases noting that without the treatment the patient might require feeding tubes and such to sustain life.

But I do not like ECT.  And I am not comfortable with studies that compare ECT with antidepressants and with nothing and then say it is better.  I was not an emerging scientist when I worked at the hospital - but I am now and the research is flawed.  Where is the study that compares it with exercise, for example? 

Another concern is that ECT as a medical device/treatment was approved under the 1976 FDA legislation that allowed current drugs to stay on the market temporarily.  The new FDA would henceforth require standardized, rigorous clinically controlled trials before deciding on whether to grant approval to any drug or device maker to unleash its product on the people of the USA.  The PMA status or premarket approval - was meant to be a temporary stay - the companies were supposed to submit the safety and efficacy data for after market approval - no one did.

The gig is up.  The FDA has requested this information and a hearing is to be held this month.  Here are links to some FDA documents pertaining to the issue.  This one lists several devices that are being asked to provide information. If you scroll down, you will see what that information must contain.

The agenda for the ECT meeting is as follows:
On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.

And this is the link to PMA policy.

If you or a loved one has had ECT and found it to be helpful then it WAS helpful.  If you are concerned about the treatment for yourself or another, check out the announcement again.  There are means by which the public can comment and of course, follow up to see what information was provided to the FDA on the safety and efficacy and review the subsequent panel recommendations.